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Neopharm Stock Slumps; Cancer Drug Falls Short Of Hopes

Neopharm Inc. shares slumped 75%, to a 52-week low, after the company announced that its experimental drug for brain cancer didn't perform statistically better in a clinical trial than an existing drug.

The stock was trading recently at $1.73, off $4.99 from Friday's close at $6.72. Earlier, the shares fell to $1.68, off $5.04 from Friday's close and surpassing a previous 52-week low of $4.32 set in July.

Volume was 10.4 million shares traded, compared with a daily average of 426,000.

Analysts called the sell-off warranted.

"It's a very fair reaction," said Brean Murray Carret & Co. analyst Jonathan Aschoff, who noted that he had a sell rating on Neopharm shares prior to Monday's development.

Aschoff said he thinks shares of Neopharm, a Waukegan, Ill., pharmaceutical company, are worth "a couple bucks," or a slight premium to the company's cash.

Neopharm's drug - cintredekin besudotox - "did not beat the control" in the study, Aschoff said. "It was slightly better, but no where near statistically so."

ThinkEquity Partners analyst Vinny Jindal said it's unclear what the company will do now.

Jindal described the investor reaction as "largely justified," and he said he plans to listen closely to a Neopharm conference call that's been scheduled for after Monday's market close to see "how (company executives) plan to put Humpty Dumpty back together again."

Drug Pipeline Series: Submissions, Dec 4 - Dec 11, 2006

Theravance, Inc. announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for telavancin, a rapidly bactericidal injectable antibiotic with a unique multifunctional mechanism of action, for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria.

Eli Lilly and Company announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration's Division of Drug Oncology Products (DDOP) for EVISTA® (raloxifene HCl) for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer. EVISTA is currently indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Drug Pipeline Series: Phase III, Dec 4 - Dec 11, 2006

Isotechnika Inc. announced that the Company has enrolled its first patient in a pivotal Phase III European/Canadian clinical trial for the treatment of moderate to severe psoriasis with its lead immunosuppressive drug, ISA247.

Vanda Pharmaceuticals Inc. announced positive top-line results from the company's Phase III clinical trial evaluating iloperidone, an atypical antipsychotic, in patients with schizophrenia.

Drug Pipeline Series: Phase II, Dec 4 - Dec 11, 2006

Helix BioPharma Corp. announced that it has initiated patient enrollment in a Phase II clinical trial of Topical Interferon Alpha-2b for the treatment of ano-genital warts (condylomata accuminata) associated with human papilloma virus ("HPV") infection. The trial, which is taking place in Sweden, will assess the efficacy and safety of Topical Interferon Alpha-2b compared with placebo using a double blind, randomized design over an examination period of four months per patient.

Immtech Pharmaceuticals, Inc. announced that it has initiated a Phase II trial in the U.S. of its oral drug candidate, pafuramidine maleate, as a prophylaxis to prevent malaria infections for travelers to endemic regions. This study protocol was reviewed by the U.S. Food & Drug Administration and has been approved by the Institutional Review Board of a major U.S. medial center. It is estimated that each year 125 million travelers go to countries where malaria is endemic.

MethylGene Inc. , along with its partner Pharmion Corporation announced the initiation of a Phase II clinical trial with its isotype-specific histone deacetylase (HDAC) inhibitor product candidate, MGCD0103, in patients with high-risk myelodysplastic syndromes (MDS) or relapsed or refractory acute myelogenous leukemia (AML). Specific patient populations include elderly patients who have previously untreated disease or adult patients who have relapsed or refractory disease.

Cleveland BioLabs has begun a Phase II efficacy study of Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer.
Curaxin CBLC102 is an oral drug used in the past to treat malaria that demonstrates efficacy in vitro, in animal models and in live tumors removed from patients. Initial test results indicate that CBLC102 can be effective against a number of malignancies, including hormone refractory prostate cancer, renal-cell carcinoma and soft-tissue sarcoma.

Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth and Lundbeck A/S presented clinical study results for bifeprunox at a major medical conference this week. Bifeprunox is an investigational treatment for schizophrenia studied as a once-daily regimen. Results of these efficacy and safety studies showed that, in a six-month trial, bifeprunox maintained stability in patients with stable schizophrenia versus placebo.

EPIX Pharmaceuticals, Inc. announced the initiation of a Phase 2a clinical trial to further evaluate PRX-03140 as monotherapy and in combination with donepezil for the treatment of Alzheimer's disease. This Phase 2a trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once-daily for 14 days in patients with mild Alzheimer's disease who are on a stable dose of donepezil (10 mg). Data from this trial are expected in the second half of 2007.

Inspire Pharmaceuticals, Inc. announced the initiation of a Phase 2 clinical trial to evaluate epinastine nasal spray for the treatment of seasonal allergic rhinitis.
This Phase 2 clinical trial is a 14-day randomized, double-blind comparison of two doses of epinastine nasal spray (0.05% and 0.1%) to placebo in approximately 580 subjects who have a documented history of seasonal allergic rhinitis to mountain cedar pollen.

Drug Pipeline Series, Phase I, 4 Dec - 11 Dec, 2006

Nastech Announces Positive Phase 1 Clinical Results of Insulin Nasal Spray Compared to Exubera® Inhalation Powder and NovoLog(C) Insulin Aspart Injection.

Vernalis plc announced that it has started a Phase I trial of V24343, a CB1 antagonist, as a potential treatment for obesity, type II diabetes and related disorders.

Neose Technologies Presents Positive NE-180 Phase I Clinical Trial Data at American Society of Hematology Annual Meeting, a Novel GlycoPEGylated™ Erythropoietin, Demonstrates Dose-Dependent Activity in a Phase 1, Single Dose, Dose Escalation Study in Normal Human Volunteers". NE-180 is being developed for the treatment of anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

OMRIX Biopharmaceuticals Commences Phase 1 Clinical Trial for Fibrin Patch product for the management and rapid control of bleeding including severe bleeding in surgery.

ArQule, Inc. announced the enrollment and successful dosing of the first patient in a Phase 1 clinical trial with ARQ 171, a second-generation compound generated through its Activated Checkpoint Therapy(SM) (ACT) program. Phase 1 data from this compound, together with Phase 2 data from the ongoing ARQ 501 program, will form the basis of a future licensing decision by Hoffmann-La Roche (Roche).

Merck & Co., Inc. and Vertex Pharmaceuticals Incorporated announced results of a Phase I clinical trial for MK-0457 (also known as VX-680), an investigational small molecule inhibitor of Aurora, FLT-3, JAK-2 and BCR-ABL kinases. The study, conducted at The University of Texas M. D. Anderson Cancer Center and Duke University Medical Center, showed that MK-0457 demonstrated clinical activity in select patients with chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL) with the T315I BCR- ABL mutation and also in patients with refractory JAK-2 positive myeloproliferative diseases (MPD).

Novacea, Inc. announced that Phase 1 data of AQ4N (banoxantrone), an investigational anti-cancer prodrug, demonstrated that AQ4N was active and well tolerated when administered to patients with non-Hodgkin's, chronic lymphocytic and Hodgkin's lymphomas.

Dynavax Technologies Corporation announced the initiation of a Phase 1 dose escalation clinical trial of its TLR9 agonist in combination with a standard chemotherapeutic regimen for metastatic colorectal cancer. The enrollment target of the trial is 15 patients, all of whom will have been previously treated for colorectal cancer but had a recurrence of the disease.

Avigen, Inc. announced findings from a Phase I clinical trial for AV650 (tolperisone), an oral therapy intended for the treatment of disabling neuromuscular spasticity and spasm. AV650, a New Chemical Entity (NCE) in the U.S., was found to be well tolerated with no evidence of sedation in this trial.
The Phase I study enrolled 30 healthy adult volunteers at one center in the U.S.

DURECT Corporation announced that it has successfully completed Phase I clinical trials with a new product, DUR-843, which is intended to treat a persistent pain condition. We believe that the persistent pain market remains underserved and that DUR-843 has the potential to provide several advantages over existing pain medications.

Nuvelo Hit As Drug Fails In Trial

Shares of Nuvelo Inc. (NUVO) plummeted 80% to $3.97 before the opening bell Monday after the company and partner Bayer AG (BAY) said a Phase III clinical trial of its blood clot dissolving drug didn't meet its primary endpoint.

The drug, alfimeprase, used for treatment of thrombotic, or clot-related disorders, didn't meet its primary endpoint of avoidance of open vascular surgery within 30 days of treatment in patients with acute peripheral arterial occlusion, known as "leg attack," the company said Monday.

The companies also suspended enrollment in two other Phase III trials.

"While Nuvelo did not say exactly why the trials failed, we believe that it is safe to assume that there was almost nothing encouraging about the results of the trials," Brean Murray says, adding it expects deal with Bayer to dissolve.

Nuvelo and Bayer HealthCare have a global collaboration for the development of alfimeprase, whereby Bayer would bring it to market outside the U.S. and will pay Nuvelo tiered royalties, and Nuvelo retains marketing rights in the U.S.

American Depositary Shares of Bayer had yet to trade.

Shares of travel-booking company Sabre Holdings Corp. (TSG) rose 11% to $31.30 on news reports that the company is up for sale and could be sold to a new buyer as early as this week, at a premium to its $3.75 billion market capitalization.

Private-equity groups were viewed as the most likely purchasers of Sabre, the reports said. Citing people involved in the negotiations, The New York Times said the bidding group favored to win the auction includes Silver Lake Partners and Texas Pacific Group, while a rival bidding group is led by Apollo Group. The people involved in the talks said a third group of investors is also considering a bid, the Times said.

Shares of Biomet Inc. (BMET) rose 4.8% to $41.80 after a newspaper report said British company Smith & Nephew Ltd.(SN.LN) will this week make a GBP5 billion offer for the company, in an attempt to to create the world's fourth-largest orthopedic implants maker.

Biomet in effect put itself up for sale in April when it appointed Morgan Stanley (MS) to advise on strategic options, The Independent, a U.K. daily, said on its Web site.

Shares of DuPont Co. (DD) rose 0.7% to $47.25, after the company lifted its fourth-quarter outlook. DuPont also said it would close or change manufacturing processes at 10 of its sites and cut about 1,500 jobs worldwide.

DuPont now anticipates 2006 earnings of $3.25 a share, up from a previous outlook of $2.86 a share. The company said it would list additional benefits in the fourth quarter, including about $60 million from insurance payments from asbestos litigation and Hurricane Katrina-related claims and $500 million from tax adjustments.

Analysts polled by Thomson Financial presently forecast 2006 earnings, on average, of $2.88 a share.

Shares of DirectTV Group Inc. (DTV) rose 2.1% in pre-market trading to $24.80, after Deutsche Bank upped its rating on the company to buy, saying the digital television service provider is best positioned to take advantage of high-definition TV and will benefit from becoming part of the Liberty Media Corp. empire.

Shares of Cepheid (CPHD) rose 5.4% to $9.49 after the company received approval from the Food and Drug Administration to market its Smart GBS test for Group B Streptococcus on its SmartCycler platform.

Novartis Drug Tasigna Helps Leukemia Patients

Swiss drugmaker Novartis AG (NVS) said Monday an intermediate stage study showed that its experimental drug Tasigna achieved impressive results in the treatment of blood cancer patients who no longer responded to treatment with its drug Gleevec.

The study showed that 74% of patients in the chronic phase of chronic myeloid leukemia, or CML, a blood cancer, achieved normal white blood cell counts after six months of treatment. Of 279 patients treated, the defective chromosome that causes the disease was significantly reduced in more than half, and was completely eliminated in about a third of these patients.

All these patients had developed resistance to Gleevec, the standard of care for the condition, or didn't tolerate Gleevec.

The study was presented at the American Society of Hematology, or ASH, meeting in Orlando, Florida.

Gleevec, launched five years ago and one of the first of what are known as targeted cancer drugs is Novartis' second-best selling drug with sales of $2.17 billion in 2005. Targeted cancer drugs work by killing cancer cells specifically, or by hindering their proliferation, while traditional chemotherapy often kills deranged and healthy cells alike, leading to troublesome side effects.

Tasigna, known generically as nilotinib, and Gleevec, known generically as imatinib, both work by telling a specific gene to stop producing excessive white blood cells. Tasigna was designed to also work in cases when this gene had mutated. Such mutations can cause resistance to the Gleevec treatment. CML patients usually go through three phases: chronic phase, accelerated phase and blast phase.

In 52% of patients in the chronic phase of CML, the Ph+ chromosome - the genetic abnormality that characterizes most cases of this form of leukemia - was significantly reduced, while in 34% it was undetectable after treatment with Tasigna, Novartis said.

Patients in a more advanced phase of CML also responded to the Tasigna therapy.

Of the 64 patients in the accelerated phase, 59% achieved a normalization of their white blood cell counts, and in 36% the Ph+ chromosome was reduced or eliminated after eight months of treatment.

The study researchers concluded that Tasigna was generally well tolerated. Specifically, the investigators said that the compound wasn't associated with many of the side effects seen with Gleevec, such as fluid retention and superficial edema.

Novartis, based in Basel, Switzerland has recently submitted Tasigna for U.S. and European Union regulatory approval, on the basis of this study. When considering cancer drugs, the regulators sometimes accept earlier phase II studies rather than larger phase III trials that it typically requires most companies to submit with drug-approval applications.

James Shannon, head of drug development at Novartis, said recently that he expects global peak sales of Gleevec and Tasigna combined to exceed $3.5 billion.

David Epstein, who heads Novartis' oncology business told an agency that the company plans to start a trial that directly compares Tasigna to Gleevec in the first half of 2007. Should Tasigna turn out to be more effective, as well as safer, in this trial, it could eventually replace Gleevec as the standard of care for this form of leukemia.

However, both Gleevec and Tasigna will also be competing with Sprycel, or dasatinib, a drug developed by Bristol-Myers Squibb Co. (BMY), which has been launched in both Europe and the U.S. this year.

Tasigna and Sprycel have never been tested against each other, which makes it difficult to compare them, but data so far suggest that the Novartis drug has less unwanted side effects, analysts say.

"Tasigna appears to be at least as effective as Sprycel, but with fewer side effects," said Karl-Heinz Koch, analyst in Zurich at private bank Vontobel, who has a buy rating on Novartis.

Bristol-Myers also presented data at the ASH conference, that are directly comparing Sprycel to a high dose of Gleevec, when given to patients who no longer responded to the standard Gleevec those.

After 15 months of treatment, the defective chromosome that causes CML was significantly reduced in 53% of patients who were given Sprycel, compared to 33% of patients who took the high dose of Gleevec.

"This study may help answer important questions about treating resistant chronic-phase CML patients and suggests that physicians should consider treatment with Sprycel in patients resistant to lower doses of Gleevec," said Neil Shah, an assistant professor at the division of hematology and oncology of the University of California, in a statement.

Still, given that these patients had already developed resistance to the standard dose of Gleevec, it shouldn't come as a huge surprise that Sprycel was shown to work better for these patients, Vontobel's Koch added.

Actelion about To Disclose New Cardiovascular Drug

Swiss pharmaceutical company Actelion Ltd (ATLN.EB) will release details of a new experimental heart drug this month that most analysts say could be either a successor to its flagship drug Tracleer, or a new niche treatment.

Actelion has been tightlipped so far on the compound, dubbed Actelion-1, and has not revealed which specific disease the drug is aimed at. But in a survey of 10 analysts by an agency, five said Actelion-1 would probably be a specialty cardiovascular drug, while two thought it would likely be a follow-up to Tracleer. Three were undecided. Two of the analysts said they thought the compound could also be a diabetes-related drug.

Actelion is heavily dependent on revenue from Tracleer right now, and industry experts say a positive announcement regarding either an improved Tracleer follow-up or a wholly new drug could substantially boost the stock.

"It's either an improved follow-up to Tracleer or an innovative compound in the cardiovascular specialty area," said Birgit Kulhoff, an analyst at Rahn & Bodmer.

Actelion spokesman Roland Haefeli would only say, "We do expect to make a disclosure on Actelion-1 before the end of the year...it's a compound evaluated for cardiovascular diseases in Phase II testing."

Tracleer is used to treat pulmonary arterial hypertension, or PAH. The condition is rare but often fatal and causes arteries in the lungs to become narrow or blocked and blood pressure to rise.

Actelion derived around 95% of the CHF247.2 million (US$206.4 million) in sales it posted during the third quarter from the drug, which was the only available treatment for PAH when it was launched in 2001, though competition is now waiting in the wings.

Encysive Pharmaceuticals Inc.'s (ENCY) Thelin is expected to soon receive final U.S. approval, while Myogen Inc. (MYOG) - recently bought by Gilead Sciences Inc. (GILD) - is expected to file its ambrisentan drug soon.

Given Actelion's current dependence on Tracleer, some analysts said investors could respond more positively if Actelion-1 turns out to be a new specialty cardiovascular drug rather than a new version of Tracleer.

At 1310 GMT Friday, Actelion's shares were up 1.4% at CHF223 in a lower Swiss market.

"Positive results from (a trial on Actelion-1 and another trial on Tracleer) would...likely cause us to boost our target price, perhaps substantially," said Denise Anderson, an analyst at Kepler Equities who has a buy rating on the stock with a CHF255 target price.

Negative results would leave her estimates unchanged, and any dip in the share price would also be a good entry point, she added.

Of those pharmaceutical analysts expecting a Tracleer follow-up, one said it could be a more targeted compound and could therefore potentially be more effective or have a smaller risk of side effects.

"It's likely to be a follow-on compound to Tracleer," he said. "In order to make the secrecy around Actelion-1 economically sensible, the only thing I can come up with is that it's a selective endothelin antagonist."

An endothelin receptor antagonist works by blocking endothelin receptors, with which endothelin - responsible for constricting blood vessels and raising blood pressure - connects in order to be activated.

However, most analysts say they don't expect an updated version of Tracleer and note it's hard to predict with so little information available which heart conditions a cardiovascular drug might target.

"It's not going to be a hypertension drug as Actelion says it plans to market the drug themselves" and marketing a hypertension drug would involve collaboration with another company due to the higher costs involved, said Anderson at Kepler Equities. "And the number of cardiovascular indications that it could be, is huge," she added.

Auxilium Pharma Shares Dn On Disrupted Trial

Auxilium Pharmaceuticals Inc. (AUXL) shares fell 8% Thursday after the company said it has to suspend dosing in a Phase III trial of a drug for the treatment of Dupuytren's contracture, a rare hand deformity, due to a manufacturing issue.

Dupuytren's contracture, which usually occurs in white adults in their 50s and 60s and is currently treated by surgery, can cause the fingers to bend towards the palm, and is caused by a thickening of the skin of the palm.

Late Tuesday, the company said it was temporarily stopping the dosing of patients in its ongoing Phase III trials for its AA4500 drug, and will conduct an investigation into the problems, which it believes are due to a higher-than-expected moisture content within some vials used to store the drug, possibly because of faulty equipment.

Shares of the company were recently changing hands at $14.68, down $1.28, or 8%, with around 1.3 million shares traded, more than three times average daily volume.

Auxilium's drug is unique in that it is a non-surgical approach. Currently there is no cure for the problem, and surgery doesn't prevent a recurrence. Injectable enzymes can break down the knots and cords of the hardened tissue.

The company said during a conference call that it has notified the U.S. Food and Drug Administration before re-starting the clinical trials and expected the FDA to take around 30 days to review the data. Management said it was uncertain whether it would have to create a new batch of drugs for the trials, adding investigators will continue to monitor patients already dosed in the trials.

Piper Jaffray said a delay could push back its launch timeline for late 2008, but may not have an impact on Auxilium's exclusivity for the drug, as Auxilium has orphan-drug protection - which is granted for drugs that treat rare diseases - for seven years in the U.S.

Iloperidone NDA Seen In 4Q 2007

Vanda Pharmaceuticals Inc. (VNDA) said that its antipsychotic drug, iloperidone, performed well in a late-stage clinical trial, adding that a New Drug Application for it likely will be filed with federal regulators late next year.

Separately, Vanda Chief Executive Mihael Polymeropoulos said during a CNBC interview Thursday that various pharmaceutical companies have expressed interest in buying his company because of its pipeline of products.

The dual developments sent shares of Vanda, a Rockville, Md.-based biotech company, soaring to a 52-week high of $28.67 in early trading, up 85% from Wednesday's close and surpassing a previous 52-week high of $17 set Nov. 15.

The shares were trading recently at $26.31, up $10.81, or about 70%. Volume was 5.12 million shares traded, compared to a daily average of 312,000.

Vanda executives said the Phase III clinical trial evaluated iloperidone, an atypical antipsychotic, in patients with schizophrenia. The drug demonstrated statistically significant improvement compared to placebo on the Positive and Negative Symptom Scale, the trial's primary endpoint, they said.

Paolo Baroldi, Vanda's chief medical officer, said in a prepared statement that the successful trial means the company is getting closer to filing a New Drug Application for iloperidone with the Food and Drug Administration, which is expected in late 2007. The company also is "one step closer to making iloperidone available to patients and providers dealing with schizophrenia," Baroldi said.

JP Morgan concurred in a research note, saying the Phase III results are sufficient for the NDA filing expected in late 2007.

Meanwhile, Vanda's Polymeropoulos said during his CNBC interview that no decisions have been made regarding a possible sale of the company, although he said many suitors likely would be interested.

Microbicides Against HIV

Women are increasingly at risk of contracting the HIV virus, and yet the most well-known method to prevent transmission during sexual activity is ultimately a decision made by the man.

But the days where male condoms are the best and easiest solution might be coming to an end as four different forms of microbicides - gels or creams with antivirals women can apply vaginally to prevent HIV (human immunodeficiency virus) infection - are now in final testing phases.

Experts say a total of more than 60 microbicides are in various stages of development and testing with some formulated as a pre-loaded diaphragm, cervical cap, sponge or vaginal ring releasing an active ingredient over time. The different microbicides include antivirals that use different methods of targeting the cells and virus.

"We know if there are more options, it's more likely to be used," said Anna Forbes, deputy director of the Global Campaign for Microbicides, a nonprofit organization based in Washington, D.C.

The first microbicide expected to complete testing is Carraguard, which is made from seaweed. It's being developed by the nonprofit Population Council in New York. Phase III trials are being conducted in three locations in South Africa and will be completed in March 2007.

Analysis of the data should be published by the end of 2007, and if Carraguard shows effectiveness at blocking HIV transmission, the council will seek the first regulatory approval from the South African Medicines Control Council. The council does intend to seek approval afterwards, if the data justifies it, by the U.S. Food & Drug Administration.

"Our goal is to develop a product used by women in the countries hardest hit by HIV and so we will work with regulatory entities in those countries," said Melissa May, director of public information for the council.

New Prophylactic

So far, Carraguard hasn't shown any significant side effects in testing on animals and humans, according to May.

"It's hard" for many of these women to persuade their partners to use condoms," May said. "Women really liked" the concept that they were in control with microbicides, she added. May noted that an additional benefit comes from the increased lubrication that the microbicides provide, a feature received positively both by men and women in testing.

Carraguard is currently being tested for use one hour before intercourse. But later testing and the subsequent versions of microbicides will be tested for use up to 24 hours or even on a monthly basis, according to Dr. Zeda Rosenberg, chief executive of the nonprofit International Partnership for Microbicides of Silver Spring, Md.

That would be a particular incentive for use in areas such as Darfur, where gang rapes are commonplace and a leading source for HIV transmission. Young girls could use microbicides as well, as rapes of children are on the rise. Subsequent microbicides are expected to be tested for effectiveness in blocking HIV transmission during anal sex.

The efficacy of first-generation microbicides is expected to range from 40% to 70%, with the lowest rate averting 18% of infections; and at 60% effectiveness, 35% of infections could be prevented. That could translate into countless lives being saved - more than 25 million people have died of AIDS since 1981, according to a recent report by the United Nations AIDS/World Health Organization. HIV causes AIDS (acquired immunodeficiency syndrome) by damaging white blood cells and other defenses against infection.

Currently, the only known way to spread the HIV virus is through the exchange of bodily fluids such as blood or semen from an infected person.

Cost-Effectiveness

Most versions of microbicides are coming from nonprofit organizations such as the Population Council and from small companies, such as Polydex Pharmaceuticals Ltd. (POLXF) of Canada. Pharmaceutical powerhouses such as Bristol-Myers Co. (BMY), Merck & Co. (MRK) and Johnson & Johnson (JNJ) are providing compounds for research as well.

It makes sense for the nonprofit organizations to take the leading role in the development of microbicides since they are better positioned to conduct trials in the developing world, according to John Moore, a professor of microbiology and immunology at Weill Medical College of Cornell University in New York. Moore has been working with Bristol-Myers and Merck on these projects.

Experts say that among the three compounds from the major companies, the Bristol-Myers and Merck versions stop the HIV virus from entering cells whereas the Johnson & Johnson compound - developed by its Tibotec subsidiary - stops replication of the virus.

TMC120, the Tibotec compound, is in a number of Phase I/II trials, according to Karen Manson, a spokeswoman for Tibotec, which is collaborating with the International Partnership for Microbicides.

The primary audience, at least initially, for microbicides are mostly women who live at the poverty level.

With antiviral therapy, "if it's not inexpensive," it won't be used, said Polly Harrison, director of the Alliance for Microbicide Development of Silver Spring, Md.

This could be very attractive for companies that are interested in "high-volume and low-margin products," the International Partnership for Microbicides' Rosenberg said.

The U.N. estimates that nearly 40 million people worldwide are currently living with HIV and AIDS, including 4.3 million newly infected in 2006. More than half of new infections are occurring in women. Research has shown that women are biologically more vulnerable to infections.

High-Profile Support

Meanwhile, 45 million new HIV infections are expected to occur between 2002 and 2010. Across sub-Saharan Africa, where the highest rates of infection are occurring, UNAIDS/WHO said that women between 15 and 24 years old are at least three times more likely to be HIV-positive than young men.

The dollar amounts targeted for microbicide research have grown tremendously amid public support from former President Bill Clinton, the Bill and Melinda Gates Foundation, the Rockefeller Foundation and others. Five years ago, much of the focus on HIV prevention was on finding a vaccine, but today many experts are more encouraged about the potential immediate impact of microbicides. In 1997, about $28 million was given to fund microbicide research; in 2005 that grew to $163 million.

In a Rockefeller Foundation report, estimates for the net present value of investing in a first-generation microbicide range from negative $65 million to negative $27 million. The second-generation product could be self-funding, with figures ranging from a negative $56 million to a positive $122 million.

Reneuron Seeks FDA OK For Human Stem Cell Trials

Stem cell specialist Reneuron (RENE.LN) said Wednesday it's seeking approval from the U.S. Food and Drugs Administration to start testing its stroke therapy, ReN001, on human patients.

The Surrey, U.K.-based company, which has a market capitalization of less than GBP15 million, wants to conduct the trials on 12 humans. Trials on paralyzed rats showed that they regained some movement after treatment.

The trials would involve the injection of stem cells - taken from an aborted foetus - directly into the patients' brains. The tests would be carried out the Medical Centre at the University of Pittsburgh, with the patients under local anasthetic.

The news, which has sparked much ethical debate, drove ReNeuron shares almost 30% higher in early trading on London's Alternative Investment Market, AIM. At 1002 GMT, they were up 31%, or 4.6 pence, at 19.50 pence.

Chief Executive Michael Hunt said the company has already had "extensive" talks with the regulator and is "pretty confident".

Hunt believes the company will be able to meet concerns they FDA may have over the therapy's safety.

He said his team had sourced all the tissue it needed from one foetus.

"We're open about what we do. Clearly, there's an ethical issue here - but we have no need to extract more tissue, it was done with full maternal consent and it's also important to look at the patient benefit angle."

The use of embrionic stem cells - immature cells that have yet to have a function - destroys the embryo, and research in this area has sparked fierce ethical and moral debate. A different type of stem cell, known as adult cells, can be sourced from umbilical cords and bone marrow.

Hunt said the company will be tapping the market for further cash in the coming year.

The U.K. is seen as a supportive environment in which to conduct stem cell research, and the sector has received considerable Government support.

The Australian Parliament Wednesday lifted its ban on cloning human embryos for stem cell research, despite opposition from the prime minister and other party leaders. However, the anti-stem cell research in the U.S. remains very vocal. In 2001, President George Bush vetoed the use of public funds for stem cell research.

Reneuron has had a bumpy ride on the stock exchange. Founded in 1997 by scientists at London's Kings College, the company initially listed in 2000, valued at around GBP60 million, only to be taken private in 2003 for GBP3.6 million. The group subsequently relisted in 2005 at 25 pence per share.

Drug-Related Suicidal Thoughts May Abate With Age

The Food and Drug Administration said antidepressants appear to increase the risk of suicidal thinking in young adults but that in older adults the risk declines.

The FDA reviewed data from 372 clinical studies involving 11 antidepressants including GlaxoSmithKline PLC's Paxil, Pfizer Inc.'s Zoloft and Eli Lilly & Co.'s Prozac. The studies involved almost 100,000 patients.

The FDA requested the data from drug makers last year in the wake of evidence antidepressants increased suicidal thoughts and behavior in children and adolescents to see if the same risk carried through to adulthood. The drugs carry a "black box" warning about the increased risk in children and adolescents.

The FDA review of the data, which date back to 1985, suggested a "differential risk of antidepressant-induced suicidality across the age spectrum." The agency said in documents posted to its Web site the risk was greater at the younger end of the spectrum and that it declined with age with a likely "protective" effect in adults age 65 and older.

The FDA review was posted ahead of a Dec. 13 advisory committee meeting scheduled to discuss the data and whether updated drug labels are needed to discuss the finding on suicidal thinking in adults. An FDA spokeswoman said the agency planned to update the labels but will seek the panel's input before the labels are changed.

This year, GlaxoSmithKline released an analysis of studies that involved 8,958 patients on Paxil and 5,953 on placebo, or a fake pill. Among the findings was a small but statistically significant increase in suicidal thoughts among young adults patients diagnosed with a major depressive disorder. The company updated Paxil's label warning doctors about the possibility of an increase in suicidal behavior in young adults.

Sanofi Drug Helps Diabetic Sugar Levels

Sanofi-Aventis SA's obesity drug Acomplia can improve blood-sugar levels and weight loss in diabetic patients, according to a study presented at the World Diabetes Congress in South Africa.

The findings from the clinical trial have shown newly diagnosed patients with type-two diabetes who weren't taking antidiabetic drugs had significantly improved blood-sugar levels and lost more weight with Acomplia, compared with a dummy pill over a period of six months. In addition, Acomplia -- also known as rimonabant -- helped raise good cholesterol and control triglycerides, compared with a placebo.

The trial, the second study demonstrating that Acomplia can improve blood-sugar levels in people with type-two diabetes, was carried out on 278 diabetic patients whose sugar levels weren't responding adequately using a controlled diet alone.

Acomplia, hailed as a potential multibillion-dollar "blockbuster" drug and sold in several European countries, is the first in a new class of drugs that help with weight loss by curtailing cravings. Because it also controls blood-sugar levels, it might also become a future breakthrough to treat diabetics.

Given its potential as a diabetes drug, Acomplia is undergoing a number of clinical trials across the diabetes spectrum, from prediabetes patients to people who have to rely on daily insulin injections.

Acomplia's benefits shown in the trial support its use as a diabetes drug that is completely different from antidiabetic pills now on the market, said Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center, an investigator in the trial.

Among the side effects reported by patients taking Acomplia were nausea, depressed mood and skin tingling, which led to a discontinuation rate of 9.4%, compared with 2.1% in the placebo patients.

"While Sanofi claims Acomplia is an important treatment for diabetes, the data have to be tempered with the side-effect issues," said Navid Malik, an analyst with London-based brokerage Collins Stewart.

In the trial, more than 50% of patients taking Acomplia achieved blood-sugar levels below 7%, the target for good glucose control, as recommended by the American Diabetes Association.

In addition, these improvements were linked to a weight loss of 14.7 pounds, compared with 5.9 pounds in patients on placebo.

Around 5% of adults world-wide have been diagnosed with diabetes, with type-two constituting the majority of diabetes cases in developed countries.

Glaxo Avandia Can Slow Diabetes Progression

Long-term treatment with GlaxoSmithKline PLC's (GSK) blockbuster drug Avandia is more effective in slowing the progression of early-stage diabetes than two older treatments, according to a study published Monday in the New England Journal of Medicine.

The trial, presented Monday at the World Diabetes Congress in Cape Town, South Africa, showed that initial treatment of type-2 diabetes with Avandia slowed disease progression more effectively than did metformin and glyburide, which are currently used as first-line treatments.

Avandia is GlaxoSmithKline's second best-selling drug, with sales of GBP1.3 billion last year. It is prescribed to patients who do not respond to treatment with older anti-diabetics.

Compared with metformin, Avandia showed a risk reduction of 32%. This increased to 63% when it was compared with glyburide. The minimum target required in the trial, which studied 4,360 newly diagnosed diabetes patients over the course of four years, was a risk reduction of 30%.

However an accompanying editorial in the journal said that given Avandia's modest benefits, higher cost and side-effects, metformin remains "the logical choice" in the initial treatment of diabetes.

With all three drugs there was a high rate of patients dropping out of the trials due to adverse events. Around 60% of patients completed the study, the researchers said.

Treatment with Avandia highlighted a number of side-effects that are usually linked to the use of the drug, such as weight gain, increased levels of bad cholesterol and fluid retention.

However, Lawson Macartney, head of GlaxoSmithKline's cardiovascular and metabolic medicine development center, told an agency that the data underscore the fact Avandia performs significantly better than older drugs.

"Metformin performed well, but Avandia performed better," he said, noting that the data also support the effectiveness of combination therapy with both drugs in earlier-stage diabetes.

The trial showed that Avandia had clearer beneficial effect on older people and on those with a larger waist circumference.

Type-2 diabetes, the most common form of diabetes, is a chronic disease marked by high levels of sugar in the blood, and is more prevalent among older, overweight people. In addition to Avandia, GlaxoSmithKline's diabetes portfolio includes Avandamet, which is a combination of Avandia and metformin, as well as Avandaryl, which combines Avandia with glimepiride, an older oral antidiabetic.

GlaxoSmithKline is planning to file the results of the trial with drug regulators worldwide in the first half of 2007, Macartney said.

Bayer,Onyx:Nexavar Trial Doesn't Meet Targets

Bayer AG (BAY) and its U.S. partner Onyx Pharmaceuticals Inc. (ONXX) said Monday that cancer drug Nexavar didn't meet the companies' primary targets in a trial to treat skin cancer.

Recently, shares of Bayer were up 5 cents at $51.90. Shares of Onyx were down $5.20, or 29.7%, at $12.30.

Late-stage Phase III tests on the treatment of advanced melanoma showed no improvement when Nexavar was compared with drugs already used to treat this kind of cancer, the companies said.

The target set by the companies was to improve the progression-free survival rate of patients suffering from advanced melanoma.

"This trial does not change our commitment to, and belief in, Nexavar," said Hollings Renton, chairman, president, and chief executive of Onyx.

The drug is already approved and on the market to treat renal cancer in the U.S., Europe and other countries.

Late November, Bayer reported third-quarter sales of the drug of EUR37 million and said it expects full-year 2006 sales to be over EUR100 million.

The companies are also evaluating Nexavar for treatment of liver and non-small-cell lung cancer, and are conducting the last of three clinical trials.

Pfizer Halt Of Torcetrapib Seen A Heavy Blow

Pfizer Inc. (PFE) halted development of a drug to boost good cholesterol that was the most important medicine in its pipeline, after more patients than expected died during a large clinical test.

The unanticipated excess of deaths, whose number was small but wasn't specified by the company, became known Saturday after a board of independent experts reviewed the latest data from a 15,000-patient test of the drug called torcetrapib.

Citing patient safety, Pfizer said in a statement that it is terminating all clinical tests of torcetrapib and its plans to bring the drug to market.

The failure of torcetrapib is a heavy blow to Pfizer, the world's largest drug maker by sales. The company had bet on torcetrapib to take the place of cholesterol-fighter Lipitor, the company's best-selling product with $12.19 billion in revenue last year. Lipitor could lose patent protection as soon as 2010.

Doctors and investors have been watching torcetrapib closely because it seemed able to profoundly raise the type of cholesterol - called HDL - that could help keep arteries clear.

But torcetrapib has been dogged by safety worries. The medicine showed a tendency to raise blood pressure as it also raised good cholesterol.

Still, the increase in deaths for the patients who received torcetrapib was a shock. "We were very surprised ," said Philip Barter, director of the Heart Research Institute in Australia and chairman of the committee overseeing the large study, in the Pfizer statement. "We believed that the study was coming along as expected," he said.

Dr. Steven Nissen, chairmain of cardiovascular medicines at the Cleveland Clinic, called the setback "terribly disappointing." Nissen is the leader of another clinical test of torcetrapib to see if the medicine reversed the plaques that clog arteries feeding the heart. He said that finding new drugs to raise HDL safely and effectively remains an important goal. "We still don't know if this is a problem specific to torcertrapib or this approach to raising HDL isn't going to work."

The test that detected the more serious problems was a 15,000-patient study that was supposed to continue until 2009 or early 2010. Half the patients received tocetrapib plus Lipitor. The other half got Lipitor alone. Pfizer said the study cast no doubt on the safety and effectiveness of Lipitor.

Some analysts thought that the blood pressure problems that were already known would doom torcetrapib. Other companies, including Merck & Co. (MRK) and Roche Holding AG (RHHBY), were working on alternatives to torcetrapib that don't appear to increase blood pressure.

Only last Thursday Pfizer management had affirmed confidence in torcetrapib at a meeting with analysts to review the company's pipeline. The company affirmed its plan to seek Food and Drug Administration approval of torcetrapib taken in combination with Lipitor in the second half of 2007.

During the meeting, Pfizer research president John LaMattina said, "We believe this is the most important new development in cardiovascular medicine in years."

FDA Weighs Celebrex Studies On Juvenile Arthritis

Pfizer Inc. might have to conduct further studies on its pain reliever Celebrex before it is approved to treat rheumatoid arthritis in children, the Food and Drug Administration staff said.

Celebrex, which is approved to treat arthritis in adults, has faced safety concerns over an increased risk of heart attacks and strokes for those who take it.

The drug belongs to the same class of painkillers as Merck & Co.'s Vioxx. Merck pulled the drug from the market in 2004 after its studies showed Vioxx doubled the risk of heart attacks and strokes. Pfizer continued to sell Celebrex after it strengthened label warnings about its risks.

This year the New York drug maker requested FDA approval for Celebrex to treat juvenile rheumatoid arthritis in patients ages two years and older. The FDA is holding a meeting today with an outside panel of experts, who will be asked to weigh the risks and benefits of the drug for the treatment in children.

According to documents posted on the FDA's Web site, about 30,000 to 60,000 children in the U.S. suffer from the condition. In severe, uncontrolled cases, rheumatoid arthritis can cause permanent disability.

While there are other drugs approved to treat the condition in children, "for some patients these approved products may provide limited efficacy or intolerable side effects," the FDA said. Those drugs include aspirin, ibuprofen and naproxen to treat the pain.

On the safety of the drug, the staff said "a key consideration" in assessing the issue "is the evidence of increased risk of cardiovascular adverse events in adults." Heart risks to children who take Celebrex long term are unknown.

In a trial conducted with children, the most common adverse events of Celebrex were certain infections and infestations, and nervous-system disorders. Compared with naproxen, common adverse events with Celebrex were similar in type and frequency, the staff said.

Drug Pipelineline Series: Phase III, 27 Nov - 4 Dec, 2006

Dynavax's HEPLISAV™ Hepatitis B Vaccine Shows Statistically Significant Results in Phase 3 Trial

Dynavax Technologies Corporation announced statistically significant results from the primary endpoint analysis of a Phase 3 trial comparing HEPLISAV, its hepatitis B virus (HBV) vaccine, to GlaxoSmithKline's Engerix-B® vaccine in a difficult-to-immunize population of older adults. The primary endpoint is seroprotection four weeks after the third immunization.

The data show that after three doses, HEPLISAV provided seroprotection to 100% of subjects versus 73.1% for Engerix-B (p < 0.0001). The greatest difference in seroprotection after three doses was seen in subjects 56 to 70 years of age where HEPLISAV provided 100% seroprotection and Engerix-B provided 56.1%. Data for the entire study population show that after two doses, HEPLISAV provided 98.5% seroprotection versus Engerix-B's 25%. Furthermore, HEPLISAV provided a level of immunity as measured by geometric mean concentrations of anti-HBsAg antibodies 18.5 times higher than Engerix-B four weeks after the third dose.
The Phase 3 trial enrolled more than 400 seronegative subjects, 40 to 70 years of age, at study sites in Singapore, Korea and the Philippines. One group of subjects received three doses of Dynavax's HBV vaccine; the other group received three doses of Engerix-B.

Drug Pipelineline Series: Phase II, 27 Nov - 4 Dec, 2006

CHEMOCENTRYX PRESENTS DATA FROM CROHN'S DISEASE STUDY

ChemoCentryx has presented data from a Phase II study of the company's drug candidate Traficet-EN (CCX282-B), a first-in-class, orally active, anti-inflammatory agent that targets the chemokine receptor known as CCR9, at the 2006 Crohn's and Colitis Foundation of America's annual meeting. New data were presented from a trial in patients with moderate-to-severe Crohn's disease analyzing the effect of Traficet-EN on lowering pro-inflammatory cytokine and chemokine concentrations in the intestine.

BAYER PUBLISHES RESULTS OF ANTICOAGULANT STUDY

Bayer has announced that results of a Phase II trial of the novel oral anticoagulant rivaroxaban, a direct Factor Xa inhibitor, have been published in Circulation. In the trial, rivaroxaban demonstrated that it may have similar safety and efficacy to subcutaneous enoxaparin (the current standard), for the prevention of venous thromboembolism (VTE) in patients undergoing elective total hip replacement surgery.

The publication completes the Phase II program with rivaroxaban for the prevention of VTE after major orthopaedic surgery and contains the full data set from the once-daily dosing trial; results from twice-daily trials in hip and knee replacement surgery have already been published. These data taken together formed the basis of the decision to initiate the Phase III program with rivaroxaban for the prevention of VTE after orthopaedic surgery using a once-daily dosing regimen.

Cleveland BioLabs Initiates Phase II Hormone-Refractory Prostate Cancer Trial for Curaxin CBLC102

Cleveland BioLabs, Inc. announced the initiation of its Phase II efficacy study for Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer at the Cleveland Clinic and Case Western Reserve University Hospital.
Curaxin CBLC102 is a safe, oral drug used in the past to treat malaria that demonstrates efficacy in vitro, in animal models, and in live tumors removed from patients. Initial test results indicate that CBLC102 can be effective against a number of malignancies, including hormone refractory prostate cancer, renal cell carcinoma (a highly fatal form of kidney cancer), and soft-tissue sarcoma. The FDA permitted Cleveland BioLabs to advance directly to Phase II studies, based on CBLC102's historic safety profile.

Sangamo BioSciences Initiates Phase 2 Clinical Trial of Novel Therapy for Diabetic Neuropathy

Sangamo BioSciences, Inc. announced that the company has initiated a multi-center Phase 2 clinical trial of SB-509 for diabetic neuropathy (DN). The clinical trial is a double-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TF™), designed to upregulate the vascular endothelial growth factor A (VEGF-A) gene.

Phase II Data Shows Ovation's Novel Compound Clobazam to Be Well Tolerated in Patients With Catastrophic Epilepsy

Results from the first study in the United States designed to evaluate the safety and efficacy of clobazam as adjunctive therapy in patients with Lennox-Gastaut syndrome (LGS), one of the most severe forms of childhood epilepsy, demonstrated that clobazam is well tolerated. In the trial, clobazam was shown to be effective in significantly reducing drop (or atonic) seizures, the most debilitating of the LGS seizure types, which can result in severe trauma to the brain and body, by 85.3 percent compared to baseline (in the high dose group versus 12 percent in the low dose group; P=.0001). Adverse events leading to the discontinuation of clobazam were rare. Data were presented at the North American Regional Epilepsy Congress.
This phase II, multi-center, randomized, double-blind, dose-finding clinical trial was the first study conducted in the U.S. to evaluate the safety and efficacy of clobazam as adjuvant therapy in patients with LGS. Sixty-eight patients (ages 2 to 26 years) with LGS were randomized to two treatment groups with a low dose (target of 0.25 mg/kg/day) of clobazam or a high dose (target of 1.0 mg/kg/day) for a total treatment duration of up to 10 weeks.

EPIX Announces Full Results from Phase 2a Clinical Trial of EP-2104R Presented at RSNA Annual Meeting

EPIX Pharmaceuticals, Inc. announced the results from a Phase 2a clinical trial of EP-2104R, a novel fibrin-binding thrombus (clot) imaging agent, as presented during an oral presentation at the Radiological Society of North America (RSNA) Annual Meeting in Chicago, Illinois. The results of the Phase 2a trial found that EP-2104R was able to detect blood clots not previously seen on magnetic resonance imaging (MRI) and enhanced the images of clots previously seen on MRI. Blood clots are a major underlying cause of several diseases including deep vein thrombosis, pulmonary embolism, heart attack and stroke, and identifying a minimally invasive method for detecting clots would address a substantial medical need.

Drug Pipelineline Series: Phase I, 27 Nov - 4 Dec, 2006

Ligand Announces Initiation of Clinical Trials for Thrombocytopenia Drug, LGD 4665

Ligand Pharmaceuticals Incorporated announced that the Company is initiating Phase I clinical trials of LGD 4665, an oral, small molecule drug that mimics the activity of thrombopoietin (TPO), a growth factor that promotes growth and production of blood platelets.

Thrombocytopenia or low platelet count is a common clinical finding associated with a diverse group of clinical disorders or conditions affecting platelet production and/or survival. Prevalent clinical disorders where platelet loss or dysfunction leads to significant morbidity include idiopathic thrombocytopenia purpura (ITP), myelodysplastic syndrome, liver dysfunction associated with hepatitis C viral and severe cirrhosis, chemotherapy-induced thrombocytopenia (CIT) as well as a number of other disorders. Current therapeutic options are mostly palliative, including steroids, immunosuppresants, splenectomy and, for the most severe thrombocytopenias, platelet transfusion.

ARROW'S HEPATITIS C TREATMENT ENTERS PHASE I STUDY

Arrow Therapeutics has begun a Phase I study of A-831, a small-molecule antiviral inhibitor of the hepatitis C virus. The study will evaluate the safety, tolerability and pharmacokinetics of single escalating doses of A-831 in healthy volunteers in the UK.

A-831 targets the NS5a protein, a novel mechanism of action, and is the first NS5a inhibitor to enter clinical trials. The drug showed good safety and pharmacokinetics in preclinical studies and excellent potency in the replicon assay. A-831 is the first compound from Arrow's broad approach to the NS5a target.
The current standard treatment for hepatitis C, pegylated interferon plus ribavirin, has a poor side effect profile and is only effective in around 50 percent of patients, according to Arrow. Patients often need multiple drugs in combination therapy to overcome drug resistance.
The company also plans to develop other drugs for hepatitis C, which will be licensed to other companies between the preclinical and Phase IIb stages.

SEATTLE GENETICS BEGINS TRIAL OF HODGKIN'S LYMPHOMA DRUG

Seattle Genetics has initiated a Phase I clinical trial of SGN-35 for patients with Hodgkin's lymphoma and other CD30-positive hematologic malignancies. SGN-35 is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics' proprietary technology to empower antibodies by linking them to potent cell-killing drugs.
The single-agent, dose-escalation study is designed to evaluate the safety, pharmacokinetic profile and antitumor activity of SGN-35 in patients with relapsed or refractory CD30-positive hematologic malignancies, including Hodgkin's lymphoma. The trial is expected to enroll up to approximately 40 patients at multiple centers in the United States.

SGN-35 is an ADC composed of an anti-CD30 antibody joined by an enzyme-cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in a targeted cell-killing effect. Treatment with SGN-35 resulted in complete tumor regressions in preclinical models of Hodgkin's disease and anaplastic large-cell lymphoma.

Pain Therapeutics Announces Positive Phase I Study Results With PTI-202

Pain Therapeutics, Inc. announced positive results from a Phase I clinical trial evaluating PTI-202, the Company's second abuse- resistant opioid painkiller.
This clinical trial was designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of a single, oral dose of PTI-202 in healthy volunteers. We believe results also indicate PTI-202 is safe and well-tolerated and its release profile appears well-suited to use with a chronic pain population. There were no unexpected adverse events in this trial.
PTI-202 is a novel abuse-resistant formulation of an opioid painkiller. Its active pharmaceutical ingredient remains undisclosed. PTI-202 is intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimize the risks of drug diversion, abuse or accidental patient misuse.

Novartis Files Drugs For Approval Ahead Of Plan

Swiss drugmaker Novartis AG (NVS) Tuesday said it has submitted a bone and a cancer drug for regulatory approval earlier than planned, and added that it is starting late-stage testing on five experimental medicines.

Demonstrating that it has one of the strongest pipeline of new drugs in the industry, Novartis, based in Basel, said it has a total of 138 projects in development, comprising both new possible treatments for disease for which there is no cure, as well as studies for possible new uses of medicines that are already on the market.

Around two thirds of these projects are in the second and third phase of clinical testing. Most drugs are being studied in three phases of testing before companies submit them for regulatory approval.

"Over the next two years we will launch several innovative medicines and continue to invest aggressively in discovery research and development activities and complement our own skills and technologies through attractive collaborations," chief executive Daniel Vasella said in a statement.

The Swiss drugmaker also suffered some setbacks, terminating the development of osteoporosis medicine AAE581 and of anxiety drug XBD173, while saying that the development of LIC477, a potential new treatment for manic-depression, was delayed. Analysts had expected Novartis to submit LIC477 for regulatory approval next year.

Development of cancer drug EPO906 is also progressing more slowly than planned because the company failed to recruit patients fast enough to the clinical testing phase.

In addition, experimental diabetes treatment Galvus, a potential blockbuster with expected annual sales of at least $1 billion, was shown to work less well than metformin in a two-year trial, confirming results already seen after one year of treatment.

Novartis expects the U.S. Food and Drug Administration to decide on approving this drug in the first half of 2007. Analysts generally expect Galvus to win approval, but that the drug, which treats diabetes in a new way, will come to the market about half a year later than Januvia, a similar drug, for which its maker Merck & Co. (MRK) gained U.S. approval recently.

In contrast, hypertension drug Tekturna, another potential blockbuster, was shown to lower blood pressure more effectively than a diuretic, or water pill. Diuretics are commonly prescribed hypertension treatments, and are available as cheap generics. Tekturna, which was developed jointly with Speedel Holding AG, a small Swiss pharmaceutical company, was also shown to work well in combination with Diovan, the company's best-selling drug.

"The data on the Tekturna-Diovan combination are very important, because they will essentially allow Novartis to double the life cycle of Diovan," said Karl-Heinz Koch, analyst in Zurich with private bank Vontobel, who has a buy rating on the stock. "As a result, rather than falling to around $2 billion as expected, hypertension sales will remain at around $6 billion after the patent expiration of Diovan."

Diovan, which had sales of $3.68 billion in 2005, will lose patent protection in 2012.

Having accelerated the submissions for regulatory approval in Europe and the U.S., Novartis has filed for approval of cancer drug Tasigna, and bone drug Aclasta. Many analysts had expected the filing of these drugs only later in 2006 or next year.

Tasigna, or nilotinib, was filed for approval for use in patients with resistance or intolerance to treatment with Gleevec for certain forms of chronic myeloid leukemia. Gleevec is also a Novartis drug and the company's second-best selling product after hypertension drug Diovan. A few months ago, Bristol-Myers Squibb Co. (BMY) received U.S. approval for Sprycel, a drug that some analysts consider a potential threat to Gleevec sales. Sprycel was approved for use in patients for whom Gleevec doesn't work.

The second drug, Aclasta, or zoledronic acid, is a once a year infusion for the treatment of women with postmenopausal osteoporosis. The most frequently prescribed osteoporosis drugs available today need to be taken once a week, which is a drawback that leads to poor compliance among patients, because the drugs are cumbersome to take.

In its first detailed update on drugs in development in almost two years, Novartis also said that five experimental drugs are moving into the third, and usually last, phase of clinical testing.

They are: FTY720, or fingolimod, for multiple sclerosis, QAB149, or indacaterol for smoker's cough and asthma, AG0178, or agomelatine, for depression and ABF656, or albuferon for hepatitis C, as well as RAD001, or everolimus, for cancer and SOM230, asireotide, for Cushing's disease.

Akzo, Pfizer End Collaboration On Asenapine

Dutch chemical group Akzo Nobel NV (AKZOY) and U.S. drug maker Pfizer (PFE) Tuesday said they will end joint development of a drug seen as a key factor in the planned stock market listing of Akzo's pharmaceuticals unit.

Asenapine, a new drug candidate for treating schizophrenia and acute mania associated with Bipolar I Disorder, had been expected to become the first billion-dollar blockbuster drug for the Organon BioSciences unit.

But Pfizer - the world's leading drugmaker measured by prescription sales - said "commercial considerations" had caused it to withdraw.

Akzo said it remains fully committed to bringing the new drug to market, and stressed the move will not derail plans to float Organon in early 2007.

Analysts said Pfizer's decision to withdraw was negative for Akzo Nobel and cast doubt over the flotation. Analysts said the success of the new drug remains uncertain, and that without Pfizer, the product's sales potential looks shaky.

"That Pfizer (PFE) is abandoning the partnership deal with Akzo Nobel (AKZOY) on the development of the new drug asenapine is bad news for Akzo Nobel," said Rabo Securities-analyst Mark van der Geest, who rates Akzo Nobel hold.

Akzo Nobel shares at 1102 GMT were down 0.5%, or EUR0.2 lower, at EUR41.84 in a firmer overall market.

Toon Wilderbeek, Organon BioSciences chief executive officer said Organon's plans for an initial public offering remain on course. "This will not affect the IPO - We are still planning to list a minority of the shares on Euronext Amsterdam."

Akzo Nobel aims to list 20% to 30% of Organon so that the group can concentrate on its profitable coatings and chemicals sectors.

Akzo Nobel now must decide whether it needs another partner to commercialize asenapine, Wilderbeek said in a statement. Pfizer said it will return all product rights, intellectual property and data on Asenapine to Organon during 2007.

Under terms of their 2003 co-development pact, Pfizer paid Akzo Nobel $100 million up front in initial fees and was committed to pay up to $270 million in milestone payments if asenapine received regulatory approval in the U.S., Europe and Japan and reached certain sales targets.

Analyst Danny van Doesburg of SNS Securities said that the fact that Akzo Nobel will now develop the drug on its own is bad news because now it will have to pay all costs related to the development of Asenapine.

"If the drug makes it to the market, and the drug starts bringing in revenues, Akzo Nobel will have to pay a total of $350 million to Pfizer," he said.

He said one positive aspect is however that Akzo will consequently not have to share revenues with Pfizer once the drug is on the market. Van Doesburg rates Akzo a hold and has a price target of EUR48.

Akzo Nobel said Organon will now assess whether further clinical trials are needed to convince the U.S. Food and Drug Administration that asenapine is a useful drug. In October phase II trials for asenapine weren't sufficiently conclusive for Akzo Nobel to seek approval for filing the drug to the US Food and Drug Administration.

Drug Pipeline Series: Submissions, Nov 20 - Nov 27, 2006

Anesiva Announces Filing of New Drug Application for Zingo™ to Reduce Pain Associated with Needle Insertion Procedures in Children
Anesiva, Inc. announced that the company has filed a New Drug Application (NDA) with the FDA for marketing clearance of Zingo™ to treat the pain associated with venous access procedures in children. As part of the company's continued development of Zingo, Anesiva expects to begin a follow-on clinical trial in adults in early 2007. As previously announced, Anesiva has obtained commitments to purchase approximately $45 million of its common stock, which it anticipates closing on November 28, 2006.

Drug Pipeline Series: Phase III, Nov 20 - Nov 27, 2006

Dyax Announces Final Patient Treated in Pivotal Phase III Clinical Trial (EDEMA3) for DX-88 in Hereditary Angioedema
Dyax Corp. announced that it has completed the double-blind portion of its pivotal Phase III clinical trial, known as EDEMA3, for its lead product candidate DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). In addition, the U.S. Food and Drug Administration has also broadened the Fast Track designation for DX-88 for the treatment of all types of acute HAE attacks, a rare and life-threatening inflammatory condition for which there is no approved therapy in the United States.


First Patient Treated in Phase III Ovarian Cancer Trial
Marshall Edwards, Inc. announced that the first patient had commenced treatment in the Phase III "OVATURE" clinical trial at The Royal Women's Hospital in Melbourne, Australia.
Royal Women's is one of 60 hospitals that will be participating in this multi-center multi-national ovarian cancer study to confirm the effectiveness of phenoxodiol in resensitizing patients to chemotherapy.


SOMAXON REPORTS RESULTS FROM THIRD PHASE III STUDY OF SILENOR
Somaxon Pharmaceuticals has announced positive results from its Phase III clinical trial evaluating Silenor (doxepin HCl) in elderly patients with primary sleep maintenance insomnia. The drug demonstrated a statistically significant improvement compared with placebo in the primary endpoint of this trial, subjective total sleep time as measured at week one. Statistical significance was maintained for all time points measured throughout the four-week treatment period.

Drug Pipeline Series: Phase II, Nov 20 - Nov 27, 2006

Genzyme Begins Phase 2 Pivotal Study of Clolar® in Adult Acute Myelogenous Leukemia
Genzyme Corporation announced that it has begun treating patients in a phase 2 clinical trial examining the safety and effectiveness of Clolar® (clofarabine) in previously untreated, older adult patients with acute myelogenous leukemia (AML) who are unlikely to benefit from standard induction therapy.
This is Genzyme's second pivotal clinical study of clofarabine in adult patients with AML to commence this year, and it is expected to provide substantial support for expanding the current product label.


BIOMS MEDICAL BEGINS TRIAL OF TREATMENT FOR MS
BioMS Medical has announced that the first patients have been enrolled in its placebo-controlled, multicenter, Phase II clinical trial of MBP8298 for the treatment of relapsing-remitting multiple sclerosis (RRMS).
The 15-month, double-blind, placebo-controlled trial will enroll up to 215 patients with RRMS from up to 30 sites. The trial will be followed by a 12-month open-label extension period. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.
MBP8298 is also currently undergoing a pivotal Phase III trial for the treatment of secondary progressive multiple sclerosis (SPMS) patients with immune response genes HLA-DR2 and/or DR4.

Drug Pipeline Series: Phase I, Nov 20 - Nov 27, 2006

FIBROGEN ANNOUNCES DATA ON CTGF ANTIBODY IN MICROALBUMINURIA
FibroGen has announced results of a Phase Ib study of FG-3019, a fully human monoclonal antibody against connective tissue growth factor (CTGF), in people with Type 1 or 2 diabetes and microalbuminuria, the earliest clinical sign of diabetic nephropathy.
The primary objectives of this open-label, multiple-dose, sequential-group, dose-escalation, multicenter study were to characterize the safety, tolerability and pharmacokinetics of FG-3019. Results demonstrated that FG-3019 was well-tolerated. Only one serious adverse event was reported, which was considered unrelated to the study drug. No dose-limiting toxicities were observed. Clearance of FG-3019 was saturable, and accumulation of FG-3019 in the bloodstream was limited during the dosing interval.


AEterna Zentaris Reports Positive Top Line Phase 1 Results for AN-152 in Patients with Gynaecological and Breast Cancers
AEterna Zentaris Inc. disclosed additional positive top line Phase 1 results for its cytotoxic conjugate AN-152 in patients with gynaecological and breast cancers. Further data showed the compound's good safety profile and established the maximum tolerated dose (MTD) at 267 mg/m(2) which will be the recommended dose for a Phase 2 trial. In addition to good safety data, the trial provided a hint of efficacy as disease stabilization and regression of lesions were observed at the 160 mg/m(2) and 267 mg/m(2) dose levels.


PEREGRINE BEGINS COMBINATION THERAPY CANCER TRIAL
Peregrine Pharmaceuticals has initiated a Phase Ib clinical trial to evaluate its lead anti-phospholipid immunotherapy agent bavituximab given in combination with common cancer chemotherapy agents. The trial is expected to enroll up to 12 patients at three clinical sites in India.
The trial is designed to test the safety and tolerability of bavituximab over an eight-week administration period when given with standard chemotherapy regimens including docetaxel, gemcitabine and carboplatin/paclitaxel. These regimens are commonly used for treating major cancer types, including breast, lung and pancreatic cancer. Study endpoints include safety and drug pharmacokinetics. Patients will also be evaluated for tumor response according to Response Evaluation Criteria in Solid Tumors criteria, although this assessment is not a formal endpoint of the study. Patients will be followed for an additional four weeks after their last dose of bavituximab and may continue with chemotherapy according to standard-of-care guidelines.


NEOPHARM PRESENTS SAFETY DATA ON MALIGNANT GLIOMA TREATMENT
Neopharm has announced the presentation of final Phase I safety results at the Society for Neuro-Oncology's annual meeting. Data from this 22-patient trial showed that 0.5 micrograms/mL of Cintredekin Besudotox delivered via convection-enhanced delivery followed by external beam radiation therapy (EBRT), with or without concurrent temozolomide, following tumor resection appears to be safe in patients with newly diagnosed malignant glioma.


Kamada Begins Phase I Clinical Trials of Its Aerosolized API Treatment for Congenital Emphysema
Kamada announced that it has begun human Phase I trials of an inhaled formulation of its flagship drug, Alpha 1-Proteinase Inhibitor (API). The trials will examine the product's safety on approximately 20 participants and will continue for several months according to a plan approved by the EMEA, the European Agency for Evaluation of Medicinal Products.

Drug Pipeline Series: Approvals, Nov 13 - Nov 20, 2006

FDA Approves Herceptin® for the Adjuvant Treatment of HER2-Positive Node-Positive Breast Cancer
Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Herceptin® (Trastuzumab), as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. Adjuvant therapy is given to women with early-stage (localized) breast cancer who have had initial treatment - surgery with or without radiation therapy - with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease.
The FDA approval was based on data from an interim joint analysis of more than 3,500 patients enrolled in two Phase III clinical trials. These results showed that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of breast cancer recurrence, the primary endpoint of the studies, by 52 percent (or a hazard ratio of 0.48) in women with HER2-positive breast cancer, compared to those patients who received standard adjuvant therapy alone.


Abbott's HUMIRA® (adalimumab) Receives FDA Approval for Inhibiting Structural Joint Damage and Improving Physical Function in Patients With Psoriatic Arthritis
Abbott announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for HUMIRA® (adalimumab) that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis (PsA). The expanded indication is in addition to the psoriatic arthritis approval granted in October 2005.
HUMIRA is also approved in the U.S. for use in moderate to severe rheumatoid arthritis (RA) and active ankylosing spondylitis (AS).
The expanded indication is based on results from an extension of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), the largest randomized, placebo-controlled biologic trial in PsA. ADEPT was a Phase III, controlled study in 313 patients with moderate to severe PsA, who had an inadequate response to NSAID (non-steroidal anti-inflammatory drug) therapy. Patients were randomized to receive either HUMIRA 40 mg every other week or placebo. At week 24, 285 patients elected to enroll in a 24-week open-label extension.


Allergan Announces FDA Approval of INAMED® Silicone-Filled Breast Implants for Breast Augmentation, Reconstruction and Revision Surgery
Allergan, Inc. announced that the United States Food and Drug Administration (FDA) has approved Allergan's INAMED® Silicone-Filled Breast Implants for use in breast augmentation, reconstruction and revision surgery. Until , INAMED® Silicone-Filled Breast Implants were only available in the United States to women seeking breast reconstruction and revision surgery through clinical studies. The approval is a significant development for women in the United States who now have the same options that women in more than 60 countries have had for the last 25 years.
Silicone gel-filled breast implants are among the most studied medical devices in existence, with thousands of peer-reviewed and published reports on studies, including robust epidemiological studies supporting their safe use. The safety of INAMED® Silicone-Filled Breast Implants is supported by the company's extensive pre-clinical device testing, their use in approximately 1,000,000 women worldwide and nearly a decade of U.S. clinical experience involving more than 80,000 women. Furthermore, silicone is used safely in the body in many medical devices and products, including pacemakers, heart valves, artificial joints and baby pacifiers.

Drug Pipeline Series: Submissions, Nov 13 - Nov 20, 2006

Angiotech submits application for European regulatory approval for its Vascular Wrap™ product
Angiotech Pharmaceuticals, Inc. announced that it has submitted an application for a CE Mark for its Vascular Wrap™ paclitaxel-eluting mesh / ePTFE vascular graft combination product on the strength of the results from its European first-in-man study.
The two-year trial which supports the CE Mark application produced evidence that treatment with the Vascular Wrap reduced the overall incidence of leg amputation and prolonged limb retention time in patients suffering from late stage peripheral arterial disease who underwent bypass surgery. For the patients that required an amputation during the study period, the mean interval to amputation for patients treated with the Vascular Wrap was 156 days - more than double the mean interval to amputation for the control, which was 76 days. At the same time, the Vascular Wrap appeared to be well tolerated, with no adverse events being considered related to the use of the product.

About peripheral arterial disease
Angiotech's Vascular Wrap™ paclitaxel-eluting mesh / ePTFE graft combination product technology is being developed for use in hemodialysis access and peripheral arterial bypass surgery. It is a combination product consisting of both the ePTFE graft and the Vascular Wrap paclitaxel-eluting mesh. The Vascular Wrap component is a biodegradable mesh implant incorporating Angiotech's paclitaxel technology in a novel biomaterial with the goal of mitigating scar formation caused by abnormal blood flow thereby potentially enhancing graft patency rates in AV-access patients as well as in peripheral bypass procedures.

Drug Pipeline Series: Phase III, Nov 13 - Nov 20, 2006

DVANCED MAGNETICS REPORTS POSITIVE RESULTS FROM IRON-REPLACEMENT STUDY
Advanced Magnetics presented positive results from a Phase III clinical trial of ferumoxytol as an intravenous iron replacement therapeutic at the American Society of Nephrology's annual meeting.
The study enrolled 304 non-dialysis-dependent chronic kidney disease patients who were randomized to receive either two 510-mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks. The study demonstrated a statistically significant achievement of all the primary and secondary endpoints. Additionally, all endpoints were statistically significant in both patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs.
Efficacy results in the intent-to-treat and efficacy-evaluable populations were similar. In the intent-to-treat population, ferumoxytol significantly outperformed oral iron for the primary endpoint of change in hemoglobin at day 35.
The results from the efficacy-evaluable population analysis showed that at day 35 patients receiving ferumoxytol had a significantly greater mean increase in hemoglobin compared with patients in the oral iron group. Ferumoxytol was more likely to increase baseline hemoglobin by greater than or equal to 1 g/dL compared with oral iron. Also, an increase in serum ferritin was significantly greater in the ferumoxytol group compared with the oral iron group at day 21. Stratifying by ESP use, there was a significant difference in hemoglobin increase for ferumoxytol compared with oral iron in both patients who were on ESP and those who were not.
Ferumoxytol was well-tolerated with repeated dosing. Adverse events occurred in 52.0 percent of oral iron patients compared with 35.5 percent of ferumoxytol patients. Similarly, drug-related adverse events occurred in 24.0 percent of oral iron patients compared to 10.6 percent of ferumoxytol patients.


Medicure Announces Initiation Of Enrollment In Pivotal Phase III MEND-CABG II Study
Medicure Inc. announced it has commenced enrollment in the MEND-CABG II study. This single confirmatory Phase III study for registration will evaluate the cardioprotective effects of the Company's FDA Fast Tracked product, MC-1, in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery.
MEND-CABG II is a double-blind, randomized, placebo-controlled clinical trial that will enroll up to 3,000 patients undergoing CABG surgery at approximately 120 cardiac surgical centers throughout North America and Europe. The study design was reviewed with the United States Food and Drug Administration (FDA). Study patients will be randomized to receive placebo or MC-1 250mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis.


Auxilium Pharmaceuticals, Inc. Initiates Phase III Trials for AA4500 in Dupuytren's Contracture
Auxilium Pharmaceuticals, Inc. announced that the first patients have been dosed in the Company's second U.S. Phase III pivotal trial and the first Phase III study outside the U.S. for AA4500 for the treatment of Dupuytren's contracture, a disabling and recurring condition in which the joints in the hand contract, impairing patients' ability to straighten and move their fingers.
The U.S. study is a double-blind, randomized, placebo controlled study of AA4500 involving more than 200 patients at up to 15 sites throughout the U.S. Patients in the study will be randomized on a 2:1 basis in favor of AA4500 treatment. To qualify for the study, patients must have at least 20 degrees of contracture. The primary endpoint of the study is to determine if AA4500 can reduce the contracture angle to within 0 to 5 degrees of normal as measured by digital goniometry.


Vanda Pharmaceuticals' VEC-162 Demonstrates Positive Results in a Phase III Transient Insomnia Clinical Trial
Vanda Pharmaceuticals Inc. announced positive top-line results from the company's Phase III clinical trial evaluating VEC-162, a balanced melatonin receptor agonist, in transient insomnia. VEC-162 demonstrated statistically significant improvements at all three tested doses compared to placebo (p<0.001) in the primary endpoint of the trial, Latency to Persistent Sleep (LPS), a measure of sleep onset. VEC-162 also produced statistically significant improvements relative to placebo in Latency to Non-Awake (LNA), another measure of sleep onset, Wake After Sleep Onset (WASO), a measure of sleep maintenance, and Total Sleep Time (TST). VEC-162 was also demonstrated to be safe and well-tolerated.
The Phase III trial was a randomized, double-blind, placebo-controlled, multi-center study that enrolled 412 adults in a sleep laboratory setting using a phase-advance, first-night assessment model of induced transient insomnia. The trial examined VEC-162 dosed 30 minutes before bedtime at 20, 50 and 100 mg versus placebo.


MEDICINOVA BEGINS TRIAL PROGRAM FOR ASTHMA TREATMENT
MediciNova has initiated a Phase III clinical program to determine the safety and efficacy of its novel oral treatment for bronchial asthma, MN-001.
The first Phase III trial in this program will involve approximately 705 asthma patients enrolled at 75 to 90 clinical sites in the U.S. Mild-to-moderate asthma patients will receive placebo or MN-001 for 12 weeks in this randomized, placebo-controlled, double-blind study. The primary endpoint of the trial will be the change from baseline in mean FEV1 (forced expiratory volume in one second) after 12 weeks of treatment. Secondary outcome measures will include a self-administered asthma quality-of-life questionnaire, the change from baseline in morning and evening peak flow rates, rescue beta-agonist use, serial spirometry parameters including assessment of acute effects following first dose on day one, daytime asthma symptom scores, nighttime awakenings from asthma, physician's global assessment, number of asthma exacerbations, discontinuations due to asthma, clinical global impression evaluations and change in urinary LTE4 levels. Additional Phase III trials are planned. Development of a continuous-release formulation of MN-001 will parallel the initial Phase III trials.
MN-001 is a novel, orally bioavailable compound that has been shown to block a number of the inflammatory mechanisms activated by mast-cell degranulation (e.g., leukotriene receptor antagonism and inhibition of phosphodiesterases III and IV, 5-lipoxygenase, phospholipase C and thromboxane A2) that are important in the pathogenesis of inflammatory disorders including asthma.
MN-001 is also under development by MediciNova for the treatment of interstitial cystitis. MN-001 is currently being evaluated in a pivotal-design Phase II/III clinical trial in 305 patients with moderate-to-severe interstitial cystitis at 39 clinical sites in the U.S. MediciNova anticipates having results from this trial by the beginning of 2007.

Drug Pipeline Series: Phase II, Nov 13 - Nov 20, 2006

CuraGen and TopoTarget Announce Initiation of NCI-sponsored Phase II Clinical Trial of PXD101 for Myelodysplastic Syndrome
CuraGen Corporation and TopoTarget A/S announced the initiation of patient dosing in a Phase II open-label, multi-center clinical trial evaluating the efficacy and safety of intravenous PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of Myelodysplastic Syndromes (MDS). This trial is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen for PXD101.
The primary endpoint for the study is the proportion of confirmed responses as defined by the International Working Group. Secondary endpoints include the time to progression, overall survival, duration of response, and toxicity. The pharmacodynamic activity of PXD101 will also be evaluated by the assessment of histone acetylation, gene expression profiling and DNA methylation. Patients will be enrolled at multiple sites in the United States.

Helix Biopharma Completes Phase 2 Clinical Study With Topical Interferon Alpha-2B In Patients With Low-grade Squamous Intraepithelial Lesions
Helix BioPharma Corp. announced completion of enrollment and treatment in its Phase 2 clinical study of Topical Interferon Alpha-2b in women with low-grade squamous intraepithelial lesions ("LSIL") that are positive for human papilloma virus ("HPV") infection.
The study was designed to evaluate the safety and effectiveness of Topical Interferon Alpha-2b in patients with cytologically confirmed LSIL and polymerase chain reaction ("PCR") confirmed HPV. Patients received Topical Interferon Alpha-2b therapy applied intravaginally three times a week for a period of six weeks, followed by a six week follow-up period. The primary study endpoint is to determine the proportion of patients with resolution of their abnormal Pap smear during the twelve week study duration.
No serious adverse drug reactions were reported in the study. The Company is completing analytical work on patient samples collected over the duration of the patient testing and will be gathering and analyzing the final data. The Company expects to complete all data analyses and report the final integrated study findings during the first quarter of calendar 2007.

Human Genome Sciences Announces Positive 76-Week Results of Phase 2 Clinical Trial of LymphoStat-B™ in Systemic Lupus Erythematosus
Human Genome Sciences, Inc. announced that the 76-week results of a Phase 2 clinical trial demonstrated that LymphoStat-B™ (belimumab) reduced disease activity in patients with serologically active systemic lupus erythematosus (SLE), exhibited durable biological activity, and appeared safe and well tolerated. In the LymphoStat-B treatment groups, the percentage of serologically active SLE patients who achieved the combined response rate selected as the primary efficacy endpoint for Phase 3 trials of LymphoStat- B™ increased from 46% at Week 52 to 56% at Week 76, with no increase in infections or infectious events observed over time.
The results were presented in two oral presentations in Washington, DC at the 70th Annual Meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals (ACR/ARHP). Additional LymphoStat-B results were reported in poster presentations throughout the meeting.

Quigley Pharma's QR-333 Phase IIb Clinical Study Has Commenced; Drug Product and Clinical Trial Sites Prepared for Phase IIb Study of Lead Drug Candidate
Quigley Pharma Inc. announced that patient enrollment in a phase IIb multi center clinical study of QR-333 for the treatment of symptomatic Diabetic Peripheral Neuropathy (DPN) has commenced. The Phase IIb double blind multi-center study will evaluate the safety and efficacy of QR-333, as compared to placebo-treated patients. The active QR-333 Investigational New Drug and placebo have been prepared for shipment and will be available to clinical investigators to begin treatment starting in December.
The Phase IIb trial will evaluate the safety and efficacy of QR-333 applied three times daily compared to placebo-treated patients over 12 weeks. Efficacy will be determined by Symptom Assessment Scores, a Visual Analogy Scale (VAS), Quality of Life and Sleep Questionnaires. Safety will be determined by medical history, physical examination, vital signs, 12-lead ECG, laboratory tests and nerve conduction studies. The study will involve 150-200 randomized male and female patients with Type 1 & 2 diabetes, as defined by the ADA (American Diabetes Association) and distal symmetric diabetic polyneuropathy.

EVOTEC BEGINS TRIAL OF INSOMNIA DRUG IN ELDERLY PATIENTS
Evotec has announced the initiation of a second Phase II study with EVT 201 under an investigational new drug application. This randomized, multicenter, double-blind study is a parallel design study with two doses of EVT 201 and placebo in 135 elderly patients with chronic primary insomnia and daytime sleepiness. It is designed to assess the hypnotic efficacy of EVT 201 during seven nights of treatment and also to determine the effect of improved sleep quality on daytime performance.
According to the company, the elderly are a significant portion of the insomnia patient population.
The primary endpoint of this trial is to assess total sleep time determined by polysomnography. The secondary endpoints include a variety of tests of daytime sleepiness and functional performance as well as additional sleep efficacy measures such as latency to persistent sleep, wake after sleep onset and number of awakenings, determined by polysomnography. In addition, effects on sleep architecture will be examined and patients will evaluate sleep quality and quantity subjectively.
In September Evotec initiated its first Phase II clinical trial with EVT 201, which is ongoing. Prior to this, in two Phase I/II studies using the traffic noise model of insomnia in healthy male volunteers, EVT 201 significantly reduced wake after sleep onset while significantly increasing total sleep time and quality of sleep with no subjective residual effects. The compound was well-tolerated without significant adverse events.

Drug Pipeline Series: Phase I, Nov 13 - Nov 20, 2006

SURFACE LOGIX PRESENTS POSITIVE DATA ON DYSLIPIDEMIA DRUG
Surface Logix announced the presentation of positive data from its first Phase I clinical trial assessing the safety and tolerability and establishing the pharmacokinetic and pharmacodynamic profile of its investigational drug candidate for dyslipidemia, SLx-4090. Results were presented at the American Heart Association's conference in Chicago.
SLx-4090 is a novel microsomal triglyceride transfer protein (MTP) inhibitor being developed for the treatment of dyslipidemia. Surface Logix designed SLx-4090 using its proprietary small-molecule Pharmacomer Technology to act specifically in the gastrointestinal (GI) tract to prevent the transport of fats through the intestinal wall. This unique feature of intestinal selectivity allows activity against fat uptake while avoiding toxicity at other sites of MTP expression including the liver, heart, testis, ovary and eye, according to the company.


SOSEI BEGINS TRIAL OF EMERGENCY CONTRACEPTIVE PILL
Sosei has announced the initiation of a Phase I clinical trial for the emergency contraceptive pill NorLevo. Sosei acquired the exclusive distribution rights to the product in Japan from Laboratoire HRA Pharma, and it is currently approved and marketed in more than 50 countries.
NorLevo is an oral emergency contraceptive used to prevent pregnancy after unprotected intercourse. NorLevo contains only levonorgestrel as an active ingredient. The dosing is started within 72 hours after unprotected sexual intercourse.
As a result of a large multinational study in 1998, the World Health Organization (WHO) demonstrated that levonorgestrel monotherapy, such as NorLevo, was well-tolerated and more effective than the Yuzpe method (ethinyl estradiol and levonorgestrel), an emergency contraception method used since 1977. Levonorgestrel monotherapy for emergency contraception is listed by WHO as an essential drug, according to Sosei.

Seattle Genetics Initiates Phase I Clinical Trial of SGN-35
Seattle Genetics, Inc. announced that it has initiated a phase I clinical trial of SGN-35 for patients with Hodgkin's disease and other CD30-positive hematologic malignancies. SGN-35 is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics' proprietary technology to empower antibodies by linking them to potent cell-killing drugs.
The single-agent, dose-escalation phase I study is designed to evaluate the safety, pharmacokinetic profile and antitumor activity of SGN-35 in patients with relapsed or refractory CD30-positive hematologic malignancies, including Hodgkin's disease. The trial is expected to enroll up to approximately 40 patients at multiple centers in the United States.