Takeda's Ads To Tout Safety Of Diabetes Drug Actos

Takeda Pharmaceutical Co. (4502.TO) plans to launch print ads Friday touting the safety of its diabetes drug Actos, just days after the U.S. Food and Drug Administration slapped new safety warnings on rival drug Avandia, from GlaxoSmithKline plc. (GSK).

Full-page ads set to run in about 60 newspapers and in several news magazines in the U.S. tell patients: "If you have type 2 diabetes, Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke," according to a copy of the ad provided by Takeda.

The FDA handed Takeda this marketing edge Wednesday, when it forced Glaxo to add a new warning to Avandia's prescribing label about potential heart attack risks for patients taking the drug. The FDA also said it would ask makers of other diabetes drugs, including Takeda, to note in their labels that their drugs haven't been proven to reduce cardiovascular risk.

Takeda, based in Japan, has tried to turn that into an advantage in the ads, telling consumers that Actos at least doesn't increase their risk of having a heart attack or stroke. The ad notes that a "major study" showed that Actos did not increase this risk in patients.

Shay Weisbrich, general manager of diabetes marketing at Takeda, said the company is concerned that the Avandia controversy has scared some patients off oral diabetes drugs altogether. "The more media there is out there, the more confusing it is for patients. We designed (the ads) to cut through that and provide some clarity," she said.

Some doctors have been switching their patients to Actos from Avandia in recent months, as concerns about Avandia's safety have mounted. Avandia's troubles began in May, when a prominent cardiologist published a study saying that patients taking Avandia had a higher chance of suffering a heart attack than those taking placebo or other oral diabetes medications. Glaxo has always maintained that Avandia is as safe for the heart as other oral diabetes drugs.

Actos is the only other marketed drug that works in the same way as Avandia. Before concerns about Avandia surfaced, the two drugs' sales were running neck and neck in the U.S. By midsummer, Actos sales were soaring while Avandia sales were plummeting. Ms. Weisbrich declined to say how Actos is selling currently.

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Japan Group Aiming To Test AIDS Vaccine In US In 2010

A Japanese consortium plans to begin clinical testing of its AIDS vaccine in the U.S. and elsewhere as early as 2010 in what would mark the first such testing of a Japanese-developed AIDS vaccine, The Nikkei reported in its Tuesday morning edition.

Developed using the proprietary technology of biotech venture firm Dnavec Corp., the nasal-spray vaccine is aimed at increasing the number of immune cells available to attack cells infected by HIV, the virus that causes AIDS.

The consortium includes the University of Tokyo, Dnavec, and the National Institute of Infectious Diseases, among others.

By using the vaccine, people who do not have AIDS would be able to increase their chance of fighting off the disease and reduce the risk of passing it on to others.

In tests that the group conducted using monkeys, HIV did not propagate among 60% of subjects given the vaccine prior to being exposed to the virus. Various AIDS vaccines have been tested around the world, but only a few were found to be effective in tests using monkeys, which belong to the same primate family as humans.

Clinical tests involving several dozen healthy people are expected to be organized through the International AIDS Vaccine Initiative, or IAVI, according to a basic agreement that has been struck with the Japanese group. If the tests prove the vaccine's safety and effectiveness, larger scale clinical tests will be carried out. The consortium hopes to commercialize the vaccine around 2015.

The IAVI, a global organization working to promote the development of preventative AIDS vaccines, is financed by donors including a foundation set up by Microsoft Corp. Chairman Bill Gates.

Switch From Lipitor To Generic Ups Heart Risks

Switching patients from Pfizer Inc.'s (PFE) cholesterol drug Lipitor to a generic version of Merck & Co Inc.'s (MRK) Zocor has been linked to a 30% increase in the risk of major heart complications, according to a Pfizer-sponsored study.

The study was presented Wednesday at the European Society of Cardiology meeting in Vienna, Austria, and is due to be published in the British Journal of Cardiology.

The study was based on an analysis of a database of more than 11,000 U.K. patients which included records from October 1997 to June 2005.

The analysis compared 2,522 patients who had taken Lipitor for six months or more and were switched to Zocor, which is generically known as simvastatin, with 9,009 patients who remained on Lipitor therapy.

According to the study, patients who switched cholesterol treatment had 30% higher risk of death, heart attack, stroke and heart surgery than those who continued taking Lipitor.

Zocor and Lipitor belong to a class of drugs called statins, used to lower cholesterol levels in people with, or at risk of, cardiovascular disease.

"It's not beneficial to have a universal switch to cheaper statins," said study author Peter Lansberg, of the Academic Medical Centre, University of Amsterdam, The Netherlands.

"We need to make a distinction between patients who benefit from generic statins and high-risk patients who need a more aggressive therapy."

The launch of generic copies of Zocor, which lost patent protection in June last year, has hurt Lipitor sales as health insurers have been encouraging patients to switch to the cheaper cholesterol-lowering drug.

In 2006, Lipitor sales reached $12.9 billion, making it the top-selling drug of all time and a key product for New York-based Pfizer in the last decade.

However, in the second quarter of 2007, the company's profit fell 48% on the back of slowing Lipitor prescriptions, whose global sales fell 13% compared with the same period in 2006.

The decline was steeper in the U.S., where sales slid 25% to $2.7 billion in the second quarter.

Iressa Near To Sanofi's Taxotere In Lung Cancer

Lung-cancer patients who took AstraZeneca PLC's (AZN) Iressa drug lived about as long as those taking Sanofi-Aventis's (SNY) Taxotere chemotherapy, according to a new study.

AstraZeneca said Wednesday the late-stage study compared overall survival between Iressa and Taxotere in 1,466 patients with advanced, non-small cell lung cancer who had received previous treatment.

The study showed Iressa was "non-inferior" to Taxotere. AstraZeneca said it was the first time a drug in Iressa's category has proven non-inferiority for overall survival, relative to chemotherapy, in a head-to-head Phase 3 study in patients with previously treated non-small cell lung cancer.

The data were presented at the World Conference on Lung Cancer in Korea. AstraZeneca didn't provide specific survival figures in a press release.

AstraZeneca also said Iressa had a more favorable "tolerability profile" and "superior quality of life" for patients, versus Taxotere.

Iressa is a type of targeted therapy known as an epidermal growth factor receptor tyrosine kinase inhibitor. AstraZeneca initially had high hopes for the drug but they were dashed when a study in 2004 showed that Iressa failed to extend lives in lung cancer patients. The U.S. Food and Drug Administration subsequently restricted use of the drug to people who are benefiting or have benefited from it. Iressa has been shown, however, to be effective in treating Asians with lung cancer.

Iressa is available in 36 countries, but not in most major European countries. Global sales were $113 million for the first six months of 2007. Taxotere sales were EU402 million in the first half of the year.

AstraZeneca said it's sharing the latest data with regulatory agencies.

J&J Ends Plan To Seek Wider Procrit Use

Johnson & Johnson called off plans to seek a broader list of approved uses for its drug Procrit, after the drug failed to show a reduction in the need for red-blood-cell transfusions among critically ill patients.

The finding, published today in the New England Journal of Medicine, is the latest blow to Procrit and other forms of erythropoietin, or EPO, a hormone that stimulates red-blood-cell production and is used widely in cancer, kidney and HIV patients.

In March, J&J added a prominent notice to Procrit's label, warning of an increased risk of death, heart attacks, and tumor growth in some situations, after studies indicated such risks. Next week, a Food and Drug Administration panel will hold a hearing on risks to kidney patients. Procrit sales have fallen 21% from two years ago.

The FDA has approved Procrit to treat anemic patients going into surgery or chemotherapy, and those who have kidney failure or HIV. J&J wanted to broaden that list to include anemic patients in an intensive-care unit, irrespective of a particular disease.

In the study, which J&J funded, doctors enrolled 1,460 ICU patients. Half received three injections of Procrit over a 15-day period, and the other half received a placebo.

A previous J&J study, published in 2002, suggested Procrit would reduce the need for red-blood-cell transfusions, but the latest study didn't show a reduction. As a result, J&J is calling off its attempt to broaden the drug's approved uses, a spokeswoman said.

Doctors are allowed to prescribe Procrit in the intensive-care unit anyway, but few do, said Aryeh Shander, the chief of the department of anesthesiology and critical-care medicine at the Englewood Hospital in Englewood, N.J. Today's study is likely to decrease such "off-label" use, said Dr. Shander, who has received grants and consulting fees from J&J.

In today's study, Procrit patients showed a drop in deaths, but the result wasn't statistically significant. Procrit did increase the risk of blood clots and other "thrombotic vascular" events, by roughly 40%, confirming the FDA's warnings and previous studies.

Procrit is made by Amgen Inc., which gets a 10% royalty from J&J. It sells the same drug to kidney patients undergoing dialysis as Epogen. J&J also sells a different synthetic erythropoietin, Eprex, internationally. J&J sold $758 million of Procrit and Eprex in the quarter ended in June.

Mylan Laboratories Says FDA Approves Carvedilol Tablets

Mylan Laboratories Inc. (MYL) said Thursday its Mylan Pharmaceuticals Inc. unit received Food and Drug Administration approval for its Abbreviated New Drug Application for carvedilol tablets.

Carvedilol is the generic for GlaxoSmithKline PLC's (GSK) Coreg tablets.

Mylan, a Canonsburg, Pa. drug company, said about $1.65 billion of the tablets were sold in the U.S. in the year ending June 30.

Teva Gets OK To Sell Generic Protonix, Though It May Wait

Though Teva Pharmaceutical Industries Ltd. (TEVA) won the right to sell a generic version of Wyeth's (WYE) Protonix, it remains unclear if it will actually move to launch the product immediately.

On Thursday, a federal court denied a preliminary motion to block Teva from launching a generic version of the treatment for erosive esophagitis associated with gastroesophageal reflux disease.

But complicating the matter is that the basis for the denial is unknown because the judge's opinion in the ruling, coming from the U.S. District Court for the District of New Jersey, was filed under seal pending review that it doesn't contain any confidential or proprietary information.

"Teva would obviously be much more willing to launch if the ruling was predicated on strong likelihood of success on the merits," writes Ken Cacciatore from Cowen & Co.

The full decision is expected to become available this coming Wednesday, according to a report from Bear Stearns.

"Teva intends to complete a thorough analysis of (Thursday's) decision before deciding upon its next course of action," the Israel company said in a statement.

Cacciatore said this is more cautionary language than usual from Teva following a preliminary injunction victory.

"Our best guess without seeing the ruling is that Teva and Wyeth may now reach a settlement and/or Teva will wait for a decision at trial," he said.

Though obviously, if the ruling does contain strong language on the merits of Teva's rationale for challenging the patent, then it may move to launch immediately.

Such a move is known as an "at-risk" launch because the generic maker can later be compelled to pay substantial damages to the branded-drug companies if their patent is upheld in court.

In its own statement, Wyeth said the court emphasized that its findings were preliminary and that the generic companies "would need to meet a higher burden of proof, clear and convincing evidence."

The court determined that Teva had raised sufficient questions about the validity of the patent to preclude issuance of the "extraordinary remedy" of a preliminary injunction, the Madison, N.J., company said.

Wyeth and Altana Pharma AG, recently acquired by Nycomed, sued Teva and Sun Pharmaceutical Industries Ltd. (524715.BY) for alleged patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications seeking Food and Drug Administration approval to market generic Protonix before the patent expires July 19, 2010.

Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until Aug. 2, 2007, and Sun's ANDA until Saturday.

Teva received that approval, but agreed not to launch before a decision was issued on Wyeth's motion for a preliminary injunction to prevent the launch until the resolution of the lawsuit.

Teva will have a 180-day period of marketing exclusivity, which will begin to run from the date of first commercial marketing or a final court decision.

A trial date has not been set.

Protonix was Wyeth's third-best-selling product in 2006, with $1.8 billion in sales. Wyeth licenses the drug from Nycomed.

Aspreva, Roche Won't Submit CellCept Reg Filings

Aspreva Pharmaceuticals Corp. (ASPV) and Roche Holdings AG will not submit regulatory filings for using the drug CellCept to treat lupus nephritis because its Phase III trial showed the drug was not "superior" to another treatment.

The Victoria, B.C., pharmaceutical company Aspreva said the trial compared CellCelpt, an immunosuppresant, with intravenous cyclophosphamide to treat the disease, which causes swelling of the kidneys.

The disease is caused by a malfunction of the immune system, which, if suppressed, can relieve symptoms.

Insights And Items Of Interest From Other Sources

Biotech's Future Could Reside in the Home

The enormous potential of biotechnology won't be realized by large corporations making new crops, but by companies aiming at homes and small farms, says physicist Freeman Dyson.

Biotechnology will enter into individuals' daily lives in the 21st century much in the same way that electronic devices like personal computers and digital cameras brought the advances in physics and chemistry into the homes of the late 20th century, Dr. Dyson says.

In the early computer era, pioneers like John von Neumann wrongly assumed computers would develop into "large centralized facilities." Similarly, people today generally think of genetic engineering as the exclusive domain of large corporations. Instead, Dr. Dyson says, biotechnology will make its largest advances by becoming "small and domesticated." For centuries, people have been effectively genetically engineering plants and animals through selective breeding. As individuals gain access to the tools of biotechnology, they will expand the diversity of pets and plants for recreational purposes, even creating games that allow children to tinker with genes, competing to make the prickliest cactus or scariest lizard. Genetically modified tropical fish with new colors already are appearing in pet stores.

Beyond household fun, Dr. Dyson, the father of information-technology guru Esther Dyson, anticipates that the domesticated form of biotechnology will allow rural communities to challenge the economic power of cities, by transforming themselves into biotechnology research centers. He notes that Dolly, the first cloned sheep, came from an animal-breeding center in Scotland, rather than Silicon Valley. With their expertise in biotechnology, rural communities might even come up with technologies for heavy industry, such as developing earthworms that could wring aluminum from clay or seaweed that could extract magnesium from sea water.

Dr. Dyson, known for making bold predictions in many scientific fields and a favorite source for science-fiction writers, says biotechnology still poses many dangers. He leaves it to future generations to resolve how his futuristic vision can be safely adopted.

Radiate Study Meets Primary End Point

Swiss drugmaker Roche Holding AG (RHHBY) said Tuesday that RADIATE, the third study in Actemra's (tocilizumab) extensive multinational phase III development programme, successfully met its primary endpoint.

The study examined Actemra in combination with methotrexate in rheumatoid arthritis (RA) patients who had an inadequate response to anti-tumour necrosis factor therapy (anti-TNFs).

The study conducted in 498 patients with difficult-to-treat RA disease, showed that a greater proportion of patients treated with Actemra plus methotrexate, achieved a significant improvement in disease signs and symptoms (ACR scores3) following 24 weeks of treatment, compared to patients treated with placebo plus methotrexate.

"RADIATE's positive outcome further confirms the critical role of IL-6 in the pathophysiology of rheumatoid arthritis," said Urs Schleuniger, Business Director, Inflammation and Autoimmune Disease, Roche Pharmaceuticals. "These results add to the wealth of data being compiled ahead of the anticipated regulatory filing later this year," he added.

Roche In $1B Alliance With Alnylam On RNAi

Roche Holding AG (RHHBY) Monday entered an alliance worth up to $1 billion with Alnylam Pharmaceuticals Inc. (ALNY) of the U.S. in which the Swiss drugmaker obtains access to the U.S. biopharmaceutical company's technology platform for developing treatments based on RNA interference.

Roche, based in Basel, said it will pay Alnylam $331 million upfront, including a cash payment and an equity investment of $42.5 million, which represents a stake of just under 5% of Alnylam's outstanding shares.

The close of the agreements, including Roche's purchase of Alnylam shares and purchase of Alnylam's site in Germany, is subject to certain regulatory approvals and is expected within around 30 days.

RNA interference, or RNAi, is considered one of the hottest new areas of drug research. It represents breakthrough in understanding how genes are turned on and off in cells. RNAi was the basis for last year's Nobel Prize in medicine, as it is seen offering a completely new approach to drug discovery and development.

Roche's deal follows on the heels of AstraZeneca's (AZN) deal with U.K.-based Silence Therapeutics Plc (SLN.LN), announced on Friday and valued at as much as GBP200 million. Last fall, Merck & Co. (MRK) agreed to pay $1.1 billion for Sirna Theruapeutics Inc. of the U.S. to get access to RNAi technology.

Santhera And Novartis Set Licencing Deal On CMD Treatment

Switzerland-based Santhera Pharmaceuticals AG (SANN.EB) Monday said it has enetered a licensing agreement with Novartis AG (NVS) covering the compound omigapil for the treatment of Congenital Muscular Dystrophy, or CMD.

Santhera will pay Novartis an upfront fee, and a further milestone payment upon entering into the pivotal clinical trial in CMD. Santhera will have the right to use all preclinical and clinical data generated on omigapil and receives the remaining drug substance on stock at Novartis. Furthermore, Novartis will receive an additional payment if the drug receives market approval in the EU and the United States as well as royalties based on the sales of the product.

Santhera will develop omigapil as a potential treatment for this severe, genetically determined neuromuscular condition which frequently affects infants or young children with life-threatening progressive muscle weakness. Santhera expects to commence a Phase II trial in CMD patients by the end of 2008. Santhera also has the option to expand the development of omigapil into other neuromuscular indications while Novartis retains a buy-back option confirming Novartis' continuing interest in the compound and its potential as identified by Santhera.

Novartis retains the option to buy back the rights to omigapil under certain conditions. If Novartis decides to exercise this buy back option Santhera would be reimbursed a multiple of its development costs and would receive milestone payments upon market approval as well as royalties based on future product sales. In addition, Novartis is committed to use Santhera's specialized sales and marketing organization in the U.S., which is expected to be in place to support the launch and marketing of Santhera's lead compound SNT-MC17 for Friedreich's Ataxia and other indications.

Santhera will need to perform additional preclinical development work with SNT-317, given its intended use in children, before commencing a Phase II clinical trial in CMD patients. This trial is expected to start before the end of 2008.

Galapagos Extends Osteoarthritis Deal With GlaxoSmithKline

Galapagos NV (GLPG.BT) announced Monday that its existing multiyear alliance in osteoarthritis with GlaxoSmithKline (GSK) will be expanded, and that Galapagos has issued 513,281 new shares for an investment of EUR4.4 million by GSK.

GSK will bring a drug discovery program against a selected GSK target into the alliance. Within this additional program, Galapagos will progress a disease-modifying drug towards completion of clinical Phase IIa or "Proof-of-Concept", at which point GSK's global research and development organization will be responsible for the late-stage development, production and marketing of the drug. Furthermore, GSK may add a second osteoarthritis drug discovery program against a selected GSK target into the alliance.

Industries and Government Promote E-Prescribing

The widespread use of electronic systems to send prescriptions from doctors to pharmacies promises to prevent thousands of life-threatening medical errors, save billions of dollars in health-care costs and even drive more business to drug stores.

Most U.S. physicians, however, have yet to adopt electronic prescribing, or e-prescribing, for the estimated 4 billion prescriptions they write annually, a situation that a phalanx of corporations and the government are working to change.

E-prescriptions, at only a couple of million a month today, "are on the verge of an explosion," Walgreen Co. (WAG) Chairman David Bernauer told the National Association of Chain Drug Stores in April.

With e-prescribing, physicians can use hand-held or desktop computers or "smart" mobile phones to send patient drug prescriptions to pharmacy computers.

Beyond conveying prescriptions, systems can alert doctors to potential drug interactions or dosing problems, eliminate handwriting errors, automate the time-consuming renewal process, provide data on a patient's drug plan, and potentially cut thousands of pharmacy calls to doctors. Hospitals, insurers, technology companies, regional collaboratives and pharmacies have been working to advance adoption of e-prescribing.

The drug store industry formed an organization, SureScripts, in 2001 to develop a network that now allows doctors to electronically transmit prescriptions to almost all U.S. pharmacies. More than 120 physician and pharmacy software companies are certified or nearly certified to send or receive prescriptions over the SureScripts exchange.

The scores of physician software companies with products used in e-prescribing include large electronic health-records businesses such as General Electric Co.'s (GE) GE Healthcare and standalone e-prescribing concerns such as Zix Corp. (ZIXI).

Early this year, one of those companies, clinical software maker Allscripts Inc. (MDRX), joined computer maker Dell Inc. (DELL) to form a broad coalition - the National ePrescribing Patient Safety Initiative - in a $100 million effort to provide for free Allscripts' Web-based e-prescribing technology to every physician in the U.S.

The NEPSI coalition includes health insurers Aetna Inc. (AET) and WellPoint Inc. (WLP), technology giants Microsoft Corp. (MSFT) and Cisco Systems Inc. (CSCO), Fujitsu Ltd.'s (FJTSY) U.S. computer business, Google Inc. (GOOG), Sprint Nextel Corp. (S), SureScripts, Wolters Kluwer N.V.'s (WTKWY) health division, and several academic medical centers.

The coalition targets doctors in small group practices, aiming to address concerns about costs and difficulty, among other barriers to their adoption of e-prescribing technology.

"A doctor can sign up within an hour," Allscripts Chief Executive Glen Tullman, co-chair of NEPSI, said in an interview. The coalition isn't providing statistics yet but Tullman said the effort is "making great progress."

NEPSI estimates that as many as 20% of the 550,000 practicing U.S. physicians had the technology to send e-prescriptions but that only 5% of the nation's doctors actually have been using it to prescribe electronically.

Allscripts' Tullman said the coalition's effort so far has added thousands of more physicians nationwide to the ranks of e-prescribers. He expects "a very strong, very high-visibility" ramping up in September, with large employers and more managed-care companies and payors joining the coalition. He also expects state governments to become active in mandating electronic prescribing.

After recent updates to state laws and regulations, e-prescribing is now legal in 49 states and soon will become so in all 50 with the addition of Alaska, according to SureScripts President and Chief Executive Kevin Hutchinson.

E-prescribing proponents, including the U.S. Department of Health and Human Services, point to a study that estimates adoption of e-prescribing technology could save $27 billion in U.S. health-care costs by reducing adverse drug events and improving work flow.

"Clean and correct scripts safeguard our patients' safety, save our pharmacists time and increase our business," Walgreens' Bernauer said in his speech. Bernauer cited a study showing that 11% more prescriptions make it to the pharmacy when a doctor switches to e-prescribing.

HHS, in a recent report to Congress, cited expert projections that e-prescribing could avoid more than 2 million adverse drug events annually, 130,000 of which are life-threatening. Even so, five government-funded e-prescribing pilot projects did not establish the effect on patient safety, the report said, noting the role of office staff members in handling e-prescribing tasks. The effect on safety requires more study, the report said.

The Allscripts-Dell coalition cites statistics from the nonprofit Institute of Medicine of the National Academies that 1.5 million patients a year are injured and more than 7,000 die as the result of preventable medication errors. The numbers actually may be higher, as Allscripts says studies indicate that doctors using the NEPSI-provided software cancel 1% of prescriptions because of improper-dosage or adverse-reaction warnings during prescribing.

Investment firm Stifel Nicolaus expects the move to e-prescriptions to accelerate in the near term, and sees its adoption as "a key on-ramp to the adoption of electronic medical records," a view that some others share.

E-prescribing is a component of insurer WellPoint's multi-million-dollar health information-technology efforts, said Charles Kennedy, WellPoint vice president for health IT. In Ohio, doctors can earn higher reimbursement from WellPoint if they fill prescriptions electronically.

WellPoint sees e-prescribing as a way to lower costs and improve safety and quality of care, including driving greater use of generic drugs, Kennedy said. The company is seeing very rapid growth in the transactions, although e-prescribing, in its early stages, remains "a drop in the bucket," he said.

Allscripts is "doing the right thing" and making health-care better in giving doctors free access to its web-based e-prescribing software, Allscripts CEO Tullman said. He acknowledged that the company also aims to build its brand and sell its wider offering of electronic-health-records software to physicians. "We think of this as the on-ramp to the electronic health-care highway," he said.

The company estimates that its paying customers and those receiving the free software account for approximately half of all prescriptions filled electronically in the U.S. today.

Among other efforts in recent years, regional partnerships in Massachusetts, where Blue Cross and Blue Shield of Massachusetts is involved, and Rhode Island have made those states e-prescribing leaders. In Michigan, the big three U.S. automakers joined with insurers and others to launch an e-prescribing effort.

Researchers from the Center for Studying Health System Change noted in the journal Health Affairs this spring that physicians with e-prescribing equipment reported various problems with using it but said employment of such technology improves prescribing safety and the efficiency of their practices, "and they did not want to go back to paper."

The Medicare Modernization Act of 2003 required adoption of technical standards for processing electronic prescriptions and mandated that Medicare prescription-drug plans support e-prescribing.

The law effectively resolved industry debate over which standards to use, according to SureScripts CEO Hutchinson. He also serves as a commissioner on HHS's American Health Information Community, which develops standards to accelerate adoption of health-care technology.

E-prescribing is one process the federal government is exploring to improve health-care interoperability and keeping patients on their medications, he said. The prescription "makes it beyond the glove box of the car," Hutchinson noted.

Dr. Jan Cornell, a family practice physician in Calumet, Mich., adopted Allscripts' free software in February. "The pharmacists were really happy to see me use something that has a printout," he said. The initial loading of patient information into the system can be a chore, and his colleagues are wary of the task, he said.

NICE OKs Elan, Biogen MS Treatment Tysabri

Ireland-based Elan Corp. (ELN) and U.S.-based Biogen Idec (BIIB) said Tuesday they welcome the U.K. National Institute for Health and Clinical Excellence recommendation for the use of their drug Tysabri, the first NICE approval for any multiple sclerosis drug.

The companies said Tysabri represents a significant advance in MS treatment, offering hope of delaying the progression of disability and reducing the frequency of relapses.

According to the companies, treatment with Tysabri over two years leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo.

As of late May, the treatment was being used in about 12,000 patients in both commercial use and clinical trials in the U.S., Germany, France, Ireland and other countries.

However, said one analyst who follows the sector, a key approval for the drug is still awaited from the U.S. Food and Drug Administration.

"This has to be seen in that context," he said, though he added that approval in the U.K. clearly bodes well for the drug.

Roche's Actemra Clears Hurdle On Way To Approvals

Drugmaker Roche Holding AG (RHHBY) Friday said Actemra, an experimental drug that treats rheumatoid arthritis in a new way, showed positive results and was safe in a key study, paving the way to file the drug for regulatory approval in Europe and the U.S. later this year.

Roche, based in Basel, Switzerland, said the study, dubbed OPTION, showed that a greater proportion of patients treated with Actemra in combination with traditional drugs achieved a significant improvement in disease signs and symptoms after 24 weeks, compared to those treated with the traditional drugs alone.

Sufferers of rheumatoid arthritis, or RA, begin to experience progressive joint damage early in the disease. The disease differs from what is popularly known as arthritis, typically associated with age-related joint pain; RA is a far more serious inflammatory disease that leads to destruction of cartilage and bone, and can lead to disability.

Patients have a big number of treatment options to chose from, but many drugs merely relieve pain, in some cases at the cost of severe long-term side effects including osteoporosis and high blood pressure.

Actemra works by inhibiting the activity of interleukin-6, a protein that plays a major role in the inflammation process of rheumatoid arthritis; it's generally well tolerated, Roche said.

If approved, Actemra will compete with other biological drugs called anti-TNF medicines. These medicines target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory disease.

Johnson & Johnson's (JNJ) Remicade and the drug Enbrel, which is co-marketed by Amgen Inc. (AMGN) and Wyeth (WYE), are all part of this class.

In the study, four times the number of patients in the Actemra group experienced a 50% improvement in disease symptoms compared to the control group, while more than ten times the number of Actemra patients achieved 70% improvement in disease signs and symptoms compared to the control group. In addition, 28% of patients achieved the ultimate goal of remission in the Actemra group against only 1% of patients in the control group.

At 0950 GMT, Roche shares were up CHF1.60, or 0.7%, at CHF219.90, in a higher broader market.

Actemra, also known as tocilizumab, was developed by Japanese pharmaceutical company Chugai Pharmaceutical Co. (4519.TO), which is controlled by Roche. Roche owns the rights to market Actemra outside Japan.

The drug has shown very good results in trials conducted in Japan, and Roche hopes to replicate these early data from the Japanese trial in large American and European studies. The study presented Friday, is is the first of five international late-stage trials that are investigating Actemra's efficacy and safety.

Roche plans to file Actemra for regulatory approval in Europe and the U.S. by the end of 2007. It usually takes around a year for regulators to review data submitted by a company and decide on approving a new drug.

In Japan, where the approval process usually takes somewhat longer, Actemra was filed for regulatory approval in April 2006.

Gilead Says FDA Approves Drug To Treat PAH

Gilead Sciences Inc. (GILD) said the U.S. Food and Drug Administration late Friday approved its drug ambrisentan for the treatment of a lethal form of hypertension that strikes without warning and can kill within three years if untreated.

The drug, which will carry the U.S. trade name Letairis, is designed to treat a disease known as pulmonary arterial hypertension (PAH), in which arteries in the lungs constrict and thicken, raising blood pressure and eventually causing heart failure. Patients typically go to doctors complaining of exhaustion, breathlessness, and inability to walk distances or perform activities of normal daily living. Often no cause can be identified, although the condition also can be triggered by diseases like scleroderma or advanced HIV, or by certain medicines like the diet drug combo Fen-Phen.

Letairis belongs to a class of drugs called ERAs or endothelin receptor antagonists, compounds that relax the vessels, lowering blood pressure and lightening the load on the heart and lungs. However, such drugs can't be taken by pregnant women due to risk of major birth defects, and can cause liver damage.

In studies, the drug improved patients exercise capacity, as measured by a six-minute walking distance test. Gilead said it has priced the drug at $3,940 a month, comparable with other oral drugs for the disease. Gilead said it established a program to ensure greater access to patients who are underinsured or face high co-payment requirements.

Because of the risks of liver damage and birth defects, the drug's label will carry strong cautionary language in a black box, as do other drugs of its class. Gilead says its studies show that incidence of liver damage is less with Letairis than with other products in this class. The company said Letairis will be available only through a special restricted program to educate patients and doctors about safe usage.

Gilead acquired the drug as a result of its merger with the drug's developer Myogen Inc. in November 2006, and plans to make it the centerpiece of a third branch of its business in the cardio-pulmonary field. Gilead's core business has focused mainly on products for HIV and hepatitis.

Based on market research, Gilead said it estimates about 75,000 to 90,000 people in the U.S. suffer from PAH, and 200,000 people worldwide, although fewer than half of them are currently believed to be diagnosed. The condition is often misdiagnosed as exercise-induced asthma or other respiratory ailments.

Letairis will be marketed in the U.S. by Gilead, and by GlaxoSmithKline PLC (GSK) outside the U.S.

Basilea Superbug Filed For European Approval

Basilea Pharmaceutica AG (BSLN.EB) said Monday its superbug antibiotic has been submitted for European approval, prompting a milestone payment of 12 million Swiss Francs ($9.8 million) for the Basel-based company.

Basilea said the anti-infective treatment ceftobiprole was submitted to the European Medicines Agency by a subsidiary of Johnson & Johnson (JNJ), with whom Basilea will sell the treatment in the U.S. and major European countries.

"Today's marketing authorization application submission as well as the recent new drug application filing in the USA reflect our view that ceftobiprole could play an important role globally in the future management of important medical problems posed by methicillin-resistant Staphylococcus aureus," Basilea's Chief Executive Anthony Man said in a statement.

The filing, in keeping with Basilea's pledge to submit the treatment this year, follows favorable study date from January, where the treatment was shown to be effective against complicated skin infections.

In January, Basilea said ceftobiprole demonstrated high cure rates in a range of patients, including those with methicillin-resistant Staphylococcus aureus, or MRSA, and diabetics with foot infections.

Basilea shares, which jumped earlier this year after the most recent data from ceftobiprole, have gained 28% this year, giving the company a market capitalization of $2 billion.

The stock closed at CHF272 Friday; trading resumes at 0700 GMT Monday.

Ceftobiprole is in Phase-III testing to treat patients who develop pneumonia while in hospital, as well as community-acquired pneumonia, for which Basilea expects results in the latter half of 2007.

New Option For Rare Condition

People with a rare and lethal high blood pressure now have more options for convenient treatment with less drug toxicity.

Late Friday the Food and Drug Administration approved Letairis, a pill made by Gilead Sciences Inc. for the treatment of pulmonary arterial hypertension, in which lung vessels constrict, raising blood pressure and leading to heart failure.

Mysterious and often misdiagnosed, PAH can arise without warning. It also can result from diseases like scleroderma or advanced HIV, or the diet drug combo known as fen-phen. Based on market research, Gilead, of Foster City, Calif., estimates 75,000 to 90,000 people in the U.S. have PAH, over half of them undiagnosed.

About a half-dozen PAH drugs exist, all of them expensive, including round-the-clock infusions and some oral drugs that risk birth defects and liver damage. Some patients require lung transplants, though drug therapy can stave off the need for it. Letairis's label carries a black-box warning about such risks, but the company and some analysts say it has the best safety profile of any oral drug to date. Shashi Sahgal, a 42-year-old homemaker and mother of two teenagers in Mission Viejo, Calif., was hiking and bounding up stairs two at a time back in 2002. When she felt winded, doctors thought she had exercise-induced asthma. By the end of 2002, exhaustion and an enlarged heart led doctors to perform a right-heart catheterization. That nailed the diagnosis of PAH.

Without treatment, PAH can be fatal within three years. Referred to lung specialist Ronald Oudiz of Harbor UCLA Medical Center in Torrance, Calif., Mrs. Sahgal entered a trial of the new Gilead drug, then known by its generic name ambrisentan. "It made a huge difference," she says.

Gilead acquired ambrisentan as part of its merger with Myogen Inc. last November, and it now plans to launch sales in the U.S. this week. Under a co-marketing agreement with GlaxoSmithKline PLC, GSK is seeking approval to market the drug outside the U.S. On Friday, the FDA delayed action on another PAH drug, Thelin by Encysive Pharmaceuticals Inc. of Houston, urging more studies.

The first drug approved for the condition in 1995 was GSK's Flolan, an infusion given continuously through a chest catheter. Originally designed as a bridge to a transplant, the drug treatment alone has extended some of his patients' lives by 13 or 14 years, says UCLA's Dr. Oudiz. Gilead now sells Flolan in the U.S., while GSK markets it outside the US.

United Therapeutics Corp., Silver Spring, Md., markets a similar drug, Remodulin, which is given as a subcutaneous or intravenous infusion. A pill form is being studied.

Swiss drug maker Actelion Ltd. markets an inhaled drug, Ventavis. It also markets a pill, Tracleer, part of an oral-drug family that expands vessels but can cause liver damage or birth defects.

Gilead's Letairis is also part of the same drug family, known as ERAs (endothelin receptor antagonists, which work by relaxing blood vessels). Gilead says its studies show Letairis has a lower incidence of liver toxicity than rival products. Common side effects include peripheral edema (or swelling), nasal congestion, flushing and palpitations. Patients must have liver enzymes monitored to detect any signs of damage, and women -- who account for most PAH patients -- must avoid becoming pregnant.

Pfizer Inc. entered the field after discovering its erectile-dysfunction drug, Viagra, could benefit vessels of the lungs as well. The New York company rechristened the drug as Revatio for PAH. Another such drug, Indianapolis-based Eli Lilly & Co.'s Cialis, is now in tests for PAH.

Like other orphan drugs for rare but serious diseases, PAH treatment is costly. A year of Flolan can run $100,000, while Tracleer tops $40,000, according to Gilead officials.

On Friday, Gilead said it set the price of Letairis at $3,940 a month, or $47,280 a year, using Tracleer's pricetag as a benchmark. The company plans to offer patient assistance with reimbursement, as well as some discounts and free drugs to patients lacking coverage.

A year of Revatio given as a thrice-daily 20-milligram tablet is about $10,000, says Dr. Oudiz. But for uninsured patients who are taking higher doses, he says it is less costly to take the drug as Viagra.

Dr. Oudiz has received funding support from Actelion, Gilead, Pfizer, United Therapeutics, Encysive and Lilly.

Like many patients who move to combination therapy, Mrs. Sahgal now also takes Revatio, along with the blood-thinner coumadin to prevent clots.

"I still can't go uphill fast, and I'm not going to climb Mt. Everest," says Mrs. Sahgal, now 46. But she adds, "If all goes well, we're looking at 20-plus years."

BioMS Gets FDA Approval For Pivotal Trial Of MS Drug

BioMS Medical Corp. (MS.T) has received approval from the U.S. Food and Drug Administration to start a pivotal trial of its lead drug, MBP8298, a potential treatment for patients with secondary progressive multiple sclerosis, the company confirmed.

The Phase III trial will enroll about 510 patients and take about two years, said Kevin Giese, BioMS Medical's president and chief executive.

The company has already begun a Phase III trial of the drug in Canada and Europe, which will enroll about 550 patients.

Multiple sclerosis is a disease of the central nervous system, marked by such things as paralysis, blindness and cognitive impairment.

Shares of BioMS are halted in Toronto Friday. The stock last traded at C$3.48.

Kevin Giese, president and chief executive of BioMS Medical Corp. (MS.T), said the company submitted an application for the trial with the U.S. Food and Drug Administration last month, and the agency gave its consent relatively quickly.

That means BioMS will soon have two Phase III trials in secondary progressive multiple sclerosis, or MS.

He hopes to commence the U.S. trial, which will cost a total of about C$50 million, in the first half of this year. While the company does have the funds to initiate the study, it will eventually have to raise more to get it done, he added.

Giese also noted that the Alberta-based biotech is close to completing patient enrollment in the Canada/Europe MS trial, and that data from an interim analysis of the trial are due 16 months from now, which isn't that far off in biotech terms. This trial has passed six safety reviews by an independent board to date.

Geron Spinal Cord Treatment Produces Nerve Growth

Geron Corp. (GERN) said Wednesday its stem-cell treatment for spinal-cord injuries produced nerve growth in animal models, potentially removing a first hurdle for it to begin clinical trials in the future.

Shares of the company were recently trading up 29 cents, or 3.4%, at $8.94, on heavy early volume.

Menlo Park, Calif.-based Geron said Wednesday findings for the treatment, GRNOPC1, affirmed the company's cell-based approach to spinal-cord injury.

When injected into animal models, the therapeutic stimulated nerve growth and extension, in addition to its already reported remyelinating activity - which repairs the coating around the neurons without which nerves are unable to function.

"The multiple functions of GRNOPC1 affirm the potential therapeutic utility of our cell-based approach to the repair of spinal cord injury and provide multiple mechanisms within a single therapy to achieve functional recovery," said Thomas B. Okarma, Geron's president and chief executive officer.

Geron operates at a loss, and recently reported its third-quarter loss narrowed to $9.84 million, or 15 cents a share, from $11.9 million, or 21 cents a share, in the year-earlier period.

But research advances are lending hope to doctors that spinal-cord injuries will one day be treatable.

"They are on the road to entering the clinic and this is the first step for that to proceed," said WBB Securities analyst Stephen Brozak, who had no conflicts to report.

The treatment could improve survival of the neurons, and allow formation of alternative circuitry, where they have been disrupted due to spinal-cord injury. Return of sensation would markedly improve quality of life, Brozak said.

Although stem-cell research has been inhibited by federal legislation in the U.S., shares of Geron and other companies recently received a lift after an approved constitutional amendment in the state of Missouri was passed protecting the research, and amid hopes a Democrat-controlled House of Representatives will be more amenable towards the field.

There are an estimated 10,000 to 12,000 spinal-cord injuries in the U.S. every year, and a quarter of a million Americans currently live with spinal-cord injuries, most of those being under 30 years old.

FDA Approves Shire Drug For Ulcerative Colitis

The Food and Drug Administration has approved a new Shire PLC (SHPGY) drug to treat mild to moderate ulcerative colitis, the company said Tuesday.

The drug, Lialda, is a once-daily formulation of mesalamine, a drug commonly used to treat the condition.

Ulcerative colitis is a type of inflammatory bowel disease, a chronic condition that causes inflammation of the digestive tract. It's believed that about 500,000 Americans have ulcerative colitis.

Mike Yasick, Shire's senior vice president who oversees gastrointestinal drugs, said Lialda will offer much more convenient dosing than other mesalamine pills, which include another Shire drug, Pantasa. Those drugs require dosing three to four times daily and six to 16 pills.

A survey released last month by the Crohn's and Colitis Foundation of America found that 65% of patients with ulcerative colitis aren't compliant with their medication, which can make the disease more difficult to control.

Shire said Lialda would be available during the first quarter of this year.

More serious cases of ulcerative colitis are treated with steroids and other medications, such as Johnson and Johnson's (JNJ) Remicade, designed to block a protein involved with the inflammatory process.

OraSure Sees Oral Hepatitis C Test Trials Ending In 2007

OraSure Technologies Inc.'s (OSUR) chief executive Thursday said he expects clinical trials of a rapid oral test for the detection of hepatitis C to be completed by the end of this year.

Once the trials of the test - being jointly developed by OraSure and Schering-Plough Corp. (SGP) - are completed, the company will apply for marketing approval in the U.S., and in Europe soon thereafter.

Last week, Schering-Plough and Bethlehem,Pa.-based OraSure - which already makes the only approved HIV rapid oral test - inked a two-year deal to jointly develop and market the oral hepatitis C test.

The CEO also said OraSure was looking globally to acquire companies with complementary product profiles and with new technologies related to the treatment of infectious diseases.

"We have $90 million in cash right now and are looking to deploy it," Michels said. "We are actively evaluating potential acquisitions and technology-licensing agreements."

Michels said the development of novel treatments for hepatitis C that cut down on treatment time would be a boost to the market's acceptance of the company's test.

Vertex Pharmaceuticals Inc. (VRTX) is engaged in developing such a therapy, as is Schering-Plough, which makes the current standard treatment for hepatitis C, pegylated interferon, called Peg-Intron, which is often used with ribavirin.

The hepatitis C virus is the most common blood-borne infection in the U.S., with around 4 million people suffering from it. It affects as many as 170 million people worldwide. It is the main reason for liver transplants in the U.S.

Michels said as many as 2 million to 3 million Americans who may have the virus remain untested.

While new infection rates have declined in the U.S., and blood is now screened for the virus, those who caught it through blood transfusions in the late 1970s and early 1980s are approaching treatment age, and many more in the population may have the virus but remain unchecked as symptoms can take up to 20 years to appear.

Basilea Shares Jump On Positive Test Results

Shares in Basilea Pharmaceutica AG (BSLN.EB) hit record highs Wednesday after the Swiss biotechnology company said late-stage testing of its superbug antibiotic ceftobiprole showed it to be effective in treating complicated skin infections.

The Basel-based company said ceftobiprole demonstrated high cure rates in a range of patients, including those with methicillin-resistant Staphylococcus aureus, or MRSA, and diabetics with foot infections. Basilea also said it plans to submit its first regulatory filing for the drug this year.

Analysts said the positive results weren't a surprise, given that the drug had already been proven successful in an earlier late-stage study, but are still good news for the company.

"A good outcome was expected, but this trial was perceived as slightly riskier than earlier ones, so this (outcome) is nice," said Denise Anderson, an analyst at Kepler Equities, who believes ceftobiprole will become best-selling antibiotic globally with annual sales of at least $1B.

Still, Anderson doesn't plan to change her estimates following the latest trial data, noting the stock is already generously valued. She has a reduce rating on Basilea with a CHF170 target price.

At 0953 GMT, shares in Basilea, which plans to jointly sell ceftobiprole with Johnson & Johnson (JNJ) unit Cilag GmbH International in North America and major European countries, were up 3.1% at CHF220.50 - off its earlier record high of CHF221.90 - in a lower Swiss market.

Basilea said 91% of clinically evaluable patients in the Phase III trial were cured with ceftobiprole, compared to 90% of patients treated with combination therapy.

The clinical response in patients with diabetic foot infections was 86% for ceftobiprole and 82% for comparator combination therapy, respectively.

Over 20% of microbiologically evaluable patients had confirmed MRSA infections. The cure rate for ceftobiprole in MRSA patients was 91% compared to 86% for the comparator regimen.

One third of patients had infections involving a Gram-negative pathogen. The microbiologic eradication rates in these patients were similar at 84% in both treatment groups. Markus Metzger, an analyst at Bank Vontobel, said in a note he expects ceftobiprole to hit the market in 2008. He noted the revenue potential of the antibiotic also depends on the results of testing against another condition.

"Ceftobiprole is reflected in our estimates with a peak sales potential of CHF1.5 billion...across all indications, with the potential to a large part being dependent on the second indication," hospital-acquired pneumoniae, or HAP, he said.

Results from that trial are expected during the second half of 2007, he added. Metzger's price target for Basilea's stock remains at CHF188.

Bacteria such as MRSA have developed resistance to conventional antibiotics in recent decades as major pharmaceutical companies have focused on treatments for chronic lifestyle diseases and new cancer therapies, leaving research to small biotech companies.

Basilea, which listed on the Swiss stock market in March 2004, first signed an agreement with Johnson & Johnson to develop, manufacture and sell ceftobiprole in early 2005. As part of the agreement, the Swiss company would get upfront and milestone payments of up to CHF370 million. It would also get double-digit royalties on worldwide sales if the MRSA drug made it to the market.

volutec Open To Offers As Key Drug Fails Test

Biopharmaceutical company Evolutec Group PLC (EVC.LN) said it would be open to sale offers Wednesday after its key development drug rEV131 failed to produce results in a key trial.

Chief Financial Officer Nicholas Badman said the trial result means all options are on the table, including a potential sale of the company: "Someone may seek to take the whole company," he said, adding: "We are very much open to all routes."

Badman's comments follow an earlier announcement by the company that in a Phase II trial on reducing allergic inflammation after cataract surgery rEV131 performed the same as a placebo.

At 0930 GMT the shares were down 3.5 pence or 18% at 14.75 pence, leaving the company with a market value below GBP4 million. The group listed in August 2004 at 125 pence per share.

The compound rEV131 was being tested as a treatment to combat inflammation after post-cataract surgery, but the company's statement Wednesday said the trial found "no significant differences" between rEV131 and the placebo.

In December Evolutec's shares slumped 70% in a day's trading after negative results using rEV131 to treat hay fever were announced. Evolutec is now scrapping investment in the drug. However it is pursuing another compound, rEV576, which it says has shown potential in therapy for myasthenia gravis and Guillain-Barre Syndrome.

The CFO would not say whether the company has received any expressions of interest, or whether it has approached potential buyers, nor would he give a timeline for a potential sale of the company: "There is no time line but we are going to actively pursue [options], we will do whatever."

The CFO said the group has enough cash for the foreseeable future and that the company is undervalued: "We're worth a lot more than our current share price suggests, we've got the cash and there's a lot of potential value in rEV576."

Nomura Code analyst Gary Waanders said the trial result leaves little value in the company: "This was the supporting indication for their lead product, that's gone now so there's not much in their pipeline of any real value," Waanders said, adding: "It's pretty hard to see where they might go from here."

Waanders highlighted that the group is trading at a discount to its cash reserves of GBP8.7 million or 33 pence per share, and said it may be a target for a biotechnology company looking to top up its cash.

The analyst does not have a rating on the company.

The compound rEV131 had been touted as a potential blockbuster, and in October the group raised GBP2.8 million to fund the trials of the drug.

The Reading, UK based company's drugs are based on compounds found in the saliva of blood-feeding ticks. Ticks can remain undetected on their hosts for weeks and the company's products aim to use compounds to treat allergic, autoimmune and inflammatory diseases.

The company's only other pipeline drug, rEV576 is at the preclinical stage of trials for its use as a treatment against muscle weakness, or myasthenia gravis. It is also being tested as a treatment for Guillain-Barre Syndrome, a nerve system disorder and against asthma and heart attack.