Thursday, November 15, 2007

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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Tuesday, October 09, 2007

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.

Thursday, September 13, 2007

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.

Wednesday, September 12, 2007

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.

Thursday, July 12, 2007

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.

Monday, July 09, 2007

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.

Thursday, July 05, 2007

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.