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Pharma news in brief

Our weekly round-up of Pharma news in brief

US firms submit European marketing application
Bristol-Myers Squibb, Gilead Sciences and Merck & Co have submitted an application to the European Medicines Agency to approve a new pill to treat HIV-1 infection. The application for the drug, Atripla, will be reviewed by the Committee for Medicinal Products for Human Use (CHMP). Atripla is a once-daily single tablet regimen approved in the US for the treatment of HIV-1 infection in adults for use either as a stand-alone therapy or in combination with other antiretroviral agents, the companies said in a joint release. It was approved by the US Food and Drug Administration in July this year.

Adderall XR successor given FDA green light
Shares in Shire jumped by 9 per cent after the UK company and its partner, New River Pharmaceuticals, received an `approvable' letter from the US Food and Drug Administration (FDA) for their successor to attention deficit hyperactivity disorder (ADHD) blockbuster, Adderall XR. Analysts believe the drug, NRP104, has the potential to make over $1bn in annual sales and plug the gap left by Adderall XR, which loses patent protection in 2009. Shire said full approval was contingent on the scheduling, or restrictions, placed on the drug by the Drug Enforcement Administration. The FDA has proposed that the drug be placed as a ìschedule II' controlled substance, the same ranking as Adderall XR and other drugs for the treatment of ADHD.

Wyeth loses first HRT case
Wyeth suffered its first loss in litigation over its HRT drugs, Prempro and Premarin when a jury in Philadelphia decided they caused the breast cancer of a 67-year old woman. Jennie Nelson, from Ohio, took the drugs for six years starting in 1995. After finding that Ms Nelson should be paid $1.5m in compensation, jurors must now decide whether Wyeth is liable for paying the damages and whether it should pay punitive damages as well. A Wyeth spokesman said the firm was disappointed with the decision, which he said was ìin no way indicative of future trialsî. Analysts said they were not concerned about the long-term impact of the verdict as Wyeth was likely to appeal the decision and could yet have it overturned.

UK patients lose out on chance for US Vioxx compensation
British patients who claim they suffered heart attacks after taking Merck's COX-2, Vioxx, will not be able to fight for compensation in the US, after a New Jersey court ruled that they must challenge the pharma firm in the UK courts. Lawyers representing some of the patients said their clients have been refused legal aid and insurers will not fund `no-win, no-fee' cases in the UK. Sally Booth, from Irwin Mitchell solicitors, representing almost 100 claimants, told the BBC the decision was disappointing. ìWhile they should not be forced to look to a foreign jurisdiction to determine their cases, the restricted availability of funding for claimants in group actions in this country, especially public funding is having the effect of denying these people proper access to justice,î she said.

SkyePharma drug progresses
Drug delivery firm, SkyePharma has announced positive phase III results for its anti-inflammatory drug, Lodotra, for the treatment of pain caused by rheumatoid arthritis. The news comes one week after the company reported widening interim losses as it increased R&D expenditure on its key asthma drug, Flutiform. In a research note, Evolution Securities analyst, Jonathan Senior, described Lodotra as relatively `minor' for SkyePharma, estimating fifth year sales at about $50m (£26.6m). SkyePharma is currently in talks with prospective buyers for its injectables unit and is hoping to complete a deal by the end of November.

30th September 2008


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