Europe's CHMP serves up negative opinion for Ark's Cerepro and calls for ban on benfluorex drugs, but good news for B-MS, Sanofi, GSK, Novartis

At its meetings last week, Europe's Committee for Medicinal Products for Human Use (CHMP) gave out doses of disappointing medicine for the UK's Ark Therapeutics and on the future of benfluorex-containing medicines, but also gave its backing to several new drugs applying for approval, as well as updating on influenza vaccines and sibutramine.

Ark's shares plunge 50%

Ark saw its share price plummet 50% to 15 pence on December 18, after the HMP adopted a negative opinion, recommending that its Cerepro (sitimagene ceradenovec - adenoviral vector-mediated Herpes Simplex Virus-thymidine kinase gene used with subsequent administration of ganciclovir), should not be granted a marketing authorization. Cerepro is a gene therapy medicinal product, intended for the treatment of high-grade glioma). Because Cerepro is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT). Taking into account the assessment performed by the CAT, the CHMP concluded that the benefits of Cerepro did not outweigh its risks and recommended that it be refused approval.

KBC Peel Hunt analysts Paul Cuddon commented: 'Ark now has to consider writing off Cerepro altogether,' and now put a price target of 10 pence on the stock.

Update on pandemic medicines

The Committee has reviewed further data on the centrally-authorized pandemic medicines, the pandemic influenza vaccines Celvapan, Focetria and Pandemrix, and the antiviral Tamiflu. In the European Union at least 26 million people have been vaccinated so far and worldwide 13 million patients have taken Tamiflu from May 1 to October 31, 2009. The Agency has reaffirmed their positive balance of benefits and risks in the context of the current H1N1 influenza pandemic.