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Pin to quick picksGlaxosmithkline Share News (GSK)

Share Price Information for Glaxosmithkline (GSK)

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Share Price: 1,770.50
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UPDATE 2-EU regulator backs Bayer, GSK drugs, knocks back Novartis, Teva

Fri, 24th Jan 2014 13:52

* European Medicine Agency backs Bayer's Adempas

* Also recommends marketing approval for GSK's Eperzan

* Knocks back Teva's Nerventra and Novartis' serelaxin

By Kate Kelland

LONDON, Jan 24 (Reuters) - Europe's drugs regulator gave itsbacking on Friday for marketing approval to be granted forBayer's pulmonary hypertension drug Adempas and forGlaxoSmithKline's diabetes medicine Eperzan.

The European Medicine Agency (EMA) also backed a new drugfrom Dainippon Sumitomo Pharma called Latuda, for thetreatment of schizophrenia, and Bemfola, a new biosimilarmedicine for the treatment of infertility.

But the regulator decided against recommending Teva's new multiple sclerosis (MS) pill Nerventra,or laquinimod, which the Israeli firm is developing with Swedishpartner Active Biotech, and recommended rejecting anapplication from Swiss drugmaker Novartis to marketits heart failure drug serelaxin.

Recommendations for marketing approval by the EMA'sCommittee for Medicinal Products for Human Use (CHMP) arenormally endorsed by the European Commission within a couple ofmonths.

The prospects for laquinimod were already viewed by analystsas uncertain, since the drug missed its main goal in alate-stage trial in 2011 and U.S. regulators have asked foranother Phase III study before considering it.

Analysts at Jefferies in London said the rejection of Teva'sMS drug was as they had expected and was driven by three majorconcerns - about the possible link to risk of cancers andpregnancy dangers, and its modest effect on relapse rates whichsuggested an unfavourable risk-benefit balance for the drug.

On Bayer's Adempas, the EMA said the key benefits of thedrug were "its ability to provide significant improvement inexercise capacity and pulmonary haemodynamics in two specificconditions known as chronic thromboembolic pulmonaryhypertension and pulmonary arterial hypertension."

Adempas, which belongs to a class of drugs known as solubleguanylate cyclase stimulators that help arteries relax toincrease blood flow and decrease blood pressure, got backingfrom drugs regulators in United States in October last year, andin Japan earlier this month.

The EMA also issued negative opinions for two so-calledorphan medicines - Masiviera from France's AB Science,intended for certain types of advanced pancreatic cancer, andTranslarna, from PTC Therapeutics, designed to treatDuchenne muscular dystrophy.

GSK's once-weekly diabetes drug albiglutide won the EMA'srecommendation and will be sold under the brand name Eperzan. Itbelongs to the same class of injectable GLP-1 drugs as Victoza,from Novo Nordisk, as well as Byetta and Bydureon,from Bristol-Myers Squibb and AstraZeneca.

Last year regulators in the United States pushed back anapproval decision on the drug until April 15.

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