Vertex: dipping into the non-responders pool

Vertex has unveiled encouraging results from a phase Ib trial evaluating VX-950 in hepatitis C. Although investors have reacted well to the news, sending the company's stock to a new 52-week high, the battle is by no means won as continued uncertainty regarding class-specific toxicity demands caution. Indeed, it may well be too early for Vertex to celebrate just yet.

Published By Datamonitor

Vernalis/Endo: gain in menstrual migraine

New phase III data have confirmed previous results showing Vernalis and Endo's Frova to be an effective preventative treatment for menstrual migraine. This should pave the way for the migraine drug's approval in this additional indication. Anticipated in 2007, this approval is then expected to transform Frova's sales significantly.

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Valeant/GlaxoSmithKline: side effects may jeopardize Trobalt's prospects

The first-in-class anti-epileptic drug Trobalt has received its first license after gaining European Commission approval as an adjunctive treatment for partial epilepsy. While Trobalt has shown impressive efficacy in a poorly managed patient population, its positioning in the treatment algorithm may be hindered by poor tolerability and a narrow label.

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Valeant/GlaxoSmithKline: Potiga's novel mechanism provides hope for drug-resistant epilepsy patients

The FDA has approved Potiga as an adjunctive treatment for partial-onset epilepsy in adults, the first potassium channel activator to receive approval for the treatment of epilepsy. While this novel drug will provide a useful treatment option for patients with drug-resistant epilepsy, its three times-daily dosing and high incidence of minor side effects will offset the benefits of efficacy.

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Vaccines: Intercell buys Iomai

Intercell has acquired Iomai for $189 million, in a deal motivated by the Austrian company's desire to gain ownership of Iomai's traveler's diarrhea vaccine and transdermal delivery technology. With the potential to deliver both vaccine and adjuvant, independently, through Iomai's transdermal patch, Intercell's development of its proprietary adjuvant IC31 may also benefit from the technology.

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US healthcare: antibacterial prescriptions to increase at 0.8% per annum to 2010

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US cholesterol: generics to benefit most from guidelines

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US and EU regulators close in on pharmaceutical pay-for-delay deals

The evolving relationship between branded and generics pharmaceutical companies is set to undergo considerable change as regulators in both the US and EU move to restrict 'pay-for-delay' deals in a bid to increase generics cost-savings. As deals that delay the market entry of generics come under increasing scrutiny, the industry may find that its best option is to cease such practices altogether.

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Underwhelming data at IEC detract from perampanel's innovative mechanism

Eisai has presented positive data from the latest Phase III clinical trial of its novel anti-epileptic drug perampanel. Despite mixed Phase III data suggesting lower efficacy to perampanel's closest competitor, Trobalt/Potiga, Datamonitor recognizes potential for the novel AMPA receptor antagonist in the treatment of patients with drug-resistant epilepsy.

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Ulcer drugs: generic launches threaten branded market

Novartis [NVS] has joined Mylan [MYL] and Schwarz [SRZG.F] in offering a generic version of blockbuster ulcer drug Prilosec in the US. The arrival of Novartis may open the floodgates for multiple generics in the ulcer drug market. Yet for companies launching generics before legal issues are settled, the risks are huge.

Published By Datamonitor