P

fizer has suffered a setback with the news that regulators in the USA have again rejected the epilepsy and pain drug Lyrica as a treatment for anxiety.

The US Food and Drug Administration has issued a complete response letter regarding the company’s New Drug Application for Lyrica (pregabalin) as a monotherapy for GAD. In it the agency says the data contained in the NDA “were insufficient to support approval”.

This is particularly disappointing for Pfizer considering the NDA was a resubmission in response to a ‘not-approvable’ letter issued by the FDA in August 2004. However the agency is still reviewing a separate application for Lyrica as adjunctive therapy for GAD.

Steve Romano, medical affairs head of Pfizer’s primary care business unit, said “we are disappointed with the FDA’s decision and will work with the agency to determine next steps”. He added that “given the chronic nature of GAD and the number of patients who continue to experience anxiety symptoms despite treatment, there is a clear unmet need for new and different treatment options.” In the USA, Lyrica is approved for epilepsy, fibromyalgia and neuropathic pain

Meantime, Pfizer is selling worldwide rights to an investigational heart drug to The Medicines Company in a deal which could be worth over $420 million.

The deal revolves around ApoA-I Milano, a naturally-occurring variant of a protein found in human high-density lipoprotein. The firms say that it has “the potential to reverse atherosclerotic plaque development and reduce the risk of coronary events in patients with acute coronary syndrome”.

The variant has been found in 45 individuals from Limone sul Garda, a small village in northern Italy and carriers appear to have reduced risk of cardiovascular disease. Pfizer got hold of the drug after it forked out $1.3 billion to buy Esperion Therapeutics in 2004.

Cashwise, TMC will pay Pfizer a $10 million upfront fee and an additional $410 million depending on how the drug progresses. The drugs giant will also be eligible to receive single-digit royalties and TMC will also pay $7.5 million to third parties.

Compugen deal
On a busy day for the firm, Pfizer has also entered into a collaboration with Compugen, an agreement which has sent the Israeli firm’s shares through the roof.

The deal is being described by the Tel Aviv-based company as a “discovery on demand” collaboration producing therapeutic peptide candidates for three drug targets of interest to Pfizer. The discovery process, which will be based on various Compugen discovery platforms and funded by Pfizer, is expected to take a few months.