Vectura close to US deal on generic asthma drug

Last Updated: 2006-07-31 14:00:41 -0400 (Reuters Health)

By Mark Potter

LONDON (Reuters) - Vectura Group Plc, a British specialist in inhaled drugs, is close to signing a major generic drugmaker as U.S. partner for its experimental asthma drug VR315, Chief Executive Chris Blackwell said on Monday.

Vectura has not formally disclosed details of its VR315 project, but analysts say it is a copycat of GlaxoSmithKline Plc's top-selling Advair, which racked up some 3 billion pounds ($5.6 billion) of sales last year.

"We're at a late stage of negotiations," Blackwell told Reuters in an interview, adding that Vectura had whittled down the list of potential partners to less than five.

"I would be surprised if we didn't have something to announce in the second half of this year."

Analysts say several companies, including Vectura's British rival Innovata Plc, are competing to develop a generic version of Advair, which combines two drugs in one medicine.

Copying inhaled drugs is notoriously difficult, usually involving clinical trials, and GlaxoSmithKline (GSK) is bound to fight hard to uphold its patents.

Serevent, one of the components of Advair, loses U.S. patent protection in 2008, when Advair itself will lose patent cover in Europe. In the United States, patent protection on the Advair combination runs out from 2010.

A spokeswoman for Glaxo, the world's second biggest drugmaker, said the group was confident of the intellectual property surrounding Advair, which covers not only the combination of drugs but also the delivery device.

CEO Blackwell says VR315 could be the first challenger to reach the market.

"Formulating the product is not the difficult bit; it's delivering it in a way that is competitive with the Diskus device that GSK uses," he said. "I can't see any other device, other than our own GyroHaler, that is close to Diskus in the way the drug is delivered and protected."

Vectura floated in June 2004 and, with partner Arakis, leapt to prominence in April last year when the two firms agreed a $375 million deal to license an experimental lung drug to Novartis in what remains one of the European biotech sector's biggest ever deals.

Last month, Vectura also pulled off the biggest fundraising for a UK biotech firm this year, securing 43 million pounds.

Blackwell said part of the money was to enable Vectura to negotiate a profit-share deal with a U.S. partner, which could be more lucrative than the traditional model of taking a large upfront payment from a commercial partner.

"It's (generic Advair) projected to be a $1 billion a year product with 80 percent margins... and the price of the first generic will probably be largely upheld -- we reckon about 70 percent of the originator price. That makes it a very attractive prospect for a profit share."

Vectura signed up an unidentified international generic drugmaker as European partner for VR315 in April. Blackwell said the same firm was also on the short-list to be the U.S. partner.

He said Vectura expected to start clinical trials needed to win approval in Europe and the United States by the second half of 2007 and to file VR315 for assessment by regulators in 2008.

TAKING ON VIAGRA

The firm is also in talks to find a partner for VR004, an inhaled treatment for impotence that could compete with Pfizer Inc.'s Viagra, Blackwell said.

Vectura specialises in developing inhaled drugs, which can be absorbed more quickly than medicines that are ingested. This means they can be taken in lower doses, potentially reducing side effects, and can also speed up their effectiveness -- something particularly important when treating impotence.

The firm reported intermediate clinical trial results last month showing that 50 percent of patients who responded to VR004 achieved an erection within five minutes.

"We think we have an opportunity to target a niche that's (worth) somewhere around 300 million pounds a year," Blackwell said.

"We're not close to a deal at the moment. We hope that will crystallise over the next 12 to 18 months," he said, adding Vectura could package VR004 with its VR776 treatment for premature ejaculation, which is due to report intermediate clinical trial results in the first half of next year.