Forest Labs notches victory en route to FDA ruling on COPD drug

Posted under Advair, Almirall, Blog, Companies, COPD, Diagnostics, FDA, Forest Laboratories, Funding, Medical Devices, Medical Supply, Pearl Therapeutics, Pharmaceuticals, QVA149, Relovair, Startups, Universities, Videos by Ryan McBride

Eyeing the major market for a chronic lung condition, Forest Laboratories ($FRX) picked up the backing of an FDA panel for its experimental COPD drug known as aclidinium. It's a key endorsement for the New York-based drugmaker, which would be competing in the COPD arena with a crowd of Big Pharma outfits that includes GlaxoSmithKline ($GSK), Pfizer ($PFE) and AstraZeneca ($AZN) if the FDA approves its treatment.   

Impressed with the clinical evidence on the inhaled drug, the non-agency experts on the FDA panel voted 12-2 that the treatment should be approved, Bloomberg reported. Yet there were concerns raised about the potential cardiovascular side effects linked to the drug, and at least one panelist called for a post-marketing study to dig deeper into the question about the risk. Still, clinical studies showed the drug's cardiovascular risks were lower than those of other COPD treatments, The Wall Street Journal reported.

Forest, which has rights to market aclidinium in the U.S. from Spanish developer Almirall, is in a crowded race to grab a piece of the blockbuster COPD market with a new product. GSK, which already markets Advair for the lung ailment, has a Phase III program under way with partner Theravance ($THRX) for the experimental drug Relovair. Swiss drug giant Novartis ($NVS) has a horse in this race as well with its potential blockbuster QVA149. And up-and-coming developer Pearl Therapeutics, a 2011 Fierce 15 company, is making headway with its mid-stage trials for its own contender.

With a number of existing products already on the market for COPD, which affects 12 million Americans, expect U.S. regulators to have a high safety standard for any candidate that would be used to treat the chronic illness. No doubt they'll likely see plenty of new drugs for the condition over the next few years, allowing regulators to be choosy.  

- check out the WSJ's article
- see the Reuters report
- and Bloomberg's piece

Related Articles:
GSK, Theravance report Ph3 successes for COPD treatment
PhRMA's COPD pipeline report spotlights blockbuster hopefuls
FDA raises cardio concerns on Forest's new COPD drug
Biotechs round up new venture cash for COPD, Alzheimer's programs
Pearl's combo COPD treatment beats market rivals as it races to Ph3

Sir Andrew Witty – The 25 most influential people in biopharma today

Posted under Advair, Andrew Witty, Avandia, Blog, Companies, Diagnostics, Funding, GlaxoSmithKline, Impax Labs, Medical Devices, Medical Supply, Pharmaceuticals, Relovair, Startups, Theravance, Universities, Videos by Ryan McBride

Righting the ship

Sir Andrew Witty
CEO
GlaxoSmithKline

Since Andrew Witty beat Chris Viehbacher and at least one other candidate for the top job at GlaxoSmithKline ($GSK) in 2007, he has led several efforts to right a ship that had sailed in the wrong direction in a number of ways for years. He's sliced and diced the London-based drug company's R&D groups into smaller and more autonomous shops, piloting recent efforts in his industry to boost accountability among scientists and get better returns from R&D investments.

Witty, who took the helm at GSK in 2008 after leading its European pharma business, has had to navigate some industrywide squalls and bugs within his company's ranks. In the aftermath of the Avandia scandal, for instance, GSK has recently promoted ethical conduct among its sales reps through changes in how they are compensated. (We'll see how that works out.) Also, his aim to sharpen the company's R&D focus on truly novel medicines has gained lots of attention in the industry, with some detractors and boosters of the company's plan to split up its R&D efforts into nearly 40 separate groups with biotech-like agendas.

Like other drugmakers, GSK has been grappling with slow business growth in the U.S. and Europe, and it's not been immune to the ills of the patent cliff. Witty, like some of his counterparts, has sought expansion into fast-growing emerging markets in places such as Asia, but he's steered the company away from the megamergers that have largely defined Merck and Pfizer's strategies for weathering the storm. Yet the Asian pharmaceutical market, despite its rapid growth, doesn't match the size of the European and U.S. markets, which makes bringing new drugs to the U.S. and European markets critical to GSK's long-term growth. This year, Witty's company has more than a dozen late-stage programs yielding data, giving the industry an indication of whether GSK can replace sales of its big-time drugs that face generic competition such Advair with its next-generation products. For now, those products will have to come from the R&D groups at GSK and those of its partners such as Impax Laboratories ($IPXL) and Theravance ($THRX).

Yet this year got off to a rough start on the R&D front, with GSK and Theravance reporting in January that there were pneumonia-related deaths in patients taking their experimental COPD and asthma therapy Relovair, which GSK hopes will succeed Advair as a top respiratory product. If GSK suffers a string of setbacks in the clinic, Witty might not be able to avoid a big merger to bring in new products.

Theravance shares tank on troubling study results for Relovair

Posted under Advair, Blog, Clinical Trial Results, Companies, COPD, Diagnostics, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Pharmaceuticals, Relovair, Startups, Theravance, Universities, Videos by Biotech News

by Suzanne Elvidge and John Carroll

Shares of GlaxoSmithKline ($GSK) caught a chill this morning after investigators released mixed late-stage data and flagged troubling safety concerns for its COPD and asthma therapy Relovair. Shares of the pharma giant slipped a bit as analysts raised concerns about pneumonia-related deaths in a study. But its biotech partner Theravance ($THRX) suffered a much more painful slide as the news wiped out more than a third of its stock value in a matter of minutes.

Officially, GlaxoSmithKline and Theravance maintained an upbeat tone today, noting that the study results warrant the treatment's submission to regulators for an approval. Relovair is their crucial next-gen drug for their blockbuster treatment Advair. But investors were much less sanguine, possibly because they began to discount the persistent rumors that Glaxo would likely buy Theravance in the wake of a successful clinical program.

In both studies for COPD, Relovair reduced the annual rate of worsening of disease (exacerbations) compared with vilanterol alone--however, in one study, the reduction for the highest dose wasn't statistically significant. GlaxoSmithKline is also looking at drug safety after reports of fatal pneumonia at the highest dose. For both COPD and asthma, at the lowest dose, Relovair didn't meet the threshold for demonstrating superiority over Seretide (fluticasone propionate/salmeterol).

Relovair is in development as part of a collaboration between GlaxoSmithKline and Theravance, and the two companies "believe that it is appropriate to request that regulatory authorities review the totality of the exacerbation data, including the effects seen across both studies for the 100/25mcg dose," according to GlaxoSmithKline's press release.

The company plans submissions for COPD for the US and Europe for mid-2012. The expectation for asthma is to submit an application in Europe in mid-2012, followed up with a submission in the USA after discussions with the FDA.

- here's the GSK release

Related Articles:
GSK sets stage for big late-stage drug events, potential blockbusters
GSK relying on Ph3 strategy in R&D comeback bid
GSK, Theravance report Ph3 successes for COPD treatment
GSK boosts Theravance stake after grabbing lead in drug race