UPDATED: GSK, Theravance share mixed bag of lung drug data ahead of FDA filing

Posted under blockbuster, Blog, Companies, Diagnostics, FDA, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Pharmaceuticals, Relovair, Startups, Theravance, Universities, Videos by Ryan McBride

GlaxoSmithKline ($GSK) and partner Theravance ($THRX) have dropped another up-and-down set of data related to development of their blockbuster hopeful Relovair today. Yet the duo remains on schedule to file for U.S. and European approval of the drug for chronic pulmonary obstructive disorder (COPD) by mid-2012, the companies said.

The important data in today's release are the non-pivotal results of two studies that compared Relovair taken once a day to GSK's blockbuster lung treatment Advair taken twice per day. Relovair, an inhaled treatment, provided statistical superiority in a breathing test in one of the studies but not in the other. This is par for the course in this elaborate development program: These data follow others that provided mixed results. 

Meantime, GSK said that it expects to seek regulatory approval for the drug as an asthma treatment in Europe in mid-2012, and it's in talks with U.S. regulators about its FDA submission.

The Relovair program has emerged as one of the most closely watched in London-based GSK's extensive pipeline, as the drug is expected to eventually replace Advair. Reuters reports that Advair had sales last year of $8 billion, making it the drug giant's biggest blockbuster. GSK CEO Andrew Witty (photo) has reportedly talked up the company's future sales prospects, and he's bet heavily on a combo of internal R&D efforts and external partnerships like the Relovair tie-up with Theravance.

For South San Francisco-based Theravance, there is much more at stake with the Relovair program. In fact, the company's stock is down about 15% this year after troubling safety data from the program revealed in early January caused the company's stock to tank.

- here's the companies' release
- check out the Reuters report

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Correction: This story incorrectly stated that Theravance has no products on the market. The company has one drug on the market, Vibativ, an antibiotic for skin infections. We apologize for the error.

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.

GSK will cut 3 R&D units, add 4 as DPU review triggers shakeup

Posted under Andrew Witty, Blog, Companies, Diagnostics, Funding, GlaxoSmithKline, Hepatitis C, Medical Devices, Medical Supply, Melanoma, Moncef Slaoui, Pharmaceuticals, Promacta, Relovair, Startups, Theravance, Universities, Videos by John Carroll

Following a three-year review of its new approach to R&D, GlaxoSmithKline ($GSK) today revealed that it has decided to ax three of its 38 tightly-focused research units and add four more in a shakeup. The final tally, which doesn't specify exactly who wins or loses, also included plans to beef up the budgets for 6 of their Discovery Performance Units while slicing funding on 5 others. And CEO Andrew Witty (photo) pronounced himself quite satisfied with the DPUs' overall performance, with the new annual numbers reflecting a boost in productivity as GSK moves ahead with plans to file for approvals on four new drugs and vaccines--including an MEK inhibitor for melanoma, trametinib, which scored paydirt data in Phase III, according to today's release.

Alone among the Big Pharma companies, GlaxoSmithKline has been tracking the rate of return on the money it spends on its late-stage pipeline work. In 2010, the return rate was 11%. Last year, that figure swelled to 12% as Witty vows to make it to the 14% mark. GSK says it will keep its R&D budget, a bellwether in the industry, flat at 3.7 billion euros.

In one of the most closely watched R&D restructurings in the industry, GSK launched its DPU approach to drug development back in 2008, promising to cut groups that underperform and back those making headway after winning three-year budgets for their work. The idea, advanced by Witty and R&D chief Moncef Slaoui, was that scientists would stay more closely focused if they knew their teams' funding relied on tangible progress--a daily reality for most biotech companies.

"These units comprise 5-70 scientists, with each group focusing on one particular disease or pathway," noted Witty in GSK's annual report. "Over the last three years, I have visited many of the DPUs and am very pleased with the energy, approach and productivity we are seeing from our scientists in these units." There's no word of any layoffs or departures in R&D today. GSK has made it clear that even if some teams didn't make the cut, it would transfer employees to other DPUs.

Now that the three-year review is over, GSK says the next three years will see 30 programs move into late-stage development.

Those DPUs are now wrapping six late-stage programs, Witty says. The four slated to be filed for approval this year include Relovair, its COPD treatment partnered with Theravance ($THRX), Promacta for hepatitis C and the MEK inhibitor for melanoma. The melanoma drug is GSK'212, or trametinib, which went into Phase III about a year ago.

- here's the release from GSK (.pdf)

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PhRMA’s COPD pipeline report spotlights blockbuster hopefuls

Posted under Blog, Companies, COPD, Diagnostics, Elevation Pharmaceuticals, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Novartis, Osiris Therapeutics, Pearl Therapeutics, Pharmaceuticals, PhRMA, QVA149, Relovair, Startups, Theravance, Universities, Videos by John Carroll

Anyone looking for a basic primer on experimental COPD drugs should check out PhRMA's latest compilation of new drugs in the pipeline. The big trade group found 54 COPD studies underway, which include trials for some of the biggest potential blockbusters nearing an FDA decision. But be prepared to do some digging if you want to find out what's really happening here.

For PhRMA, which mistakenly categorized everything in clinical development as distinct, late-stage treatments, some of the highlights in the report include an adult stem cell therapy, an IL-1 receptor-targeted antibody and a therapy that zeroes in on inflammation related to COPD. Their success could help reduce the nearly $50 billion annual tab for treating the disease.

Dig down into the report and you'll find eight Phase III studies underway. That includes Relovair, a new drug from GlaxoSmithKline ($GSK) and Theravance ($THRX), which chilled analysts with mixed data recently, and Novartis' ($NVS) potential giant slayer QVA149, which has run into dosage issues in the U.S. Pearl Therapeutics, a 2011 Fierce 15 company, is in the race now that it is wrapping an ambitious mid-stage program.

Elevation and Osiris are also focused on Phase II. Osiris's Prochymal, the stem cell treatment noted by PhRMA, hasn't performed very well. In an update, Osiris recently noted that the treatment had failed to outperform a placebo after a year of treatment.

- here's the press release
- read the full report (.pdf)

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