Elevation boasts ‘gold standard’ IIb data for COPD therapy

Posted under Blog, Companies, COPD, Diagnostics, Elevation Pharmaceuticals, EP-101, Funding, Medical Devices, Medical Supply, PARI Pharma, Pharmaceuticals, Relovair, Startups, Universities, Videos by john

Four months ago San Diego-based Elevation Pharmaceuticals unveiled a $30 million venture round as it mapped out plans to complete an ambitious mid-stage program for its COPD treatment. Today the biotech boasted that the therapy--EP-101--had registered positive data in a Phase IIb study, positioning it as a potential new "gold standard" in nebulized treatments for the ailment.

Investigators report that their formulation of glycopyrrolate--a long-acting muscarinic antagonist, or LAMA, delivered by an experimental nebulizer device licensed from PARI Pharma--delivered the desired bronchodilation in a matter of minutes. Elevation compared the drug's effects with a placebo arm.

"These positive results from our first multi-dose trial of EP-101 are very encouraging and supportive of our mission to significantly improve the standard of care for patients with severe COPD," said Elevation CEO Bill Gerhart. "Pulmonologists are enthusiastic about the potential availability of a nebulized once-daily LAMA, and patients love the significant improvement in convenience offered by our new handheld delivery device." Another IIb study will be mounted to determine the precise dose the biotech will test in a late-stage study.

COPD is a bustling field in biopharma R&D. Novartis ($NVS) has high hopes for QVA149, its combination of indicaterol and NVA237. GlaxoSmithKline ($GSK) and Theravance ($THRX) are pushing ahead with their application for Relovair. Forest ($FRX) enjoyed an upbeat FDA panel review for its contender, aclidinium (licensed from Almirall), back in February. And Pearl Therapeutics has its own promising mid-stage program.

None of the competition, though, has deterred Elevation's venture backers. Novo Ventures led the latest round for the developer, with Canaan Partners, TPG Biotech, Care Capital and Mesa Verde Venture Partners all chipping in as well.

- here's the press release

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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

Related Articles:
PhRMA's COPD pipeline report spotlights blockbuster hopefuls
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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.

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

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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.