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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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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Canaan Partners adds $200M in venture funds for life sciences

Posted under Biotech Venture Capital, Blog, Canaan Partners, Civitas Therapeutics, Companies, Diagnostics, Elevation Pharmaceuticals, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Theraclone Sciences, Universities, Videos by John Carroll

Canaan Partners is starting off 2012 with a bang. The venture fund announced it has rounded up $600 million for its new fund, with $200 million carved out for new healthcare and life sciences investments. A busy backer in the biotech field, Canaan general partner Brent Ahrens tells FierceBiotech that the cash is likely to be spread among 40 to 45 companies, with about 15 in healthcare gaining anywhere from $12 million to $20 million each over a three- to four-year cycle.

"Two hundred million dollars keeps us on strategy," says the venture partner. The money from Canaan IX brings the total amount of investments managed at Canaan to $3.5 billion.

Despite some dire forecasts recently from the likes of the National Venture Capital Association and others, Ahrens expects to maintain a steady pace on new venture deals. While the venture group has targeted a broad range of new technologies, Canaan has backed biotechs like Theraclone, a Fierce 15 company, the startup Civitas, spun out of Alkermes ($ALKS), as well as Elevation.

All of its target biotech companies, added the venture investor, are working on treatments at different stages of clinical development that promise to offer "real benefits," with a focus on efficacy, safety and a clear understanding of the cost strategy involved. And while the FDA may have raised the bar for drug developers, he says, there's still a clear clinical trial path for the biotech world to follow if developers expect to cap their efforts with success.

While Ahrens notes the frustrations the NVCA and others have been voicing in recent months, he's also quick to add there are some positive trends in play right now. Pharma drug deals are still being struck at a fast pace, pharma venture arms have filled part of the gap left by the dwindling pool of VC cash in the U.S., and investors in Europe and China have been sounding out opportunities in the U.S.

That may not all add up to a perfect world, but it leaves plenty of room to explore new opportunities.

- here's the press release

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Biotechs round up new venture cash for COPD, Alzheimer’s programs

Posted under Blog, Companies, COPD, Diagnostics, Elevation Pharmaceuticals, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Probiodrug, Startups, Universities, Videos by John Carroll

San Diego-based Elevation Pharmaceuticals has raked in enough venture cash to push development of its nebulized LAMA treatment for COPD—the biotech's lead drug program—right up to the threshold of Phase III trials. A group of investors spearheaded by Novo Ventures and including Canaan Partners, TPG Biotech, Care Capital and Mesa Verde Venture Partners all joined in the $30 million round.

Their money will be used to pay for a pair of Phase IIb studies for EP-101.

"We believe that Elevation Pharmaceuticals' EP-101 will provide a much needed new treatment option for an underserved segment of the COPD patient population. EP-101 has already demonstrated improved lung function in multiple human clinical trials and Elevation's management team has a successful track record of developing drugs using new delivery technologies. Novo Ventures is very pleased to be able to support Elevation's efforts to improve the lives of COPD patients with our investment in the company's Series B financing," said Heath Lukatch, Ph.D., a partner in Novo Ventures who is now joining Elevation's board of directors.

In a separate venture announcement, Germany's Probiodrug AG reported that the developer had snagged a 15 million euro round from a group of investors—including Biogen Idec New Ventures—avid to back its work on a new Alzheimer's treatment. BB Biotech, Edmond de Rothschild Investment Partners, Life Sciences Partners, TVM Capital, HBM BioVentures, Goodvent/IBG as well as private investors also invested.

Olivier Litzka, a member of the Probiodrug board and a partner at Edmond de Rothschild Investment Partners, said Probiodrug "has made significant progress and created high value during the last two years with its innovative programs, culminating in the successful Phase I study with the first QC inhibitor PQ912. We are delighted to welcome Wellington Management to our already distinguished list of venture investors."

- here's the press release on Elevation
- here's the release on Probiodrug

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