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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Novartis posts promising Phase III results for blockbuster hopeful QVA149

Posted under Blog, Companies, COPD, Diagnostics, Funding, Medical Devices, Medical Supply, Novartis, Pharmaceuticals, QVA149, Startups, Universities, Videos by john

Novartis touted a slate of positive results for its COPD blockbuster hopeful QVA149, heralding promising results from three Phase III studies. Investigators for Novartis ($NVS) said the batch of data for the combination of indicaterol and NVA237 underscored the treatment's superiority over either of the two essential ingredients on their own, and outperformed a placebo in producing better exercise endurance.

That's all upbeat news for Novartis, which has high hopes of trumping Advair and a next-gen COPD treatment from GlaxoSmithKline ($GSK) and Theravance. But analysts weren't overly impressed. QVA149 is engaged in a total of 10 Phase III studies, and the analysts want to see signs of clear superiority over Advair in head-to-head studies. David Kaegi with Bank Sarasin in Zurich also fretted to Dow Jones that "In the important U.S. market, there is still considerable uncertainty over how Novartis will proceed with QVA149."

It hasn't hurt Novartis that the investigative team for Relovair, the intended successor to Advair, has been turning in mixed results from its late-stage program for the treatment. Both GSK and its partner Theravance, though, insist that they are well positioned to file for an approval later this year. Novartis seems just as determined to forge ahead. 

"Meeting the primary endpoints in the IGNITE Phase III clinical trial program signals significant progress in establishing the potential of QVA149, which is expected to be the third innovative medicine in our strong COPD portfolio," said Tim Wright, head of development for Novartis.

- read the press release
- here's the story from Dow Jones

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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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FDA raises cardio concerns on Forest’s new COPD drug

Posted under aclidinium bromide, Almirall, Blog, Companies, COPD, Diagnostics, Forest Laboratories, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Forest Laboratories ($FRX) and Almirall got a thumbs up from the FDA for their efficacy data on a COPD drug candidate. But regulators want an upcoming panel review to closely explore cardio risks linked with the entire drug class it belongs to. One big issue is whether the companies designed large enough trials to accurately gauge the cardio risk. Story