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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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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