Analysts give Actelion’s key lung drug 63% odds of success

Posted under Actelion, Amgen, Blog, Clinical Trial Results, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, pulmonary arterial hypertension, Startups, Tracleer, Universities, Videos by Ryan McBride

Swiss biotech Actelion ($ATLN) could use a win for its experimental lung drug. In need for a new product to follow its big hit Tracleer, the company's big moment for its lung disease treatment macitentan is likely to come in the second quarter when late-stage data are revealed, and analysts are giving the program a 63% chance of succeeding in the pivotal study, Bloomberg reports.

Actelion CEO Jean-Paul Clozel has a lot riding on macitentan, an experimental drug that he hopes will be better than the company's existing drug Tracleer for combating pulmonary arterial hypertension. Tracleer has lost ground to competing PAH drugs, loses patent protections in three years, and accounts for 90% of the company's revenue, Bloomberg reports. And the company has suffered a string of pipeline setbacks in recent years, making the success of macitentan all the more important to the company.

"It's make or break," top analyst Michael Leuchten of Barclays told Bloomberg. "If macitentan fails, what's left to manage?"

Rumored to be a buyout target for Amgen ($AMGN) in late 2010, Actelion's stock gains and speculation about an Amgen buyout offer fizzled out. Now the company is poised to either make a comeback or fall hard depending on how the macitentan data in PAH look.

- get more in Bloomberg's article

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Theravance shares tank on troubling study results for Relovair

Posted under Advair, Blog, Clinical Trial Results, Companies, COPD, Diagnostics, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Pharmaceuticals, Relovair, Startups, Theravance, Universities, Videos by Biotech News

by Suzanne Elvidge and John Carroll

Shares of GlaxoSmithKline ($GSK) caught a chill this morning after investigators released mixed late-stage data and flagged troubling safety concerns for its COPD and asthma therapy Relovair. Shares of the pharma giant slipped a bit as analysts raised concerns about pneumonia-related deaths in a study. But its biotech partner Theravance ($THRX) suffered a much more painful slide as the news wiped out more than a third of its stock value in a matter of minutes.

Officially, GlaxoSmithKline and Theravance maintained an upbeat tone today, noting that the study results warrant the treatment's submission to regulators for an approval. Relovair is their crucial next-gen drug for their blockbuster treatment Advair. But investors were much less sanguine, possibly because they began to discount the persistent rumors that Glaxo would likely buy Theravance in the wake of a successful clinical program.

In both studies for COPD, Relovair reduced the annual rate of worsening of disease (exacerbations) compared with vilanterol alone--however, in one study, the reduction for the highest dose wasn't statistically significant. GlaxoSmithKline is also looking at drug safety after reports of fatal pneumonia at the highest dose. For both COPD and asthma, at the lowest dose, Relovair didn't meet the threshold for demonstrating superiority over Seretide (fluticasone propionate/salmeterol).

Relovair is in development as part of a collaboration between GlaxoSmithKline and Theravance, and the two companies "believe that it is appropriate to request that regulatory authorities review the totality of the exacerbation data, including the effects seen across both studies for the 100/25mcg dose," according to GlaxoSmithKline's press release.

The company plans submissions for COPD for the US and Europe for mid-2012. The expectation for asthma is to submit an application in Europe in mid-2012, followed up with a submission in the USA after discussions with the FDA.

- here's the GSK release

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Trius shares surge as antibiotic matches Zyvox in pivotal PhIII

Posted under Achaogen, antibiotic, Blog, Clinical Trial Results, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Rib-X Pharmaceuticals, Startups, tedizolid, Tetraphase Pharmaceuticals, Trius Therapeutics, Universities, Videos by John Carroll

Shares of Trius Therapeutics ($TSRX) surged on the news that its late-stage antibiotic tedizolid closely matched Zyvox (linezolid) in one of a series of pivotal studies, helping nail down support for its case that the experimental antibiotic is just as good as the blockbuster with a once-daily dosing schedule over a shorter period. The antibiotic hit its primary endpoint for acute bacterial skin and skin structure infections as well as all secondary goals. The news helped push up Trius shares a little more than 10% this morning in early trading.

Trius also bolstered its case that its antibiotic is safer than the mainstay product, which had worldwide sales of $1.2 billion in 2010. Investigators reported that about one in four of the tedizolid patients experienced "drug-related treatment emergent adverse events" compared to 31% of linezolid treated patients. Gastrointestinal adverse events were the most commonly reported events and were statistically significantly lower in tedizolid patients than in linezolid patients.

"We are very pleased the trial demonstrated that a 6-day course of once daily oral tedizolid is as efficacious as a 10-day course of twice daily oral linezolid while showing an improved tolerability profile," said Jeffrey Stein, Ph.D., the CEO of Trius. "We look forward to presenting the detailed results of this study, the first Phase 3 study to be conducted under the new regulatory paradigm, both in a peer reviewed journal and at a major conference in 2012."

Trius is one of a handful of biotechs like Rib-X, Tetraphase and Achaogen which are pushing ahead with experimental antibiotics despite a tough regulatory environment and years of neglect by Big Pharma. Last July Bayer Pharma stepped up with a $94 million deal for the antibiotic, paying $25 million upfront for the Asian, African and Latin American rights to tedizolid (formerly torezolid) while the biotech held on to the key U.S. and European rights.

- here's the Trius release

Special Report: Trius Therapeutics - 10 Biotech IPOs of 2010

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Sygnis Pharma’s shares plunge as key stroke drug fails PhII

Posted under AX200, Blog, Clinical Trial Results, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Sygnis Pharma, Universities, Videos by John Carroll

Germany's Sygnis Pharma ($LIOK) says its lead drug failed a mid-stage stroke trial, flunking both the primary and secondary endpoints and triggering a meltdown in its share price.

AX200 is designed to spur development of a protein believed to help heal damaged brains. But investigators say the drug looked no better than a placebo in a study which recruited 328 patients. That's very bad news for investors. Sygnis cut its workforce in half recently as it circled its wagons around the stroke study. AX200 is its only drug in development, and the biotech's shares plunged 63%.

Last summer Sygnis was forced to turn to its main investor, SAP's Dietmar Hopp, for a €6 million loan to finance the company through the end of 2012.

As Bloomberg points out, stroke is a tough target. AstraZeneca has tried and failed with a stroke drug and others have steered clear of a research field strewn with clinical landmines.

"We are very disappointed about the outcome of the study and will have to analyze the full data set in order to fully understand these results, which are not in line with our previous findings. Although the patient group treated with AX200 on average showed a slightly more severe infarct; this does, however, not explain why we could not see any relevant differences between the two groups regarding the patient outcome," said Dr. Frank Rathgeb, the chief medical officer of Sygnis.

- check out the Sygnis release
- here's the story from Bloomberg