Swiss biotech Actelion grabs rights to biologic in $68.5M deal

Posted under Actelion, Auxilium Pharmaceuticals, Blog, Companies, Diagnostics, Funding, macitentan, Medical Devices, Medical Supply, Pharmaceuticals, pulmonary arterial hypertension, Startups, Universities, Videos, Xiaflex by Ryan McBride

With plans to beef up its limited commercial offerings, Swiss biotech Actelion ($ATLN) has secured rights in certain countries to Auxilium's ($AUXL) biotech drug for treating tissue buildups under the skin, the companies reported yesterday. Auxilium gets $10 million upfront and could rake in up to $68.5 million in the deal via upfront, regulatory and sales milestone payments as the Malvern, PA-based company continues development of the drug.

Actelion, which is known for its best-selling drug Tracleer, has gained rights to Auxilium's drug Xiaflex in Canada, Mexico, Brazil and Australia. The drug, which is not on the market in those four counties but has won FDA and European approval, is the first biologic to combat Dupuytren's contracture, which causes buildups of tissue under the skin of patients' palms, and Peyronie's disease, a condition that causes abnormally bent erections.

"Actelion and Auxilium have forged a partnership, which we believe has the opportunity to offer, subject to regulatory approval, the first, effective nonsurgical treatment for two diseases in multiple new geographies," said Adrian Adams, Auxilium's CEO, in a statement. "With the strength of Actelion's commercialization and development organization in these diverse and far-ranging markets, this relationship should further enhance our ability to bring this potentially groundbreaking product to a global audience."

Actelion could use some additional products to grow its income stream after heavy competition for Tracleer, a treatment for pulmonary arterial hypertension (PAH), ate into sales of the company's No. 1 moneymaker last year. The big news from Actelion is expected to come later this quarter when the company announces results of a late-stage trial for its next-gen PAH drug macitentan.

- here's the release

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Actelion hunts for answers about 120 deaths in key drug trial

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

Actelion ($ATLN) CEO Jean-Paul Clozel has been clear about the importance of macitentan for the Swiss biotech's future in the blockbuster market for pulmonary arterial hypertension (PAH) drugs. So investors appeared to take notice when it was reported that 120 patients in a late-stage trial for the key drug had died, and the company's uncertain about what causes the deaths.

The company's stock took a hit today, and part of the concern appears to surround Clozel's comment quoted in Bloomberg that he thinks it's unlikely the trial for macitentan--which the company is hoping will replace revenue from its PAH drug Tracleer--will show a survival benefit. Yet the lack of a survival benefit won't determine the success of the trial, which involves more than 700 patients and is expected to yield more complete data in the second quarter of the year.

"The stock has taken a nosedive on what appears to be a misinterpretation around CEO comments regarding the all-important SERAPHIN trial," an unnamed analyst told Reuters. "Nothing negative was said, and we still wait for the data Q2 2012. Expect the stock to recover."

Analysts have given the PAH trial for macitentan good odds of success--a nice change for Actelion after a series of pipeline setbacks that have stirred gossip about the company's chances of continuing as an independent organization. The company reported its business swung to a loss in 2011 after rival PAH drugs ate into the sales of its top-selling Tracleer.

- read Actelion's earnings statement
- check out Bloomberg's report
- see the Reuters article
- and the item from The Guardian

Related Articles:
Analysts give Actelion's key lung drug 63% odds of success
Actelion braces for looming pivotal data on blockbuster macitentan program
Actelion drug flunks PhII but safety data bolsters confidence in blockbuster PhIII

Actelion hunts for answers about 120 deaths in key drug trial

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

Actelion ($ATLN) CEO Jean-Paul Clozel has been clear about the importance of macitentan for the Swiss biotech's future in the blockbuster market for pulmonary arterial hypertension (PAH) drugs. So investors appeared to take notice when it was reported that 120 patients in a late-stage trial for the key drug had died, and the company's uncertain about what causes the deaths.

The company's stock took a hit today, and part of the concern appears to surround Clozel's comment quoted in Bloomberg that he thinks it's unlikely the trial for macitentan--which the company is hoping will replace revenue from its PAH drug Tracleer--will show a survival benefit. Yet the lack of a survival benefit won't determine the success of the trial, which involves more than 700 patients and is expected to yield more complete data in the second quarter of the year.

"The stock has taken a nosedive on what appears to be a misinterpretation around CEO comments regarding the all-important SERAPHIN trial," an unnamed analyst told Reuters. "Nothing negative was said, and we still wait for the data Q2 2012. Expect the stock to recover."

Analysts have given the PAH trial for macitentan good odds of success--a nice change for Actelion after a series of pipeline setbacks that have stirred gossip about the company's chances of continuing as an independent organization. The company reported its business swung to a loss in 2011 after rival PAH drugs ate into the sales of its top-selling Tracleer.

- read Actelion's earnings statement
- check out Bloomberg's report
- see the Reuters article
- and the item from The Guardian

Related Articles:
Analysts give Actelion's key lung drug 63% odds of success
Actelion braces for looming pivotal data on blockbuster macitentan program
Actelion drug flunks PhII but safety data bolsters confidence in blockbuster PhIII

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

Related Articles:
Actelion braces for looming pivotal data on blockbuster macitentan program
Actelion drug flunks PhII but safety data bolsters confidence in blockbuster PhIII