Actelion surges as positive PhIII macitentan data reignites buyout buzz

Posted under Actelion, Blog, Clinical Trials, Companies, Diagnostics, Funding, macitentan, Medical Devices, Medical Supply, Pharmaceuticals, Phase III, Pipeline, Startups, Tracleer, Universities, Videos by john

Actelion cleared a crucial hurdle today, reporting that its late-stage study of macitentan for pulmonary arterial hypertension beat the primary endpoint. The data clears a path to the regulatory agencies, signaling to investors that the Swiss company can be ready for the loss of patent protection on its primary earner with the introduction of another blockbuster. And Actelion shares ($ATLN) jumped more than 20% on the news.

News of the positive Phase III provides a clean win for founding CEO Jean-Paul Clozel, who has had to fend off repeated claims that the company was on the road to ruin. Actelion gets 90% of its revenue from Tracleer, which loses patent protection in 2015. If macitentan--a successor to Tracleer--can clear a regulatory review, the drug can replace lost revenue.

According to investigators, a 10 mg dose of macitentan reduced the risk of mortality and morbidity 45% compared with a placebo, while the 3 mg dose cut the same risks 30%. It managed those results without evidence of liver toxicity, giving it an edge on Tracleer. And in this heated M&A environment, the promising Phase III quickly triggered fresh speculation of a possible buyout.  

"The results of SERAPHIN suggest the market's assumption that its business will simply disappear has been overly negative and are likely to make chances the company becomes an M&A target realistic," noted Richard Parkes, an analyst at Deutsche Bank, according to a Reuters report.

"Essentially 'best case' Phase III results for macitentan should ensure a long-term future for Actelion's PAH franchise and shift the disease treatment paradigm," noted Jefferies.

- read the press release
- here's the Reuters article

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UPDATED: Merck drug homes in on new baldness target

Posted under Actelion, baldness therapies, Blog, Companies, Diagnostics, Follica, Funding, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

Drug developers have a new target to pursue in their search for remedies against baldness, which afflicts most males to some degree. Researchers have uncovered spikes in levels of a protein in samples of bald scalps, and U.S. drug giant Merck ($MRK) and Swiss biotech heavyweight Actelion ($ATLN) have compounds in development for other uses that could inhibit the protein linked to baldness, Bloomberg reports.

University of Pennsylvania dermatologist George Cotsarelis, a rock star among men hoping for a cure for baldness, contributed to the research that found high amounts of the protein prostaglandin D2 synthase in samples of bald scalps from men, Bloomberg reports. Merck's and Actelion's drugs--in late-stage development for treating facial flushing and allergies, respectively--block the protein, but neither company is developing the treatments to stymie baldness. And a Merck spokesperson told the news service that the company hasn't seen clinical evidence that its drug, called laropiprant, prevents baldness.    

Let's stop here and acknowledge that to most, baldness is considered a cosmetic condition, nowhere near as serious as the illnesses typically covered in these pages. Nevertheless, there's a multibillion-dollar market for anti-baldness remedies that has drawn major companies and biotech investors into the hunt for new treatments and possible cures. Johnson & Johnson ($JNJ) and Merck are major players in this market, and UPenn's Cotsarelis is a founder of biotech called Follica that has been testing treatments for baldness and has drawn investments from major venture firms.

Whether inhibition of prostaglandin D2 synthase could lead to a long-sought cure for baldness is a question that will require clinical research, which has not yet been done, and it's unknown whether blocking the protein could help restore growth of hair from dormant follicles in the scalp. It might just be a way of halting the progression of pattern baldness.

"This makes me wonder if this is the pathway," Paradi Mirmirani, a dermatologist at Kaiser Permanente, told Bloomberg. "In terms of therapeutics, it really opens the door to have someone come in and target these in a very narrow way."

- check out Bloomberg's article
- and the item from MedPage Today

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Editor's note: This story was updated and clarified to add the word "synthase" after prostaglandin D2, ensuring that readers know that new drug target is the protein called prostaglandin D2 synthase. We apologize for any confusion.

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

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