Hungry Valeant snags Eyetech in ongoing buyout spree

Posted under Blog, Companies, Diagnostics, Eyetech, Funding, macular degeneration, Medical Devices, Medical Supply, Mergers and Acquisitions, Pharmaceuticals, Startups, Universities, Valeant Pharmaceuticals, Videos by John Carroll

Valeant Pharmaceuticals today continued its restless buyout spree, snapping up Eyetech, a small FL-based company that sells the anti-VEGF pioneer Macugen in the U.S. And while Valeant ($VRX) didn't spell out the numbers, it carefully noted that it was forking out "significantly less than two times sales" for the company.

Macugen was the first anti-VEGF therapy approved for wet, age-related macular degeneration. It was developed by the original Eyetech, which was scooped up soon after the approval by OSI. But the treatment was quickly bested by Lucentis--an event that had been widely forecast by analysts--and a chastened OSI later spun off Eyetech in 2008 with a license to market the therapy in the U.S. Pfizer ($PFE), which acquired the ex-U.S. rights, recently made an effort to garner a fresh approval for the treatment to cover visual impairment due to diabetic macular edema. But the EMA batted down that attempt last summer.

"This acquisition of Eyetech will fit nicely with our existing ophthalmology business, which includes a preservative free Timoptic in Ocudose and Lacrisert, products obtained through our acquisition of Aton in 2010," said Valeant CEO J. Michael Pearson. "The ophthalmology market has similar characteristics to the dermatology space and is a natural extension of our development capabilities. We will continue to look for future opportunities to acquire additional products and gain important critical mass in this specialty space."

Pearson has been hungrily snapping up biotechs, acquiring Biovail in 2010 and then a string of other companies. Each new buyout has been followed by the quick elimination of any overlapping operations, as Pearson underscored a few weeks ago when he vowed to slice $200 million in costs this year.

- here's the press release

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ACT trumpets positive efficacy data from ESC trial sampling

Posted under Advanced Cell Technology, Blog, Companies, Diagnostics, embryonic stem cells, Funding, Geron, macular degeneration, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

The beleaguered embryonic stem cell field got a boost today from a clinical trial sample in which two legally blind patients demonstrated partially restored vision after getting an injection of new cells prepared by Advanced Cell Technology ($ACTC). The two subjects suffer from two types of macular degeneration, a common condition in which vision blurs as retinal cells die. And after injections of ESC-derived retinal cells, both scored better on vision tests, leaving ACT to claim bragging rights for reporting the first efficacy data in the ESC field.    

"Despite the progressive nature of these conditions, the vision of both patients appears to have improved after transplantation of the cells, even at the lower dosage," says Advanced Cell Technology CSO Robert Lanza. "This is particularly important, since the ultimate goal of this therapy will be to treat patients earlier in the course of the disease where more significant results might potentially be expected."

The data from the tiny Phase I/II study by ACT, which has skirted financial disaster in the past, is being reported in The Lancet. Regulators, obviously, would require much larger trials before even considering an approval. But the news marks a bright spot after a major setback in ESC research.

The recent news that the pioneering ESC company Geron ($GERN) is selling off its programs has cast a pall over the field. Alan Trounson, who runs the California stem cell agency, said recently that Geron's decision to exit the field created "a very strong negative influence internationally." According to the California Stem Cell Report Geron has been talking with two potential bidders.

- read the press release
- here's the story from The Telegraph

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Regeneron finally captures an FDA OK with new eye drug

Posted under Aflibercept, Avastin, Blog, Companies, Diagnostics, Eylea, Funding, Genentech, Lucentis, macular degeneration, Medical Devices, Medical Supply, Pharmaceuticals, Regeneron Pharmaceuticals, Roche, Startups, Universities, Videos by John Carroll

Late on Friday Regeneron Pharmaceuticals ($REGN) scored a big win as it announced that the FDA has approved Eylea (aflibercept) for wet, age-related macular degeneration. But after pricing an injection at a slight discount to Roche's Lucentis--$1,850 to $1,950--most of the market buzz centered on the $50 competitor available from an off-label dose of Genentech's Avastin.

As The New York Times' scribe Andrew Pollack noted, Regeneron has racked up $1.2 billion in losses as it spent its way through 24 years of R&D, often plagued by setbacks in the clinic. But the approval marks a solid achievement for CEO Leonard Schleifer, who holds the title for longest-running chief in the biotech industry.

"We thought that good science would win out a little earlier, but we are patient," he told Pollack.

He'll need all the patience he can muster on this next step. Eylea has an edge on Lucentis, with an injection needed every eight weeks--significantly less frequent than Lucentis. And almost every practitioner will tell you that patients are highly motivated to reduce the number of injections they need in their eyes. But the much cheaper off-label Avastin has a solid hold on 60% of the market, according to Bloomberg.

"Eylea offers the potential of achieving the efficacy we've come to expect from current anti-VEGF agents, but with less frequent injections and no monitoring requirements," said Jeffrey Heier, M.D., a clinical ophthalmologist, in a release from Regeneron. 

- read the press release
- get the story from The New York Times
- here's the Bloomberg report

Special Report: Regeneron Pharmaceuticals - Biotech's Biggest Spenders 2011

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