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| EUSA Swings an Ideal Exit with The $700M Acquisition by Jazz The privately held UK specialty oncology firm EUSA Pharma Ltd. is to be acquired by Jazz Pharmaceuticals Inc. in a $700 million cash deal that is motivated by the early commercial success of EUSA's Erwinaze treatment for pediatric acute lymphoblastic leukemia (ALL), approved by the FDA in November 2011. That approval is expected to translate to 2012 sales of $115 million to $125 million of the orphan drug, a huge chunk of EUSA's forecasted overall revenues for the year of $160 million to $180 million. It is expected that 75 percent of Erwinaze sales will be in the U.S. This is the second large European expansion in four months for Jazz, following its all-share combination with Elan plc spinout Azur Pharma Ltd of Dublin, Ireland, which completed in January. | Vivus Gains ED Approval; Obesity Still Center Stage As expected, the FDA green-lighted Vivus Inc.'s erectile dysfunction drug Stendra (avanafil) on Friday, but analysts and investors remain focused on the looming July 17 PDUFA date for obesity drug Qnexa (phentermine/topiramate). Stendra is a phosphodiesterase type 5 (PDE-5) inhibitor, putting it in the same class as entrenched competitors Viagra (sildenafil, Pfizer Inc.) and Cialis (tadalafil, Eli Lilly and Co.), among others. Vivus is hoping its drug will be differentiated by a rapid onset of action: Its label advises dosing as-needed 30 minutes before sexual activity, while Viagra hits its maximum plasma concentration about an hour after dosing – longer if it's taken on a full stomach. Cialis works even slower – it takes two hours on average to hit maximum plasma concentration. | |||
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| Mitochondria's Bacterial Past Is Problem for Failing Hearts Mitochondria, the energy-producing centers of cells, very likely got their start more than a billion years ago as bacteria that gradually went from a symbiotic relationship to a full-fledged part of the cells they colonized. Overall, that relationship has been a successful one for both partners – cells got aerobic metabolism and mitochondria, the protection of cells. But through it all, the mitochondrion has hung onto its heritage, in the form of its own DNA. And that can be a problem. Mitochondrial DNA has some similar features to bacterial DNA – not too surprisingly, given its evolutionary history. | Gilead's HIV Franchise Solid; HCV, Quad to Round out 2012 Gilead Sciences Inc. beat revenue estimates for the first quarter, but missed earnings-per-share consensus by 2 cents, as it reported solid sales for its antiviral franchise, including impressive uptake of recently launched tripledrug, single-tablet HIV drug Complera. But much of the focus on the Foster City, Calif.-based biotech's earnings call was on its hepatitis C virus (HCV) pipeline, namely its potentially industry-leading all-oral, interferon-free regimen. The company wowed investors earlier this month with data from GS-7977, a nucleotide NS5B inhibitor acquired in the recent buyout of Pharmasset Inc., at the European Association for the Study of the Liver (EASL) meeting in Barcelona, Spain, and analysts spent a large portion of the call trying to tease out regulatory plans and timelines. | |||
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