Today's Top Stories Also Noted: Spotlight On... UT team tackles therapeutic Parkinson's vaccine More Fierce Life Sciences News Today's Top News1. FDA panel backs new epilepsy drug from GSK, Valeant
GlaxoSmithKline and Valeant got a solid endorsement for their new epilepsy drug Potiga (ezogabine) from the FDA's panel of experts, putting them on track to a likely approval. The experts unanimously agreed that the drug would benefit epilepsy patients whose meds couldn't stop seizures. And they agreed that careful monitoring would flag patients who experience an inability to urinate while taking the drug. Two of the experts abstained on the main safety issue, which is typically reversible once spotted. And while the agency won't be bound by the expert backing, it's rare to see them go against this kind of tide. "For appropriate patients, we believe ezogabine could offer an important adjunctive treatment option for partial-onset seizures that are not well-controlled," said Atul Pande, a Glaxo senior vice president. That leaves the two developers laying the groundwork to begin marketing a new therapy for the $13 billion U.S. epilepsy market, where they say about a third of all patients could benefit from the drug. The vote is also good news for Biovail, which has a deal to buy Valeant. - read the Valeant release Related Articles: Read more about: GlaxoSmithKline, Valeant Pharmaceuticals, epilepsy, Biovail
2. Will new Genzyme stumble cripple its bargaining position?
After taking a good hard look at its troubled Allston plant, Genzyme (GENZ) has extended the scope of its repair mission to up to four years--which could extend federal oversight until late in the decade. And that whiff of lingering trouble could smell sweet to Sanofi, which would like nothing better than to be the only bidder at Genzyme's M&A party. Pictet Asset's Marc Booty tells Bloomberg that the new timeline on remediation at Genzyme could let Sanofi cap its solo bid at $70, well below the $80 threshold that Genzyme would need to celebrate. After all, who wants to get stuck with Genzyme at $50 again if Sanofi walks away anytime soon? According to Booty: "It's a game of chicken." The Boston Globe, meanwhile, turns the spotlight back to Genzyme's rivals, Shire and Protalix, which are seeing a big opportunity for their competing therapies while Genzyme grapples with its seemingly endless production woes. "People understand there will be two or three treatments out there," says Protalix CEO David Aviezer. "They all work, they all do the job, and that's a good thing.'' It's a particularly good thing for a company competing with a weakened market leader. Genzyme has been playing a delicate balancing act--often not doing a very good job of it. The new production timeline was outlined in documents filed with the feds and quickly spotted by a pack of journalists who are closely following every step the company makes. Any stumble it makes now will trigger headlines that can only hurt the big biotech. - here's the WSJ story Related Articles: Read more about: Shire Pharmaceuticals, Sanofi-Aventis, Protalix, Genzyme 3. Cardiome shares sag after Merck delays PhIII study
Investors in Canada's Cardiome Pharma (CRME) are more than a little disappointed to hear that the company's Big Pharma partner Merck isn't going to keep to its late-stage development schedule for the oral formulation of vernakalant, an experimental drug for irregular heartbeat. Once slated for a summer start date, the Phase III study is now up in the air, with no firm countdown in place. The news took some of the wind out of Cardiome's sails, along with a chunk of its stock price, which slid 13 percent. "Depending on the start of the Phase III program, this is likely to push back our forecast launch date from 2015 to at least 2016," writes Philippa Flint, an analyst at Bloom Burton. "We intend to revisit our financial model once full financial results are available, but for now we assume a launch of 2016." Flint also speculated that the delay could be the result of Merck's tinkering with the program design, possibly adding new goals such as improved safety or easier dosing compared to the market leader. Merck, however, wasn't in much of a mood to tell Dow Jones why it's experiencing a delay. "Merck remains committed to the vernakalant oral clinical program which is moving forward," a spokesperson says. But when you pay the biotech piper, you get to call the tune and set the tempo. Merck handed over $60 million to Cardiome when it signed up for the pact, along with promises of $300 million more in milestones. - here's the Dow Jones report Related Article: Read more about: Merck, Cardiome Pharma 4. Ramius tempts Cypress shareholders with sweetened offer
Ramius isn't taking 'no' for an answer after Cypress Bioscience's board opted to reject its buyout offer. In a carefully worded letter, which the hedge fund operator was equally careful to make public, Ramius says that it may even be open to offering more than $4 a share--a figure that Cypress (CYPB) has spurned as grossly inadequate--after it gets a close look at the books and management decides to negotiate a deal. "The clear message we have received from a large number of shareholders is that shareholders want maximum value for their shares now through a negotiated transaction and that this is clearly a better alternative than management continuing with its current strategy," said Ramius Partner Managing Director Jeffrey Smith. Ramius also reiterated its willingness to hand over a 50 percent interest in Cypress's BL-1020, an antipsychotic, provided management or some other third party funded the trial. That gives its offer an "implied value" of $4.39. At $4 a share the company would be worth $150 million. So far, though, investors haven't bought on to the idea that Ramius will win out, with the stock trading well under Ramius' offer. - here's the Ramius release Related Articles: Read more about: Ramius, Cypress Bioscience 5. Drug-resistant superbug highlights need for new antibiotics
A new superbug equipped with a gene that renders the current generation of antibiotics useless has begun to spread around the globe. The bacteria--which is armed with the NDM-1 gene--has been found in close to 200 patients in south Asia as well as the UK, raising the prospect that it will soon appear in other countries as well. MRSA has already raised fears about drug-resistant bacteria, spurring a lineup of biotech companies to start work on a new generation of bacteria-fighters. But this new superbug belongs to a separate family from the MRSA strain, living in the gut and swiftly jumping to other bacteria that it comes in contact with. And the appearance of this new superbug is likely to fuel R&D programs into a new and more effective generation of antibiotics. Health officials for now are spreading an alert to watch out for ailing travelers who have been hospitalized recently in India and Pakistan. "The possibility of this becoming a global problem very quickly is immense," says Timothy Walsh in an interview with Bloomberg. Walsh was the lead researcher of a new study on the NDM-1 gene. - here's the story from Dow Jones Related Articles: Read more about: antibiotic, NDM-1, MRSA, India Also NotedSPOTLIGHT ON... UT team tackles therapeutic Parkinson's vaccine Investigators engaged in preclinical studies have already seen how blocking a particular protein can reduce the level of nerve damage associated with Parkinson's disease. Now researchers at the University of Texas Health Science Center at Houston want to see if that same approach can be used to develop a therapeutic vaccine for the debilitating ailment. Report
> FDA panel backs new epilepsy drug from GSK, Valeant. Story > The FDA has put Pharmasset's hepatitis C drug, PSI-7977, on its fast track, offering an expedited review to speed development. Story > Numerate and Intellikine have called off the cancer research collaboration. Report > Daiichi Sankyo is having a hard time keeping a CEO at Dr. Reddy's. The Indian company, which has been expanding into new drug development, says that Atul Sobti resigned, shortly after he celebrated his first anniversary in the post. Story > Ann Arbor, MI-based Swift Biosciences has banked a $3 million Series A to fund its work on genetic analysis technology. DFJ Mercury led the round. Release > Norway's biotech business is getting more positive press. The Independent focuses on promising new cancer therapies now in development. Report Special Report: Top 5 Medical Device VC Deals, H1 2010 Special Report: Top 10 Generic Drug Companies 2010 And Finally... Researchers in the Faculty of Medicine & Dentistry at the University of Alberta say they are a step closer to a treatment for pulmonary arterial hypertension, a potentially deadly disease. University of Alberta release
> Analysts: Sanofi won't go hostile for Genzyme. Story > FDA probing GSK over Avandia disclosures. Report > J&J discloses more state, federal recall probes. News > Sigma denies sweetened buyout bid from Aspen. Article
> Medicago to develop vax facility in NC. News
> Warning letter cites decade-old violations. Story > Injunction will test FDA rule over stem cell remedy. News > Contractor Positron opens radioactive-drug plant. Article > Genzyme reports batch disposal; lengthens remediation time. Story
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@FierceBiotech: Biotech M&A frenzy shows no sign of slowing. 
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