Tag Archive | "University of Virginia"

Biogen Licenses Knopp’s Phase III-Ready ALS Drug for $80M

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Milestone payments could reach $265 million.

Biogen Idec is paying about $80 million up front for exclusive, worldwide rights to Knopp Neurosciences’ mid-stage candidate for amyotrophic lateral sclerosis (ALS) called KNS-760704. The firm agreed to pay an additional $265 million in development, regulatory, and sales milestones and will be able to leverage the drug in other indications as well.

The up-front fee is split into a $60 million purchase of Knopp stock and a $20 million cash payment. Biogen Idec will lead further development and potential commercialization of KNS-760704 in global markets. Knopp will provide development support and conduct certain U.S. commercialization activities under Biogen Idec’s direction. The company will receive tiered, double-digit royalties from Biogen Idec on worldwide sales.

Biogen Idec expects to initiate a Phase III program in the first half of 2011. In a Phase II ALS study, KNS-760704 achieved its primary endpoint evaluating safety and tolerability and showed favorable dose-related effects in preserving motor function and extending survival.

KNS-760704 is the chirally pure form of dexpramipexole, a low molecular weight benzothiazole shown to improve mitochondrial function and to confer significant cellular protection in neurons under stress. It is highly orally bioavailable, water soluble, renally excreted, and only moderately protein bound.

KNS-760704 was originally identified as a candidate therapy for ALS by James Bennett, M.D., Ph.D., then of the University of Virginia. Certain rights licensed by Knopp to Biogen Idec include rights licensed from the University of Virginia Patent Foundation. The compound received orphan drug designation from the FDA and the European Commission for the treatment of ALS as well as Fast Track designation from the FDA.

Source: GEN

Popularity: 2% [?]

Obama faces healthcare insurrection from left flank

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The White House worked on Thursday to tamp down an insurrection from some of President Barack Obama’s liberal backers who feel he has been too willing to compromise away their priorities on a healthcare overhaul.

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The frictions reflect the tortured state of negotiations over Obama’s top domestic legislative priority as the White House and Democratic leadership in the U.S. Congress seek to piece together enough supporters to approve a healthcare plan that Republicans oppose.

Leading the grousing from the left has been Howard Dean, a former Democratic National Committee chairman who ran unsuccessfully for his party’s presidential nomination in 2004.

Dean, a medical doctor and former governor of Vermont, in recent days has said a Senate healthcare bill that Obama supports and which is lurching toward a possible vote in coming days should be killed.

Dean and others on the left argue that the Senate legislation does not permit competition with medical insurance companies, would expand private insurers’ grip on healthcare and does not really amount to reform.

His complaint came because Senate leaders have ditched a plan for a government-run insurance plan and a measure that would allow people under 65 to buy into the Medicare government insurance plan for the elderly.

“If I were a senator, I would not vote for the current healthcare bill,” Dean wrote in a Washington Post opinion article on Thursday, his latest broadside on the matter.

Obama’s senior adviser, David Axelrod, went on MSNBC’s “Morning Joe” program on Thursday to fire back at Dean, saying his argument is “predicated on a bunch of erroneous conclusions” and that the legislation does meet most Democratic goals.

Axelrod found himself challenged on the program by Ed Schultz, a liberal anchor on MSNBC’s evening programing.

“They key is, people in this country right now don’t believe that the White House has stood up to the insurance industry,” Schultz said.

REPUBLICANS APPLAUD DEAN

Obama himself took up the argument in an ABC News interview on Wednesday, saying the legislation will reduce the budget deficit over the long run, will help reduce insurance premiums for families, will force companies not to deny coverage to individuals due to pre-existing health conditions, and permit 30 million uninsured to get coverage.

“There’s got to be a sense sometimes that we’re willing to rise above our particular interests, our particular ideas in order to get things done,” Obama said.

Republicans who are trying to defeat the bill found themselves happy to have Dean’s help.

“If you live long enough all things can happen,” Republican Senator John McCain said with a smile. “I now find myself in complete agreement with Dr. Howard Dean, who says that we should stop this bill in its tracks, we should go back to the beginning and have an overall bipartisan agreement. Dr. Dean, I am with you.”

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Bickering in the healthcare debate is taking its toll. An NBC News/Wall Street Journal poll published on Thursday found Americans turning against an overhaul. It said 44 percent said it is better to pass no plan at all, compared with 41 percent who want passage.

Larry Sabato, a political science professor at the University of Virginia, said at this stage it is critical for Obama to emerge with a victory on healthcare because he has spent so much time on it this year.

“If Dean isn’t costing him the critical votes in Congress, battling Dean could be a plus because it could position Obama’s healthcare program more in the center. Right now it’s seen as too big, too costly, too big-taxing,” Sabato said.

Source: Reuters

Popularity: 5% [?]

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