News
FDA lifts hold on Geron study
Geron announced today that the FDA has lifted a clinical hold placed on the company's Investigational New Drug (IND) application, allowing the Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury to proceed. Geron release
Orexigen weight-loss drug shows positive results in study
Results from COR-I, one of the Phase III trials supporting the NDA for Orexigen Therapeutics' (NASDAQ: OREX) weight-loss drug Contrave, show that patients taking the drug were two to three times more likely to lose at least 5 or 10 percent of their body weight compared with those taking placebo. The study results have been published online in the journal Lancet.
Treatment with Contrave also resulted in significant improvements versus placebo in waist circumference, insulin resistance, HDL cholesterol, triglycerides and hsCRP, which are accepted measures of cardiometabolic risk. Patients taking Contrave also showed significant improvements in patient-reported control of eating, the company says in a statement.
But, as Reuters points out, only half the volunteers finished the trial, dropping out for various reasons. "The people in the placebo group seemed to drop out more frequently because they were dissatisfied with the lack of weight loss. People in the drug arm seemed to drop out more because of side-effects. Overall, the groups seemed to be equal," Frank Greenway, who led the trial, tells Reuters. The most frequent adverse event in participants taking Contrave was nausea. Headache, constipation, dizziness, vomiting and dry mouth were also more frequent in those taking the drug than in the placebo group, according to the study results.
Orexigen is one of three company trying to get weight-loss drugs to the market. Earlier this month, an expert panel recommended against approval of Vivus' (NASDAQ: VVUS) competing drug Qnexa. The vote was six in favor and ten against, with many of the no voters citing the need for more safety data. As Bloomberg points out, some of the panelists' safety concerns have plagued other weight-loss drugs. For example, Abbott Laboratories pulled Meridia from the European market over concerns about heart risks in January.
Orexigen's other rival, Arena Pharmaceuticals (NASDAQ: ARNA), recently released promising data for its own obesity drug, lorcaserin. Results showed that just about half of the patients taking the drug in a two-year trial lost at least five percent of their body weight--roughly twice the rate of weight loss registered in the placebo group.
The FDA has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting for Dec. 7, and the Prescription Drug User Fee Act action date has been set for Jan. 31, 2011.
- see the Orexigen release
- here is a summary of the study in the Lancet
- read the Reuters story
- get more from Bloomberg
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Sanofi looks beyond blockbusters
Sanofi CEO Chris Viebacher (photo) wants his company to avoid the peaks and valleys that come with blockbuster drugs such as Lovenox, a $2 billion-a-year anti-clotting drug that's now facing generic competition. Instead, he's looking at emerging markets, consumer health products and generic medicines to help boost revenue, as well as focusing more on deals for drugs aimed at smaller patient groups. That may help explain Sanofi's interest in Genzyme--a biotech company that makes treatments for a variety of rare diseases. Such drugs are rarely susceptible to generic competition. "Above all, what I'm looking for is businesses that are not dependent on patents," Viehbacher told the AP in an interview. "This is my fourth patent cliff in my career and I'm looking to avoid a fifth."
- read the AP report for more
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Molineaux turns her attention to start-up Calithera
Susan Molineaux (photo) helped guide cancer drug developer Proteolix from early stage multiple myeloma research through Phase II trials. The developer was snapped up by Onyx Pharmaceuticals, which last year paid $276 million up front for the company, leaving Molineaux free to concentrate on a new project. "I'm a risk taker," Molineaux tells the San Francisco Business Times. "There's probably no super-safe program I've ever been associated with."
The entrepreneur has now turned her attention to South San Francisco-based Calithera Biosciences, which earlier this month landed a $40 million Series A round to ramp up development work on a new group of cancer drugs discovered in the lab of Jim Wells, chair of the Department of Pharmaceutical Chemistry in the University of California, San Francisco School of Pharmacy. Wells was impressed by Proteolix's ability to find the correct dosing, formulation and potency for its cancer drug--a challenge he suspects Calithera will face in its work. Wells' compounds activate procaspases and trigger apoptosis (cell death) in cancer cells.
Wells and Chris Christoffersen, managing partner at Morgenthaler Ventures (one of Calithera's VC backers), agreed that Molineaux was the right choice to head up Calithera. They were impressed with her ability to bridge the gap between science and business. During Molineaux's interview for the CEO spot, "we talked serious science and candidly and openly with great strategic clarity about businesses she's been involved with," Christoffersen tells the San Francisco Business Times. "I walked out of the interview saying, 'That's impressive.'"
- here's the San Francisco Business Times article
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Charles River, WuXi call off $1.6B deal
Shareholder opposition has forced Charles River to call off its $1.6 billion plan to purchase China's WuXi PharmaTech. Despite CEO James Foster's assurances that the deal would bring up to $100 million in potential operational savings, several investors were never able to overcome their concerns that the deal wasn't in the company's best interests. Charles River has been expanding its Chinese operations for the past several years and had hoped to increase the size of its footprint in China with the WuXi deal.
Investors Jana Partners, Relational Investors and Neuberger Berman were among the firms concerned that Charles River was overpaying for the Chinese CRO, and that the company would face significant challenges integrating the two businesses. The termination agreement provides for Charles River to pay WuXi a $30 million breakup fee. Additionally, the company announced that its board of directors has authorized the repurchase of up to $500 million of Charles River stock.
"We believed that this transaction, which would have created the premier early-stage contract research organization, would have resulted in long-term strategic benefits for our business and our shareholders," said James in a statement. "We also value our stockholders' views and given their concerns about the proposed transaction, and our commitment not to proceed without their support, we have decided that terminating the transaction is the appropriate action to take."
- see Charles River's release
- here's the WSJ report
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Anacor gets $15M from GSK
GlaxoSmithKline (NYSE: GSK) has obtained an exclusive licence to develop and commercialize an antibiotic derived from Anacor's boron chemistry platform. As a result, Anacor will receive $15 million and is eligible for further milestone payments and royalties on any future product sales. GSK is assuming responsibility for further development of the compound and any resulting commercialization.
In early stage studies, GSK2251052 (GSK '052) has shown robust activity against multi-resistant gram-negative bacteria with no cross resistance to existing classes of antibiotics. GSK '052 is being looked at as a potential treatment for complicated urinary tract infection, complicated intra-abdominal infections and hospital/ventilator-associated pneumonia (HAP/VAP).
"GSK '052 has an entirely novel mechanism of action with the potential to be the first new class antibacterial to treat serious hospital gram-negative infections in 30 years," says David Payne, VP of GSK's anti-bacterial drug discovery unit. "Our collaboration with Anacor has enabled the rapid progression of GSK '052, and we are excited about the opportunity to address the growing need for new treatments for serious hospital acquired infections."
GSK and Anacor entered into a worldwide strategic alliance for the discovery, development and commercialization of novel medicines for viral and bacterial diseases in October 2007. The alliance grants GSK access to Anacor's proprietary boron-based chemistry for use in four target-based project areas. Contingent on achieving certain milestones, Anacor is eligible to receive development and regulatory milestone payments of up to $84 million as well as commercial milestones and tiered double-digit royalties up to the mid-teens, which are dependent on sales achieved.
- read the Anacor release
ALSO: Colgate-Palmolive hasasked a federal court to rule that its new "Triple Action" toothpaste doesn't infringe trademarks of GSK's competing product, Aquafresh. Report
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