FierceBiotech
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FDA panel overwhelmingly backs Vivus' diet drug
Who said this panel vote would be close? Non-agency experts gave strong support to Vivus' ($VVUS) quest to gain FDA approval for its diet pill Qnexa, voting 20-2 this afternoon to support the drug getting a green light to hit the U.S. market, TheStreet reported.
The Endocrinologic and Metabolic Drugs Advisory Committee vote comes ahead of the FDA's decision, which is expected by April 17, on whether to stamp an approval on the Mountain View, CA-based developer's drug. If approved, Qnexa would be the first new diet pill to garner FDA approval in more than a decade. The agency, as many know, is not required to follow such panel's recommendations, but it often does.
Industry watchers have been largely split on Vivus' chances of gaining a nod for its latest approval bid, as U.S. regulators have taken a tough stance on the safety of diet drugs because of their side effects. The FDA, which shot down Vivus' first bid for Qnexa's approval in 2010, released its staff review of the company's latest application, noting previous concerns about the cardiovascular side effects of the drug, as well as the risk of birth defects in the offspring of mothers on the treatment.
During today's committee session, non-agency experts and company officials discussed having a risk evaluation and mitigation strategy for Qnexa to limit any ill effects of the drug on patients. Prior to today's panel vote, analysts had speculated from the tenor of the FDA's briefing documents that the agency might delay approval of Qnexa to seek additional safety information.
Vivus has been among three drug developers including Arena Pharmaceuticals ($ARNA) and Orexigen ($OREX) that have been racing to gain approval for new weight-loss drugs. The panel's favorable vote on Qnexa appears to have spurred a jump in the stock prices of Arena (6%) and Orexigen (14%) in after-hours trading.
There's no question that a stout market awaits new weight-loss drugs. Two out of three Americans are either overweight or obese, and drug developers have been vying to fill a gap in the market that isn't addressed with existing interventions such as dieting, exercise and bariatric surgery. The CDC has put the annual cost of obesity--which can lead to diabetes, heart attacks and other health problems--at $147 billion in the U.S. alone.
- here's The Street's live blog
- get more from Reuters
- and here's more from the Los Angeles TimesRelated Articles:
FDA notes concerns about Vivus diet pill safety ahead of panel
Vivus buoyed by FDA's willingness to drop Qnexa restriction
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Eisai co-developing cancer drug fueled by bacteria; U.S. trials launch soon
Tokyo's Anaeropharma Science is launching U.S. clinical trials as early as March for a new stomach cancer drug fueled by bacteria. The biotech is partnering with Japanese drug giant Eisai to bring the treatment to market, according to the Daily Yomiuri. Testing will involve 60 patients over 3 ½ years. Anaeropharma loads the drug with bifidobacteria, which helps the drug both reach and build up within its tumor target because it is drawn to environments lacking oxygen, just like solid tumors. An anticancer agent taken by mouth then selectively targets those tumors after reacting to the drug, according to the article. Story
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Venture backer makes $7M bet on cardio drug tech that could rival stents
With drug delivery tech from a children's hospital in Philadelphia, Vascular Magnetics has pocketed a $7 million Series A round from lone investor Devon Park Bioventures. And the startup has ambitious plans to advance magnetic drug-loaded particles for the huge market to treat peripheral artery disease--offering a potential alternative to a range of existing interventions against the disease that affects some 10 million Americans, according to the company.
The startup's tech is based on the published work of Dr. Robert Levy at The Children's Hospital of Philadelphia. The company proposes to develop Levy's magnetic drug-loaded particles to deliver treatments directly to diseased tissue with the aid of a magnetic catheter system and an external device to create a magnetic field, making the proposed product a true drug-device combo. The financing is expected to be enough to propel the company through preclinical development and an initial human trial, according to the company's COO and co-founder Richard Woodward.
"Current treatments for PAD such as angioplasty, grafts and stents, including drug-eluting stents, are not durable, with arterial re-obstruction (restenosis) occurring frequently," company Chairman Georges Gemayel said in a statement. "Vascular Magnetics' innovative approach to enhance local drug delivery has great potential to transform PAD treatment by delivering anti-restenotic drugs specifically to diseased artery sites at higher concentrations than are possible with drug-eluting stents."
Woodward stated that the startup aims to launch its maiden trial in 2014.
- here's the release
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Collegium Pharma scores $22M round for abuse-preventing painkiller in Phase III
Venture backers have rallied behind Collegium Pharmaceutical to continue a late-stage trial for its extended-release version of oxycodone. The investors--led by Longitude Capital and Skyline Ventures, and including Frazier Healthcare Ventures and Boston Millennia Partners--are betting $22.5 million in the developer's Series B round.
With traditional oxycodone offering a recipe for abuse, Collegium has a proprietary formulation of the popular pain drug dubbed COL-003 that aims to thwart the type of tampering such as crushing and snorting the drug that addicts employ. A late-stage trial for the company's lead drug is under way, and the fresh round of capital is expected to be enough to fund the developer through potential FDA approval of the treatment, according to the company's release. Collegium plans to file an application for U.S. approval of COL-003 in 2013.
"We believe that with the ongoing national epidemic of prescription drug abuse there remains a significant unmet clinical need for tamper-resistant formulations that can mitigate abuse/misuse of opioid products," Collegium CEO Michael Heffernan said in the release.
A challenge for Collegium, naturally, will be setting itself apart from the pack of drugmakers in the pain field. Competitors are at various stages of advancing their own recipes for stymying abuse of pain pills. For instance, Purdue Pharma won FDA approval for a new formulation of OxyContin (oxycodone) in 2010 that offers controlled release of the drug and measures to prevent tampering.
- here's Collegium's release
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Biotech VCs wait for big checks from string of buyout deals
Holding most of the cards in M&A deals, drugmakers have increasingly scored biotech buyouts with much of the payments to startup investors delayed unit certain goals are met. The danger of the deals is that investors face slim odds of raking in all the milestone payments tied to the buyouts, as many of the programs that must succeed in order for payments to be made often fail. One biotech backer from Atlas Venture has taken a stab at calculating the actual earnings from a sample of such deals.
Plucking numbers from a variety of public sources and data from individuals, Atlas Partner Bruce Booth writes that 24% of milestone payments were actually received from buyout deals involving drug developers from January 2005 to December 2009. Those payments amounted to $1.7 billion to biotech investors, and some of the milestone money remains on the table as related programs advance, but the figure illustrates how the big "potential" buyout figures seldom become real dollars. His research shows that 40% of the milestones from those 35 deals could be collected, yet 37% of the payments are out the window because programs to which they are tied have been tossed.
The so-called "biobucks" tied to these deals are often overlooked in the press after the deals are closed, but biotech investors obviously pay close attention to how much money they will actually receive from M&A events. With VCs dropping from the ranks of potential sources of capital, hope that the "biobuck"-laden deals bear fruit for these investors and entice them to make more bets on biotech startups. With IPOs hard to come by for small drug developers, drugmakers might offer venture backers their best shot at returns on their biotech investments.
Booth and his firm are among the ranks of VCs still waiting for big checks from drugmakers that have bought their portfolio companies. In the past two months, the VC firm has seen two of its drug developers--Stromedix and Avila--scooped up in deals that provided only part of the total payouts upfront. For instance, Biogen Idec ($BIIB) snapped up Stromedix for $75 million upfront and the lion's share of the potential payout, $487.5 million, tied to the success of the startup's fibrosis programs. Booth is asking his counterparts in the industry to help him compile a more complete picture of how much in the way of biobucks they are actually pocketing.
- get more from Booth's blog
Related Articles:
Biogen's lead dealmaker makes case against corporate VC
Big drugmakers lend hand in forming biotech startups
Biotech IPOs: It's just a flesh wound
The best of times, the worst of times?