UPDATE: Vivus soars after experts offer surprising support for weight drug

Posted under Blog, Companies, Diagnostics, FDA, Funding, Medical Devices, Medical Supply, obesity, Pharmaceuticals, Qnexa, Startups, Universities, Videos, Vivus by Ryan McBride

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 Wednesday evening to support the drug getting a green light to hit the U.S. market.

Vivus' stock was up a whopping 110.5% in early morning trading Thursday.

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 Wednesday'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.

Cowen's Simos Simeonidis quickly conceded that he had guessed wrong on the outcome of the vote. The analyst now counts himself as a believer in a looming approval. "We see FDA approval by April 17 as pretty much a done deal, attention shifts to hiring the right salesforce, and executing on launch, pricing and reimbursement efforts," he said in a note to investors today.

It's important to note, though, that while a panel vote as lopsided as this one typically precedes a formal approval, regulators in the FDA have made it clear that any new obesity drug will have to clear a very high safety bar.

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 Times

Related Articles:
FDA notes concerns about Vivus diet pill safety ahead of panel
Vivus buoyed by FDA's willingness to drop Qnexa restriction
 

Dr. Jill Biden Kicks-Off Community College to Career Bus Tour

Posted under Biden, Blog, Companies, Diagnostics, education, Events, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, STEM Education, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

Dr. Jill Biden and U.S. Labor Secretary Hilda Solis will embark on a five-state “Community College to Career” bus tour to highlight innovative industry partnerships this week. The tour will begin on February 22 with a visit at Columbus State Community College before continuing to DG Medical.

At DG Medical, Dr. Biden and Secretary Solis will join BioOhio and Sinclair Community College officials to see first-hand the impact of a U.S. Department of Labor grant-funded biomedical training program led by BioOhio.

Launched in 2010, the three-year Ohio Bioworkforce Training Partnership aims to deliver training to 660 displaced or underemployed workers in declining industries for careers in Ohio’s growing bioscience industry. In addition, 40 incumbent workers will receive more advanced training to move into higher level jobs. Several DG Medical employees have completed training at Sinclair Community College, one of the program’s six college partners.

Last week, President Obama announced a new $8 billion Community College to Career Fund co-administered by the Department of Labor and Department of Education to forge new partnerships between community colleges and businesses to train two million workers with skills that will lead directly to jobs.

Dr. Biden, a community college instructor for 18 years, and Secretary Solis, who began her career in public service as a community college trustee, will highlight the unique role community colleges can play in creating a flexible, highly-skilled 21st-century workforce to help businesses meet the specific emerging needs in their regions.

Special thanks to my friends at BioOhio for the heads-up and press release on this public awareness initative.

Eisai co-developing cancer drug fueled by bacteria; U.S. trials launch soon

Posted under Anaeropharma Science, bacteria, Blog, cancer treatments, Companies, Diagnostics, Eisai, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, stomach cancer, Universities, Videos by Mark Hollmer

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

Venture backer makes $7M bet on cardio drug tech that could rival stents

Posted under Biotech Venture Capital, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Vascular Magnetics, Videos by Ryan McBride

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