Vivus gets ED drug approval, spurring fresh talk of a deal

Posted under Blog, Companies, Diagnostics, erectile dysfunction, FDA approval, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Qnexa, Regulatory, Startups, Stendra, Universities, Videos, Vivus by john

The FDA issued word this afternoon that it had stamped its OK on Stendra (avanafil), an erectile dysfunction treatment designed to spur a quicker response for men. The drug will enter a crowded field of rival and better known treatments in a mass market, leaving some analysts to suggest that the Mountain View, CA-based biotech ($VVUS) would be better off making a deal on it as soon as possible with a Big Pharma company.

Like Viagra and Cialis, the treatment works by increasing blood flow. Its marketing edge is getting results for most men in only 15 minutes. But shares of Vivus barely budged on the unsurprising news, with investors less than enthusiastic about Stendra's short-term prospects.

"Does anyone really need another ED drug?" asks Simos Simeonidis, an analyst at Cowen, in a note to investors. "Probably not, but given the large market opportunity and the potentially differentiating faster onset of action, we believe that in the hands of big pharma Stendra is probably worth around $300 million. We remind investors that management's intent is to outlicense/divest Stendra."

Vivus faces a much more important July 17 deadline for an FDA response on Qnexa, which has a solid shot at becoming the first new obesity drug to get an OK in more than a decade. Once again, Vivus is looking at a drug aimed at a mass market; not the kind of field a small company can play in. If it does get an approval, analysts like Simeonidis wonder how they could ever market it successfully. And that makes the ideal outcome here a buyout, giving a Big Pharma company a chance to scoop up the entire company and its products.

Adds Simeonidis: "We believe that Qnexa is a drug with tangible blockbuster potential that should be in the hands of big pharma; with all its problems and issues, this is the one thing big pharma has always done better than anyone: get primary docs to prescribe its products. We believe that Vivus management, which is both competent and sophisticated, should pursue a sale of the company, and they're probably in the process of doing so." 

- here's the company's release
- here's the story from The Wall Street Journal

Related Articles:
Vivus basks in limelight of rampant M&A speculation
Vivus shares slide as FDA delays decision on Qnexa

Sanofi colorectal cancer contender Zaltrap suffers a PhIII trial setback

Posted under Aflibercept, Blog, Chris Viehbacher, colorectal cancer, Companies, Diagnostics, FDA approval, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Prostate Cancer, Regeneron, Regulatory, Sanofi, Startups, Universities, Videos, Zaltrap by john

Sanofi and Regeneron opened their update on the cancer drug Zaltrap (aflibercept) on a sweet note: The FDA has granted a priority review of their new drug application for colorectal cancer. But the news wrapped a bitter pill, as they quickly went on to acknowledge that their cancer contender had failed a late-stage study for prostate cancer.

The Phase III Venice study involving patients with metastatic, androgen dependent prostate cancer "did not meet the pre-specified criterion of improvement in overall survival," the companies reported. No data was put out in the release and investigators noted that they would review the results at a later scientific meeting.

Last fall, as analysts were growing increasingly skeptical about Sanofi ($SNY) CEO Chris Viehbacher's (photo) promise for better results from the pharma giant's restructured R&D operation, the company listed Zaltrap as one of its top late-stage prospects in the pipeline. Today's mixed news may not help much in making its case for a turnaround, but the primary focus in R&D has long been on the positive colorectal cancer results seen in Phase III. And that's the note Sanofi was trying to stay focused on today.  

"Sanofi and Regeneron are committed to the continued development of Zaltrap and we are very pleased that the FDA has chosen to grant priority review to Zaltrap in metastatic colorectal cancer," said Debasish Roychowdhury, who heads up Sanofi's cancer drug work. "We look forward to working closely with the FDA to potentially bring an important new option to patients with this difficult disease."

The target date for their application on colon cancer is August 4. 

- get the press release
- here's the Reuters story

Related Article:
Sanofi, Regeneron buoyed by PhIII colon cancer success for aflibercept

UPDATED: FDA rejects Chelsea’s Northera, demands additional study data

Posted under Biotech Stock, Blog, Chelsea Therapeutics, Companies, Diagnostics, Droxidopa, FDA approval, Funding, Medical Devices, Medical Supply, neurogenic orthostatic hypotension, Northera, Pharmaceuticals, Pipeline, Regulatory, Startups, Universities, Videos by john

After the markets closed on Wednesday, Chelsea Therapeutics ($CHTP) put out the word that the FDA had rejected Northera, a troubled program that drew regulatory frowns for an absence of long-term efficacy data and troubling safety signals. In handing Chelsea a complete response letter, the agency opted to overlook the majority vote in favor of Northera by a panel of outside experts, where Northera earned some grudging respect. 

The FDA concluded that Chelsea needed to file positive data from an additional two- to three-month study, and Chelsea immediately raised the prospect that an ongoing 10-week trial could provide the data it needs. That didn't sit well with investors, though. Chelsea's shares plunged more than 30% in a matter of minutes.

"We believe there continues to be an important unmet medical need in addressing the symptoms associated with Neurogenic OH and remain committed to working with the FDA to determine the appropriate next steps required to bring a much-needed new therapy to the market as quickly as possible," said CEO Simon Pedder in a statement.

Analysts had been kept guessing on the outcome throughout the day, balancing the official stance of the FDA with the 7-4 panel vote and the simple fact that this drug has been available for years in Japan. For Chelsea, that track record had initially allowed the biotech to claim that their program had been significantly de-risked. Advocates maintained that Northera--or droxidopa--offered perhaps the best hope for patients with symptomatic neurogenic orthostatic hypotension, the sudden drop in blood pressure that can trigger fits of dizziness for some 180,000 patients.

For some analysts, the first of two Phase III studies was considered something of a cakewalk. But Northera flunked that study. A subsequent Phase III produced positive data, adding to the biotech's reputation for treating investors to a roller coaster ride on its share price.

Even if it is approved at a later date, the FDA is already considering a black box warning on safety concerns. FDA reviewers have raised concerns about links to a neurological condition.

- here's the release
- here's the Bloomberg report

Related Articles:
Conflicting signals cloud Chelsea's chances on D-Day for Northera
Chelsea Therapeutics surges on FDA panel nod for Northera
FDA staffers advise agency to deny Chelsea's key drug
Chelsea shares nosedive on FDA's questions about key drug

Dealing with Rejection, the Regulatory Kind

Posted under Blog, Business and Investments, Companies, CRL, Diagnostics, FDA approval, Funding, Industry Analysis, Inside BIO Industry Analysis, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

The ubiquitous CRL in biotech has made its way into the news headlines again. But is the Complete Response Letter a game-changing hurdle for a biotech, or is it par for the course these days?

It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1^st round. However, most companies resubmit their application, and by the 2^nd review 75% of drugs gain FDA approval. After heading for a 3^rd attempt, the cumulative percentage climbs to 83%. After that there is little data to support that subsequent submissions materially impact the probability of approval.

These percentages come from our BIO/BioMedTracker analysis of FDA reviews from 2005-2010 (n=748). The exact percentages for cumulative approval rates are shown in the chart above.

As it relates to content within the CRL, here is an interesting point: When we analyzed 83 NDA/BLA filings that never made it to approval (i.e. were finally suspended by the sponsor), only one was attributed to a manufacturing issue.