Savient hammered after hedge fund claims it’s bankrupt

Posted under Blog, Companies, Dendreon, Diagnostics, Funding, John Johnson, Krystexxa, Medical Devices, Medical Supply, Pharmaceuticals, Provenge, Savient Pharmaceuticals, Startups, Tang Capital, Universities, Videos by john

John Johnson has a good reason today to be thankful for his new job at Dendreon: He won't have to face the music at Savient, where his former colleagues will be grappling with a high-profile lawsuit from a West Coast hedge fund claiming that the company is being looted by an executive team that has badly fumbled a drug launch and bankrupted the developer.

Shares of Savient ($SVNT) skidded down 25% on Tuesday after the company filed notice at the SEC that Tang Capital has asked a court in Delaware to declare Savient insolvent and appoint a receiver to liquidate assets and divvy up the cash among creditors. Savient, for its part, says there's no merit to the suit and intends to fight.

When John Johnson moved from the top post at Savient to the helm at troubled Dendreon ($DNDN), there was considerable speculation about just what he had learned from the launch of the gout drug Krystexxa that would help him with Provenge. Tang officials would likely suggest it wasn't much, based on the gleeful coverage by TheStreet's Adam Feuerstein, who snagged a copy of the lawsuit and quoted from it extensively. 

Tang--which wants $100 million in damages--insisted that Krystexxa's 5-quarter track record demonstrate that it was not only an "abject failure," but the least successful new drug launch in the industry's history. And it was just as bitter about management:

"The Company's officers and Director Defendants are incentivized to maintain the status quo and continue to pursue a hopeless drug launch while ignoring the fact that it has already failed," says the Tang suit. "While recognizing failure and drastically cutting head count and expenses would preserve value for creditors, it would also mean an end to officers' and Director Defendants' lucrative cash compensation and would extinguish any chance, however remote, of recognizing any value from their out-of-the-money stock options."

- here's the Bloomberg report
- get the story from TheStreet

Related Articles:
Gold out, Johnson in as troubled Dendreon aims for a turnaround
New Medicare code could boost Krystexxa sales

Dendreon vets grab the helm of a troubled vaccine developer

Posted under Blog, Chris Henney, Companies, Dendreon, Diagnostics, flu vaccine, Funding, Grant Pickering, Juvaris BioTherapeutics, Medical Devices, Medical Supply, Mymetics, Pharmaceuticals, Pipeline, Startups, Universities, Videos by john

A pair of Dendreon veterans has swooped in to take charge of the troubled Swiss biotech Mymetics with ambitious plans to move the company to the U.S., find some fresh financial backing and get back into gear developing a slate of new vaccines.

Biotech vet Grant Pickering, who has been scouting opportunities recently as executive-in-residence at Kleiner Perkins, is taking the helm of the company as CEO while Dendreon ($DNDN) co-founder Chris Henney takes the chairman's spot at Mymetics. The publicly traded Mymetics ($MYMX) has burned through about $64 million since it was founded in the late '90s, fueling the development of a pipeline with 5 vaccines for RSV, flu, HIV-1/AIDS, malaria and herpes. Its claim to fame rests on a virosome platform that promises a better approach to vaccine development. Now trading as a penny stock, though, Mymetics hadn't managed to make it "over the hump" of its latest financing challenge, says Pickering.

"For me the draw of vaccines was quite intoxicating," Pickering told FierceBiotech this morning. The company has an RSV candidate the new CEO wants to get into the clinic. "There's been hard work under way," adds Pickering. "They've been making good progress but hadn't pulled the financing together. We think we can deliver on that."

Pickering has been CEO of Juvaris BioTherapeutics, another vaccine developer that out-licensed its lead program in the fall of 2011, wrapping up its involvement in the development process. That left him focused on his role at Kleiner Perkins, looking for the new, new thing. Now he says Mymetics' best shot at success lies in one of the biotech hubs in the U.S. And his experience gained in San Francisco and Seattle make those two locations leading contenders in an upcoming relocation. 

"Mymetics' novel virosome vaccine platform appears to have the potential to address a variety of important infectious diseases that have yet to be addressed with prior vaccine technologies," noted Henney in the company's release.

- here's the press release

Provenge critic gaining attention after taking shots at study data

Posted under Blog, Companies, Dendreon, Diagnostics, Drug Safety, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Prostate Cancer, Provenge, Regulatory, Startups, Universities, Videos by rmcbride

Provenge, Dendreon's ($DNDN) pioneering cancer vaccine that disappointed investors last year with its sales, is under fire again. Reuters today spotlights former hedge-fund analyst Marie Huber and her journey to expose holes in the study that supported FDA approval of Provenge for treating prostate cancer in 2010. A scientist by training, Huber has been making a case that the placebo in the pivotal study might have caused harm to men who took the dummy treatment and made Provenge shine by comparison. There are many critics of Huber's analysis, including the doctors who led the Provenge trial. Article

J&J wows analysts with early success of Zytiga PhIII for prostate cancer

Posted under Blog, Companies, Dendreon, Diagnostics, Funding, Medical Devices, Medical Supply, Medivation, Pharmaceuticals, Prostate Cancer, Provenge, Startups, Universities, Videos, Zytiga by John Carroll

The news just keeps getting better for Johnson & Johnson's new prostate cancer drug Zytiga (abiraterone). Investigators unblinded a late-stage study of the drug--plus prednisone--for prostate cancer victims who had not been treated with chemotherapy. The blockbuster drug is already approved for treatment-resistant cases and the news heralds a quick-step expansion of the prospective patient population.

No data was delivered, but Johnson & Johnson ($JNJ) says the independent monitoring committee members for the study were satisfied that they had the results they were looking for on progression-free survival as well as the co-primary endpoint of overall survival along with key secondary endpoints. The move paves the way for J&J to start filing for expanded use later this year.

According to Adam Feuerstein at TheStreet, a J&J spokesperson confirmed that investigators had established a statistically significant response for PFS and a "strong trend" on OS, though the data in that category was not statistically significant. The independent data monitors "stopped the trial based on the totality of the data they saw," Kellie McLauglin told TheStreet, which included a statistically significant benefit for all secondary endpoints.

Dendreon ($DNDN), which will face additional pressure from an increasingly popular rival treatment to Provenge, saw its shares slide 13% on the news. Zytiga has been eating up market share as its reputation as a faster acting, more convenient therapy for prostate cancer--quick to ease pain and other effects of cancer--has spread among patients and physicians.

"The COU-AA-302 study has been a key priority for us as we expand our understanding of the utility of Zytiga in metastatic prostate cancer," said William N. Hait, the global chief of Janssen R&D. "We're delighted that these data will soon be added to the growing body of literature about this important medication."

The Phase III results also have implications for Medivation ($MDVN), which has a lot at stake with its late-stage program for MDV-3100. Medivation has been counting on a new approach that does away with the need for prednisone, which can trigger high blood pressure.

- here's the press release
- here's the report from TheStreet

Related Articles:
J&J's Zytiga's pain relief, ease of use beat Provenge
UPDATED: Medivation shares skyrocket on positive PhIII prostate cancer data
What will Dendreon's new chief do about Provenge?