Biovail sues U.S. FDA; Dendreon's stock climbs after seeking application from FDA

By Sheri Kasprzak

New York, Aug. 24 - Biovail Corp. led biotech news on Thursday with a lawsuit it filed against the U.S. Food and Drug Administration.

The Toronto-based pharmaceutical company is seeking an injunction against the U.S. FDA to resolve issues connected to Biovail's Citizen Petition concerning Wellbutrin XL. The petition, according to a Biovail statement released Thursday afternoon, was filed to ensure protection "against the potentially harmful effects of generic versions of Wellbutrin XL that may not, in fact, be bioequivalent to Biovail's branded product or that may be misleadingly labeled under the criteria set forth in the company's Citizen Petition."

The pharmaceutical company is seeking the injunction to resolve issues raised by the petition one week before the FDA's expected approval of any generic versions of Wellbutrin XL.

Biovail's stock climbed by 17 cents, or 1%, to close at $17.01 (NYSE: BVF) Thursday.

One sellside market source familiar with the company said he could understand Biovail's concern.

"The FDA could, technically, approve some generic version of Wellbutrin that may not live up to [Biovail's] standards," he said. "Then Biovail has to deal with the consequences of that. I say they have a case and they'll probably get the injunction."

Toronto's Biovail develops drugs to treat cardiovascular disease, pain and central nervous system disorders.

In other FDA-related news, Dendreon Corp. saw its stock climb by 5.16%, or 22 cents, to close at $4.48 (Nasdaq: DNDN) after the company submitted a biologics license application to the FDA.

The company is seeking approval to market Provenge, to treat prostate cancer.

"Prostate cancer is the second-leading cause of cancer death in American men and remains a serious unmet medical need with few effective treatment options," said Mitchell Gold, the company's chief executive officer, in a news release.

"Based upon the results of our clinical trials, we believe that Provenge has a highly favorable benefit-to-risk profile and we are focused on working closely with the FDA so that Provenge can be made available to help prostate cancer patients."

The FDA granted fast-track review status to Provenge.

Seattle-based Dendreon develops treatments for cancer.

CombiMatrix to update flu array

Acacia Research Corp. subsidiary CombiMatrix Group said Thursday it will update its influenza A array.

The updated version, according to a CombiMatrix release from Thursday morning, includes strains from recent infections and deaths in Indonesia.

The arrays, the statement said, are being used in testing programs to track Eurasian avian influenza H5N1, or bird flu.

Despite the news, the company's stock slipped by a penny on Thursday to end the session at $1.13 (Nasdaq: CBMX).

"Again we demonstrate the strength of our technology in taking the most up-to-date genetic information and incorporating it into an array that can be used for research and diagnostics," said Amit Kumar, the company's CEO, in a statement. "We applaud the CDC in its efforts to make this information public and we support its efforts as well as that of the WHO in encouraging other labs around the world to do the same."

Located in Newport Beach, Calif., CombiMatrix develops arrays used in semiconductor-based tools to identify genes, gene mutations and proteins.

Shire's stock climbs

After announcing that it has filed a New Drug Application with the U.S. FDA Thursday, Shire plc's stock gained 1.7% on the day.

The stock ended the session up 15p at 896.50p (London: SHP).

The British drug maker is seeking approval for its guanfacine drug, marketed under the name Connexyn, to treat attention deficit hyperactivity disorder in children ages six to 17.

Shire is based in London.

Symbollon, Gardent cancel agreement

Symbollon Pharmaceuticals, Inc. said it has terminated its licensing agreement with Gardent Pharmaceuticals, Inc. to co-market IoGen to treat pain associated with fibrocystic breast disease.

The news didn't budge Sybollon's stock, which remained at $1.50 Thursday (OTCBB: SYMBA).

Under the terms of the original agreement, Gardent, formerly known as Bioaccelerate Holdings, Inc., would fund the development of the drug.

To replace that agreement, Symbollon announced that it had closed a series of private placements totaling $1,366,500.

The offerings were completed over the course of the summer with the final tranche, for 366,500 settled Aug. 21.

In all, the company sold 1,366,500 class A shares and issued warrants for the same number of shares.

The warrants are exercisable at $1.00 each through Aug. 21, 2011.

Proceeds from the offering will be used for an ongoing phase 3 clinical trial of IoGen to treat pain associated with fibrocystic breast disease.

"We are extremely pleased that we were able to raise these funds," said Paul Desjourdy, Symbollon's chief in a statement. "These funds will allow us to complete the enrollment of our ongoing phase 3 pivotal clinical trial evaluating IoGen for the treatment of pain and tenderness associated with fibrocystic breast disease. Study enrollment is progressing and we are planning an active subject recruitment campaign over the remainder of 2006 in order to complete enrollment by yearend."

Symbollon is a pharmaceutical company based in Framingham, Mass.

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