Indevus

Indevus inks licensing pact, lands FDA deal

John Carroll — Mon, 29 Sep 2008 11:50:35 -0400

Indevus Pharmaceuticals ended last week on the upbeat news that it had struck a licensing deal for one of its experimental therapies and worked out an advantageous arrangement with the FDA on another drug up for approval. The news sent the company's shares up 86 percent.

Teva signed on to develop the stuttering drug pagoclone in a deal which is worth up to $92.5 million for Indevus in milestone payments. Under certain circumstances the deal can be structured for a 50/50 royalty split.

On another front, Indevus announced that the FDA gave it a green light to submit additional data for the testosterone replacement therapy Nebido rather than mount a new trial for the therapy. The agency's concerns are centered on adverse reactions at the injection site. Indevus can now resubmit its applications in the first quarter of next year rather than face a lengthy delay for a new trial. An approval could come in the fourth quarter of 2009.

- check out the Indevus release regarding the licensing deal
- read the Indevus release regarding the FDA agreement

Indevus shares plunge on approval delay

Wed, 04 Jun 2008 06:59:56 -0400

Indevus is facing a major setback in its efforts to gain approval for Nebido. The drug treats male hypogonadism, a condition in which the testicles fail to produce enough testosterone. Indevus said it expects the FDA to formally request more safety information on the drug, which will include another Phase III trial. According to Indevus' release, the FDA wants data related to a reaction immediately following the injection--a known rare complication of oil-based depot injections. Indevus attributes the reaction to "improper injection technique." The additional trial will delay the drug's approval by 18 months. Wall Street was greatly displeased by the news and Indevus' stock took a 67 percent plunge in early trading.

"We are very surprised and disappointed by the position the FDA is taking regarding the safety profile of Nebido given the large European experience. Rare coughing reactions have been well-described in the European product labeling of Nebido... From our verbal discussion with the FDA, we are not aware of any other approvability issues," said CEO and chairman Glenn L. Cooper in a statement.

- see Indevus' release on the delay
- read this article for more

ALSO NOTED: Adolor shares rise on NDA news; Indevus plans Phase III; Exelixis earns milestone; and much more...

Thu, 29 Nov 2007 06:59:50 -0500

> Shares of Adolor surged on the news that the FDA's Gastrointestinal Drugs Advisory Committee will review the new drug application for the pain drug Entereg on Jan. 23. Report

> Backed by a fresh batch of positive, mid-stage data for its experimental therapy to treat a rare hormone condition, Indevus says it will launch Phase III by mid-2008. Release

> Exelixis has earned a $5 million milestone payment from Bristol-Myers Squibb. Report

> Belgium's Galapagos wins up to $2.4 million in upfront fees and research funds in a development deal with Cystic Fibrosis Foundation Therapeutics. Up to $5.7 million in milestones is also on the table. Report

> Protein therapy company Medgenics has raised £3.28 million from a share placing with investors. Report

> AstraZeneca got a bit of a windfall today from the FDA, which granted six extra months of exclusive marketing rights to its Arimidex cancer drug. Report

> New warnings and warning recommendations are flying out of the FDA this week like geese flying south for the winter, partly because of an FDA advisory panel is meeting. Report

> Talk about an outpouring of adverse-event reports. After WFAA-TV in Dallas reported musician Carter Albrecht's violent death--perhaps under the influence of Pfizer's smoking-cessation drug Chantix--more than 5,000 complaints about the med's side effects poured into the FDA. Report

And Finally… Hospital superbugs that can break down antibiotics are so widespread throughout Europe that doctors increasingly have to use the few remaining drugs that they reserve for emergencies. Release

Indevus gets approvable letter

Fri, 17 Aug 2007 06:59:56 -0400

The FDA has handed an approvable letter to Indevus Pharmaceuticals for VALSTAR, a sterile solution of valrubicin for intravesical instillation for the treatment of bacillus Calmette-Guerin-refractory carcinoma in situ of the urinary bladder. In 2002, Valstar was pulled from the market due to formulation impurities, which Indevus has since corrected. In the approvable letter, the FDA asked for clarification regarding manufacturing validation protocols and for additional data on the manufacturing process.

- see the Indevus release for more

Indevus trumpets positive results of Nebido study

Wed, 06 Jun 2007 20:01:38 -0400

Indevus Pharmaceuticals says that a late-stage study of Nebido--an injectable testosterone therapy for the treatment of male hypogonadism--met its primary endpoint, paving the way to a new drug application that will be filed later in the summer. The Lexington, MA-based company licensed the drug program from Bayer Schering Pharma.

"The market opportunity for Nebido is substantial," says Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "The results of our trial demonstrate the potential of NEBIDO, the only once every three month treatment for male hypogonadism, to dramatically improve the treatment options for men who suffer from this condition."

- check out the release for more on the data

Related Articles:
Indevus in $120M deal to acquire Valera. Report
Indevus halts research on pagoclone for PE. Report
Indevus shares rise on pagoclone data. Report
Indevus shares buoyed by new Sanctura data. Report

Indevus halts research on pagoclone for PE

Mon, 25 Sep 2006 20:01:35 -0400

Indevus Pharmaceuticals of Lexington, MA has halted research on pagoclone as a treatment for premature ejaculation, citing lack of efficacy data from a Phase II trial. But following a meeting with the FDA, Indevus says it will push ahead with a Phase III trial of pagoclone for stuttering in the first half of next year. Pagoclone is a novel, non-benzodiazepine, GABA-A selective receptor modulator.

"Although the FDA had never considered a drug for stuttering, FDA officials were, in my opinion, extremely well-prepared and were able to give us specific and useful guidance that has allowed us to map out a clear path toward an NDA submission," said Glenn L. Cooper, M.D., president, CEO and chairman of Indevus.

- see the release on pagoclone

Indevus shares rise on pagoclone data

Tue, 23 May 2006 20:01:38 -0400

Indevus saw its shares bounce higher this morning after researchers announced that a mid-stage trial of its experimental therapy pagoclone for stuttering demonstrated statistically significantly responses in two out of three patient evaluations. Researchers evaluated 132 subjects in the study, with about two thirds receiving pagoclone. There is currently no approved drug for stuttering.

- here's the AP report on the trial data