Phase III

J&J psoriasis drug may carry cancer risk

Maureen Martino — Fri, 13 Jun 2008 11:19:19 -0400

Outside experts are preparing to review ustekinumab, Centocor's injectable treatment for severe psoriasis. Two Phase III studies demonstrated positive results, but staffers will have to consider possible increased risk of cancer associated with the drug. Animal studies indicated that the drug may encourage tumor growth. "Long-term use of ustekinumab may lead to increased risk of tumor development in psoriasis patients," FDA reviewers noted. Centoror, a division of Johnson & Johnson, is expecting an FDA decision by September.

Though ustekinumab may have produced impressive results in trials, J&J may have an uphill battle convincing insurers to cover the expensive drug for patients with severe forms of psoriasis. Insurers would prefer members to stick with older, cheaper psoriasis drugs rather than allow them to switch to one of the newer biologics that have hit the market.

- see this report for details

Jazz Pharma axes staffers after delaying two trials

John Carroll — Thu, 12 Jun 2008 10:56:28 -0400

Jazz Pharmaceuticals says it needs to extend the development time line for two key drug programs, a move that triggered a decision to lay off 33 workers, or eight percent of its workforce. In a statement, Jazz also said it is actively hunting out partners for its development programs. The biotech has delayed a planned Phase III of JZP-7 for restless leg syndrome and a planned Phase II trial of JZP-4, in development for epilepsy and bipolar disorder. The layoffs are targeted at the company's R&D and administrative areas.

CEO Samuel Saks said that Jazz is "actively seeking partners for several of our development programs. We have been pleased with the level of interest from potential partners and look forward to completing one or more development partnerships to help us bring these important therapies to the market as quickly as possible."

- check out Jazz's release
- read the AFX story

Novo Nordisk discontinues Phase III on disappointing results

John Carroll — Wed, 11 Jun 2008 11:14:01 -0400

Concluding that a late-stage trial of its experimental therapy to prevent bleeding in trauma patients was headed to a likely failure, Novo Nordisk discontinued the study of NovoSeven. "Due to an observed lower mortality than anticipated in the overall study group (around 10 percent in the Phase III trial in total compared to more than 25 percent in the Phase II trial), a futility analysis was conducted to assess the likelihood of reaching a successful outcome on the primary endpoint. The analysis predicted a low likelihood of obtaining a positive trial outcome with the planned study population, and as a consequence, Novo Nordisk has decided to discontinue the trial," the company announced.

"It is regrettable that this trial is coming to an end," said Mads Krogsgaard Thomsen, executive vice president and CSO. "It has, however, already now provided a lot of important data on the treatment of severely injured patients. We will share these findings with the medical community as soon as the full clinical analysis has been completed."

- check out Novo's release

BioSante Pharma exploring its strategic alternatives

John Carroll — Tue, 10 Jun 2008 11:54:01 -0400

BioSante Pharmaceuticals has brought in Deutsche Bank to advise the company on its "strategic alternatives." The developer has advanced LibiGel, a topical therapy for female sexual dysfunction, into a late stage trial. BioSante has told investors that it hopes to gain an FDA approval on the treatment by 2010.

News of the Deutsche Bank move helped buoy shares of BioSante. The company announced in March that it had begun a Phase III trial on LibiGel.

- read the AP report

GSK collaborates on immune disease research

Wed, 04 Jun 2008 06:59:57 -0400

GlaxoSmithKline has inked a five year, $25 million collaboration deal with the Disease Institute of Boston to conduct on immunoinflammation research. GSK and IDI researchers will develop joint grant proposals in targeted areas of research under an Alliance Research grant program. GSK gets first dibs on any drug targets identified through the collaboration.

"GSK is committed to becoming a world leader within 3 years in drug discovery of immuno-inflammation," said Jose Carlos Gutierrez-Ramos, head of the Immuno-Inflammation Center of Excellence for Drug Discovery of GSK. "This agreement fits perfectly with our strategy to pursue scientific excellence and technologies both internally and externally."

- see GSK's release for more

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

Transgene to partner after cancer vax passes trial

Mon, 02 Jun 2008 06:59:56 -0400

France's Transgene is taking the wraps off of positive Phase IIb data for its experimental cancer vaccine, TG4010. The European trial of 148 patients saw progression-free survival of 44 percent of patients for six months compared to 35 percent in the control arm. The cancer vaccine uses the Modified Vaccinia Anakara virus vector to spur an immune response.

"These results clearly warrant pursuing development into a Phase III program and we will be seeking to establish a partnership in order to complete the last stages of clinical development and bring TG4010 to the market," said CEO Philippe Archinard.

- check out the press release
- read the AFX report

Related Article:
Big Pharma takes an interest in cancer vaccines

Flurizan program worries hurt Myriad's stock

Fri, 30 May 2008 06:59:54 -0400

Myriad Genetics' stock continues to fall as investors fear poor results from a late-stage study of Flurizan for Alzheimer's. A phase II study of the drug found that Flurizan didn't benefit those with a moderate form of the disease, and Myriad designed the Phase III trial to focus on those with mild Alzheimer's. Investors aren't wild about the approach. "In a rush to Phase III, Myriad has made several critical mistakes, in our view," said one analyst.

- read the report for more

BMS buys Kosan for $190M

Thu, 29 May 2008 06:59:58 -0400

Bristol-Myers Squibb is adding two oncology drugs to its pipeline with the acquisition of Kosan Biosciences. The company is paying $5.50 per share in cash for Kosan and gains two anticancer agents: novel Hsp90 (heat shock protein 90) inhibitors and epothilones.

"Kosan has done great work advancing two classes of novel anticancer medicines: epothilones and Hsp90 inhibitors," said Elliott Sigal, M.D., Ph.D., executive vice president and chief scientific officer, Bristol-Myers Squibb. "Epothilones are microtubule stabilizers with multiple therapeutic applications in various cancers and potentially in neurodegenerative diseases. The Hsp90 program includes a Phase III compound for the treatment of patients with multiple myeloma, an area of high unmet medical need."

- see the buyout announcement for more

Alfacell stock takes a hit on Onconase data

Thu, 29 May 2008 06:59:56 -0400

New Jersey-based Alfacell took a major hit this morning as it announced that its drug Onconase missed the primary endpoint in a Phase III study. The drug failed to improve survival rates of patients with inoperable malignant mesothelioma. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen. Alfacell plans to submit an NDA for this patient population, which it says represents a currently unmet medical need. It expects to complete the filing by the end of 2008. Investors were not impressed with Alfacell's good news/bad news announcement, and took a bite out of the company's stock.

- see this release for more
- read the Forbes report

Related Article:
Strativa acquires Onconase rights