The Burrill Report


Intercell said its experimental patch-based Travelers' Diarrhea vaccine failed to meet efficacy endpoints to protect against enterotoxigenic E. coli mediated diarrheal infections in pivotal, randomized and placebo-controlled efficacy mid- and late-stage studies. The company noted that because it will not receive an expected $52.7 million milestone payment in connection with the program, its year end loss for 2010 will be substantially higher than previously expected. Intercell will reduce R&D expenses by approximately 40 percent in 2011 compared to 2010 and will realign its organizational structures. However, it said the studies support the continued investigation of the patch technology as a suitable route of immunization for future potential vaccine candidates. The pivotal studies confirm that the vaccine candidate induces reproducible levels of protective antibodies against the toxin resulting in a meaningful reduction of specific enterotoxigenic E. coli episodes, following transcutaneous immunization.

The U.S. Food and Drug Administration notified AstraZeneca that it would not approve its experimental oral antiplatelet drug Brilinta as a treatment for acute coronary syndromes without additional analysis of the data. The agency did not request that additional studies, including clinical studies, be conducted as a prerequisite for approval of the application. AstraZeneca said it is evaluating a letter from the agency and will respond to its request.

ARYx Therapeutics said it terminated all of its employees in order to reduce the company's operational expenses as part of an effort to attracting interim financing while it seeks an FDA response on how to best move forward with its experimental gastroinetsinal drug naronapride. Under the approved restructuring plan, all employees of ARYx, including officers, were terminated effective December 15. All employees have entered into consulting agreements to continue to provide to the company services needed to allow it to continue to function, including facilitating on-going FDA interactions. In April 2010, the FDA clarified the remaining clinical development requirements for the compound. As a result, the lead investors in ARYx encouraged the company to seek substantial additional funding to continue the development of naronapride internally, and it has been seeking the funding since late summer without final resolution.

Lexicon Pharmaceuticals said results from a mid-stage study of its experimental treatment for rheumatoid arthritis show mixed results at three doses against a placebo. The drug, which targets a new anti-inflammatory mechanism, was well tolerated. The company said the largest dose used in the trial suggested that patients treated with 150 mg once daily of LX2931 showed an improvement in the primary efficacy endpoint, the percentage of patients achieving an American College of Rheumatology 20 response at week 12 (60 percent versus 49 percent for placebo). "We believe the preliminary signal of efficacy and the favorable safety profile observed in this trial supports further study of additional higher doses of LX2931 as an orally-delivered treatment for rheumatoid arthritis,” said Arthur Sands, president and CEO of Lexicon. “While we were disappointed by the unusually high placebo effect in this trial, we are encouraged by the excellent overall safety profile observed in the first test of this new mechanism of action in patients with RA.” The company said it intends to commence discussions with potential pharmaceutical partners to pursue further development of LX2931 in rheumatoid arthritis.















December 17, 2010
http://www.burrillreport.com/article-intercell_slashes_rd_after_vaccine_failure.html