Biotech's Latest Failed Trials, Missed Targets

Includes: ABT, ISPH, MRK, PFE
by: The Burrill Report

Abbott Laboratories (NYSE:ABT) said it will stop selling its weight loss drug following a recommendation from European regulators that cardiac risks from the prescription pill are too great, Reuters reported. The European Medicines Agency called for companies to halt the sales of drugs containing sibutramine, which are sold under the names Reductil, Reduxade and Zelium in Europe and Meridia in the United States. The agency said the risks of these drugs are greater than their benefit. It noted that weight loss from their use is modest and may not last after use of the drugs is stopped. Abbott said it disagreed with the agency but would comply with its recommendation. It will continue to sell the drug under the Meridia brand outside of Europe.

Wyeth Consumer Healthcare, a subsidiary of Pfizer (NYSE:PFE), withdrew its application to market Ibuprofen/Diphenhydramine Hydrochloride with the European Medicines Agency. In a letter to the agency, the company said that it decided to withdraw the application because the agency’s Committee for Medicinal Products of Human Use believed the data provided by the company did not present a positive balance between risk and benefit. The drug was intended to be used for the short-term treatment of mild to moderate pain in adults who experience sleeplessness as a result of pain.
ConjuChem Biotechnologies said that it has established a Special Committee of independent Board members to explore and evaluate strategic alternatives including a possible sale of the company or a substantial part of its assets. The Committee will be working with management and external consultants to make recommendations as to the optimal path forward for ConjuChem. ConjuChem said it has not yet made a decision to pursue any specific strategic transaction or other strategic alternative but there is an expectation that this process will result in a transaction or other strategic alternative being implemented. The Montreal-based company is a developer of next generation medicines from therapeutic peptides, and is creating long-acting compounds based on bioconjugation platform technologies. When applied to peptides, the company said its technologies enable the creation of new drugs with significantly enhanced therapeutic properties as compared to the original peptide.
Merck (NYSE:MRK) said in an update on its website that at this time it will not submit an application to the U.S. Food and Drug Administration for clearance to begin marketing vicriviroc, for in treatment-experienced HIV-infected patients. In two late-stage studies in this patient population, vicriviroc failed to meet the primary efficacy endpoint. These studies enrolled a high percentage of patients who had three or more active drugs in their optimized background therapy regimen. Results from these studies have been shared with the FDA and will be presented at the Conference on Retroviruses and Opportunistic Infections in San Francisco, February 16 to 19. The company said it continues to evaluate vicriviroc in treatment-naïve HIV-infected patients.
Inspire Pharmaceuticals (NASDAQ:ISPH) said that its treatment for dry eye disease failed in a late-stage trial. Proclacria (diquafosol tetrasodium ophthalmic solution) 2 percent also failed to meet its secondary endpoint in the trial. “We have provided the top-line results from this trial to our partner Allergan (NYSE:AGN) and we will be conducting a thorough review of the program before determining next steps, if any,” says Christy Shaffer, president and CEO of Inspire.
Mitsubish Tanabe Pharma is shutting its Tanabe Research Labs in La Jolla, California, according to a report in the San Diego Union-Tribune. About 35 jobs will be cut as a result of the closing. The lab conducts programs in small molecule drugs for metabolic and inflammatory diseases, which duplicates efforts elsewhere in the company, an attorney for the company told the newspaper. Tanabe is expected to convert the lab to work on biologics later this year.