Sanofi’s experimental therapy for lung cancer, iniparib, given in combination with chemotherapy failed a late-stage trial in patients with squamous cell lung cancer. The combination therapy did not improve overall survival compared to chemotherapy alone. In the international trial, previously untreated patients with squamous cell lung cancer received iniparib in combination with gemcitabine/carboplatin or only gemcitabine/carboplatin. Iniparib was initially predicted to function as a poly-ADP-ribose polymerase inhibitor, or PARP-1 inhibitor, based on its chemical structure and its ability to induce DNA damage, cell cycle arrest, and increase the efficacy of other DNA-damaging agents. The exact mechanism of action for iniparib has not yet been determined. But in June 2011 an edit was made to an open-label, expanded access protocol of iniparib in breast cancer indicating that BiPar and Sanofi researchers determined the compound cannot inhibit PARP-1 at pharmacologic concentrations. As a result of the trial failure, Sanofi will discontinue its development program for the compound and subtract approximately $285 million after taxes from its consolidated net income. Company investigations into potential targets of iniparib and its metabolites are ongoing.

The U.S. Food and Drug Administration put a clinical hold on the trial of Pluristem Therapeutics’ experimental therapy for calf pain on exercise, known as intermittent claudication, in patients with peripheral arterial disease. The therapy is a placental-derived mesenchymal-like stromal cell product, and one study participant had a serious enough allergic reaction to be hospitalized. According to Pluristem, the patient had multiple diseases that might have contributed to the severity of the reaction and was discharged from the hospital the next day with all symptoms resolved. The FDA will issue a letter within the next 30 days detailing a list of questions and requests for information.

Eli Lilly’s approved lung cancer drug, pemetrexed, failed in a late-stage clinical trial aimed at expanding its use for the treatment of nonsquamous non-small cell lung cancer. The drug, which works by inhibiting three enzymes used in the formation of nucleotides required for DNA and RNA synthesis, failed to meet its primary endpoint of superiority in progression-free survival without grade four adverse events when given in combination with carboplatin. The comparator treatment was a triple regimen of paclitaxel, bevacizumab, and carboplatin. The double combination treatment also did not meet any of the secondary endpoints, including progression-free survival, overall survival, overall response rate, or disease control rate. Patients receiving the double treatment had significantly greater incidence of, anemia, or low red blood cells and of decreased blood platelets.

Dr. Reddy’s Laboratories and Fujifilm mutually agreed to terminate a memorandum of understanding created in 2011 that would have established a joint venture between the companies in Japan and form an exclusive partnership to create generic drugs for the Japanese market. The companies will shift their focus from common generics and instead explore partnership or alliance opportunities in the development and manufacturing of active pharmaceutical ingredients, super-generics, and contract research opportunities. On its own, Fujifilm said its priorities are new cancer drugs, super-generics, and bio-related business that use the company’s strengths in analysis, nanotechnology, and manufacturing technologies. Dr. Reddy’s will continue a planned entry into the Japanese market.

GlaxoSmithKline is investigating whether a scientific paper that was published in Nature Medicine in 2010, co-authored by scientists at its research and development center in Shanghai, China, contained fabricated data. The paper describes modifications to the signaling pathway of a specific molecule that promotes an inflammatory response, and the effect of the modifications on cells obtained from mice with a disease that models multiple sclerosis and from patients with the disease. According to online publication PharmaLot, the existence of the internal investigation recently became known after blogs in China wrote about the development. This prompted GSK’s vice president of chemistry, vice president of medicine, and the leader of neuroscience development, all at the Shanghai site, to issue an internal memo. “We can acknowledge that we are carrying out an internal investigation into alleged issues related to a scientific paper. As you know, we take such matters very seriously – the integrity of our research is critical to our work and we are doing whatever is required to investigate these matters fully,” they wrote in their memo, according to the PharmaLot website.