The last quarter of 2006 produced plenty of unique research, inventions, drug candidates being developed, medicines approved, and even an old timer entering the acquisition spree.
Genentech made its first acquisition, paying $919 million for Tanox. The company thus eliminated the royalties it pays Tanox for Xolair, a treatment for allergic asthma, which made $107 million in the third quarter of 2006.
New drug types went on the market to treat indications never before treated. Approval of Merck & Co.’s Januvia made it the first DPP-4 inhibitor in the U.S. for type 2 diabetes. Berlex’ YAZ® became the first oral contraceptive to treat emotional and physical symptoms of premenstrual dysphoric disorder. Remicade from Centocor, already approved for Crohn's disease and ulcerative colitis (UC), received an added indication related to the maintenance therapy in UC, representing the first biologic for inducing and maintaining clinical remission of both types of inflammatory bowel disease.
Novel candidates for particular diseases also moved into clinical trials. Neurologix successfully completed a Phase I trial of the first gene therapy for Parkinson’s disease. Sanofi pasteur finished the first clinical trial lot of a new generation of H7N1 pandemic vaccine, which will be assessed in a Phase I study. This trial will be the first to determine the safety and ability to generate an immune response of a split, inactivated prototype pandemic H7N1 vaccine produced on cells. Semafore Pharmaceuticals received grants to begin clinical trials on the first PI3K inhibitor, SF1126, for treating multiple myeloma as well as solid cancers. Generex Biotechnology plans on conducting the first human trial for a synthetic avian influenza vaccine in collaboration with the Lebanese-Canadian Hospital in Beirut, Lebanon.
Two companies set up shop in the U.S., AstraZeneca opened its first U.S.-based clinical pharmacology unit (CPU) at the University of Pennsylvania Health Care System’s Penn Presbyterian Medical Center, and IntegraGen SA established IntegraGen, Inc., as a wholly owned U.S. subsidiary, based in New York.
In the works for 13 years and finally completed in 2003, the Human Genome Project laid the base for a continuous slew of avant-garde genomic studies. The first genome-wide linkage study of prostate cancer in African American men was published by researchers from 12 institutes. They found regions of the genome where the alteration of specific genes increased the risk of developing prostate cancer. Qiagen launched the first siRNA sets for whole mouse genome, FlexiPlate siRNA. This tool enables users to determine the particular RNAi assay as well as the exact amount of siRNAs needed. The first comprehensive copy number variation (CNV) map of the human genome was created. The team from the International Genome Structural Variation Consortium’s Copy Number Variation Project believes this will enable researchers to perform more powerful association studies on various diseases.