The roadmap and conservative substitution methods Amgen Inc. laid out to “enable” its genus claims for antibodies that inhibit PCSK9 to lower LDL cholesterol are “little more than two research assignments,” the U.S. Supreme Court said in a unanimous opinion handed down May 18 in Amgen Inc. v. Sanofi SA that gave the win to Sanofi. The roadmap “merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies — calling on scientists to create a wide range of candidate antibodies and then screen each to see which happen to bind to PCSK9 in the right place and block it from binding to LDL receptors,” the court said in the decision written by Justice Neil Gorsuch.
The U.S. FTC’s unprecedented antitrust challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc, could be a disruptor to biotech investment if the agency is victorious, some analysts are warning. “With essentially zero commercial overlap [between the two companies], this deal would seem to be a slam dunk under long-established antitrust considerations,” said Christopher Raymond, a senior research analyst with Piper Sandler Research.
Amgen Inc. and Tscan Therapeutics Inc. have entered into a multi-year collaboration that will use Tscan’s proprietary target discovery platform, Targetscan, to identify the antigens recognized by T cells in patients with Crohn’s disease.
Tscan Therapeutics Inc.’s Wall Street-pleasing deal with Amgen Inc. in Crohn’s disease (CD) could expand into ulcerative colitis, but meanwhile is bringing $30 million up front with the potential for more than $500 million in preclinical, clinical, regulatory and commercial milestone payments, plus tiered single-digit royalties. Shares of Waltham, Mass.-based Tscan (NASDAQ:TCRX) closed May 9 at $3.40, up $1.25, or 58%, as the world learned of the multiyear collaboration with Amgen, of Thousand Oaks, Calif., that will use Tscan’s target discovery platform, Targetscan, to identify the antigens recognized by T cells in patients with CD.
At the ongoing AACR meeting, Amgen Inc. provided details on the discovery and preclinical characterization of AMG-305, a novel dual-targeting bispecific T-cell engager (BiTE) molecule, being developed as a potential new anticancer agent. While BiTE molecules offer a targeted immune therapy approach to treat cancer, on-target toxicity from normal tissue target expression has been a key issue in the development of T-cell engager molecules in solid tumors.
At least 64 biopharma companies have announced workforce reductions so far in 2023, resulting in 6,000 jobs lost in the industry. It is a clear indication of a continuing trend begun last year in which executives needed to rein in spending to keep innovative programs afloat.
A lot of eyes and ears were tuned to the U.S. Supreme Court’s March 27 argument in Amgen Inc. v. Sanofi SA with its focus on how much enablement is necessary in broad genus patent claims.
The U.S. Court of Appeals for the Federal Circuit once again delved into genus claims as it affirmed Gilead Sciences Inc.’s win in its inter partes review (IPR) challenge of several claims in a patent held by the University of Minnesota.
During two different panels at Biocom California’s Global Life Science Partnering & Investor Conference, executives from a variety of pharmaceutical companies laid out their wants and needs in the current market environment. Large drug companies have relied on biotech companies to build out their pipelines for many years, but the level of outside inventions has been increasing over the last few years.
