Genentech became the latest to be involved in industry espionage cases as three of its former scientists were indicted for stealing trade secrets for a Taiwanese biosimilar firm. Astellas invests $255 million to build new gene and cell therapy manufacturing and R&D facilities. Takeda saw sales grow by about 10% for its focus therapeutic areas in the first half of 2018. And more.—Angus Liu
Weeks after two former GlaxoSmithKline scientists admitted stealing trade secrets for their Chinese company, three ex-Genentech researchers were indicted for similar charges that accused them of passing trade secrets to Taiwanese biosimilar specialist JHL Biotech. The company has several biosimilars of Genentech drugs in its pipeline, including copycats to Avastin, Herceptin and Rituxan.
Astellas is pushing further into gene and cell therapies with an investment of $255 million on manufacturing and R&D facilities in Japan and the U.S. Construction of two API plants in Japan are slated to be completed next year. It is relocating R&D operations from its current facility in Massachusetts to a new site within the state, with a two-story, 24,000-square-foot building.
Takeda managed to grow sales by 9.8% for its focus areas of gastrointestinal, oncology, neuroscience and emerging markets collectively in the first half of its fiscal year. GI drug Entyvio and multiple myeloma therapy Ninlaro both grew over 30%. Velcade’s decline also was gentler than expected, pushing Takeda to raise its profit forecast.
To win European approval for its gigantic Shire buyout, Takeda has proposed selling Shire’s inflammatory bowel disease candidate SHP647 to avoid therapeutic overlap with Entyvio. That came shortly after rumors emerged that Takeda is looking to sell Shire’s Xiidra and Natpara to offset the massive debt it’s taking to fund the deal.
WuXi AppTec and in silico drug discovery expert Schrödinger have established a New York-based joint venture called Faxian Therapeutics. The new firm will combine Schrödinger’s computational platform and WuXi’s chemistry, biology and DMPK capabilities to identify new targets and create drugs.
Merck & Co. is gradually pulling out of a RotaTeq supply deal with Gavi, as the rotavirus vaccine’s Chinese launch kicks in. The rotavirus vaccine was supposed to be given to four African countries at a big discount, but Merck said global production constraints mean it can only ship two-thirds of the promised doses this year and next and will completely stop distribution in 2020.
Sino-American biotech Terns Pharma, which recently took over three NASH programs from Eli Lilly, has bagged $80 million in series B led by OrbiMed and Vivo Capital. The money will help fund its two lead candidates’ clinical studies, which are on track to commence in the first half of 2019.
After learning of valsartan API contamination with two possible carcinogens, the FDA is testing all sartans. Now, one of the impurities, NDEA, has shown up in irbesartan made by SciGen using Indian manufacturer Aurobindo’s API, and the U.S. company is recalling all unexpired lots.
Chinese AI drug discovery startup XtalPi has raised another $46 million this year, in an extension of its original $15 million series B round early this year, to finance expansion of its computerized drug research platform.
Glenmark opened its first U.S. plant in North Carolina. The 100,000-square-foot, $100 million facility will produce fixed-dose oral drugs, vials and prefilled syringes, as well as ampoules for inhaled formulations. The site has already won its first Abbreviated New Drug Application in June.
Dr. Reddy’s oncology formulation facility in Duvvada, India, has been cited again by the FDA. The agency found several problems with the plant in a 2015 warning letter, and a follow-up inspection in 2017 found more than a dozen issues, some of them repeats.