Against a backdrop of overall sales growth after years of decline, AstraZeneca's China business delivered a 25% sales jump in 2018. Pfizer Japan is recalling a blood pressure drug on possible carcinogens in Mylan's valsartan API. Japanese doctors noticed viral strains resistant to Shionogi and Roche's Tamiflu follow-up drug Xofluza, and some feared the cases might stem the flu therapy's future adoption. And more.
AstraZeneca is back on the growth track, with 2018 sales rising 4% to $21 billion. Its China business skyrocketed 25% during the year and reached $3.8 billion. Though star lung cancer drug Tagrisso saw fourth-quarter sales decline in China quarter over quarter because of its recent addition to the national insurance list, AZ insisted that the underlying volume growth was robust and will continue into 2019.
Pfizer’s Japanese subsidiary is recalling five lots of its blood pressure combination drug Amubaro from the country, because its valsartan API contains probable carcinogens. The API was sold by Mylan and made at a plant in India. Mylan recently expanded a recall of its own to include all of the unexpired valsartan drugs it had made with the tainted API.
Japan’s National Institute of Infectious Diseases has recorded six influenza strains resistant to Shionogi and Roche’s new flu drug Xofluza as of Feb. 6. The institute noted that resistance also cropped up in 25% of children in late-stage clinical trials. Roche said that while some strains showed reduced susceptibility to Xofluza, the drug still delivered some effect for patients, and therefore it’s not deemed resistant by U.S. standards.
China will cut the value-added tax rate for 21 drugs and four APIs for rare diseases from 16% to 3%, the State Council decided. The tax cut in orphan drug territory reflects China’s renewed interest in ensuring treatment options for about 20 million rare disease patients in the country. Its recent moves in the area include rolling out the first catalog of orphan diseases last year.
Avanir Pharmaceuticals, a subsidiary of Otsuka, agreed in principle to settle an investigation by the Department of Justice into its Nuedexta marketing. The company came under public pressure after CNN reported that it had targeted nursing home residents for the neurological treatment, even though it hasn’t been tested enough in elderly people.
India’s Glenmark Pharmaceuticals will spin off its innovation business into a separate U.S. subsidiary. All innovative molecules in its pipeline, including five clinical and three preclinical assets in immunology, oncology and pain management, as well as R&D centers, manufacturing infrastructure, platform technology and about 400 employees, will come to the new company.
Two years into a licensing agreement, Astellas and partner Affinivax have started human testing of a pneumococcal vaccine designed using the latter’s novel Multiple Antigen Presenting System technology. The phase 1/2 includes Pfizer’s Prevnar 13 and Merck & Co.’s Pneumovax 23 as direct comparators.
Dr. Reddy’s disclosed that the FDA had cited its facility in Bachupally, India, with 11 violations, without specifying the nature of the observations. The plant in 2017 also got 11 observations from the FDA. At that time, the Indian company said the observations were mostly procedural; and later, it reported clearance.
After reaching a biosimilar pact with Samsung Bioepis in January, China’s 3SBio has exclusively licensed rights from Verseau Therapeutics to a number of macrophage checkpoint modulators for cancer indications in China. Verseau will be responsible for discovery and optimization of the antibodies, while 3SBio will fund and conduct antibody development manufacturing and commercialization.
Korea’s SCM Life Science and Genexine have paid 12.5 billion won ($11.1 million) for a stem cell manufacturing site, research and intellectual property of defunct Argos Therapeutics. The Durham, North Carolina-based company closed shop last year after its dendritic cell-based cancer vaccine failed a phase 3 trial.