PRV Payout In 2007, the USFDA initiated a program to accelerate the development of drug for neglected diseases, a central piece of which is the granting of a Priority Review Voucher (PRV) to a developer who may use or sell it to speed another drug’s approval. Only three have been granted, one most recently to Knight Therapeutics which sold it recently at auction to Gilead Sciences for $125 million (FierceBiotech story). This is a good deal for Knight, a venture-backed Canadian company, but it would be a better deal if Knight applied some of the bounty to getting the drug for which it received the voucher (a treatment for the disabling disease, leishmaniasis) to people who need it. For more on Knight, its founder, Jonathan Goodman, and the PRV, see my post, “GUD Knight”).
More Competition in Europe’s Vaccine Market The Indian generics company, Cipla Global Ltd., completed a deal to market the low-cost pediatric vaccines of the Serum Institute of India (SII) in the European Union (FierceVaccines story). SII is a major supplier of subsidized vaccines to the developing world and the CEOs of both companies see the new agreement as part of their commitment to affordable medicine and global health.
Malaria Vector Vax Advance Mymetics Corp., a Swiss vaccine start-up, announced that it received a contract with PATH’s Malaria Vaccine Initiative to produce a malaria-transmission-blocking vaccine formulation (press release in FierceVaccines). Preclinical results on the vaccine, that is aimed at inoculating mosquitoes (for more, see my post, “Vector Vax”), are expected in 2016.
Amgen Aims to Lower Costs in Asia Amgen, the leading US biologics company with annual sales north of $18 billion, said its continuous bioprocess plant in Singapore is now up and running (FiercePharmaManufacturing story). The $200 million facility is designed to enable bulk production at lower cost and higher rate and be easily configured for new products and is part of the company’s strategy to compete in the Asian biologics market (Biopharma Reporter story).
Ebola Product Development Update More companies are applying expertise and finances to counter the Ebola epidemic. Cepheid, the CA-based diagnostics company that launched a MDR-TB test with Gates Foundation help in 2012 (see my post, “TB Dx”), is developing a rapid, small-sample-volume Ebola test based on its RT-PCR platform with a $3.3 million grant from the Allen and Gates Foundations (FierceDiagnostics story). One rub, as I noted in previous posts, is that the Cepheid reader costs $17,000 at the discounted price and the company needs to work hard on a adoption and deployment strategy. Hamburg-based Altona Diagnostics received an emergency use authorization from the USFDA for its Ebola molecular diagnostic test (Altona press release). Also based on RT-PCR, the Altona diagnostic can be read on a standard PCR machine costing as little at $5000 but requires considerable molecular biology skills. In 2012, the company has a strategy to develop and sell tests for ROW (rest-of-world) diseases and opened an office in Malaysia in 2012 (GenomeWeb story). An effort to test the collection and use of antibodies in therapy from recovered Ebola patients is being backed by the Gates and two other foundations. Also involved are almost twenty medtech companies that are donating equipment and support, three universities, and the US Army’s Medical Research Institute (press release in FierceMedicalDevices). On the vaccine front, the big pharma, Merck, purchased the development and commercialization rights to the Ebola vaccine of Newlink Genetics for an undisclosed amount per Merck’s MO (FierceBiotech story). As I noted in BGH No. 10, human trials have started; Merck’s involvement should accelerate the effort.