Deals and Financings
Otsuka Pharma (TYO: 4768) of Japan snagged marketing rights to Iclusig, a leukemia drug developed by ARIAD Pharmaceuticals (NASDAQ:ARIA), for Japan, China and eight other Asian countries (see story). Otsuka will pay $77.5 million upfront plus additional regulatory milestones. ARIAD will receive a "substantial" share of net product revenues. Iclusig, a tyrosine kinase inhibitor, is designed to be effective in cases of chronic myeloid leukemia with the T315I mutation, which renders it resistant to other approved therapies.
Therapix Biosciences (TASE: TRPX; OTCQB: OTCQB:THXBY), an Israeli biotech accelerator, announced a MOU to out-license China rights for its anti-CD3 antibody to Nanjing BioSciKin (see story). As it currently stands, the agreement calls for BioSciKin to be responsible for all China development costs of the antibody plus build a GMP-compliant manufacturing line. BioSciKin will pay $300,000 upfront. Once BioSciKin takes over, Therapix intends to turn its attention to the synthetic cannabinoid drugs being developed by Lara Pharma, a company in which it owns a 25% stake.
Eddingpharm of China secured greater China rights to Brinavess from Cardiome Pharma (NSDQ: CRME; TSX: COM) of Canada (see story). Brinavess is a treatment for recent onset atrial fibrillation. Eddingpharm paid $1 million upfront and will make up to $3 million in regulatory milestones. It will also be responsible for meeting China regulatory requirements, including clinical trials, and agreed to undisclosed sales targets for Brinavess.
China Pioneer Pharma (HK: 1345) expanded its marketing relationship with Swiss pharma Polichem SA. Pioneer will now add Cripar, a treatment for Parkinson's disease and both senile and vascular dementia, to its portfolio of China offerings. In addition, the two companies agreed to a five-year extension of Pioneer's marketing rights for Macmiror Complex and Macmiror in China and an equal term for Polimod in eight China provinces.
Government and Regulatory
Starting next month, China is expected to change the way it sets drug prices, a change that could have a profoundly negative effect on the China revenues of multinational drug companies. For years, MNCs have enjoyed premium pricing in China on drugs that have lost their patent protection elsewhere in the world. The class of preferred generics constitute as much as 70% of MNC drug revenues in China. But in January, China will most likely remove the price differential of these drugs, forcing MNCs to price these drugs at the same level as comparable China generics.
Last week, at the end of an annual high-level meeting of US-China trade officials, it was announced that China agreed to speed up approvals of US drugs and medical devices. China said it would work off its backlog of drugs awaiting approval over the next two to three years, which probably means the CFDA will hire more staff. China also promised it would not ask US pharmas to conduct unnecessary clinical trials. Presumably, these upbeat statements are supported by specific steps, but officials did not release any further details in a post-meeting press conference.
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