Welcome to this week's FiercePharmaAsia report, which includes stories about Takeda's cancer assets transfer, AstraZeneca's $132.5 million China joint venture, Biocon's plant that will make a Herceptin biosimilar and more.
1. Takeda spins off cancer assets to incubated startup
A team of ex-Takeda scientists has started a new biotech, Chordia Therapeutics, with early cancer drugs, lab space and funding from the Japanese firm. The startup is one of three companies established through its entrepreneurship venture program and is also the result of Takeda’s transformation of its Shonan, Japan, program into an incubator.
2. Riding on booming drug sales, AstraZeneca forms $133M China joint venture
AstraZeneca is transferring its R&D capabilities in China to a joint venture just formed with state-backed private equity firm China State Development & Investment Corporation. The new firm, Dizal Pharmaceutical, starts shop with a capital of $132.5 million and exclusive rights to three preclinical drugs from the British pharma.
3. Biocon and Mylan say their plant is good to go as FDA decision nears for their Herceptin copy
Biocon said it has resolved FDA concerns that emerged from an inspection in spring about a biologics plant in India, just in time for its potential first U.S. approval of a Mylan-partnered biosimilar of Roche’s Herceptin on Dec. 3. The news came as Biogen and Samsung announced that their version, Ontruzant, had become the first to be approved in Europe.
4. Gilead prices hepatitis C giant Sovaldi in China at one-fifth the U.S. price: report
Gilead is pricing Sovaldi at 58,980 yuan ($8,939) in China, about one-fifth of the drug’s current U.S. retail price, which has already dropped sharply since its 2013 launch. In the country, Sovaldi is facing competition from Bristol-Myers Squibb and AbbVie, as well as an upcoming rival from Merck, but its price there is still higher than in some other emerging markets.
5. MorphoSys sells China rights to Darzalex rival in $120M deal
MorphoSys is licensing rights to multiple myeloma candidate MOR202 in China to I-Mab Biopharma, which will pay $20 million upfront and $100 million plus royalties as milestones clear. Celgene previously partnered on the drug through an $818 million deal but decided to walk away after Johnson & Johnson’s Darzalex showed more promise.
6. NICE rejects Eisai’s Halaven for earlier use in breast cancer
Eisai won British approval for Halaven last year to treat breast cancer patients after two rounds of chemo. Its recent attempt to improve sales by winning approval for earlier use was struck down by cost regulatory NICE, which said that the drug’s unclear progression-free survival data don’t merit its cost, even though it adds an average of 4.6 months to overall survival.
7. Takeda pushes U.S.-backed Zika vaccine into the clinic
Takeda has advanced its purified, inactivated Zika vaccine into phase 1 trial, planning to enroll 240 healthy adults in the U.S. The project received financial backing from the Biomedical Advanced Research and Development Authority potentially all the way to an FDA application.
8. Dr. Reddy’s facing more legal battles in U.S. over FDA inspections, warning letters
Dr. Reddy’s said it has been dragged into a securities class-action lawsuit in the U.S. for alleged violation of federal securities laws. The case, filed in U.S. District Court for New Jersey, claims the decline in the company’s stock price was due to misstatements or omissions regarding FDA inspections of the company’s plants that resulted in warning letters.
9. Add Boehringer Ingelheim to HitGen’s drug discovery collaboration list
Chengdu, China-based HitGen will screen its DNA-encoded libraries for potential novel drugs of interest to Boehringer Ingelheim. The Chinese drug discovery firm has signed collaborations with Takeda, Pfizer, Merck & Co., Aduro, the Scripps Research Institute and more in 2017.
10. Eisai tracking device keeps tabs on out-and-about dementia patients
Working with tech startup Mamorio, Eisai has developed a buttonlike sensor that can be put or sewn into clothing to help track seniors and dementia patients. The company has signed agreements with local Japanese governments and medical associations to introduce the tracker in over 110 locations.
11. German regulators OK corrective plan for a Dr. Reddy’s formulation plant
Dr. Reddy’s atonement plan for a formulation production plant in India has been cleared by German regulators, allowing it to make drugs for the EU. An inspection earlier found six major violations and resulted in the suspension. The plant will need to go through a reinspection at the end of next year.
12. India’s Glenmark reports 7 FDA observations at Baddi facility
India’s Glenmark disclosed that it received seven observations during an FDA inspection in November of its Baddi manufacturing plant, which produces about 10% of the company’s sales to the U.S. market.