Welcome to this week's FiercePharmaAsia report, which includes stories about possible Chinese buyers' bids for Johnson & Johnson's diabetes unit, a Novartis and Biocon's biosimilar deal, Keytruda-Lenvima combo's breakthrough designation in kidney cancer and more.
Johnson & Johnson’s diabetes care units LifeScan, Animas and Calibra Medical have reportedly drawn interest from potential buyers in China, including a consortium formed by Sinocare. The Chinese diabetes market is estimated to grow from $6.6 billion in 2016 to $20 billion by 2025 but has been tough for foreign companies to penetrate.
Aiming at riding the “next wave of biosimilar opportunities globally,” Novartis and Biocon have formed a partnership to develop and commercialize biosimilars in immunology and oncology. Sandoz will take North America and most of Europe, while Biocon will take care of the rest of the world. Both companies were early biosimilar players but have also faced issues over manufacturing.
Merck and Eisai’s Keytruda-Lenvima combo has nabbed the FDA’s breakthrough designation as a potential treatment for patients with advanced and/or metastatic kidney cancer. The duo posted overall response rates of 83% in the first-line setting and 50% in second-line in a phase 1b/2 last year. Now, the partners are on a sped-up path to challenge Bristol-Myers Squibb’s Opdivo.
Chinese biotech Innovent Biologics, which has a $1 billion immunotherapy alliance with Eli Lilly, is reportedly considering a $200 million IPO later this year either in Hong Kong or the U.S. An anti-PD-1 included in that deal is under review by China’s FDA. The potential IPO follows a $260 million series D in November and a proposal by Hong Kong Stock Exchange to relax its requirements for listing preprofit biotech companies.
Sanofi Pasteur agreed to refund the Philippine government for unused Dengvaxia doses worth about $28 million. The compromise came as initial findings from two separate autopsies on children who died after receiving the dengue vaccine showed compatible patterns of death, including bleeding in vital organs consistent with severe dengue, but no causal link has been established yet.
The Indian government has put price caps on certain medical devices, prompting companies like Abbott, Boston Scientific and Medtronic to try to pull products from the market or get the ceiling raised. Statistics suggest that foreign direct investment in the country’s medtech sector has dropped 59% year on year over the first nine months of 2017.
Celltrion Chairman Seo Jeong-jin confirmed that the South Korean drugmaker will build its third plant outside of its home country. The facility’s capacity of 360,000 liters is actually more than twice what it had earlier indicated.
After Samsung BioLogics CEO Kim Tae-han raised the possibility of a fourth plant during an interview at the J.P. Morgan Healthcare Conference, its shares spiked. But the company soon moved to clarify that a plan is under review but it will depend on the outcomes of Roche and Biogen’s Alzheimer’s clinical trials that are not expected to be complete until 2019.
Medtronic sits with international brands Marriott, Delta and Zara that have been scolded by the Chinese government for listing regions like Taiwan as an independent country. Medtronic soon moved to publish a statement apologizing for “causing misunderstanding among the public.”
The FDA had previously cited three Ipca plants in a warning letter over data manipulations. The Indian company has just paid $9.65 million to acquire Pisgah Labs, an API maker based in North Calrolina that Ipca said would complement the operations of its Onyx Scientific unit in the U.K.
Honda has picked up a CE mark for its walking assistance device designed to help people who had suffered from conditions that affect mobility. The clearance follows almost 20 years of work by the car manufacturer to get the exoskeleton-style device ready for widespread use.
A recent inspection by Belgium authorities found one critical and eight major deficiencies at Inner Mongolia Changsheng Pharmaceutical. That led to the European Medicines Agency’s decision to block the amoxicillin trihydrate API produced by the company.