Japanese firms eye sale of patent-expired drugs to fund new blockbusters

Japan PM Abe
Japan PM Abe

Astellas Pharma and Shionogi are looking to sell branded drugs that have seen patents expire in Japan in a play to take the funds and invest in newer therapies or business lines, Nikkei Asian Review reports.

For Osaka-based Shionogi, the news service said that it has already laid the groundwork to sell unspecified off-patent therapies in infectious diseases and gastrointestinal ailments, among other areas. The portfolio represents 10% of domestic prescription sales, with a drugmaker with close ties to GlaxoSmithKline ($GSK) among contenders for a sale that could be announced this month.

Nikkei said Shionogi could raise nearly ¥20 billion ($195 million) and pursue new therapies to help cure pain, influenza and other infectious diseases.

That would be a bit of an about-face for Shionogi. In April, CEO Isao Teshirogi told Bloomberg that the codeveloper of the heart drug Crestor (rosuvastatin) would embrace a government push to greatly increase the use of generics. Off-patent branded drugs still command a premium in Japan, as they do in China, with many patients and doctors reluctant to switch.

Japan's government--led by Prime Minister Shinzo Abe--hopes 80% of prescriptions are written for generics by March 2021. Currently, about half of all prescriptions are for generics. 

The plan allows makers of the drug to bring their own generic to the market as soon as its patent for the medicine has expired. If several generics of a brand are available, the generic cap would be set at 40% of the price of the innovator's drug.

At the same time, however, Japanese regulators and government ministries are attempting to remove roadblocks to newer therapies in areas like stem cells and provide funding for a sharper level of collaboration between top research institutes in the country and domestic drug firms.

For Tokyo-based Astellas, plans are already afoot to build on its prostate cancer drug Xtandi (enzalutamide) franchise by branching into vaccines, including the possible purchase of the vaccines unit of Japan's Chemo-Sero-Therapeutic Research Institute, known as Kaketsuken.

Nikkei said money for moves into new areas could come from as much as ¥50 billion in revenue from sales of drugs like Gaster (famotidine), which alone hauled in ¥14.7 billion last year. A generic drugmaker--that has operations in Japan--is reportedly interested, along with an investment company.

Osaka-based Takeda Pharmaceutical has been furiously busy on the deal front, shedding scores of generic products in April alone, Nikkei said. Led by CEO Chrisophe Weber, the company has also signed partnerships and collaboration deals with biotechs in core areas of oncology, GI and CNS.

Indian firms such as Mumbai-based Lupin and Sun Pharmaceutical Industries are eager to expand in Japan, while drugmaker Eisai has expanded active pharmaceutical ingredient manufacturing in India to capture cost savings for the home market in generics.

- here's the story from Nikkei Asian Review

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