Japan Pharma News: Kirin Looks Beyond Beer; Sanofi Rare Disease Approval; Japanese COVID Vaccines Incoming

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A roundup of the latest news from Japanese pharma, including Kirin’s USD 870 million investment in its healthcare and pharmaceuticals businesses over the next three years, Sanofi’s world-first approval for its Niemann-Pick types A/B and B medicine in Japan, and the prospect of domestically developed COVID-19 vaccines being rolled out in the coming months.

 

Kirin looks beyond beer with $870mn push into healthcare and pharma (FT)

https://www.ft.com/content/1d99a0be-6e76-4327-8516-da549a5f767e

CEO of Japanese brewer wants to reinvent company as alcohol consumption declines

Kirin wants to use the technology of the beer-making process in its biotech ventures and avoid the fate of Eastman Kodak, which did not adapt quickly enough to digital photography

Kirin will invest about ¥100bn ($870mn) in its healthcare and pharmaceutical businesses over the next three years, as the Japanese brewer pushes beyond the shrinking beer market at home and setbacks to its core businesses in Asia.

Yoshinori Isozaki, chief executive, told the Financial Times in an interview that the pivot was Kirin’s “second revolution” after branching out to pharmaceuticals in the 1980s.

 

Sanofi rare disease med clinches world-first nod in Japan, presaging potential approvals in US, Europe (Fierce Pharma)

https://www.fiercepharma.com/pharma/sanofi-med-clinches-world-first-rare-disease-nod-japan-presaging-approvals-europe-and-us

The world’s first therapy for rare disease Niemann-Pick types A/B and B has surfaced in Japan, courtesy of Sanofi. With one global approval down, Sanofi hopes to score nods for the drug in the U.S. and Europe before the year is out.

Japan’s drug regulator has cleared Sanofi’s Xenpozyme, also known as olipudase alfa, to treat kids and adults with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), the company said Monday.

 

Japan-developed Covid-19 vaccines might be available for use in next few months (The Yomiuri Shimbun)

The development of domestic vaccines has lagged far behind that of foreign countries – partly because of lawsuits over adverse reactions to vaccinations.

TOKYO — The prospect of Japan using domestically developed COVID-19 vaccine products practically is coming closer to being realized.

Japan has had to rely on products developed by foreign entities throughout the vaccination rollout, but a few domestic pharmaceutical companies have advanced their own vaccines to the clinical trial stage, after lagging behind foreign firms in development and procurement.

 

Roche’s Chugai lines up a $185M deal to switch drug candidate to subcutaneous formulation (Endpoints News)

Back in the spring of 2020, J&J and its partner on the big multiple myeloma drug Darzalex announced a big improvement for the program after using Halozyme’s platform tech to switch it from an IV needing hours for infusion to a subcutaneous version that could be dosed in minutes.

The new version, Darzalex Faspro, was more convenient and the impact on the marketing side was illuminated a few days ago, when Sanofi nabbed $330 million in funding from Blackstone to develop a subcutaneous version of Sarclisa, its myeloma rival, in exchange for royalties.

Chugai, a Roche sub, got the message, and on Tuesday the company announced its own deal with Halozyme, paying out $25 million in cash and offering $160 million in royalties to get a subcutaneous version of one of its drugs. Halozyme will also get royalties on the drug, which it isn’t disclosing at this stage of the game.

 

Takeda’s rare disease drug’s manufacturing and supply woes continue as FDA rejects supplement (Endpoints)

https://endpts.com/takedas-rare-disease-drugs-manufacturing-and-supply-woes-continue-as-fda-rejects-supplement/

Almost 3 years after Takeda had to recall a drug that can help people with the rare condition known as hypoparathyroidism, those waiting for any sign that supplies of their reliable injection from Takeda might reemerge will have to wait even longer.

Takeda announced on Tuesday that the FDA rejected its Prior Approval Supplement (PAS) submitted last August to address the formation of rubber particulates that led to the initial recall in September 2019.

More than 2,000 people have been stranded without Natpara (parathyroid hormone) as they do not have access to the company’s Special Use Program (SUP), which is only for about 400 of those who are at extreme risk of life-threatening complications. But when those manufacturing issues will be resolved remains an open question. The company previously said that it might resume supply by next week, but now that forecast has been thrown out.


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