FiercePharmaAsia—Ono’s new BMS deal, Eisai’s Lenvima, Sanofi’s Dengvaxia testimony

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Ono, Bristol-Myers Squibb, Eisai and Sanofi made the news this week.

Welcome to this week's FiercePharmaAsia report, which includes stories about a new immuno-oncology deal between Bristol-Myers Squibb and Japan's Ono Pharmaceutical, NICE's decision on Eisai's Kisplyx/Lenvima, Sanofi's efforts to dig out of Philippines Dengvaxia fallout, and more.

1. Bristol-Myers boosts I-O offering with new Ono drug deal

Ono and Bristol-Myers Squibb are already in a standing collaboration over development and commercialization of Opdivo in Japan, South Korean and Taiwan. Now, the two have formed another pact where BMS has taken on rights to an immuno-oncology drug targeting PGE2 receptor from Ono for $40 million upfront. It also includes licensing of other assets in certain Asian territories.

2. Eisai’s Lenvima wins nod from NICE for kidney cancer, but fight for thyroid cancer approval rages on

After turning down Kisplyx, marketed as Lenvima in the U.S., in draft guidance in August, England’s drug cost watchdog has decided to back the med to treat certain patients with kidney cancer. But regulators still haven’t included it for coverage in treating thyroid cancer, a tug of war between the drugmaker and NICE that can be traced back to more than a year ago.

3. Sanofi official testifies to Dengvaxia's safety as questions in Philippines multiply

Sanofi looks for path forward with Dengvaxia as challenges mount

During a Philippines Senate hearing, Sanofi’s Asia-Pacific head Thomas Triomphe tried to assure everyone that Dengvaxia is a safe and efficacious vaccine, and told officials their decision to halt a national immunization program is a regression in the fight against dengue. Sanofi is now trying to find a way out of the fallout, which followed Sanofi’s new analysis that found Dengvaxia could cause more serious infections if given to dengue-naïve individuals.

4. FDA cites Glenmark plant where warehouse temperatures exceeded 110˚F

The FDA found that a Glenmark warehouse in Baddi, India, had previously reached temperatures as high as 112˚F. That might have been the cause behind more than 20 complaints in the last two years about a cream that buyers said was watery, but the company never investigated. The agency laid out seven observations for the plant, which accounts for about 10% of Glenmark's U.S. sales.

5. Serum Institute eyes pharma's big-selling vaccines as CEO touts growth ambitions

Serum Institute of India has big plans, to reach Rs 10,000 crore ($1.55 billion) sales in five years. To reach that goal, it is planning to launch four vaccines in the coming years for pneumococcal disease, HPV, meningococcal disease and dengue virus, and will enter the Western market with a Tdap vaccine expected to be launched in Europe in three years.

6. Vernalis, Daiichi form oncology drug discovery collaboration

Daiichi Sankyo has tapped Vernalis for its drug discovery platform for undisclosed cancer targets. The platform is designed to identify molecules with low molecular weights that interact with the binding site of the target. Vernalis is in active drug discovery collaborations with Servier and Lundbeck, and has a history of working with companies such as Genentech and Novartis.

7. Novo and partner Torrent plan major plant expansion in India

Novo Nordisk has been partner with Torrent Pharmaceuticals since 1992 and is relying on the Indian drugmaker to produce much of the insulin it sells in that country. Now, the two will expand a Torrent plant dedicated to producing Novo insulins to increase capacity by 30% to 35%. Torrent has already invested more than $9 million in the plant.

8. Temasek unit backs dialysis startup’s CE mark push

A subsidiary of Singapore’s national wealth fund Temasek has invested in dialysis startup Advent Access, a spinoff from Singapore’s science agency A*STAR. The company is focused on a small titanium device intended to make access to the vascular systems of dialysis patients more reliable and less painful.

9. FDA bans products from Korean company that handled manufacturing over the phone

The FDA found South Korean company Seindni had no quality checks in place and was handling manufacturing decisions with its contractor by phone. After banning all products from the OTC drugmaker, the regulatory agency issued a warning letter.

10. U.K. regulators uncover data integrity issues at Bangladesh drugmaker

The Acme Laboratories had applied to manufacture metronidazole for the U.K., but a recent inspection uncovered reasons to doubt data the company had supplied to prove product quality. The U.K. agency also shared the info with other EU members.