UPDATE: Takeda confirms eyeing opportunities in India, elsewhere, in vaccine space

Japan's Takeda Pharmaceutical has looked at Indian companies in the vaccine space as it moves to tighten focus on that aspect of its business ahead of a Phase III trial for a dengue candidate and more broadly emerging markets, as seen by a recent M&A deal in Turkey.

Christophe Weber

Last week, Takeda announced it had opened an emerging markets headquarters in the gleaming new research hub of Biopolis on Feb. 25 in Singapore with new CEO Christophe Weber and senior management on hand, including Giles Platford, president of emerging markets who has experience in the Turkish market and was previously based in Singapore.

Rajeev Venkayya, president, Global Vaccine Business Unit, Takeda Pharmaceutical Co. Ltd., told FiercePharmaAsia on Feb. 25 that indeed the company has looked at Indian vaccinemakers as targets for M&A or other deal structures as it gets ready to take a plunge into a market that saw rival Daiichi Sankyo find nothing but trouble, as reported on Jan. 22.

"Yes, we have looked at and held discussions with several firms in India," Venkayya said in a telephone interview. "It would be rational to do because Indian companies are a major player in that (vaccine) space, and we have looked elsewhere as well."

Venkayya declined to discuss areas of focus in vaccines, though Takeda has been active on the M&A front fairly recently with the May 2013 purchase of U.S.-based Invitrogen in May 2013 for up to $250 million subject to clinical milestones, with $35 million upfront for its lead candidate, DENVax, a four-strain recombinant viral vaccine for the prevention of dengue infection. The vaccine has completed Phase II trials.

In addition to DENVax, Inviragen is working on a vaccine to protect against hand, foot and mouth disease caused by enterovirus 71 (EV71) and has also developed a recombinant vaccine to protect against chikungunya, a viral disease spread by mosquitoes, which is currently in preclinical studies.

Inviragen had deep regional ties, having merged with Singapore-based SingVax in 2009 and worked with Vietnam's VABIOTECH on a Japanese encephalitis vaccine.

According to a source spoken to in late January, Takeda has eyed Bharat Biotech, an injectables, vaccines and contract firm, and vaccine and diagnostic firms like Indian Immunologicals, Biological Evans, widely known as Biological E--all based in the southern Indian city of Hyderabad. It has also had informal talks with the Serum Institute of India, the world's fifth largest vaccinemaker by volume.

A move into India would be a major change for Japanese drugmakers that saw Daiichi Sankyo famously pay $4.6 billion for a 64% holding in Ranbaxy in 2008 in a deal that and quickly ran into a storm of manufacturing troubles with quality, including allegations that executives smuggled in samples from other manufacturers to use in testing. Last year, the Japanese pharma set the stage to exit with a $4 billion all-share deal with India's Sun Pharmaceuticals, marking a point where almost all Japanese drug firms were thought to consider the country out-of-bounds for future M&A.

However, there have been rumblings since last year that Takeda was interested--but that it also eyed a 2009 Sanofi foray into India's vaccines arena as a further cautionary tale. Sanofi has successfully completed Phase III trials for its own dengue vaccine candidate and has moved into the regulatory filing phase for a hoped for launch by the end of the year. Takeda would not likely finish Phase III work on its dengue candidate until 2016.

After buying Shantha Biotechnics in 2009, the French drugmaker watched the biotech run into quality-control issues. In 2010, UNICEF and WHO recalled and destroyed about 24 million doses of its pentavalent, Shan5, based on reports of white sediment in vials. The move impacted vaccination programs in 7 countries, and when the vaccinemaker couldn't meet the organizations' deadline for identifying the source of the issues and putting together a corrective plan, they disqualified it as a supplier--a status it didn't win back until May of last year.

Takeda executives, however, tell sources that have taken their time and done the homework--and that India is the place to be.

"They see it as a low-cost manufacturing base with quality," the first source said. "The timeline for any deal is not rush-rush--but sooner rather than later."

Bharat Biotech and Indian Immunologicals and the Serum Institute of India had not responded to email queries by press time.