Takeda Pharmaceutical Co. Ltd. made a number of moves last week to expand its presence in Europe and China, including licensing Dainippon Sumitomo Co. Ltd.'s antipsychotic agent lurasidone in 26 EU member states and committing to more than triple its sales reps in China by 2015. But in Japan, Takeda and other pharma still grapple with assessing how the Tohoku earthquake has changed the Japanese market.

Osaka-based Takeda endured the earthquake and tsunami better than many drug manufacturers in Japan. The company sustained no structural damage to its facilities in the Southern Kansai region while other top pharma suspended operations of manufacturing facilities in the affected regions (Also see "Southwest Japan-heavy Takeda And Dainippon Sumitomo Spared Earthquake Damage, Others May Rebound, But Tokyo Headquarters' Quieted By Rail Disruptions" - Scrip, 15 March, 2011.).

Still, Takeda says it is not fully operational because its affiliated companies have been affected. Takeda serves as the sole distributor in Japan for Wyeth KK - now owned by Pfizer Inc. - and Aska Pharmaceutical Co Ltd. Takeda said that both companies were impacted by the natural disaster, particularly Aska, which has its main manufacturing city in Iwaki in Fukushima Prefecture. Iwaki borders the evacuation zone surrounding the troubled Fukushima nuclear reactors. "Are we doing alright? We cannot say yes, because we represent Aska in front of wholesalers," Takeda said. Pfizer did not respond immediately to questions about the status of its Wyeth KK facilities.

"I don't think it's appropriate for any pharma to say they are alright. People in the affected areas are suffering because of the lack of supply of pharmaceuticals," Takeda Public Relations Director Seizo Masuda said.

The Japan Pharmaceutical Manufacturers Association, which represents domestic pharma companies and foreign companies' Japan subsidiaries, said it has partnered with the Ministry of Health, Labor and Welfare and the Japan Medical Association to deliver 80 tons of antibiotics, diabetes and cardiovascular drugs and other medications to the disaster areas. But reports from the region indicate that doctors are still woefully undersupplied.

Swapping Rights

Takeda announced cross-licensing deals with Dainippon Sumitomo - also of Osaka - March 30 in a rights swap in Europe and Japan.

Dainippon Sumitomo gained Japan rights for the antibiotic ceftaroline in exchange for an upfront payment of ¥500 million and milestone payments up to ¥2.5 billion as well as royalty payments. Ceftaroline was approved in the U.S. last year for U.S. licensee Forest Laboratories Inc., and Takeda felt the time was right to find a Japan partner for the drug. Takeda has removed antibiotics from its therapeutic focus, instead shifting to cardiovascular, metabolic, oncology and CNS therapies. Ceftaroline is still in the preclinical stage in Japan, so approval isn't expected for at least five years.

The ceftaroline deal was negotiated in tandem with a deal that gives Takeda development and marketing rights for lurasidone in 26 EU countries, excluding the UK, Switzerland, Norway, Turkey and Russia. A far bigger deal, Takeda agreed to ¥10 billion upfront and milestone payments that could reach $180 million if the drug receives marketing authorization approval for schizophrenia and bipolar disorder.

Dainippon Sumitomo received approval for lurasidone in the U.S. Feb. 4 as Latuda, hoping to crack a crowded but dispersed antipsychotic market (Also see "Dainippon Sumitomo Rolls Out Latuda; Will Sepracor's $2.6 Billion Sales Force Pay Off?" - Scrip, 9 February, 2011.).

Dainippon Sumitomo completed some Phase III trials for lurasidone in Europe, but there is a possibility that EMA will require additional clinical trials for a maintenance therapy study, which could push back the MAA to 2012 or 2013.

According to Takeda, Dainnipon Sumitomo is currently in talks with EMA, and Takeda will now join the discussion. Takeda said it does not think it will be possible to submit the MAA application immediately. At issue are draft guidelines for schizophrenia drug development which were published several weeks ago and open to public comment until the summer. If additional trials are requested, Takeda will share development costs in Europe.

China Growth

Takeda also announced initiatives to expand its presence in China. The company said it will expand its sales force from 250 to roughly 900 by 2015. The company also established a holding company in Shanghai to oversee its China operations.

However, Takeda denied media reports that it had established a facility at the government-sponsored technology park China Medical City. "[CMC] offers very attractive incentives...but we are not announcing anything about China Medical City," a Takeda spokesman said.

Takeda's main products in China include Actos (pioglitazone), Blopress (candesartan), Takepron (lansoprazole), Basen (voglibose), and Enatone (leuprorelin). The company hopes to have the expanded sales force in place in time for the launch of alogliptin, which is estimated to receive approval in China in 2014. Alogliptin has faced regulatory setbacks in the U.S., but the drug is a high priority for the company in China. Takeda posts minimal sales in the country, but fully acquired Tianjin Takeda - a joint venture with Tianjin Lishen Pharmaceutical - to accelerate its exposure in the market (Also see "Takeda Buys Out Chinese Venture, Gains Flexibility In Decision-making For Commercial Expansion" - Scrip, 21 October, 2010.).

[Editor's note: This article appears courtesy of PharmAsiaNews.com , Elsevier Business Intelligence's source for Asian biotech and pharmaceutical news. Register for a 30-day risk free trial.]

- Daniel Poppy (d.poppy@elsevier.com)

Takeda Expands Abroad While Finding Its Way In Its Home Market

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