Dainippon Sumitomo Pharma Advances Pipeline Despite Setbacks

TOKYO - Osaka-based Dainippon Sumitomo scored a few advances in its pipeline despite an earlier setback for its epilepsy medicine Stedesa (eslicarbazepine) when U.S. FDA asked for additional information last November and extended its PDUFA date 90 days to April 30, the company reported Feb. 3 when it announced earnings results for the April-December period. Stedesa is being developed by Dainippon's new subsidiary Sepracor.

Japan's Ministry of Health, Labor and Welfare approved in January Dainippon's Metgluco (metformin) for type 2 diabetes and is now awaiting National Health Insurance pricing decision by Chuikyo, Executive Director International Business Hiroshi Nomura told analysts during the call.

Meropen (meropenem) won MHLW approval in January for the additional indication of febrile neutropenia. It is also indicated for treating moderate to severe infection caused by gram-positive and negative bacteria

Dainippon also filed an NDA for SMP-508 (repaglinide) for diabetes with MHLW.

In Japan, AS-3201 (ranirestat) is in Phase II trials for diabetic neuropathy, as is hypertension combination drug DSP-8153 (amlodipine/irbesartan).

In the United States, the company submitted an NDA to U.S. FDA in December 2009 for atypical antipsychotic lurasidone for schizophrenia, ahead of initial plans to file in the third quarter of 2010. The company attributes the earlier submission date to the positive results, and particularly the safety profile, established in two Phase III studies - PEARL 1 and PEARL 2.

In Japan, the compound is in Phase III trials under a pan-Asia study in Japan, South Korea and Taiwan, it said. The company is hoping its newly acquired Sepracor sales force is up to the challenge in a crowded, but still fruitful, market (Also see "Dainippon Sumitomo Submits Lurasidone NDA, Preps For Marketing Scramble" - Scrip, 6 Jan, 2010.).

In discussing Sepracor's performance, Nomura said for the year ending December 2009, net sales were $1.336 billion, "which increased compared with the previous year by $44 million or 3.4 percent. Hypnotic sedative Lunesta , and Xopenex for asthma treatment declined in sales. However, Brovana for COPD treatment and Omnaris for allergic rhinitis increased its sales."

"Our pharmaceutical businesses are performing better than estimated," he said, "and also we included Sepracor newly into consolidations. Therefore, we estimate the increase of sales by ¥31 billion to be ¥295."

Nine-month sales ending in December 2009 increased 0.9 percent to ¥203.8 billion ($2.2 billion); operating income rose 16.1 percent to ¥32 billion; and net income was up 23.8 percent to ¥21.2 billion compared to the same year-ago period, the company reported.

Sales growth was boosted by antipsychotic agent Lonasen (blonanserin), up 93.6 percent on year to ¥4.7 billion; high blood pressure agent Avapro (irbesartan), up 76.9 percent to ¥2.4 billion; AmBisome, up 31.4 percent to ¥3.1 billion.

However, sales for hypertension treatment Amlodin decreased 9.7 percent to ¥41.6 billion, the company said, due to generic competition.

- Toshio Aritake ([email protected])