Astellas Announces 32 Percent Increase In Earnings; Anticipates 10.4 Percent Drop With Prograf Patent Expiry In FY '08

TOKYO - Astellas posted May 13 fiscal 2007 net revenue of ¥177.4 billion ($1.7 billion), a 32 percent increase over the ¥131.3 billion ($1.3 billion) posted the previous fiscal year.

For the present fiscal year however, the Tokyo-based company, which focuses in urology, immunology and inflammatory, diabetes, CNS/pain, infectious diseases and cancer, forecasts a 10.4 percent drop in net revenue to ¥159 billion ($1.518 billion).

In a May 14 earnings call with investors and analysts, company president and CEO Masafumi Nogimori noted sales of immunosuppressant Prograf (tacrolimus) grew in each region, with global sales of ¥203 billion. However, the drug's substance patent expired in April. "Based on this, U.S. sales will decline by 5.5 percent," Nogimori said.

Astellas had been aiming to win U.S. FDA approval of a once-daily formulation under the tradename Prograf MR (FK506 ) ahead of the patent expiry, but the firm received a second "approvable" letter for the liver transplant indication April 30, after receiving a second approvable letter for a kidney transplant indication in March (Also see "Astellas Tacrolimus Approval Remains At Bay" - Scrip, 8 May, 2008.).

For FK506 MR, FDA raised issues over gender difference in both indications and and pharmacokinetic issues in kidney transplants. For the liver transplant indication, FDA recommended further analyses of the Phase III study and/or additional clinical trials to explore gender difference. For the latter, FDA recommended submission of Phase III data conducted in Europe with additional gender analysis. The company submitted a response to the approvable letter for the kidney indication and anticipates a six-month review.

The overactive bladder treatment Vesicare (solifenacin) increased sales in Japan, the U.S. and Europe, with total sales of ¥60.1 billion ($574 million). Astellas foresees total 2008 sales rising 23 percent to ¥74 billion ($707 million).

Year-on-year sales for benign prostatic hyperplasia drug Harnal (tamsulosin), also known as Flomax , declined 2.6 percent overall to ¥122.4 billion ($1.2 billion). "In Europe, the decline is the same, but in Spain and some non-EU5 countries, we have been able to keep stable sales," Nogimori said.

Acquired in November, Agensys now fully operates as Astellas' antibody research base, part of the company's strategy of introducing new drugs into the market (Also see "Astellas Advances Antibody R&D Agenda With Agensys Purchase Worth Up To $537 Million" - Scrip, 27 Nov, 2007.).

Astellas also entered into an agreement with CoMentis last April to develop products from CoMentis' beta-secretase inhibitor program, including the recently initiated Phase II lead candidate compound CTS-21166, an oral beta-secretase inhibitor for the treatment of Alzheimer's disease (Also see "Astellas To Develop Beta-Secretase Inhibitor For Alzheimer’s In Deal With CoMentis" - Scrip, 26 Apr, 2008.).

The agreement also includes a research collaboration to develop additional beta-secretase inhibitors. "We will further increase our activities for licensing and acquiring products," Nogimori said.

Pipeline products include antifungal antibody Mycamine , pharmacologic radionuclidestress imaging agent Lexiscan (regadenoson) for myocardial perfusion, and immunosuppressant FK506 MR. Approved in the U.S. since 2005, Mycamine received approval in Europe last April. "When we are ready, we will start selling in the U.K, and then in other countries sequentially," Nogimori said (Also see "EMEA Recommends Approval For Astellas’ Mycamine" - Scrip, 22 Feb, 2008.).

Lexiscan was approved in the U.S. in April. "We will launch it as soon as we are ready," Nogimori said (PharmAsia News, April 17, 2008).

Major projects include rapidly acting bactericidal injectable antibiotic telavancin , the concomitant use of the immunosuppressants FK506 and MMF (U.S.), immunosuppressant Alefacept , and 5-HT3 receptor agonist YM060 (Japan). Astellas expects an action date for telavancin by the U.S. FDA July 21.

The Japanese authority review meeting was held in April for YM060, but the description of the labeling was not agreed to by members, and the review meeting for labeling will be held again this month, Astellas said. Phase II clinical trials for Alefacept started in the U.S. in February.

- Richard Smith ([email protected])