Japan’s Astellas Pharma has posted a 2.6% fall in earnings for the first quarter ended June 30, with growth being driven once again by the immunosuppressant Prograf.

Net income came in at 44.01 billion yen (about $470 million), while sales slipped 0.9% to 252.14 billion yen, hit by the appreciation of the yen against the dollar and the euro. Turnover was driven by the immunosuppressant Prograf (tacrolimus), down 0.4% to 52.00 billion yen, and Harnal (tamsulosin) for benign prostatic hyperplasia, sold as Omnic in Europe and Flomax in the USA. Turnover of the drug increased 7.5% to 33.90 billion yen.

Vesicare (solifenacin) for overactive bladder was up 15.2% to 20.5 billion yen, while sales of the cholesterol blockbuster Lipitor (atorvastatin), which Astellas markets in Japan in collaboration with the product's originator Pfizer, were up 5.0% to 25.6 billion yen.

Sales growth for Prograf is particularly welcome seeing as how it has lost patent protection in the USA in June 2008 and in the major European countries in June this year. Analysts are surprised that no copycat counterpart has made it to the market and if one is approved by the US Food and Drug Administration, sales may still not fall by much, observers believe, as doctors specialising in organ rejection are not expected to switch to any generic transplant drug. Harnal could also be threatened by generic competition.

In terms of pipeline, Astellas expects to file YM178 (mirabegron), a follow-up to Vesicare, in 2011. It also plans to submit ASP8825 in Japan as a potential treatment for moderate-to-severe primary restless legs syndrome in the second half of this fiscal year, which ends in March 2010. The drug is licensed from the USA’s Xenoport and at the moment there are no approved drugs in Japan for RLS.

However Astellas also noted that it does not intend to continue the development of the latter compound in Japan as a potential treatment for painful diabetic neuropathy. In a Phase II study, ASP8825 did not demonstrate a statistically significant advantage of over placebo.

AstraZeneca pact
Meantime Astellas has signed a deal with AstraZeneca to co-promote the latter's asthma treatment Symbicort Turbuhaler (budesonide/formoterol) in Japan.

Under the terms of the deal, Astellas will make an initial payment of 3.00 billion yen (about $31.5 million) and may also pay up to 5.5 billion yen more, depending on sales and approval of an additional indication. .

Symbicort Turbuhaler was filed in Japan in May, 2007 and the Anglo-Swedish drugmaker said that "the outcome of this submission is expected in the fourth quarter of 2009". Development is also under way for an indication to treat chronic obstructive pulmonary disease.

Bruno Angelici, executive vice president for international sales and marketing at AstraZeneca, said that it has been "a long-time partner" of Astellas, which has "one of the strongest sales and marketing organisations in Japan”. He added that the agreement "will ensure that we successfully launch and maximise the potential of Symbicort Turbuhaler for the roughly five million people in Japan living with asthma".