Japanese drugmaker Astellas Pharma expects strong growth in European sales of Eligard (leuprolide) with the launch of a unique six-monthly injection of this hormonal treatment for advanced prostate cancer.

Ugo Bello, Astellas Brand Director Prostate, Europe, said that the first launch (in Germany) would be followed by launches in most EU countries except Greece and the UK over the next 18 months. Eligard is a luteinising hormone-releasing hormone agonist designed to reduce the amount of testosterone produced by the testicles and is sold in tandem with German-American biotechnology firm MediGene.

This market segment is currently worth some 300 million euros of which Astellas – a relative newcomer to this segment – currently holds just under a 10% share with its existing one-month (7.5mg) and three-month (22.5mg) Eligard formulations. Sales of these formulations rose by 86% in 2005-2006.

According to Mr Bello, the launch of a 45mg injection – the first and only six-monthly injection option – should see sales grow rapidly. “We think we can double our share to closer to 20% of European market share,” he said. “Without any promotion of this product we are already hearing from urologists that this could be a very successful treatment.”

Astellas chose this week’s Berlin meeting of the Annual Congress of the European Association of Urology to release findings from a survey of prostate cancer patients in five EU countries showing that nine out of ten prefer less frequent injections, with 81% under the age of 70 saying they would prefer a six-monthly injection to either a one- or three-month version.

Pierre Teillac, head of urology at Saint-Louis Hospital, Paris, said that feedback from clinical trails had been very positive, noting that “patients are happy because they only need one injection twice a year. When the three monthly formulation arrived, all the patients who had been receiving once a month injections moved to three months. We feel the same will happen with six monthly injections.” By Ian Mason

Prograf sNDA gets knockback from FDA

Meantime Astellas has been hurt by the news that it has received an approvable letter from the US Food and Drug Administration on Tuesday regarding its supplemental New Drug Application for the use of its immunosuppressant Prograf (tacrolimus) in combination a drug from Roche for the treatment of organ rejection in kidney transplant patients.

The agency expressed concerns in a letter that the combination of Prograf and Roche’s CellCept (mycophenolate mofetil) could lead to an increase in infection-related mortality related to over-immunosuppression based on review of a study in the sNDA. The FDA's letter will mean a delay of at least six months in any approval, and Astellas said it will working with the agency “to resolve the differences in interpretation of the data” in the pursuit of getting the go-ahead for the sNDA.

In the USA, Prograf is currently used in around 80 percent of kidney transplants, more than 90 percent of liver transplants and around 60 percent of heart transplants.