Astellas loses bid to stave off copycat Prograf

It's a pitched battle over Prograf. Fast-moving, too: FDA rejected Astellas Pharma's petition for tougher-than-normal approval standards for copycat forms of its transplant drug. Novartis got the FDA nod for its version. Astellas vowed to sue the agency. Novartis announced the launch of its generic Prograf. Boom, boom, boom.

With $2.1 billion in 2008 sales, Prograf is a key drug for Astellas, especially now that its Flomax drug is facing generic competition. The company had hoped to hold off generic rivals for the transplant drug by persuading the FDA that Prograf copycats would need clinical trials to prove they work, rather than the usual less-stringent tests. After all, if generic Prograf didn't work, a transplant patient could well experience organ rejection. Now that it's failed to convince the agency, it's planning to a.) sue, and b.) ask for labelling changes that would require doctors to be notified before pharmacists can subsititute a generic.

Analysts, however, expect that patients and doctors' own caution will be enough to keep generic Prograf from making huge inroads against the branded drug. "Sales will fall even though it won't be as rapidly as for drugs such as diabetes medicines," Deutsche Bank analyst Kenji Masuzoe told Bloomberg, "because doctors will be careful about switching treatments for something life-threatening like organ transplants." Masuzoe projects Prograf sales in the U.S. will fall 24 percent to $676 million in the two years ending March 31, 2011.

Novartis' generics unit Sandoz isn't deterred; citing its parent company's experience with transplant meds, Sandoz trumpeted its first-to-market status with the drug. "Tacrolimus is an important new product for Sandoz," CEO Jeff George said in a statement. We'll have to wait and see whether Novartis' pedigree incites transplant patients to take the generic plunge.

- read the Novartis release
- see the story from Bloomberg
- check out the Reuters coverage