* Orphan drug status means marketing exclusivity
* Isavuconazole being developed with Japan's Astellas
* Backing follows management shake-ups
ZURICH, May 28 Swiss biotech group Basilea
has won coveted orphan drug status from U.S. health
authorities for antifungal treatment isavuconazole, the company
said on Tuesday.
Orphan status is granted to drugs that treat conditions or
diseases that affect fewer than 200,000 people in the United
States. The designation usually comes with a seven-year
marketing exclusivity period if the drug is approved for sale.
"The granting of orphan designation for isavuconazole in the
U.S. reflects the high medical need and is an important
regulatory milestone for Basilea and our partner Astellas,"
chief Basilea medical officer Achim Kaufhold said in a
Isavuconazole, which treats both mould and yeast infections,
is being developed with Japan's Astellas.
The U.S. drug backing comes shortly after a string of
shake-ups at Basel-based Basilea, including the departure of its
chief financial officer just two months after that of the firm's
founder and chief executive.
Basilea faces a year of waiting for regulatory approval on
its main product, antibiotic drug ceftobiprole. The company is
in the process of answering questions from European agencies on
the drug and said any possible approval could come in the fourth
The firm has been hunting for a partner for ceftobiprole -
which it hopes will make it to market to treat hospital and
community-acquired pneumonia - for several years and said it was
aiming for a partnership by the end of 2013.