NORWELL, Mass., March 1 /PRNewswire/ -- Serono Laboratories, Inc. has received
a complete response letter to its Biologics License Application (BLA) for
interferon beta-1a, Rebif(R). The agency has requested clarification of
clinical information and data. "Serono does not see any difficulty in
responding quickly to the FDA request for more information necessary for
tentative Rebif approval," said Hisham Samra, M.D., president of Serono
Laboratories. "We have also received a proposal for labeling for both doses
which we are in the process of evaluating." In its letter, the FDA also noted
that there are pending orphan exclusivity issues that are separate and
distinct from the requested clarifications concerning the Rebif license
application. The FDA has further stated that Rebif may not be approved for
marketing while orphan exclusivity remains in effect for Avonex or Betaseron.
"Serono will continue its discussions with the FDA on outstanding orphan drug
issues to determine how it can make Rebif available to MS patients as soon as
possible," said Dr. Samra.
The Ares-Serono Group is a leading Swiss developer and marketer of
pharmaceutical products with headquarters in Geneva, Switzerland. Serono
Laboratories, Inc., headquartered in Norwell, MA, is the U.S. member of
international company. World leader in the treatment of infertility, Ares-
Serono is also active in the fields of growth, wasting and multiple
sclerosis/immunology. With nine recombinant products under development, Ares-
Serono is one of today's biotechnology leaders. Four of the products are
already marketed for various indications. Ares-Serono operates subsidiaries
in 36 countries and its products are sold in more than 90 countries. Shares
of Ares-Serono S.A., the holding company of the Group, are traded on the Swiss
stock exchange.
SOURCE Serono Laboratories, Inc.
CO: Serono Laboratoratories, Inc.; U.S. Food and Drug Administration; Ares-
Serono S.A.
ST: Massachusetts
IN: MTC
SU: EXE