ANDRX ENTERS INTO ALLIANCE FOR GENERIC LOVENOX
WITH AMPHASTAR
FORT LAUDERDALE,
FLORIDA, May 4, 2005
– Andrx Corporation (Nasdaq: ADRX) (“Andrx” or
the “Company”) announced today that it has entered into
an agreement to obtain certain exclusive marketing rights for both
strengths of Amphastar Pharmaceuticals, Inc.’s
(“Amphastar”) proposed generic version of Lovenox®,
Aventis Pharmaceuticals, Inc.’s (“Aventis”)
enoxaparin sodium injectable product. Amphastar submitted its
Abbreviated New Drug Application (“ANDA”) for generic
Lovenox to the FDA in March 2003. Amphastar’s product is
the subject of a patent infringement lawsuit filed by Aventis, and
the 30-month stay imposed by law, which runs through
February 2006. Lovenox is indicated for the prevention of deep
vein thrombosis in certain patients undergoing abdominal surgery
and knee or hip replacement surgery, and for the prevention of
certain cardiovascular events. According to IMS Health data,
Lovenox generated total 2004 U.S. sales of approximately
$1.5 billion.
Andrx’s marketing rights
generally extend to the U.S. retail pharmacy market, representing
approximately 30% of total Lovenox sales. To obtain such rights,
Andrx paid $4.5 million upon execution of the agreement and
will make an additional $5.5 million payment to Amphastar once
certain milestones relating to the product are achieved, including
obtaining FDA marketing approval and a favorable resolution of the
pending patent litigation. In exchange, Andrx will receive up to
50% of the net profits, as defined, generated from sales of
Amphastar’s product in the retail pharmacy market. Under
certain specified conditions, Andrx has the right to receive a
refund of the amounts it paid to Amphastar.
Larry Rosenthal, Andrx
Pharmaceuticals, Inc. Presi
