HAYWARD, Calif. (July 31, 2003) – IMPAX Laboratories, Inc. (NASDAQ NM:
IPXL) announced today that it has entered into an Exclusivity Transfer Agreement
with Andrx Corporation (NASDAQ:ADRX) and a subsidiary of Teva Pharmaceutical
Industries Ltd. (NASDAQ:TEVA) pertaining to pending Abbreviated New Drug Applications
(ANDAs) for bioequivalent versions of Wellbutrin® SR and Zyban® (Bupropion
Hydrochloride) 100 mg and 150 mg Extended Release Tablets filed by Andrx, as
well as by the Company. Pursuant to the Company's existing strategic alliance
agreement with Teva, Teva has U.S. marketing rights to IMPAX's versions
of these products. Wellbutrin SR and Zyban, marketed by GlaxoSmithKline, had
U.S. sales of over $1.7 billion for the twelve-month period ended May 31, 2003
according to NDCHealth.
The parties believe that the Andrx ANDAs for the products are entitled, under
the Hatch-Waxman Act, to a 180-day period of marketing exclusivity. Under the
Exclusivity Transfer Agreement, Andrx will continue to seek approval of its
ANDAs. The agreement provides, among other things, that if Andrx is unable to
launch its own products within a defined period of time, and IMPAX is able to
market its products, Andrx will enable IMPAX to launch its own products through
Teva, with the parties sharing certain payments with Andrx relating to the sale
of the products for a 180-day period. Should Andrx launch its own products prior
to the Impax product launch, it will share with IMPAX certain payments for a
180-day period.
“We are pleased that our technology has enabled us to provide patients
affordable alternatives to both Wellbutrin SR and Zyban,” said Barry R.
Edwards, Co-Chief Executive Officer of IMPAX. “This agreement with Andrx
and Teva provides us with an opportunity to bring our products to the market
earlier than would be possible alone.”
Andrx and IMPAX have both obtained favorable summary judgment decisions that
their formulations of the products do not infringe GlaxoSmithKline's patents.
GlaxoSmithKline, however, has appealed both decisions.
The transactions that are contemplated by the Exclusivity Transfer Agreement
are subject to all necessary government approvals.
IMPAX has 20 applications pending at the FDA, including three tentatively approved
that address approximately $6.2 billion in U.S. branded product sales for the
twelve months ended May 31, 2003. Fifteen of these filings were made under Paragraph
IV of the Hatch-Waxman Amendments.