Product Launched Under Exclusivity Transfer Agreement with Anchen and Teva
HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 18, 2006--IMPAX
Laboratories, Inc. (OTC: IPXL) ("IMPAX" or "the Company") announced
today that the U.S. Food and Drug Administration (FDA) has granted
final approval of the Company's Abbreviated New Drug Application
(ANDA) for a generic version of Wellbutrin XL, 300 mg. The product has
been launched, pursuant to an Exclusivity Transfer Agreement with
Anchen Pharmaceuticals, Inc. and a subsidiary of Teva Pharmaceutical
Industries Ltd. (NASDAQ:TEVA).
Anchen obtained approval of its generic Wellbutrin XL product, and
in accordance with this agreement, selectively waived its 180-day
period of marketing exclusivity in favor of IMPAX Laboratories.
Pursuant to the Company's existing strategic alliance agreement with
Teva, Teva has U.S. marketing rights to IMPAX's version of this
product. Wellbutrin XL 300 mg, marketed by GlaxoSmithKline, had U.S.
sales in excess of $1.0 billion for the 12 months ended October 31,
2006, according to Wolters Kluwer Health.
Under the Exclusivity Transfer Agreement, Teva will make certain
payments to Anchen in return for a waiver of its exclusivity to IMPAX.
In addition, Teva is indemnifying IMPAX against certain losses that
might arise from certain legal risks.
"We are very pleased to have received our ninth FDA approval this
year, and look forward to offering patients this widely sold
anti-depressant as a generic drug beginning immediately," commented
Larry Hsu, Ph.D., President and Chief Executive Officer of IMPAX
Laboratories.
"In addition, generic Wellbutrin XL is the first of our Tier 3
products to be marketed under the 12-product Strategic Alliance
Agreement signed with Teva in July 2001. Under that agreement, upon
the first launch date of any Tier 2 or Tier 3 product in the U.S.,
IMPAX plans to repurchase for $1.00, 16.67% of the IMPAX common stock,
or approximately 244,000 shares, sold to Teva during the development
phase of the agreement," Dr. Hsu added.
Both the IMPAX and Anchen ANDAs for generic Wellbutrin 300 mg were
filed with Paragraph IV certifications with respect to certain patents
held by Biovail Laboratories International SRL and listed in the
Orange Book. Biovail initiated patent infringement lawsuits against
both companies. The IMPAX litigation is ongoing, and IMPAX has filed a
motion for summary judgment of noninfringement. Anchen has been
granted summary judgment of noninfringement with regard to the Anchen
product.
About IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of branded products.
IMPAX markets its generic products through its Global Pharmaceuticals
division and markets its branded products through the IMPAX
Pharmaceuticals division. Additionally, where strategically
appropriate, IMPAX has developed marketing partnerships to fully
leverage its technology platform. IMPAX Laboratories is headquartered
in Hayward, California, and has a full range of capabilities in its
Hayward and Philadelphia facilities. For more information, please
visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations of
management. Such statements are based on current expectations and
involve a number of known and unknown risks and uncertainties that
could cause IMPAX's future results, performance or achievements to
differ significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Such risks
and uncertainties include, but are not limited to, possible adverse
effects resulting from the delisting of IMPAX's stock, IMPAX's delay
in filing its 2004 Form 10-K, its Form 10-Q for each of the first
three quarters of 2005, its Form 10-K for 2005, and its Form 10-Q for
each of the first three quarters of 2006, IMPAX's ability to obtain
sufficient capital to fund its operations, the difficulty of
predicting FDA filings and approvals, consumer acceptance and demand
for new pharmaceutical products, the impact of competitive products
and pricing, IMPAX's ability to successfully develop and commercialize
pharmaceutical products, IMPAX's reliance on key strategic alliances,
the uncertainty of patent litigation, the availability of raw
materials, the regulatory environment, dependence on patent and other
protection for innovative products, exposure to product liability
claims, fluctuations in operating results and other risks detailed
from time to time in IMPAX's filings with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on
which they are made, and IMPAX undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of
whether new information becomes available, future developments occur
or otherwise.
CONTACT:
IMPAX Laboratories, Inc.
Larry Hsu, Ph.D. President & CEO, 510-476-2000, Ext. 1111
Arthur Koch, CFO, 215-933-0351
www.impaxlabs.com
or
Investor Relations:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
[email protected]
or
Bruce Voss, 310-691-7100
[email protected]
www.lhai.com
SOURCE:
IMPAX Laboratories, Inc.