HAYWARD, Calif., Nov 07, 2005 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC:IPXL) announced today it
has entered into a ten year Exclusive Supply and Distribution
agreement with DAVA Pharmaceuticals, Inc. (DAVA) for IMPAX's 10mg,
20mg, 40mg and 80mg dosage strengths of Oxycodone Hydrochloride
Extended Release Tablets. In exchange for payments of up to $60
million over the next 5 years and sharing of gross profits, DAVA will
have exclusive sales and distribution rights in the United States and
Puerto Rico. IMPAX will be responsible for all manufacturing and
regulatory aspects. The combined branded and generic U.S. sales for
the 10mg, 20mg, 40mg and 80mg strengths of Oxycodone Hydrochloride
Extended Release Tablets were over $1.8 billion for the twelve-month
period ended August 31, 2005 according to NDCHealth.
"We are looking forward to working with DAVA on this important
product," said Barry R. Edwards, Chief Executive Officer of IMPAX. "We
believe the combination of economic terms and DAVA's strong sales and
marketing organization make this a very attractive business
opportunity for IMPAX."
IMPAX had been marketing the 80mg dosage strength through its
Global Pharmaceutical Division; and will be transitioning sales and
marketing responsibilities to DAVA. IMPAX currently has a tentative
Abbreviated New Drug Application (ANDA) approval for the 10mg, 20mg
and 40mg dosage strengths with final approval subject to the
expiration of market exclusivity on December 5th, 2005.
About DAVA Pharmaceuticals
DAVA Pharmaceuticals, a specialty pharmaceutical company, is
focused on product development and marketing a broad portfolio of
pharmaceutical products. DAVA Pharmaceuticals is aggressively building
its product portfolio through a combination of acquisitions, strategic
alliances, in-licensing transactions, partnerships and development.
For further information, please visit www.davapharma.com.
About IMPAX Laboratories
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 intends to market 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 and its Form 10-Q's for the first two
quarters of 2005, 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.
SOURCE: IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Barry R. Edwards, 215-933-0360
Larry Hsu, Ph.D., 510-476-2000, Ext. 1111
Arthur Koch, 215-933-0351
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz (kgolodetz@lhai.com)
212-838-3777
Bruce Voss (bvoss@lhai.com)
310-691-7100
www.lhai.com