Management Provides Company Update at Annual Meeting
May 23, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced
that, at its Annual Meeting held May 6, 2002, shareholders voted to retain all
members of its Board of Directors. The following individuals were re-elected
to serve until the next Annual Meeting of Shareholders: Messrs. Robert L. Burr,
Barry R. Edwards, David J. Edwards, Michael Markbreiter, Oh Kim Sun, Michael
G. Wokasch and Drs. Leslie Z. Benet, Nigel Fleming, Charles Hsiao and Larry
Hsu have been re-elected as directors of IMPAX.
The IMPAX shareholders also approved the adoption of the 2002 Equity Incentive
Plan and ratified the appointment of PricewaterhouseCoopers LLP as the Company's
independent certified public accountants for the 2002 fiscal year.
Barry R. Edwards, Co-Chief Executive Officer, and Larry Hsu, Ph.D., President
and Chief Operating Officer, provided an update to shareholders on the Company's
business.
"Year 2001 was another year of accomplishment for IMPAX Laboratories,"
stated Edwards. "Once again, we hit our new product filing goal of eight
ANDAs and received a new ANDA approval, Terbutaline Sulfate Tablets. As a result
of new strategic alliances formed in 2001, we now have two very strong marketing
partners: Teva (controlled release generics) and Novartis Consumer Health (OTC).
We also began construction of our new 50,500 square foot manufacturing facility
in Hayward, which currently is being validated and is anticipated to be operational
by mid 2002."
Edwards continued with the sales and distribution update: "Our products
are currently stocked in all of the top pharmaceutical wholesalers, warehousing
chains, mass merchandisers, as well as in the largest mail order provider, through
our Global Pharmaceuticals Division. These distribution channels allow us to
continue to access the market when launching new products as we did in 2001
for Terbutaline Sulfate Tablets. We currently have captured about 62% of all
prescriptions and about 68% of new prescriptions written for this product. Regarding
the Fludrocortisone Acetate Tablets ANDA, for which we received approval in
March 2002, we have captured about 35% of new prescriptions only one month post
launch."
"Although the per-quarter rate of ANDA submissions may be `lumpier' than
in previous years due to increased brand development activities," stated
Dr. Hsu, "we are on track to meet our goal of six to eight new ANDA filings
for 2002." Dr. Hsu also indicated that, so far this year, IMPAX filed its
first brand product, as an ANDA filing.
"Our last two ANDAs were reviewed and approved by the Food and Drug Administration
(FDA) in only 13 months, compared with the industry average of 18 to 19 months,"
continued Dr. Hsu. "We believe this is due in part to the strong emphasis
we place on performing high quality development work, which is reflected in
the comprehensiveness of our submissions."
Dr. Hsu summarized the development projects as follows:
Niche Generics
GROUP STAGE BRAND MARKET VALUE(a)
----- ----- ------------------
Group 1 At FDA, six Projects $638 million
Group 2 Additional ten Projects under development $555 million
Total 16 Projects $1.2 billion
Controlled Release Generics
GROUP STAGE BRAND MARKET VALUE(a)
----- ----- ------------------
Group 1 At FDA, eight Projects $7.8 billion
Group 2 Additional seven Projects under development $3.5 billion
Total 15 Projects $11.3 billion
Brand Projects (Focusing on drugs to treat Central Nervous System
disorders)
Three Level 1 Projects are under development, the first of which
was filed last month. In addition, the Company has identified three
Projects for Level 2, some of which are currently under development.
TARGET MARKET VALUE(a)
Three Projects under development, Level 1 $1.4 billion
Total addressable therapeutic market, Level 1 $4.5 billion
(a) Source: 2001 IMS Health
IMPAX Laboratories, Inc. is a technology focused specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and niche 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. 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.