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Advancis Pharmaceutical, Par Pharmaceutical Finalize Amoxicillin
PULSYS Agreement
Par to Fund Development and Co-promote
Company's First Anticipated Pulsatile Antibiotic Product; Product
Launch Could Be as Soon as 2006
GERMANTOWN, MD
June 2, 2004
Advancis Pharmaceutical Corporation (NASDAQ:AVNC), a pharmaceutical
company focused on developing and commercializing novel anti-infective
products, today announced it signed a definitive agreement with Par
Pharmaceutical, Inc. (Par), a subsidiary of Par Pharmaceutical Companies,
Inc. (NYSE: PRX), as its strategic partner to develop and commercialize
its most advanced pulsatile product candidate, Amoxicillin PULSYS.
The product utilizes Advancis' proprietary once-a-day pulsatile delivery
technology called PULSYS™, and is expected to be commercially available
by as early as 2006. This agreement finalizes the letter of intent
signed and announced in March.
Under the terms of the agreement, Advancis received an upfront license
payment of $5 million and a commitment from Par to fund further development
expenses in exchange for granting Par the exclusive right to sell
Amoxicillin PULSYS and the co-exclusive right to market the product.
Advancis will be responsible for the development and manufacturing
programs, and the two parties will jointly fund and run the marketing
and sales program and share operating profits from product sales on
an equal basis.
Amoxicillin PULSYS is designed to deliver amoxicillin at lower dosages
over a shorter duration of therapy in a once-daily formulation. Advancis'
preclinical studies demonstrated improved bactericidal effect for
amoxicillin when delivered in a pulsatile fashion versus standard
dosing regimens, even against resistant bacteria. Amoxicillin is one
of the most widely prescribed drugs in the world, with over 60 million
prescriptions written annually and over one billion patient exposures.
About Par Pharmaceutical:
Par Pharmaceutical Companies, Inc. develops, manufactures and markets
generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical,
Inc. The company is also developing a line of proprietary specialty
pharmaceuticals and expects to market the first of these in 2005.
Through its FineTech subsidiary, Par also develops and utilizes synthetic
chemical processes to design and develop intermediate ingredients
used in the production of finished products for the pharmaceutical
industry. Par currently manufactures and distributes more than 170
products representing various dosage strengths of 73 drugs. For press
release and other company information, visit www.parpharm.com.
About Advancis Pharmaceutical:
Advancis Pharmaceutical Corp. (Nasdaq: AVNC) is a pharmaceutical company
focused on the development and commercialization of pulsatile drug
products that fulfill substantial unmet medical needs in the treatment
of infectious disease. The Company is developing a broad portfolio
of anti-infective drugs based on its novel biological finding that
bacteria exposed to antibiotics in front-loaded staccato bursts, or
"pulses," are killed more efficiently and effectively than
those under standard treatment regimens. Based on this finding, Advancis
has developed a proprietary, once-a-day pulsatile delivery technology
called PULSYS™. By examining the resistance patterns of bacteria
and applying its delivery technologies, Advancis has the potential
to redefine infectious disease therapy and significantly improve drug
efficacy, shorten length of therapy, and reduce drug resistance versus
currently available antibacterial products. For more on Advancis,
please visit www.advancispharm.com.
This announcement contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities and Exchange Act of 1934, as amended. These
statements are based on Advancis' current expectations and assumptions.
These statements are not guarantees of future performance and are
subject to a number of risks and uncertainties that would cause actual
results to differ materially from those anticipated. The words, "believe,"
"expect," "intend," "anticipate," and
variations of such words, and similar expressions identify forward-looking
statements, but their absence does not mean that the statement is
not forward- looking. The actual results realized by Advancis could
differ materially from these forward-looking statements, depending
in particular upon the risks and uncertainties described in the Company's
filings with the Securities and Exchange Commission. These include,
without limitation, risks and uncertainties relating to the Company's
financial results and the ability of the Company to (1) reach profitability,
(2) prove that the preliminary findings for its product candidates
are valid, (3) receive required regulatory approvals, (4) successfully
conduct clinical trials in a timely manner, (5) establish its competitive
position for its products, (6) develop and commercialize products
that are superior to existing or newly developed competitor products,
(7) develop products without any defects, (8) have sufficient capital
resources to fund its operations, (9) protect its intellectual property
rights and patents, (10) implement its sales and marketing strategy,
(11) successfully attract and retain collaborative partners and secure
their performance under collaborative agreements , and (12) retain
its senior management and other personnel. Existing and prospective
investors are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of today's date. Advancis undertakes
no obligation to update or revise the information in this announcement,
whether as a result of new information, future events or circumstances
or otherwise.
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