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Advancis Pharmaceutical Acquires Keflex Brand from Lilly
Acquisition to Begin Advancis' Sales
of Antibiotic Products; Keflex to be Added to Company's Pulsatile
Drug Development Pipeline
GERMANTOWN, MD
July 1, 2004
Advancis Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical
company focused on developing and commercializing novel anti-infective
products, today announced it has acquired the U.S. rights to the KeflexÂ
brand of cephalexin from Eli Lilly and Company (Lilly) (NYSE: LLY).
Under the terms of the agreement, Advancis paid Lilly $11 million
for the exclusive rights to manufacture, market and sell Keflex (cephalexin
capsules, USP) in the United States. With the acquisition, Advancis
acquires Keflex trademarks, technology, and new drug applications
(NDAs) supporting the approval of Keflex. Following a transition period,
Advancis will assume product inventory and begin marketing and distributing
the Keflex brand.
Cephalexin is the third most prescribed outpatient antibiotic in the
United States, with over 24 million prescriptions written and sales
of $140 million in 2003. Keflex is the most-recognized brand of cephalexin
in the United States with more than 15 million prescriptions written
each year. Although the majority of these prescriptions are substituted
with generic cephalexin, Lilly's Keflex net sales in 2003 were approximately
$4 million. First introduced in the 1970s, Keflex is most commonly
prescribed for skin and skin structure infections.
In addition to assuming sales and marketing responsibilities for Keflex,
Advancis expects to begin clinical development of an enhanced cephalexin
utilizing Advancis' proprietary once-a-day pulsatile dosing technology
called PULSYS™. Cephalexin is currently dosed two to four times
daily for a period of seven to fourteen days. Advancis' initial preclinical
data support the Company's intention to develop a once-daily version
of cephalexin. With the acquisition of Keflex, Advancis now has under
development PULSYS versions of three of the top five most-prescribed
antibiotics in the United States; the other products are amoxicillin,
partnered with Par Pharmaceutical and amoxicillin/clavulanate, partnered
with GlaxoSmithKline.
"The acquisition of Keflex is an illustration of our ongoing mission
to develop and acquire antibiotic products that we believe can be
improved through our novel pulsatile approach," said Edward M. Rudnic,
Ph.D., chairman, president, and CEO of Advancis. "In addition, we
believe the acquisition and subsequent sales of Keflex will enable
us to prepare for the eventual commercialization of PULSYS products,
including our recently announced lead product under development, Amoxicillin
PULSYS."
The acquisition of Keflex marks a significant step in Advancis' transition
to a fully integrated pharmaceutical company with commercial product
sales. The Company expects to gain valuable experience in product
sales and marketing, key account management, manufacturing, distribution,
billing, and other essential commercial operations that could be leveraged
for future proprietary products. Revenue from this product is expected
to be used to develop the acquired assets and build these commercial
capabilities in preparation for PULSYS products. Advancis expects
to begin recognizing revenue from Keflex sales on July 1, 2004.
"Unlike most specialty pharma business models," Dr. Rudnic continued,
"Advancis is in a unique position to greatly improve acquired products
and ultimately launch re-invigorated brands. We believe that the near-universal
recognition of the Keflex name and proven safety record for the compound
will help pre-position the PULSYS version of the drug for launch."
The PULSYS technology has been developed to create anti-infective
products that are taken once-daily, with a lower dose and a shorter
duration of therapy. Cephalexin has been added to the Advancis preclinical
product development pipeline and is the Company's tenth pulsatile
antibiotic product program under preclinical or clinical development.
Although preclinical data on Keflex PULSYS are promising, additional
studies will be necessary to qualify cephalexin PULSYS as a clinical
candidate. Advancis believes that cephalexin's relatively short half-life
and rapid absorption make it a compelling candidate for the Company's
proprietary pulsatile dosing approach. Additionally, limited indication
overlap with other Advancis product candidates, the large number of
cephalexin prescriptions, and the lack of brand competition in the
cephalexin market make a PULSYS version of Keflex an attractive commercial
opportunity.
About Keflex:
Keflex* (cephalexin capsules, USP) is a first-generation cephalosporin
antibiotic shown to be active against strains of both gram-positive
and gram-negative aerobes in vitro and in clinical infections. Keflex
is indicated for treatment of the following infections: respiratory
tract infections, otitis media, skin and skin structure infections,
bone infections, and genitourinary tract infections. More information
on Keflex and prescribing information are available at www.advancispharm.com/products/keflex
.
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 (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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