28.06.2007 20:05:00
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Santarus and Victory Pharma Announce Co-Promotion Agreement for NAPRELAN Prescription Products
Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company, and
Victory Pharma, Inc., a privately held specialty pharmaceutical company,
today announced that they have entered into a co-promotion agreement
relating to Victory’s NAPRELAN®
(naproxen sodium) Controlled Release Tablets prescription pharmaceutical
products. NAPRELAN Tablets are a once-daily, controlled release
formulation of naproxen sodium, a non-steroidal anti-inflammatory drug
(NSAID) indicated for the treatment of a number of conditions, including
arthritis and the relief of mild to moderate pain.
Santarus expects to train its field sales representatives and to
commence promotional activities in the third quarter of 2007 for the
NAPRELAN brand products. Santarus plans to have its sales
representatives promote NAPRELAN to Santarus’
group of targeted primary care physicians in the second detail sales
position. ZEGERID®
(omeprazole/sodium bicarbonate) brand products will continue to be
promoted by the Santarus, inVentiv Health and Otsuka America field sales
representatives in the primary detail sales position to targeted
gastroenterologists and primary care physicians.
"With this co-promotion agreement for NAPRELAN
products, we are executing on our previously stated strategy to leverage
our commercial organization by adding a marketed product that we believe
will be attractive to our targeted physicians and their patients,”
said Gerald T. Proehl, president and chief executive officer of
Santarus, Inc. "Our analysis indicates that
the primary care physicians we currently target are frequent prescribers
of NSAID products, which we believe makes NAPRELAN Tablets a good fit
for our product portfolio.” "We are excited to enter into this agreement
with a quality partner such as Santarus and extend the reach of NAPRELAN
products beyond pain specialists and other selected physician
specialties who are the primary focus of our current sales force calls,”
said Matt Heck, president of Victory Pharma, Inc. "Our
decision to acquire the rights to market NAPRELAN earlier this year was
based on the potentially significant opportunity we saw for
differentiated pain therapeutics following the U.S. market withdrawal of
certain widely prescribed COX-2 inhibitor drugs. We believe NAPRELAN is
an attractive product for pain management given that its active
ingredient, naproxen sodium, has a well known efficacy and safety
profile and NAPRELAN has the benefit of once-daily dosing.”
The initial focus of Santarus’ promotional
efforts will be on the 375 mg dosage strength. Under the terms of the
agreement, Santarus will promote NAPRELAN Tablets to Santarus’
targeted primary care physicians and will be paid a co-promotion fee
calculated as a percentage of the net sales value of the prescriptions
generated by its targeted physician group, offset by an initial credit
in recognition of existing sales. Santarus did not pay Victory an
upfront fee, but will incur certain incremental expenses associated with
its promotion of NAPRELAN products, including the cost of training the
Santarus field sales representatives, and purchasing samples and
promotional literature at cost from Victory.
Santarus’ management plans to further discuss
the NAPRELAN products co-promotion opportunity during its 2007 second
quarter financial results conference call on Monday, August 6, 2007 at
8:30 a.m. Eastern time. Details about the conference call and webcast
will be forthcoming.
About NAPRELAN
NAPRELAN (naproxen sodium) Controlled Release Tablets are commercially
available in 375 mg and 500 mg dosage strengths.
NAPRELAN Tablets use Elan’s proprietary
Intestinal Protective Drug Absorption System (IPDAS®)
Technology. The tablet system combines an immediate release component
with a sustained release component of microparticles that are widely
dispersed, allowing absorption of the active ingredient throughout the
gastrointestinal tract, providing convenient once-daily administration.
NAPRELAN Tablets are indicated for the treatment of rheumatoid
arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis
and acute gout. It is also indicated for the relief of mild to moderate
pain and the treatment of primary dysmenorrhea.
Important Safety Information
NAPRELAN Tablets are contraindicated in patients with known
hypersensitivity to naproxen or naproxen sodium.
NAPRELAN Tablets should not be given to patients who have experienced
asthma, urticaria, or allergic-type reactions after taking aspirin or
other non-steroidal anti-inflammatory drugs (NSAIDs). Severe, rarely
fatal, anaphylactic-like reactions to NSAIDs have been reported in such
patients.
Please see full prescribing information including BOXED warning
regarding cardiovascular and gastrointestinal risks.
Full prescribing information for NAPRELAN Tablets may be obtained in the
U.S. from Victory Pharma Professional Services by calling toll free
866-427-6819 or on Victory Pharma's Web site at www.victorypharma.com.
About Victory Pharma
Victory Pharma, Inc. is a privately held specialty pharmaceutical
company headquartered in San Diego with sales and marketing operations
in Cary, N.C. focused on acquiring, developing and marketing products to
treat pain and related products. Victory markets NAPRELAN and
complementary pain products to pain management specialists,
rheumatologists, orthopedics and select primary care physicians though
its physician-based field sales force. Victory is currently developing
several proprietary products for the treatment of chronic severe pain
and commonly associated opiate-induced side effects. Its lead
development compound is nearing completion of Phase II clinical testing.
Further information regarding Victory is available at www.victorypharma.com.
About Santarus
Santarus, Inc. is a specialty pharmaceutical company focused on
acquiring, developing and commercializing proprietary products that
address the needs of patients treated by gastroenterologists or primary
care physicians. The company currently markets ZEGERID Capsules and ZEGERID Powder for Oral Suspension. These products
are immediate-release formulations of omeprazole, a widely prescribed
proton pump inhibitor. More information about Santarus is available on
the company's Web site at www.santarus.com.
Santarus cautions you that statements included in this press release
that are not a description of historical facts are forward-looking
statements. The inclusion of forward-looking statements should
not be regarded as a representation by Santarus that any of its plans
will be achieved. Actual results may differ materially from those
set forth in this release due to the risks and uncertainties inherent in
Santarus’ business, including, without
limitation: risks related to the co-promotion arrangement with
Victory (including Santarus’ ability to
increase market demand and sales of NAPRELAN products; competition from
other products, including a generic formulation of NAPRELAN, which is
currently commercially available in a 500 mg dosage strength and is the
subject of pending patent infringement litigation initiated by Elan
Corporation, plc and/or its affiliates, as the patent holder for the
NAPRELAN product; unexpected adverse side effects or inadequate
therapeutic efficacy of NAPRELAN products; the scope and
validity of patent protection for NAPRELAN products, and Santarus and
Victory’s ability to commercialize NAPRELAN
products without infringing the patent rights of others; and the
potential for termination of the co-promotion arrangement); difficulties
or delays in manufacturing and marketing of, and maintaining regulatory
approvals for, Santarus’ ZEGERID brand
products; and other risks detailed in Santarus’
prior press releases as well as in public periodic filings with the
Securities and Exchange Commission. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement and Santarus undertakes no obligation to revise or
update this news release to reflect events or circumstances after the
date hereof. This caution is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation Reform
Act of 1995. NAPRELAN®
is a trademark of Elan Corporation, plc. IPDAS®
is a trademark of Elan Pharma Int. Ltd. Santarus®
and ZEGERID®
are trademarks of Santarus, Inc.
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