ATLANTA, Feb 25, 2008 (BUSINESS WIRE) -- Sciele Pharma, Inc. (NASDAQ:SCRX) today announced it has extended
its alliance with sanofi-aventis (NYSE:SNY) by entering into a new
exclusive, three-year agreement to market Allegra(R) Orally
Disintegrating Tablets (ODT) and Allegra(R) Oral Suspension in the
pediatric market in the U.S. Under the terms of this agreement, Sciele
will be responsible for all sales and marketing programs associated
with these products in the U.S. and will share revenues on both
Allegra OS and ODT. Sciele expects to launch Allegra ODT in March 2008
through its 100 pediatric sales representatives.
Allegra Oral Suspension, 30mg/5ml (6mg/ml), is indicated for the
relief of symptoms such as sneezing, runny nose, itchy
nose/palate/throat, and itchy watery, red eyes associated with
seasonal allergic rhinitis in children two to 11 years of age. It also
is indicated for the treatment of uncomplicated skin manifestations of
chronic idiopathic urticaria (CIU) in children six months to 11 years.
Allegra ODT, 30mg, treats the same seasonal allergy symptoms and CIU
in children 6 to 11 years of age in a convenient formula that
dissolves on the tongue and can be taken with or without water.
Patrick Fourteau, president and Chief Executive Officer of Sciele
Pharma, Inc., commented, "We are pleased to expand our alliance with
sanofi-aventis, and are excited about the anticipated launch of
Allegra ODT by our Pediatric sales force. We continue to execute our
strategy of forming partnerships with major pharmaceutical companies
to capitalize on the full market potential of key branded products and
maximize profits in cost-efficient manner."
Important Safety Information
Allegra ODT contains phenylalanine, a component of aspartame.
Other Allegra products do not contain phenylalanine.
Side effects with Allegra Oral Suspension 30mg/5mL for seasonal
allergies are low and may include vomiting, diarrhea and/or runny
nose.
Side effects with Allegra 30mg for seasonal allergies are low and
may include cough, common cold, fever and/or ear infection.
For additional important information, please
visit http://products.sanofi-aventis.us/allegra/allegra.html.
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in
sales, marketing and development of branded prescription products
focused on Cardiovascular, Diabetes, Women's Health and Pediatrics.
The Company's Cardiovascular and Diabetes products treat patients with
high cholesterol, hypertension, high triglycerides, unstable angina
and Type 2 diabetes; its Women's Health products are designed to
improve the health and well-being of women and mothers and their
babies; and its Pediatrics products treat allergies, asthma, coughs
and colds, and attention deficit and hyperactivity disorder (ADHD).
Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma
employs more than 900 people. The Company's success is based on
placing the needs of patients first, improving health and quality of
life, and implementing its business platform - an Entrepreneurial
Spirit, Innovation, Execution Excellence, Simplicity, and Teamwork.
Safe Harbor Statement
This press release contains forward-looking statements that are
subject to risks and uncertainties that could cause actual results to
materially differ from those described. Although we believe that the
expectations expressed in these statements are reasonable, we cannot
promise that our expectations will turn out to be correct. Our actual
results could be materially different from and worse than our
expectations. With respect to such forward-looking statements, we seek
the protections afforded by the Private Securities Litigation Reform
Act of 1995. These risks include, without limitation:
We may not attain expected revenues and earnings. If we are
unsuccessful in obtaining or renewing third party payor contracts for
our products, we may experience reductions in sales levels and may
fail to reach anticipated sales levels. If demand for our products
exceeds our initial expectations or the ability of our suppliers to
provide demand-meeting quantities of product and samples, our future
ability to sell these products could be adversely impacted. The
potential growth rate for our promoted products may be limited by
slower growth for the class of drugs to which our promoted products
belong and unfavorable clinical studies about such class of drugs.
We may encounter problems in the manufacture or supply of our
products, for which we depend entirely on third parties. Strong
competition exists in the sale of our promoted products, which could
adversely affect expected growth of our promoted products' sales or
increase our costs to sell our promoted products. We may not be able
to protect our competitive position for our promoted products from
patent infringers. If generic competitors that compete with any of our
products are introduced, our revenues may be adversely affected.
Certain of our products have experienced manufacturing issues. If
the issues recur and cannot be resolved, our ability to acquire
product for sale and sampling will be adversely affected. We may incur
unexpected costs in integrating new products into our operations.
We may be unable to develop or market line extensions for our
products or, even if developed, obtain patent protection for our line
extensions; further, introductions by us of line extensions of our
existing products may require that we make unexpected changes in our
estimates for future product returns and reserves for obsolete
inventory. If these risks occur, our financial results could be
adversely affected.
If we have difficulties acquiring new products or rights to market
new products from third parties, our financial results could be
adversely impacted. Our licensor/supplier can terminate our rights to
commercialize Nitrolingual and the 60mg. dose size of this product has
not yet met our expectation. We may not experience the beneficial
results of our acquisitions that we expect to receive, and the
acquired products may not meet our sales expectations.
We depend on a small senior management group, the departure of any
member of which would likely adversely affect our business if a
suitable replacement member could not be retained.
An adverse interpretation or ruling by one of the taxing
jurisdictions in which we operate could adversely impact our operating
results. An adverse judgment in the securities class action litigation
in which we and certain current and former directors and executive
officers are defendants could have a material adverse effect on our
financial results and liquidity. Our business is subject to increasing
government price controls and other healthcare cost containment
measures. Side effects or marketing or manufacturing problems with our
products could result in product liability claims which could be
costly to defend and could result in the withdrawal or recall of
products from the market which would adversely affect our business. We
may be found noncompliant with applicable federal, state or
international laws, rules or regulations which could result in fines
and/or product recalls or otherwise cause us to expend significant
resources to correct such non-compliance.
A small number of customers account for a large portion of our
sales and the loss of one of them, or changes in their purchasing
patterns, could result in substantially reduced sales, substantially
and adversely impacting our financial results. If third-party payors
do not adequately reimburse patients for our products, doctors may not
prescribe them.
We rely on operational data obtained from IMS, an industry
accepted data source. IMS data may not accurately reflect actual
prescriptions (for instance, we believe IMS data does not capture all
product prescriptions from some non-retail channels).
Our business and products are highly regulated; the regulatory
status of some of our products makes these products subject to
increased competition and other risks; and we run the risk that we, or
third parties on whom we rely, could violate the governing
regulations.
Some unforeseen difficulties may occur.
The above are some of the principal factors that could cause
actual results to differ materially from those described in the
forward-looking statements included above. These factors are not
intended to represent a complete list of all risks and uncertainties
inherent in our business, and should be read in conjunction with the
more detailed cautionary statements and risk factors included in our
other filings with the Securities and Exchange Commission.
SOURCE: Sciele Pharma, Inc.
Sciele Pharma, Inc.
Joseph T. Schepers, 678-341-1401
Director of Investor Relations
ir@sciele.com