ATLANTA--(BUSINESS WIRE)--July 16, 2007--Sciele Pharma, Inc.
(NASDAQ:SCRX) today announced that it has acquired an innovative head
lice asphyxiation product developed by Summers Laboratories, Inc. for
the United States, Canada and Mexico. Under the terms of the
agreement, Summers will receive an upfront payment, deferred payments
upon achievement of certain regulatory milestones including FDA
approval of the product and deferred payments based on meeting certain
sales targets.
Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said,
"This innovative and patented product for the treatment of head lice
is an excellent addition to and strategic fit for our new pediatric
product portfolio. Upon FDA approval, this product is expected to be
the first prescription medication that kills head lice by asphyxiation
instead of utilizing a neurotoxic pesticide."
Summers recently completed Phase III clinical studies and
submitted a New Drug Application (NDA) to the FDA in June 2007. The
prescription lice treatment market generated approximately $50 million
in sales last year (according to IMS Health's National Prescription
Audit Plus(TM) data), and the over-the-counter lice treatment market
is several times larger.
This product is an easy-to-use, water-based, water-soluble gel,
similar in consistency to a hair conditioner, which consists of a
mixture of dermatological and cosmetic ingredients. Lice need oxygen
to live and breathe through sophisticated spiracles. Lice can close
their spiracles and go into suspended animation for many hours. This
novel product contains a naturally occurring monohydric aralkyl
alcohol, which prevents lice from closing their spiracles, thereby
asphyxiating the lice within ten minutes.
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/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/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, Speed
of Execution, Simplicity, and Teamwork.
About Summers Laboratories, Inc.
Summers Laboratories is a privately held pharmaceutical company
specializing in highly targeted prescription and non-prescription
products for pediatric and adult dermatology. Summers' leading brand
is Triple Paste(R) Medicated Ointment for diaper rash. According to
IRI data, Triple Paste is one of the fastest growing diaper rash
treatments in the U.S. Triple Paste and other Summers Labs products
are carried nationwide by the largest drugstore chains: Target,
Wal-Mart and other major retailers. In addition to the lice
asphyxiating product recently acquired by Sciele Pharma, Summers
Laboratories is working on developing licensing or acquiring niche
prescription and non-prescription dermatological products.
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 including Prenate, Sular, Triglide, Nitrolingual, Altoprev
and Fortamet, 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 60 dose size of this product has
not yet met our expectation.
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.
CONTACT: Sciele Pharma, Inc.
Joseph T. Schepers, 678-341-1401
ir@sciele.com
SOURCE: Sciele Pharma, Inc.