ATLANTA--(BUSINESS WIRE)--March 13, 2008--Sciele Pharma, Inc.
(NASDAQ:SCRX) ("Sciele" or "the Company") today announced that it has
acquired from Verus Pharmaceuticals, Inc. ("Verus") the Twinject(R)
epinephrine auto-injector (epinephrine injection, USP 1:1000) for the
treatment of severe allergic reactions and anaphylaxis. Under the
agreement, Sciele acquired Twinject and certain other related Verus
products under development for $29 million. Verus may also receive
additional payments resulting from the achievement of certain
development milestones. Sales in the auto-injectable epinephrine
market have increased by 17% per year over the past five years and
totaled approximately $200 million in 2007, according to IMS Health(R)
NPA data.
Anaphylaxis is a sudden, severe, and potentially life-threatening
allergic reaction triggered by exposure to one or more allergens,
including foods, insect stings, drugs, and latex products. Up to 43
million people in the U.S. alone are at risk for anaphylactic
episodes, and underlying incidence rates of food-based allergies are
increasing. Up to eight percent of children have food allergies, and
sensitivities to peanuts and tree nuts among children have doubled in
the past five years.
Twinject is available in 0.3 and 0.15 milligram dosage strengths
and is indicated in the emergency treatment of severe allergic
reaction including anaphylaxis to stinging and biting insects,
allergen immunotherapy, foods, drugs, diagnostic testing substances,
and other allergens, as well as anaphylaxis to unknown substance or
exercise-induced anaphylaxis. Twinject is the only available product
approved by the FDA that contains two doses of epinephrine in a
single, compact device. This is an important feature, as one out of
three reactions may require more than one dose of epinephrine, with
the second dose often needed within 10 minutes after the first dose.
Commenting on the announcement, Patrick Fourteau, Chief Executive
Officer of Sciele Pharma, Inc., said, "The agreement with Verus allows
us to further diversify our product portfolio by adding another new
launch to our growing pediatric line. Sciele continues its business
development strategy to leverage our sales force, enhance our product
portfolio, and provide additional revenue and earnings growth."
"At Verus, we have been committed to providing innovative
solutions for anaphylaxis patients and their caregivers," added Robert
W. Keith, President and Chief Executive Officer of Verus. "We are very
pleased to complete this transaction with Sciele, a company with
significant sales and marketing capabilities, which should help
broaden and strengthen Twinject's market reach for the treatment of
patients at risk for this life-threatening condition."
As a result of this acquisition and the previously announced
agreement with sanofi-aventis to market Allegra ODT, Sciele is
increasing its revenue and earnings guidance for 2008. Revenues are
now expected to increase between $7 million to $15 million to $447
million-$470 million, and earnings per share are expected to increase
between $0.02 to $0.04 to $1.99-$2.11 per share. This guidance
for 2008 assumes an R&D expenditure rate of approximately 8% of
revenues and does not include any unapproved products or any potential
additional restructuring charges related to the new Sular conversion.
More information about anaphylaxis and Twinject is available at
www.twinject.com. Verus Pharmaceuticals(R) is a registered trademark
of Verus Pharmaceuticals, Inc.
About Verus Pharmaceuticals
Verus Pharmaceuticals is dedicated to improving the lives of
children and those who care for them. Verus is building a portfolio of
products for the unmet medical needs of children through acquisitions
and alliances, with an initial focus on the treatment of asthma,
allergies, and related diseases and conditions. Verus is
differentiated by its pediatric orientation and its strong financial
position and experienced management team, which allows the company to
capitalize on an extensive network to build its product portfolio and
pursue complementary transactions. The company's rigorous, disciplined
approach to strategic decision-making and core competencies in
development and commercialization is expected to provide significant
value to its partners. More information about Verus is available on
the company's corporate website at www.veruspharm.com.
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.
Important Safety Information
Twinject is designed as an emergency supportive therapy only and
is not a replacement or substitute for immediate medical care.
Side effects of Twinject may include anxiety, apprehensiveness,
restlessness, weakness, tremor, dizziness, headache, sweating,
irregular heartbeat, nausea, vomiting, and/or breathing difficulty.
Twinject should be used with extreme caution in people who have heart
disease. There are no absolute contraindications to the use of
epinephrine in a life threatening allergic reaction.
Epinephrine auto-injectors have fixed amounts of epinephrine. If
the patient weighs less than 33 pounds (15 kilograms), please consult
a physician.
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.
An adverse judgment in the pending patent litigation or in the
securities class action litigation in which we and certain and former
directors and executive officers are defendants could have a material
adverse effect on our results of operations and liquidity.
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
Director of Investor Relations
ir@sciele.com
SOURCE: Sciele Pharma, Inc.
