Sciele Pharma, Inc. ("Sciele" or "the Company") recently announced that it has acquired from Verus Pharmaceuticals, Inc. ("Verus") the Twinject 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 $29M. 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 $200M in 2007, according to IMS Health 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 $7M to $15M to $447M -$470M, 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.
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.
SOURCE: Sciele Pharma, Inc.