FDA Approves Benzyl Alcohol Lotion 5%

Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment

ATLANTA--(BUSINESS WIRE)--Apr 13, 2009 - Sciele Pharma, Inc., a Shionogi Company, today announced that the U.S. Food & Drug Administration (FDA) has approved Ulesfia (benzyl alcohol lotion 5%), the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects. Sciele acquired from Summers Laboratories the rights to this novel, patented product in the United States, Canada and Mexico. The Company expects to launch the product in the third quarter of 2009, in time for peak head lice season.

"We are excited to introduce this novel product to the prescription head lice treatment market. This product will meet the unmet need for an effective treatment that does not contain a neurotoxic chemical and addresses possible resistance issues," said Ed Schutter, President and Chief Operating Officer of Sciele Pharma. "The approval of this new head lice product marks an important milestone for Sciele's pediatric portfolio."

Each year, approximately 6 to 12 million children between the ages of 3 and 12 years are infested with head lice, parasites that survive by injecting small amounts of saliva and removing small amounts of blood from the scalp every few hours(1). To survive, lice breathe through sophisticated spiracles that close upon contact with most liquids, allowing the lice to go into suspended animation and survive for hours without respiration. The mechanism of action of Sciele's product is facilitated through the use of benzyl alcohol which prevents lice from closing their spiracles, thereby asphyxiating them within ten minutes and causing death.

"Head lice are an all-too-common and challenging medical problem that causes anxiety in families, schools and summer camps," said Ira A. Pion, MD, Clinical Assistant Professor, Department of Dermatology, New York University Medical Center. "Sciele's new product should be welcomed by health professionals and parents as a safe and effective treatment option that treats children with head lice without the use of harsh chemicals and addresses concerns about the increased resistance of lice to therapies that contain neurotoxic chemicals."

Sciele is working with professional organizations, such as the National Association of School Nurses, to educate health professionals and the public about head lice. The Company has assembled a national advisory board of leading head lice experts from various medical specialties (pediatrics, dermatology, family practice and clinical research) to provide guidance on these efforts. Full prescribing information is available at www.sciele.com.

About Head Lice

Generally found on the scalp, around the ears and at the nape of the neck, the adult louse is about the size of a sesame seed and can be a yellowish-gray or reddish-brown color(2). Eggs, or nits, are smaller and are silver in color(3). The most common symptom of head lice is head scratching caused by sensitivity to the louse's saliva(1), although red bite marks may also be noticed(2). While lice are not considered an infectious disease, transmission from one individual to another can occur during direct contact or through the sharing of personal items such as hats, helmets, brushes or combs(1). Lice are not a sign of poor hygiene, and they do not transmit disease.

About Sciele Pharma, Inc.

Sciele Pharma, Inc., a Shionogi Company, is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of 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 employs more than 1,000 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.

On October 9, 2008, Shionogi & Co., Ltd. and Sciele Pharma announced the completion of Shionogi's acquisition of Sciele. Sciele is now an indirect wholly owned subsidiary of Shionogi.

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd. is a major research-driven Japanese pharmaceutical manufacturer. The company's primary businesses are research and development, manufacturing, marketing, and import and export sales of pharmaceuticals and diagnostics. Shionogi follows a basic policy of continually providing the superior medicines essential to people's health. For more details, please visit www.shionogi.co.jp.

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.

(1) Frankowski, B.L., Weiner, L.B, the Committee on School Health, the Committee on Infectious Disease (September 2002). American
Academy of Pediatrics Clinical Report: Guidance for the Clinician in Rendering Pediatric Care: Head Lice. Pediatrics, 110 (3).
(2) Head Lice Control. Beyond Pesticides/NCAMP fact sheet.
(3) Hansen, R.C (September 2004). Overview: The State of Head Lice Management and Control. Am J Manag Care, 10, S250-S263.

Contact: Sciele Pharma, Inc.
Joseph T. Schepers, 678-341-1401
ir@sciele.com

Posted: April 2009

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Ulesfia (benzyl alcohol) FDA Approval History

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