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Norwich Pharmaceuticals Meets Manufacturing Challenges to Support Launch of Today® Sponge for Canada

February 14, 2003, Norwich, NY – Following a period of equipment acquisition, installation, process optimization and certification within the company’s cGMP-compliant facilities,  Norwich Pharmaceuticals has commenced commercial production of the Today® Sponge for distribution to the Canadian market by Allendale Pharmaceuticals. This is one of nine new projects which  Norwich currently has underway for a variety of its pharmaceutical customers.

 Norwich, a full-service contract manufacturer of prescription and over–the–counter pharmaceuticals, entered into an agreement to manufacture and package the Today® Sponge for Allendale Pharmaceuticals. Allendale owns all rights to the product and offers considerable marketing expertise, but has no captive manufacturing capabilities. In its search for a facility capable of making improvements to the existing manufacturing processes of the Sponge, the company turned to  Norwich.

Gene Detroyer, president of Allendale Pharmaceuticals, comments, “We were looking for a contract manufacturer who had a strong record of cGMP compliance, and process capability mastery who could, and would, meet our rigorous timetable, and who also had strong and consistent customer focus. We found this crucial combination in the Norwich operation.”

“The key to reaching this production milestone was superior technical collaboration between  Norwich and Allendale. Our multidisciplinary team designed a complete manufacturing and quality system for the Today® Sponge, and we are quite proud of the results,” adds Chris Calhoun, vice president of quality and regulatory affairs,  Norwich.

Dr. Robert Staab, chief scientific officer of Allendale, stated, “Part of the technical challenge met by  Norwich was to make the desired process-control improvements to reliably meet the expected quality standards of the product. This was critical to assure compliance with the export regulations that govern the Canadian distribution of this product.”

The Today® Sponge is constructed of soft polyurethane foam containing a locally-acting, non-systemic spermicide. The innovative manufacturing process involves both sponge creation and active ingredient introduction in a continuous-process production environment.

The Today® Sponge provides barrier protection for a 24-hour period allowing for sexual spontaneity, and is safe and convenient to use. The Today® Sponge was originally introduced in 1983 and later acquired by Wyeth in the late 1980s. Wyeth made a business decision to end production of the Sponge in 1995. While on the market the Today® Sponge was the most popular over-the-counter birth control method for women, and the market interest in the Sponge never ceased. With the reintroduction of the product to the Canadian market by Allendale, annual sales in the millions of units are expected.

 Norwich is a contract manufacturer and packager based in Norwich, NY, providing comprehensive support–from clinical trial manufacturing through scale-up to commercial launch–to the pharmaceutical industry. The company brings over 100 years of experience to the production, packaging and distribution of solid dose, semi-solid and liquid pharmaceuticals.

 

For more information, please contact:

Bob Calabro
VP, Sales & Marketing
 Norwich Pharmaceuticals
6826 State Highway 12
Norwich, NY 13815
Tel. 607-335-3209
Fax. 607-335-3100
E-mail. bob.calabro@norwichpharma.com

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For more product information, please contact:

Melissa Skabich
Williams Whittle Rothstein
525 West 36th St., Ste 5B
New York, NY 10018
Tel. 212-714-0300
E-mail. mskabich@wwafsp.com

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For more press information, please contact:

Darren Palmieri
Delia Associates
456 Route 22 West
Whitehouse, NJ 08888
Tel. 908-534-9044
Fax. 908-534-6856
E-mail. dpalmieri@delianet.com