Perrigo Bentley To Develop Generics

November 10, 2004
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ALLEGAN — Perrigo Co. has entered into a product development, licensing and manufacturing agreement with Bentley Pharmaceuticals Inc. of Exeter, N.H., to co-develop, market and sell generic prescription drugs in the U.S. market.

Under the agreement, Bentley will manufacture selected pharmaceutical products in its "active pharmaceutical ingredients" (API) manufacturing facility and finished products in its Laboratorios Belmac subsidiary in Madrid. Perrigo will be responsible for submitting Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration for approval.

Perrigo, the largest U.S. manufacturer of over-the-counter (OTC) pharmaceuticals for the store brand and contract manufacturing markets, and Bentley already have their eyes on a couple of generic prescription drugs that either are no longer under U.S. patent protection or have soon-to-expire patents, said Ernest Schenk, Perrigo's manager of investor relations. He said the companies could not disclose the identity of the drugs for competitive reasons.

Co-development of those drugs will be the first order of business under the agreement, Schenk said.

"The development process entails a regulatory filing and we will work that part," he said. "The physical development of the process to make a product — the formulation and manufacturing side — is what Bentley will do. This is a process that from the time you start until the time you have a commercial product approved and ready typically takes anywhere between 18 and 30 months."

Bentley is described as a specialty pharmaceutical company "focused on advanced drug delivery technologies," which refer to drug delivery systems such as transdermal patches, drug-coated stents, implantable drug delivery products, injections and the more traditional pill and liquid forms of drugs.

Bentley has a growing branded and generic product line of pharmaceuticals in Europe that treat cardiovascular, gastrointestinal, neurological and infectious diseases. Bentley ranked 38th on Fortune magazine's 2004 roster of the 100 fastest growing companies in the United States.

Schenk said Bentley was an especially attractive partner for Perrigo because of its drug development, manufacturing and formulation expertise.

"Another aspect of the collaboration is that Bentley does not sell very much in the U.S.," Schenk pointed out. "We will handle the sales and marketing and logistics so it will expand their presence here."

Mark Olesnavage, executive vice president and general manager of Perrigo Pharmaceuticals, said Bentley's API manufacturing will provide Perrigo with a competitive cost position and bring Perrigo "significant drugs" for the generic prescription market.

"We believe these drugs could also provide a strong position in the future for Perrigo's OTC business as well," he commented.

Perrigo announced late last year its intention to enter the generic prescription market. The company committed $5 million to $7 million to additional research and development this year for the internal development of generic drugs and continues to invest money in that effort, Schenk said. Perrigo also has an R&D company under contract for the development of 10 to 12 generic prescription drugs over this year and next.

In early October, Perrigo received FDA approval to market prescription ibuprofen oral suspension, representing the company's first generic prescription drug approval. The product was developed internally, and Perrigo will begin shipping it in the first half of 2005.

Perrigo's objective, President and CEO David Gibbons has said, is to build a product line and future pipeline of generic prescription products as soon as possible, while continuing to build Perrigo's core OTC drug business.

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