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R&D Firm Galephar To Add Manufacturing

Experience has led the company’s management to see licensing and production as necessary components for R&D to survive


March 7, 2002
Copyright © 2002 CARIBBEAN BUSINESS. All Rights Reserved.

While many pharmaceutical companies are considering adding research & development (R&D) to their manufacturing capabilities, Galephar P.R. Inc., Puerto Rico’s only registered company dealing strictly in manufacturing-related R&D, is readying to add a manufacturing component this year.

Galephar Vice President and General Manager Arthur Deboeck, a fervent researcher, did not make this decision lightly. Since 1986, Deboeck has proven himself to be a successful drug developer, having already sold Tiazac, a generic version of Cardizem CD to Canada’s Biovail and licensed five drugs to Cipher Pharmaceuticals.

"Galephar has two new solutions (out of at least eight products in its pipeline) that have very good characteristics and Cipher Pharmaceuticals is willing to license them. So approximately a year from now we will also be involved in the production process. But we will not become a manufacturer—simply add manufacturing to R&D. There really is no choice," said Deboeck.

According to Deboeck, the decision to go into manufacturing is a necessary—albeit costly—choice. As he found out when he sold his product and facility in Carolina to Biovail in 1996, without licensing or production revenue there can be no R&D. By manufacturing his own product, Galephar can develop the manpower needed to keep R&D going.

Galephar’s latest product was licensed by Cipher last year. The patent is a dry powder inhaler formulation of Budesonide, a treatment for asthma and other pulmonary diseases. Previous patents sold to Cipher include fenofibrate, which helps lower cholesterol and trigliceride levels, and Isotretinoin capsules for severe acne.

Tramadol, a once a day treatment of moderate to chronic pain syndromes, will also be developed by Cipher. In mid-February, the company was expected to begin clinical trials at the University of Puerto Rico’s School of Dentistry. Rarely held on the island, the tests are needed to comply with U.S. Food and Drug Administration certification.

Deboeck, a Belgian chemical engineer, first came to Puerto Rico in 1986. As an R&D professional, he wanted to take advantage of the island’s high concentration of pharmaceutical manufacturing companies.

After selling to Biovail in 1996, Deboeck established his current R&D facility in Juncos. Since 1999, he has invested approximately $4 million in equipment and specialized developing new formulations of FDA approved drugs.

"Last year we added 20 employees and our total workforce now is 35, 50% of them technical staff. Galephar needs to continue developing products and getting licensing agreements, which is what brings us money to continue," said Deboeck.

According to Deboeck, it can take five to 10 years to develop a new formulation of an older drug, at a cost of $5 million to $15 million until it is licensed to a manufacturing company. Approximately the same amount may be spent from licensing to FDA product approval. New product development through manufacturing can cost up to $500 million.

"As an R&D company that produces its applications, we wait until the last possible moment to solicit a patent to extend the marketing time for the product. But we risk another company coming up with a similar formula," said Deboeck.

Canadian Medical Laboratories Ltd., Cipher’s parent company, expects to invest more than $19 million of a planned three-year $30 million budget in drug development during fiscal year 2002, which ends Sept. 20. This includes R&D, clinical trials, and licensing agreements.

"Cipher’s interest in Galephar is to expand its drug development division," said Cipher President Dr. Ian French. "The first four products that were licensed for that division came from Galephar. We now have an agreement by which the R&D company develops the drug’s technology and files the patents and Cipher funds the clinical development of the products for the Americas."

This Caribbean Business article appears courtesy of Casiano Communications.
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