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Schering-Plough Las Piedras Overcomes Regulatory Hurdles To Manufacture Zetia

Company’s product pipeline may bring two more medicinal drugs to Puerto Rico in 2003


April 17, 2003
Copyright © 2003 CARIBBEAN BUSINESS. All Rights Reserved.

A leader in the development of allergy and respiratory pharmaceutical products, Schering-Plough Products LLC (SP) Las Piedras can finally take a deep breath after two long years of regulatory problems.

In May 2002, SP signed a consent decree with the U.S. Food & Drug Administration (FDA) concerning its U.S. plants’ current good manufacturing practices. Since these practices involve a complex procedure, the company has submitted a work plan for its sites in Puerto Rico (Las Piedras and Manati) and New Jersey (Union and Kenilworth) to ensure that methods, facilities, and controls used to manufacture drugs at each site are continuously maintained and in FDA compliance.

But that isn’t what SP Las Piedras General Manager Frank Rodriguez wants people to talk about anymore.

"Over the past four years, SP has invested about $125 million in expansions, equipment, and facility upgrades and is now expanding nonproduction and support areas as a result of rapid growth," said Rodriguez. "Having added 300 new employees in the past three years, SP Las Piedras has 714 employees plus seasonal workers. The company’s additional 30,000 square feet will house a new cafeteria plus administrative offices, a records retention center, an infirmary, a new security system, and an additional 115 parking spaces."

Fast growth on the island

SP’s growth in Puerto Rico has been fast, said Rodriguez. "Our 318,000-square-foot plant is situated on 41 acres in Las Piedras. In 1984 Miami-based Key Pharmaceuticals [KP] built its pharmaceutical manufacturing plant here to produce Theo-Dur, an oral bronchodilator used to treat asthma, chronic bronchitis, and emphysema. When KP received regulatory FDA approval in 1986, SP bought the company and its products."

Theo-Dur continues to be manufactured in Puerto Rico, but only for Japan’s market. One of the best-selling drugs in Japan, Theo-Dur is provided in bulk and is packaged in Japan.

"In 1989, SP transferred K-Dur, a low-blood-potassium chloride supplement, to Puerto Rico," said Rodriguez. "Distributed worldwide from Las Piedras, it enjoyed double-digit growth until 2000, when it became a generic. K-Dur is now produced by Warrick Pharmaceuticals, an SP subsidiary that produces generics. The pharmaceutical drug still accounts for most of our plant’s labor production hours."

SP is one of a few global pharmaceutical companies hat have chosen to continue producing the generic equivalents of some of their drugs once they have lost their patents. "Because of sales volume and market share, the company thought it was significant enough to continue to support K-Dur’s production," said Rodriguez. "Generally, however, a company won’t continue producing a generic drug because its overhead costs remain the same and plants that produce generics have a lower cost structure."

Several drugs were transferred to SP Las Piedras’s manufacturing plant in the 1990s. The first was Normodyne, previously produced in New Jersey and used in the treatment of high blood pressure (the drug is now discontinued). In 1992, prostrate cancer treatment Eulexin was transferred to Puerto Rico.

Claritin’s golden era

In 1995 SP’s golden egg, in the form of allergy-treatment drug Claritin, was assigned to Las Piedras for production, packaging and worldwide distribution. Claritin became the company’s blockbuster and its best-selling prescription product.

In 2002, Claritin lost its patent and the SP chose to produce its over-the-counter (OTC) generic. Claritin has had competition from several pharmaceutical companies’ products that are determined to capture a share of the $4.8 billion U.S. allergy-relief market.

This significant market also includes SP’s Clarinex, a follow-up antihistamine brand to Claritin. With stiff competition from both generics and brand names, Clarinex’s advantages over the original Claritin have been hard to prove. Also affecting the market is U.S. health insurers’ decision to protect their bottom lines by setting high co-payments for prescription allergy drugs, charging as much as $50 for brand-name antihistamines.

"We have been making Clarinex since 2002, when Claritin became an OTC product," said Rodriguez. "Our production supplies the U.S. market and we anticipate reaching $800 million in sales for Clarinex in 2003. Claritin is currently being produced in New Jersey, but we have plans to bring it back to Puerto Rico."

Another important product that is manufactured by SP Las Piedras is Rebetol, part of the company’s Intron franchise, which includes Intron A and PEG-Intron. The combination of PEG-Intron with Rebetol has become standard care in treating Hepatitis C in the U.S. and is also the only approved therapy in Japan. SP Las Piedras is responsible for its worldwide distribution.

Zetia adds 40 new jobs

Most recently, SP Las Piedras was selected to produce Zetia, a new cholesterol-lowering treatment that can be used alone or with other cholesterol-lowering drugs called statins in patients whose cholesterol levels don’t reach desired goals.

"Cholesterol management is an $18 billion market today and is expected to reach $30 billion in 2007," said Rodriguez. "It is very important to us that the company has been selected for solid-dosage product manufacturing and for certain new compounds and existing marketed products. It takes a lot of work to manage the transfer of a product to a new site and to work around new technologies."

This year, 40 new jobs have already been created as a result of Zetia’s production in Las Piedras, which will benefit from the ongoing investment in the plant’s expansion and equipment. Sales of Zetia began in the U.S. and in several international markets in November 2002. By the end of that year, 100,000 prescriptions had been written in the U.S., accounting for $23 million in sales.

In April, SP announced it had struck a deal with Swiss drug maker Novartis AG to develop a new asthma drug that combines two different classes of medicines used in the treatment of that disease. SP’s Asmanex, a new asthma drug recently approved for sale, and Novartis’ Foradil Aerolizer, a beta agonist, will be combined into one inhaler to treat both asthma and chronic obstructive pulmonary disease.

Part of the company’s new product pipeline, Asmanex will be jointly developed and sold by SP & Novartis. Rodriguez already has his eye on the product for Puerto Rico and we could very well see its production here sometime this year.

This Caribbean Business article appears courtesy of Casiano Communications.
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