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Amgen CEO Kevin Sharer confirms company’s commitment to Puerto Rico

Fifth biotechnology product to be manufactured locally could be osteoporosis treatment AMG 162


March 3, 2005
Copyright © 2005 CARIBBEAN BUSINESS. All Rights Reserved.

Amgen CEO Kevin Sharer’s recent visit to Puerto Rico served to confirm the company’s commitment to establishing a world-class center of excellence in biotechnology on the island.

"Our confidence in Puerto Rico is evident in our [$1.2 billion] plant investment, the number of staff we have, and the fact that every product we make goes through Puerto Rico before it reaches a patient," said Sharer. "The government has been responsive and we haven’t had any problems with permits or infrastructure, so we’re happy. What we are trying to work out now is expanding our relationship with educational organizations so they can develop more staff."

Sharer shared perspectives in innovation in the biotechnology industry during a special event organized by the Puerto Rico Manufacturers Association. According to Sharer, people, companies, industry, and national environment are the critical drivers of innovation.

"Innovation in biotechnology is delivering," said Sharer. "Although only 11%, or $18.6 billion, of Research & Development (R&D) spending in 2003 came from biotechnology, approximately 39% of all drugs approved by the U.S. Food & Drug Administration (FDA) came from the biotechnology sector. [This proves] R&D can’t be an afterthought and that a sustained view of R&D is required in our field. At Amgen, we have enormously talented people, with at least 1,500 PhDs and MDs. As CEO, I decided early on that the most important decision was who would be in charge of R&D and found the very best leadership team."

Sharer admitted the company doesn’t have plans to transfer bench science R&D, or what is known as discovery research, to Puerto Rico. "We do employ scientists and PhDs at our site in Juncos, so we have a very technically-based company and hire the highest level of education employees there. Still, R&D is not limited to bench science. It consists of four points.

"One is basic scientific research, such as biology. Another is the products’ biology. The next point includes plants that are R&D intensive. The biotech product is not just the molecule itself but also the process used to make the molecule. Finally, our quality organization is also an R&D operation. In Puerto Rico, this kind of R&D is in the factory’s quality area, in the clinical trials. We don’t have plans for a dramatically different R&D footprint but we touch on a lot of R&D here already," said Sharer.

If all goes well, in a couple of years Sharer said a new osteoporosis treatment still in registration trials with the FDA and called AMG 162 will be manufactured in Puerto Rico. According to Sharer, the story of how it came to be is relevant to the kind of innovative investigation that Amgen R&D scientists conduct every day.

"Our scientists were able to discover the biology of how bones, which are living tissues, are constantly being crushed and rebuilt," said Sharer. "We figured out that in a disease such as osteoporosis, which makes bones get quite thin, there were overactive molecules. We also found out what biological agents were involved in the process and how to intervene in that biological pathway. This antibody product candidate is AMG 162."

While this is an innovative approach, the process is far from over, according to Sharer. Amgen is now conducting the largest trial in the history of the company with more than 10,000 patients in 25 countries. The real challenge will be to collect all the data and come up with safe guidelines to create a new product.

"We still have to design the process and scale up the product, one part of being innovative," said Sharer. "We’ve got to be innovative in showing the people, the insurance companies, and the FDA that AMG 162 is safe, that it works, and that it gives a quality of life that wasn’t there previously. Innovation never, ever stops. This particular product could benefit millions and millions of people."

Amgen is continuing its expansion in Juncos, increasing its operation from 300,000 square feet to 1.1 billion square feet. By 2008, the company should have finished construction and validation of two bulk production plants, adding approximately 500 new jobs to its 1,000-employee formulation and fill-and-finish operation. From Juncos, Aranesp, Epogen, Neupogen, and Neulasta are exported worldwide. Amgen reported global sales in 2004 of more than $8 billion, a 23% increase over sales of $6.5 billion in 2003. Last year’s earnings for Amgen decreased 77% to $700 million compared to $3.1 billion in 2003, over sales of $10.6 billion, a 26% increase compared with $8.4 billion in 2003.

This Caribbean Business article appears courtesy of Casiano Communications.
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