Alexion Pharmaceutical Hopes the Fourth Time is a Charm for Smithfield Site

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--The most recent incarnation of the former Dowpharma (NYSE:DOW) (Midland, Michigan) plant in Smithfield, Rhode Island, is now complete. Alexion Pharmaceuticals (Cheshire, Connecticut) has made a capital investment of $80 million into renovating the 60,000-square-foot plant for the production of its blood disorder drug, Soliris. The company is hoping it will fare better than the 15-year-old site's previous three owners, all of whom watched their ambitious plans turn to dust.

First opened in 1993, the plant's initial owner was Alpha Beta Technology. Following the failure of its lead drug candidate, the company sold the Smithfield site in 1999 and was ultimately dissolved in 2001. The new owners were the privately held Collaborative Group, who operated at the site until 2000 as the Collaborative BioAlliance, and Collaborative Smithfield Corporation. Upon the company's decision to focus on developing proprietary products rather than contract manufacturing, it was time for the Smithfield plant to change hands once again.

In 2000, Dow Chemical's biopharmaceutical division purchased both of the companies operating at the site in addition to the physical plant. The remainder of the Collaborative Group was subsequently purchased in 2004 by the Engelhard Corporation, which in turn was absorbed by BASF and thus, exists no more.

Dowpharma had its own ambitious intentions for the site, including a planned $100 million expansion (reference: Industrial Info's Pharmaceutical Tracker). The company was going to base its contract biomanufacturing division in Smithfield, offering mammalian cell culture capacity as well as contract process development. While it did invest an additional $8 million into the site, Dowpharma later reorganized and decided to change its focus to therapeutic proteins and peptides. In 2004, the company scrapped its expansion plans for Smithfield and the "For Sale" sign was back out front.

Connecticut-based Alexion (NASDAQ: ALXN) purchased the plant in 2005 and quickly set about revamping the facility. Improvements included the addition of two 10,000L bioreactors, the associated purification suites and a pilot plant.

Following validation of the site, the company will begin commercial production of Soliris. The drug received approval in March 2007 from the U.S. Food and Drug Administration (FDA), followed by the European Commission's (EC) approval in June, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). PNH destroys red blood cells and causes severe anemia, blood clots and damage to the kidneys and liver. It is a rare disease that only affects an estimated 8,000 to 10,000 people in North America and Europe. The treatment has a hefty price tag with an annual cost of $300,000.

Only time will tell whether Alexion will finally be the company to break the bad luck run of the Smithfield site. With only one product approved, another in Phase I trials and the rest in preclinical status, it will not be an easy journey. The company hopes the European market will help triple Solaris sales in 2008 to $215 million, up from the 2007 figure of $72 million. Plans are in the works to file for Japanese regulatory approval for Soliris within the next year. Even at $300,000 per year, with the rarity of the target illness, the company needs all of the patients it can get if it wants to keep the lights on in Smithfield.

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