Shire Adds Patients, Capacity for Replagal, Vpriv

Shire Plc (SHP) is adding patients for the Replagal and Vpriv treatments for rare disorders and increasing manufacturing capacity as larger drug companies seek to expand into the market for so-called orphan diseases.

Construction on a second manufacturing plant in Lexington, Massachusetts, has been completed, said Sylvie Gregoire, head of human genetics at Shire, which is based in Dublin with headquarters in Basingstoke, England. The company is seeking approval to make Replagal at the plant this year and Vpriv in 2012, Gregoire said.

“We’ve added patients in the last month and to the end of the year,” Gregoire said in a Jan. 7 phone interview. “I don’t see sales peaking anytime soon. New products will come onto the market that are now in development so we can see a steady growth in this area.”

A rare, or orphan disease, affects fewer than 200,000 people, according to the National Organization for Rare Disorders. More than 30 million Americans have one of 6,000 orphan diseases, the group said on its website. Pfizer Inc. (PFE), GlaxoSmithKline Plc (GSK) and Sanofi-Aventis SA (SAN) are moving into the rare-disease market to replace revenue lost to copies of their top-selling medicines. Shire is also seeking to acquire new products, Gregoire said.

“We’re always on the lookout,” she said. “In the rare disease space often the products and the new technology comes from very small companies.”

Amicus Deal

Glaxo, based in London, agreed Oct. 29 to pay Amicus Therapeutics Inc. (FOLD) $30 million upfront and took a $31 million stake in the Cranbury, New Jersey-based company to license the rights to Amigal, a novel treatment for Fabry’s disease. Patients with the inherited disorder have low levels of certain enzymes needed to break down fatty substances that can build up in the body’s organs. Shire’s Replagal is approved for Fabry’s disease.

“2011 is going to be a very, very exciting year in the rare diseases as we see companies like GSK and others continue to expand their portfolio,” John Crowley, chief executive officer of Amicus, said in an interview last month. “You’ll see new players come in, you’ll see acquisitions, you’ll see mergers, you’ll see global partnerships, U.S. partnerships.”

The new plant where Replagal and Vpriv, a treatment for Gaucher disease, will be made is in the process of making demonstration batches for regulatory approval, Gregoire said.

About 2,300 patients take Replagal and about 1,000 use Vpriv, Shire said Oct. 29. The company reports full-year earnings on Feb. 10.

Share Performance

Shire shares have risen 33 percent in the last year before today, compared with an 8.3 percent increase in the Bloomberg Europe Pharmaceutical Index of which it is a member. The stock fell 6 pence to 1,640 pence in London trading.

“At this level, the valuation is pretty undemanding given the amount of long-term growth on offer,” MF Global U.K. Ltd’s London-based Justin Smith, the most accurate analyst of Shire’s performance according to data compiled by Bloomberg, said in a phone interview. “Most of their orphan drug products are on the market, have been approved and are now growing. Because they are proteins, they are probably very difficult to copy and their patents expire in 10 years’ time.”

Replagal sales rose 91 percent in the third quarter, because of delays in the manufacturing of Cambridge, Massachusetts-based Genzyme Corp.’s competing Fabrazyme therapy.

Replagal Sales

Fabrazyme production may return to previous levels in the middle of the year, and “then the normal market dynamics will come back,” Gregoire said.

Sanofi, France’s biggest drugmaker, is seeking to buy Genzyme to help replace revenue it will lose as some of its biggest-selling products, such as the blood thinner Plavix, face competition from generic versions. The Paris-based company took its $18.5 billion bid for Genzyme hostile on Oct. 4. The companies this week said that talks are progressing.

Pfizer, the world’s biggest drugmaker, in September bought closely held FoldRx Pharmaceuticals Inc., which develops treatments for conditions caused by the improper folding of proteins.

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