Biogen Idec, Eisai to partner in RTP

Dec. 12, 2012 @ 07:40 PM

Biogen Idec will be using Research Triangle Park facilities of Eisai Inc., the U.S. pharmaceutical business of a Japanese company, to make oral, solid dose products such as tablets through a partnership announced Wednesday.

Eisai, which lost U.S. patent protection in November 2010 for the Alzheimer’s tablet Aricept, has seen a decline in utilization of its oral solid dose manufacturing facility in the park, a company official said. The company has shifted its therapeutic focus in the U.S. to oncology and other products.

Massachusetts-based Biogen Idec, which has biologic products manufacturing operations in the Research Triangle Park, also has oral products in its development pipeline. A 10-year agreement announced Tuesday will allow Biogen Idec to lease a portion of Eisai’s facility for manufacturing oral solid dose products for both companies.

In addition, Eisai will provide Biogen with packaging and vial-filling services for biologic therapies. About 50 Eisai workers are expected to become Biogen Idec employees early next year.

Biogen Idec has more than 1,000 employees in the park, while Eisai employs about 225 full-time workers at its park location, according to a news release.

“Our alliance will enable both companies to focus on respective areas of expertise while continuing to deliver high-quality and innovative products to patients,” said Lou Arp, general manager of the Eisai RTP site, and president of global oncology manufacturing for Eisai Inc., in a statement.

Eisai’s business activities in the United States were centered around Aricept and AcipHex, a tablet for treatment of acid reflux symptoms, according to the company’s annual report for the fiscal year that ended March, 31, 2012.

Arp said the company has seen decreased manufacturing for oral tablets after it lost patent protection for Aricept.

The company cut its Research Triangle Park workforce last year by about 70 workers. Suzanne Grogan, a spokeswoman for Eisai Inc., said in an email message that that was part of a restructuring that marked the beginning of a new, global five-year strategic plan for the company.

She said the plan took the patent expiration of Aricept into account, as well as the future expiration of the U.S. patent for AcipHex, which she said remains on patent through Nov. 8 of next year.

“We had two blockbuster drugs that we produced, and had full utilization of the facility for years,” Arp said. “That has declined on the oral solid dose side – that’s where we began having discussions with Biogen.”

Eisai has shifted its U.S. therapeutic focus to treatment of cancers primary affecting women, according to the annual report, and has also looked to expand its pipeline in treatments of central nervous system disorders, including epilepsy.

Arp said the company’s employment base has been stable to incrementally growing since the reduction was made last year.

“We’re making investments in our parenteral business, and we’ve transferred some global functions, such as partnership management, global logistics, and so forth,” Arp said. Parenteral medications are medications that are not taken orally.

The partnership with Biogen Idec allows Eisai to focus on its parenteral business, Arp said. In terms of Eisai’s vial-filling services, Eisai will be making products for Eisai as well as for Biogen, which has oral drugs in its development pipeline.

“Eisai will continue to make investments in the vial-filling service because that’s where our pipeline has products for the future,” Arp said. “Our pipeline has a number of products, but if you characterize them, they’re more oncology-type products for ovarian cancer, thyroid cancer, lung cancer, and melanoma. These are injectable drugs.”

In addition, Biogen will continue to make its oral solid drugs for Eisai, and will also look to bring in some of its own pipeline candidates.

Machelle Sanders, vice president of manufacturing and the general manager at Biogen Idec’s Research Triangle Park campus, said the company has two candidates in the later stages that are both oral candidates.

The company makes bulk drug substance for Avonex and Tysabri in the RTP – both of which hare biologic therapies, which are made from living cells, rather than through chemical synthesis, said Mike McBrierty, a spokesman for Biogen Idec. In comparison, tablets are made through chemical synthesis.

“We have biologics … in our pipeline, and we do have a growing number of small-molecule or oral solid doses products in our pipeline (in) the later stages,” she said.