Bristol-Myers Squibb's rheumatoid arthritis therapy abatacept will likely launch in the U.S. with limited supply until a manufacturing facility from third-party contractor Lonza is approved in 2006.

Bristol completed the rolling BLA for abatacept at the end of March, and has requested a priority review. Assuming a six-month review clock at FDA, the biologic could be approved by the end of September.

While initial supply will be manufactured out of Bristol's Syracuse, N.Y. facility, the approval of third-party manufacturer Lonza is necessary to meet full market demand, the company said. Bristol plans to file an sBLA for the Lonza facility by early 2006.

Under that timeline and assuming no delays with the Lonza application, Bristol's Syracuse facility would be the only manufacturing plant for abatacept for nearly a year, until the Lonza site comes online in mid-2006.

Should abatacept be approved by FDA after a 10-month standard review, however, Lonza could be cleared by FDA about six months after the abatacept BLA user fee action date.

Bristol CEO Peter Dolan outlined that timeline during a first quarter earnings call with analysts April 28.

"We expect to file the sBLA for the approval of Lonza manufacturing during the fourth quarter 2005 or the early part of first quarter 2006," he said.

"We plan to generate initial supply from our Syracuse facility. However, we need Lonza in order to support a broad product launch and what we believe would be full market demand."

Dolan's comments reiterate earlier statements on the supply issues. During Bristol's R&D day in November, the exec said he expects Syracuse to meet initial launch demand, but acknowledged the need for a timely Lonza approval (¹ Also see "Abatacept Launch Will Be Bolstered By Unmet Need In RA Market – Bristol" - Pink Sheet, 17 November, 2004.).

The expected supply constraints with abatacept evoke memories of similar experiences with another rheumatoid arthritis therapy: Amgen/Wyeth's Enbrel (etanercept). Enbrel was under supply constraints for two years before another facility opened.

Bristol is preparing for an expected FDA advisory committee review of abatacept. The first-in-class selective T-cell co-stimulation modulator would be an alternative to TNF inhibitors (Enbrel, Abbott's Humira and Johnson & Johnson's Remicade ).

The company is also planning for an expected advisory committee review of muraglitazar, a dual peroxisome proliferator activated receptor agonist (² Also see "Bristol Expects FDA Advisory Committee Review Of Muraglitazar" - Pink Sheet, 17 November, 2004.). The NDA was submitted in December.

In general, Bristol predicts that the recent drug safety issues at FDA will result in the agency taking a harder look at new drugs and convening more advisory committees prior to approval.

"Both with abatacept and muraglitazar, and potentially for more and more compounds in front of the agency, we can expect a robust discussion about benefit-risk of any new agent," Chief Scientific Officer Elliott Sigal told investors.

"It would not be surprising to have advisory committees perhaps even more routinely than before," he said. Dolan made a similar prediction during a Morgan Stanley conference in January (³ Also see "Drug Safety Issues Will Raise Regulatory Expectations, Bristol Says" - Pink Sheet, 5 January, 2005.).

- Kate Rawson

Bristol's Abatacept Launch Supply Limited Until FDA Clears Contract Facility

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