Bristol-Myers Squibb: arthritis antibody bolsters pipeline but competition will limit impact

ALD518, a humanized monoclonal antibody (mAb) against interleukin (IL)-6, is currently in Phase II for both rheumatoid arthritis and cancer. Bristol-Myers Squibb (BMS) has in-licensed the candidate from Alder Pharmaceuticals despite the recent acquisition of Medarex, which Datamonitor believes went some way to reinvigorating the company's immunology pipeline. Although Datamonitor is unaware of any publically released in-depth efficacy or safety data for ALD518, Alder Pharmaceuticals says that it has completed Phase IIa trials involving three intravenous doses in methotrexate-inadequate responder patients.

The licensing agreement is a great deal for Alder. The company is entitled to an $85m upfront cash payment, while further payments of $764m for regulatory and development milestones and $200m for sales-based milestones will be payable by BMS. Alder will retain its rights to develop the drug in cancer indications, while BMS has full rights to ALD518 in all other indications.

BMS' experience will be an advantage for ALD518. Prior to this global agreement, the company's late-stage pipeline was uninspired. It is developing BMS-582949, a small molecule p38 MAPKinase inhibitor, although Datamonitor sees no potential for drugs with this mechanism. Indeed, the likely introduction of a subcutaneous formulation of Orencia in 2011 will have the only real near-term impact for BMS in rheumatoid arthritis.

As demonstrated by Actemra (tocilizumab; Chugai/Roche), targeting the IL-6 pathway is a validated and viable approach for treating rheumatoid arthritis, and this bodes well for ALD518. Moreover, a subcutaneous formulation of the drug is currently in the pipeline, and this will be essential if it is to have a competitive edge over Actemra.

However, ALD518 will reach the market up to five years after Roche/Chugai's offering, and will experience competition from other Phase II IL-6 mAbs like Centocor Ortho Biotech's subcutaneous-delivered CNTO136. Furthermore, given that BMS already markets T cell co-stimulation inhibitor Orencia (abatacept), there may be a conflict of interest as ALD518 will compete in the same rheumatoid arthritis patient pool.

With the small patient population eligible for biologics and significant competition in this market segment, Datamonitor believes that ALD518 is unlikely to make a major impact. That said, given Actemra's slow move to expand into other rheumatic disease indications, ALD518 may face similar opportunities in immunology areas other than rheumatoid arthritis.

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