PRINCETON, New Jersey & BOTHELL, Washington—Roche's Actemra (tocilizumab) interleukin-6 (IL-6) blocker is not yet approved for the US market but may already have a serious competitor.

ALD518 has similar activity but is produced by yeast, a process believed to be much less expensive than the conventional Chinese hamster ovary cultures used to make Actemra and many other biologicals.

ALD518 hit the big time this week when maker Alder Biopharmaceuticals, Inc, inked a major marketing deal for the monoclonal with Bristol-Myers Squibb (BMS) Company. The agreement gives Bristol global rights for the development and commercialization of ALD518 for rheumatoid arthritis (RA) treatment. The drug was initially developed for cancer treatment, and Alder retains those rights. ALD518 recently completed a Phase IIa trial in RA.

Alder gets an upfront cash payment of $85 million, potential development-based and regulatory-based milestone payments of up to $764 million across a range of indications, potential sales-based milestones that might exceed $200 million, and royalties on net sales.

“With its novel mechanism of action, ALD518 has the potential to offer an exciting new option for patients with rheumatoid arthritis,” said Brian Daniels, MD, senior vice president, Global Development & Medical Affairs, Bristol-Myers Squibb. “We are pleased to have the opportunity to develop this novel monoclonal antibody. As part of our String of Pearls strategy, this transaction provides Bristol-Myers Squibb with the opportunity to strengthen our immunoscience pipeline, and leverage our company’s experience in developing and delivering novel biologics to help patients prevail over rheumatoid arthritis and, potentially, other autoimmune diseases.”

The “novel mechanism of action” claim is accurate mainly because Actemra is not yet on the US market.

If Phase III trials are successful, ALD518 would make a nice addition for BMS, which already sells Orencia (abatacept). Orencia is approved for use in the US for the treatment of RA in the case of inadequate response to anti-TNFα therapy.

According to Randall Schatzman, president and chief executive officer of Alder Biopharmaceuticals, ALD518 has a longer half-life than Actemra and can be injected less frequently, possibly 3-4 times/year rather than monthly. ALD518 can be given intravenously or as a subcutaneous injection, while Actemra is IV only. ALD518 also can be given in much smaller doses than Actemra, and is cheaper to manufacture.

ALD518 might also have safety advantages, since it is designed to remove a carbohydrate chain that has been blamed for causing rare, but potentially dangerous infusion reactions.