Bristol-Myers Squibb could be in a position to launch ipilimumab for the treatment of second-line metastatic melanoma early next year if the recently submitted drug is granted a priority review by regulators.

The company announced during a second quarter earnings call July 22 that it submitted regulatory filings for ipilimumab with both the U.S. FDA and European Medicines Agency at the end of June.

Approval of the cytotoxic T lymphocyte antigen-4 inhibitor seems likely based on a Phase III trial showing it offered a survival benefit to metastatic melanoma patients, though not without some immune-related adverse events. The data's June release at the American Society of Clinical Oncology attracted headlines since ipilimumab is the first drug to demonstrate a survival benefit in this patient population, which currently has few treatment options (Also see "Ipilimumab Boosts Survival, But With Adverse Events That Need Strict Oversight" - Pink Sheet, 6 June, 2010.).

Bristol also said it plans to initiate a Phase III trial studying ipilimumab in patients with non-small cell lung cancer later this year based on positive Phase II results. The drug is also in Phase III trials for adjuvant metastatic melanoma and prostate cancer.

Like other oncology drug manufacturers, Bristol will need to wrestle with pricing strategy for a drug that might eventually be used across multiple indications.

The company will have to take future potential indications account when setting the initial price for ipilimumab in metastatic melanoma. The potential NSCLC indication, for example, could turn out to be more costly based on its more frequent dosing schedule. Ipilimumab was dosed in the Phase II NSCLC study at 10 mg/kg every three weeks for initiation and then 10 mg/kg every three months in a maintenance schedule. In the metastatic melanoma study, ipilimumab was dosed at 3 mg/kg every three weeks for four doses with no maintenance dosing.

Management declined to comment on ipilimumab pricing but did note that the issue is a challenging one, especially because there is no existing comparator in the market for metastatic melanoma. "This is a really different situation from what we experienced in the past with our other oncology products because of the emerging profile," CEO Lamberto Andreotti said. "We don't want to exclude any possible new approaches to pricing."

The ipilimumab filing serves as a one-year anniversary present for Bristol's acquisition of Medarex. The acquisition, announced July 22, 2009, evolved from a multi-year collaboration by the two firms centered on ipilimumab development (Also see "In Obtaining Strong Price From BMS, Medarex Also Ameliorates Significant Pipeline Pressure" - Pink Sheet, 29 July, 2009.).

Bristol also reported second quarter sales of $4.8 billion, up 2 percent compared to the year ago period, including a 1.5 percent negative impact from U.S. health care reform. Net income was $927 million, down 6 percent versus $983 million a year ago, reflecting the spin-off of its Mead-Johnson Nutritionals business. That spin-out, announced last November improved earnings-per-share however by reducing the number of Bristol's shares outstanding (Also see "Bristol Flying Solo As A Pure Biopharma After Mead Johnson Spin Out" - Pink Sheet, 16 November, 2009.).

-Jessica Merrill (j.merrill@elsevier.com)

BMS Files Ipilimumab With FDA And EMA, Positioning It For Launch Next Year

More from Archive

More from Pink Sheet