Bristol-Myers' (BMY) Yervoy Label Expanded in Canada
Yervoy is one of the most promising drugs in Bristol-Myers Squibb’s (BMY) portfolio. The drug has performed very well since its approval in the U.S. in 2011 as a monotherapy for treating patients suffering from unresectable or metastatic melanoma. Metastatic melanoma is the most severe form of skin cancer.
Yervoy is now approved in more than 40 countries across the globe. Global sales of the skin-cancer drug climbed 38% year over year to $321 million in the second quarter of 2014.
Earlier in the week, Bristol-Myers received good news from Canada when the drug was cleared for a new indication in the country. Health Canada cleared Yervoy for treating adults newly diagnosed with advanced melanoma. The drug was initially cleared in the country in 2012, for treating patients who had failed or could not tolerate other systemic therapy.
Approval as a first-line therapy in Canada would boost the sales potential of the drug. Sales of Yervoy in international markets climbed 59% to $148 million in the second quarter of 2014. Increased demand and favorable foreign currency movements aided international sales. U.S. sales in the quarter were up 24% to $173 million.
In Jul 2014, Bristol-Myers inked a deal with Ono to jointly develop and commercialize Yervoy in Japan, South Korea and Taiwan. Apart from Yervoy, the deal with Ono also covers Bristol-Myers’ high potential immune-oncology treatment Opdivo (nivolumab). Opdivo was approved in Japan in early July 2014 for treating patients with unresectable melanoma.
In Jul 2014, the company announced that it intends to seek FDA approval for Opdivo for the advanced melanoma indication in previously treated patients by Sep 30, 2014. Bristol-Myers said that it will seek FDA approval for the indication on the basis of positive results from a phase III study (Checkmate -037). The patients in the trial were previously treated with Yervoy and with a BRAF inhibitor regimen in case they were BRAF-mutation positive.
In Apr 2014, Bristol-Myers initiated a rolling BLA submission for Opdivo in third-line squamous cell non-small cell lung cancer (:NSCLC). The company expects to complete the first submission by the end of the year.
Multiple important data readouts on trials involving Opdivo are expected by Dec 31, 2014. Bristol-Myers intends to evaluate the combination of Opdivo and Yervoy in a phase III study to treat lung cancer. The study is expected to commence by year end.
Bristol-Myers carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care space are Gilead Sciences (GILD), Allergan (AGN) and Celgene Corp. (CELG). Gilead and Allergan sport a Zacks Rank #1 (Strong Buy) while Celgene holds a Zacks Rank #2 (Buy).
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