Just hours after Bristol-Myers Squibb beat Wall Street expectations with earnings that got a goose from antipsychotic Abilify, the FDA opened the floodgates to generics of the blockbuster.
Bristol-Myers Squibb was staring down the end of a barrel at the beginning of this year, bracing for a sales hit as its blockbuster antipsychotic Abilify nears patent expiration. But in an about-face, the drugmaker is celebrating first-quarter earnings that beat the Street's forecasts thanks to promising numbers for some of its newer meds.
Bristol-Myers Squibb's immuno-oncology med Opdivo is racking up positive data and earning regulatory gold stars in record time. Now, the drug is poised to gain even more ground after the European Medicines Agency gave Opdivo its marketing thumbs-up as a first-line treatment for advanced melanoma--an approval it has yet to earn in the U.S.--and in previously treated patients.
Hot on the heels of Bristol-Myers Squibb, Merck announced over the weekend that it has filed for FDA approval to market its PD-1 star Keytruda for non-small cell lung cancer.
The immuno-oncology drug Opdivo from Bristol-Myers Squibb continued on its charmed path today when the drugmaker cut short another trial for lung cancer because it had nailed its goal for overall survival. This comes after accelerated FDA approval of Opdivo for melanoma and then lung cancer, which has led analysts to keep jacking up earnings forecast, now to $7 billion in annual sales in 5 years.
Erbitux is one of the top 10 best selling cancer drugs in the world and for years Bristol-Myers Squibb has sold it in the U.S. But Erbitux no longer fits in the sweet spot for Bristol-Myers which is hot for immuno-oncology right now and so is turning over marketing of the colorectal cancer drug to others. In the U.S. that is Eli Lilly, whose ImClone unit developed the cancer drug and put the marketing deal in place before Lilly bought ImClone some years back.
UniQure has moved quickly to cash in on its position in the biotech limelight. Within 24 hours of unveiling its $1 billion tie-up with Bristol-Myers Squibb, the gene therapy specialist had filed the paperwork for a follow-on offering that could net it upwards of $100 million (€92 million).
Bristol-Myers Squibb is the latest pharma heavyweight to buy into gene therapy's renaissance, signing a deal with uniQure worth as much as $1 billion and getting its hands a novel cardiovascular treatment.
Bristol-Myers Squibb and Otsuka won't have to fight claims that they promoted Abilify for off-label uses or used kickbacks to persuade doctors to prescribe the antipsychotic drug. A U.S. judge tossed out those allegations, leveled by a couple of whistleblowers in 2011, for lack of specific evidence.
What's better than a new drug launch? A launch destined for greatness, of course. For sales and marketing teams, that's about as much job security as you can get.