Print“Since December’s launch, Sovaldi has been prescribed for more than 80,000 patients in the U.S. and Europe, underscoring the medical community’s recognition of the benefits of this product, said Gilead CEO John Martin. ”
Gilead Sciences, the biotech company at the center of the growing controversy over the high price of specialty drugs, gave investors two reasons to cheer. Besides reporting second-quarter 2014 revenue of $6.53 billion, more than double the $2.77 billion in revenue in the same period last year, the U.S. Food and Drug Administration approved the Foster City, California-based biotech’s cancer drug Zydelig for three blood cancers.
Gilead’s jump in revenue was largely due to sales of Sovaldi, which reached $3.5 billion in the second quarter, and almost $6 billion for the first half of 2014, making it the best drug launch ever. The drug’s sales contributed to net income hitting $3.6 billion for the quarter compared to $772.6 million in the second quarter of 2013.
The $84,000 treatment course for hepatitis C that promises to cure the disease in a majority of patients has come under attack as overpriced due largely to the large number of people infected with the virus that could benefit from treatment. Gilead Chairman and CEO John Martin noted that he expected price concerns to die down as more patients taking Sovalid are cured of the disease.
“Since December’s launch, Sovaldi has been prescribed for more than 80,000 patients in the U.S. and Europe, underscoring the medical community’s recognition of the benefits of this product,” said Martin. “We look forward to making Sovaldi available in additional countries.”
The strong earnings report was followed by news that the U.S. Food and Drug Administration approved its new blood cancer drug Zydelig for three indications. Known primarily as a leader in infectious disease therapies such as HIV and hepatitis, Gilead moved into cancer treatments with its acquisition of Calistoga Pharmaceuticals and its lead compound idelalisib in 2011 for $375 million upfront with potentially another $225 million in milestones.
Approval of Zydelig, which had breakthrough therapy designation, came almost two months ahead of the September 11 PDUFA date. It is the fifth drug with breakthrough designation to gain FDA approval. The first-in-class P13k inhibitor was approved to treat patients with relapsed chronic lymphocytic leukemia in combination with rituximab, and to treat patients with relapsed follicular B-cell non-Hodgkin’s lymphoma or small lymphocytic lymphoma, after they have received two prior therapies. The drug carries a black box warning on the risk of fatal and serious toxicities such as liver toxicity, diarrhea, colon and lung inflammation, and intestinal perforation. The approval comes with a Risk Evaluation and Mitigation Strategy requiring a communication plan to make sure prescribing doctors are aware of all the risks.
Gilead is pricing the drug at $7,200 a month, slightly below its competitor Imbruvica, which also had breakthrough therapy designation and beat Gilead to market. The FDA approved Imbruvica in November 2013 for mantle cell lymphoma and in February for chronic lymphocytic leukemia.
A couple of days after Zydelig received FDA approval, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorizations for both Imbruvica and Zydelig for similar and different indications. Both drugs were recommended for use in adult patients with chronic lymphocytic leukemia who had received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy.
Imbruvica was also recommended to treat adult patients with relapsed mantle cell lymphoma, while Zydelig was recommended for use in adult patients with follicular lymphoma who had not responded to two previous therapies. The committee recommendations are an intermediary step with final marketing decisions on the two drugs now before the European Commission.
Gilead Sciences is currently the world’s biggest biotech company with a market capitalization of $136 billion, rivaling many Big Pharmas.
July 25, 2014
http://www.burrillreport.com/article-gilead_sciences_on_a_roll.html
