Bristol-Myers Squibb Bets $975 Million on Bavarian Nordic's Prostate Cancer Vaccine
Published: Mar 05, 2015
March 4, 2015
By Alex Keown, BioSpace.com Breaking News Staff
PRINCETON, N.J. – Under a nearly $1 billion agreement announced Wednesday, Bristol-Myers Squibb Company will develop and market Prostvac, Bavarian Nordic ’s investigational Phase 3 prostate-specific antigen (PSA)-targeting cancer immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Shares in Bavarian Nordic were up 33 percent this morning after the agreement was announced. Shares for Bristol-Myers were down slightly this morning.
Prostvac is an immuno-oncology agent administered subcutaneously that stimulates an immune response that attacks prostate cancer cells. PROSTVAC is currently being evaluated in a phase III study that includes 1,298 patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Prostate cancer is the second most frequently diagnosed cancer and the sixth most deadly cancer in men, although it is the most common cancer among American men, according to the U.S. Centers for Disease Control and Prevention.
Approximately 220,800 cases of prostate cancer are diagnosed annually, and about 27,540 people die annually from the disease. Most deaths will be caused by metastatic castration-resistant prostate cancer, which occurs when the cancer becomes resistant to standard hormonal treatment and spreads from the prostate to other organs in the body.
“While additional treatment options have become available, metastatic castration-resistant prostate cancer remains largely incurable,” said Michael Giordano, Bristol-Myers’ head of oncology development. “Our agreement with Bavarian Nordic reflects our commitment to following the emerging science in immuno-oncology and supports our strategy to transform the treatment of cancer across multiple tumor types, lines of therapy and stages of disease.”
The agreement between the two companies has the potential to generate nearly $1 billion for Denmark-based Bavarian Nordic when future sales are factored into the agreement. Bristol-Myers will make an upfront $60 million payment to Bavarian Nordic, with additional milestone payments up to $915 million based on clinical trial results and marketability of the drug. The parties have also agreed to enter into a supply contract, under which Bavarian Nordic will undertake the future commercial manufacturing of Prostvac.
Bristol-Myers is currently planning a phase II study investigating the combination of Prostvac with Bristol-Myers Squibb’s own Yervoy. Additionally the companies entered into an agreement to conduct combination studies of Prostvac and other agents from Bristol-Myers Squibb’s immuno-oncology portfolio. Last week results from a small trial conducted by the U.S. National Cancer Institute, showed Prostvac helped extend survival in patients with advanced prostate cancer by many months. Full results of the trial are not expected to be released until 2017.
On Monday the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application for Yervoy for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection, Bristol-Myers reported.
Bristol-Myers’ deal with Bavarian Nordic is the latest in the company’s increased foray into cancer research and development. Last month Bristol-Myers expanded its immuno-oncology pipeline with a $1.25 billion acquisition of Flexus Biosciences, a private company focused on developing anti-cancer therapeutics. Also last month the company entered into a $339 million agreement with Rigel Pharmaceuticals, Inc. to develop cancer treatments based on Rigel’s portfolio of small molecule TGF beta receptor kinase inhibitors.
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Last week controversy erupted over the compensation package for Sanofi’s new CEO, Olivier Brandicourt, with several French government officials decrying the amount, calling it "incomprehensible." Brandicourt could walk off with as much as $4.5 million in a “golden handshake” payment in addition to making $4.76 million a year. That base figure is comprised by a fixed annual salary of $1.36 million a year, which is supplemented by a performance-related bonus of between 150 to 250 percent, as well as stock options and performance shares.
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