Enterprising Investor
10 years ago
Bristol-Myers Squibb and Celgene Enter Clinical Collaboration Agreement to Evaluate Immunotherapy and Chemotherapy Combination Regimen (8/20/14)
Phase I study to evaluate OPDIVO (nivolumab), Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, with Celgene’s ABRAXANE® for multiple cancers
NEW YORK & SUMMIT, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (Nasdaq:CELG) announced today the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, OPDIVO (nivolumab), and Celgene’s nab® technology-based chemotherapy ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in a Phase I study. Multiple tumor types will be explored in the study including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC). The proprietary name OPDIVO has been proposed in the U.S. and other countries, but remains subject to health authority approval.
OPDIVO is part of a new class of cancer treatments known as immunotherapies that are designed to harness the body’s own immune system in fighting cancer. OPDIVO targets distinct regulatory components of the immune system, while ABRAXANE works by interfering with the ability of cancer cells to divide. By combining an immunotherapy with a standard chemotherapy, the companies will explore whether these two agents may lead to an enhanced anti-tumor response compared to either agent alone.
“Bristol-Myers Squibb continues to forge partnerships focused on exploring the effects of combination regimens that utilize promising therapies from our immuno-oncology portfolio,” said Michael Giordano, senior vice president, Oncology Development, Bristol-Myers Squibb. “Through this collaboration, Bristol-Myers Squibb and Celgene will work together to advance the science and understanding of how the body’s own immune system and chemotherapy might work together to fight cancer.”
“Our collaboration with Bristol-Myers Squibb further underscores our commitment to understanding and modulating the immune system to advance the treatment paradigm in cancer,” said Markus Renschler, MD, Senior Vice President, Global Head of Hematology & Oncology Medical Affairs, Celgene. “We believe that ABRAXANE is appropriate as a combination partner for novel immuno-oncology therapies due to its proven anti-tumor activity and that it can be administered without steroid premedication.”
The study, which is expected to begin in the fourth quarter of 2014, will be conducted by Celgene. Patients with HER-2 negative breast cancer will be treated with ABRAXANE and OPDIVO, patients with NSCLC will be treated with the combination of ABRAXANE, carboplatin and OPDIVO, and patients with pancreatic adenocarcinoma will be treated with ABRAXANE, gemcitabine and OPDIVO. Additional details of the collaboration were not disclosed.
About OPDIVO (nivolumab)
Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. OPDIVO is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. The company is investigating whether by blocking this pathway, OPDIVO would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.
OPDIVO was approved in Japan on July 4, 2014 for the treatment of patients with unresectable melanoma and is studied in multiple tumor types consisting of more than 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in NSCLC, melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma. In 2013, the FDA granted Fast Track designation for OPDIVO in NSCLC, melanoma and RCC. In May 2014, the FDA granted OPDIVO Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. On July 4, Ono Pharmaceutical Co. announced that OPDIVO received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, making OPDIVO the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world.
About ABRAXANE®
ABRAXANE is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com. Follow us on Twitter @Celgene as well.
http://www.businesswire.com/news/home/20140820005037/en/Bristol-Myers-Squibb-Celgene-Enter-Clinical-Collaboration-Agreement#.U_oJLol0yUk
Enterprising Investor
10 years ago
CVR Terms:
Each holder of a CVR is entitled to receive a pro rata portion, based on the number of CVRs then outstanding, of each of the following contingent cash payments:
• Milestone Payment #1. $250.0 million upon FDA approval of ABRAXANE® for use in the treatment of NSCLC if such approval permits us to market ABRAXANE® with FDA approval that includes a progression-free survival, or PFS, claim, but only if this milestone is achieved no later than the fifth anniversary of the Merger.
• Milestone Payment #2. $400.0 million (if achieved no later than April 1, 2013) or $300.0 million (if achieved after April 1, 2013 and before the fifth anniversary of the Merger) upon FDA approval of ABRAXANE® for use in the treatment of pancreatic cancer, if such approval permits us to market ABRAXANE® with FDA approval that includes an overall survival claim.
• Net Sales Payments. For each full one-year period ending December 31 during the term of the CVR Agreement, which we refer to as a net sales measuring period (with the first net sales measuring period beginning January 1, 2011 and ending December 31, 2011):
-- 2.5% of the net sales of ABRAXANE® and the Abraxis pipeline products that exceed $1.000 billion but are less than or equal to $2.000 billion for such period, plus
-- an additional amount equal to 5% of the net sales of ABRAXANE® and the Abraxis pipeline products that exceed $2.000 billion but are less than or equal to $3.000 billion for such period, plus
-- an additional amount equal to 10% of the net sales of ABRAXANE® and the Abraxis pipeline products that exceed $3.000 billion for such period.
No payments will be due under the CVR Agreement with respect to net sales of ABRAXANE® and the Abraxis pipeline products after December 31, 2025, which we refer to as the net sales payment termination date, unless net sales for the net sales measuring period ending on December 31, 2025 are equal to or greater than $1.000 billion, in which case the net sales payment termination date will be extended until the last day of the first net sales measuring period subsequent to December 31, 2025 during which net sales of ABRAXANE® and the Abraxis pipeline products are less than $1.000 billion or, if earlier, December 31, 2030.
Milestone Payment #1 update: In October 2012, the FDA approved ABRAXANE® for the first-line treatment of locally advanced or metastatic NSCLC, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. The FDA approval was based on tumor response rates and did not result in the use of a marketing label that includes a progression-free survival claim, and accordingly, the CVR Milestone Payment #1, as described above, has not been achieved. This approval resulted in the related $1.172 billion intangible asset obtained from the Abraxis acquisition being reclassified in October 2012 from an acquired IPR&D intangible to an acquired developed product rights intangible asset and amortization commenced in October 2012.
Milestone Payment #2 update: In September 2013, the FDA approved ABRAXANE® for use in the treatment of pancreatic cancer, permitting us to market ABRAXANE® with a label that includes an overall survival claim. This approval resulted in the achievement of milestone #2 and the subsequent payment of $300.0 million to CVR holders in October 2013.
http://www.sec.gov/Archives/edgar/data/816284/000144530514000438/a2013123110k.htm
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