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BMS sees ambiance with Ambrx
November 2011
by Kelsey Kaustinen  |  Email the author


PRINCETON, N.J.óBristol-Myers Squibb Co. (BMS) has added another pearl to its string of partnerships in the form of a collaboration with biopharmaceutical company Ambrx Inc., which will grant BMS exclusive worldwide rights to research, develop and commercialize biologics based on Ambrx's research with regards to the fibroblast growth factor 21 (FGF-21) protein and the relaxin hormone.
The two targets have potential in treating type 2 diabetes and heart failure respectively, and Ambrx has developed derivatives of both FGF-21 and relaxin using its ReCODE platform technology to modify the native proteins with amino acid buildings blocks to produce enhanced versions for investigation.  
 "Bristol-Myers Squibb has a strong heritage of discovering, developing and delivering medicines to treat diabetes and cardiovascular disease," Francis Cuss, senior vice president of research for BMS, said in a press release. "As part of our String of Pearls strategy, we seek to build relationships with companies that have innovative programs and capabilities that complement our own internal efforts."
Under the agreement, Ambrx will receive an upfront payment from BMS of $24 million, and BMS will make potential additional payments based on collaboration milestones as well as royalty payments on worldwide sales for both programs. The two companies will enter into research collaborations for both programs as well.
"These programs have shown tremendous potential in preclinical studies, and we believe that Bristol-Myers Squibb has the necessary expertise to best lead their continued development," Simon Allen, chief business officer for Ambrx, said in a press release. "We look forward to using the revenues from this partnership to continue to grow our internal pipeline, which includes our promising antibody drug conjugate programs."
FGF-21 is a naturally occurring protein and is characterized as a potent metabolic inhibitor. In preclinical studies, this protein has been shown to lower blood glucose, elevate good cholesterol and promote weight loss as well. Ambrx's lead compound in the FGF-21 program is ARX618, a long-acting variant of FGF-21 shown to have retained potency as well as extended pharmacokinetics compared to wild-type FGF-21. The compound is in the last stages of preclinical development for diabetes.  
Relaxin is also naturally occurring, though the hormone is found only in pregnant females. It belongs to the insulin superfamily, and according to the Encyclopedia Britannica, is produced by the ovaries during pregnancy. Relaxin inhibits muscular contractions of the uterus that might cause natural abortion, and preclinical studies show that it might have potential in the treatment of heart failure by improving cardiac function. This program is also in preclinical development.  
"We are excited to be working with Ambrx, which has used its unique ReCODE technology to create precisely engineered investigational biologics in both of these therapeutic areas," Cuss said. "Our combined expertise will provide the best chance of bringing these innovative medicines to patients."
As of press time, neither company could be reached for additional comments.
Ambrx's RECODE (reconstituting chemically orthogonal directed engineering) technology grants exceptional control of the site-directed placement of chemistry that is designed to be non-disruptive to protein function. The company's website notes that the proprietary methods "for design, evolution and selection of amino acid and amino-acyl tRNA synthetase pairs have enabled incorporation of over 30 different chemically-specified amino acids into biosynthetic proteins in E. coli, yeast and mammalian cell systems." The ReCODE technology has merit across a variety of protein classes such as antibodies, cytokines and peptides, and in a variety of therapeutic areas as well, such as cancer, inflammation, infectious disease and endocrine disorders.

BMS teams up with Japan's Ono Pharma on cancer immunotherapy and RA product
OSAKA, JapanóBristol-Myers Squibb Co. (BMS) also announced last month an agreement with Ono Pharmaceutical Co. Ltd. to expand BMS' territorial rights to develop and commercialize BMS-936558/ONO-4538, an anti-PD-1 antibody.  
BMS acquired the North American rights to the antibody in 2009 when it acquired Medarex. The agreement with Ono extends those rights to the rest of the world except Japan, Korea and Taiwan, where Ono has retained all rights to develop it.
The agreement also calls for the companies' partnership on the development and commercialization of ORENCIA, a biologic therapy for rheumatoid arthritis, in Japan. The agreement applies to both the currently approved intravenous (IV) formulation of ORENCIA and the subcutaneous (SC) formulation of ORENCIA, and includes all current and future indications. ORENCIA IV was launched in Japan in September 2010 by BMS' Japanese subsidiary, Bristol-Myers K.K., and is indicated for use in patients for whom other therapies have failed. ORENCIA SC is currently in Phase III development in Japan.  
Bristol-Myers K.K. will distribute and book sales of ORENCIA IV. Ono will distribute and book the sales of ORENCIA SC. The companies will jointly promote both formulations with Ono's participation beginning when the post-marketing surveillance period for ORENCIA IV has concluded, which is expected to be in 2013.
Code: E111102



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