BMS sees ambiance with Ambrx

New collaboration to develop biologics for diabetes, heart failure

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PRINCETON, N.J.—Bristol-Myers Squibb Co. (BMS) has addedanother pearl to its string of partnerships in the form of a collaboration withbiopharmaceutical company Ambrx Inc., which will grant BMS exclusive worldwiderights to research, develop and commercialize biologics based on Ambrx'sresearch with regards to the fibroblast growth factor 21 (FGF-21) protein andthe relaxin hormone.
The two targets have potential in treating type 2 diabetesand heart failure respectively, and Ambrx has developed derivatives of bothFGF-21 and relaxin using its ReCODE platform technology to modify the nativeproteins with amino acid buildings blocks to produce enhanced versions forinvestigation.
 "Bristol-Myers Squibb has a strong heritage of discovering,developing and delivering medicines to treat diabetes and cardiovasculardisease," Francis Cuss, senior vice president of research for BMS, said in apress release. "As part of our String of Pearls strategy, we seek to buildrelationships with companies that have innovative programs and capabilitiesthat complement our own internal efforts."
Under the agreement, Ambrx will receive an upfront paymentfrom BMS of $24 million, and BMS will make potential additional payments basedon collaboration milestones as well as royalty payments on worldwide sales forboth programs. The two companies will enter into research collaborations forboth programs as well.
"These programs have shown tremendous potential inpreclinical studies, and we believe that Bristol-Myers Squibb has the necessaryexpertise to best lead their continued development," Simon Allen, chiefbusiness officer for Ambrx, said in a press release. "We look forward to usingthe 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 characterizedas a potent metabolic inhibitor. In preclinical studies, this protein has beenshown to lower blood glucose, elevate good cholesterol and promote weight lossas well. Ambrx's lead compound in the FGF-21 program is ARX618, a long-actingvariant of FGF-21 shown to have retained potency as well as extendedpharmacokinetics compared to wild-type FGF-21. The compound is in the laststages of preclinical development for diabetes.
Relaxin is also naturally occurring, though the hormone isfound only in pregnant females. It belongs to the insulin superfamily, andaccording to the Encyclopedia Britannica, is produced by the ovariesduring pregnancy. Relaxin inhibits muscular contractions of the uterus thatmight cause natural abortion, and preclinical studies show that it might havepotential in the treatment of heart failure by improving cardiac function. Thisprogram is also in preclinical development.
"We are excited to be working with Ambrx, which has used itsunique ReCODE technology to create precisely engineered investigationalbiologics in both of these therapeutic areas," Cuss said. "Our combinedexpertise will provide the best chance of bringing these innovative medicinesto patients." 
As of press time, neither company could be reached foradditional comments.
Ambrx's RECODE (reconstituting chemically orthogonaldirected engineering) technology grants exceptional control of thesite-directed placement of chemistry that is designed to be non-disruptive toprotein function. The company's website notes that the proprietary methods "fordesign, evolution and selection of amino acid and amino-acyl tRNA synthetasepairs have enabled incorporation of over 30 different chemically-specifiedamino acids into biosynthetic proteins in E. coli, yeast and mammaliancell systems." The ReCODE technology has merit across a variety of proteinclasses such as antibodies, cytokines and peptides, and in a variety oftherapeutic areas as well, such as cancer, inflammation, infectious disease andendocrine disorders.

BMS teams up withJapan's Ono Pharma on cancer immunotherapy and RA product
OSAKA, Japan—Bristol-Myers Squibb Co. (BMS) also announcedlast month an agreement with Ono Pharmaceutical Co. Ltd. to expand BMS'territorial rights to develop and commercialize BMS-936558/ONO-4538, ananti-PD-1 antibody.
BMS acquired the North American rights to the antibody in2009 when it acquired Medarex. The agreement with Ono extends those rights tothe rest of the world except Japan, Korea and Taiwan, where Ono has retainedall rights to develop it.
The agreement also calls for the companies' partnership onthe development and commercialization of ORENCIA, a biologic therapy forrheumatoid 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 inJapan in September 2010 by BMS' Japanese subsidiary, Bristol-Myers K.K., and isindicated for use in patients for whom other therapies have failed. ORENCIA SCis currently in Phase III development in Japan.
Bristol-Myers K.K. will distribute and book sales of ORENCIAIV. Ono will distribute and book the sales of ORENCIA SC. The companies will jointlypromote both formulations with Ono's participation beginning when thepost-marketing surveillance period for ORENCIA IV has concluded, which isexpected to be in 2013.

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