Bristol-Myers Squibb and Ambrx : Collaboration for Novel Biologics Programs in Diabetes and Heart Failure

September 22, 2011 - Bristol-Myers Squibb Company (NYSE: BMY) and Ambrx, Inc. announced a collaboration under which Bristol-Myers Squibb will receive exclusive worldwide rights to research, develop and commercialize biologics based on Ambrx’s research surrounding the Fibroblast Growth Factor 21 (FGF-21) protein, for potential use in treating type 2 diabetes, and the Relaxin hormone, for potential use in treating heart failure. Derivatives of FGF-21 and Relaxin were developed using Ambrx’s unique ReCODE™ platform technology to modify the native proteins with amino acid building blocks beyond the common 20 to engineer enhanced versions for investigation for therapeutic use.

Under the terms of the agreement, Bristol-Myers Squibb will make an upfront payment of $24 million to Ambrx. In addition, Bristol-Myers Squibb will make potential milestone payments and royalty payments on worldwide sales for both programs. Bristol-Myers Squibb and Ambrx will also enter research collaborations for both programs.

FGF-21 is a naturally occurring protein that has been characterized as a potent metabolic regulator, and has been shown to lower blood glucose, elevate good cholesterol and promote weight loss in preclinical studies. The lead compound in this program, ARX618, or PEG-FGF-21, is in the final stages of preclinical development.

Relaxin is a naturally occurring hormone known for its role in pregnancy and childbirth. Preclinical studies suggest Relaxin may aid in the treatment of heart failure by improving cardiac function. This program is in preclinical development... Bristol-Myers Squibb's Press Release - Ambrx's Press Release -

BMS & AstraZeneca : Dapagliflozin Study Demonstrated Improved Glycemic Control In Type 2 Diabetes Patients Treated With High Doses of Insulin...

June 06, 2009 -Results from a 12-week study demonstrated that the investigational drug dapagliflozin, a novel, selective, sodium glucose co-transporter 2 (SGLT2) inhibitor, produced greater improvements across all key glycemic measures studied [glycosylated hemoglobin level (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG)] in type 2 diabetes patients who were treated with high doses of insulin and commonly used oral anti-diabetes medications (OADs), compared to placebo (placebo plus OADs plus insulin).

Overall adverse events across the dapagliflozin treatment arms were reported at a similar rate to placebo. The study also showed that individuals receiving dapagliflozin had greater reductions in body weight compared to individuals taking placebo, and support the findings from a previous 12-week, Phase 2b study. Results from the 12-week study were presented at the 69^th American Diabetes Association Annual Scientific Sessions.

Dapagliflozin is an investigational SGLT2 inhibitor currently in Phase 3 trials under joint development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) as a once-daily therapy for the treatment of type 2 diabetes. SGLT2 facilitates the reabsorption of glucose in the kidney, thereby returning filtered glucose to the circulation.. BMS' Press Releases -

AstraZeneca & Bristol-Myers Squibb : ONGLYZA™ (saxagliptin) demonstrated significant reductions in key measures of glucose control in treatment ...

June 7, 2008 – Results from a 24-week Phase III study presented at the 68th American Diabetes Association Annual Scientific Sessions demonstrated that saxagliptin, a selective, reversible inhibitor of the dipeptidyl peptidase (DPP-4) enzyme in development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN), produced significant reductions in key measures of glucose control (glycosylated hemoglobin level [A1C], fasting plasma glucose [FPG] and postprandial glucose [PPG]) in treatment naïve people with type 2 diabetes compared to placebo (PBO).
Over 24 weeks, saxagliptin had an adverse event profile that appeared similar to placebo. The companies have proposed the trade name ONGLYZA™ for saxagliptin if approved by the U.S. Food & Drug Administration... AstraZeneca's Press Release - Bristol-Myers Squibb's Press Release -

Pfizer and Bristol-Myers Squibb Worldwide Collaboration on Metabolic Disorders Program including diabetes

Aug. 27, 2007 - Pfizer Inc. (NYSE: PFE) and Bristol-Myers Squibb Company (NYSE: BMY) ("companies") have finalized a definitive agreement for the worldwide collaboration to research, develop and commercialize DGAT-1 inhibitors. Pfizer's DGAT- 1 discovery program includes advanced pre-clinical compounds with potential applications for the treatment of metabolic disorders, including obesity and diabetes... Pfizer's Press Release. - BMS' Press Release. -

(The program also includes DGAT-1 inhibitors in-licensed by Pfizer from Bayer Pharmaceuticals Corporation in June 2006, including a pre-clinical compound (known as PF-04415060 or BAY 74-4113) originally discovered by Bayer.) 14 June 2006 Bayer Pharma's Press Release.