BMS, Ambrx ink deal to research, develop, commercialize diabetes, heart failure biologics
PRINCETON, N.J., and LA JOLLA, Calif. — Two drug makers have entered a collaboration for novel biologics programs in diabetes and heart failure.
Under the partnership, Bristol-Myers Squibb will receive exclusive worldwide rights to research, develop and commercialize biologics, based on research by Ambrx of fibroblast growth factor 21 (FGF-21) protein and relaxin hormone, which potentially can treat Type 2 diabetes and heart failure, respectively.
Under the terms of the agreement, Bristol will make an upfront payment of $24 million to Ambrx, as well as potential milestone payments and royalty payments on worldwide sales for both programs. Bristol and Ambrx also will enter research collaborations for both programs.
The lead compound in the FGF-21 program, ARX618 (or PEG-FGF-21) is in the final stages of preclinical development, while the relaxin program is in preclinical development.
“Bristol-Myers Squibb has a strong heritage discovering, developing and delivering medicines to treat diabetes and cardiovascular disease,” Bristol-Myers Squibb SVP Francis Cuss said. “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. Our combined expertise will provide the best chance of bringing these innovative medicines to patients.”
“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,” Ambrx chief business officer Simon Allen said. “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.”
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OTC asthma inhalers phased out by year end
SILVER SPRING, Md. — Epinephrine inhalers will not be made or sold after Dec. 31, and patients using them should get new prescriptions to replace them, the Food and Drug Administration said Thursday.
Epinephrine inhalers, which Armstrong Pharmaceutical markets under the brand name Primatene Mist, are used to relieve symptoms of mild asthma and are sold over-the-counter.
But because the inhalers contain chlorofluorocarbons, the product will no longer be available after the year’s end due to requirements under the Montreal Protocol on Substances that Deplete the Ozone, of which the United States is a signatory. Part of the protocol included an agreement to phase out CFCs.
"If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a healthcare professional to talk about switching to a different medicine to treat your asthma," FDA Division of Allergy and Rheumatology Products director Badrul Chowdhury said.
I wasn't and am still not a fan of this decision. The effect of OTC in asthma inhalers on the environment was practically nothing. This makes getting rescue inhalers more of a hassle, not to mention prescription asthma inhalers seem less effective, at least with my asthma.
I use one of the new style rescue inhalers. http://bit.ly/nHS8l6
LifeStraw now available to consumers
NEW YORK — A portable, personal water filter now is available to consumers in the United States and Canada for the first time.
LifeStraw, designed to remove bacteria and parasites from water, is powered by user-generated suction and ideal for outdoor activities, overseas travel, and emergency preparedness, parent company Vestergaard Frandsen said. The straw’s filter is chemical-free and made of durable plastic and when properly used, will filter at least 1,000 liters (or 264 gallons) of water. In 2010, Vestergaard Frandsen distributed thousands of LifeStraw personal water filters to victims of the Haiti earthquake and Pakistan floods.
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