Bristol-Myers Squibb Company announced that its subsidiary Mead Johnson & Company has signed a purchase agreement with OPR Development, L.P. to acquire Cafcit (caffeine citrate) Injection and Oral Suspension, the only drug approved by the U.S. Food and Drug Administration (FDA) for the short-term (10-12 days) treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. Cafcit was developed and marketed by OPR in close collaboration with Boehringer Ingelheim Pharmaceuticals, Inc. and its affiliate Roxane Laboratories Inc. Cafcit will be marketed by Mead Johnson & Company.
"Bristol-Myers Squibb has a unique history of leveraging acquisition and co-promotion opportunities to support products which address unmet medical needs," said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb. "We look forward to utilizing the company's expertise to educate physicians and patients regarding the use of Cafcit in treating infants in the U.S. who develop apnea of prematurity."
Cafcit Injection received FDA approval in November 1999 and Cafcit Oral Suspension received FDA approval in April 2000. Premature infants are at greater risk than are full-term babies for apnea of prematurity (AOP). AOP is a condition in which the infant experiences episodes of apnea that exceed 20 seconds and for which there is no identifiable cause. It is estimated that 300,000 babies are born each year at 33 weeks or earlier in the U.S., and more than half of these premature infants will be diagnosed and treated for AOP.