Healthcare Industry News:  patent ductus arteriosus 

Biopharmaceuticals Cardiology

 News Release - July 20, 2006

OVATION Pharmaceuticals Announces First New Drug Treatment in 20 Years for Premature Infants with Patent Ductus Arteriosus

DEERFIELD, Ill.--(HSMN NewsFeed)--July 20, 2006--OVATION Pharmaceuticals announced today its launch of the first new pharmaceutical product in 20 years to treat a potentially life-threatening congenital heart defect in premature infants. NeoProfen (ibuprofen lysine) Injection (10mg/mL) is indicated -- when usual medical management is ineffective -- to close a clinically significant patent ductus arteriosus (PDA), a condition in which a blood vessel (ductus arteriosus) in the heart fails to close after birth.

"The development and introduction of NeoProfen demonstrates OVATION's commitment to provide medically necessary therapies for patients suffering from severe illnesses," according to Jeffrey S. Aronin, president and chief executive officer of OVATION Pharmaceuticals. "We are pleased to be able to introduce the first new alternative in decades for a condition that affects a very vulnerable patient population. OVATION remains the only company that offers drug therapies approved to treat this rare but serious condition."

ABOUT patent ductus arteriosus

The ductus arteriosus is part of the fetal pathway that helps to distribute oxygen from the mother to the baby's organs in utero. A patent (or open) ductus arteriosus (PDA) allows blood flow to avoid the lungs, which are not needed before birth because the baby receives its oxygen from the mother across the placenta. A PDA is present in all babies before birth. When the baby is born, the lungs expand, blood vessels relax to accept more flow, and the ductus arteriosus usually closes on its own within the first hours or days of life. On occasion, however, the ductus arteriosus does not close on its own, a condition referred to as PDA.

Premature infants, particularly very-low-birth-weight neonates, are more likely to have problems related to PDA. If the ductus arteriosus is large, does not close shortly after birth, and becomes symptomatic, the infant has a higher likelihood of pulmonary morbidity, necrotizing enterocolitis (ulceration and death of intestinal tissue) and the need for surgery(1). According to the March of Dimes, 2 percent of all live births in the U.S. in 2003 were infants who had completed less than 32 weeks of gestation (2) and were at risk of PDA-related problems. Approximately 30,000 infants are treated pharmacologically each year for PDA.

"For 20 years, neonatologists had very few options for closing the ductus in very-low-birth-weight infants," says Jacob V. Aranda, M.D., Pediatric Pharmacology Research Unit Network at Children's Hospital of Michigan in Detroit. "Few companies were willing to invest in new therapies for this population. NeoProfen offers a safe and effective treatment option, providing a significant benefit to physicians, patients and families."

Emphasizing the company's commitment to focusing on medically necessary products, Aronin added, "NeoProfen delivers on OVATION's promise of improving patient lives and developing medicines that satisfy unmet medical needs. We also ensure that physicians and their patients have access to these therapies, which other companies generally under-invest in or overlook altogether."

IMPORTANT SAFETY INFORMATION ABOUT NEOPROFEN

NeoProfen (ibuprofen lysine) Injection (10mg/mL) has been shown to prolong bleeding time, to decrease urinary output, and to cause adverse events classified as renal insufficiency. There are no long-term evaluations of ibuprofen's effects on neurodevelopmental outcome, growth and disease processes associated with prematurity. The most frequent side effects associated with NeoProfen in the primary clinical trial supporting NDA approval include sepsis, anemia, total bleeding and intraventricular hemorrhage. Please see full prescribing information for NeoProfen at www.ovationpharma.com/prod_hos_neopro.htm.

ABOUT OVATION PHARMACEUTICALS

OVATION is a fully integrated pharmaceutical company that develops, manufactures and markets medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on central nervous system (CNS), hematology/ oncology, and hospital-based therapies. Four of its anticipated five new product launches in the next five years will be fueled by the company's late-stage CNS pipeline, which is one of the most robust in the industry.

References:

1. Clyman RI. patent ductus arteriosus in the premature infant. In: Taeusch, HW, Ballard, RA, eds. Avery's Diseases of the Newborn. 7th ed. Philadelphia, Pa: W.B. Saunders Company; 1996:699-710.

2. March of Dimes PeriStats page. Available at www.marchofdimes.com/peristats. Accessed June 7, 2006.


Source: OVATION Pharmaceuticals

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