Cornerstone Therapeutics Inc., a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets, has entered into an agreement with Digestive Care, Inc. (DCI) to acquire exclusive US rights to market Pertzye (pancrelipase) for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF).

Pertzye is a unique pancreatic enzyme product and is protected by several US patents. The Pertzye formulation was previously marketed by DCI for more than a decade under the trade name Pancrecarb MS-16. It is estimated that about 90% of patients with CF receive pancreatic enzyme replacement therapy (PERT) with the therapeutic category experiencing 24% annual growth from 2008-2012.

"The acquisition of the exclusive US CF marketing rights for market-ready Pertzye will have an immediate revenue impact for Cornerstone," said Craig A Collard, Cornerstone's chief executive officer. "With net sales of PERT products reaching approximately $200 million in the CF category in 2012, we see significant opportunity for growth. Also, the addition of Pertzye complements Cornerstone's launch of the CF drug Bethkis (tobramycin inhalation solution) later this year. This is yet another strategic step in our commitment to building a portfolio of industry-leading brands for the growing US hospital and adjacent specialty markets."

Dr Tibor Sipos, president and chief scientific officer of DCI, stated, "We are pleased to partner with Cornerstone and are confident that their CF-focused marketing efforts will enhance patient accessibility to Pertzye and provide support for educational programmes. Going forward, DCI's sales and marketing efforts for Pertzye will be focused on meeting the needs of patients with EPI due to conditions other than CF in the US market."  

Pertzye is approved by the US Food and Drug Administration (FDA) for the treatment of Exocrine Pancreatic Insufficiency due to cystic fibrosis or other conditions. Pertzye is the only FDA approved PERT containing bicarbonate-buffered, enteric-coated microspheres. This unique formulation was designed to optimize the pH environment for enzyme activity and nutrient absorption). Pertzye is currently available in two strengths: 8,000 and 16,000 USP units of lipase/capsule.

 Digestive Care, Inc., headquartered in Bethlehem, PA, is a fully integrated pharmaceutical company, founded in 1990, dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders.