Cornerstone Thera gets US rights to Chiesi's Bethkis

USA-based specialty pharma firm Cornerstone Therapeutics Inc. (Nasdaq: CRTX) says it has entered into an agreement with privately-owned Italian drugmaker Chiesi Farmaceutici to acquire the US rights to market Bethkis (tobramycin inhalation solution) indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia. Bethkis received approval from the US Food and Drug Administration on October 12, 2012 and the licensing agreement with Chiesi, headquartered in Parma, Italy, was executed on November 6, the US company noted.

"The FDA's approval of Bethkis and our subsequent licensing agreement with Chiesi is another step forward in the execution of our strategic focus to be a trusted partner to the hospital and related specialty markets," said Craig Collard, Cornerstone's chief executive, adding: “Bethkis will play an important role in the treatment of patients with cystic fibrosis, and we are proud to add this therapy to our growing offering of products. Additionally, this agreement illustrates the strength of our partnership with Chiesi which continues to bring opportunities for growth and added value to our company."