Cornerstone Therapeutics Inc., a specialty pharmaceutical company focused on commercializing products for the hospital and related specialty markets, has entered into an agreement with Chiesi Farmaceutici S.p.A. (Chiesi) 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 n Drug Administration (FDA) on October 12, 2012 and the licensing agreement with Chiesi, headquartered in Parma, Italy, was executed on November 6, 2012.
"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 A. Collard, Cornerstone's chief executive officer. " 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."
Bethkis is the second product Cornerstone has licensed from Chiesi since the companies' strategic transaction in 2009 making Chiesi Cornerstone's largest shareholder. Under the agreement, Chiesi will receive an initial payment of $1 million, a milestone payment of $2.5 million upon first commercial sale of the product and royalties based on a percentage of net sales.
"The availability of Bethkis will provide another treatment option for patients with cystic fibrosis who face daily challenges and struggles," added Collard who currently serves on the board of the Triangle Chapter of the Cystic Fibrosis Foundation. "Cornerstone has long supported the CF community in numerous initiatives, and we look forward to bringing a therapy like Bethkis to those patients who need it most. Currently, the only inhaled tobramycin choice for cystic fibrosis patients is Novartis' Tobi, which generated sales of approximately $290 million in 20111. We plan to launch Bethkis in the first half of 2013."
Pseudomonas aeruginosa is one of the major pulmonary pathogens in patients with cystic fibrosis and by adulthood 80% of patients have respiratory colonization with this type of bacteria.
Bethkis (Tobramycin Inhalation Solution) is owned by Chiesi Farmaceutici S.p.A. and is licensed to Cornerstone Therapeutics for sales and marketing purposes in the United States. Tobi is a registered trademark of Novartis Vaccines and Diagnostics, Inc.