CARY, NC--(Marketwire - November 08, 2012) - Cornerstone Therapeutics
Inc. (NASDAQ: CRTX
), a specialty pharmaceutical company focused on commercializing products for the hospital and related specialty markets, today announced it has entered into an agreement with Chiesi Farmaceutici S.p.A. (Chiesi) to acquire the U.S. 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 U.S. Food and 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 2011(1). 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.(2)
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.
IMPORTANT SAFETY INFORMATION
BETHKIS® (Tobramycin Inhalation Solution) is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Caution should be exercised when prescribing BETHKIS® to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. Bronchospasm can occur with the inhalation of BETHKIS®. Audiograms, serum concentration, and renal function should be monitored as appropriate. Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus. Nursing mothers should make a decision to discontinue BETHKIS® or nursing, taking into consideration the importance of the drug to the mother. Concurrent and/or sequential use of BETHKIS® with other drugs with neurotoxic or ototoxic potential should be avoided. BETHKIS® should not be administered concomitantly with ethacrynic acid, furosemide, urea, or mannitol. Common adverse reactions (more than 5%) occurring more frequently in BETHKIS® patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia.
About Cornerstone Therapeutics
Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and related specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and related specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies, marketed and/or registration-stage products and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit www.crtx.com.
(1) IMS Health sales information provided is an estimate derived from the use of information under license from the IMS Health. IMS expressly reserves all rights, including rights of copying, distribution and republication.
(2) Cystic Fibrosis Foundation Patient Registry. Annual Data Report. 2010.
B-Q412-01, November 2012