SOURCE: Cornerstone Therapeutics

Cornerstone Therapeutics

October 17, 2013 09:00 ET

Cornerstone Therapeutics Announces Events to Be Held at the 2013 North American Cystic Fibrosis Conference

SALT LAKE CITY, UT--(Marketwired - Oct 17, 2013) -  Cornerstone Therapeutics Inc. (NASDAQ: CRTX) will exhibit at the North American Cystic Fibrosis Conference (NACFC), Oct. 17-19 at the Salt Palace Convention Center in Salt Lake City. The annual scientific meeting, sponsored by the Cystic Fibrosis Foundation, is designed for medical professionals focused on CF research and patient care.

"This is our first time participating at NACFC and we are energized by the amount of information we have to share with the CF community," said Craig A. Collard, Cornerstone's Chief Executive Officer. "In less than one year's time, we have begun to unveil a portfolio of therapeutic products, educational resources and support tools for CF patients in the U.S. We are passionate about improving the lives of people with CF and look forward to continuing to build our CF portfolio and the supporting resources in the future."

As part of the conference, Cornerstone will sponsor Product Theater sessions in the exhibit hall to give attendees an opportunity to learn about recent developments. The events are as follows:

  • Thursday, Oct. 17 (12:10-12:30 p.m.) - Exocrine Pancreatic Insufficiency is About More Than Just Enzymes. The clinical discussion will be led by Steven Strausbaugh, M.D., FCCP, CPI, and Megan Hart, M.S., R.D., L.D., from UH/Rainbow Babies & Children's (Cleveland, OH). The session will provide an overview of PERTZYE® (pancrelipase) for the treatment of exocrine pancreatic insufficiency in patients with CF.

  • Friday, Oct. 18 (12:10-12:30 p.m.) - BETHKIS® (Tobramycin Inhalation Solution) - A Concentrated Option for Nebulization, led by Kimberly Novak, Pharm.D., B.C.P.S., pharmacy clinical specialist, pulmonary medicine, Nationwide Children's Hospital (Columbus, OH). BETHKIS will launch later this fall and is FDA approved for the management of cystic fibrosis patients with Pseudomonas aeruginosa.


PERTZYE (pancrelipase) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Limitation of Use: PERTZYE is not interchangeable with any other pancrelipase product.


Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).

To avoid irritation of oral mucosa, do not chew PERTZYE or retain in the mouth.

Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.

There is theoretical risk of viral transmission with all pancreatic enzyme products including PERTZYE.

Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

The most common adverse reactions (≥ 10% of patients treated with PERTZYE) are diarrhea, dyspepsia, and cough.

PERTZYE full Prescribing Information and Medication Guide are available at

ABOUT BETHKIS (Tobramycin Inhalation Solution)

BETHKIS® is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia.


BETHKIS is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Bronchospasm can occur with inhalation of BETHKIS. Bronchospasm and wheezing should be treated as medically appropriate.

Caution should be exercised when prescribing BETHKIS to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Audiograms, serum concentration, and renal function should be monitored as appropriate.

Avoid concurrent and/or sequential use of BETHKIS with other drugs with neurotoxic or ototoxic potential.

BETHKIS should not be administered concurrently with ethacrynic acid, furosemide, urea, or mannitol. 

Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus. 

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.

BETHKIS full Prescribing Information is available at


PERTZYE® (pancrelipase) is owned by Digestive Care, Inc. and is licensed to Cornerstone Therapeutics for sales and marketing purposes in the United States. BETHKIS® (Tobramycin Inhalation Solution) is owned by Chiesi Farmaceutici S.p.A. and is licensed to Cornerstone Therapeutics Inc. for sales and marketing purposes in the United States.

About Cornerstone Therapeutics Inc.

Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies, marketed 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


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