Cornerstone Therapeutics Inc. Initiates PERTZYE® (pancrelipase) Sales and Marketing Efforts for the Treatment of Exocrine Pancreatic Insufficiency in Patients With Cystic Fibrosis

CARY, NC--(Marketwired - July 29, 2013) -

Cornerstone Therapeutics Inc. (NASDAQ: CRTX) announced today it is now actively marketing PERTZYE® (pancrelipase) in the U.S. for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis. PERTZYE is the only U.S. Food and Drug Administration (FDA) approved pancreatic enzyme replacement therapy (PERT) containing bicarbonate-buffered, enteric-coated microspheres.(1) It is estimated that about 90% of patients with cystic fibrosis require PERT.(2)

In healthy individuals, the pancreas produces bicarbonate that helps regulate the pH of the small intestine to hydrolyze fat, support sufficient lipase bioactivity, and optimize nutrient absorption.(3-5) Patients with CF who have EPI may have a more acidic duodenal pH environment because the pancreas does not produce the bicarbonate-rich secretion required to neutralize gastric acid.(3,5) PERTZYE’s unique formulation, containing pancreatic enzymes buffered with bicarbonate, is designed to simulate normal pancreatic function in CF patients with EPI. (1,3-5)

“We are pleased to now be able to provide patients a unique PERT formulation to help manage this complex condition,” said Craig A. Collard, Cornerstone’s Chief Executive Officer. “PERTZYE is the first of two FDA approved cystic fibrosis therapies that Cornerstone plans to offer this year. PERTZYE, together with BETHKIS® (tobramycin inhalation solution) when it launches this fall, will deliver on our goal to build a portfolio of cystic fibrosis treatments and educational support for people living with this disease.”

Cornerstone Therapeutics licensed exclusive U.S. marketing rights to PERTZYE for the treatment of EPI in patients with cystic fibrosis from Digestive Care, Inc. (DCI) in May 2013. DCI’s sales and marketing efforts for PERTZYE will continue to focus on meeting the needs of patients with EPI due to conditions other than cystic fibrosis in the U.S. market.

ABOUT PERTZYE (pancrelipase) DELAYED-RELEASE CAPSULES

PERTZYE 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. PERTZYE is not interchangeable with other pancrelipase products. 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.(1) PERTZYE is currently available in two strengths: 8,000 and 16,000 USP units of lipase/capsule.

IMPORTANT SAFETY INFORMATION ABOUT PERTZYE

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 www.pertzye.com.

IMPORTANT SAFETY INFORMATION 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 FEV(1) 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 www.crtx.com.

TRADEMARKS

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 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 www.crtx.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein, other than statements of historical fact, including our strategy and our future operations and opportunities. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the degree of market acceptance of our products and product candidates by physicians, patients, healthcare payers and others in the medical community, our ability to successfully and effectively launch our products and product candidates, our ability to develop and maintain the necessary sales, marketing, supply chain and distribution capabilities to successfully commercialize our products and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 14, 2013 and in our subsequent filings with the SEC. In addition, the statements in this press release reflect our expectations and beliefs only as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as may be required by law. Our forward-looking statements do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this release.

(1) PERTZYE (pancrelipase) Prescribing Information. Bethlehem, PA: Digestive Care; May 2012
(2) “Patient Registry Annual Report 2011.” Cystic Fibrosis Foundation. Cystic Fibrosis Foundation. Date Accessed 5/3/13 (http://www.cff.org/UploadedFiles/research/ClinicalResearch/2011-Patient-Registry.pdf).
(3) Borowitz, DS, Grand RU, Durie PR. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Consensus Committee. J Pediatr. 1995; 127(5); 472-480.
(4) Manual of Clinical Enzyme Measurements. Freehold, NJ; Worthington Biomedical Corporation; 1972: 1-56.
(5) Ishiguro H, Steward MC, Naruse S, et al. CFTR functions as a bicarbonate channel in pancreatic duct cells. J Gen Physiol. 2009;133(3):315-326.

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