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Digestive Care, Inc. Donates Year-Long Supply of PERTZYE(R) (Pancrelipase) to Cystic Fibrosis Patients in El Salvador

Companies mentioned in this article: Cornerstone Therapeutics

BETHLEHEM, PA -- (Marketwired) -- 03/10/14 -- Digestive Care, Inc. (DCI), the manufacturer of PERTZYE® (pancrelipase) and its marketing partner in the U.S. cystic fibrosis (CF) market, Cornerstone Therapeutics Inc., are pleased to announce that on February 11, 2014, a year's supply of PERTZYE® was donated to the Benjamin Bloom Children's Hospital in San Salvador, El Salvador. The donation is part of an ongoing charitable program sponsored through collaboration with John Stevens, MD, Professor of Clinical Pediatrics at Indiana University, and CF care physician at the James Whitcomb Riley Hospital for Children CF Center in Indianapolis.

Dr. Stevens has been working with the Benjamin Bloom Children's Hospital CF Center in El Salvador since 2011. The CF Center at Bloom Hospital was first established in 1997 and houses one of the only two CF Centers in Central America. For the last ten years, the CF Center has been under the direction of Dr. Mauricio Romero, a pediatric pulmonologist and his efforts have contributed to an improvement in the lifespan of the CF patients. The need for PERTZYE became apparent to Dr. Stevens when he established a CF patient registry and began following the 25 CF patients currently under care at the hospital. Patient registry data revealed a mean age of 9.8 years with patients generally living into their mid teenage years in El Salvador, which compares to a median age of survival in the high 30s for CF patients in the United States.

"The difference in survival rates was so dramatic and frustrating, which calls for someone to do something to positively impact the lives of young patients with CF in the region," said Dr. Stevens. "The median household income in El Salvador is just $2,500 a year, treatment options for this disease are very limited and the patients do not have medical insurance which limits their access to life sustaining therapies. I realized that we needed to and could do so much more to provide greater access to treatments which prompted me to contact Dr. Tibor Sipos, President of Digestive Care."

Exocrine Pancreatic Insufficiency is very common in patients with CF and it is estimated that about 90% of patients with CF require pancreatic enzyme replacement therapy (PERT) such as PERTZYE. "We worked very closely with the office of the Ministry of Health for El Salvador to enable this donation. Dr. Romero and the CF patients have expressed their great appreciation for the gift of this pancreatic enzyme therapy which is extremely important to maintaining nutrition for these patients," said Dr. Tibor Sipos.

ABOUT PERTZYE (pancrelipase) DELAYED-RELEASE CAPSULES

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.

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.pertzyecf.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.

About Digestive Care, Inc.
Digestive Care, Inc., headquartered in Bethlehem, PA, is a fully integrated pharmaceutical company, founded in 1990, dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders. For more information, visit www.digestivecare.com.

About Cornerstone Therapeutics Inc.
Cornerstone Therapeutics Inc., 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.

Cornerstone Therapeutics is a wholly-owned subsidiary of Chiesi Farmaceutici S.p.A. For more information, visit www.crtx.com.

About Chiesi Farmaceutici
Chiesi Farmaceutici is a research-focused international group, with more than 75 years of experience headquartered in Parma (Italy). Chiesi researches, develops and commercializes innovative pharmaceutical solutions in the respiratory therapeutics and specialist medicine areas.

In 2013, Chiesi achieved sales of over 1.2 billion Euros, constituting double digit growth over 2012. Its R&D centers in Parma (Italy), Paris (France), Rockville (USA), Chippenham (UK) and the R&D team of the newly-acquired Danish company Zymenex, integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programs. The Chiesi Group employs approximately 3900 people, 480 of which are dedicated to R&D activities.

For more information, please visit www.chiesi.com

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