Cornerstone Therapeutics Acquires Exclusive U.S. Marketing Rights to PERTZYE(R) (pancrelipase) for Treatment of Exocrine

Cornerstone Therapeutics Acquires Exclusive U.S. Marketing Rights to PERTZYE(R) 
(pancrelipase) for Treatment of Exocrine Pancreatic
Insufficiency in Patients With Cystic Fibrosis 
Acquisition of Marketing Rights to FDA Approved Therapy Expands
Company's Cystic Fibrosis Portfolio 
CARY, NC -- (Marketwired) -- 05/09/13 --  Cornerstone Therapeutics
Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on
commercializing products for the hospital and adjacent specialty
markets, today announced it has entered into an agreement with
Digestive Care, Inc. (DCI) to acquire exclusive U.S. rights to market
PERTZYE(R) (pancrelipase) for the treatment of Exocrine Pancreatic
Insufficiency (EPI) due to cystic fibrosis (CF). PERTZYE is a unique
pancreatic enzyme product and is protected by several U.S.
patents(1). The PERTZYE formulation was previously marketed by DCI
for more than a decade under the trade name PANCRECARB(R) MS-16. It
is estimated that about 90% of patients with CF receive pancreatic
enzyme replacement therapy (PERT)(2) with the therapeutic category
experiencing 24% annual growth from 2008-2012. 
"The acquisition of the exclusive U.S. CF marketing rights for
market-ready PERTZYE will have an immediate revenue impact for
Cornerstone," said Craig A. Collard, Cornerstone's Chief Executive
Officer. "With net sales of PERT products reaching approximately $200
million in the CF category in 2012, we see significant opportunity
for growth. Also, the addition of PERTZYE complements Cornerstone's
launch of the CF drug BETHKIS(R) (tobramycin inhalation solution)
later this year. This is yet another strategic step in our commitment
to building a portfolio of industry-leading brands for the growing
U.S. hospital and adjacent specialty markets." 
Dr. Tibor Sipos, President and Chief Scientific Officer of DCI,
stated, "We are pleased to partner with Cornerstone and are confident
that their CF-focused marketing efforts will enhance patient
accessibility to PERTZYE and provide support for educational
programs. Going forward, DCI's sales and marketing efforts for
PERTZYE will be focused on meeting the needs of patients with EPI due
to conditions other than CF 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 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.  
Exercise caution when administering pancrelipase to a patient with a
known allergy to proteins of porcine origin. 
There is theoretical risk of viral transmission with all pancreatic
enzyme products including PERTZYE. 
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(R) 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 www.crtx.com. 
TRADEMARKS 
PERTZYE(R) (pancrelipase) is owned by Digestive Care, Inc. and is
licensed to Cornerstone Therapeutics for sales and marketing purposes
in the United States. BETHKIS(R) (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. 
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.  
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, including our
plans regarding the manner and timing for the launch and sale of
PERTZYE, constitute forward-looking statements. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including our
ability to satisfy FDA and other regulatory requirements, our ability
to develop and maintain the necessary sales, marketing, supply chain
and distribution capabilities to successfully commercialize PERTZYE,
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) U.S. Patent Numbers: 5,260,074; 5,302,400; 5,324,514; 5,460,812;
5,578,304; 5,750,104. 
 (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]. 
PERTZYE(R) (pancrelipase) Delayed-Release Capsules are manufactured
in the USA by Digestive Care, Inc., Bethlehem, PA. 
Contacts  
CRTX Investor Relations Contact: 
Josh Franklin
Vice President, Strategy and Business Development
+1-919-678-6520
josh.franklin@crtx.com 
CRTX Media Relations Contact: 
FleishmanHillard
Andrea Moody
+1-919-457-0743
andrea.moody@fleishman.com 
DCI Contact: 
Steve Berens
Vice President Sales and Marketing
+1-610-882-5950
sberens@digestivecare.com 
 
 
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