SOURCE: Cornerstone Therapeutics

Cornerstone Therapeutics

November 20, 2013 08:02 ET

Cornerstone Therapeutics Launches BETHKIS® (Tobramycin Inhalation Solution) for Management of Cystic Fibrosis Patients With Pseudomonas Aeruginosa

CARY, NC--(Marketwired - Nov 20, 2013) - Cornerstone Therapeutics Inc. (NASDAQ: CRTX) announced today the launch of BETHKIS® (Tobramycin Inhalation Solution), a nebulized therapy indicated for the management of cystic fibrosis (CF) 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.1

In the U.S., approximately 30,000 adults and children are living with CF, an inherited chronic disease2 characterized by the production of thick, sticky mucus that alters normal processes in the lungs and digestive system. In the lungs, this thick mucus promotes the establishment of chronic bronchial infections due to bacteria, the most important of which is Pseudomonas aeruginosa. By adulthood, 80% of CF patients are infected with this potentially life-threatening bacteria.3 The Cystic Fibrosis Foundation strongly recommends the chronic use of inhaled tobramycin to improve lung function and reduce exacerbations.4

BETHKIS contains 300 mg of tobramycin -- the most widely used aerosolized antibiotic in patients with CF.2 BETHKIS' concentrated formulation delivers the same amount of antibiotic as other available nebulized tobramycin products (300 mg) in only 4 mLs -- allowing nebulization in approximately 15 minutes via the PARI LC® PLUS.1,5

"Cystic fibrosis patients have many challenges to navigate and we are pleased to be able to offer BETHKIS as a management option for this chronic and debilitating condition," said Craig A. Collard, Cornerstone's Chief Executive Officer. "With the addition of BETHKIS, along with PERTZYE® (pancrelipase) which we added to our portfolio earlier this year, we are building a strong therapeutic offering to patients living with CF as well as providing the support and resources they need. We look forward to growing these relationships and continuing to be a trusted resource to the CF community."

As part of Cornerstone's ongoing support, the company is expanding Cornerstone CareDirect, a comprehensive patient assistance program, to those patients prescribed BETHKIS. Cornerstone CareDirect provides reimbursement support and additional resources to help provide affordable access to treatment. Inquiries and enrollment in CareDirect may be handled via the BETHKIS website or by calling 888-865-1222 Monday through Friday, 9 a.m. to 6 p.m. EST.

For more information on BETHKIS educational materials, community news and general information, please visit the BETHKIS website and Facebook page.

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 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


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

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. BETHKIS® (Tobramycin Inhalation Solution) full prescribing information. Cornerstone Therapeutics Inc. October 2012.
2. Cystic Fibrosis Foundation Website. Accessed 4/22/13.
3. Cystic Fibrosis Foundation Patient Registry. Annual Data Report. 2011.Updated October 18, 2012.
4. Mogayzel PJ, Naureckas ET, Robinson KA, et al. "Cystic Fibrosis Pulmonary Guidelines", American Journal of Respiratory and Critical Care Medicine, Vol. 187, No. 7 (2013), pp. 680-689.
5. TOBI® (Tobramycin Inhalation Solution) full prescribing information. Novartis Pharmaceutical Corporation. November 2009.

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