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FDA Grants Orphan Drug Designation for Bayer's Investigational Ciprofloxacin DPI (Dry Powder for Inhalation) for Treatment of Non-Cystic Fibrosis Bronchiectasis

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Wednesday, April 23, 2014

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Not intended for U.S. and UK Media - Non-Cystic Fibrosis Bronchiectasis (NCFB)

Bayer HealthCare announced that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development has granted an orphan drug designation for its investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis (NCFB). Patients with NCFB suffer from frequent severe acute pulmonary bacterial exacerbations that lead to further lung damage and inflammation. The Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders. Any disease that affects less than 200,000 patients in the US is regarded as rare by the FDA. At present there are no long-term treatment options approved for patients with NCFB to reduce frequency of exacerbations.

“As frequent and severe exacerbations are common amongst patients with NCFB, there is a significant unmet medical need for long-term treatment options,” said Dr. Jörg Möller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “We are pleased to receive the orphan drug designation from the FDA for Ciprofloxacin DPI. If the Phase III trial program confirms our belief that Ciprofloxacin DPI can become an effective and safe treatment for this condition, patients may benefit from significantly fewer exacerbations and an improved quality of life.”

Ciprofloxacin DPI is in development by Bayer HealthCare for NCFB patients with respiratory bacterial pathogens, including Pseudomonas aeruginosa, to reduce the frequency of acute exacerbations. It comprises ciprofloxacin formulated into dry powder for inhalation using Novartis’ PulmoSphere™ technology combined with its pocket-sized T-326 inhaler. The clinical efficacy and safety of chronic intermittent Ciprofloxacin DPI therapy in NCFB is currently being studied in a global Phase III trial program (RESPIRE). It aims to demonstrate superiority of Ciprofloxacin DPI compared to placebo.

NCFB is a chronic respiratory disease of which up to 50 to 80% of cases are idiopathic. [1] A vicious cycle of recurrent microbial infections and persistent inflammation leads to further damage of airway walls and predisposes the lung to new infections. [1] [2] Bacterial colonization of the airways, most commonly with Haemophilus influenzae and Pseudomonas aeruginosa, is found in more than 60% of adult patients with stable bronchiectatic disease. [3] [4] In particular, presence of Pseudomonas aeruginosa has been associated with accelerated decline in lung function. [1] The well-known fluoroquinolone antibiotic ciprofloxacin shows bactericidal activity against both Haemophilus influenzae and Pseudomonas aeruginosa [5], as well as most other bacterial pathogens cultured in sputum of NCFB patients.

About Ciprofloxacin DPI

Ciprofloxacin DPI is in development by Bayer HealthCare for NCFB patients with respiratory bacterial pathogens, including Pseudomonas aeruginosa, to reduce the frequency of acute exacerbations. It comprises ciprofloxacin formulated into dry powder for inhalation using Novartis’ PulmoSphere™ technology combined with its pocket-sized T-326 inhaler. PulmoSphere™ technology is an emulsion-based spray drying process producing light, porous particles for deep delivery into the lung. [6] This proprietary technology results in Ciprofloxacin DPI particles of less than 5 micrometers in aerodynamic diameter [6] to deliver efficient and targeted antibacterial therapy to the lung. The pocket-sized breath-actuated delivery device is designed to be patient-friendly. It does not require a power source, does not need cleaning and has a short administration time.

About the Phase III programme RESPIRE

The global RESPIRE programme comprises two multinational, randomized, placebo-controlled, double-blind, multi-centre studies that investigate the clinical efficacy and safety of chronic intermittent Ciprofloxacin DPI therapy in NCFB.

About non-CF bronchiectasis

Non-CF bronchiectasis (NCFB) is a distinct disease with multiple aetiologies including post-infectious or underlying anatomic or systemic diseases [7] [8]. There are currently no long-term treatment options available that are specifically approved for patients with NCFB.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.

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References

[1] O'Donnell AE, “Bronchiectasis,” Chest, 134, 815-823, 2008.

[2] King PT, “The pathophysiology of bronchiectasis,” International Journal of COPD, 4, 411-419, 2009.

[3] Angrill J, et al., “Bacterial colonization in patients with bronchiectasis: microbiological pattern and risk factors,” Thorax, 57, 15-19, 2002.

[4] Pasteur MC, et al., “An investigation into causative factors in patients with bronchiectasis,” Am J Respir Crit Care Med, 162, 1277-84, 2000.

[5] Campoli-Richards DM, et al., “Ciprofloxacin. A review of its antibacterial activity, pharmacokinetic properties and therapeutic use,” Drugs, 35, 373-447, 1988.

[6] Duddu SP, et al., “Improved lung delivery from a passive dry powder inhaler using an engineered PulmoSphere(R) powder,” Pharmaceutical Research, 19, 689-695, 2002.

[7] Li AM, et al., “Non-CF bronchiectasis: does knowing the aetiology lead to changes in management?,” European Respiratory Journal, 26, 8-14, 2005.

[8] Shoemark A, et al., “Aetiology in adult patients with bronchiectasis,” Respiratory Medicine, 101, 1163-1170, 2007.

Source: Bayer HealthCare
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