Advanced Inhalation Therapies Granted European Orphan Drug Designation for Nitric Oxide for the Treatment of Cystic Fibrosis
Rehovot, Israel and New York, NY – May 1, 2015 – Advanced Inhalation Therapies Ltd (AIT), a leading anti-microbial therapeutic company, announced that the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, granted orphan medicinal product designation to AIT-CF, the Company’s proprietary high dose formulation of nitric oxide (NO), for the treatment of cystic fibrosis. The Orphan Designation is held by AIT’s European agent, Biological Consulting Europe Ltd, which is located in the United Kingdom.
AIT has completed a Phase IIa trial in adult CF patients. In February 2015, the Company disclosed that the U.S. Food and Drug Administration (FDA) also granted Orphan Drug Designation to AIT-CF for adjunctive treatment of cystic fibrosis (CF).
Dr. David Greenberg, Chief Medical Officer of Advanced Inhalation Therapies, commented, “AIT-CF potentially affords a significant benefit to CF patients. As a naturally occurring chemical in the body, NO, when inhaled at high concentrations, kills bacteria and fungi in the lungs of CF patients and has shown broad anti-infective activity. The European Orphan Drug Designation for AIT-CF affords additional benefits as we continue to advance its clinical development.”
The European Commission’s Orphan Designation is a status assigned to a medicine intended for use against a rare condition (prevalence of the condition in the European Union (EU) must not be more than 5 in 10,000). At the time of the designation, cystic fibrosis affected approximately 0.8 in 10,000 people in the EU or the equivalent of around 41,000 people based on current estimates. The EMA Orphan Medicinal Product Designation allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a disease that is life-threatening or a chronically debilitating rare disease. In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Medicinal Product Designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and gives direct access to centralized marketing authorization route.
About Cystic Fibrosis
Cystic Fibrosis (CF) is a lifelong, hereditary disease that causes mucus to form in the lungs and other organs. In 90% of CF cases, this mucus blocks the airways in the lungs, making it hard to breathe and leading to serious lung infections. For hospitalized CF patients, current treatments are supportive through the administration of oxygen through inhalation with bronchodilators, and include broad spectrum antibiotics and sometimes systemic steroids. Because these treatments do not eliminate all microbes, patients often suffer recurrent infections causing lung damage and ultimately in many cases respiratory failure.
About Advanced Inhalation Therapies
AIT is a biopharmaceutical company developing novel anti-viral therapeutics based on Nitric Oxide. The Company is applying its therapeutic expertise in NO to address significant medical needs, many of which cannot effectively be addressed with current standards of care, including small molecules and antibodies. AIT is building a pipeline of Nitric Oxide therapeutics as it has completed a Phase II trial for the treatment of respiratory syncytial virus (RSV) infection and a Phase II trial for the treatment of cystic fibrosis. The Company’s leadership position in fundamental patents, technology, and know-how relating to NO has enabled it to develop a unique NO drug formulation for the treatment of RSV infection and Cystic Fibrosis. AIT’s integrated proprietary system continuously monitors safety and efficacy parameters in patients. The Company, founded in 2011, maintains global headquarters in Rehovot, Israel and has an additional operating unit in New York, NY. For more information, visit www.AIT-Pharm.com.
Various statements in this release concerning our future expectations, plans, and prospects, including without limitation, statements concerning the use of Nitric Oxide therapeutics for the treatment of RSV and other viral disease and the availability of results of clinical trials and studies, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; and our short operating history; In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.
Amir Avniel, CEO, AIT
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