Garden Grove, CA—December 18, 2013 (eReleases): Novoteris, LLC. A clinical stage medical device and pharmaceutical developer focused on innovative applications for nitric oxide gas where it can be applied for unmet medical needs, announced today that the European Commission, Health & Consumers Directorate-General Medicinal products – authorizations, EMA, has granted it orphan drug designation for the use of inhaled nitric oxide for the treatment of Cystic Fibrosis.
The European Orphan Drug Act is intended to encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a ten year term of data exclusivity upon final EMA approval, orphan drug designation also positions Novoteris to be able to leverage a wide range of financial and regulatory benefits, including government and institutional grants, and reductions in filing fees for the potential submission of a request for marketing approval.
“The EMA’s decision to grant nitric oxide orphan drug designation for this indication signifies another important step for Novoteris” stated Alex Stenzler, President of Novoteris. “This builds on the marketing exclusivity as an orphan drug that Novoteris received from the US Food and Drug Administration earlier this year.” Chris Miller, PhD, Chief Science Advisor noted that “The results from our pilot trial demonstrated more than a 15% increase in lung function following two weeks of therapy and we anticipate that we will be able to demonstrate similar outcomes in our Phase II trials.” Following the presentation of the data from the pilot trial, both the US Cystic Fibrosis Foundation and the European Cystic Fibrosis Society sent letters of support for the Orphan Drug designation to the EMA.
About Cystic Fibrosis
Cystic fibrosis (CF) is an autosomal recessive genetic disorder that affects most critically the lungs. Difficulty breathing is the most serious symptom and results from frequent lung infections that are most often treated with lifelong inhaled antibiotics. Development of drug resistance to available antibiotics is a major concern for patients with CF.
About Nitric Oxide
Nitric oxide, an endogenous molecule, is the most important signaling molecule in the body and plays an important role in every organ system, including the innate defense system against microorganisms. Exogenous nitric oxide has been demonstrated to be an effective antimicrobial agent against a broad spectrum of microbes, including drug resistant strains. A lower concentration of nitric oxide is already on the market from other manufacturers for the treatment of pulmonary hypertension in newborns. “This new application brings years of work with nitric oxide gas for antimicrobial uses to the clinical forefront.” added Dr. Miller.
About Novoteris, LLC
Novoteris is a privately held limited liabilities corporation that is managed by a group of international industry veterans and clinicians involved in developing and producing innovative, cutting-edge medical products.