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Scioderm Receives Orphan Drug Designation In The European Union For Novel Topical Therapy To Treat Epidermolysis Bullosa


1/23/2014 10:49:37 AM

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DURHAM, N.C.
, Jan. 22, 2014 /PRNewswire/ -- Scioderm, Inc., today announced that the European Commission (EC) has granted orphan drug designation for SD-101 for the treatment of patients with Epidermolysis Bullosa (EB), a group of rare genetic skin diseases. This decision follows a positive opinion adopted by the Committee for Orphan Medicinal Products (COMP), recommending such designation. Epidermolysis Bullosa is a rare genetic connective tissue condition that, in all of its forms, share the prominent manifestation of extremely fragile skin that blisters or tears with the slightest friction or trauma. This particular manifestation has led to EB patients being known as "Butterfly children" due to the analogous nature of the fragility of the skin to the wings of a butterfly.

An Orphan Drug designation provides 10 years of market exclusivity upon receipt of European Union (EU) marketing approval. This period of marketing exclusivity can be extended by two additional years for medicines that have also complied with an agreed pediatric investigation plan (PIP), which Scioderm has submitted and is currently under review. It also allows for regulatory assistance in preparing the marketing application, free protocol assistance to optimize clinical development, reduced regulatory fees associated with applying for marketing approval and direct access to the centralized procedure for Marketing Authorization Application (MAA) through the European Medicines Agency (EMA). This allows companies to make a single application to the EMA, resulting in a single opinion and a single decision from the EC, valid in all EU member states.

"We are very pleased to receive orphan designation for SD-101 from the European Commission," said Robert Ryan., Ph.D., President and Chief Executive Officer of Scioderm. "This designation recognizes the potential of SD-101 by the European Commission to address a great unmet medical need."

Dr. Ryan continued: "Now that we have commenced our Phase 2B/3 study of SD-101 in treating EB, we intend to pursue strategic commercial partners more aggressively. We believe orphan designation and the expectation of up to 12 years of marketing exclusivity in Europe will enhance partnering interest for Europe."

About SD-101 and Scioderm

SD-101 is a topical cream that has previously demonstrated potential to provide improvement in treating the severe skin effects seen in patients across all EB subtypes, including complete wound closure.

Scioderm is a privately held, clinical-stage pharmaceutical company focused on developing innovative therapies to address diseases with critical unmet medical needs, including orphan products. In 2013, Scioderm, Inc. was the first biotech to receive "Breakthrough Therapy" designation for SD-101 from the Food and Drug Administration (FDA) for the treatment of skin effects in patients with Epidermolysis Bullosa. In addition, Scioderm was recently selected as a 2013 "Fierce Top 15" company by FierceBiotech, considered as one of the top 15 emerging companies in the biotech industry. Additional information about Scioderm can be found at www.sderm.com.

Forward Looking Statement

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. Scioderm disclaims any intent or obligation to update these forward-looking statements.

Investor and Media Contact

Robert Coull
Chief Operating Officer
robert.coull@sderm.com
(919)-824-2594

SOURCE Scioderm, Inc.



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