Positive Recommendation for Marketing Authorization from the European Medicines Agency for its innovative drug – NexoBrid™
Positive Recommendation for Marketing Authorization from the European Medicines Agency for its innovative drug – NexoBrid™Tel Aviv, Israel, September 23, 2012: Clal Biotechnology, (TASE: CBI), a leading investment company in the field of life sciences, is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended to grant marketing authorization for NexoBrid in the European Union (EU) for removal of eschar in adult patients with deep partial- and/or full-thickness thermal burns. This approval follows EMA’s Good Manufacturing Practices (cGMP) approval for MediWound’s sterile manufacturing plant and laboratories.

NexoBrid’s  Marketing Authorization Application was assessed in the framework of EMA’s centralized procedure, whereby marketing authorization is granted for all countries within the EU. MediWound estimates that the European Commission will adopt the recommendations of EMA during the fourth quarter of 2012.

NexoBrid, MediWound’s innovative drug, has shown statistically significant effect in earlier eschar removal from partial and/or full thickness burns in a number of multi-national, multi-centered, controlled clinical studies. Upon adoption of the EMA recommendation by the European Commission, MediWound will have two ground-breaking products approved for marketing in the EU: NexoBrid for burn wound eschar removal and PolyHeal, which is already approved in Europe, for the treatment of chronic, hard to heal wounds. MediWound is initiating the preparations towards the launch of both products.

Ruben Krupik, CEO Clal Biotechnology, commented: “We are very pleased to announce today the first product, from the extensive portfolio of the Clal Biotechnology group, to receive EMA approval. This significant achievement will provide additional stimulus for our efforts in promoting the development of advanced innovative drugs, and to further develop Israel’s biotechnology industry”.

Gal Cohen, CEO MediWound, stated: “Today, MediWound has two well-differentiated innovative products in the field of wound management, which can position MediWound as a major player in this large and growing market. We continue to expand our efforts to ensure maximization of the potential of these products from a commercial point of view while further developing these products for other indications that will benefit additional patients with significant unmet needs”.

About NexoBrid

NexoBrid is an innovative drug indicated for removal of eschar in adult patients with deep partial- and/or full-thickness thermal burn. The drug, which is manufactured in MediWound’s sterile production plant, consists of a mixture of enzymes extracted from the stem of the pineapple plant. NexoBrid removes the eschar after a single 4 hour topical application without harming viable tissues, enabling earlier successful eschar removal and direct visual assessment of the burn’s depth for informed decision on further treatment. Moreover, the effective non surgical eschar removal allows significant reduction in the number and extent of surgical excision and autografting. 

About MediWound

MediWound is a late-stage biotechnology company committed to develop, manufacture & commercialize global innovative products that address unmet needs in the fields of burn and wound management. MediWound operates a cGMP and ISO13485 manufacturing facility for sterile pharmaceutical products and medical devices. MediWound’s drug, NexoBrid for removal of eschar in adult patients with deep partial- and/or full-thickness thermal burn was approved by EMA.  MediWound’s medical device, PolyHeal for dechronification of hard to heal and chronic wounds, was granted a CE mark. The market for each of the products is estimated to be in the hundreds of millions of dollars. MediWound’s major shareholder is Clal Biotechnology Industries, holding a 52% equity position.

About Clal Biotechnology Industries

Clal Biotechnology Industries (CBI), driven by strategic vision and backed by significant financial resources, is Israel’s largest life sciences investment group. CBI targets promising companies with innovative biopharmaceutical technologies and transforms them into viable, sustainable businesses. Managing assets valued over US$ 1 Billion in capital, CBI successfully leverages a unique investment model of large-scale, long-term financial and managerial commitment that yields significant results and value creation.

CBI is held by Clal Industries Ltd. (holding 57% of CBI’s shares) and Teva Pharmaceutical Industries Ltd. (holding 14% of CBI’s shares). CBI is traded on the Tel Aviv Stock Exchange (TASE: CBI) and is included in the TA 100 Index, BioMed Index, and the BlueTech index.