Friday, March 3, 2017

MediWound (NASDAQ: MDWD) to Extend Label for Pineapple Drug to Larger Burns

When Christopher Columbus introduced the pineapple to Europe in the late fifteenth century, he undoubtedly would have had no idea that extracts from the plant could be used to treat severe thermal burns. Yet, 500 years later, a next-generation proteolytic enzyme platform for wound debridement, NexoBrid, derived from pineapples, has been developed by MediWound Ltd. (NASDAQ: MDWD). Now, positive results from a Phase II study evaluating NexoBrid will be used to support a request to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to extend the label for NexoBrid to larger burns. The painstaking research undertaken by niche specialty biotech MediWound is beginning to bear fruit.

That research has laid bare one ‘secret’ of the medicine practiced traditionally by natives of South and Central America and developed on it to improve the treatment of wounds. Pineapples, it turns out, are a rich source of proteolytic enzymes, referred to generally as bromelain, which promote healing in wounds by stimulating debridement, the removal of dead tissue and foreign material. Proteolytic enzymes remove this necrotic tissue, known as eschar, at a much faster rate than would occur otherwise. To harness this powerful chemical process, MediWound has developed its proteolytic enzyme platform. NexoBrid is a concentrate derived from a mixture of proteolytic enzymes extracted from the stem of the pineapple plant, enriched in bromelain. The drug is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.

Last month, MediWound announced positive results from a Phase II study that evaluated the safety, pharmacokinetics (transcutaneous absorption) and efficacy of NexoBrid in hospitalized children and adults with severe thermal burns. The multicenter, open-label, single-arm study was conducted in Europe, Israel and India and included 36 patients with severe burns of 4 percent to 30 percent total body surface area (TBSA).

NexoBrid was applied to burns of up to 15 percent TBSA in one session, and when the wound area to be treated was more than 15% TBSA, NexoBrid was applied in two separate sessions, each up to 15 percent TBSA. Trial results showed that the use of NexoBrid was safe and effective. Furthermore, the pharmacokinetic profile following NexoBrid’s first and second topical application was comparable, suggesting no concern with accumulation following a second topical application of NexoBrid. As a result, the company intends to send requests to the FDA and EMA to extend the label for NexoBrid to larger burns.

MediWound is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, as well as chronic and other hard-to-heal wounds. Its first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency for removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns and has already been launched in Europe.

MediWound’s second innovative product, EscharEx®, is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds, a large and growing market. EscharEx® is complementary to the large number of existing wound healing products, which require a clean wound bed in order to heal the wound. EscharEx®contains the same proteolytic enzyme technology as NexoBrid® and benefits from the wealth of existing development data on NexoBrid®.

Aegis Capital, which initiated coverage on MediWound late last year, has issued a ‘Buy’ rating on the stock, setting a price target of $11.00. The stock, under the symbol MDWD, currently trades on the NASDAQ at around $6.00.

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