MediWound -- Positive Recommendation for Marketing Authorization From the European Medicines Agency for Its Innovative Drug --
25 September 2012 - 4:45AM
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 NexoBridTM 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.
NexoBridTM'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.
NexoBridTM, 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:
NexoBridTM for burn wound eschar removal and PolyHealTM, 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 NexoBridTM
NexoBridTM 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. NexoBridTM 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, NexoBridTM for removal of eschar in adult
patients with deep partial- and/or full-thickness thermal burn was
approved by EMA. MediWound's medical device, PolyHealTM 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.
CONTACT: MediWound Ltd.
42 Yarkon St
81227 Yavne, Israel
Tel: 972-8-9324010
Web: www.mediwound.com
Fax: 972-8-9324011