Washington, D.C.  20549
______________________

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

 

Pursuant to Rule 13a-16 or 15d-16 of the
Securities Exchange Act of 1934

 

For the month of May 2019

 

Commission File Number: 001-36349

 

                  MediWound Ltd.                   
(Translation of registrant’s name into English)

 

 (Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F  ☒        Form 40-F   ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  __

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  __

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	MEDIWOUND LTD.
Date: May 29, 2019	By:	/s/ Sharon Malka
	Name:	Sharon Malka
	Title:	Chief Executive Officer

 

 

 

EXHIBIT INDEX

 

 

Total non-dilutive funds for NexoBrid now valued at up to $196 Million

MediWound to initiate NexoBrid expanded access treatment protocol (NEXT) in the third quarter of 2019,

allowing for ongoing use of NexoBrid to treat burn patients in U.S

YAVNE, Israel, May 29, 2019 -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has upsized its awarded contract with MediWound and provided supplemental funding of $21 million to initiate NexoBrid expanded access treatment protocol (NEXT).

As a result of the additional $21 million in committed funds for the thermal burn contract, the total non-dilutive funding under both contracts with BARDA is now valued at up to $196 million. As of March 31, 2019 the Company has received approximately $31 million from BARDA.

“We are very pleased with BARDA’s continued commitment towards the development of NexoBrid, allocating supplemental funds to support multiple indications. BARDA’s continuous support underscores its endorsement of our breakthrough therapy for treatment of severe burns and its mission for building mass casualty event preparedness,” said Sharon Malka, CEO of MediWound. “BARDA’s significant continuous support and our recently announced commercial agreement with Vericel for rights within North America further validate NexoBrid’s role as an important treatment for patients with severe burns.  We look forward to continuing our collaboration with BARDA and Vericel in order to make NexoBrid available to U.S. burn patients.”

Mr. Malka added, “We plan to initiate the NEXT expanded access treatment protocol in the third quarter of 2019, in tandem with our preparation of the NexoBrid BLA, which is planned for submission in the fourth quarter of this year, subject to FDA concurrence. The NEXT protocol allows for the continued clinical use as well as non-declared emergency use of NexoBrid on U.S. patients, prior to NexoBrid approval by the FDA. We believe the NEXT treatment protocol will further extend the NexoBrid user-base across the U.S. and generate further awareness, advocacy, and use at U.S. centers of excellence, potentially facilitating significant market penetration”.

 

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA. Funding and support for development of NexoBrid has been provided by BARDA, under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C and HHSO100201800023C.

About MediWound Ltd.

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, chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean and Russian Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and without harming viable tissues.

MediWound's second innovative product, EscharEx^® is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds. EscharEx is complementary to the many 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.  In two Phase 2 studies, EscharEx demonstrated safety and efficacy in the debridement of chronic and other hard-to-heal wounds, within a few daily applications.

For more information, please visit www.mediwound.com.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to timing of regulatory filings and submissions; expected funding from BARDA and/or exercise of its options; our ability to meet the timeline for the initiation of the NEXT treatment protocol, results of the NEXT treatment protocol and Vericel’s ability to commercialize NexoBrid.. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. In particular, you should consider that we may not submit the BLA to FDA in the timeframe expected, or at all; we will not continue to receive funding under BARDA contract or BARDA may choose not to exercise its options, we meet the timeline for the initiation of the NEXT study FDA may not provide marketing approval for NexoBrid in the United States and, if such approval is obtained, Vericel may not be able to successfully commercialize NexoBrid in the United States; and the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2018 as well as information contained in other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

 

Contacts:                                 Jeremy Feffer

Sharon Malka                          Managing Director

Chief Executive Officer          LifeSci Advisors

MediWound Ltd.                   212-915-2568

ir@mediwound.com               jeremy@lifesciadvisors.com