11.06.2018
Fresenius Medical Care AG & Co. KGaA DE0005785802
DGAP-News: Fresenius Medical Care and Humacyte announce strategic global partnership supported by a $150M equity investment
DGAP-News: Fresenius Medical Care AG & Co. KGaA / Key word(s): Miscellaneous
Fresenius Medical Care and Humacyte announce strategic global partnership
supported by a $150M equity investment
11.06.2018 / 14:01
The issuer is solely responsible for the content of this announcement.
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Fresenius Medical Care, the world's largest provider of dialysis products
and services, and Humacyte, Inc., a medical research, discovery and
development company, today announced a strategic, global partnership and a
$150M USD equity investment. This agreement has the potential to make
Humacyte's investigational human acellular vessel, HUMACYL(R), available to
more patients worldwide following approval of the product. HUMACYL is
currently being investigated for vascular access for hemodialysis and may
prove more effective than current synthetic grafts and fistula. Under the
terms of the agreement, Fresenius Medical Care will obtain the exclusive
global rights to commercialize HUMACYL.
Fresenius Medical Care will be responsible for the marketing, sales and
distribution of HUMACYL following approval by the relevant health
authorities. In addition, Fresenius Medical Care will make a $150M USD
equity investment in Humacyte to gain a 19% fully diluted ownership stake in
the company. With the investment, Fresenius Medical Care will have the
opportunity to bring transformative clinical innovation in the form of
Humacyte's bioengineered human acellular vessels to the worldwide end stage
renal disease (ESRD) patient population following product approval. The
transaction is subject to customary closing conditions, including expiration
or termination of the waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976, as amended, and is expected to close in July 2018.
"By partnering with Humacyte, Fresenius Medical Care has an opportunity to
offer a dialysis vascular access option with the potential for significant
clinical efficacy and safety improvements, including the potential to
minimize catheter contact time to the benefit of our patients," said
Franklin Maddux, MD, Chief Medical Officer for Fresenius Medical Care North
America. "Our exclusive rights to distribute this innovative technology to
dialysis patients worldwide may have significant benefits not only to
patients, but health systems as well. With the potential for fewer
anticipated complications and interventions compared to synthetic grafts, we
may see increased safety for patients and reduced medical and economic
burdens to the healthcare system."
The current vascular access modalities necessary to deliver dialysis
treatment include fistulas, grafts and central venous catheters. All three
options have limitations. Half of fistulas fail and do not mature in
patients, delaying vascular access for dialysis treatment. In the meantime,
many patients need a central venous catheter, which significantly increases
the risk of infection. Humacyte has developed a novel human tissue-based
investigational product, HUMACYL, for patients with ESRD requiring
hemodialysis. Compared to an arteriovenous fistula, HUMACYL can be available
for use in hemodialysis within weeks and may have an overall higher rate of
maturation. It also may offer a more durable, biologic alternative to
synthetic grafts.
"This is a transformational milestone for Humacyte, giving us the world's
strongest partner to help bring our product to more patients globally," said
Carrie Cox, CEO and Chairman of Humacyte, Inc. "Our partnership will allow
Humacyte to focus on advancing the potential for HUMACYL as a substantial
breakthrough in the science of regenerative medicine, and to continue our
development of an exciting future pipeline."
Humacyte's bioengineered blood vessel is currently in Phase III pivotal
trials in the U.S. and Europe, and the company plans to seek regulatory
approval in both regions upon completion of the trials.
About Fresenius Medical Care
Fresenius Medical Care is the world's largest provider of products and
services for individuals with renal diseases of which around 3.2 million
patients worldwide regularly undergo dialysis treatment. Through its network
of 3,790 dialysis clinics, Fresenius Medical Care provides dialysis
treatments for 322,253 patients around the globe. Fresenius Medical Care is
also the leading provider of dialysis products such as dialysis machines or
dialyzers. Along with its core business, the company provides related
medical services in the field of Care Coordination. Fresenius Medical Care
is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock
Exchange (FMS).
For more information visit the company's website at
www.freseniusmedicalcare.com.
About Humacyte
Humacyte, Inc., a privately held company founded by Dr. Laura E. Niklason,
M.D., Ph.D., in 2004, is a medical research, discovery and development
company with clinical and pre-clinical stage investigational products.
Humacyte is primarily focused on developing and commercializing a
proprietary novel technology based on human tissue-based products for key
applications in regenerative medicine and vascular surgery. The company uses
its innovative, proprietary platform technology to engineer human,
extracellular matrix-based tissues that can be shaped into tubes, sheets, or
particulate conformations, with properties similar to native tissues. These
are being developed for potential use in many specific applications, with
the goal to significantly improve treatment outcomes for many patients,
including those with vascular disease and those requiring hemodialysis. The
company's proprietary technologies are designed to create off-the-shelf
products that, once approved, can be utilized in any patient.
The company website is www.humacyte.com.
Disclaimer
This release contains forward-looking statements that are subject to various
risks and uncertainties. Actual results could differ materially from those
described in these forward-looking statements due to certain factors,
including changes in business, economic and competitive conditions, risks
and uncertainties in research and development and the regulatory approval
process; failure to satisfy the conditions to the consummation of the
transaction, including the receipt of regulatory approval; regulatory
reforms, foreign exchange rate fluctuations, uncertainties in litigation or
investigative proceedings, and the availability of financing. These and
other risks and uncertainties are detailed in Fresenius Medical Care AG &
Co. KGaA's reports filed with the U.S. Securities and Exchange Commission.
Without prejudice to its obligations under capital market laws, neither
Fresenius Medical Care AG & Co. KGaA nor Humacyte, Inc. undertakes any
responsibility to update the forward-looking statements in this release.
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11.06.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: Fresenius Medical Care AG & Co. KGaA
Else-Kröner-Straße 1
61352 Bad Homburg
Germany
Phone: +49 (0) 6172- 609 2525
Fax: +49 (0) 6172- 609 2301
E-mail: [email protected]
Internet: www.freseniusmedicalcare.com
ISIN: DE0005785802
WKN: 578580
Indices: DAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange; NYSE
End of News DGAP News Service
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