Full Press Release Details
HISTOGENICS CORPORATION AND MEDINET CO., LTD ENTER INTO LICENSING AGREEMENT FOR DEVELOPMENT AND
COMMERCIALIZATION OF NEOCART FOR THE JAPANESE MARKET
Transaction Terms Include a $10 Million
Up-front Payment with a Potential of $87 Million in Total Milestones, and Tiered Royalties on Sales
Japanese Cartilage Repair Market is Large and Growing with Established Reimbursement, and Physicians and Patients Seeking Improved
Treatments for Cartilage Defects that may Prevent the Progression to Knee Osteoarthritis
Plans to Initiate Phase 3
Clinical Trial in Japan in the Second Half of 2018 with Potential Commercialization in Japan in 2021
December 21, 2017 /GLOBE NEWSWIRE/ Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced
that it has entered into an agreement with MEDINET Co., Ltd. (MEDINET), a pioneering leader in the development and commercialization of cancer immuno-cell therapy technologies, for the development and commercialization of NeoCart for the
This transformative collaboration for Histogenics is a clear validation of the value NeoCart potentially provides to the
physicians and patients who suffer from painful cartilage defects and related loss of function. MEDINET is one of the leaders of the burgeoning regenerative medicine sector in Japan, with strong capabilities in development and manufacturing of cell
therapy products. We believe their recent initiatives to further develop their therapeutic capabilities with the addition of innovative products such as NeoCart will provide a rapid entry into the Japanese market, stated Adam Gridley,
President and Chief Executive Officer of Histogenics. Our ability to leverage our long clinical and translational medicine history in the U.S. in markets such as Japan was a first step in bringing NeoCart to other regions, and we look forward
to expanding our global presence more broadly in 2018 into other potential territories in Asia and Europe.
Histogenics formal consultations
with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (the PMDA) concluded in the second quarter of 2017 and the positive conclusion of those consultations played an integral role in enabling
this collaboration. Formal feedback from the PMDA regarding the development and approval pathway for NeoCart in Japan included:
I am excited about the potential to bring this exciting therapy to Japanese patients and physicians
through this new partnership, stated Dr. Shuichi Mizuno, Ph.D., a scientific founder of NeoCart, Assistant Professor, Orthopedic Surgery, Brigham and Women s Hospital, and Harvard Medical School, in whose laboratory the underlying
technology for NeoCart was discovered.
Japanese Cartilage Repair Market
The Japanese cartilage repair market is estimated to be the second largest market in the world after the U.S. and it is estimated that there may be at least
10,000 NeoCart treatments per year. If left untreated, cartilage defects may result in Osteoarthritis (OA) and ultimately, total knee replacements. Market forecasts predict that the number of OA patients in Japan aged 40 and older amounts to more
than 25 million and is expected to accelerate as the population ages.
In the first half of 2017, Histogenics conducted market research in Japan with
approximately 80 leading surgeons with the findings summarized below:
This licensing deal has been realized based on our longtime close relationship with Histogenics. I am excited about and proud of, the big challenge to
enter into the regenerative medical product market with NeoCart in collaboration with the excellent team of Histogenics, stated Yoshiji Kimura, Chief Executive Officer of MEDINET. We believe this restorative cell therapy will contribute
to better treatment by the physicians and quality life, of the patients with knee cartilage defects in Japan.
Locust Walk served as transaction
advisor to Histogenics.
Conference Call and Webcast Information
Histogenics management will host a conference call on Thursday, December 21, 2017 at 9:00 a.m. ET. A question-and-answer session will follow Histogenics remarks. To participate on the live call, please dial 877-930-8064
(domestic) or 253-336-8040 (international) and provide the conference ID: 5982636 five to ten minutes before the start of the call.
A live audio webcast of the presentation will be available via the Investor Relations page of the
Histogenics website, www.histogenics.com, or by clicking here. A replay of the webcast will be archived on Histogenics website for approximately 45 days following the presentation.
About Histogenics Corporation
Histogenics (Nasdaq: HSGX)
is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics lead investigational product, NeoCart, is designed to rebuild a patient s own knee cartilage to treat
pain at the source and potentially prevent a patient s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics recently completed enrollment of its NeoCart Phase 3
clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at
the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics technology platform has the potential to be used for a broad range of
additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.
MEDINET is a pioneering leader in the development and commercialization of cancer immuno-cell therapies.
MEDINET is also rigorously preparing to enter into the regenerative medical product market to leverage its long clinical and translational medicine history responding to the expected aging of the population. MEDINET went public in October, 2003 on
the MOTHERS, Tokyo Stock Exchange. For more information, visit http://www.medinet-inc.co.jp/english/.
Forward-Looking Statements
Various statements in this
release are forward-looking statements under the securities laws. Words such as, but not limited to, anticipate, believe, can, could, expect, estimate,
design, goal, intend, may, might, objective, plan, predict, project, target, likely, should,
will, and would, or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in
Histogenics forward-looking statements include, among others: the timing and success of Histogenics NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the
ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; NeoCart s regulation as a Regenerative Medical Product; the market size and potential patient population in
Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following
our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics product candidates and the ability to serve those markets; Histogenics expectations regarding its expenses and
revenue; and other factors that are described in the Risk Factors and Management s Discussion and Analysis of Financial Condition and Results of Operations sections
of Histogenics Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30,
2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC s website at www.sec.gov. In addition to the risks described above and in Histogenics annual report on Form
10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or
unpredictable factors also could affect Histogenics results.
There can be no assurance that the actual results or developments anticipated by
Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and
estimates will be achieved.
All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are
expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The
information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new
information, future events or otherwise.
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