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Histogenics Corporation and MEDINET Co., Ltd Enter Into Licensing Agreement for Development and Commercialization of NeoCart for the Japanese Market
– Transaction Terms Include a
‒ 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
“This transformative collaboration for
Histogenics’ formal consultations with the Office of Cellular and Tissue-based
- A 30-patient, one-year confirmatory clinical trial in Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in
Japanin conjunction with data from Histogenics’ fully enrolled U.S. Phase 3 clinical trial.
- NeoCart would be regulated as a Regenerative Medical Product, as covered by the recently enacted laws in
Japan, and Histogenicscan supply the confirmatory clinical trial from the U.S. using the current good manufacturing process (cGMP) for NeoCart.
“I am excited about the potential to bring this exciting therapy to Japanese patients and physicians through this new partnership,” stated Dr.
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
In the first half of 2017,
- Approximately 60% of patients with knee cartilage defects are either not treated, or treated solely for temporary pain relief.
- Approximately 60-70% of patients with knee cartilage defects that are left untreated will likely progress to OA in the knee.
- Cartilage defects are believed to have caused OA in 15-20% of patients suffering from knee OA.
- More than 85% of orthopedic surgeons are not satisfied with the current options to treat knee cartilage defects.
- Approximately 80% of orthopedic surgeons consider early improvement in pain and function to be important and more than half of the surgeons feel they would prescribe NeoCart based on published data.
“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
Locust Walk served as transaction advisor to
Conference Call and Webcast Information
Histogenics’ management will host a conference call on
A live audio webcast of the presentation will be available via the “Investor Relations” page of the
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,
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
There can be no assurance that the actual results or developments anticipated by
All written and verbal forward-looking statements attributable to
Contact: Investor Relations Tel: +1 (781) 547-7909 InvestorRelations@histogenics.com
Source: Histogenics Corporation