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Histogenics Announces Agreement With the Japan Pharmaceuticals and Medical Devices Agency Regarding Japanese Regulatory Pathway for NeoCart®
– Long history and significant US data package may enable full Marketing and Manufacturing Authorization of NeoCart subject to successful completion of small confirmatory clinical trial in
– PMDA Consultations concluded in first quarter of 2017 encompass all parts of potential regulatory submission including: Clinical Trial, Quality/Manufacturing and Non-Clinical Safety –
– Japanese cartilage repair market estimated to be second largest in the world with established reimbursement, and physicians and patients seeking treatments for cartilage defects that may prevent osteoarthritis in the knee –
“We are very pleased with the formal feedback we received from the PMDA regarding the relatively expeditious approval pathway for NeoCart in
Various aspects of the Japanese regenerative medicine laws were updated in 2014 to potentially expedite the clinical development and commercialization pathways for innovative, qualified regenerative cell-based medicines that have demonstrated safety and probable efficacy. Shortly after reacquiring Japanese rights for NeoCart from
During the first quarter of 2017,
In addition to the confirmatory clinical trial,
“We are thankful for the leadership and partnership with the PMDA,” commented Dr.
In conjunction with the launch of its commercial partnering efforts,
The findings from the
- Cartilage defects account for approximately 40% of total knee trauma cases causing pain and loss of function in the knee (with or without other injuries).
- Approximately 60% of patients with knee cartilage defects are either not treated at all, or treated only with conservative therapies (such as debridement) to temporarily treat pain.
- Approximately 60-70% of patients with knee cartilage defects that are left untreated will likely progress to OA, and 15-20% of their patients currently suffering from knee OA have such OA likely due to cartilage defects.
- More than 85% of orthopedic surgeons are not satisfied with the currently available treatment options for pain and loss of function due to knee cartilage defects.
- Approximately 80% of the surgeons consider early improvement in pain and function to be important and over half of the surgeons feel they would prescribe NeoCart based on the data already published.
“As is the case in
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; possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates in the U.S. and
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