MiMedx Group, an integrated developer, processor and marketer of patent-protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced that it expects to file its first Investigational New Drug ("IND") application with the Food and Drug Administration ("FDA") during the month of July 2014. The IND submission is the Company's initial submission for certain indications for use of its micronised allografts towards targeted Biologics License Applications ("BLAs") which the Company expects to submit at a future date. This IND filing is the first major milestone in the process described in the Company's December 4, 2013 press release.
Parker H. "Pete" Petit, chairman and chief executive officer, said, "We have made significant progress in the meetings and discussions we have held with the FDA. In fact, our activities related to our first IND application for one indication for use of our micronized tissue have progressed very quickly so we are on track for that submission to the FDA next month. The filing of this IND is the first step in the process that we expect will culminate in at least two separate BLAs for certain indications for use of our micronised allografts. Other BLA applications will follow. We believe the rapid submission of our first IND application with the addition of new staff demonstrates MiMedx's level of commitment to this process and our ability to successfully transition certain indications for use of our micronised products from Section 361 HCT/Ps to licenced biologics."
The Company announced the addition of two key executives to support its IND and BLA initiatives. "We have already expanded our Quality Assurance and Regulatory Affairs group with new staff members who have expertise in drug and biologic quality systems," noted Bill Taylor, president and COO. "Additionally, we have previously communicated that we were expanding our Research and Development ('R&D') function and increasing related R&D and clinical investments in support of our BLA applications. These include the addition of two executives with a wealth of experience in managing pre-clinical and clinical studies in support of this complex regulatory process: David H. Mason, M.D. and Conan S. Young, Ph.D."
"Dr. Mason has joined MiMedx in the position of Vice President of Medical Affairs for Clinical Programs, and Dr. Young has joined the MiMedx team as our Director of Research. Dr. Mason has extensive clinical and regulatory experience with devices and with drug applications and Dr. Young has extensive research experience in regenerative medicine," Taylor continued.
Dr. Mason previously served as senior vice president and chief medical officer of Given Imaging where he led clinical trials, regulatory affairs and medical marketing initiatives. Before joining Given, Dr. Mason served with UCB Pharma as the company's vice president, Clinical Development and Global Head of Inflammation Clinical Research. In this role, Dr. Mason led the U.S. and U.K. teams in support of the regulatory pathways for the company's portfolio of anti-inflammatory drugs. Dr. Mason also served with AVI BioPharma as its senior vice president of Clinical Development and Regulatory Affairs where he led drug development efforts including clinical programs in multiple therapeutic areas. After medical school, Dr. Mason was a practicing physician in internal medicine, infectious diseases and rheumatology. He received his M.D. from Duke University Medical School.
"Dr. Mason has extensive experience in all phases of drug development including preclinical, regulatory and clinical trials from Phases I through IV. His vast experience handing IND filings, protocol writing, successful BLA and NDA submissions, preparation for NDAs and surveillance studies will be a solid complement to our Medical Affairs function," added Taylor.
Conan Young served as Director of R&D with Shire Regenerative Medicine prior to joining MiMedx. At Shire, Dr. Young was instrumental in the company's successful IND approval of its Dermagraft product for new Phase III clinical programs in the US, Europe and Canada. Additionally, Dr. Young was instrumental in the initiation of Phase IIb clinical trials for the Shire Vascugel therapy program. Before Shire, Dr. Young was with BioMimetic Therapeutics serving in various roles including the company's senior scientist and its director of preclinical biology. With BioMimetic, Dr. Young developed biologic/device combination products and drug/device products through multiple phases of development.
Dr. Young began his career with Harvard/Forsyth Institute where he last served as Staff Scientist and gained expertise in tissue engineering. Dr. Young received his Ph.D. in Microbiology from the University of British Columbia.
"We are making significant and rapid progress to support the BLA regulatory pathway for certain of our micronised allografts. This experience will be extremely beneficial to us as we pursue other amniotic tissue products that may need approval via the FDA's BLA process," concluded Petit.