First Biologic to Receive Orphan Drug Status for Ocular Graft-Vs.-Host Disease Dry Eye
ATLANTA, GA –Feb. 26, 2020 – Cambium Medical Technologies (Cambium), a clinical stage company developing novel processed platelets for therapeutic applications, announced today that the U.S. Food & Drug Administration (FDA) has granted the company orphan drug designation for its fibrinogen-depleted human platelet lysate for the treatment of ocular graft-versus-host disease (oGvHD).
Orphan Drug Designation is a special status to drugs or biologics demonstrating promise for the treatment of rare diseases or conditions. Sponsors of such drugs or biologics, after meeting stringent criteria, are awarded attractive rights and benefits as incentives for development and commercialization. For more information, see About Orphan Drug Designation below.
“We are honored to be awarded Orphan Drug status. It is another key milestone in the development of our Elate Ocular® biologic,” said Terry Walts, President and CEO of Cambium Medical Technologies. “As recently announced about the enrollment of the final patient in our Phase I/II Dry Eye Study, we selected oGvHD because of the need, because there is no approved therapeutic to date, and finally to assess our biologic among a very severe patient population as a statement of its potential going forward.”
About Orphan Drug Designation
Orphan Drug Designation (ODD) was created in 1983 when the Orphan Drug Act was enacted by Congress. The program is administered by the Office of Orphan Products Development at the FDA. The purpose of ODD is to encourage the development and commercialization of new drugs and biologics for rare diseases with unmet medical needs. The FDA does this by awarding ODD sponsors attractive incentives to help recoup the costs of researching and developing such drugs. Examples of incentives are partial tax credits for clinical trial expenditures, waived New Drug or Biological License Application user fees and eligibility for seven years of marketing exclusivity. To qualify, both the drug and disease must meet stringent criteria as specified in 21 CFR 316.20 and 316.21 of the Act. According to the FDA the Act has enabled the development and marketing of over 600 drugs and biologics for rare diseases since 1983.
About Cambium Medical Technologies
Founded in 2013 by four distinguished physician/scientists at Emory University, Atlanta, Georgia (USA), Cambium is focused on the development of regenerative therapies through novel processed human platelets. Cambium’s Mission: To improve patients’ quality of life—from within. The Company’s first FDAapproved therapy is targeted to be Elate Ocular®, a topical biologic eye drop for dry eye disease (keratoconjunctivis sicca or KCS). Elate Ocular® contains Aurarix®, Cambium’s novel processed enriched platelet-rich-plasma (PRP) lysate. Cambium’s Aurarix® contains over 30 key nutritive/regenerative components documented important to corneal health. The Company believes a complex, multi-component therapeutic like Elate Ocular® may be required to better address the complex, multifactorial nature of dry eye. Cambium’s Aurarix® is sublicensed for sale worldwide in the stem cell growth supplement market under the names UltraGRO™-Advanced and UltraGRO™ -PURE to Cambium’s strategic partner AventaCell Biomedical Corp., Ltd, a subsidiary of Zheng Yang Biomedical Technology Co., Ltd, Taipei, Taiwan.
For more information about Cambium, contact David Doolittle at +1 404-337-5990 or e-mail David at email@example.com or go to www.cambiumbio.com. To learn more about AventaCell and their
line of UltraGRO™ stem cell growth supplements, contact William D. Milligan at firstname.lastname@example.org or visit www.atcbiomed.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Act”) and are intended to be covered by the safe harbors created thereby. These forward-looking statements include, but are not limited to, statements regarding the expected benefits of the Company’s technologies, investment in product development, possible future financings or other activities and/or statements preceded by, followed by or that include the words “believes,” “could,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “projects,” “seeks,” “potential,” “targets” or similar expressions. Investors are cautioned that all forward-looking statements involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements for any reason. All forward-looking statements speak only as of the date of this press release and the Company undertakes no obligation to update such forward-looking statements.