NEW YORK – ChemioCare USA Inc. (“ChemioCare”) today announced it will be leveraging novel transdermal patch technology for the treatment of chemotherapy-induced nausea and vomiting. CINV is a therapeutic area with significant unmet medical needs, most notably in the delayed emesis segment. Patients in this segment suffer from poor quality of life and broad patient compliance issues related to IV and oral dosing. ChemioCare transdermal patch technology could potentially improve treatment outcomes and improve patient compliance.
The company is founded by industry-executive Pedro Lichtinger who will serve as Chairman and Chief Executive Officer and by Dr. Fotios Plakogiannis, who operates a development laboratory in Long Island City. Pedro Lichtinger said about the strategy for ChemioCare, “We have multiple shots on goal with a low technical and clinical risk and a fast path to market. We are reformulating well known generic drugs with the objective of achieving on label meaningful improvements. Our development programs are designed to follow the 505(b)2 pathway and require a relatively low financial investment. I am excited to leverage my experience and our proprietary patch formulations to impact patient outcomes and quality of life while creating significant value for our shareholders.”
ChemioCare plans to reformulate four standard-of-care and guideline-recommended generic anti-emetics. Each patch has a target of 2-3 key differentiators from the current oral and IV formulations. The expectation is that at least one of the differentiators will be on label, intended to address patient outcomes and quality of life. In addition, the company plans to design combination patches aimed at improving guideline adherence and improving patient outcomes and has the long-term option of expanding labels of each patch to other indications.
The chemotherapy-induced nausea and vomiting market was valued at US$1.50 Bn globally in 2015 and is forecasted to grow at a compounded annual growth rate of 5-7%. Despite improvements in chemotherapy agents for the treatment of cancer, and the concomitant use of multiple genericized anti-emetic medicines, nausea and vomiting remains a major problem – up to 28% of patients on highly or moderately-emetogenic chemotherapy regimens do not respond to standard of care anti-emetic combination treatments and continue to experience nausea and vomiting. The medicines currently used to control CINV are used at high doses that result in many medically important side effects, impacting quality of life and outcomes for chemotherapy patients. The company believes that patch technology could offer potentially improved product profiles as well as guideline and patient adherence in a cost-effective way.
ChemioCare transdermal formulations are being developed through an exclusive partnership with the experienced researchers and scientists at Transdermal Research Pharm Laboratories, LLC (“TRPL”) in Long Island City, New York. TRPL is a full-service research facility led by Dr. Fotios Plakogiannis, who has over 40 years of experience in transdermal drug delivery and pharmaceutical development and owns patents covering novel technologies, formulations, and delivery methods. Transdermal technology has significantly evolved in the last 10-15 years and there are novel approaches that allow for the successful development of patches that were not feasible in the past. The company expects to have broad patent coverage with 3-5 Orange Book listable patents for each patch. Initial provisional licenses have been filed.
Altogether, the company has clinically differentiated product candidates that leverage broadly used, well-known proven generic medicines that allow for leveraging 505(b)2 regulatory paths and fixed combination registrations.
ChemioCare Founding Members
Pedro Lichtinger is an industry executive with a 37-year career in biotechnology and a proven track record of developing turnaround and financing strategies, executing strategic alliances, and building commercial and R&D capabilities. Former President and CEO of Asterias Biotherapeutics and Optimer Pharmaceuticals with 16 years experience at Pfizer Inc as President of Global Primary Care and President of Europe. He currently serves on Private and Public Boards for companies including, Gemphire Therapeutics, and Sanfer de Mexico. He holds an MBA degree from Wharton School of Business and an engineering degree from the National University of Mexico.
Fotios Plakogiannis served as a Professor at the A & M Schwartz College of Pharmacy, LIU, and for 25 years was the Director of the Division of Pharmaceutical Science of the College. He was instrumental in establishing the Graduate Division in Pharmaceutical Science (MS and Ph.D.). In addition, he was the recipient of the TASA Award for Lifetime Achievement at LIU, and the recipient of Founders Award. Authored more than 90 research papers with the majority in the area of Transdermal Drug Delivery. Currently, he serves on the Board of Directors of the ALMA BANK, a NY Community Bank.
Fotios Plakogiannis added: “Advances in patch technology today allow for multi-day patches with improved bioavailability and reliability to the benefit of patients and providers. We have the opportunity to transform the treatment of chemotherapy induced emesis through novel patentable technologies.”
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