ChemioCare Expands Proprietary Transdermal Platform

ChemioCare USA Inc. (“ChemioCare” or the “Company”), a biotech company focused on transforming patient outcomes in cancer supportive care, today announces a successful Drug Enforcement Administration (DEA) registration: ChemioCare’s exclusive formulation development partner, Transdermal Research Pharm Laboratories LLC (TRPL), has obtained a new registration with the DEA as a Manufacturer authorized to handle Schedule 1 controlled substances.

This successful DEA registration allows TRPL to initiate formulation development of a dronabinol transdermal patch, CMIO-DRONAB, the fourth program in parallel development in the ChemioCare supportive care platform. Pedro Lichtinger, ChemioCare Chairman and CEO explains, “Advancing our dronabinol program is another development milestone for our Company. We have made significant progress establishing unique profiles for each patch, all are driven by on-label superiority. The profiles have expanded beyond our initial focus on CINV, establishing ChemioCare as a platform supportive care company.” The DEA registration also establishes an opportunity to research additional indications for dronabinol by leveraging its activity at cannabinoid receptors.

The Company has identified significant unmet medical needs that its Olanzapine and Dexamethasone patches, CMIO-OLANZ and CMIO-DEX, are uniquely positioned to address:

  • CMIO-OLANZ, olanzapine 7-day transdermal delivery system (TDS), is the first product in development for PARP inhibitor induced nausea and vomiting. CMIO-OLANZ formulation development is expected to complete its Proof Of Concept in animals before the end of the year.

  • CMIO-DEX, dexamethasone 7-day TDS, dexamethasone is used extensively in the control of swelling and edema in Brain Cancer and Brain Surgery. Dexamethasone is highly effective in this setting but unfortunately causes severe side effects. We believe that the use of transdermal technology can maintain efficacy while significantly reducing side effects by bypassing the first metabolism pass and CMax characteristics of the current oral use. Our Laboratory has shown flux and is working on improving steady state delivery.

CMIO-ONDAN, ondansetron 5-day transdermal patch, has completed a POC study in animals and is also expected to complete its human POC study mid 2019. CMIO-ONDAN is in development to be the first 5HT3 Receptor Antagonist to obtain an indication for delayed CINV in the Highly Emetogenic Chemotherapy (HEC) patient segment. This product’s Phase 3 clinical program has been validated by our Scientific Advisory Board and is in the process of being included in our request for a pre-IND meeting with the FDA.

By leveraging its Transdermal Platform and the 505(b)2 regulatory path, both CMIO-ONDAN and CMIO-OLANZ are expected to be ready to enter their phase 3 clinical programs next year.

About ChemioCare

A biotech company focused on transforming patient outcomes in cancer supportive care. ChemioCare has a platform of transdermal patches in development using proprietary, proven technology. The company is targeting the 505(b)2 regulatory path and establishing on-label superiority that addresses a major unmet medical need for patients, establishing improved efficacy and reduced or eliminated side effects from reference products.

To learn more, visit www.chemio.care

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the company's control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the company. Neither the company, nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, business, financial condition, liquidity and results of operations may vary materially for from those expressed in the aforementioned forward-looking statements.

ChemioCare Announces Addition of Three Experienced Team Members

ChemioCare USA Inc. (“ChemioCare” or the “Company”), a biotech company focused on transforming chemotherapy induced nausea and vomiting (CINV) outcomes through transdermal patch technology, today announced a strengthening of its Board and Management team. Andy Rensink joins the Company as Chief Manufacturing Officer, Hemal Shah joins as Health Economics and Outcomes Advisor, and Eric Baum joins the Company’s Board of Directors.

“The strength and depth of our pipeline and rapid development pace are being made possible by the addition of best in class support. Andy Rensink will lead our transition from the preclinical setting into Manufacturing, and Hemal Shah is adding incredible insights into the value our products will create by addressing the significant unmet medical need in the CINV setting" said Pedro Lichtinger, Chairman and CEO. “Our Board is also strengthened by the addition of Eric Baum who has rich experience financing and advancing emerging Companies; with his addition we now have three independent directors an important step in positioning the company for a successful IPO.”


Eric Baum

Eric Baum brings over fifteen years of experience in advising Executive leadership teams for both well-established Fortune 50 companies and emerging ventures, across a spectrum of industries (life sciences, education, travel, technology, real estate). In his concurrent roles as Managing Director of Acquis Consulting Group and Managing Director / Co-Founder of its affiliate, Solidea Capital, Eric leverages his extensive management and operational consulting expertise to guide companies in areas such as business and corporate strategy, market positioning, growth and scale strategies, board governance, financing / trajectory management, partnering frameworks, risk evaluation, and more. He also serves in several advisory and Board of Director roles for public and private companies such as Kush Bottles, Big Rentz, Tenant Tracker, Level 8, Data Exchange, and Golfler, supporting the full lifecycle of needs from idea conception through expansion and growth strategies.  

Andy Rensink

Executive bringing over 30 years of operational experience including 13 years experience in transdermal development and manufacturing. Former President and COO of Tapemark, leading development, strategy implementation for pharmaceutical CDMO developing and manufacturing Transdermal Patches and Oral Thin Film products. Currently sits on the Board of Advisors for Hydra-Flex chemical dispensing systems. Holds a Masters in Engineering  from Marquette University, BSME from University of Wisconsin and completed the GE Manufacturing Management Program.

Hemal Shah

Executive bringing over 20 years of experience in health economics & outcomes research (HEOR), real world evidence generation, pricing, market access, value demonstration and health policy. Former Senior Vice President, Medical Affairs, Healthcare Quality, Policy and Outcomes at Optimer Pharmaceuticals and Executive Director of HEOR at Boehringer Ingelheim. She holds a Doctor of Pharmacy from The State University of New Jersey, a BSc. in Pharmacy and a BSc. in Molecular & Cell Biology from University of Connecticut and has completed a post-doctoral fellowship in outcomes research at Geisinger Health System/Novartis.

About ChemioCare

A biotech company focused on transforming chemotherapy induced nausea and vomiting (CINV) outcomes through transdermal patch technology. ChemioCare has 4 single active ingredient patches in development using proprietary, proven transdermal patch technology. The company is targeting the 505(b)2 regulatory path with key differentiators on-label, establishing improved efficacy and reduced or eliminated side effects from originator products. 
To learn more, visit www.chemio.care 


This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the company's control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made.  The forward-looking statements are based on the company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the company. Neither the company, nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, business, financial condition, liquidity and results of operations may vary materially for from those expressed in the aforementioned forward-looking statements.
 

ChemioCare Announces Addition of Chief Medical Advisor and Director

ChemioCare USA Inc. (“ChemioCare” or the “Company”), a biotech company focused on transforming chemotherapy induced nausea and vomiting (CINV) outcomes through transdermal patch technology, today announced the addition of two experienced professionals to its management and Board. Dr. Julian Howell joins the Company as Chief Medical Advisor and Nitin Kaushal joins the Company’s Board of Directors.

"We are pleased to welcome Julian and Nitin to our team, and believe their experience will be invaluable to the company in its rapid development pace," said Pedro Lichtinger, Chairman and CEO. "Their experience in clinical development and in financing will support our low risk, fast to market, and limited capital needs strategy. Julian and Nitin have strong track records as trusted leaders in the biotech industry and I look forward to working with them."

"I am very pleased to be joining the ChemioCare team as the company is preparing to take products in to clinical development," stated Dr. Howell. "I look forward to bringing my experience in supportive care specifically to assist the Company as we develop differentiated products to improve CINV control for patients."

"I am excited to join ChemioCare’s Board of Directors," said Mr. Kaushal. "This is a unique opportunity to help shape a Company with de-risked products targeting markets with significant unmet medical needs.”

Julian Howell, MBBS, FRCS, FFPM, MBA

Dr. Julian Howell, MBBS, FRCS, FFPM, MBA, has broad experience in development of CINV products; including successful registration and launch of Sancuso® (granisetron patch) and Kytril® (granisetron oral). Clinical development experience spanning 15 years, bringing small molecules and biological products through all phases of clinical development including multiple product approvals in Europe and the US. He gained medical and surgical qualifications in the UK and worked in the UK health service before completing an MBA at Cranfield University and joining the pharmaceutical industry, initially at SmithKlineBeecham and subsequently in senior clinical and medical affairs roles at Roche, Chiron and Pharmion.

Nitin Kaushal

Nitin Kaushal is a Managing Director in the Deals practice at PwC Canada. Nitin has more than 25 years experience in the financial investing, life sciences, consumer health care, health care services and medical device industries. His experience includes board of directorships with pharmaceutical and health care companies. He has also held senior roles in investment banking, venture capital and consulting firms. Nitin has performed over 50 merger, acquisition, strategic advisory, and licensing assignments. He has been an advisor to many of the leading global pharma companies and has participated in capital market transactions raising in excess of $2Bn.

About ChemioCare

A biotech company focused on transforming chemotherapy induced nausea and vomiting (CINV) outcomes through transdermal patch technology. ChemioCare has 4 single active ingredient patches in development using proprietary, proven transdermal patch technology. The company is targeting the 505(b)2 regulatory path with key differentiators on-label, establishing improved efficacy and reduced or eliminated side effects from originator products. 
To learn more, visit www.chemio.care 

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the company's control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made.  The forward-looking statements are based on the company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the company. Neither the company, nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, business, financial condition, liquidity and results of operations may vary materially for from those expressed in the aforementioned forward-looking statements.
 

ChemioCare Formed to Transform Chemo-Induced Emesis Outcomes Through Patch Technology

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

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

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.”
 

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the company's control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made.  The forward-looking statements are based on the company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the company. Neither the company, nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, business, financial condition, liquidity and results of operations may vary materially for from those expressed in the aforementioned forward-looking statements.