Client Spotlight – ChemioCare
ChemioCare is a biotechnology company focused on improving the profile of approved drugs with a proprietary delivery system. It develops unique transdermal patches, delivering drugs through the skin to improve efficacy and/or reduce toxicities when compared to the original oral or IV forms.
Compared to drug development of a new molecular entity (NME), ChemioCare is low risk, fast to market, with limited capital needs. Risk is reduced by reformulating FDA registered medicines where efficacy, safety, and manufacturing are established. The transdermal technology is proven and uses all FDA-approved components. Time to market is accelerated by using the “505(b)2 regulatory path” with the US FDA, this path allows accelerated development by referencing work done by approved drugs. Typical new drug development takes over 10 years and costs over $250M to reach approval, this approach cuts the time down to approximately 5 years to approval and a fraction of the expected development costs. Since basic efficacy and safety are well known for the original medicine the risk profile is significantly improved.
ChemioCare has 2 patches in development for cancer and cancer supportive care and others in the pipeline. Its first product is a once-weekly patch for the treatment of nausea and vomiting due to a new class of cancer therapy called PARP inhibitors. There is currently no treatment approved by the FDA or suitable for use in chronic nausea caused by PARP inhibitors. 77% of patients experience nausea, leading to significantly reduced quality of life, and it is estimated that 17% of patients have to interrupt their therapy, and another 5% have to reduce the dose of the PARP therapy due to nausea. ChemioCare’s product is designed to reduce these serious side effects. The product is currently in its Phase 1 clinical study, with results expected Q1 2020. Following that study, the product is expected to advance directly to its Phase 3 clinical study which will support its FDA approval, targeting a launch on the US market in 2024.
Its other product in development is a transdermal formulation of Revlimid® (lenalidomide). Revlimid is a $10.6 Bn drug that has been the heart of Celgene. The currently approved drug is the standard of care for multiple myeloma but has significant toxicities. In multiple myeloma many patients have to stop therapy due to gastrointestinal toxicities. ChemioCare believes their patch will have a significantly improved toxicity profile that will reduce dose reductions and treatment abandonment in mutiple myeloma. There are opportunities for the ChemioCare lenalidomide transdermal patch to expand in to other hematologic cancers, including chronic lymphocytic leukemia (CLL). Revlimid failed in obtaining a CLL registration as result of its oral toxicity profile and selected dose regimen. The ChemioCare transdermal patch provides an improved product at the right dose for this important indication, the most common form of leukemia.
ChemioCare’s therapeutic areas of focus are key areas of strategic focus for large pharma and biotech, which historically has resulted in strategic partnerships and acquisitions. Similar reformulation companies with products designed to show on-label superiority have been very successful in being acquired during the Phase 3 phase. For example, CNS-focused transdermal company Neuroderm was acquired by Mitsubishi Tanabe for $1.1bn July 2017 while their Phase 3 was underway. CNS-focused Cynapsus reformulated an injectable into a sublingual film, addressing the unmet need of burning acidity on injection. Their product eliminated that acidity and improved absorption. Cynapsus was acquired by Sunovion for $635M US at the start of Phase 3.
The company has successfully raised $19.7 million since it started two years ago. They are entirely funded through wealthy families and family offices. ChemioCare has no debt, no warrants, and no institutional investors at this time. The company has sufficient cash on hand through the end of next year and is planning a 2020 crossover/IPO Nasdaq listing.
ChemioCare’s senior management has experience in large pharma and biotechnology companies. This includes Chief Executive Officer and co-founder, Pedro Lichtinger Waisman, MBA. Mr. 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. He is the 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.
Dr. Jamie Oliver, Chief Medical Officer, brings experience which spans 12 years in academia and 24 years in both the public and private sectors of the biotechnology/pharmaceutical industry and contract research organizations. He has served in numerous roles in clinical development operations including Chief Operating Officer, SVP Clinical Research and Regulatory Affairs, Chief Science Officer, and Medical Officer. Dr. Oliver has significant FDA experience with both the Drug and Biologic divisions having prepared more than 50 INDs and participated in seven successful NDA submissions for U.S./Global pharmaceutical companies. In addition, Dr. Oliver has served in licensing negotiations and out-licensing of several oncology assets.
The company also has a strong board of directors, with a recent addition of Dr. Mohamad Hussein who brings more than 30 years of combined academia and biotechnology company experience in the hematological malignancy space. He recently retired from his role as Corporate Vice President: Global lead, Multiple Myeloma at Celgene. There, he led the therapeutic vision and strategy for multiple myeloma inline and pipeline assets, which included Revlimid® (lenalidomide) for eleven years. Prior to Celgene, Dr. Hussein was one of the founders of the multiple myeloma multidisciplinary research center at Cleveland Clinic. Working with Dr. Hussein includes the members of the company’s prominent medical advisory board who sit on international guideline committees and have led clinical development of comparable cancer and cancer supportive care products.
ChemioCare offers a unique opportunity to join an exciting new company that is moving at an accelerated pace. The valuation is low relative to its expected increase in a short timeframe. There are multiple milestones each leading to inflections in valuation over the next 12 months. The robust team, leadership, advisors, and IP position strengthen its value proposition.