ChemioCare USA Inc. (“ChemioCare” or the “Company”), a platform company focused on proprietary transdermal delivery, announced today the Company is initiating development of a transdermal formulation of lenalidomide, which is currently marketed in an oral form. ChemioCare believes that by applying its permeation enhanced transdermal technology (PETT), it can potentially target and deliver the optimal continuous lenalidomide AUC (drug level area under the curve) that may lead to reduced drug toxicity and improvement in the overall safety profile of the drug. These improvements can be expected to allow patients to stay on their treatment longer with fewer dose interruptions while improving their quality of life. The benefits of transdermal delivery may transform lenalidomide PETT into a new superior drug profile.
Lenalidomide is the standard of care for the treatment of multiple myeloma, and is also indicated for the treatment of certain forms of myelodysplastic syndrome and mantle cell lymphoma. In 2018, revenues reached $9.6 billion globally with $6.5 billion in the US. The branded form is projected to continue to grow at double digit growth rates in the coming years. Lenalidomide represents a major well-established blockbuster product with no clear replacement in development in the world of Oncology. Lenalidomide is expected to experience first generic entries in 2021 or 2022.
ChemioCare conducted a systematic assessment of feasibility and market potential to identify PETT transdermal reformulation targets from the thousands of potential opportunities that exist. These opportunities were further refined to select key patches which fit in the technology and may have the potential to benefit patients the most. “ We are delighted to launch the first program out of the PETT prioritization project, which has the potential to transform the multiple myeloma treatment paradigm” said Pedro Lichtinger, Chairman and CEO.
The characteristics of our novel PETT platform provide a broad horizon to improve the delivery of many drugs to achieve superiority or enable new indications. Drugs delivered by PETT can be developed to target optimal blood levels for prolonged periods of time thereby minimizing the high and low blood levels associated with toxicities or treatment failure. “PETT technology works like a continuous injection of drug into the blood stream that can be precisely delivered to provide the right amount of drug to work without providing too much drug which can cause toxicity” said Dr. Jamie Oliver, CMO. Dr Oliver further stated that “in the case of lenalidomide, both efficacy and toxicity are associated with its AUC and oral medications just are not able to precisely maintain the optimal blood levels over the dosing interval.”
A biotechnology company focused on improving the profiles of medicines through its proprietary permeation enhanced transdermal technology (PETT). The platform technology uniquely combines high flux and sustained release into a matrix drug in adhesive patch. ChemioCare has 3 patches in development for cancer and cancer supportive care. Its lead programs are expected to enter phase 3 pivotal studies late 2019. Each product leverages the 505(b)2 regulatory path and is aiming at establishing improved efficacy, a new indication, and reduced or eliminated side effects from originator products.
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.