On October 4, 2022 ANEW MEDICAL, INC. ("ANEW" or "the Company") (OTCPK: LEAS) reported that it has acquired five market-approved anti-cancer drugs approved for sale in Germany (Press release, Anew Medical, OCT 4, 2022, View Source [SID1234621697]). The Market Authorizations (MA’s) are for four of the drugs that comprise the "FOLFOX" and "FOLFIRI" multi-drug regimens used in treatment of metastatic colorectal and gastric cancer and in two of the drugs are used to treat metastatic lung cancer . The drugs are important in the treatment of many solid tumors in both childhood and adult cancers.
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"Some of these drugs have previously been the subject of drug shortages and rationing in the past, so ANEW being able to provide an alternative, high quality source of these product was important to us," stated Dr. Shalom Hirschman, the Chief Medical Officer of the Company. He also added that, "Having a European manufacturing source for each of the five MA’s was also important to us."
Dr. Joseph Sinkule, the Founder and CEO of ANEW stated, "We will combine the oncology drugs and additional drug assets with a portfolio of biosimilar biologics also used in the treatment of cancer, and then grow the business with more additions to the portfolio. Initiating marketing and sales in Europe and then migrating the dossier to the US allows us time to build a reliable business franchise and gain name recognition both in Europe and then the US, the two major global pharmaceutical markets." Dr. Sinkule went on to say, "Our pricing of these life-saving medicines is ‘Cost Plus’, meaning the cost to produce these goods and a small margin needed to sell and distribute the drugs. The prices of our products are, therefore, affordable even in this era of significantly increased energy prices in Europe. Our biosimilar biologics will have higher margins as we will invest in Phase 3 studies and market approval expenses for each of those agents, but the strategy is still straightforward."
ANEW’s generic drug division comprised of drugs and biologics complements its "high tech" division focused on gene therapies associated with neurodegenerative diseases like Alzheimer’s disease, cancer, and aging (longevity).