Essential Medicines

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ANEW has acquired five market-approved anti-cancer drugs approved for sale in Germany. 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. Some of these drugs have previously been the subject of drug shortages and rationing in the United States and Europe. ANEW plans to migrate the European dossiers to the USA, where it envisages obtaining FDA “emergency use” approval for products in short supply, and subsequently to seek full FDA approval for those ANEW generics after the submitting under the Abbreviated New Drug Application (ANDA) process.

According to the IQVIA Institute for Human Data Science, “Drug shortages have recently received widespread news coverage for their
impact on patient care and public health. The number of drug shortages in the
U.S. is increasing as more shortages continue to be reported than resolved.
Stakeholders have recommended various approaches to mitigate shortages,
such as prioritizing essential medicines, stockpiling, and making changes to
reimbursement or statutory rebates. Shortages appear to be driven by a variety of causes that need to be better understood, as they may impact which solutions will best address them.

Drug shortages are an ongoing issue in the U.S. healthcare system, although the number and severity of shortages have changed over time, with 132 active
shortages as of June 2023. Over the past five-and-a-half years, 160 new molecule shortages have occurred through June 2023 while
only 51 have resolved, and more than half of current shortages have been ongoing for more than two years. Shortages tend to be in generic and injectable drugs, with 84% and 67% of shortages, respectively, while shortages in oral drugs are less common. Of the 132 drugs in shortage, 12 are branded and the remaining 120 are generic, and generic shortages most often affect injectable medicines.”