PA-SALADAX-BIOMEDICAL

Saladax Biomedical, Inc. (Saladax) is pleased to announce that it has acquired a patent portfolio for antipsychotic drug testing from Janssen Pharmaceutica NV. This intellectual property (IP) portfolio includes 17 patent families and has resulted in 33 U.S. patents and 296 patents in ex-U.S. countries. This IP, along with the current Saladax IP, covers the major antipsychotic drugs that are prescribed worldwide and places Saladax in a premier position in the antipsychotic drug testing field.

With this IP portfolio, Saladax has developed tests for chemistry analyzers commonly found in hospitals and a point-of-care instrument that can be used where centralized testing is not possible. These tests address a significant unmet clinical need for patients with serious mental illness (SMI) by providing rapid, actionable results to health care professionals (HCP). International and U.S. clinical guidelines have recently been established recommending antipsychotic drug testing. The availability of these tools will greatly enhance the ability of health care professionals to better manage their patients in real time.

SMI is a significant public health concern. The estimated economic impact of SMI worldwide is more than $2.5 trillion each year with the number of people that SMI affects growing rapidly. In the U.S. current data shows that more than 13 million adults in the U.S. experienced SMI in the past year. That is more than 3% of the adult population.¹

Saladax is well positioned as the leading diagnostic company in the field of antipsychotic drug testing with a full panel of antipsychotic tests already on the market and a solid pipeline of new products.

“This is a very exciting time for Saladax and the field of therapeutic drug monitoring (TDM).” stated Sal Salamone, Founder and CEO of Saladax. “The availability of antipsychotic testing is arguably the most significant step in the field of TDM since the launch of the Abbott Diagnostics TDx platform back in the 1980’s.”

About Saladax Biomedical, Inc.

Headquartered in Bethlehem, PA, Saladax Biomedical, Inc. is a privately held company that develops, manufactures, and markets assays that provide rapid therapeutic drug levels for essential and life-saving medicines prescribed by psychiatrists and oncologists. Since 2007, Saladax's proprietary technology has been used in clinical laboratories or point-of-care settings to assist clinicians in monitoring and optimizing patient care. Additionally, the company collaborates with leading pharmaceutical companies to develop tests for clinical trials and companion diagnostics. For more information, visit MyCareTests.com .

1. Substance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55) . Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration.
2. Bessonova L, Ogden K, The Economic Burden of Bipolar Disorder in the United States: A Systematic Literature review 2011. doi: 10.2147/CEOR.S259338

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