BETHLEHEM, Pa.–(BUSINESS WIRE)–Saladax Biomedical, Inc., a diagnostics company providing kits to measure drug blood levels for adherence and medication management, has signed a license agreement with Janssen Pharmaceutica, NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Under the terms of the agreement Saladax acquired the worldwide exclusive patent rights for diagnostic tests that determine drug levels in patients undergoing treatment with antipsychotic medications. This intellectual property, along with the existing patents that Saladax already owns, places Saladax in a predominant position in the field of antipsychotic drug testing.
Patients with mental health disorders struggle with high rates of poor antipsychotic drug adherence. It is estimated that 40-60% of patients do not take their antipsychotic medications as prescribed. One major issue in treating patients with mental health disorders is that psychiatrists have limited means to detect non-adherent patients and are often uncertain whether a lack of treatment response is due to poor adherence or true lack of drug efficacy. The Saladax tests will provide clinicians with rapid, objective results so that timely clinical decisions can be made.
“We are very pleased to have signed this agreement and look forward to making this line of reagents the standard of care in the field of psychiatry,” said Saladax CEO, Salvatore Salamone. “This agreement provides us with IP to extend our existing MyCare™ Psychiatry product line to include six commonly used antipsychotics.” Two of the six tests Saladax has developed have already received clearance for sale in Europe and four more tests are expected to have clearance in Q-3 2018. Saladax also plans on submitting these tests to the FDA beginning in June 2018.
Founded in 2004, Saladax Biomedical, Inc. is a privately held company headquartered as an anchor tenant with Ben Franklin TechVentures® in Bethlehem, PA. Saladax is a client of the Ben Franklin Technology Partners of Northeastern Pennsylvania. Saladax develops novel blood tests to increase the impact of personalized medicine by bringing chemotherapeutic drug monitoring to oncologists and adherence testing to psychiatrists. Saladax believes that truly personalized medicine can only exist when the right drug is given at the right dose. Our diagnostic reagents and kits are currently distributed worldwide excluding the United States. Saladax is ISO 13485:2003 certified.
About the MyCare™ Psychiatry Product Line
More than 18 million patients are on antipsychotics worldwide. The failure rate for these medications can be as high as 50%. While there are many factors contributing to this inadequate treatment response, many journals and psychiatrists point to rapid drug level tests as an important tool to reduce treatment failure. The MyCare™ Psychiatry product line includes blood-based tests for the antipsychotic drugs risperidone and paliperidone, which have a CE mark and are currently approved for sale on the European market. These immunoassays are run in clinical chemistry laboratories on routine high-throughput instruments and provide rapid test results to help guide physicians in their decision-making process by providing objective evidence of medication levels within a clinically relevant time. The Saladax MyCare Psychiatry line will eventually include tests for total risperidone, paliperidone, clozapine, olanzapine, quetiapine, and total aripiprazole in major markets around the world.