Neumedicines is on track to file its Biologic License Application (BLA) to the FDA for HemaMax™ by 2016.
Pasadena, California (PRWEB) September 26, 2011
Neumedicines Inc., a privately held drug discovery and development company focused on innovative protein therapies for the treatment of hematopoietic deficiencies and cancer, announced today that it has signed a contract worth up to $273 million to fund advanced development of Neumedicines’ HemaMax™ (recombinant human interleukin 12; rhuIL-12) for treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS). The contract was awarded on September 15, 2011 by the Biomedical Advanced Research & Development Authority (BARDA) of the U.S. Department of Health and Human Services (DHHS). BARDA provides an integrated, systematic approach to the development and purchase of necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
Neumedicines will initially receive approximately $17 million from BARDA over 18 months to speed the development of HemaMax™. Additional financing over the next 3.5 years is available in milestone-based options to be exercised by BARDA, potentially bringing the total value of the award to approximately $273 million. Funds from this award will be used to advance the late-stage development of HemaMax™ toward BLA submission under the U.S. Food and Drug Administration’s Animal Rule (21 CFR 601.90-95).
Lena A. Basile, Ph.D., J.D., President & CEO of Neumedicines, said, “We have been working with BARDA to further the development of HemaMax as a radiation countermeasure since 2008, and are now extremely pleased to extend this partnership under this current contract to fund the advanced development of HemaMax™. HemaMax™ is to be utilized after a catastrophic event where U.S. citizens and/or military personnel are exposed to lethal levels of radiation. With this funding, Neumedicines is positioned to accelerate the nonclinical efficacy and human safety development of HemaMax towards FDA approval under the Animal Rule. We thank BARDA for their continued confidence in HemaMax™ and Neumedicines.”
The new contract, one of the largest awarded by BARDA for advanced product development, will support the company's clinical and commercial strategy, including scaling up manufacturing, expanded human safety trials and pivotal, non-clinical efficacy studies in animals, through FDA licensure.
HemaMax™ is being developed by Neumedicines under the FDA’s Animal Efficacy Rule to treat the hematopoietic syndrome of ARS or radiation poisoning from exposure to radiation, such as a nuclear or radiological weapon or from a nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety, pharmacokinetic, pharmacodynamic, and biomarker testing in healthy human volunteers.
In June, the company began dosing healthy volunteers with HemaMax™ in a first-in-human phase I study to evaluate the safety, tolerability, and pharmacokinetics of HemaMax™ for the treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS).
This initial safety study involves single injections of HemaMax™ in ascending dose groups of six healthy volunteers in 4 cohorts. Participants in the study will be assessed for adverse side effects over a four-week period, and blood samples will be obtained to evaluate the effects of HemaMax™ on various biomarkers. The study has advanced to the third cohort with no safety issues and is scheduled to be completed by Q1’12. This safety study is to be followed by several larger safety studies in healthy human volunteers, prior to submission of a Biologic License Application (BLA) to the FDA. The company expects to submit its HemaMax™ BLA to the FDA by 2016.
The therapeutic under development by Neumedicines Inc., HemaMax™ (NMIL12-1), is based on rHuIL-12 (recombinant human interleukin–12). To date, Neumedicines has received $33 million in government funding for the advanced development of HemaMax™, including funding from HHS, BARDA, and NCI.
Scientists from Neumedicines discovered the previously unexplored hematological properties of IL-12 by demonstrating the potent survival effects of single, low dose IL-12 on hematopoietic recovery following lethal radiation. HemaMax™ is a new therapeutic that will be administered to potential victims of a radiation disaster in very low, microgram doses to achieve potent radiomitigation effects. To date, Neumedicines Inc. has demonstrated that HemaMax™ can increase survival in mice and non-human primates who receive the therapeutic in single, low doses 24 hours after lethal radiation exposure.
HemaMax™ is also being developed for use in cancer patients to alleviate the side effect of radiation or chemotherapy. A phase I clinical trial for the prevention of chemotherapy-induced thrombocytopenia (CIT) in patients with solid tumors is targeted to begin in Q2'12.
About Neumedicines Inc.
Neumedicines Inc. is a privately held, early-stage biotechnology company developing protein therapeutics that address unmet clinical needs in the fields of oncology, hematology, and immunology. The company’s lead product candidate, NMIL12-1 (recombinant human interleukin-12; rhuIL-12), functions as to target multiple pathways of hematopoiesis and innate immunity and is being developed to address a range of unmet clinical indications. At Neumedicines, we are committed to developing and maximizing the scientific, clinical, and commercial potential of our product pipeline. Neumedicines is developing NMIL12-1 under the trade name HemaMax™ as a biodefense radiation medical countermeasure. NMIL12-1 is also being developed for indications in hematology/oncology. The company operates from its headquarters and laboratories in Pasadena, California.
For more information visit: http://www.neumedicines.com
Follow Neumedicines on Twitter @Neumedicines
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield. In addition, BARDA manages the Public Health Emergency Countermeasures Enterprise (PHEMCE).
For more information visit: http://www.medicalcountermeasures.gov
Investor and partnership inquires please contact: Dr. Lena Basile at 626-844-3900 or basile(at)neumedicines(dot)com.