COSTA MESA, CA / ACCESSWIRE / December 1, 2016 / NEMUS Bioscience, Inc. (NMUS) announced that work performed in conjunction with its API contract developer and manufacturer, Albany Molecular Research Inc. (NASDAQ:AMRI), resulted in a synthetic pathway to manufacture the clinical-grade proprietary prodrug tetrahydrocannabinol-valine-hemisuccinate (THCVHS), including the ability to scale-up production. In addition, the purity of the API achieved a standard exceeding FDA requirements of being at least 99.5% pure. Nemus has subsequently contracted with Catalent Pharma Solutions (Catalent) to begin formulation work associated with NB2111, the candidate product for managing chemotherapy-induced nausea and vomiting (CINV).
"Reliable and consistent API manufacturing is a major step necessary for human testing, regulatory approval and ultimate commercialization of a candidate molecule. The Nemus cannabinoid compounds of NB1111, which is intended for the treatment of glaucoma and NB2111, which is intended for managing chemotherapy-induced nausea and vomiting (CINV) both utilize the patented prodrug of THC as the active ingredient," commented Brian Murphy, M.D., M.B.A., CEO and Chief Medical Officer of Nemus. "In preparing for a pre-IND meeting with the FDA, the company is focused on formulation development of NB1111 and NB2111 to meet chemistry-manufacturing-controls (CMC) requirements of the FDA. We are working with Catalent in the formulation process to achieve a clinical-grade delivery of NB2111 in CINV."
"The company is exploring formulation options for the delivery of NB1111 into the eye. Nemus anticipates this process to be completed in the first quarter of 2017 resulting in a collaboration with an ocular drug delivery formulator that will help bring the candidate- glaucoma therapy forward to satisfy regulatory requirements for human testing," stated Dr. Murphy.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements about the potential benefits of NB1111 and NB2111 and the timing of our near term, intermediate term and long term goals. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including "goal," "focus," "aims," "believes," "can," “could,” "challenge," "predictable," "will," or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of NEMUS's most recent annual or quarterly report filed with the Securities and Exchange Commission. Except as expressly required by law, NEMUS disclaims any intent or obligation to update these forward-looking statements.
ABOUT NEMUS BIOSCIENCE, INC.
The Company is a biopharmaceutical company, headquartered in Costa Mesa, California, focused on the discovery, development, and commercialization of cannabinoid-based therapeutics for significant unmet medical needs in global markets. Utilizing certain proprietary technology licensed from the University of Mississippi, NEMUS is working to develop novel ways to deliver cannabinoid-based drugs for specific indications, with the aim of optimizing the clinical effects of such drugs, while limiting the potential adverse events. NEMUS' strategy will explore the use of natural and synthetic compounds, alone or in combination. The Company is led by a highly qualified team of executives with decades of biopharmaceutical experience and significant background in early-stage drug development.
For more information, visit http://www.nemusbioscience.com.
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SOURCE: NEMUS Bioscience, Inc.