• 08 Jan 2016

    NEMUS Bioscience Provides Corporate Update on Prioritization of Developmental Pipeline

    COSTA MESA, CA (Accesswire, January 5, 2016) – NEMUS Bioscience, Inc. (OTCQB: NMUS) has announced that the company has completed a review of its product assets and will be implementing a corporate strategy based on the prioritization of drug candidates in the Company’s pipeline according to a projected commercialization timeline. The asset review was prompted by the recent in-licensing of cannabidiol (CBD) derivatives from the company’s research and commercial partner, the University of Mississippi (“UM”). UM is the only entity in the United States with a forty-seven year history of isolating and studying cannabinoid molecules sanctioned with licensure by the Federal Government. 

    Brian Murphy, MD, MPH, NEMUS Bioscience CEO and CMO, commented: “Our company is focused on achieving two major objectives: developing therapeutics that improve conditions with unmet medical needs, and by so doing, increasing shareholder value through reaching milestones in NEMUS’ pipeline. Management has prioritized corporate goals into the following near-term, intermediate-term, and longer-term drug development initiates, and we look forward to updating our shareholders as we move ahead.” 

    NEAR-TERM: The development and filing of a New Drug Application (NDA) of the Company’s prodrug of THC (NB1222) for use in chemotherapy-induced nausea and vomiting (CINV), utilizing the expedited U.S. Food and Drug Administration (FDA) 505(b)(2) regulatory pathway. 

    INTERMEDIATE-TERM: Advancement of the Company’s cannabinoid prodrug for the treatment and management of glaucoma (NB1111) into an implanted sustained release technology, and the completion of proof-of-concept studies for the use of NEMUS’ CBD derivatives in the management of chemotherapy-induced peripheral neuropathy (CIPN), a pain condition that impacts patient quality-of-life and can compromise the delivery of cancer chemotherapy. 

    LONGER-TERM: The development of anti-infective compounds against gram-positive bacteria, particularly methicillin-resistant staphylococcus aureus (MRSA) 

    Details of these programs include the following: 

    NEAR-TERM GOALs: NEMUS plans to develop a prodrug of tetrahydrocannabinol (NB1222) for the treatment and management of CINV by using a suppository formulation, followed by a product extension via buccal patch delivery. The company plans to file an NDA for the compound using dronabinol, an approved oral synthetic version of Tetrahydrocannabinol (THC), as the reference standard using the expedited FDA 505(b)(2) regulatory pathway. 

    MARKET STATISTICS: There were an estimated 15.2 million cancer cases globally in 2014 according to the International Agency for Research on Cancer (IARC) with projections of 17.1 million cases in 2020. Roughly 25%-30% of cancer patients receive chemotherapy, and of those patients, 70%-80% experience a form of CINV. The global CINV market saw estimated revenue of $1.3 billion in 2014 with a projected 5.7% compounded annual growth rate through 2020 as cancer rates climb with growing, aged populations. Oral delivery of dronabinol, like many orally administered cannabinoids, results in relatively low bioavailability, coupled with irregular pharmacokinetics secondary to absorption variability and first-pass metabolism by the liver, complicated by the need for multiple dosages per day. In addition, many patients report nausea and/or vomiting as a side-effect related to the drug. NEMUS plans to advance a once-daily suppository form of the prodrug of THC that has enhanced bioavailability, more reliable pharmacokinetics, avoids first-pass metabolism by the liver, achieves therapeutic concentrations faster, and avoids the upper gastrointestinal tract mitigating further nausea and vomiting. Current sales of dronabinol are estimated to be in excess of $110 million domestically (Source: IMS Health), and management believes that associated product attributes such as appetite stimulation and analgesia, could enhance sales in clinical populations that could benefit from the uniform dosing afforded by prodrug technology. NEMUS is working towards a pre-NDA meeting with the U.S. FDA in the first half of 2016 and plans to provide further timeline guidance pending feedback from the Agency. 

    INTERMEDIATE TERM GOALS: NEMUS plans to continue development of NB1111, our proprietary ocular prodrug of THC for the treatment and management of glaucoma, which is an estimated $8 billion global market with an urgent medical need for therapies with new mechanisms of action. Multiple testing in the rabbit glaucoma model by the University of Mississippi demonstrated a 45% reduction in elevated intra-ocular pressure (IOP) and the ability of the drug to reach all compartments of the eye. Based on the evolving shift of drug delivery to enhance compliance in eye diseases, particularly glaucoma, the company will be looking to administer the drug via an implantable sustained release technology. Studies have shown (Am J Ophthal, 2007; 144(4):533-40) that poor topical drop compliance is a significant factor in the progression of glaucoma to blindness. In addition to improving therapy adherence, this type of drug delivery has the potential to reduce side effects associated with drops, lower complication rates of the disease that result in cost-effective care –leading to improved clinical outcomes. NEMUS plans on advancing testing of NB1111 into a second animal model in the first quarter of 2016 and hold a pre-Investigational New Drug (IND) meeting with the FDA in the first half of 2016. The company has been approached by a number of manufacturers of sustained delivery devices and anticipates identifying a compatible technology in 2016. 

    NEMUS has in-licensed unique derivatives of cannabidiol (CBD) from UM and based on research conducted at the University, has embarked on research exploring the utility of CBD derivatives in the treatment and management of chemotherapy induced peripheral neuropathy (CIPN). The CIPN market in the United States approaches $500 million annually (LifeSci Advisors; 2013) and the opioid-induced constipation market, which is an adverse event associated with using opioids in treating CIPN, is projected to exceed $600 million globally by 2019 (GlobalData; 2015). The company believes that the use of cannabinoids can supplant the dosing of other medications that carry a significant safety and addictive risk, ultimately becoming a mainstay of therapy in this population, especially if cannabinoid use allows for the completion of cycles of chemotherapy. NEMUS’ formulation technology is designed to permit better transmembrane translocation of cannabinoids and thereby not rely on dosing cannabinoids via the oral route. The company expects to complete proof-of-concept in vitro and in vivo studies throughout 2016, resulting in a formulation choice along with a route of delivery that avoids first-pass metabolism by the liver. 

    LONGER-TERM GOALS: NEMUS will look to complete in vitro and in vivo studies of unique cannabinoid formulations with activity against gram-positive bacterial pathogens, especially methicillinresistant Staphylococcus aureus (MRSA) during 2016. Antibiotic development is a longterm commitment requiring significant capital expenditures. The company will pursue a non-dilutive financing arrangement from grants to supplement near-term research needs and complete a significant data portfolio for a potential joint-venture to bring its assets to commercialization. 
    Dr. Murphy concluded: “The library of unique cannabinoid molecules at UM allows NEMUS multiple therapeutic development options in the coming years. Given the broad reach and depth of medicinal possibilities, NEMUS plans to aggressively monetize these assets.” 
    Cosmas N. Lykos, Co-Founder of NEMUS and Executive Chairman of the Board, commented: “NEMUS is committed to enhancing therapeutic options for patients by tapping our new class of compounds that can be utilized for a host of unmet medical indications. We intend to act deliberately and strategically to achieve our patient-centric goals to broaden our base of investors as we move these products forward.” 

    The Company is a biopharmaceutical company, headquartered in Costa Mesa, California, focused on the discovery, development, and commercialization of cannabis-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 cannabis-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 www.nemusbioscience.com 

    Statements in this press release that are not descriptions of historical facts are forwardlooking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties, including statements about the potential benefits of cannabinoid-based medicine and the timing of our near term, intermediate term and long term goals. 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," "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, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of NEMUS’ 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.