Ottawa/SASKATOON, Aug. 11, 2016 -CanniMed Ltd. has entered into a letter of intent with CTT Pharmaceutical Holdings Inc. (OTCQB:CTTH) to license CTT’s Orally Dissolvable Thin Film (ODF) Wafer technology. This industry-first collaboration will enable CanniMed Ltd. to develop and commercialize this novel, smoke-free, drug delivery system in both Canada and the United States.
Orally Dissolvable Thin Film (ODF) Wafers are paper-thin polymer films used as carriers for several pharmaceutical agents, including opioids for pain management. In this innovative format, the drug is taken orally but does not require water or swallowing. ODF Wafers dissolve quickly in the oral cavity (5-15 seconds) ensuring that the active ingredient is rapidly absorbed and diffused into the dense network of capillaries for direct access to the bloodstream via the oral mucosa. The active ingredient, once absorbed, bypasses the liver’s first-pass effect and effectively improves bioavailability and facilitates excellent patient compliance.
“Our novel and breakthrough technology will provide a more convenient, smoke-free, effective and healthier drug delivery system allowing patients to take precise and accurate doses of cannabinoids as prescribed for pain management, mental disorders like depression, anxiety, post-traumatic stress disorder and a reduction in epileptic seizure syndromes in children,” said Dr. Pankaj Modi, President and CEO, CTT Pharmaceutical Holdings. “We sought out this collaboration with CanniMed as a result of their industry-leading cultivation and extraction processes.”
Orally Dissolvable Thin Film Wafers improve therapeutic outcome and efficacy through immediate onset of action in a convenient and discrete delivery. ODF Wafers are suitable for geriatric and pediatric patients who experience difficulty swallowing or patients who suffer from Phagophobia (fear of swallowing) or Pnigophobia (fear of choking).
“Physicians and patients are looking for novel and effective drug delivery systems to help with their consumption of medical cannabis, and this ODF Wafer system will complement the already well-integrated line of CanniMed® Oil products we have in market,” said Brent Zettl, CEO CanniMed Ltd. “Standardizing and supporting patients with dose-sensitive and discrete delivery systems will continue to position medical cannabis as an important therapeutic option for thousands of patients in Canada and the United States.”
About CTT Pharmaceutical Holdings
CTT’s principal asset is a unique and novel patented drug delivery technology, an orally administered, fast dissolving thin film (the “Wafer”). This technology platform will target both the human and veterinarian (pet) markets for treatment of many diseases including pain management.
The Oral Thin Film (Wafer) formulation is protected by several Canadian and US Patents. CTT’s oral fast dissolving drug delivery systems will consist of edible thin films (wafers) that dissolve without water, within a few seconds after placement in the mouth. The majority of drugs administered using our drug delivery system mirror injections in that they have the ability to enter the bloodstream quickly, are convenient and discrete, and can be administered anywhere. A faster absorption rate is achieved because the mouth contains a very thin mucosa and is extremely vascular. There is no bitter taste, no smoke inhalation as is the case with cannabis, and less degradation of medication (by bypassing the stomach) and most importantly lower dosage units are required given the efficacy of absorption. Patient compliance is improved, especially with those who have a fear of choking and/or are pediatric, geriatric or incapacitated patients who have difficulty swallowing.
Most fast dissolving systems on the market today deliver anti-inflammatories, antihistamines and cough and breathing related medications. CTT believes that its Wafer technology will be one of the first to gain use in major markets such as pain management.
For more information, please visit our website: www.cttpharmaceuticals.com
About CanniMed Ltd.
CanniMed Ltd. was the first producer to be licensed under the Marihuana for Medical Purposes Regulations (MMPR) and has the longest growing history as a result of the parent company, Prairie Plant Systems Inc., being the sole supplier for the entirety of Health Canada’s former medical marijuana program.
Prairie Plant Systems, the cultivation arm of the company, follows Good Manufacturing Practices (GMP) regulations, the criteria used to manufacture all pharmaceuticals in Canada. This industry-leading production excellence, including a 281-point quality control process, ensures product consistency and patient safety.
The company has a strong corporate priority to design and execute clinical research that will close the gap between the anecdotal benefit and evidence based medicine in order to standardize care. Prairie Plant Systems is the only Licensed Producer whose cannabis has already been used in two published clinical trials.
A randomized, controlled trial of smoked cannabis for chronic neuropathic pain - this study found that a single inhalation of 25 mg of 9.4% THC herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep quality, reduced anxiety and was well tolerated.i
The results of this study were used in the development of the Canadian Pain Society’s Pharmacological management of chronic neuropathic pain: Revised consensus statement positioning medical cannabis as third line treatment for neuropathic pain.ii
A randomized controlled trial of herbal cannabis on chronic non-cancer pain - this was the first and largest study looking at the long term safety of medical cannabis use by patients suffering from chronic pain. Patients were given access to herbal cannabis containing 12.5% THC (CanniMed 12.0) and were followed over one year. The researchers found that patients with chronic pain, who used cannabis daily for one year, when carefully monitored, did not have an increase in serious adverse events compared to pain patients who did not use cannabis. This study was published in the Journal of Pain.iii
Patient recruitment has begun on the Health Canada approved CAPRI Trial (Cannabinoid Profile Investigation of Vaporized Cannabis in Patients with Osteoarthritis of the Knee), a randomized, double blind, placebo controlled, proof-of-concept, crossover clinical trial of single dose vaporized cannabis in adults with painful osteoarthritis of the knee.
For more information, please visit our website: www.cannimed.ca
Upon execution of the Letter of Intent, CTT was paid $25,000USD. Upon execution of the Licensing Agreement CTT will be paid $40,000USD and will receive a royalty of 5 per cent based on gross sales. Additional payments will be made to CTT upon reaching certain milestones to be negotiated between the parties. The parties will use their best efforts to execute a Licensing Agreement by September 30, 2016. However, there can be no assurance that the parties will come to terms on a definitive agreement.
Forward Looking Statements
This press release contains forward-looking statements, which can be identified by the use of statements that include words such as "could", "potential", "believe", "expect", "anticipate", "intend", "plan", "likely", "will" or other similar words or phrases. These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. The Company does not intend, and does not assume any obligation, to update forward-looking statements, whether as a result of new information, future events or otherwise, unless otherwise required by applicable securities laws. Readers should not place undue reliance on forward-looking statements.
For more information or to schedule an interview, please contact:
Dara Willis Communications
i Ware, M.A., Wang, T., Shapiro, S., Robinson, A. and others. (2010) Smoked Cannabis for Chronic Pain: a Randomized Controlled Trial. Canadian Medical Association Journal (CMAJ). 182:E694-E701.
ii Moulin, D.E., Boulanger, A., Clark A.J., Dao, T. and others. (2014) Pharmacological Management of Chronic Neuropathic Pain: Revised Consensus Statement from the Canadian Pain Society. Pain Research and Management. Nov-Dec; 19(6): 328–335.
iii Ware, M.A., Wang, T., Shapiro, S. and others. (2015) Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). The Journal of Pain. Vol 16. Nov 12. http://www.jpain.org/article/S1526-5900(15)00837-8/pdf