Oxford Cann Regulatory News (OCTP)

Oxford Cannabinoid Technologies Holdings plc

New Partnerships Targeting Trigeminal Neuralgia

Accelerated focus on chronic pain relief underpinned by new service agreements

· Extension of pain management portfolio - initially targeting trigeminal neuralgia

· Strengthened relationships with key industry providers

· Focus on reducing time and cost to market

Oxford Cannabinoid Technologies Holdings plc ("OCTP" or the "Company"), the holding company of Oxford Cannabinoid Technologies Ltd ("OCT")(together, the "Group"), a pharmaceutical company developing prescription cannabinoid medicines for approval by key medicines regulatory agencies worldwide and targeting the US$ multi-billion pain market, announces the signing of new partnerships to target trigeminal neuralgia ("TN") - an increasingly prevalent chronic pain condition.

TN, which is also known as tic douloureux, is a chronic pain condition that affects the trigeminal nerve producing an excruciating, stabbing, electric shock-like pain. A patient may experience up to 100 attacks per day, with a constant throbbing, aching or burning sensation between attacks. About 150,000 new cases of TN are diagnosed each year, and in 2021 there were over 65,000 cases in the UK.

With current treatments only partially effective and with adverse side-effects, OCT aims to provide a drug-device combination product for sufferers and has signed a number of service agreements to accelerate development.

The Group's TN product concept is a combination of unnamed phytocannabinoids (pCBs) that will be administered to the lungs using a simple metered dose inhaler. Administration to the lungs should reduce onset time and the extensive first-pass metabolism associated with oral administration of cannabinoids.

The Group aims to obtain Orphan Drug Designation (ODD) which will allow OCTP to retain market exclusivity through regulatory protections, and may reduce time and cost to market. The programme is designed for an accelerated route to first-time-in-human (FTiH) with Phase 1 clinical trials planned for Q3 2022.

Supply Agreements

Purisys

A new supply agreement with Purisys LLC ("Purisys")(Athens, GA, USA) secures ultra-high purity, cannabinoid active pharmaceutical ingredients ("APIs") for the current preclinical drug development and future clinical and commercial supplies for the Group's Programme 2. Purisys has an industry-leading track record of more than a decade producing cannabinoid APIs under commercial drug master files (DMFs) that have been successfully referenced in registered pharmaceutical marketing applications. Purisys operates in full compliance with global regulatory pharmaceutical standards and utilizes its DMFs as well as extensive regulatory experience to aid pharmaceutical companies in gaining regulatory approval of new and improved therapies to treat, cure, or prevent disease.

Oz-UK Ltd

In addition, OCTP has entered into a commercial agreement with Oz-UK Ltd, Corsham, UK, for the development of a cannabinoid metered dose inhaler formulation, which will include studies aiming to identify and define the excipient/formulation components, as well as the selection of the canister, valve, and actuator. The selected formulation and device aim to deliver high-purity cannabinoids through the inhalation route which will allow faster and more efficient absorption of the APIs intended to provide both short and long term relief from neuralgias.

Voisin Consulting Life Sciences ("VCLS")

In order to enable the development and regulatory strategy of the Group's combination product, it has entered a further work package under the agreement with VCLS previously announced on 1 June 2021. VCLS is a global leader in supporting pharmaceutical, biotech and medtech partners in expediting access of healthtech products to regulated markets. VCLS will provide support to define nonclinical risk and gap analysis, regulatory strategy and roadmap, as well as clinical development strategy.

Dr John Lucas, Chief Executive Officer of OCTP, said: "We are delighted to have further expanded our portfolio. The pain caused by TN can be extremely debilitating and we are looking forward to working towards a pain management solution with our partners. We remain focused on developing our portfolio and increasing our growth potential as we progress our drug development programmes through preclinical and clinical trials." 

The Directors of the Company accept responsibility for the content of this announcement.

Enquiries:

About Oxford Cannabinoid Technologies Holdings Plc:

Oxford Cannabinoid Technologies Holdings plc ("OCTP") is the holding company of Oxford Cannabinoid Technologies Ltd ("OCT") (together the "Group"), a pharmaceutical company developing prescription cannabinoid medicines for approval by key medicines regulatory agencies worldwide and targeting the U$ multi-billion pain market. Cannabinoids are compounds found in the cannabis plant that have been shown to have a range of therapeutic effects on the body, including pain relief. The Group has a clearly defined path to commercialisation, revenues and growth. The Group is developing drug candidates through clinical trials to gain regulatory approval (FDA/MHRA/EMA) that will enable medical professionals to prescribe them with confidence.

The Group's portfolio aims to balance risk, value and time to market, whilst ensuring market exclusivity around all its key activities. The Group's lead compound, OCT461201, is a highly potent and selective CB2 agonist and is being developed by OCT in a solid oral dosage form. OCT is conducting pre-clinical testing and development with pre-clinical trials scheduled for 2022. The Group's product pipeline also uses a balanced drug product strategy that employs both naturally occurring and synthetic compounds for the treatment of rare diseases and includes chemically modified phytocannabinoids with improved drug-like characteristics and a proprietary library of cannabinoids.

OCTP operates a partnership model with external academic and commercial partners, including the University of Oxford with whom OCT has had an umbrella research collaboration since 13 March 2018.

About Purisys, LLC

Purisys states on its website that, Purisys is a leading supplier of active pharmaceutical ingredients (APIs), contract development and manufacturing (CDMO) services, and pharmaceutical reference materials. It's 17,000-square-foot manufacturing facility and innovation center in Athens, Georgia is staffed by scientists and other professionals who have decades of experience in complex high-barrier, niche synthetic chemistry. Purisys' expertise in specialty and DEA-scheduled products, including cannabinoids, psychedelics and other controlled substances for registered pharmaceutical applications, is complemented by its extensive regulatory filing experience and know-how to produce dozens of APIs across multiple categories and indications. The company offers a fully operational global supply chain and exports to over 30 countries with full international regulatory compliance. Purisys' CDMO services are designed to support the development of custom APIs for a wide range of clinical and niche commercial applications, linking product development services, analytical support, and manufacturing in an integrated process. Purisys' thriving reference standards business stocks a catalogue of more than 250 commercial reference standards including structural elucidation and comprehensive analytical data. Purisys also offers custom reference standard synthesis services to support customers' developmental and commercial needs

About Oz-UK Limited

Oz-UK Limited, with laboratories in Australia and the UK, is a privately owned independent company. As stated on the company's website, founded in 2015, Oz-UK is focused upon delivering the highest quality metered dose inhaler formulation and packaging technologies to the Pharmaceutical Industry. Experts in inhaled drug delivery, the management team has more than 70 years of combined experience within the industry and are authors of over 500 publications/patents.

About VCLS

As stated on the company's website, VCLS is a global regulatory science and clinical consultancy firm, which guides biotechnology, pharmaceutical and MedTech manufacturers throughout product development and market access. From early-stage to patients, VCLS assists innovators by designing product development strategies that optimise clinical development to drive commercial success.

The firm offers integrated solutions with regulatory and market access development strategy, chemistry formulation, manufacturing scale-up & control services, nonclinical & clinical regulatory development planning, clinical trial operations, safety monitoring, thanks to continuous interactions with regulators and payers. With offices in Cambridge, and Somerville (MA & NJ, USA), London (UK), Paris and Rennes (France), Lausanne (Switzerland), Copenhagen (Denmark), Antananarivo (Madagascar), Bangalore (India) and Shanghai (China), VCLS serves a broad range of developers and investors in life sciences.

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ''believe'', ''could'', "should" ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', "expect", ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.