2019 was a busy year for CURE Pharmaceutical. The California-based drug development company moved to strengthen its position in both the wellness and pharmaceutical markets as a provider of proprietary formulation and delivery platforms, with partnerships, acquisitions and product line expansions all on the menu.
Founded in 2011 by chief executive officer, Robert Davison, the company initially focused on the nutraceutical market, the perfect playground to develop and launch its pioneering oral film technology as it posed fewer regulatory hoops to jump through than the pharmaceutical pathway.
The advantages of film over pill have been well-documented. Most notably, film offers a potential solution for geriatric patients with swallowing difficulties and greater dosing precision as it can be cut to size in a way that gel caps and drops under the tongue cannot.
With a vertically integrated business model, CURE possesses its own cGMP commercial manufacturing and packaging facility in Oxnard and has developed its CUREfilm oral soluble film technology into a stable platform to enhance the delivery of both third party and in-house products.
Targeting the cannabinoid space
The company is now keen to make a name for itself as a pharmaceutical innovator with a deep focus on the potentially lucrative cannabinoid space.
CURE chief operating officer Jessica Rousset says CURE sees itself as a provider of advanced formulation solutions for the cannabis industry and more acutely, the pharmaceutical cannabinoid sector.
CURE’s key differentiator is its flexibility within a clearly defined therapeutic area, she adds.
“We design formulations for a variety of drugs, but we also do commercial manufacturing at scale,” she says. “Something unique to CURE is we’ve embraced and pursued both the wellness markets with nutraceuticals and dietary supplements as well as drug products. The two sides of that coin come together in a unique way when it comes to cannabinoids.”
Of course, a lot still depends on the results of the US Food and Drug Administration’s ongoing evaluation of the science, safety and quality of products containing cannabis or cannabis-derived products including cannabidiol (CBD).
With only one CBD-based drug currently approved by the FDA – GW Pharmaceuticals’ Epidiolex for the treatment of two rare forms of epilepsy – the agency’s approach to the compound could best be described as cautious, particularly in view of the limited data on CBD safety.
Rousset is optimistic that CURE’s decision to position itself within CBD-based product development will reap dividends: “Let’s see what the FDA have to say, but we certainly believe there will be a regulatory framework both for [CBD] as a wellness product and nutraceutical dietary supplement and as a pharmaceutical.”
Rousset highlights the passage of the Agricultural Improvement Act (commonly known as the US Farm Bill) in December 2018 as a key event for companies developing cannabinoid-based delivery solutions. This expansive piece of federal legislation allowed hemp cultivation, the transfer of hemp-derived products across US state lines for commercial purposes and put no restrictions on the sale, transport or possession of hemp-derived products.
“That opened up a lot of possibilities for us to start working with cannabinoids that are derived from the plant, specifically cannabidiol,” she says.
She explains that while Epidiolex paved the way for the sector, the complex manufacturing process involved in plant- and extract-based products means most firms on the pharma side are taking the synthetic API approach.
CURE has also been on the acquisition trail, with a clear strategy of identifying assets and partnerships that either boost its presence in cannabinoids or present opportunities for revenue via other sectors.
Within the last twelve months, CURE has bought formulation technology company Chemistry Holdings and announced a partnership with Canopy Growth to develop low-dose CBD products using the film delivery mechanism.
One deal that failed to materialize was CURE’s potential purchase of Coeptis Pharmaceuticals, which would have given it exclusive rights to Coeptis’ approved drug Consensi, a fixed-dose combination drug for comorbid osteoarthritis and hypertension.
While Rousset won’t be drawn on why the deal did not come to fruition, she says Coeptis represented both the critical near revenue opportunity which fell within CURE’s overall strategy.
“We’re certainly looking for other late stage assets that may be similar to that one in terms of a near revenue potential, but we’re also looking at acquisition opportunities and strategic partnerships in the cannabinoid space… we’re casting a broader net in that particular sector,” she says.
Innovation at the core
Despite its vertically integrated approach, Rousset is keen to stress that innovation will remain at the heart of CURE going forward: “We believe our core competencies are in the innovation part, developing unique formulations that need specific pharmacokinetic (PK) profiles that are desirable for a new product on the pharmaceutical side. Our business model on the pharma development side is not to take on the whole process inhouse. We secure the IP, we do the early formulation and scale up, and then we have external partners who help us take it to the next level while we continue to manufacture inhouse.”
CURE’s first pharmaceutical product is CUREfilm Blue, which would represent a conversion of the widely used erectile dysfunction treatment, sildenafil, from pill into oral thin film. CURE has taken the relatively straightforward and streamlined 505 (b)2 regulatory pathway for the drug and is currently scaling up manufacturing and preparing for clinical trials.
“It’s a two-year process to go through the clinicals and get that drug approved,” she says. “Sildenafil is a lifestyle-type drug that falls in that broad consumer type base.”
On the drug delivery side, CURE is focusing on generating IP and proof of concept data for its oral formulation platform, which has expanded beyond thin film to include chewables and emulsions. The pipeline includes thin film delivered buccally, orally, sublingually and a proprietary emulsion that can be combined with the topical, transdermal or put in a gel cap and taken orally.
“Taking these molecules and putting them in an oil carrier like almond oil or MCT is stage one and that’s what most companies are doing but it’s still inefficient and hasn’t been optimised,” Rousset says. “We’re also working on self-emulsifying drug delivery systems: taking these oily, fatty molecules and putting them into solutions and increasing their bioavailability in the process. That’s a big gap in the field.”