AFT Pharmaceuticals is highly selective about the products it brings to the Australasian market – and its eyecare portfolio exemplifies this. CEO Dr Hartley Atkinson discusses the company’s dual role as a distributor and innovator on the local ophthalmic scene.
Dr Hartley Atkinson knows just how difficult it can be to bring a drug to market in 2023. As the founder of AFT Pharmaceuticals – a New Zealand-based pharma company punching above its weight – he’s seen the list of requirements expand over the decades whether it be greater demands for approvals and pharmacovigilance, through to accurate marketing, and transparency around carbon emissions and other ESG policies.
In some markets, it has also become challenging for clinical-stage biopharmaceutical to raise the required funds to progress their therapies through vital testing phases.
In Australasia – and increasingly in other markets – AFT has positioned itself as a go-to licensee of pharmaceutical products. This includes an eyecare portfolio built on a preservative-free approach and spearheaded by brands like NovaTears, Opti-Soothe and Hylo, which includes Hylo-Forte – ranked the number one eye lubricant in the Australian market in terms of dollars and units sold.
The diversity within AFT’s business is one of its strengths and eyecare is among a host of therapeutic areas it focuses on. But the company does much more than in-licence products – it has a significant R&D pipeline with 15 investigational products, including an ophthalmic therapy.
In the early days, Atkinson says AFT would typically scour overseas markets for therapies that could fill a distinct gap locally. This was the case with German ophthalmic manufacturers Ursapharm (Hylo range) and Novaliq (NovaTears range). But nowadays the shoe is on the other foot. A major reason for this is the 360-degree service AFT can provide for overseas manufacturers seeking a share in the ANZ market.
The company has experts that take care of regulatory approvals with bodies such as the Therapeutic Goods Administration (TGA) and Pharmaceutical Benefits Scheme (PBS), through to business development activities like marketing, sales and distribution directly to its network of optometrists, ophthalmologists and other healthcare professionals.
Recently, it reached an agreement with San Diego firm Latitude Pharmaceuticals for intellectual property for an anti-bacterial eye drop and, as part of this, AFT will run the full development of this product including a large scale, multisite trial to bring the therapy to market (more details on this below).
“I think these companies choose to work with us due to the breadth of what we can cover – we’re well-placed in areas like drug registration, clinical development, quality assurance, pharmacovigilance and a promotional programme that is compliant with a sophisticated market like Australia,” he says.
“Today, we have the number one selling eye lubricant on the Australian market, so people have worked that out and want to work with us. Over the years we have been offered a number of products. On the bottom of our business cards it says, ‘working to improve your health’ and we have turned down products we think don’t have this aim in mind.”
NovaTears backed by pivotal study
AFT, a NZX and ASX-listed firm, has continued its annual trend of posting a record operating revenue, with its latest FY23 figures reaching NZ$156 million (AU$144 m), up 20% on the previous year. Australia continues to be its largest market, accounting for 61% of sales, growing by 23% to NZ$94 million (AU$86 m).
Atkinson says the company’s eyecare portfolio continues to build momentum in Australia, with the latest ophthalmic addition being the glaucoma eye drop Vizo-PF Dorzolatim dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL, available in a preservative-free multidose bottle.
He believes there are more opportunities like this. But for now, the company is placing an emphasis on growing the NovaTears range that caters for a large chunk of the dry eye market where more than 85% have the evaporative form of the disease.
The company has been somewhat surprised with the performance of NovaTears + Omega-3. It’s a line extension of the NovaTears eye drop introduced only a few years ago that combines perfluorohexyloctane and concentrated Omega-3 fatty acids of algae origin. However, there is more untapped potential for NovaTears, Atkinson believes.
“There’s a large market in Australia where people take fish oil tablets for their cardiovascular health, but if you’re doing it to promote good eye health via this method then it makes a lot of sense to deliver it topically to the eye. That’s why we’re seeing NovaTears + Omega-3 perform better than we thought,” he says.
AFT already has a six-strong team of representatives visiting eyecare practices and an optometry network distribution agreement with Good Optical Services, but has recently appointed 10 salespeople to target the GP setting where NovaTears is a top priority.
“NovaTears has done well, but with the quality of this product, we think it has even greater potential. The range has performed not dissimilar to Hylo at the same point in time; in fact, NovaTears sales are slightly higher comparatively – but then Hylo took off,” he says.
“We saw the GP setting as an important one to drive greater education and awareness of the brand. Doctors have a more holistic view of the patient and, as part of ageing, people often have dry eye and are recommended eye drops.”
Atkinson hopes NovaTears can ride the wave of recent US Food and Drug Administration (FDA) approval in May 2023. In America, the therapy is marketed as MIEBO and became the first and only FDA-approved treatment for dry eye that directly targets tear evaporation.
Key to this approval was the GOBI study, a Phase 3, multicentre, randomised, double-masked, saline controlled trial with 26 investigational sites and 597 patients. The work was published in the American Academy of Ophthalmology journal.
The primary sign and symptom end points were change from baseline in total corneal fluorescein staining (tCFS) and eye dryness score (0-100 visual analog scale [VAS]) at week eight. Key secondary end points were change from baseline in eye dryness score at week two, tCFS at week two, eye burning or stinging score (0-100 VAS) at week eight, and central corneal fluorescein staining (cCFS; 0e3 NEI scale) at week eight.
“Ultimately, it showed that dry eye associated with meibomian gland dysfunction provides statistically significant and, importantly, clinically meaningful evidence of the reduction of signs and symptoms of dry eye during eight weeks of treatment with NovaTears,” Atkinson says.
“But the other pleasing aspect was that we were getting statistically significant improvements as early as week two, so the product is working quickly in patients.”
A greenlight from the FDA is a big deal for any product, Atkinson explains.
“It’s the world’s largest healthcare market and regulatory approval there creates a lot of noise that tends to spill over to other geographies,” he says.
“It’s positive to have NovaTears reinforced by a large, well-conducted, published clinical study that led to approval by the US FDA. As an agency, they are very particular. We’ve had one approval and another one pending for a pain medication and when the FDA arrives, they stay several days to ensure they are happy with study conduct. They audit study sites and request the full open data files and recalculate everything to make sure it corresponds. They are a very thorough organisation.”
New horizons, new opportunities
Looking ahead, Atkinson can see more opportunities on the horizon for AFT to introduce more preservative-free, multidose therapies in the ophthalmic space.
“We are working on two projects, but hopefully we’ll be able to tell you more about those in time; there is something good happening in America that I think we can bring down to Australia,” he says.
However, Atkinson could provide more details on the October 2023 deal with Latitude Pharmaceuticals. AFT will license Latitude’s key technology to develop a stable antibiotic eye drop for patients at risk of serious eye infections, with a potential addressable market worth US$1 billion (AU$1.5 b) globally.
The licensed intellectual property (IP) involves a patented aqueous stable formulation for an antibiotic eye drop. The antibiotic is already approved for treating various bacterial infections, including those caused by the antibiotic-resistant MRSA (Methicillin Resistant Staphylococcus Aureus) bacteria. However, no approved ophthalmic solution for this antibiotic exists for serious, potentially sight-threatening infections.
Atkinson warns the market is being served with eye drops by compounding pharmacies that come with the risk of contamination. But extensive off-label use has validated the market potential for the antibiotic for treating a number of important ophthalmic conditions.
The program will be included within AFT’s existing R&D budget, which is forecast to be circa NZ$12 million (AU$11 m) per annum in the FY2023 and FY2024 financial years. It’s another example of AFT’s value proposition in the pharmaceutical market, locally and globally.
“This is our first R&D project in eyecare. It’s a good opportunity because a lot of these companies in the US, with their economic conditions, are struggling to raise finance, so a company like ours can take it over, conduct the clinical research, studies, formulation, etc, bring it to market and then share in the revenue,” Atkinson says.
“In Latitude, we see a company with strong IP and with the potential to treat eye infections, as well as being used preventatively, it could add up to a sizable market. In saying that, we’ve got three- to-four years of work ahead of us that will involve studies with 300-plus patients, but that’s an area we specialise in, often across multiple sites internationally.”