SUDA Pharmaceuticals sets sights on development of oral sprays

Hot off the press. Good article and very happy to hear the business development side is progressing.
Seems like a no nonsense and forward thinking management team.


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SUDA Pharmaceuticals Ltd (ASX:SUD) is focused on developing solid dose drugs and converting them to oral sprays.

Chief executive officer Michael Baker said the many potential benefits of administering drugs through the oral mucosa (cheeks, tongue, gums, and palate) included ease of use, lower dosage, reduced side effects and faster response time.

He said: “When a tablet goes through your digestive tract it gets to your stomach where it gets degraded and then it also undergoes a second processing step in the liver (called first-pass metabolism) before entering your bloodstream.

“There are multiple routes of degradation for a drug that’s taken in pill form compared to when taken in an oral spray which increases bioavailability.”

This dosage method is also convenient for children and in situations where patients are unconscious or having a seizure or where swallowing a tablet is impractical.

SUDA’s product pipeline

The company has three core products including ZolpiMist™, which is a US Food and Drug Administration (FDA) approved oral spray version of the drug known as Ambien (or Stilnox in Australia) which is used for the treatment of short-term insomnia.

Other products in the pipeline include Sumatriptan which is for the treatment of migraines, and Anagrelide, which could play an important role in cancer treatment.

ZolpiMist™ commercialisation strategy

ZolpiMist™ is already marketed in the USA and SUDA has the rights to the product in the rest of the world.

Baker said: “Currently we’re taking it through regulatory submissions in Australia through the Therapeutic Goods Administration (TGA) and expect to hear an outcome from that regulatory submission in 2020.

“We’ve got a licensing and supply agreement with Teva Pharmaceuticals International GmbH, an affiliate of Teva Pharmaceutical Industries Limited (NYSE:TEVA) (TLV:TEVA) (OTCMKTS:TEVJF), which covers Brazil, Mexico and Chile, and also a licence and supply agreement with Mitsubishi Tanabe Pharma Singapore which covers Malaysia, Singapore and the Philippines.

“We recently added Mitsubishi Tanabe Pharma Korea which is great for us because it’s a nice indication of Mitsubishi Corporation showing their commitment to the program by adding another territory to the agreement.”

Product partnerships

Baker said the aim was to create additional partnerships to roll the product out globally so each territory would get approval by their regulatory authority to be able to commercialise the product in each region.

He said: “We work with drugs that are already approved so we know they are already effective, and we create partnerships with pharmaceutical companies.

“With the Mitsubishi Tanabe Korea partnership, as all our agreements, we take an upfront payment because they’re getting access to the SUDA platform.”

“Upon completion of agreed development work or regulatory approval or achieving commercial sales levels, we are entitled to milestone payments.”

Once drugs are commercialised, SUDA will then take a royalty of net sales as well as a handling fee for the manufacture and supply of the product.

The royalty rate for the Mitsubishi Tanabe Korea partnership is 12%.

Digital business development deals

In the half-year to December 31, 2019, SUDA secured three new agreements, including Cann Pharma Australia, for a novel oral spray of cannabinoid derivatives and two feasibility studies with Laboratorios Ordesa, SL and Sanofi-Aventis Groupe.

The company also recently closed the deal with Mitsubishi Tanabe Pharma Korea, which highlights that business is continuing as usual despite COVID-19 restrictions impacting travel.

Baker said this came down to the company leveraging the digital space for business development.

The recent Bio Spring meeting in Paris was cancelled and converted to a digital meeting but SUDA was able to generate a number of leads with large pharma, mid-size pharma and biotech.

Baker said: “We’re trying to take a positive mindset and embrace the situation as it stands by being really proactive on the digital business development front.

“There are advantages, you don’t have to travel which can take a significant amount of time and you can reduce some of the travel costs associated with business development.

“It doesn’t beat face-to-face, but it means we’ve been able to continue discussions around our product portfolio.”

Medium-long term goals

As well as continuing business development, Baker said that making significant progress with SUDA’s products throughout 2020 was a key focus for the company.

He said: “Hopefully at the end of the year we’ll have made great headway with programs like our cancer product Anagrelide.

“We’re aiming to get the formulation completed and show that we can get penetration through the oral membranes that would provide good uptake into the blood stream in humans.

“We also expect to hear the outcome from the TGA for ZolpiMist™ regulatory approval.”