Suda Pharmaceuticals (ASX: SUD) has had a setback in the development of its ArTiMist anti-malaria mouth spray.

In short; it looks like the product won’t meet the minimum safety requirements set out by Australian regulatory authorities.

The company has received a “preliminary notice of denial” for approval to market ArTiMist in Australia.

The notice was issued by the Advisory Committee of Medicines (ACM) — an independent body which advises the federal health minister and the Therapeutic Goods Administration (TGA).

Suda went into a trading halt at 9:09am AEST today, and advised the market about its regulatory stumbling block at 3:45pm, 15 minutes before markets closed for the Easter break.

Shares in the company have been struggling for traction below 1 cent since the start of the year, and closed the week at 0.4 cents.

Unexpected result

The preliminary ruling by the ACM came as a bit of a body blow, Suda said, given that it first launched the approval process almost two years ago.

During that time, “neither SUDA nor its regulatory advisors received any indication that the process would not be successful”, the company said.

However, it’s not giving up just yet.

Firstly, Suda’s regulatory experts have advised that although the ACM has ruled against ArTiMist, the resolution is only issued in an advisory capacity. It’s still up to the TGA to make a final decision.

As a result, the company will wait for the official delegate’s letter, scheduled for release in mid-May, before making a final decision on how it will proceed.

If the TGA rules in the negative, Suda said that expert advice provided to the company indicates there may be appeal options available.

Suda CEO Stephen Carter said he still believes that ArTiMist “has a role in the global fight against malaria”.

“We are very surprised by the decision of the ACM, especially as the various TGA reviewers had all recommended the product for approval,” he added.

More than one spray

While its malaria treatment is hitting a roadblock, Suda manufactures a number of mouth-spray treatments used to treat a unique array of problems and ailments, including insomnia.

Shares in the company have declined steadily from around the 1 cent mark since last November, when they spiked by 80 per cent after it struck a deal to develop a migraine drug in the United States. It also makes a Viagra spray.

The company had a busy run into the end of last year, signing a South-East Asian distribution deal with the $936 billion pharma company Mitsubishi Tanabe.

That followed a joint venture agreement with the ASX-listed Zelda Pharmaceuticals (ASX: ZLD) to develop an “oral spray of pharmaceutical-grade cannabinoid derivatives”.