• AFT Pharma gets US FDA approval
  • Microba moves into Turkey and the Czech Republic

AFT Pharma get US FDA approval

AFT Pharmaceuticals (ASX:AFP) has gained a US FDA approval for its Maxigesic Rapid tablets, a drug used to treat mild to moderate acute pain.

The US approval is the first step for AFT’s family of medicines in the important US market.

The company is now awaiting approval for the intravenous form of the patented medicine Maxigesic IV, and is also considering the release of other dose forms in the market.

Maxigesic Rapid is a combination of 325mg of paracetamol, and 97.5mg of ibuprofen that deploys a patented rapid release technology.

The analgesic market in the US is worth around US$7 billion, and is expected to grow by 6% a year between now and 2027.

Today’s approval follows on other commercial successes with Maxigesic.

Maxigesic Oral Liquid, a patented unique combination of 160mg paracetamol and 48mg ibuprofen per 5ml oral suspension for children, has recently received approval in an additional 12 European countries.

“We are delighted with the FDA approval of this prescription medicine and excited about the growth opportunities it opens for the company,” says AFT Pharma CEO, Dr Hartley Atkinson.

“We have held talks with potential US licensees for the medicine, and are evaluating US market entry plans to maximise its commercial potential.

“We also importantly see this as a therapeutic option to help doctors battle the opioid epidemic in the US,” he added.


Microba penetrates further into Europe

Microba Life Sciences (ASX:MAP) meanwhile has executed a deal with SYNLAB to distribute Microba’s testing technology into Turkey and the Czech Republic.

The deal was signed with SYNLAB’s affiliate organisations in those two countries.

The deal today was preceded by a master agreement signed in 2020 between Microba and SYNLAB to deliver Microba’s testing to healthcare providers in Spain.

That initial agreement had an option to expand the contract across SYNLAB’s affiliate organisations which operate in 36 countries.

Microba believes entry into both Turkey and the Czech Republic represents a major development in the distribution of its products into Europe.

The company says further affiliate country agreements are now anticipated in the near term to continue this expansion activity with SYNLAB.


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