New Zealand pharmaceutical company AFT Pharmaceuticals has obtained regulatory approval for its liquid pain reliever developed for children in Europe and is hoping to eventually gain approval from the United States.
Italy and Malta have approved the use of Maxigesic Oral Liquid, a combination of paracetamol and ibuprofen for children aged 2 to 12 years. This follows a study of 251 patients in three countries.
“There is often a concern around the world that many drugs are not available in children’s versions, and on the other hand, they are actually quite difficult to develop,” AFT CEO said on Wednesday. Pharmaceuticals, Hartley Atkinson.
“A lot of times it’s really unethical to dose kids with placebos, so you have to design studies differently, which we did, and we did a lot of computer modeling as well as part of the submission, so it gets really pretty complicated. “
* Monitor Economics Q&A: Hartley Atkinson, CEO of AFT Pharmaceuticals
* A Covid-free Australia would help AFT Pharmaceuticals’ growth
* Pharmaceutical Company Shares Rise After Deal Signed In World’s Largest Market
The oral liquid was not yet approved for use in New Zealand and Australia, but Atkinson was hoping to gain some time this year.
AFT had children’s versions of some of its other medications, but this was its first product intended only for children. The company was working on a children’s version of its intravenous pain reliever Maxigesic, which has been approved in 21 countries.
Earlier this year, AFT signed its first distribution agreement in the United States, the world’s largest drug market. The deal was for its intravenous, opioid-free, intravenous IV postoperative pain medication Maxigesic, and it was still awaiting US Food and Drug Administration (FDA) approval for its Maxigesic tablet.
Approval was delayed by a final inspection of the AFT manufacturing site, which had been delayed by Covid-19, Atkinson said.
“At this point everything is clear except for this final approval, so we’re just waiting for that to be confirmed.
“I think it’s going to be more like next year to be honest, so obviously it’s frustrating, but it’s still progress in progress. “
Ultimately, intravenous pain relief might be AFT’s biggest product, he said.
“We’ve recorded this, licensed it in a number of countries, and it should be a pretty interesting product.”
The company, like other manufacturers, was grappling with ongoing supply issues due to Covid-19 disruptions in global transportation and freight.
“Even simple things like getting a shipping container, which was previously just a job of an email, it actually takes about a month now from some places,” Atkinson said.
“So we had almost $ 10 million in additional inventory, and we’re going to continue because we don’t really see it resolving for at least the next 12 months, that’s what our experts are telling us.”
Freight issues also contributed to increasing costs.
“Shipping containers have literally increased about three times … we’ve had price increases ourselves, because of input costs, and it’s possible we may have other price increases because we have to. really do it, ”he said.
The price of raw materials used in various drugs was also increasing, with the price essentially doubling, adding to inflationary pressures.
“In fact, there have been a lot of price increases. I know you read rumors about these things, but from our perspective, we see it’s real, it’s not something people make up. “
AFT shares fell 1.1% to $ 4.50 by late afternoon.