Profile: Michael Ankersen

The biotech brain drain typically runs from Australia to the United States, but Dr Michael Ankersen has swum against the tide. His belief in Infensa Bioscience was strong enough to bring him from San Francisco to Brisbane to join the company.

As Infensa’s Head of Project Management, Michael is overseeing development of the company’s clinical drug candidate for treating heart attacks and strokes.

With more than 30 years of experience in the pharmaceutical industry across Europe and the U.S., he already boasts two commercially available drugs improving patient lives worldwide.

An appetite stimulant for cancer patients

Originally from Denmark, Michael cut his teeth at Novo Nordisk, a Danish company now recognised as Europe’s largest by market capitalisation, largely due to the runaway success of Ozempic.

After more than 10 years in Novo Nordisk’s Research Department, Michael moved to the Clinical Development Department and actually spearheaded the first Obesity Clinical Development program, long before Ozempic and Wegovy.

But when Michael joined in 1993, Novo Nordisk focused primarily on insulin and growth hormone, working on big proteins. After Merck discovered a small molecule that triggered the release of growth hormone from the pituitary gland, Novo Nordisk launched a decade-long research effort to counter this threat.

With Michael at the helm, they developed a range of clinical candidates. While many progressed to phase 1 trials, researchers eventually found that the pituitary became desensitised to the small-molecule drugs they were developing, limiting their long-term viability.

Novo Nordisk and Merck both abandoned research in this area, with Novo reluctant to commercialise any drug candidates from the program, even one that was demonstrating an unexpected therapeutic value.

“We discovered one of the last drug candidates to be developed had an orexigenic effect, meaning it makes you hungrier, which is beneficial for some cancer patients who develop a wasting disease called cachexia,” Michael says.

“This occurs specifically when cancer patients are lying in bed and have no appetite, so they don’t eat and gradually lose their muscle mass and strength.”

Seeing the potential value, Michael persisted with the drug and found a commercialisation partner: a new company set up by a former Merck growth hormone researcher.

The drug candidate made it through clinical trials. Now called Anamorelin, it is on the market in Japan to treat cancer cachexia, with Michael the sole inventor on the first of many patents.

Combining science with business to help patients

Michael’s leadership role at Novo Nordisk frequently involved collaboration with the marketing department, leading him to realise the value of business expertise in drug development.

Having already completed a chemistry degree with a business minor—unusual at the time—Michael pursued an industrial MBA while working full-time. This combination of scientific and commercial skills has proven invaluable in his career.

His next major project took him to Mylan Pharmaceuticals in 2013, where Michael would develop his second drug.

“The long-acting insulin that was on the market at the time was extremely expensive, so my work at Mylan involved making a biosimilar of Lantus, which is Sanofi’s long-acting insulin,” Michael says.

Biosimilars are large biological drugs expressed in living systems such as yeast and bacteria. While they may have the exact same core structure and show a similar therapeutic effect as their parent biologic, they can differ in some aspects, such as the specific sites where carbohydrates are added.

This means biosimilars require much more complex regulatory approvals than traditional generics, which are exact copies of small-molecule drugs.

“It was an interesting time, because we started from scratch and took the drug through to the market,” Michael says. “I was involved in a lot of new things that I’d never done before, such as analysis of large biologics, manufacturing, quality and other new areas, and it gave me an insight into what it really takes to develop a drug.

“There’s a lot of different disciplines that all have to line up.”

This effort was a collaboration with the Indian biopharmaceutical company, Biocon, which handled the manufacturing through its facilities in Malaysia and India, so Michael spent a lot of time in those two countries. He also gained extensive experience liaising with several regulatory agencies.

“At the time, the US lacked regulatory guidelines for biosimilars, making it difficult to get approval,” Michael says.

“Europe was a little bit ahead; they had already approved a biosimilar of growth hormone at that time, so they had the process in place. We worked a lot with the European Medicines Agency and the German regulatory agency, BfARM, to gain approval before approaching other countries to implement a process for biosimilar approval.”

Michael and his team’s persistence paid off. The insulin biosimilar Semglee is now available in more than 45 countries, including the US, EU nations and Australia.

What does it feel like to have two products out in the world helping people?

“It feels good,” Michael says, “but you don’t really think too much about it until some ‘stranger’ one day reminds you, or when you are at the doctor’s office and you suddenly see an advertisement for ”your drug”.

“I was at a meeting in Sydney and as part of my introduction, I said I was involved in the development of Semglee. Afterwards, a parent came up to me and said his son was taking Semglee every night and he appreciates my work.

“It’s a good reminder of why you do this work.”

A fateful collaboration leads to a job Down Under

After Mylan Pharmaceutical, Michael joined Genentech (part of Roche) in San Francisco, and moved into the respiratory space not long before the COVID-19 pandemic.

While it might seem good timing, the pandemic put paid to an asthma drug he was developing – the rise in face masks saw such a marked drop in asthma attacks that there weren’t enough eligible patients for a clinical trial.

After Genentech, Michael pivoted to freelance consulting with various biotech companies – including Infensa Bioscience.

“I’ve known Mark for more than 25 years, since my Novo Nordisk days,” Michael says of Infensa CEO Mark Smythe, whose research at The University of Queensland led to a collaboration with Novo Nordisk.

“We kept in touch and after consulting to Infensa for a while, I eventually said, ‘Why don’t I just move down there and join you instead?’”

Michael is now based in Brisbane, leading Infensa’s Drug Development, including Phase I and II clinical trials.

It’s a long way – literally and figuratively – from working at Novo Nordisk and Genentech, two of the world’s biggest pharmaceutical companies, and leading drug development projects with hundreds of coworkers involved, to a start-up in Australia with 11 employees.

But Michael is relishing the benefits of a small operation, such as his close involvement with the trials and the freedom to choose the team who will implement them on the ground.

“There’s no certainties in drug development, but I’m very optimistic,” he says.

“It’s a good environment here and I think we’re on to something promising - we have very exciting times ahead.”