Arvelle Therapeutics, founded in 2019, is a Switzerland-based biopharmaceutical company that focuses on innovative central nervous system drugs.

The company’s noticeable idiosyncrasy? It has only one pipeline, which happens to be South Korean SK Biopharmaceuticals’ cenobamate, a drug used to treat partial-onset seizures in adults.

“Arvelle was founded to in-license cenobamate,” said Mark Altemeyer, CEO of Arvelle, in an exclusive interview with The Korea Herald held across time zones via Zoom.

“Our first priority will be to make cenobamate successful. The whole thing (Arvelle) started because of the ability to have a product as good as the cenobamate,” Altemeyer said.

In-licensing refers to a practice where companies strategically trade licenses for promising drug candidates in varying stages of development -- or, as in Arvelle’s case, commercialize a drug in a specific region, in this case Europe -- to minimize costs, risks and research time. The pipeline is transferred like a baton in a marathon from an out-licensing company to the in-licensing partner.

This pattern of license trading is widespread, and even encouraged by investors, due to the nature of the drug development business, a painstakingly long process that entails great financial costs, with a high risk of projects failing to materialize in the form of tangible products.

Arvelle bypassed all that drama by in-licensing cenobamate after SK Biopharmaceuticals finished clinical trials and obtained approval from the world’s strictest drug authority, the US Food and Drug Administration.

It was Altemeyer who first reached out with a business proposal. He had an eye for promising candidates based on his experience working for Axovant, BMS and Otska Pharmaceutical, where he helped form licensing partnerships.

Altemeyer, who has 30 years of experience in the pharmaceutical business, 20 of them focused on treatments for central nervous system disorders, said he was most impressed by cenobamate’s effectiveness.

“There is about 40 percent of patients who remain seizing despite the fact that there are couple dozen medicines out there because they have developed resistance or tolerance to those drugs. The data we’ve seen both in clinical trials and open-label trials have convinced us that cenobamate has a really nice potential role to play in combination with other drugs,” said Altemeyer.

Cenobamate trials have demonstrated an unprecedented number of people with epilepsy reporting prolonged periods of zero seizures, and the drug has also proven through long-term open-label tests that its effects hold for at least five to eight years, he noted.

“I’ve never seen a drug this well differentiated. I was so excited to be able to do this deal with SK Biopharmaceuticals,” Altemeyer said.

As of February 2019, Arvelle has the right to develop and market cenobamate in 32 countries in Europe.

SK Biopharmaceuticals’ global clinical trials had already included Europe, and Arvelle is awaiting marketing authorization approval from the European Medicines Agency to market cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy.

It submitted the application in March, and this offered favorable leverage for Arvelle’s Series A funding in May, bringing the total financing to $207.8 million.

Among the investors are NovaQuest Capital Management, BRV Capital Management, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investments.

After the EMA approval, Arvelle will approach individual countries' drug authorities to gain local authorizations.

“We think, with Arvelle in Europe, there is a real opportunity to leverage the commercial late-stage infrastructure we got,” Altemeyer said.

Arvelle is the only foreign partnership SK Biopharmaceuticals has for cenobamate. In North America, SK Biopharmaceuticals is independently marketing the drug through its US entity, SK Life Science. The brand name of cenobamate in the US market is Xcopri.

In Europe, the same brand name cannot be used due to administrative reasons, but SK Life Science and Arvelle are thinking up a name that will retain cenobamate’s brand value.

Logistics-wise, SK Biopharmaceuticals is going to send bulk tablets to Arvelle, which will then package them in Germany, the European country that has turned out to be the most capable vendor.

Arvelle anticipates receiving EMA approval in the first half of 2021, after which it intends to launch cenobamate in Germany within a matter of weeks.

The UK is likely to be the second destination.

“Initial public offering (of Arvelle) is clearly something we’re talking about. An IPO is a way to show our commitment, but not because we need to raise more money,” said Altemeyer.

“Right now the company’s well-funded, with a clear path to profitability. But between now and then we will need to do more financing, and exactly when to do it is going to depend on many different factors such as how good is the market, whether we should do a Series B funding, and such,” he said.

Currently, SK Biopharmaceuticals has a 12 percent stake in Arvelle.

While the first priority is to launch cenobamate across Europe, Arvelle’s long-term vision is to add more later-stage CNS assets that will complement cenobamate.

Looking ahead, Altemeyer said he sees Arvelle gaining a presence not only in Europe, but also in the US and Asia.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)