Serial entrepreneur wants to revolutionize syringes - French pharmaceutical company may be first customer

Egalet founder Jan Quistgaard is currently raising funds for his new company Medilet, which is behind a dual-barrel syringe that may soon have its first buyer - a French pharma company. "It looks promising," says the CEO.

Jan Quistgaard, CEO of Medilet Photo: PR/ Privat

Money may be on its way to Danish medtech firm Medilet, which owns the rights to a dual-barrel syringe called Dualet that can keep freeze dried and liquid medicines separate.

The company, which is run by serial entrepreneur Jan Quistgaard, is well on the way to landing a DKK 13.5 million (USD 2 million) investment from a range of investors, including Danish family offices, business angels and venture funds.

"We are also in dialogue with two venture firms; one English and one Dutch. We are around halfway. Half of the potential investors have said yes, and we are currently negotiating with 15 others, who are also very interested and close to joining. It looks very promising," says Quistgaard to MedWatch.

Quistgaard founded Egalet in 1995 alongside Copenhagen University professor Daniel Bar-Shalom, who invented Dualet. Quistgaard ran the company until 2007, and since then, it has been taken over and renamed Zyla Life Sciences.

Half of the potential investors have said yes, and we are currently negotiating with 15 others, who are also very interested.

Jan Quistgaard, CEO, Medilet

In 2014, Quistgaard bought the rights to Dualet from Bioneer and Copenhagen University, and founded Medilet with a private investor.

The company is currently pursuing the first customer for the syringe, which in contrast to existing versions on the market is made of plastic and can be used by patients without assistance from healthcare professionals.

"This gives us a huge competitive advantage, as customers are demanding syringes that are safe to use. There is also enormous savings potential for healthcare systems as patients can take medicine at home without going to hospital and burdening their already stretched resources," Quistgaard explains.

Playing their cards close to their chests

Quistgaard does not want to reveal the identity of the French customer.

"I am not allowed to say the name, but it is a large French pharmaceutical company that produces a cancer drug, and who we were contacted by in mid-January," he says, adding:

"They said that they needed a dual-barrel syringe, that they needed it quickly, and that our product looked like it was the most modern and safe one on the market."

He is currently negotiating about the final conditions with the company, which include, among other things, a significant down payment and a milestone payment within one year.

This milestone payment will come once Medilet has created the first molds for the syringe and a number of production trials.

"We will be able to supply the finished syringe within a year, so at the start of 2021, we will have received two meaningful payments from the French firm," Quistgaard says.

Potential sales percentages of the French cancer drug may follow, if and when it is approved and reaches the market.

"New cancer drugs are particularly expensive, so the sales percentages could reach several million dollars," Quistgaard reports.

Corona complications

Before they get this far, Medilet needs to raise the USD 2 million (DKK 13.5 million) and a significant hurdle has arisen - the coronavirus, which makes in-person meetings impossible.

"I have raised a lot of money throughout my career, and it always happens when you see people face-to-face. We can't do that now, and venture funds in particular are saying that they can only discuss the investment again once things have calmed down," Quistgaard tells MedWatch.

"This is what is weighing us down at the moment in terms of raising the money that we need. Of course it is irritating - but it is the same for everyone," he elaborates, and emphasizes that Medilet already has commitments from Danish investors.

"So we will reach our goal. It will just take a bit longer than we had hoped."

The money will be used for the production of molds - which cost up to DKK 1 million (USD 145,000) each - and machinery parts that will be used to produce the syringes.

"We will also use the money to run the company and pay for the development and validation of the product, so we can have a finished syringe to show customers and say 'Okay, we are ready to add your medicine,'" explains Quistgaard.

Today, the medicine the syringe will be used for must be mixed manually by a doctor, nurse, or in very few cases, the patient themselves.

According to Quistgaard, this takes time, and opens the process up to human error, which can mean that expensive medicine is wasted, among other things.

In contrast to existing versions, the Dualet syringe is pre-packaged and ready for use, with liquid and dry medicine in separate chambers.

Among other things, this means that it does not have to be kept cold, as the medicine and liquid is mixed just before use.

"The syringe is also a vacuum, meaning drops of medicine are not lost through extracting air, and dosages are therefore more precise," Jan Quistgaard explains.

Dualet has been developed key indications like cancer, diabetes, bacterial infections, arthritis, psoriasis and hemophilia, where medicines need to be mixed immediately before they are administered.

Dual-barrel syringes are used every day by millions of people, and Quistgaard sees significant market potential for Dualet, which will typically be used on the market for freeze-dried medicine.

"The market is currently worth around USD 1.6 billion a year, and it is growing very quickly, because the need for dual-barrel syringes is increasing rapidly due to a number of new products being released in freeze-dried form - including drugs for hemophilia and cancer," explains Quistgaard.

Better than the market leader

Today, German firm Vetter dominates the global market for dual-barrel syringes, with an 80 percent market share.

The company was the first to introduce the syringes over 20 years ago, but since the company's patents expired, several copycat firms have tried to take a bite of the billion-dollar market.

"But the product we have created is made of COC plastic, which is approved by all health authorities. Our syringe is safe, because there is no air inside, and it does not need to be kept upright or anything like that, so it can be given directly. It is the future," says Quistgaard.

"We had a consultation with an FDA specialist a few years ago to get a sense of the demand. They had a clear message for us: Get this product onto the market as quickly as you possibly can, because it will save the health authorities a lot of money as patients would be able to take medicine at home rather than going to the hospital or doctors' surgery," Quistgaard says.

"It is a fantastic advantage compared to the existing products on the market," he adds.

Positive revenue in 2021

So far, Medilet has spent DKK 13 million (USD 1.7 million) on developing its dual-barrel syringe, and Quistgaard calculates that the company will be able to produce up to one million syringes a year.

To help achieve this, Medilet has formed an alliance with contract research firm SPTVilecon, who have been responsible for product development and will manufacture the syringes for the French pharma company and Dualet's future customers.

"Our partner is a very specialized firm. Some of them are ex-Novo employees who have built up a large production capacity. We pay them for manufacturing and use their expertise. This means that we can do it a lot cheaper than at my former firm, Egalet, for example, where we spent almost DKK 1 billion (USD 144 million) on product development," explains Jan Quistgaard.

Half of the potential investors have said yes, and we are currently negotiating with 15 others, who are also very interested.

Jan Quistgaard, CEO, Medilet

Medilet expects to land one customer a year over the first few years, and aim to have a positive revenue in 2021.

"That is exclusively in the form of milestone payments - without the product even reaching the market. If we then get a 5 percent sales percentage of products sold for, let us say, USD 1 billion, that will quickly add up," says Quistgaard.

Will sell or enter stock exchange within 2-3 years

Looking further into the future, the 2-3-year plan is for Medilet to make its exit. Quistgaard estimates that investors will multiply their investments between 8 and 12 times.

How the exit will happen is not yet certain.

"That is of course something we need to discuss with investors. We have said that in 2-3 years, and after consulting with them, we will decide whether to become a listed company or sell the firm. Those are the two options we are considering," says Quistgaard.

He would like to see another Dane take over Medilet.

"As far as I can, I will fight to keep the company in Danish hands. That has succeeded so far, as our contract research partner is Danish, and we might have the chance to get a second manufacturer on board which is Danish, when we need to scale-up," says Quistgaard.

For him, it is more valuable to create Danish workplaces. Denmark is doing "fantastically well" within medtech and biotech, and Quistgaard wants to continue to contribute to that.

"I would appreciate being able to hand over a company where everything is developed in Denmark. That is one of my key principles, and has been since the start," says Quistgaard.

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