In 2017, Claus Schmidt Møller, one of the people behind Novo Nordisk's injection pen Novopen 4, embarked on a new adventure and founded the company Subcuject.

Two years later, he is almost ready to test the final version of a single-use wearable injector for an easy and comfortable delivery of biological drugs.

While Subcuject prepares the final test of the device, the company is also in dialog with different large companies to establish one or more partnerships.

"We communicate and conduct feasibility studies with several of the largest drug groups and some medium-sized specialized pharma companies, too," says Jesper Roested, CEO in Subcuject, to MedWatch.

He was previously partner in the Danish Growth Fund's venture unit, VF Ventures, and also a member of the board in Subcuject. But in the summer 2018, he took position as CEO in the young medtech company.

"I took over the CEO position, because it was a chance I couldn't refuse - it's one of the most exciting startups I've seen - and now I completely left the Danish Growth Fund," he explains.

Founder and former CEO, Claus Schmidt Møller, now serves as chief technology officer (CTO) in Subcuject.

A mechanical solution

Subcuject's product is a wearable bolus injector (WBI) based on an osmotic actuator.

The device looks like a small box and contains a needle, a drug container and an osmotic drive module, in which two chambers of liquid are separated by a semipermeable membrane.

By pressing one button, the patient inserts the needle and simultaneously adds a salt to one chamber in the osmotic drive module. Liquid is then drawn from the other chamber and generates a hydraulic pressure that drives the plunger in the primary drug container. The needle is automatically retracted after the injection, and the device can be removed.

According to the company, the result is a simple and pre-filled injection device with long shelf life at a low cost. Not least, the production cost is comparable to that of the auto-injectors that are currently used for subcutaneous drug delivery.

According to Roested, there are also competing solutions. However, the other models run on batteries and require electronics, while Subcuject's product is completely mechanical. The device already attracted attention from some of the largest drug groups working with biological drugs.

Requires close collaboration

Subcuject's product is to contain the necessary drug already when the patient receives the device. Partnerships with the relevant drug groups are therefore necessary to continue the development- and registration work.

The device will be able to deliver between 1 and 10 ml dose volumes of a biological drug. According to Subcuject, approximately 100 biological drugs, marketed or under development, are suited for delivery via such an injector.

These medicines are mainly treatments of chronic conditions, which requires frequent dosing, and there are currently no available self-administration solutions. Examples of drugs could be antibody-based treatments of inflammatory diseases or cancer.

Roested hopes to close a collaboration deal soon to initiate the actual regulatory development of the first drug device project in 2019.

"We hope to initiate the regulatory development this year, and then it will take some years before a product is fully developed," says the CEO.

Subcuject itself employs few staff members but has made a contract with Irish company Nypro that will manufacture the device. So, when the time comes, the firm is ready for mass producing the injector.

This also means that the regulatory documentation must be developed in Nypro's quality management system, so a future partner avoids further risks.

Prepares financing round

Roested and Møller currently make up the entire executive management in Subcuject, however, they are backed by experienced board members.

Chairman, Lars Guldbæk Karlsen, has over 30 years of experience from Novo Nordisk, including sixteen years with responsibility for, for instance, business development and device R&D. He currently serves as senior quality advisor in Novo Nordisk.

Other board members are former Global Head of Medical Device Development for Sanofi and Eli Lilly, Paul Jansen; Managing Partner in VF Venture, Tonni Bülow-Nielsen; CEO of Capnova, Lars Stigel, and Co-Founder of Subcuject, Claus Demant.

Subcuject is funded by Capnova, the Danish Growth Fund, Innovation Fund Denmark and investments from the board and management. Roested himself holds 10-15 percent of the company.

According to a press release, the company received a two-digit million sum from Capnova and the Danish Growth Fund when it was founded in 2017. Roested says that Subcuject is now planning a financing round that will possibly be carried out in summer.

English Edit: Ida Løjmand

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