Development in focus for Emplicure after results in PK study
Emplicure has focused on development work during the fourth quarter of 2022. During the period, the company completed an exploratory PK study with Empli03, which showed a steady profile and extended release. After the results were presented, the company announced that the development of the candidate is progressing. Emplicure also initiated a collaboration with OnDosis in the field of pain management. BioStock contacted CEO Håkan Engqvist to find out more about the last quarter.
Emplicure are active within two main areas: pain drugs and nicotine products. The operations are divided into subsidiaries where Amplicon develops nicotine products for the consumer market. Amplicon’s most advanced project is a freee, a brand for nicotine products for oral use.
In the subsidiary Emplipharm, new drugs are created for patients suffering from chronic pain, where approved drug substances are combined with the company’s patented bioceramic platforms. The goal is to create new and improved drugs with properties such as tailor-made release profiles.
The primary candidate Empli03 is a buccal tablet where the company’s bioceramic material is combined with the opioid buprenorphine for the treatment of chronic pain. Empli03 is placed under the upper lip where it provides steady pain relief through controlled release of buprenorphine. The goal is to be able to offer a painkiller and individualised treatment that is more difficult to abuse than the drugs available on the market today.
Focus on consumer product
During the last quarter of 2022, Amplicon continued its work with a consumer product for the growing global market for nicotine pouches. The focus of the development work has been on the formulation and planning for scaling up production. The company believes that the product can become an attractive alternative to smoking. They are now conducting development towards a finished product that will be tested in selected markets.
The report states that Amplicon has ongoing discussions in various phases with potential licensees and partners.
Further development of Empli03
After the end of the quarter, Emplicure announced that they are proceeding with the development of the formulation to adapt the initial release profile of buprenorphine in the candidate Empli03. The decision was made after results from the exploratory pharmacokinetic study conducted in 2022 showed a steady profile and extended release.
Another piece of news that came after the end of the quarter is that the company is initiating a collaboration with OnDosis to evaluate potential solutions for oral dosing of active ingredients. The hope is that the collaboration will enable the development of innovative treatments and safer medication.
Loan strengthens working capital
If we look at the financial part of the report, we note an operating profit of -9.4 million SEK for the fourth quarter of 2022, which can be compared with -5.2 million SEK during the same quarter in 2021. Emplicure’s cash position at year-end amounted to approximately 13.2 million SEK. During the fourth quarter, Emplicure entered into an agreement with a consortium of new and existing shareholders for a loan of 9 million SEK.
CEO Håkan Engqvist answers
BioStock spoke to CEO Håkan Engqvist about the latest quarter and the way forward for Emplicure.
Håkan, how would you describe the last quarter for Empicure?
– The development is currently going very fast on several fronts. Upscaling the production of our bioceramic powder material loaded with nicotine lays the foundation for the future launch of products, either under Amplicon’s own brand or together with partners.
– In addition, Emplipharm’s portfolio has been focused towards the cooperation with OnDosis and the further development of Empli03, where Empli03 is being prepared for finding a co–development partner.
You state that you will develop a finished consumer product in nicotine. Which markets are you considering launching the product on and how are the partnering discussions going?
– We are working on completing a nicotine product for a possible launch in a limited market. Amplicon is currently equipped for powder manufacturing and development work, and we intend to optimise the outcome from that particular competence. Discussions with future partners are ongoing at different stages and markets.
How big do you think the market potential for freee is?
– The global market for nicotine pouches is large, but above all it is expected to continue to grow at a rapid pace in the coming years. That’s what makes it so interesting to us. As with the vast majority of major consumer markets, nicotine pouches are dominated by a handful of players who are constantly evolving their brand portfolios. The rapid growth means that product innovation can become the key to positioning new brands with credibility in that competition.
In the case of Empli03, what will be the next step in its development?
– The next step in the development is to increase the initial release of buprenorphine and to prepare the basis for business development of the project.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
