Klaria Pharma presents new strategy, upcoming milestones and new website

Today, Klaria Pharma Holding AB (publ) (”Klaria”) announces that it has formulated and is now implementing a new strategy. Klaria will focus all research and development exclusively on programs where Klaria’s films have the potential to replace injections or nasal sprays, and where formulations constitute a major problem for patients, caregivers or payers. Since Klaria’s Alginate Film technology has significant advantages to both injections and nasal sprays, this strategy ensures that resources are focused on programs where the unmet medical needs are significant and where development of oral transmucosal films will meet these unmet needs. Thus, the potential for value creation in each program, and thus also shareholder value, will be maximized.  

The strategy dictates that Klaria will focus on areas where current treatments fulfil two criteria: 1) the treatment is only available as a nasal spray and/or injection, and 2) this presents a significant problem to patients, caregivers and/or paying entities. Klaria’s existing projects for epinephrine (adrenaline) against acute allergic reaction, naloxon against opioid overdose, midazolam against acute epilepsy and ketamine against acute pain and depression are excellent examples of projects fulfilling both criteria.

Klaria’s strategy will leverage the key feature of the Alginate Film; true and full transmucosal drug delivery that does not involve the stomach and oral delivery. This differentiates the Alginate Film  from other oral transmucosal technologies such as starch based oral films, fast dissolving tablets and oral sprays, where a significant portion of the active substance is mixed with saliva and swallowed.  Such technologies achieve partial transmucosal delivery but mainly oral administration. In contrast to other transmucosal technologies, Klaria’s Alginate Films are able to deliver pharmaceuticals which are not orally available (i.e. uptake from the stomach/intestines to the blood stream is low or non-existent). This is why Klaria has been able to for example develop a fully working transmucosal adrenaline film and an a ketamine film. 

By utilizing this focus, Klaria will be able to create substantial shareholder value by developing products which are far better for the patients than the products available on the market today, while they are also cheaper to manufacture.

A strong management team to execute the strategy
In 2019, two key additions to the management team were made: Jesper Wiklund as Chief Executive Officer and Marc Willuhn as Head of CMC. Jesper Wiklund brings to Klaria his 25 years of pharmaceutical industry experience. He was previously CEO of drug development company Index Pharmaceuticals and he has deep experience in business development gathered at both Swedish and international pharmaceutical companies. In addition, he brings a strong financial skillset which he developed over 5 years as responsible for European operations at the life science focused, New York based private equity fund Oberland Capital. Marc Willuhn adds over 20 years of experience from positions as head of pharmaceutical manufacturing at leading Swedish and European pharmaceutical companies. Klaria’s maturing pipeline, with Sumatriptan Alginate Film ready for a pivotal clinical study and three additional projects in late pre-clinical phase, makes it increasingly important for the company to have the strong manufacturing competence which Marc Willuhn brings.

Jesper Wiklund and Marc Willuhn form a strong complement to Klaria’s previous CEO Scott Boyer, who will now be able to focus on the key function of the company: research and development. Together, the company’s management team has a robust and broad skillset with many years of experience from leading positions at international pharmaceutical and biotechnology companies.

During 2019, several important structural changes were made:
- Acquisition of WBC Drug Delivery Technologies, a company that develops a technology that could enable the delivery of larger molecules in the future, for example vaccines which are currently only available as injections.
- Acquisition of Uppsalagruppen Medical and the patent that protects the global rights to the company’s alginate oral-transmucosal drug delivery technology.
- Fusion with Karessa Pharma (ongoing) in order to streamline all pharmaceutical development based on the company's technology and contacts with potential partners.
- Founding of Cannabis Delivery Sciences (CDS), a subsidiary focused on commercialising Klaria's Alginate Film technology in the global cannabis/cannabinoid market.

The company also made important research and development progress in 2019, creating a strong starting point for continued progress in 2020:

- Initiated large-scale production of Sumatriptan Alginate Film for clinical studies and filing for market approval.
- Successful completion of all preclinical studies with Naloxone Alginate Film, with the project now ready for clinical studies.
- Successful completion of preclinical studies with Ketamine Alginate Film, with the project now ready for clinical studies.
- Successful preclinical Proof-of-Concept study with Cannabis Alginate Film.

With these improvements and advances, Klaria is well positioned in the beginning of 2020. Unlike many other drug development companies of similar size, Klaria's Technology Platform has also been validated through the company's collaboration with the international pharmaceutical group and development partner Purdue/Mundipharma. In addition, the Alginate Film technology is also commercially validated as films with the company's technology are being manufactured and sold to consumers in Swedish pharmacies as dietary supplements loaded with vitamins by the licensee Nutrinovate.

Significant expected future milestones 
Klaria is now aiming to achieve several important milestones:

- Completion of bioequivalence studies and preparation of an application for market approval for sumatriptan against acute migraine.
- Reach clinical phase with adrenaline treatment against acute allergic reaction (with partner Mundipharma/Purdue Pharma Canada).
- Reaching clinical phase with naloxone against opioid overdose.
- Reaching clinical phase with ketamine against acute pain and depression.

Improved market communication and new website
Klaria will improve the company’s market communication in 2020 and thereafter with the goal to give shareholders, potential investors and other interested parties a deeper understanding of the company's operations and thus the value in its development projects. As a part of this effort, Klaria today launched a new website. The new website is available at same address as before, www.klaria.com.

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