One step closer to a new preparation for the treatment of migraine
- Klaria´s first product ready for clinical evaluation
- Partners have now been contracted
The first drug candidate from Klaria Pharma Holding AB (Klaria), KL-00119, intended as a superior product for treating migraine, is now ready for clinical testing. As an important step in preparation for clinical testing, contracts have now been agreed with Recipharm AB and CTC Clinical Trial Consultants AB to respectively produce the test material and to conduct the actual clinical trials.
Klaria's business concept is based on developing innovative, fast-acting medicinal products with clear competitive benefits in the therapeutic fields of migraine and cancer-related pain. The combination of the Company's patented drug delivery platform (which facilitates rapid and reliable transmucosal absorption via a mucoadhesive film) with clinically proven and marketed substances, lays the foundation for a unique concept offering considerable benefits.
Development within Klaria is presently focused on six defined projects, of which the first, KL-00119 for migraine, now has a functioning and validated manufacturing process. The next step in the development process is to perform a clinical trial to establish the actual performance of the drug candidate.
”We have chosen to start with one of the most interesting projects in our portfolio – KL-00119. All of our projects have three important steps in their development and now KL-00119 have passed the first – to assure a functional formulation. The next critical milestone will be to perform the clinical trial and this is where both Recipharm and CTC will be extremely important collaborators”, said Scott Boyer, CEO of Klaria Pharma Holding AB.
The clinical trial will begin Q2 2016 and results are anticipated to be communicated later in the spring or early summer of 2016.
Recipharm will produce Klaria’s transmucosal film, KL-00119, based on the stringent requirements of drug manufacture and with that also ensure that all required documentation is available.
Recipharm is a leading CDMO (Contract Development and Manufacturing Organisation) in the pharmaceutical industry employing some 2,200 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material including API and pharmaceutical product development. Recipharm manufactures more than 400 different products to customers ranging from Big Pharma to smaller research- and development companies. Recipharm’s turnover is approximately SEK 3.4 billion and the Company operates development and manufacturing facilities in Sweden, France, the UK, Germany, Spain, Italy and Portugal and is headquartered in Jordbro, Sweden. The Recipharm B-share (RECI B) is listed on NASDAQ Stockholm.
CTC (Clinical Trial Consultants AB) is a Contract Research Organisation (CRO) that has specialized in early clinical trials with operations in both Uppsala and Linköping, Sweden. CTC will conduct Klaria’s first clinical trials at its unit within the Akademiska University Hospital in Uppsala, which has an accumulated experience of more than 150 industry-sponsored clinical trials.
”Both Recipharm and CTC have a huge amount of experience in their respective areas and we have complete faith in their ability to execute their parts of our project with high quality, to expected costs and to the agreed timelines”, said Scott Boyer, CEO for Klaria Pharma Holding AB.
For more information, visit Klaria Pharma Holdings website klaria.com or contact:
Scott Boyer, CEO, Klaria Pharma Holding AB (publ)
scott.boyer@klaria.com
Tel: 08-446 42 99 / 0730-71 64 62
This is Klaria Pharma Holding AB
Klarias business concept is based on developing innovative products with clear competitive advantages in the therapy areas of migraine and breakthrough cancer pain. Klaria’s products are based on a patented drug delivery film which is combined with clinically-tested and established active drugs substances. Klaria is listed on Nasdaq First North under the name KLAR. Remium Nordic AB is the Certified Advisor for Klaria Pharma Holding AB. The complete company description can be downloaded from klaria.com.
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