NeuroVive receives research grant from Vinnova for development of the NVP015 genetic mitochondrial disease project

Lund, Sweden, 1 June 2017 – NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF) today announced that the company receives close to 1 million SEK in a research grant from Swedish innovation agency, Vinnova, for developing a new treatment for genetic mitochondrial diseases.

NeuroVive receives the grant from Vinnova’s 2017 Swelife call to continue progressing the preclinical project NVP015. The cutting edge NVP015 project is aimed at developing a new pharmacological treatment for patients with Complex I dysfunction mitochondrial disease, an area of critical unmet medical need. The Vinnova grant will enable NeuroVive to intensify the NVP015 project development with the aim to select a lead candidate before year end 2017. The development of the NVP015 project is performed in close collaboration with academic partners at the forefront of mitochondrial medicine research, such as Dr Marni Falk’s research group at the Children’s Hospital of Philadelphia, US and Lund University, Sweden.

“The NVP015 project has the potential to significantly improve the lives of patients, usually children, suffering from this type of mitochondrial disease. The grant is central for efficiently proceeding the project and a quality label for our program“, said Eskil Elmér, Chief Scientific Officer at NeuroVive.

Projects selected for financing within this call, or any earlier Swelife call, will be offered to apply for further grants in a follow-up call. In that call, a grant amounting to half of the eligible project costs may be received (at most 5 million SEK during a period of maximum two years).

About Swelife

Swelife is a national innovation program, funded by the Swedish Government via the Swedish innovation agency, Vinnova. Through Swelife, healthcare, academia and industry collaborate across organizational boundaries and between regions to achieve long-term effects that benefit Swedish Life Science and, in turn, public health.

About NVP015

One of the most common causes of mitochondrial diseases relates to Complex I dysfunction, i.e. when energy conversion in the first of the five protein complexes in the mitochondrion that are essential for effective energy conversion does not function normally. This is apparent in disorders including Leigh’s Syndrome and MELAS, both of which are very serious diseases with symptoms such as muscle weakness, epileptic fits and other severe neurological manifestations. The NVP015 project is based on a concept instigated by NeuroVive’s CSO Dr. Eskil Elmér and his colleagues by which the body’s own energy substrate, succinate, is made available in the cell via a prodrug technology. A prodrug is an inactive drug that is activated first when it enters the body by the transformation of its chemical structure. Results from the NVP015 project were published in the prestigious Nature Communications1) journal in August 2016.

About Mitochondrial Diseases

Genetic mitochondrial disorders are congenital metabolic diseases that affect cellular energy conversion. The disorders can manifest differently depending on which organs are affected by the gene defects and are viewed as syndromes, depending on the organs affected and the signs and symptoms.

Approximately 12 in every 100,000 people suffer from a genetic mitochondrial disorder. Mitochondrial disorders usually present in early childhood. A candidate drug from the NVP015 project would qualify for orphan drug designation in the US and Europe during clinical development, enabling a faster and less costly route to market, and a higher price. In 2016, the orphan drug market amounted to USD 114 billion and in the same year, the average annual cost for the treatment of a single patient was an estimated USD 140,443 (approx. 1.3 million SEK).2

1) Ehinger JK et al. (2016) Nat. Commun.7:12317
2) Evaluate Pharma Orphan Drug Report 2017

About NeuroVive

NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine. The company is committed to the discovery and development of medicines that preserve mitochondrial integrity and function in areas of unmet medical need. The company’s strategy is to advance drugs for rare diseases through clinical development and into the market. The strategy for projects within larger indications outside the core focus area is out-licensing in the preclinical phase. NeuroVive enhances the value of its projects in an organization that includes strong international partnerships and a network of mitochondrial research institutions, as well as expertise with capacities within drug development and production.

NeuroVive has a project in early clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®) and one project entering clinical Phase I (KL1333). NeuroSTAT has orphan drug designation in Europe and in the US. The R&D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to cancer and metabolic diseases such as NASH.

NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF).

For investor relations and media questions, please contact:
Cecilia Hofvander, NeuroVive
Tel: +46 (0)46 275 62 21

NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard)

This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 1:00 p.m. CEST on 1 June 2017.