LUND, Sweden and SEOUL, South Korea, May 2, 2017
/PRNewswire/ -- NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF) and Yungjin Pharm Corporation Ltd (South
Korea Stock Market, KRX 003520) today jointly announced that they have entered into a global licensing agreement on Yungjin
Pharm's compound KL1333 for genetic mitochondrial disorders. The in-licensed project is about to enter Phase I clinical
development.
KL1333 is a drug intended for treatment of orphan genetic mitochondrial disorders. KL1333 acts through modulating the levels
of NAD+ and thereby rectifying mitochondrial defects. Yungjin Pharm has received an IND and a clinical study approval in Korea,
and the clinical study is scheduled to start within a couple of months.
Yungjin Pharm has granted NeuroVive exclusive global rights to develop and commercialize KL1333 worldwide, except for Korea
and Japan, where Yungjin Pharm retains all commercial and marketing rights. Under the terms of
the agreement, NeuroVive will pay Yungjin Pharm upfront payments of 1 million USD at signing,
1 million USD one year after the signing and an additional 1 million
USD after the completion of a successful phase I clinical trial. Further payments will be paid upon successful achievement
of clinical development (in total 12 MUSD) market and reimbursement approval (in total 42 MUSD) milestones. In addition, Yungjin
Pharm will also be eligible to receive approval and sales milestone payments and tiered single to low double-digit royalties on
future net sales. Both companies will develop KL1333 in their respective territories, primarily for the treatment of genetic
mitochondrial disease.
"The NeuroVive team is extremely pleased to acquire the rights to the clinical stage candidate drug KL1333 for genetic
mitochondrial disorders, an area of high unmet medical need. The project is a perfect fit with our existing project portfolio in
mitochondrial disorders", said Erik Kinnman, CEO at NeuroVive.
"The addition of KL1333 is perfectly in line with our business model focusing on the development of orphan indication project
all the way to the market. We look forward to working with Yungjin Pharm on this opportunity, with the aim to bring relief to
patients suffering from genetic mitochondrial diseases", he continued.
NeuroVive will now initiate activities in preparation for the next clinical study in Europe
and/or in the US.
"With NeuroVive's specialist expertise in mitochondrial medicine and clinical development experience, we consider them an
ideal partner for Yungjin Pharm, and with this agreement global development of KL1333 has been secured. It has been a pleasure
working with NeuroVive in this process and we look forward to a fruitful collaboration", said Sujun
Park, CEO & President at Yungjin Pharm.
About KL1333
KL1333 is a potent modulator of the cellular levels of NAD+, a central coenzyme in the cell's energy metabolism. KL1333 has in
preclinical studies been demonstrated to increase mitochondrial energy output, reduce lactate accumulation, diminish the
formation of free radicals, and to have long-term beneficial effects on energy metabolism. It is in clinical development stage
for chronic oral treatment of primary genetic mitochondrial disorders such as MELAS, KSS, CPEO, PEO, Pearson, MERRF and Alpers
syndrome. It's mode of action is complementary to that of NVP015, which is intended to alleviate acute episodes of energy crises
in genetic mitochondrial disorders with dysfunction in respiratory complex I and to NVP025, intended to protect the mitochondria
in skeletal muscle from dysfunctional calcium handling and consequential muscle wasting.
A clinical trial application for a Korean Phase I study has been approved by Korean authorities and is scheduled to start
within a couple of months, performed fully by Yungjin Pharm. NeuroVive plans to initiate a complementary European and/or US based
phase I study in early 2018.
About Mitochondrial Diseases
Approximately 12 in every 100,000 people suffer from a genetic mitochondrial disorder. Mitochondrial disorders usually present
in early childhood. KL1333 qualifies 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).1
1 Evaluate Pharma Orphan Drug Report 2017
About Yungjin Pharm
Yungjin Pharm Co. Ltd., established in 1952, has been playing a major role as a forerunner in the Korean pharmaceutical
industry for half a century. With the inspiring mission statement, "To relieve the suffering of mankind from diseases with our
innovative, effective and safe pharmaceutical products", they have shown a successful contribution not only within Korea, but
also through global expansion. As a result, they have received a total of 25 awards including the President Award for Superior
Product Development, the Prime Minister Award, Industry Award and many more. These accomplishments demonstrate their
sustainability and commitment to the development of innovative products and business excellence in both overseas and domestic
segments. The company is listed on the South Korean stock market, KOSPI (KRX 003520).
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®). 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 or ir@neurovive.com
NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund,
Sweden
Tel: +46 (0)46-275-62-20 (switchboard)
www.neurovive.com
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
00:20 a.m. CEST on 2 May 2017.
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SOURCE NeuroVive Pharmaceutical