The collaboration agreement with Isomerase Therapeutics
NeuroVive has signed a collaboration agreement with the British firm Isomerase Therapeutics Ltd. for the product development and commercialization of the cyclophilin-inhibiting molecules that were recently acquired from Biotica Ltd. The collaboration will focus on cellular protection for traumatic brain injury and heart attack, as well as the new product NVP018/BC556 for antiviral indications. Isomerase Therapeutics was founded by three members of Biotica´s former senior management team, including the former Chief Scientific Officer, who have experience working with the molecules acquired by NeuroVive earlier this year. Development work will begin during the summer.
The payment from Sihuan
NeuroVive´s subsidiary NeuroVive Pharmaceutical Asia Ltd. has received the first milestone payment from Sihuan Pharmaceutical, the company´s collaboration partner for the development and distribution of the products CicloMulsion® and NeuroSTAT® in the Chinese market. The payment shows that NeuroVive´s strategy for the Chinese market is working according to plan. The work also continues on completing an application to the Chinese healthcare regulation agency (CFDA) for a clinical trial on CicloMulsion® in China. No financial details regarding the payment are being disclosed due to contractual confidentiality.
According to an existing collaboration agreement, NeuroVive´s Chinese subsidiary NeuroVive Pharmaceutical Asia Ltd. is entitled to upfront and milestone payments from Sihuan regarding CicloMulsion® and NeuroSTAT totaling 35 million and 12 million yuan, respectively. Sihuan will also pay an annual royalty of 10 percent of the net profits for the two products during the first ten years after market approval.
NeuroVive´s work in China is carried out through its subsidiary company NeuroVive Pharmaceutical Asia Ltd., co-owned by Foundation Asia Pacific Ltd. (FAP). FAP´s owner share is 30 percent of the company, and in return NeuroVive is given access to marketing resources and a valuable business network, both of great importance to any foreign company working to establish business in China. The emphasis on positioning NeuroVive in the Chinese market is expected to accelerate during the coming years, and FAP will play a key role in this process. This first milestone payment will be used primarily for NeuroVive´s Asian business.
Comment from NeuroVive
Mikael Brönnegård, CEO of NeuroVive Pharmaceutical AB said: “I am very pleased to be able to present these two news items that indicate the strong development phase currently being undertaken by NeuroVive. The first payment from Sihuan shows that our work in China has been successful so far, and that our collaboration partner is delivering on its promises. At the same time, the collaboration agreement with Isomerase Therapeutics around the molecules recently acquired from Biotica marks the beginning of a broadening of our product portfolio. This effort will strengthen NeuroVive´s position in mitochondrial medicine and further our efforts to develop products for a larger number of medical conditions.”
About Isomerase Therapeutics
Isomerase Therapeutics is a drug discovery biotech company based in Cambridge, UK. It offers drug discovery and development services for companies looking to develop microbial natural products into drugs, using its unique bioengineering services supported by a portfolio of technology IP and the combined experience of a core scientific team from over a decade of successful drug discovery and development collaborations with Pharma and Biotech.
About Sihuan Pharmaceutical
Sihuan Pharmaceutical is the fourth-largest pharmaceutical company in China’s prescription drug market, and has one of the country´s largest teams in research and development of pharmaceutical drugs. Currently, the company has more than seventy new drugs in various stages of development. Sihuan also has a strong network of over 3,000 distributors covering more than 10,000 hospitals and medical institutions in China.
About Foundation Asia Pacific
Foundation Asia Pacific Ltd. specializes in business development within the Chinese market, aiming to accelerate growth and increase the value of its collaboration partners. The company´s market analysis, vast business network, and active participation through co-ownership combine to maximize the potential for success in China.
NeuroVive Pharmaceutical AB, a leading mitochondrial medicine company, is developing a portfolio of products to treat acute cardiovascular and neurological conditions through mitochondrial protection. These medical conditions are characterized by high medical needs for which there are currently no approved pharmaceutical treatments options. NeuroVive´s products CicloMulsion® (heart attack) and NeuroSTAT® (traumatic brain injury) are currently being evaluated in phase III and phase II studies, respectively. NeuroVive´s research programs also include both a product aimed at the treatment of brain injury in stroke patients, and another for drug candidates for cellular protection and the treatment of mitochondria-related energy regulation diseases. NeuroVive´s shares are listed on the NASDAQ OMX stock exchange in Stockholm, Sweden.
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Current status for NeuroVive´s products
NeuroVive´s product CicloMulsion® is the first cyclophilin inhibitor developed for the treatment of reperfusion injury. The potential of the product as a treatment for heart attack patients is currently being evaluated in a clinical phase III study with 972 patients.
NeuroVive is developing NeuroSTAT® for the treatment of patients with traumatic brain injury. NeuroSTAT® is currently being evaluated in a clinical phase IIa study with 20 patients; the design and planning for a phase III study has been initiated. NeuroSTAT® has been granted Orphan Drug Designation in both the U.S. and in Europe for the treatment of patients with moderate to severe traumatic brain injury. The Orphan Drug Designation guarantees NeuroSTAT® market exclusivity in the U.S. for seven years and in the EU for ten years after the product attains marketing authorization.
NVP018/BC556 is the primary drug candidate in NeuroVive´s new portfolio of potent cyclophilin inhibitors. It has undergone extensive preclinical evaluation and was developed for the treatment of Hepatitis C. The product shows a powerful effect against virus replication, and has an advantageous tolerability and pharmacokinetic profile. Cyclophilin inhibitors have a broad potential application range, and NeuroVive is currently evaluating the potential of NVP018/BC556 for antiviral indications.
More information about NeuroVive´s product portfolio can be found at http://www.neurovive.com/Research–Development/Our-products/
NeuroVive Pharmaceutical AB (publ) is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was provided to the media for publication at 08:15 a.m. CEST on June 12, 2013.