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Newron Pharmaceuticals (NWRN) Snags NeuroNova AB for About $19.3 Million in Shares for Clinical ALS and Parkinson Disease Drugs


6/13/2012 7:13:53 AM

Milan, Italy, June 13, 2012 – Newron Pharmaceuticals S.p.A. (“Newron”), announces today that the company has signed an agreement with the key shareholders of Stockholm-based privately-owned NeuroNova AB (“NeuroNova”) for the acquisition of up to 100% of the shares of NeuroNova, in an all-share transaction valuing NeuroNova at €15.4m (at closing share price June 11, 2012).

The transaction adds two highly innovative Phase II compounds from NeuroNova to Newron’s CNS portfolio. NeuroNova, founded by scientists from Karolinska Institutet, has extensive experience in the field of neurogenesis. The company’s compounds act by generating new progenitor cells and protecting existing neurons with the potential to benefit patients with progressive neurodegenerative disorders.

At closing of the transaction, Newron will benefit by cash and commitments of up to €16m. These funds are sufficient to provide for a Phase II PoC study in Parkinson’s disease (PD) as well a Phase I/II study in Amyotrophic lateral sclerosis (ALS), in addition to the related corporate operations. Investor and HealthCap, holders of more than 90% of NeuroNova’s total shares, will become shareholders in Newron and each may nominate a representative to Newron’s board of directors. The transaction is conditional on the approvals under Italian law, including an independent appraisal, and approval by Newron’s shareholders. It is expected to close in August 2012.

If acceptance from 100% of the NeuroNova shareholder is achieved, NeuroNova’s shareholders will receive 3,935,773 newly issued Newron shares, representing a holding of 33% in Newron’s issued and outstanding share capital post the transaction.

At closing, NeuroNova will be restructured and free of debt. NeuroNova’s development activities will continue under Anders Haegerstrand, the current CSO of NeuroNova.

Stefan Weber, Newron’s CEO, stated: “This transaction is exciting, as it brings together global development expertise, a new generation of compounds that could alter the treatment of neurodegenerative disorders, material funding and two leading investors in a company listed on one of the leading life science stock exchanges.”

Ravi Anand, Newron’s CMO, added: “NeuroNova greatly enriches the CNS portfolio of Newron. sNN0031, a platelet-derived growth factor, stimulates the proliferation of neuronal stem and progenitor cells and improved motor performance in various models of PD, and has shown potentially beneficial effects in patients with PD. sNN029, a vascular endothelial growth factor, is being developed for the treatment of patients with ALS, an orphan indication that results in premature mortality. The compound has been differentiated from other growth factors in models of ALS, and has provided preliminary evidence of activity in patients with ALS. Placebo-controlled PoC trials are in planning for both compounds.”

Ulf Ljungberg, President and CEO of NeuroNova, commented: “It is the logical next step to NeuroNova to combine our advanced pipeline and know-how, originally stemming from research at Karolinska Institutet and developed by our team in the recent years, with a larger player in the CNS field, adding to Newron’s advanced PD treatment, safinamide, clinical development experience and the resources of a publicly listed entity. This is a strong platform on which to build the critical mass this industry is looking for.”

Jakob Lindberg from Investor: “Both Investor and HealthCap fully endorse the strategic fit of this transaction. We value Newron’s expertise in taking compounds from clinical stages to regulatory filing, and support the concept of building a European CNS player that could benefit both patients and our stakeholders.”

About NeuroNova’s development candidates

sNN0031 is a novel drug candidate for the treatment of moderate to severe stage Parkinson’s disease that is designed to act on neural stem and progenitor cells in the brain. In animal models of Parkinson’s disease, treatment with sNN0031 restores motor function and improves neurochemical deficits. In a Phase I/II trial in patients with PD, it was well tolerated and demonstrated preliminary beneficial effects on biochemical markers of the degenerating dopamine system in PD patients. The product is comprised of the naturally occurring protein PDGF-BB (platelet-derived growth factor BB) formulated for intracerebroventricular (ICV) delivery. The intended therapy involves short-term continuous infusion of sNN0031 into the ventricular lumen, in order to optimize PDGF-BB access to the lateral ventricular walls of the brain where the targeted stem and progenitor cells reside. sNN0031 holds the potential to halt and even reverse disease progression, a much-needed improvement over currently available treatments, which only address the symptoms of Parkinson’s disease.

sNN0029 is a novel drug candidate for the treatment of amyotrophic lateral sclerosis (ALS) that has demonstrated in preclinical in vivo studies the ability to slow disease progression and increase life span. In a phase I/II trial in patients with ALS, patient recruitment and treatment for the formal three months safety evaluation has been completed. Patients are offered and are currently receiving continued treatment. Short and long term safety and potential beneficial effects are under evaluation. The pharmaceutical formulation contains vascular endothelial growth factor (VEGF) protein, a naturally occurring protein scientifically proven to be an important survival factor for motor neurons. The intended therapy involves direct infusion of sNN0029 into the cerebrospinal fluid (CSF) that circulates around the brain and spinal cord by intracerebroventricular (ICV) administration. sNN0029 is intended to slow the progression of the disease, which will potentially meet an enormous medical need for patients diagnosed with ALS.

About Investor

Founded by the Wallenberg family a hundred years ago, Investor is the leading owner of high quality Nordic-based international companies. Through board participation, our industrial experience, network and financial strength, we strive to make our companies best-in-class. Our holdings include Atlas Copco, ABB, Ericsson and Mölnlycke Health Care.

About HealthCap

HealthCap is a family of multi stage venture capital funds, investing internationally in life sciences. With committed capital of EUR 900 m, HealthCap is the largest specialized provider of venture capital within life sciences in the Nordic countries and one of the largest independent actors in the sector in Europe.

About Newron Pharmaceuticals

Newron (SIX: NWRN) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Phase III trials of safinamide for the treatment of Parkinson’s disease (PD) have recently been completed and Newron anticipates a potential filing in the EU and US, in 2013. Zambon Group has the rights to commercialise safinamide globally, excluding Japan and other key Asian territories, and Meiji Seika has the rights to develop and commercialise safinamide in Japan and other key Asian territories. Newron’s additional projects are at various stages of preclinical and clinical development, including HF0220 for neuroprotection, ralfinamide for pain, NW-3509 for the treatment of schizophrenia, as well as pruvanserin and sarizotan for treatment of CNS diseases.

www.newron.com

For more information, contact:

Media

Italy

Stefan Weber - CEO

Phone: +39 02 6103 46 26

E-mail: pr@newron.com

UK/Global media

Julia Phillips

FTI Consulting

Phone: +44 (0) 20 7269 7187

Switzerland

Martin Meier-Pfister

IRF Communications

Phone: +41 43 244 81 40

Investors and analysts

Stefan Weber - CEO

Phone: +39 02 6103 46 30

E-mail: ir@newron.com



   

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