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QuickView: Newron Pharmaceuticals

ByEdison
Published 03/21/2013, 08:12 AM
Updated 07/09/2023, 06:31 AM

Detailed safinamide Phase III Parkinson’s disease (PD) data presented at AAN (American Academy of Neurology) are broadly similar to prior Phase III data and should support regulatory filings, which are anticipated in Q413. Newron Pharmaceuticals (NWRN.SW) and partner Zambon are currently seeking to sub-license safinamide in key regions including the U.S. Updates on this process and the regulatory filings will be key for the valuation in the next 12 months.

Safinamide data should support regulatory filings in Q413
Safinamide demonstrated a significant one hour improvement in daily “ON” time versus placebo (p

Additional marketing deals could drive valuation
Safinamide is partnered with Meiji Seika in Japan/Asia, and with Zambon in all other regions. Zambon, a private Italian company, does not have a presence in certain territories, including the US, and hence, additional marketing partners will be needed in these regions. The partnering process is ongoing and will likely be key for valuation.

Safinamide could treat all stages of Parkinson’s disease
Safinamide could be the first PD drug to work across all stages of disease, from first diagnosis for disease lifetime. Combined with once a day dosing and a clean safety profile, safinamide could have a unique profile in the growing PD market.

Valuation: EV of c €50m
Newron reported €29m net cash with FY12 financial results, which suggests an EV of c €50m. In view of a further €11m of committed financial income, Newron estimates this should be sufficient to fund operations into 2015. Valuation will likely be driven by safinamide regulatory updates and additional partnering deals.

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