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MEDDAY-PHARMACEUTICALS

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MedDay Secures €34 Million ($38.5M) New Funding

MedDay, a biotechnology company focused on the treatment of nervous system disorders, today announces that it has raised €34 Million ($38.5M) of new capital in a Series B financing round. Edmond de Rothschild Investment Partners (EDRIP) led the new investment round alongside existing investors Sofinnova Partners and InnoBio (Bpifrance). Large Venture (Bpifrance) also participated in the operation.

The new funds will enable MedDay to conduct a confirmatory phase-3 study in United States “SPI2”, following the successful phase-3 MS-SPI study in 2015 in progressive multiple sclerosis, with its wholly-owned lead candidate, MD1003. The funds will also accelerate pre-launch activities of MD1003 in Europe where the drug is currently being supplied by MedDay on a named patient basis, the development of other pipeline candidates as well as the advancement of a research platform aimed at identifying new metabolic targets in neurological diseases.

Frédéric Sedel, CEO of MedDay, commented: “This series B round will support the international development of our lead candidate MD1003. The €34M comes in addition to current sales under “named patient use”. Together with world-leading key opinion leaders, we believe MD1003 represents a very promising drug for patients with progressive MS. The SPI2 study is expected to confirm, in a large North American population, the results of our prior European MS-SPI study and will further advance MedDay in the field of progressive MS worldwide. We are pleased to welcome additional specialist investors to MedDay.”

Raphaël Wisniewski, Edmond de Rothschild Investment Partners, said: “We are delighted to invest in MedDay at such an important time and to be able to provide funding alongside such strong and supportive current investors. MedDay has the potential to be a game-changing biotech company in the major area of progressive MS. Due to the existing data and current use of MD1003, MedDay’s platform and pipeline opportunities and strength of the management team, we are highly confident that MedDay will create major value for patients worldwide.”

On behalf of the founding investors, Rafaèle Tordjman, Managing Partner at Sofinnova Partners, and Chahra Louafi, Senior Investment Director at Bpifrance added: “We are excited that MedDay was able to raise a significant financing. The company is funded by a group of investors who share a collective vision of creating a standalone business that will deliver medicines of exceptional benefit to patients in areas of high unmet need.”

In association with the financing, Raphaël Wisniewski, Partner at EDRIP, has joined Rafaèle Tordjman and Chahra Louafi on MedDay’s Board of Directors.

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About MedDay

MedDay is a privately held biotechnology company developing new drugs targeting brain metabolism to treat diseases of the nervous system. The company was founded in 2011 by Frédéric Sedel, MD, PhD (Chief Executive Officer); and Guillaume Brion, MD (Chief Operating Officer). The Company’s most advanced pipeline candidate, MD1003, is in phase 3 for the treatment of primary and secondary progressive multiple sclerosis. For more information, please see: www.medday-pharma.com .

About Edmond de Rothschild Investment Partners

Edmond de Rothschild Investment Partners is a leading investor in minority investments into privately-owned companies. Affiliate of the Edmond de Rothschild Group, the fund management employs 41 employees and has approximately €1.3 billion under management. Its Life Sciences team of nine professionals brings together over 60 years of experience in the Life Science industry and more than 100 years of private equity and venture capital experience. The team has raised more than €450 million through its Biodiscovery franchise and is currently completing the investment of BioDiscovery 4 fund. Since their inception, BioDiscovery Funds have invested in 53 privately-held companies, of which 14 have been sold and 16 listed on public financial markets, while 21 are active in the portfolios.

About Sofinnova Partners

Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 12 highly experienced investment professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a founding and lead investor in start-ups and corporate spin-offs, and has backed nearly 500 companies over more than 40 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.5 billion under management. For more information, please visit: www.sofinnova.fr

About InnoBio (Bpifrance)

The public investment bank Bpifrance is the result of the merger of business funding and investment organizations OSEO, FSI, CDC Entreprises and FSI Regions. It was established by French law on Dec. 31 2012. It has two shareholders, the French State and the Caisse des Depôts (The French Deposits and Consignments Fund). The aim of Bpifrance is to support businesses, (SMEs, mid-cap companies and larger entities of strategic importance to the French economy), from their seed capital stages up to stock market listing. They offer access to credit, collateral and equity funding. Bpifrance also provides assistance and enhanced support services for innovation, export and external growth. They act as a single point of contact regarding the funding and investment needs of entrepreneurs in every region. InnoBio is a EUR 173 million venture capital fund managed by Bpifrance, which is also an investor in the fund. Sanofi, GSK, Roche, Novartis, Pfizer, Lilly, Ipsen, Takeda and Boeringer-Ingelheim are among the other investors. The main aim of the fund is to make equity investments in innovative companies providing technology, products and services for health care. For more information, please visit: www.bpifrance.fr

About Large Venture (Bpifrance)

Bpifrance Large Venture is a €600M fund investing in the healthcare, digital and green technology spaces. It funds high-growth companies with significant capital requirements for their international, industrial, or commercial development. Large Venture is the next step in the financing cycle for venture-backed or revenue-generating companies, after early-stage VCs. Its goal is to help French national champions emerge, and help them scale globally. Large Venture is a long-term, active minority investor and has the ability to invest in both the private and public markets.

About progressive MS

MS is the most common disabling neurological disease among young adults, with first symptoms typically manifesting between 20 and 40 years of age. In the majority (85%) of cases, patients experience an initial phase of relapsing-remitting neurological dysfunction (RRMS), which typically evolves into a secondary progressive disease at a later point in the clinical course (SPMS). Once MS is in the progressive phase, individuals experience a gradual worsening of neurological disability. Primary progressive MS (PPMS) characterized by disease progression from onset is less common, affecting 10–15% of patients. Progressive disease (either SPMS or PPMS) can be further divided into active or not-active progressive disease based on the existence or not of superimposed inflammatory activity. Immunosuppressive and immunomodulatory drugs have been shown to decrease the frequency of relapses and CNS lesions in relapsing remitting MS. These drugs may also delay progression in the subgroup of patients with active progressive MS. However, there is currently no drug targeting not-active progressive MS which represents the larger and most difficult to treat population.

About MD1003

MD1003 is a highly dosed pharmaceutical grade biotin that has already shown efficacy in patients with progressive multiple sclerosis. MD1003 has a mode of action which potentially influences two targets related to progressive MS: (1) it activates acetyl-CoA carboxylases (ACC1 and ACC2), the rate-limiting enzymes in the synthesis of fatty acids required for myelin synthesis, and (2) it activates the Krebs cycle in demyelinated axons to avoid hypoxia-driven axonal degeneration responsible for disease’s progression. Results from two phase 3 studies, MS-SPI and MS-ON already demonstrated the unique capability of the drug to reverse disease progression in a subset of patients in addition to decreasing the overall disease’s rate of progression. The effects were specifically observed in not-active progressive forms of the disease where there is no current drug approved. The drug is already commercialized in some European countries under “named patient use”.

About MS-SPI

The MS-SPI study is a randomized 2:1, double-blinded, placebo-controlled study in patients with not-active progressive MS. Treatment duration was one year followed by a pre-planned 12 months-extension phase where the placebo was switched to the active. The primary endpoint of the study was defined as the proportion of patients who improved at 9 months (M9), with a confirmation of the improvement at 12 months (M12). The primary endpoint was met (p=0.0051). The mean change of EDSS between M0 and M12 decreased in the MD1003 group (-0.03) compared to progression in the placebo group (+0.13, p=0.014). Clinical Global Impression of change assessed by the clinician (CGI) and by the patient (SGI) after 12 months of treatment were significantly better in the intervention group compared to the placebo (p<0.0001 and p="0.0094," respectively). <>

Contact:

MedDay Pharmaceuticals
contact@medday-pharma.com
or
Consilium Strategic Communications
Mary-Jane Elliott, Jonathan Birt, Laura Thornton, +44 (0)20 3709 5700
medday@consilium-comms.com

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