Sosei Heptares Announces Medicxi to Invest Up To €40 Million in New Collaboration Based on its Orexin Agonist Program

Two newly created asset-centric companies, Orexia Limited and Inexia Limited, to develop novel therapies for neurological diseases

TOKYO and LONDON, Feb. 4, 2019 /PRNewswire/ -- Sosei Group Corporation ("the Company") (TSE: 4565), announces it has entered into a structured financing agreement[1] with Medicxi, a venture fund dedicated to financing asset-centric companies, to form two independent companies, Orexia  Limited ("Orexia") and Inexia  Limited ("Inexia"), that aim to develop novel therapies based on positive modulators of the G protein-coupled receptors Orexin OX1 and OX2 for neurological diseases. Medicxi will be investing in both companies with an aggregate amount of up to €40 million.

Under the terms of the agreement, Orexia and Inexia will obtain a portfolio of related patents from the Company[2] and have the rights to exploit a series of Orexin OX1 and OX2 positive modulators and products derived therefrom, including dual OX1/OX2 agonists, designed and developed by the Company, as well as access to proprietary know-how and development capabilities. Orexia will focus on the development of oral therapies, while Inexia will focus on the development of candidates for intranasal delivery using the Optinose Exhalation Delivery System. The Company[3] will retain an equity holding in both companies and will receive R&D payments as well as further payments on the achievement of pre-defined development milestones.

The funding, which is committed by Medicxi, will enable the further development and optimization of lead candidates for oral or intranasal administration into clinical development and through to proof-of-concept, utilizing Sosei Heptares' platform, discovery and clinical development expertise including extensive experience of neurological disorders. Specific target indications will be determined as the programs advance, and will include narcolepsy, a rare sleep disorder.

The orexin system is a key regulator of behavioural arousal, wakefulness and sleep. The loss of the orexin neurons has been shown to be strongly linked to multiple neurological conditions including narcolepsy. In this indication, orexin receptors remain intact and functional, providing an opportunity for therapeutic intervention.

The primary target indication of narcolepsy is characterized by frequent transitions between states of wakefulness and sleep and the inability of maintaining a wakeful state. Narcoleptic patients experience excessive daytime sleepiness (EDS), manifesting as attacks of falling asleep at unpredictable times, as well as often suffering from cataplexy, a sudden debilitating but transient weakening of muscle tone that can cause sufferers to collapse.

Mario Alberto Accardi Ph.D., who has a background in life sciences venture capital and helped structure the deal on behalf of Medicxi, will be appointed as CEO and Co-Founder of Orexia and Inexia, and will join the respective Boards. The other initial member of the Boards will be Francesco De Rubertis, a Partner at Medicxi. Orexia and Inexia will run out-sourced drug development programs, leveraging an experienced team of drug developers within Sosei Heptares and additional contributions from a group of leading experts in the orexin space. Both companies follow Medicxi's asset-centric virtual model utilizing minimal infrastructure and thus increasing capital efficiency.

"Orexin agonism is a very well validated therapeutic target with a clear unmet clinical need. We are excited to partner with Sosei Heptares to discover and develop such potentially valuable assets," said Francesco De Rubertis, Partner at Medicxi.

Dr. Malcolm Weir, Executive VP and Chief R&D Officer of the Company, added: "The asset-centric approach pioneered by Medicxi has proved to be very successful for developing discrete and novel assets and for creating significant value, and allows us seamlessly to transfer our ongoing activities and IP into these two special purpose vehicles. We see great promise in the orexin agonist program and believe it can be advanced significantly with this focused funding and within these new structures in which we retain a significant stake."

For more information on Orexia and Inexia, please visit www.orexiatherapeutics.com and www.inexiatherapeutics.com.

About Sosei Heptares

We are an international biopharmaceutical group focused on the design and development of new medicines originating from its proprietary GPCR-targeted StaR® technology and structure-based drug design platform capabilities. The Company is advancing a broad and deep pipeline of partnered and wholly owned product candidates in multiple therapeutic areas, including CNS, immuno-oncology, gastroenterology, inflammation and other rare/specialty indications. Its leading clinical programs include partnered candidates aimed at the symptomatic treatment of Alzheimer's disease (with Allergan) and next generation immuno-oncology approaches to treat cancer (with AstraZeneca). Our additional partners and collaborators include Novartis, Pfizer, Daiichi-Sankyo, PeptiDream, Kymab and MorphoSys. The Company is headquartered in Tokyo, Japan with R&D facilities in Cambridge, UK and Zurich, Switzerland.

"Sosei Heptares" is the corporate brand of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565).

For more information, please visit https://www.soseiheptares.com/

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About Medicxi

Medicxi is based in London, Geneva and Jersey. The firm's mission is to invest across the full healthcare continuum. Medicxi was established by the former Index Ventures life sciences team and continues to manage the legacy life sciences portfolio of Index Ventures. Medicxi has launched two new funds - Medicxi Ventures 1 (MV1) and Medicxi Growth 1 (MG1) – that focus respectively on early-stage and late-stage investments in life sciences.

GSK, Johnson & Johnson and Novartis, three of the world's largest pharmaceutical companies back Medicxi along with Verily, an Alphabet company. These companies, whilst participating in the SABs of the Medicxi funds, do not receive any preferential rights to the portfolio companies.

Medicxi's team has been investing in life sciences for over 20 years and has backed many successful companies, including Genmab, PanGenetics (sold to AbbVie), Micromet (sold to Amgen), Molecular Partners, XO1 (sold to Janssen), Minerva Neurosciences, Padlock Therapeutics (sold to Bristol-Myers Squibb) and Impact Biomedicines (sold to Celgene). Please see www.medicxi.com for more information.

About Optinose

Optinose (NASDAQ: OPTN) is a global specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. The innovative mechanism of action of the Optinose Exhalation Delivery system (EDS) technology is designed to enable broad, consistent drug delivery high and deep in the nasal passages, leveraging the mucosal surfaces as a potential target for the treatment of local, systemic, and central nervous system diseases. Please visit www.optinose.com to learn more.

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products. Various risks may cause Sosei Group Corporation's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

[1] Wholly-owned UK subsidiary Heptares Therapeutics Limited is party to the transaction
[2] Heptares Therapeutics Limited
[3] Heptares Therapeutics Limited