Sankyo Co., Ltd. (Tokyo)

Heidelberg, Germany, Cambridge, MA, USA, and CLERMONT-FERRAND, France, October 2, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, and Laboratoires Théa (Théa), the leading independent eye care group in Europe, announce European Commission approval of Vevizye® (ciclosporin 0.1% eye drops solution) in Europe and the closing of a partnership under which Théa has acquired the rights to commercialise the product in Europe and selected countries in the Middle East and North Africa (MENA). Vevizye® is based on Novaliq’s proprietary EyeSol® technology and the only water-free ciclosporin 0.1% eye drops solution approved in the European Union for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients which has not improved despite treatment with tear substitutes. “Our partnership with Novaliq highlights our dedication to delivering innovative treatments to all patients.”, stated Jean-Frédéric Chibret, President of the Théa Group. “We are looking forward to launching Vevizye® to complement our range of non-preserved treatments for dry eye, a disease that has substantial impacts on the quality of life of many patients.” Dry eye disease (DED) is one of the most common ocular surface disorders, affecting approximately 15 million diagnosed patients in the five largest European countries(1) and is difficult to treat(2). In Europe, there is a need for additional prescription treatments intended for adults suffering from moderate to severe dry eye disease. “We are thrilled to partner with Théa, the leading ophthalmic pharmaceutical company in Europe, to bring Vevizye® to patients. Théa’s focus on innovation, its leading commercial capabilities and the strong track record in Europe makes them the perfect partner for Novaliq” said Christian Roesky, Ph.D., Chief Executive Officer Novaliq. About ESSENCE 1(3) & ESSENCE 2(4) clinical studies The efficacy of Vevizye® for the treatment of dry eye disease was demonstrated by two randomised, multicentre, double-masked, vehicle-controlled studies (ESSENCE-1(3) and ESSENCE-2(4)). The change from baseline in total corneal fluorescein staining (tCFS) score at Day 29 was the primary endpoint in both trials. At Day 29, a statistically significant reduction in tCFS favouring Vevizye® was observed in both studies. Up to 71.6% of patients responded within four weeks with a clinically improvement in total corneal fluorescein staining. All other key secondary ocular surface sign endpoints (tCFS at Day 15, conjunctival staining at Day 29 and central corneal staining at Day 29) showed statistically significant effects favouring Vevizye® in both studies. Continued improvement under therapy in both signs and symptoms of DED were demonstrated over a period of up to 56 weeks.(5) About VEVIZYE® The product was approved by the US Food and Drug Administration (FDA) in May 2023 as VEVYE®. In the European Union (EU) the eligibility to the centralised procedure under Article 3(2)(b) of Regulation (EC) No 726/2004 was based on the “interest of patients”. Vevizye® is indicated for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes. Vevizye® is approved in all 27 EU member states. Full European Summary of Product Characteristics for Vevizye® is available from the EMA website at www.ema.europa.eu . At time of publication of this press release, the full SPCs have not been yet published online. Additional regulatory applications are under review in several countries, including China, Australia, and New Zealand. About Novaliq Novaliq is a private biopharmaceutical company focusing on the development of first- and best-in-class ocular therapeutics. Novaliq developed EyeSol®, a novel drug category of water-free topical eye medicines. Two FDA-approved EyeSol® medicinal products for dry eye disease – Miebo® and Vevye® – are on the market in the US and are beginning to revolutionize patient care. The Novaliq R&D pipeline provides multiple development opportunities in ophthalmology and retina therapies. Novaliq is headquartered in Heidelberg, Germany and has an office in Cambridge, MA, USA. The long-term single shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on www.novaliq.com. About Laboratoires Théa Théa is the leading independent European pharmaceutical company specialized in the research, development, and commercialization of eye care products. Based in Clermont-Ferrand, France, this family-owned and run company comprises more than 2,000 collaborators and has expanded by opening more than 35 affiliates and offices in Europe, North Africa, North and South America, and the Middle East. Its products are available in 75 countries. In 2023, Théa’s turnover reached €923 million. More on www.laboratoires-thea.com. Recommended Readings Global Data. Dry Eye Syndrome: Seven-Market Drug Forecast and Market Analysis Update | December 2022 Jones et al. TFOS DEWSII Management and Therapy Report. The Ocular Surface. 2017; 15 (3): 575-628 Sheppard et al. A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea. 2021 Oct 1;40(10):1290-1297 Akpek et al. Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease The ESSENCE-2 Randomized Clinical Trial. JAMA Ophthalmology. 2023; 141(5):459-466 Wirta et. al. Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE. Cornea. 2024 May 21.

£90m ($114m) series A co-led by new leading life science investors Novo Holdings and Abingworth Additional new investors British Patient Capital, Cancer Research Horizons and Lilly participated alongside founding investors Brandon Capital and Sofinnova Partners Funds will be used to build out Myricx Bio’s proprietary N-Myristoyltransferase inhibitor (NMTi) antibody-drug conjugate (ADC) payload platform and advance its pipeline of NMTi-ADCs through clinical proof of concept targeting clinically validated tumour-associated antigens Company to establish laboratory operations in London’s biotech hub, and expand its management and R&D teams Michael Bauer from Novo Holdings and Lucille Conroy from Abingworth will join Myricx Bio Board of Directors July 08, 2024 -- Myricx Bio (‘Myricx’), a UK biotech company focusing on the discovery and development of a completely novel class of payloads for antibody-drug conjugates (ADCs), today announced the closing of its series A financing raising £90m ($114m). The round was co-led by new leading life science investors Novo Holdings and Abingworth. Additional new investors British Patient Capital (a wholly owned commercial subsidiary of British Business Bank plc, the UK government’s economic development bank), Cancer Research Horizons and Eli Lilly and Company also participated alongside founding investors Brandon Capital and Sofinnova Partners. In connection with the financing, Michael Bauer from Novo Holdings and Lucille Conroy from Abingworth will join Myricx’s Board of Directors. The funds will be used to build out Myricx’s proprietary N-Myristoyltransferase inhibitor (NMTi) ADC payload platform and to advance its pipeline of NMTi-ADCs through clinical proof of concept targeting clinically validated tumour-associated antigens. NMT is an enzyme that adds a specific lipid modification to several protein targets that are key to cancer cell survival. Myricx is advancing a pipeline of ADCs to address serious unmet needs in oncology based on its NMTi payload chemistry platform and has demonstrated excellent preclinical efficacy and safety across multiple solid tumour-associated antigens and cancer cell types. Myricx has shown that its initial NMTi-ADCs achieve complete and durable tumour regressions, at well-tolerated doses, in multiple solid cancer models that are refractory to Topo1i-based ADCs. In addition, these NMTi-ADCs demonstrate potent bystander activity, and deliver high efficacy in patient-derived xenograft (PDX) organoid models across a broad range of antigen expression levels. Michael Bauer, Partner in the Venture Investments group at Novo Holdings, said: “Myricx has gained unique insights into the biology of NMT and its orthogonal and differentiated mechanism. The scientific rationale behind its novel payload chemistry gives us confidence that NMTi-ADCs have the potential to greatly expand the current repertoire of ADC applications beyond the current standard-of-care payload classes, creating opportunities for new treatment options for patients. This investment reflects our strategy of investing in highly innovative and high impact biotechs, and we look forward to supporting the progress of Myricx through the clinic.” Lucille Conroy, Principal at Abingworth, said: “We were impressed by the compelling preclinical data validating Myricx’s first-in-class payload platform based on NMT inhibition. We are pleased to co-lead the investment with Novo Holdings and to be working with the company to advance its NMTi-ADC candidates to address serious unmet needs in oncology by offering new options to patients.” Jonathan Tobin, Partner at Brandon Capital, said: “Having recognised the potential of NMT inhibitors as a powerful ADC payload, what Robin and the Myricx team have generated to validate that potential over the past year is truly impressive. Together with Sofinnova, we are delighted to welcome the new investors into this series A financing to join us in supporting Myricx to become a significant player in the ADC space.” Maina Bhaman, Partner at Sofinnova Partners, said: “We’ve been strong supporters of Myricx Bio since its inception, recognising the potential of its NMT inhibition platform. We are delighted to be joined by Abingworth, Novo Holdings, Lilly, Cancer Research Horizons and British Patient Capital as we continue to champion Myricx’s ability to harness the enormous potential of ADC payloads. With these expanded resources, Myricx is poised to fully leverage its NMTi-ADC platform, advancing both its own pipeline and strategic partnerships.” Myricx was founded by Prof. Ed Tate, Dr Roberto Solari and Dr Andrew Bell. Dr Robin Carr joined the team from GSK in 2019 and has spearheaded the company’s pivot from a focus on NMTi as small molecule drugs to their potential as ADC payloads. Myricx now has the resources to grow from a virtual company into a fully-fledged R&D company with its own laboratories and an in-house R&D team, with expanded management capabilities. Currently located in the London Kings Cross biotech hotspot and with foundations in London, having spun out of Imperial College London and the Francis Crick Institute, Myricx is committed to significant growth and executive presence in London. Myricx Bio CEO, Dr Robin Carr said: “I am truly grateful for the support of our founding investors Brandon Capital and Sofinnova Partners as we developed our initial NMT inhibitor chemistry and demonstrated the potential of NMTis as ADCs. I am delighted to welcome our new investors and thank them for their support as we enter our next phase of development. Myricx now has the resources to grow into a fully-fledged R&D company with our own laboratories, and an in-house R&D team with expanded management capabilities. Consequently, we are well positioned to build on our NMTi ADC platform and advance our pipeline as we become a clinical stage company.” Myricx has already begun the process of attracting top talent to the company. In 2023, it appointed Chris Martin, a renowned biotech company founder, director and entrepreneur, and co-founder of ADC Therapeutics SA (NYSE: ADCT), to the Board of Directors as its independent non-executive Chair. It also appointed Francesca Zammarchi PhD, previously Head of Preclinical Pharmacology at ADC Therapeutics, as its Chief Scientific Officer, and Robert McCleod MD, ex-Daiichi Sankyo, as VP Clinical Development, both of whom bring considerable ADC experience. Myricx Bio (“Myricx”) is a UK biotech company focused on the discovery and development of a completely novel class of payloads for antibody-drug conjugates (ADCs), based on inhibitors of N-Myristoyltransferases (NMT) for the treatment of cancer. NMT is an enzyme that adds a specific lipid modification to a number of protein targets that are key to cancer cell survival. Myricx is advancing a pipeline of ADCs to address serious unmet needs in oncology based on its NMT inhibitor (NMTi) payload chemistry platform and has demonstrated excellent preclinical efficacy and safety across multiple solid tumour-associated antigens and cancer cell types. Based in London, Myricx is a spin out from Imperial College London and the Francis Crick Institute with investment from Abingworth, Brandon Capital Partners, British Patient Capital, Cancer Research Horizons, Eli Lilly and Company, Novo Holdings, and Sofinnova Partners. Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk and Novonesis and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seeds, Venture, Growth, and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. Abingworth is a leading transatlantic life sciences investment firm and part of the global investment firm Carlyle (NASDAQ: CG). Abingworth helps transform cutting-edge science into novel medicines by providing capital and expertise to top calibre management teams building world-class companies. Since 1973, Abingworth has invested in over 185 life science companies, leading to 50+ M&As and more than 75 IPOs. Our therapeutic focused investments fall into three categories: seed and early-stage, development stage, and clinical co-development. Abingworth supports its portfolio companies with a team of experienced professionals at offices in London, Menlo Park (California), and Boston. Cancer Research UK (CRUK) is one of the world’s largest non-profit investors in cancer research. CRUK has built a network of 4,000 exceptional scientists and now funds over £350 million of world-class academic research each year that has the potential to change the way we prevent, diagnose and treat cancer. Cancer Research Horizons (CRH), CRUK’s innovation arm, offers the full spectrum of translational expertise, from drug discovery and clinical capabilities, translational funding and entrepreneurial training to licensing, industry collaboration and start up creation expertise. It has played a role in the creation of 79 start-ups, with its portfolio companies raising over £3 billion in total capital. Its dedicated Ventures team focuses on early stage, high-risk companies, including one of the most challenging stages of start-up creation: attracting early-stage risk capital. The Ventures team manages the CRH Seed Fund, launched in June 2022, to accelerate more breakthroughs to patient benefit. Brandon Capital is Australasia's leading life sciences venture capital firm, with offices in Australia, New Zealand, the US and the UK. Its unique model includes proprietary deal flow through Brandon BioCatalyst, a collaboration of over 50 of ANZ’s leading medical research institutions, and its immersive corporate services structure enables portfolio companies to focus on research commercialisation. With more than 25 active companies in its portfolio, Brandon Capital has been sourcing and supporting the transition of world-leading science into world-leading businesses for nearly two decades. Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future. Founded in 1972, Sofinnova Partners is a deeply-established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €2.8 billion under management. The content above comes from the network. if any infringement, please contact us to modify.

Walgreens has launched an over-the-counter version of naloxone, an antidote to opioid overdose. As Walgreens launches an own-brand opioid overdose reversal drug, we take a look at the role of naloxone in combatting decades of US opioid deaths US pharmacy chain operator Walgreens Boots Alliance has launched an own-brand version of popular overdose reversal drug, naloxone, which will be available over-the-counter. The drug was approved by the US Food and Drug Administration (FDA) in April. Reuters reports that Walgreens will begin selling its naloxone-based drug as Naloxone HCl Nasal Spray in all its stores by the end of May. The spray will be sold at $34.99 a pack. Naloxone rapidly reverses the effects of an opioid overdose, crucially restoring normal respiration. Opioid abuse has plagued the US for more than two decades. According to government data more than half a million Americans have died from opioid and synthetic drug use, with fentanyl a major culprit . Naloxone was first patented in 1961 by scientists at Sankyo Company in Japan and the University of Strasbourg in France. It was approved for medical use in the US by the FDA in 1971, as an emergency treatment for opioid overdose. In light of the Walgreen announcement we take a closer look at the use of naloxone in the US, and the pharmaceutical companies involved in making and marketing it. A timeline of naloxone in the US Initially, naloxone was used primarily by anesthesiologists to reverse the effects of opioid medications given during surgery. However, as the opioid crisis escalated in the 1990s and 2000s, public health officials lobbied for naloxone to be made more generally available in a bid to tackle the rising number of overdose deaths. In 1996, Baltimore became one of the first cities to launch a community-based overdose prevention programme, providing naloxone to drug users. By 2010 an estimated 200 similar programmes were operating across the US. In the years leading up to 2020, all 50 US states had passed laws improving widespread access to naloxone, while first responders – such as police and emergency medical technicians – were also permitted to administer naloxone. From 2016-2021, naloxone prescriptions rose by over 1,500% as it became a vital tool in the national response to the opioid epidemic. US pharma and naloxone: a history Pharmaceutical companies responded to the opioid addiction epidemic by developing user-friendly naloxone products – such as auto-injectors and nasal sprays – for non-medical settings. Kaleo’s Evzio product was approved in 2014 (but is now discontinued), while Emergent’s Narcan Nasal Spray hit the market in 2015, followed by a slew of generic naloxone products. Narcan and Evzio were the first naloxone products specifically designed for easy administration by non-medical personnel. Narcan came at a higher price point because of the sophisticated way they were administered, compared to the cheaper injectable generic versions. The aim was to increase access by making naloxone easier for caregivers and bystanders to deploy during an opioid overdose emergency. Naloxone is currently produced by several major pharmaceutical companies, including Hospira, Telefex, and Mylan.