Greek prosecutors drop another inquiry in Novartis bribery case, but 3 remain open

FiercePharma | August 30, 2019

Allegations that Novartis bribed top Greek officials may look even flimsier now that prosecutors have decided to toss out yet another line of inquiry. But the case isn’t dead yet. Greece’s corruption prosecutor Eleni Touloupaki found no reason to continue investigating the country’s central bank chief Yannis Stournaras over bribery claims that involve Novartis, The Associated Press reported. Stournaras, the Bank of Greece governor, is the seventh of 10 top government officials to be cleared in the case, including two former prime ministers. However, Touloupaki is now seeking parliamentary approval to investigate former health minister Andreas Loverdos, the news site Kathimerini reported, even though previous reports said investigators had found no evidence of his accepting bribes. The case also remains open for Development Minister Adonis Georgiadis and EU Commissioner Dimitris Avramopoulos, according to the local newspaper. The probe stemmed from whistleblower allegations that Novartis had paid officials millions of euros to boost the sales of its drugs and maintain favorable pricing in Greece. But since the alleged scandal broke early 2018, it has turned into a political farce. The former administration led by radical left party Syriza—which initiated the probe—called the case “the biggest scandal” in modern Greek history, while those standing accused have called it “the most ruthless and ridiculous conspiracy theory ever” and a crusade against political opponents.

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Cellusion and Celregen a member of Fosun Pharma, Enter into Exclusive License Agreement of CLS001 for a Corneal Endothelial Cell Regenerative

Cellusion and Celregen | September 12, 2022

Cellusion Inc. a Japanese regenerative medicine startup aiming to solve the global corneal transplant waiting list problem with a unique differentiation induction method from iPS cells to Corneal Endothelial Cell Substitute from iPS Cells for bullous keratopathy novel treatment and Hangzhou Celregen Therapeutics Ltd. a member of Shanghai Fosun Pharmaceutical Co., Ltd. and focus on regenerative medicine and cell therapy and incubated by New Drug Fund of Fosun Health Capital announced an exclusive license agreement in the Greater China region for Celregen to develop, manufacture and commercialize CLS001. Under the Agreement, Celregen will have the exclusive right to develop, manufacture and commercialize CLS001 for bullous keratopathy in the Greater China region, including Mainland China, Hong Kong, Macau and Taiwan. On the other hand, Cellusion retains the rights of development, manufacturing and commercialization of CLS001 in other regions including Japan, the USA, and EU. Under the terms of the agreement, Cellusion will potentially receive over 100 million US dollars including upfront payment, development milestones and sales milestones as well as tiered royalties. “We are very enthusiastic about combining our knowledge of the underlying iPS cellular biology with Celregen and Fosun Pharma in the development and commercialization of innovative medicine in China. Together, we are committed to make best efforts on launching CLS001 for the patient suffering from bullous keratopathy due to the cornea donor shortage in the greater China region.” Shin Hatou, M.D. Ph.D., CEO of Cellusion “Today’s announcement with a global industry leader in iPS cells derived corneal endothelial regenerative therapy such as Cellusion, is an important and strategic step to build a long-term foundation for cell therapy in China,” said Cui Zhiping, the Chairman of Celregen, Fosun Global Partner, Chief Consultant of VC investment of Fosun Pharma and CEO of Fosun New Drug Fund. “This partnership, which leverages each company’s respective strengths, will help us bring novel regenerative medicine products to patients in greater China.” According to reports, there are about millions of people in China who are blind due to corneal diseases, and this number is increasing at a rate of 100,000 per year. Most of the patients with corneal blindness need corneal transplantation to restore their sight, but only less than 20,000 corneal transplants are conducted due to severe donor cornea shortage issues. Cellusion has already announced that the patient recruitment began for the First-in-Human Investigator-Initiated Study of CLS001 to initiate in 2022 at the Keio University Hospital and has been preparing to start Cellusion initiated clinical trial in Japan within a few years followed by global studies in the US and EU region. Cellusion is developing CLS001, CECSi cells for Corneal Endothelial regeneration to cure Bullous Keratopathy which is applied to more than half of all cases of corneal transplantation. CLS001 is expected to replace the current supply limitations by combining “CECSi Cells made from iPS cells with excellent proliferative properties” and “a simple injection cell delivery procedure without needs of human expertise.” About Celregen Celregen, incubated by New Drug Fund of Fosun Health Capital, focuses on stem cell and transformed cellular regenerative medicine. This platform adopts a variety of modes of cooperation with leading biotech and scientists. It is expected to be a head biotech in regenerative medicine in China. About Fosun Pharma Founded in 1994, Fosun Pharma is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system. About Fosun New Drug Fund New Drug Fund, under the management of Fosun Health Capital, is the first VC established by Fosun Pharma. The Fund focuses on innovative biopharmaceutical-based drug fields at the start-up and expansion stages, including gene therapy, cell therapy, bio-conjugate drugs, and medical aesthetics, etc. The Fund has committed to incubate cutting-edging science and revolutionary technologies from world top universities, research institutes and biotech, through which path we can establish and adopt a variety of models of cooperation.

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BUSINESS INSIGHTS

Inversago Pharma Raises $95 million CAD in Series C Financing

Inversago Pharma Inc. | October 18, 2022

Inversago Pharma Inc. a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, announced the completion of a Series C funding of $95 million CAD led by New Enterprise Associates. Additional new investors Forbion’s Growth Opportunities Fund and Amgen Ventures joined current investors including Forbion’s Ventures Fund IV Fonds de solidarité FTQ, Genesys Capital, AmorChem, JDRF T1D Fund and adMare BioInnovations in the financing round. Proceeds from the Series C financing will be used to move Inversago’s lead program, INV-202, into a Phase 2 clinical trial in Diabetic Kidney Disease in Q4 2022. This follows the previously announced IND clearance from the FDA and the upcoming promising Phase 1b topline results in subjects with metabolic syndrome. Additionally, the funds will accelerate the Company’s other key programs currently in pre-clinical development, while establishing its leadership in the field of CB1 blockers. “We are privileged to have the support and commitment of such an impressive investor syndicate at this critical stage of the Company’s development. This new round of financing is a strong endorsement of the whole Inversago team, who have carried the vision to leverage the potential of the CB1 blockade in developing potent treatments for a growing number of patients suffering from metabolic conditions, such as Diabetic Kidney Diseases and other diabetes-related conditions”. François Ravenelle, PhD, Chief Executive Officer of Inversago Pharma Commenting on the investment, Ed Mathers, General Partner at NEA, said: “Inversago has demonstrated that peripherally-acting CB1 blockers have an untapped potential to create a new class of target therapies that serve diabetic patient populations. Today’s financing reflects our shared vision and collaboration with the Company’s management as they initiate a Phase 2 clinical trial with INV-202”. Nanna Lüneborg, General Partner at Forbion Growth, added: “We are delighted to join this Series C financing of Inversago, and support the Company to develop a pipeline of new therapies which promise to make a profound impact on the lives of patients with cardiometabolic diseases. We have been impressed by the terrific progress of Inversago since Forbion led the Company’s Series B round two years ago and are excited to further support the Company from both Forbion Growth and Forbion Ventures”. About NEA New Enterprise Associates, Inc. is a global venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors and geographies. With nearly $24 billion in cumulative committed capital since the firm's founding in 1977, NEA invests in technology and healthcare companies at all stages in a company's lifecycle, from seed stage through IPO. The firm's track record of investing includes more than 260 portfolio company IPOs and more than 440 mergers and acquisitions. About Forbion Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 2 billion across multiple fund strategies that cover all stages of pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in 92 companies. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. About Amgen Ventures Amgen Ventures is Amgen's corporate venture capital fund, dedicated to investing in emerging companies and technologies to advance promising new medicines and solutions to healthcare’s biggest challenges. About Inversago Pharma Located in Montreal, Inversago Pharma is a privately owned Canadian biotech company at clinical stage, specialized in the development of new therapies focusing on CB1 blockade, based on first-in-class, peripherally-acting CB1 inverse agonists. Inversago aims to provide new treatment options that improve the lives of patients affected by metabolic conditions such as Diabetic Kidney Disease including Diabetic Nephropathy Type 1 and Type 2 Diabetes Non-Alcoholic Steatohepatitis complications of obesity and hypertriglyceridemia as well as fibrotic indications like Progressive Fibrosis-Interstitial Lung Disease including Idiopathic Pulmonary Fibrosis and other conditions.

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Everest Medicines Appoints Rogers Yongqing Luo as Chief Executive Officer to Lead Next Stage of Company Growth

Everest Medicines | September 19, 2022

Everest Medicines a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has appointed Rogers Yongqing Luo as Chief Executive Officer of the Company, effective immediately. Mr. Luo will also serve as an Executive Director on Everest's Board of Directors. Mr. Luo brings to Everest more than 25 years of experience in the healthcare industry with an extensive leadership track record across clinical development, regulatory affairs and commercialization. Previously, Mr. Luo served as President and General Manager, Greater China at Brii Biosciences and CEO of TSB Therapeutics where he spearheaded the rapid registration approval, GMP certification and successful commercialization of the amubarvimab/romlusevimab combination, the first COVID-19 neutralizing antibody treatment in China. Prior to that, he was Global Vice President and China General Manager at Gilead Sciences where he led the clinical development, regulatory approval and successful commercial launch of eight innovative therapeutics, and efforts that rapidly expanded patient access across China. Mr. Luo previously oversaw the successful launch of several high-profile medicines. He managed sales, marketing, government affairs and market access functions for various leading multinational pharmaceutical companies including Roche and Novartis, and worked two years at Novartis headquarter in Switzerland. "As Everest Medicines continues to evolve our business strategy and expand our novel product pipeline at a rapid pace, we are thrilled to have Rogers join the Company to lead Everest through its next phase of growth in becoming a fully-integrated biopharma company in China. With his robust background as a top executive at both biotech startup and large multinational pharma companies, Rogers brings to Everest a unique set of expertise including comprehensive scientific insight, proven outstanding leadership and excellent commercialization capabilities in patient access, and a demonstrated history of successfully advancing early- and late-stage innovative pipeline to commercial launch in Greater China. In particular, Rogers' leadership will strengthen Everest's new product development and commercial capabilities as we progress toward potential approvals of our late-stage anchor product candidates, including Nefecon, Xerava, etrasimod and mRNA vaccines. We look forward to leveraging Rogers' leadership and industry expertise to generate long-term growth and success across the business." Mr. Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group "I'm very excited to join Everest and I look forward to working with this talented, world-class team of scientists and industry professionals to further the Company's industry leadership. We will continue to advance our late-stage pipeline towards commercialization and with our strong balance sheet, we aim to execute synergistic business development deals to accelerate our path to become an integrated biopharma," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We will continue to invest into our discovery platform to build an innovative therapeutic pipeline for the benefit of patients with unmet needs in Greater China and other Asia Pacific markets, and to create sustained, long-term value for our shareholders." About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.

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VIEWS AND ANALYSIS

Altamira Therapeutics Provides Business Update and First Half 2022 Financial Results

Altamira Therapeutics Ltd | December 01, 2022

Altamira Therapeutics Ltd. a company dedicated to developing therapeutics that address important unmet medical needs, today provided a business update and reported its first half 2022 financial results. “We continue to make good progress with the transformation of Altamira into an RNA delivery technology company. We are optimistic of reaching an agreement to divest or partner our Bentrio nasal spray for key markets in North America and Europe by year end. Last month, we agreed to divest part or all of our inner ear therapeutics programs to a European family office. Following some delay and under slightly amended terms, we expect that transaction to close in December. Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO “Heading towards 2023, we look forward to focusing exclusively on the many emerging opportunities in the fast-growing RNA therapeutics market. We are increasingly well positioned to advance our RNA delivery technology throughout 2023.” As Altamira is going through the final stages of a major corporate transformation, management intends to hold its next investor call upon finalization of its partnering / divestiture projects. On that call, the Company will also provide its outlook for 2023. RNA delivery platform update Altamira continued to make solid progress with the development of its patented, peptide-based platform for RNA delivery to extrahepatic tissues. In recent months, the RNA team led by Chief Development Officer Covadonga Pañeda, Ph.D., and Chief Scientific Officer Samuel Wickline, MD, have advanced various projects, including selection and optimization of siRNA sequences, formulation, process development and manufacturing. Starting with project AM-401 for the treatment of KRAS-driven tumors, the Company added a second project, AM-411 for the treatment of rheumatoid arthritis. AM-411 nanoparticles comprise siRNA targeting NF-kB a key checkpoint in RA inflammation. The Company is developing both AM-401 and AM-411 with the objective of out-licensing the drug products at a later stage. They serve as a “showcase” for the application of Altamira’s RNA delivery technology; the Company’s strategy will be to out-license the technology to pharma and biotech companies for use with their own RNA molecules. In this context, Altamira has been intensifying its efforts to raise awareness about OligoPhore/SemaPhore within science and industry. In recent months, members of Altamira’s leadership team gave oral presentations at multiple international conferences, highlighting the ability to deliver RNA molecules to extrahepatic tissues and achieve efficient and rapid endosomal release inside target cells. Concurrently, further data on RNA delivered with Altamira’s delivery technology has been published by independent research groups in peer-reviewed scientific journals. Altamira anticipates entering into its first partnering agreements in 2023. Bentrio Update Earlier today, Altamira reported that its licensee and distribution partner Nuance Pharma has launched Bentrio nasal spray in Hong Kong to help provide protection against airborne viruses as well as allergens. This will be the first step to distributing Bentrio in the other Nuance-licensed territories which is comprised of mainland China, Macau and South Korea. As part of its strategy to focus exclusively on RNA delivery, Altamira has been in discussions with several well-established OTC consumer health companies for the partnering of Bentrio. Those discussions intensified following the 510(k) clearance of the product by the FDA and have advanced well, including due diligence by interested parties. The Company anticipates entering into a partnering transaction before year end. In the context of those partnering discussions, Altamira suspended preparations for launching the product in the US on its own as well as pausing major marketing initiatives in Europe. This restraint provides the prospective strategic partner for Bentrio with maximum flexibility to fit the product into its business plan. Beginning in early October, the Bentrio nasal spray was relaunched in Europe for allergic rhinitis. Previously, the Company had ceased marketing the product for the indication of viral infection in the EU and Switzerland although Bentrio’s mode of action is the same regardless of whether it provides a barrier against airborne virus or allergen particles. This had been demonstrated in various relevant in vitro assays. However, certain countries and regions require specifically clinical performance data to clear Bentrio for this indication, in particular related to COVID-19. Such data are expected to become available through the COVAMID trial. In September, Altamira announced that it had reached its extended enrollment target of 160 confirmed subjects in its COVAMID clinical investigation to evaluate the safety, tolerability, and efficacy of its Bentrio nasal spray in patients with acute COVID-19. The read-out of top-line data remains on track for the current quarter. The Company plans to seek an expansion of its product label to also include viral infections in those countries requiring supportive clinical data. In September, the Company also announced that its “NASAR” clinical trial in seasonal allergic rhinitis (SAR) resumed enrollment as the new pollen season started in Australia. The NASAR trial is expected to enroll a total of 100 patients suffering from SAR and is designed to compare the safety and efficacy of Bentrio against a (control) saline nasal spray. The primary endpoint will be the comparison of the reflective Total Nasal Symptom Score under treatment with Bentrio against control. The NASAR trial was initiated in the fall of 2021. It was suspended in spring 2022 as the pollen season came to an end before the enrollment target could be met. Interim data from the trial were used in support of the 510(k) clearance of Bentrio by the US FDA. Unless an interim analysis performed upon reaching 50% of the enrollment target to check the validity of the statistical powering assumptions requires a change to the target size of 100 patients, the Company expects to complete enrollment into the NASAR trial by year-end or in early 2023 with a read-out of top-line data in late 1Q-23.

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Flu is a viral respiratory infection passed from person to person. Seasonal flu is a contagious respiratory illness caused by flu viruses that sail through the air in droplets when an infected person speaks, sneezes, or coughs. Others can inhale the droplets, or germs can easily be transferred from contaminated surfaces or hands to the eyes, mouth, or nose.

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