Citius Pharmaceuticals Achieves Chemical Manufacturing and Control Milestones for Mino-Lok

Citius Pharmaceuticals | September 23, 2020

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has achieved a number of significant milestones over the past several weeks for Mino-Lok®. Mino-Lok is an antibiotic lock solution being developed as an adjunctive therapy for patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). Mino-Lok contains three active drug substances (minocycline, ethanol and EDTA) which are combined into two vials, MLT01 (minocycline) and MLT02 (ethanol and EDTA).  Citius has manufactured three registration lots of Mino-Lok using the commercial manufacturing process, which will be filed in the planned New Drug Application (NDA).

Spotlight

The Legatum Institute, a London-based research institute released its 10th annual global Prosperity Index in November, a huge survey that ranks the most prosperous countries in the world. The organization compares 104 variables to come up with its list, splitting those variables into nine subindexes. One of the big components of the ranking is how healthy a country's people are.


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BUSINESS INSIGHTS

Acorda Therapeutics and Biopas Laboratories Announce Agreement to Commercialize INBRIJA® in Latin America

Acorda Therapeutics, Inc. | May 12, 2022

Acorda Therapeutics, Inc. and Biopas Laboratorie announced that they have entered into distribution and supply agreements to commercialize INBRIJA® in Latin America. INBRIJA is indicated in the United States for the intermittent treatment of episodic motor fluctuations in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. Under the terms of the agreements, Acorda will receive a significant, double-digit, tiered percentage of the selling price of INBRIJA in Latin America in exchange for supply of the product. Acorda will also receive sales-based milestones. Biopas will have the exclusive distribution rights to INBRIJA in nine countries within Latin America, including Brazil and Mexico. According to current population estimates, there are at least 400,000 people living with Parkinson's disease in Latin America1. Biopas plans on seeking marketing authorization in all countries to make Inbrija available for patients as quickly as possible. “BIOPAS is the leader in commercializing CNS therapies in Latin America and we are delighted to announce these agreements to make INBRIJA available there to people with Parkinson’s disease who suffer from OFF periods. We are also in active discussions with other companies for the rights to commercialize INBRIJA in additional countries.” Ron Cohen, M.D., President and CEO of Acorda Therapeutics “We are excited to be collaborating with Acorda to make INBRIJA available to people with Parkinson’s disease in Latin America. This important partnership supports Biopas’ mission to cover unmet medical needs of patients from Argentina to Mexico. Inbrija further strengthens Biopas’ complete and innovative CNS portfolio now consisting of nine original treatments: for Parkinson’s disease, epilepsy, movement disorders, sialorrea, multiple sclerosis, anxiety, and sleep disorders,” said Pascal Forget, CEO of Biopas. About Acorda Therapeutics Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® Extended Release Tablets, 10 mg. About Biopas Laboratories Biopas is a leading and differentiated Latin American Pharmaceutical company, focused on in-licensing, marketing and selling cutting-edge specialty pharmaceutical products. Biopas offers the best-in-class capabilities in sales, marketing, medical, support functions and provides integral services to support the launch and development of products. All its functions operate in compliance with international standards and regulations. Biopas covers 20+ countries in LatAm through fully owned subsidiaries and is a trusted partner of reputable multinational pharmaceutical companies, and has products in leading positions in CNS, Immunology, Rare Disease, Oncology, and Dermatology.

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Ellipses Pharma and SunRock Biopharma Enter Into a Licensing Agreement for a First-in-class Bifunctional HER3:TRAIL Fusion Protein

SunRock Biopharma S.L | May 26, 2022

SunRock Biopharma S.L. a biopharmaceutical company that is developing a portfolio of innovative bispecific antibodies to treat incurable cancer, and Ellipses Pharma Limited a global drug development company focused on accelerating the development of new oncology treatments, announce that they have entered into an exclusive licensing agreement for SRB22, a fully human bifunctional HER3:TRAIL fusion protein, which going forward will be known as EP0017. Under the agreement, Ellipses has been granted global rights to develop and commercialise EP0017 and will assume the full cost and responsibility for the remaining pre-clinical and clinical development of the compound. In line with its strategy, Ellipses intends to out licence EP0017 for commercialisation if it proves safe and effective in clinical trials. SunRock will continue to be involved in the development of EP0017 to ensure efficient translational activities through a service agreement with Ellipses. If Ellipses out-licences EP0017, SunRock will also receive milestone payments and royalties. EP0017 is a first-in-class bifunctional fusion protein with a dual mechanism of action. It selectively targets HER3, which is overexpressed in several different tumour types, and additionally, binds to the tumour death receptors DR4 and DR5, inducing tumour cell death. Promising data has been generated in a range of preclinical models that demonstrate the potential of EP0017. Laureano Simón, Ph.D., CEO of SunRock Biopharma, said “The agreement with Ellipses will speed up the development of EP0017, moving this potentially life-changing asset towards the clinic and then hopefully towards cancer patients who desperately need novel approaches to fight invasive tumours.” Rajan Jethwa, MD, CEO of Ellipses Pharma “Our mission is to rapidly develop innovative cancer therapies, to get these therapies into the clinic as quickly as possible and potentially save more lives. We are excited about the opportunity to progress the development of this promising asset and look forward to working with SunRock to expedite the preclinical work.” About SunRock Biopharma S.L. Since its inception in 2014, SunRock has developed a comprehensive pipeline of seven therapeutic antibodies, bispecific antibodies and fusion proteins with proven therapeutic effects against several types of tumours that currently lack a treatment. The innovative spirit of SunRock defines the development of all its molecules, that are the result of a disruptive technological platform that has led to pioneer therapies with an innovative format, including first-in-class bispecific antibodies and fusion proteins that target both novel and well-known therapeutic targets. SunRock’s project portfolio is generating great expectations among patient associations, major hospitals, and biopharmaceutical companies. The Government of Galicia participates in SunRock through the Galicia Innova Tech Fund, FICC. About Ellipses Pharma Limited Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer medicines and treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimize the time it takes to advance lead products through clinical trials and reach patients.

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PHARMA TECH

Therorna completes Series A financing to accelerate pipeline development and clinical transformation of circRNA-based platform

Therorna Inc. | June 21, 2022

Therorna Inc., a China-based biotech company specialized in the development of cutting-edge circular RNA technology-based new vaccines and therapies, announced the completion of a US$42 million Series A financing round. The round was co-led by a well-known industrial investment firm and MSA Capital, with participation from Sherpa Healthcare Partners, 3H Health Investment, and existing investors Quan Capital and Cenova Capital, demonstrating their continuous commitment to supporting Therorna's growth. With the new funding, Therorna plans to accelerate the build-out of its technology platform and the development of its product pipeline, as well as the clinical trials, regulatory applications, and international collaborations. Therorna was founded in Beijing in April 2021. The company focuses on leveraging its proprietary circRNA technology platform to develop next-generation vaccines and innovative therapies. The company has established a strong pipeline of novel prophylactic and therapeutic drugs aiming to address high unmet medical needs. When combined with the previously completed angel and pre-A rounds, the company has to date raised over US$60 million. "We really appreciate the support of our investors. As the world continues to suffer from the COVID-19, scientists are obliged to shoulder the responsibility to provide scientific solutions to end this pandemic. We are devoted to accelerating the clinical application of our circRNA-based vaccines against SARS-CoV-2 and its variants." The scientific founder of Therorna, Professor Wensheng Wei Therorna Chief Executive Officer, Dr. Daniel Tang commented, "I am very grateful for the support of our new and existing investors in this financing round. The successful completion of this round will play a key role in helping Therorna accelerate the development of a new broad-spectrum COVID-19 vaccine and the discovery of additional novel therapies for a variety of diseases. Our team will continue to spare no effort to advance the circRNA platform technology to develop the next-generation of breakthrough therapies and quickly deliver meaningful social benefits." MSA Capital founder and managing partner Yu Zeng added, "We are confident in the potential of circRNA technology for drug development in the area of protein expression and regulation. Compared with linear RNA, circRNA boasts breakthroughs in expression, stability, immunogenicity, and production. In terms of the technology, Chinese scientists have proven their internationally recognized capabilities at innovation and efficient transformation. MSA Capital is impressed by Therorna's strong team of scientists and entrepreneurs. As a serial entrepreneur, Professor Wei has deep expertise in gene editing and circRNA technology application, and Therorna's management team has rich experience in drug R&D and industrial management. MSA Capital will make use of its resources to support the expansion of Therorna in international markets." Sherpa Healthcare Partners investment VP Dr. Changzu Cai said, "mRNA drugs have achieved notable success in the application of COVID-19 vaccines, but challenges in terms of side effects remain to be addressed. Linear RNA is easily degraded and its application beyond vaccines is still under exploration. Thanks to its unique structure, the circRNA as a tool for protein expression has been proven to maintain a relatively stable protein expression level in vivo for a longer time, which is expected to further expand the application scenarios of RNA therapy. The team led by Professor Wei is leveraging their experience in applying circRNA as a gene editing tool to support the development of the circRNA expression tool. The proprietary circularization method developed by Therorna has demonstrated its advantages in terms of dosage, and activation of cellular immunity by being first applied in COVID-19 vaccines. We are pleased to continue supporting the efforts of Wei Lab in converting innovations into benefits for patients and communities, while looking forward to transforming Therorna into a platform-based circRNA technology-focused company with an international presence." 3H Health partner Dr. Minchuan Wang said, "circRNA has better stability and long-lasting expression with a potential for creating a new RNA therapy platform. The combination of Professor Wei's team with strong technical expertise in circRNA and the management team established at an earlier stage of the company with members having rich experience in promoting the adoption of new technologies will help accelerate the clinical transformation of circRNA. We are honored to support Therorna in this financing round, and we will work with the company's team, and their new and existing investors, to help the company assume a leadership role in the realm of circRNA, providing patients with pioneering therapies and addressing unmet clinical needs." Exclusive financial advisor for this transaction and CEC Capital Managing Director, Echo Zhang commented, "circRNA has attracted widespread attention as an emerging technology for RNA drugs. Therorna is expected to take the lead in advancing the technology into clinical applications. We are honored to help Therorna complete this round of financing, and we believe that Therorna will lead the development of the global circRNA sector." About MSA Capital Founded in 2014, MSA Capital is an independent global private equity and venture capital firm with over $2.0 billion under management. The firm manages capital from the world's top sovereign wealth funds, international asset managers, pension funds, university endowments, fund of funds and family offices, as well as China's leading new economy entrepreneurs. MSA actively partners with outstanding entrepreneurs in China and other technology markets to build leading, innovative companies that aim to deliver strong financial returns and meaningful, positive impact. The firm is headquartered in Beijing, with resident teams in Shanghai, Hong Kong, Singapore, Middle East, North Africa and the United States. About Sherpa Healthcare Partners Sherpa Healthcare Partners ("Sherpa") was founded in 2018, the founders previously worked together in one of China's leading venture capital firms, built and led its professional medical investment team since 2011, set up the dedicated healthcare investment fund and responsible for healthcare investment. The founders have been teamed together in close co-operation, built on shared values, mutual trust, and complementary capabilities. Sherpa has now become an influential healthcare VC firm in the industry. Sherpa has invested in leading companies in many key areas, such as Pharma, GeneTech, MedTech and Medical services. From 2011 to 2020, the team has gone through 4 vintage year cycles of multiple U.S dollar funds and RMB funds and made 100 investments. Sherpa has the honor to work with many outstanding entrepreneurs and grow together with them. About 3H Health Investment 3H Health Investment is a Hong Kong and Shanghai based healthcare venture capital firm. It focuses on unmet medical needs and invests in emerging fields of science and medicine to deliver breakthroughs to patients. Leveraging its extensive resources with clinical institutions, industry partners and policy institutes, 3H builds leading innovative healthcare companies together with its partners. About Quan Capital Quan capital is a life sciences venture capital firm with strong China expertise and global capabilities. We discover, incubate, and grow next-generation life science companies in early and growth stage, worldwide. Our portfolio companies pioneer differentiated therapies and enabling technologies to address major human diseases with high unmet medical needs. Quan has offices in Shanghai, Menlo Park and Boston. Our investment professionals combine their strong expertise in both science and business with their diverse experiences in global drug development and healthcare investments, and they leverage their broad network worldwide to help maximize the company's value across geographies and development stages. Visit www.quancapital.com to learn more about us. About Cenova Capital Cenova Capital is one of the earliest healthcare funds dedicated to early and growth-stage investments in the life sciences and healthcare sectors in China. Since inception in 2010, Cenova Capital now has six funds under management with investments in over 80 companies in pharmaceuticals, medical devices,healthcare services and digital heath. Cenova Capital's investors are mainly large domestic and international institutional investors including Asian sovereign wealth investors, government institutions, insurance companies, financial institutions and multinational companies. About CEC Capital CEC Capital is a leading Chinese FA with a focus on the global TMT, consumption and health sectors. In addition to investment banking, CEC Capital is managing a RMB fund and a dollar fund with offices in Beijing, Shanghai, Los Angeles and San Francisco, and it also has a license to the US securities market. The healthcare industry is an advantageous industry that CEC Capital is concerned about. Meanwhile, CEC Capital has the largest and most professional health investment banking team in China with the most complete industry chain.

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BUSINESS INSIGHTS

SCA Pharma Names Louis Pace as Chief Financial Officer and Chief Information Officer

SCA Pharma | July 15, 2022

SCA Pharma, a nationally recognized leader in the 503B compounding pharmaceuticals outsourcing industry providing quality, service, and value to hospitals nationwide, has announced today the addition of Louis Pace as Chief Financial Officer and Chief Information Officer. Pace brings over 30 years of experience serving several successful private equity backed businesses in functional and P&L leadership roles. Most recently, Mr. Pace served as Chief Financial Officer at Orchid Orthopedic Solutions where he successfully led strategy deployment efforts that focused on growth and profitability improvement. "I am extremely excited to welcome Louis to the team and to partner with him as we continue to accelerate growth at SCA Pharma. SCA Pharma is committed to providing innovative solutions for our 503B customers that help health systems manage their drug supply chain and pharmacy operations more efficiently. That evolution requires a more strategic and diversified approach, which suits Louis' background. Louis will manage our finance and accounting teams as well as our information technology strategy. He will concentrate on prioritizing internal and external business opportunities." Scott Luce, CEO of SCA Pharma "I am looking forward to working with the exceptional team at SCA Pharma. I am excited to build on SCA Pharma's current success and be a part of the company's future growth," said Louis Pace. Mr. Pace holds an AB in Economics from Harvard University and an MBA from Northwestern Kellogg Graduate School of Management. About SCA Pharma SCA Pharma is a nationally recognized leader in the FDA 503B outsourcing industry, specializing in providing the highest quality sterile admixture services and pre-filled syringes to hospital and health-care facility pharmacies. The company serves all therapeutic areas of pharmacy — including critical care, labor and delivery, anesthesia, and pain management — and maintains a wide portfolio of products, including ready-to-use and drug-shortage medications.

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Spotlight

The Legatum Institute, a London-based research institute released its 10th annual global Prosperity Index in November, a huge survey that ranks the most prosperous countries in the world. The organization compares 104 variables to come up with its list, splitting those variables into nine subindexes. One of the big components of the ranking is how healthy a country's people are.

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