BUSINESS INSIGHTS

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

Ellipses Pharma
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. 

Spotlight

The pharmaceutical sector is at a crossroads. In a heavily disrupted marketplace, characterized by shifting payer attitudes and patient empowerment, neither incremental adjustments nor steady evolution are likely to halt the decline of the traditional pharmaceutical business model. This paper looks ahead to a 2030 scenario to examine the trends revolutionizing the sector; trends that we expect to have dramatic impacts.


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BUSINESS INSIGHTS

KemPharm Announces Strategic Acquisition of Arimoclomol from Orphazyme, Expanding its Rare CNS Diseases Pipeline

KemPharm | May 16, 2022

Arimoclomol is an NDA-stage, revenue-generating investigational drug candidate being developed for the treatment of Niemann-Pick disease type C a rare progressive neurodegenerative disease KemPharm plans to refile the New Drug Application (NDA) for arimoclomol in NPC with the U.S. Food and Drug Administration as early as the First Quarter of 2023 CELEBRATION, Fla., May 15, 2022 KemPharm, Inc. a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, announced a definitive agreement with Orphazyme A/S to acquire arimoclomol, an orally-delivered, first-in-class heat shock protein (HSP) amplifier being developed as a treatment for Niemann-Pick disease type C (NPC). NPC is a rare progressive neurodegenerative disease that impacts children, adolescents, and adults, and is characterized by an inability of the body to transport cholesterol and lipids inside of cells, which leads to the abnormal accumulation of these substances within various tissues of the body, including the brain. Arimoclomol is currently being made available to NPC patients in the U.S., France and Germany under Orphazyme’s Early Access Programs (EAP). Under the terms of the agreement, KemPharm will purchase substantially all of the assets and operations of Orphazyme, including arimoclomol, for a cash payment of USD $12.8 million. The Company expects to finance the cash payment with a revolving line of credit secured by KemPharm’s balance sheet. KemPharm intends to retain the majority of Orphazyme’s current employees. In addition, KemPharm has agreed to assume an estimated reserve liability equal to approximately USD $5.2 million, which is an estimated future rebate due to the French regulatory authorities based on the revenue generated from the EAP in France. For the year ending December 31, 2022, the EAP is expected to generate at least USD $12 million in revenue based upon enrollment in France as of March 2022. The EAP is expected to remain in place until arimoclomol becomes commercially available in each of the current EAP markets. The transaction is expected to close on or before June 1, 2022, subject to customary closing conditions and approval by Orphazyme’s creditors and the Danish bankruptcy court. Canaccord Genuity LLC acted as a strategic advisor to KemPharm for the transaction. “This strategic acquisition of arimoclomol is a transformative event that significantly expands our rare CNS disease development pipeline, bringing to KemPharm an NDA-stage, revenue-generating product upon which we intend to build commercial capabilities that allow KemPharm to create and retain value for the benefit of shareholders. Moreover, the financial structure of the acquisition combined with the revenue currently being generated by arimoclomol from the early access program in France affords us the opportunity to acquire the asset in a capital efficient manner that has the potential to create positive cash flow, while incurring no shareholder dilution.” Richard Pascoe, Executive Chairman of KemPharm Arimoclomol is administered orally and has been studied in ten Phase 1, four Phase 2, and three pivotal Phase 2/3 trials. Arimoclomol has received Orphan Drug Designation (ODD) for NPC in the United States and the European Union. Arimoclomol has received Fast-Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Rare Pediatric Disease Designation (RPDD) from the FDA for NPC. If approved in the U.S., arimoclomol would also be eligible to receive a Pediatric Priority Review Voucher. On June 17, 2021, Orphazyme received a Complete Response Letter (CRL) from the FDA regarding its NDA for arimoclomol for the treatment of NPC. Orphazyme also withdrew its European Marketing Authorisation Application (MAA) for arimoclomol for the treatment of NPC ahead of a final vote and opinion by the Committee for Medicinal Products for Human Use. “The acquisition of arimoclomol aligns perfectly with our strategy to build KemPharm’s value via the advancement and commercialization of novel treatments that address rare CNS conditions, including our lead clinical candidate, KP1077 in idiopathic hypersomnia,” stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We have carefully evaluated the CRL issued by the FDA and the minutes from the subsequent Type A meeting, as well as the data that has been generated from the development work performed to date. We believe the efficacy signal for arimoclomol in NPC is convincing and that there is a viable regulatory path that could enable a successful NDA resubmission. KemPharm has significant experience with challenging regulatory situations, having successfully led or participated in three FDA product approvals, two of which followed an initial CRL. We welcome the opportunity to work with the FDA on the resubmission of the NDA for arimoclomol in NPC, which we expect to file as early as the first quarter of 2023.” NPC is a rare progressive lysosomal storage disorder characterized by an inability of the body to transport cholesterol and lipids inside of cells. This leads to dysfunction in organs such as the brain, spleen and liver. NPC can range from a fatal disorder within the first few months after birth (neonatal period) to a late onset, chronic progressive disorder that remains undiagnosed well into adulthood. Disease progression is irreversible in all patients, and loss of neuro-cognitive function adversely impacts their daily life. The mean age of death is 13 years (Bianconi, 2019), and there are no approved treatments for NPC in the United States. “NPC is an ultra-rare, inherited neurodegenerative disease that affects people of all ages from infancy to adulthood, and leads to progressive impairment of mobility, cognition, speech, and swallowing, culminating in premature death,” said Marc Patterson, MD, Professor of Neurology, Pediatrics and Medical Genetics at Mayo Clinic. “Therapies to treat NPC are desperately needed, and there is hope that a treatment such as arimoclomol could provide a solution to patients around the world who are living daily with the disease. It is encouraging that there is an opportunity to continue the regulatory process for arimoclomol with the FDA.” About KemPharm KemPharm is a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system diseases through its proprietary LAT® platform technology. KemPharm utilizes its proprietary LAT® platform technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of idiopathic hypersomnia (IH) and other CNS/rare diseases. In addition, the U.S. Food and Drug Administration (FDA) has approved AZSTARYS®, a new once-daily treatment for ADHD in patients age six years and older containing KemPharm’s prodrug, serdexmethylphenidate (SDX), which is being commercialized by Corium, Inc. in the U.S., and APADAZ®, an immediate-release combination product containing benzhydrocodone, KemPharm’s prodrug of hydrocodone, and acetaminophen, which is being commercialized by KVK-Tech, Inc. in the U.S.

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invoX Pharma to Acquire F-star Therapeutics, Inc. a Pioneering Next Generation Bispecific Discovery Platform and Clinical Programs

F-star Therapeutics, Inc. | June 24, 2022

invoX Pharma a wholly owned subsidiary of Sino Biopharmaceutical Limited focused on research and development and business development activities outside of China, and F-star Therapeutics, Inc. a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, today announced that the companies have entered into a definitive agreement whereby invoX will acquire all of the issued and outstanding shares of F-star common stock for $7.12 per share. The proposed acquisition values F-star at approximately $161 million. The transaction has been unanimously approved by the invoX and F-star Boards of Directors and is expected to close in the second half of 2022. F-star’s proprietary platform technology pioneers the use of tetravalent (2+2) bispecific antibodies that enable the simultaneous targeting of two different antigens and a unique set of pharmacology to deliver focused, potent and safe immune activation in the tumor microenvironment. Four programs are progressing in clinic, three based on F-star’s tetravalent platform and one next generation STING agonist, with multiple further undisclosed programs in development. These programs represent potentially first- and best-in-class drug candidates for many areas of unmet medical need, including patients with cancer and other serious diseases who have few other options available. Leveraging its modular antibody technology, F-star has forged collaborations with major international biopharma companies across a wide range of therapeutic areas including oncology, immunology and neurology. invoX, established in 2021 in the United Kingdom, is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. F-star will form a key element of invoX’s strategy to accelerate Sino Biopharm’s development of innovative medicines to transform the lives of patients worldwide, complementing its existing R&D platforms and pipeline. “Today’s proposed acquisition is aligned with invoX’s strategy to become a fully integrated biopharmaceutical company with an advancing pipeline of innovative products addressing unmet healthcare needs, worldwide. We are excited to welcome F-star employees and look forward to working with them as we invest in the company to progress and grow its clinical pipeline to realize the full potential of the platform.” Ben Toogood, Chief Executive Officer of invoX Eliot Forster, Chief Executive Officer of F-star said: “We believe our tetravalent bispecifics offer the best approach to tackle hard-to-treat cancers and other serious diseases, with the ambition to deliver longer and improved lives for patients. Today’s announcement is good news for F-star, for our shareholders and, of course, for patients. This transaction enables greater and longer-term opportunities to develop the F-star platform and accelerate delivery of our novel medicines as we work together towards a future free from cancer and other serious diseases. I’d like to thank the fantastic team at F-star as well as our partners for all their hard work, support and dedication and I’m delighted to share this exciting development.” About invoX Pharma invoX Pharma was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a global top 40 pharmaceutical company with more than 24,000 employees. United Kingdom-based invoX is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. At its core, the Company aspires to improve patients’ lives by creating access to innovative medicine. About Sino Biopharm Sino Biopharm, together with its subsidiaries, is a leading, innovative research and development driven pharmaceutical conglomerate in China, with a business scope that is vertically integrated including research and development, manufacturing and sales and marketing infrastructure. The Company’s product offerings include a variety of biologics and small molecule drugs, and in therapy areas that include hepatology, oncology, cardiovascular and cerebrovascular diseases, orthopaedics, digestive and immune and respiratory diseases. About F-star Therapeutics, Inc. F-star Therapeutics, Inc. is a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives. F-star is committed to working towards a future free from cancer and other serious diseases, through the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in treatments. The Company has four second-generation immuno-oncology therapeutics in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive intellectual property estate. F-star has over 500 granted patents and pending patent applications relating to its platform technology and product pipeline. The Company has attracted multiple partnerships with biopharma targeting significant unmet needs across several disease areas, including oncology, immunology, and CNS.

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Global Pharmaceutical Market Drives Innovative Digitalization to Accelerate Drug Discovery

Frost & Sullivan | June 17, 2022

Frost & Sullivan's recent analysis, Global Pharmaceuticals Outlook, finds that the accelerated drug development timelines are driving digitalization and innovation across the pharmaceutical value chain. Data, the decentralization of clinical trials, supply-chain resilience, digital therapeutics, and manufacturing automation are the key areas driving digitalization. The industry also ensures that healthcare will remain precise, preventive, and outcome-based in promoting social and financial inclusion. The global pharmaceuticals market, including small molecules and biologics, is expected to register 3.8% growth, garnering $1.48 trillion by the end of 2022 from $1.43 trillion in 2021 under the aspirational scenario. "The partnerships and horizontal integration of technology companies with life science companies have laid the foundation for rapid and cost-effective drug discovery and development. Further, all major genomics technology companies are channeling their resources to digitalize genomic data for better selection of patients for clinical trials and to reduce the turnaround time for clinical studies." Surbhi Gupta, Healthcare & Life Sciences Senior Industry Analyst Gupta added: "Owing to the growing use of machine learning and artificial intelligence in personalized medicine, the pharmaceuticals industry will move from a symptom-driven treatment approach to a genetics-based approach. Additionally, precision medicine can offer in-depth information about cellular and molecular alterations, accelerating the development of targeted therapies." Digitalization and innovation in the pharmaceuticals industry will unlock new growth opportunities, including: Digital therapeutics companies must excel in areas where many pharmaceutical companies are lacking, including data analytics, interoperability, user-centric design, and flexible business models. Innovative formulation and delivery technologies that improve RNA stability at ambient temperatures will facilitate the rapid global adoption of RNA-based treatments at reduced costs. Contract development and manufacturing companies should partner with global companies to meet the required experience in clinical drug manufacturing and expand market reach in Asia-Pacific. Global Pharmaceuticals Outlook, 2022 is the latest addition to Frost & Sullivan's Healthcare & Life Sciences research and analyses available through the Frost & Sullivan Leadership Council, which helps organizations identify a continuous flow of growth opportunities to succeed in an unpredictable future. About Frost & Sullivan For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion

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BD Completes Acquisition of Parata Systems

BD | July 19, 2022

BD announced it has completed the acquisition of Parata Systems. Parata advances BD's transformative solutions strategy by providing a portfolio of innovative pharmacy automation solutions that power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience for retail, hospital and long-term care pharmacies. As a combined company, BD is positioned to offer a comprehensive set of technologies to the $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years. "Completing this acquisition represents an important step towards advancing our 2025 growth strategy around smart, connected care and enabling new care settings. I'd like to officially welcome the Parata team to BD as we join together to uniquely provide a more comprehensive set of smart, connected care technologies to support our customers as they expand care to new settings and centralize their pharmacy operations." Tom Polen, chairman, chief executive officer and president of BD The acquisition builds on BD's legacy and experience of seamlessly integrating teams to drive future growth and innovation. The Parata portfolio will become part of the solutions offered by BD's Medication Management Solutions business within the BD Medical segment. Together, the combined BD and Parata team will help pharmacy leaders address critical trends, such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacy staff. About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

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Spotlight

The pharmaceutical sector is at a crossroads. In a heavily disrupted marketplace, characterized by shifting payer attitudes and patient empowerment, neither incremental adjustments nor steady evolution are likely to halt the decline of the traditional pharmaceutical business model. This paper looks ahead to a 2030 scenario to examine the trends revolutionizing the sector; trends that we expect to have dramatic impacts.

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