Telstar promotes aseptic technology developments for pharma production

European Pharmaceutical Review | November 04, 2019

The Telstar portfolio also includes integrated turnkey engineering & construction services for process facilities, manufacturing plants, critical installations and laboratories, as well as GMP consultancy for regulatory compliance and IT solutions for regulated processes & logistics management. Designed to respond to Industry 4.0 challenges in the life science industry, Telstar will endorse their latest innovative smart developments in the process analytical technology field for pharmaceutical freeze-drying systems and aseptic manufacturing processes, together with integrated process equipment and laboratory integrated management systems. A selection of these technologically advanced systems is detailed below. In the freeze-drying process field, Lyogistics Zero is the only automatic vial loading & unloading system for freeze-drying processes that can be cleaned (CIP) and sterilised (SIP) in place, inside the freeze-dryer chamber. Lyonuc is the nucleation induction method developed by Telstar, suitable for any type of freeze dryer that reduces the duration of the primary drying cycle and ensures the uniformity and homogenisation of the vials in all the batches, respecting the product’s morphology and physiochemical properties. Lyomega SV is a new single-vessel GMP production freeze dryer, optimised to maintain conventional work space while making the footprint up to 20 percent smaller than a lyophiliser with standard external condenser configuration. Lyogistics Smart R3 is the new automated inline vial management device able to reject, reintroduce and retrieve vials during the loading/unloading process into pharmaceutical freeze dryers.

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Harbour BioMed Announces IND Approval for Next-Gen Anti-TSLP Fully Human Monoclonal Antibody

Harbour BioMed | February 22, 2022

Harbour BioMed announced that China National Medical Products Administration had approved its investigational new drug (IND) application for HBM9378 a next-gen fully human antibody targeting thymic stromal lymphopoietin for the treatment of moderate-to-severe asthma. HBM9378/SKB378 is a co-development project conducted by HBM and Kelun-Biotech, who together equally share the global rights in respect of HBM9378. The IND approval of HBM9378 is an achievement of the strategic collaboration between the parties. According to the strategic collaboration and license agreement between HBM and Kelun-Biotech, the parties will jointly explore innovative therapies of monoclonal antibodies and antibody-drug conjugate. Building on HBM's innovative business model leveraging its productive R&D platform to lead the next generation of valuable and innovative therapies and its mission to address the unmet medical needs, HBM will continue to expand its collaboration with industry leading partners and further leverage on the combined capabilities of HBM and its collaborators. "HBM9378/SKB378, a next-gen fully human monoclonal antibody, is developed from HBM's H2L2 platform. Its long half-life optimization and outstanding biophysical properties support the favorable dosing advantage. The approval of this IND application once again proves HBM's powerful innovation capability. Unleashing the power of our unique R&D engine, we are highly confident and determined to defeat intractable diseases across the world." Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed About HBM9378/SKB378 HBM9378/SKB378 is a fully human monoclonal antibody against TSLP generated from two heavy chains and two light chains (H2L2) platform. It inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP plays important roles in DC cell maturation, T helper 2 (Th2) cell polarization and inflammation, particularly in both eosinophilic and non-eosinophilic inflammation asthma. About Asthma Asthma is a heterogeneous disease defined by the history of respiratory symptoms that vary over time and in intensity, together with variable expiratory airflow limitation. The disease is estimated to affect more than 300 million people worldwide and affect more than 45.7 million adult people (≥20 years) in China. Approximately 5-10% of those afflicted with asthma have severe disease that is poorly controlled. Despite the use of medium to high dose inhaled corticosteroids (ICS) in combination with a long-acting β2-agonist (LABA), currently available biologic therapies and oral corticosteroids (OCS), many severe asthma remain uncontrolled. Current biologics are mainly targeting Type 2 severe asthma which manifests clinically with a combination of peripheral eosinophilia, sputum eosinophilia and/or elevated fractional exhaled nitric oxide (FENO). Severe asthma patients experience frequent exacerbations, significant limitations on lung function and a reduced quality of life. The healthcare burden associated with care for these patients is also high. Therefore, there are still significant unmet needs to develop safer and broader therapies for severe asthma. About Harbour BioMed Harbour BioMed is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.

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ClinChoice Raises $150 mm Series E Round Financing, Further Strengthening its Global Services Capabilities

ClinChoice | July 05, 2022

Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly Asia Ventures and Apricot Capital. Proceeds of the financing will be used to fund the Company's continued business expansion and innovative service offering worldwide. Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly Asia Ventures and Apricot Capital. Proceeds of the financing will be used to fund the Company's continued business expansion and innovative service offering worldwide. As a full service clinical-stage CRO, ClinChoice serves the global market by providing integrated one-stop clinical development services to emerging biopharmaceutical, medical device and consumer health clients around the world. ClinChoice has over 3000 employees worldwide covering most of drug development hotbeds in US, China, multiple countries in Europe and Southeast Asia. With over 25 years of high-quality services, ClinChoice has completed more than 1,000 Phase I-IV full-service clinical projects and supported over 100 innovative drug registrations, clinical design and development. ClinChoice strictly adheres to GCP and ICH standards and has developed robust SOPs recognized by more than 50 large multinational companies, all of which have passed multiple inspections and audits by major regulatory agencies around the world. "We thank the investors for their trust in ClinChoice. This round of capital investment fully validates ClinChoice's rapid growth and future potential in the field of clinical CRO. With the new round of financing, we will further enhance our innovative service offering and continue business expansion by organic growth and M&A, in order to better serve our clients worldwide." Global Chairman and CEO of ClinChoice, Mr. Ling ZHEN Dr. Hongbin ZHOU, Co-Chief Investment Officer of Legend Capital, said, "We would like to express our gratitude for trusting in Legend Capital and we are excited to be part of ClinChoice, together with the Management Team and the existing shareholders, including Lilly Asia Ventures, Goldman Sachs. We are very positive on the growth outlook of the CRO industry. As a rapidly growing CRO, ClinChoice has built an excellent platform combining global expertise with deep knowhow across key local markets, to support innovation. Going forward, we will work closely with the management team to improve its existing business, attract industry talent and launch new strategic initiatives." About ClinChoice ClinChoice is a global clinical CRO, providing high-quality Integrated One-stop Service Offerings for new bio-pharmaceutical and medical device clients worldwide. Our Service Offerings cover Clinical Operation, Project Management, Biostatistics, Data Management, Biostatistical Programming, Regulatory Affairs, Medical Affairs, Feasibility Research, HGRAC Submission, Clinical Safety Management, Site Management Organization, Nature Medicine/Traditional Chinese Medicine and Phase I Clinical Research, etc. Now, ClinChoice has over 3,000 employees worldwide covering most of drug development hotbeds in US, China, multiple countries in Europe and Southeast Asia. Since its inception, ClinChoice has completed multiple rounds of financing, with investments from renowned institutional investors including Goldman Sachs, Lilly Asia Ventures, and DFJ Dragon Fund. About Legend Capital In April 2001, Legend Capital was established as a fund manager under Legend Holdings, focusing on the early-stage VC and growth-stage PE investment. Since its establishment, Legend Capital has been adhereing to internationally accepted standards to create best practices in fund management and operation. With a proven track record of more than 20 years, it now has full experience in fund management and operation and has built an extensive partner ecosystem across the entire investment chain.

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Can-Fite Granted Key NASH Patent in Israel

Can-Fite BioPharma Ltd. | May 17, 2022

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced that its patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" has been granted by the Israel Patent Office. This patent has been issued in approximately 40 countries and territories including Japan, South Korea, Hong Kong, Mexico, and in the European Union. It addresses the use of the A3 Adenosine Receptor ligand, the target receptor for Can-Fite's drug platform technology, for the treatment of ectopic fat accumulation particularly in fatty liver as manifested in non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. The treatment of NASH is a market estimated to reach $35 billion by 2025. Can-Fite is currently enrolling and treating patients in a Phase IIb NASH study of its liver drug candidate Namodenoson. The multi-center, randomized, double blind, and placebo controlled study of biopsy-confirmed NASH patients will measure efficacy periodically through biomarkers, with a primary efficacy endpoint determined by liver biopsy at the end of the treatment period. In a prior Phase IIa study, Namodenoson met endpoints including reduced liver fat content, anti-inflammatory effects, and decreased body weight with excellent safety. “The treatment of NASH is an enormous unmet need that Can-Fite seeks to meet through our advanced stage clinical trial and our expanding patent estate for the use of our target A3AR in the treatment of fatty liver disease,” Can-Fite CEO Dr. Pnina Fishman About Namodenoson Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor. Namodenoson is being evaluated in a pivotal Phase III trial as a second line treatment for hepatocellular carcinoma, and in a Phase IIb trial as a treatment for non-alcoholic steatohepatitis. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson has completed enrollment in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.

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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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What is atrial fibrillation? Atrial fibrillation is an atrial arrhythmia where the upper chambers don't contract normally, causing higher heart rates in the lower chambers. Study better with Osmosis Prime. Retain more of what you’re learning, gain a deeper understanding of key concepts, and feel more prepared for your courses and exams.

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