R&D SMEs at risk due to tax credit scheme change

pharmatimes | May 14, 2019

The BioIndustry Association (BIA) has announced that changes to small and medium enterprises (SME) research and development (R&D) tax credit schemes could harm a thriving sector. This is because the Government is proposing to introduce a cap on the value of cash payments loss-making SMEs can receive through the R&D tax credits scheme, which are a valuable source of finance for young companies trying to get from one venture capital fundraise to the next. Despite Government claims that it is exploring options to reduce the impact on ‘genuine companies’, a public consultation was launched in March and will close on 24 May, detailing that cash claims would be capped at three-times the PAYE and National Insurance Contributions (NIC) liabilities of a company.

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Daewoong Pharmaceutical and HanAll Biopharma Invest in Turn Biotechnologies to Expand Growth Initiative

Daewoong Pharmaceutical and HanAll Biopharma | April 12, 2022

Daewoong Pharmaceutical and HanAll Biopharma announced expansion of their open collaboration strategy by investing in Turn Biotechnologies, a Silicon Valley based company focused on developing novel mRNA medicines. The companies are supporting Turn Bio's continued development of a high-potential platform and are considering future long-term collaborations. Turn Bio is a pre-clinical-stage biopharmaceutical company focused on cellular repair via epigenetic reprogramming of cells. The technological foundation for Turn Bio's proprietary Epigenetic Reprogramming of Age (ERA™) methodology was developed by Turn Bio's co-founders in the Sebastiano Lab, Institute for Stem Cell Biology and Regenerative Medicine, Stanford School of Medicine. The technology has since been patented and Turn Bio is currently using it to complete pre-clinical research on therapies targeting indications in dermatology and immunology, as well as developing therapies for ophthalmology, osteoarthritis and the muscular system. "Many age-related diseases have long been significant areas of patients' unmet need. Turn Bio's innovative platform may bring a pivotal transformation to a wide array of therapeutic areas. HanAll is committing support and investment to help realize the full potential of this pioneering technology as Turn Bio advances to a new phase of growth." Dr. Almira Chabi, chief medical officer and chief development officer at HanAll Pharmaceutical International "The support of Daewoong Pharmaceutical and HanAll Biopharma validates our approach to cellular rejuvenation and enables Turn to expand its efforts in multiple therapeutic indications," said Anja Krammer, the company's CEO. "We are thrilled that a company as well known for its innovation, has taken interest in our promise to transform the way medicine treats diseases of aging and we look forward to further collaborations to help change quality of life and healthcare economics globally." The proceeds from this round of financing will support Turn Bio's advancement towards a phase 1 trial of its mRNA therapy candidate TRN-001, which targets indications in dermatology. About HanAll Biopharma Co., Ltd. HanAll Biopharma is a global biopharmaceutical company founded in 1973, with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas ranging from endocrine, circulatory, and urologic diseases for more than 48 years. HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. A leading pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase 3 and Phase 2 trials across the world for the treatment of rare autoimmune disorders including myasthenia gravis, thyroid eye disease, warm autoimmune hymolytic anemia, neuromyelitis optica, and immune thrombocytopenia. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha protein drug, is in Phase 3 clinical trials in the US and China for the treatment of dry eye disease. About Daewoong Pharmaceutical. Co., Ltd. Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With a strong and innovative in-house R&D and advanced manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Continuing on its course of building a strong global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Daewoong has also expanded strategic partnerships in more than 100 countries worldwide. About Turn Biotechnologies Turn Bio is a pre-clinical-stage company focused on repairing tissue at the cellular level. The company's proprietary mRNA platform technology, ERA™, restores optimal gene expression by combatting the effects of aging in the epigenome. This restores the cells' ability to prevent or treat disease, and heal or regenerate tissue and will help to fight incurable chronic diseases.

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BUSINESS INSIGHTS

Labcorp Completes Acquisition of Personal Genome Diagnostics

Labcorp | February 21, 2022

Labcorp a leading global life sciences company, announced that it has closed its acquisition of Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products. The addition of PGDx and its technology complements and accelerates Labcorp’s existing liquid biopsy capabilities and expands Labcorp’s leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities, positioning Labcorp at the forefront of driving better patient outcomes in oncology. About Labcorp Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $16.1 billion in FY2021.

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VIEWS AND ANALYSIS

CHMP Recommends Approval of Dupixent® (dupilumab) for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation

Regeneron Pharmaceuticals, Inc | January 31, 2022

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending to extend the approval of Dupixent® (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. The CHMP positive opinion is supported by Phase 3 data recently published in the New England Journal of Medicine showing that Dupixent added to standard of care significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks, in children with uncontrolled moderate-to-severe asthma. The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma. Adverse events more commonly observed with Dupixent compared to placebo included injection site reactions, viral upper respiratory tract infections and eosinophilia. Helminth infections were also more commonly observed with Dupixent compared to placebo in patients aged 6 to 11 years. Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids (ICS) and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. Severe asthma may impact children's developing airways and cause potentially life-threatening exacerbations. Children with severe asthma also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled severe asthma can interfere with day-to-day activities like sleeping, attending school and playing sports. On October 20, 2021, Dupixent was approved by the FDA as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. The use of Dupixent in children aged 6 to 11 years with uncontrolled severe asthma is investigational in the EU and is not yet approved. About Dupixent Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). About Regeneron Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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BUSINESS INSIGHTS

Elligo Health Research® Partners With Peoples Rx

Elligo Health Research | April 21, 2022

Elligo Health Research, the largest healthcare-enabling research organization, announced they are expanding partnerships to include Peoples Rx, an Austin, Texas-based pharmacy chain. “We’re in a unique position at Peoples Rx to help inform more people about how they can participate in clinical research opportunities. Working with Elligo to offer research as healthcare to our customers helps support our mission to empower people to make educated health decisions.” Stephen Erickson, Peoples Rx president One of the first studies Peoples Rx will be working to share with Elligo is a study for people to advance screening diagnostics for cancer. “Our patients may not hear about clinical research opportunities otherwise, and this empowers patients with knowledge to become more proactive in their own healthcare journey while simultaneously supporting the advancement of health sciences,” Erickson said. Elligo began its mission to provide easy access to clinical research as care to more patients nearly six years ago. Specifically, Elligo is focused on accelerating clinical trials through healthcare by maintaining the integrity of the trusted patient and physician relationship, building local healthcare communities, and leveraging electronic health records. “Accomplishing this mission is made possible by the partnerships we have with real-world healthcare,” said Elligo CEO John Potthoff, Ph.D. “Peoples Rx has a positive impact on our local community and is a trusted partner for healthcare. This is also Elligo’s first partnership with a pharmacy, and it is our hope that this will lead to further opportunities to collaborate with more providers in the healthcare spectrum on similar initiatives and continue contributing to the changing clinical research landscape.” About Elligo Health Research® Elligo Health Research accelerates clinical trials through healthcare with access to known patients and their HIPAA-compliant healthcare data, our IntElligo® Research Stack technology, and our hybrid enrollment model, PatientSelect. Coupled with the largest Known Patient Access Network, Elligo’s Site Solutions enable healthcare practices and research sites to participate in clinical trials. By adaptive engagement of known patients and physicians, we accelerate the development of new pharmaceutical, biotechnology, and medical device and diagnostic products. About Peoples Rx Peoples Rx has been the local favorite pharmacy and wellness headquarters in Austin for over 40 years. Our integrative approach to health and wellness starts with our knowledgeable and experienced pharmacists and wellness specialists, and our cutting-edge, holistic, and professional products. We also compound custom medications in our state-of-the-art lab to meet customers’ specific needs. And because food is medicine too, our own in-house delis serve up scratch-made meals and snacks with the highest quality ingredients. With a mission to empower people to make educated health choices, several of our 170+ employees, including clinical nutritionists, herbalists, naturopaths, and homeopaths also offer their expertise through private consultations and educational events.

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