Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. It is not known if Accrufer is safe and effective for use in children. Do not take Accrufer if you are allergic to ferric maltol or any of the ingredients in Accrufer; have any illness that causes you to store too much iron in your body or if you have a problem with how your body uses iron; are receiving repeated blood transfusions. We have rolled forward our model and updated for spot FX rates. Shield Therapeutics inks exclusive licence for 'Accrufer' in Korea | Aim Bulletin News The fund-raise and open offer in March has extended the cash runway to forecast break-even in FY23. During FY20 SG&A expenses increased to £8.6m (FY19: £6.8m) and R&D expenses were mainly flat at £2.6m (FY19: £2.5m). We pride ourselves on providing solutions to unmet medical needs and delivering value to our shareholders. Feraccru®/Accrufer® has been approved by the regulators in both Europe and the US. Shield Therapeutics is a well-funded, high potential, commercial stage specialty-pharma company. Accrufer is available at a dedicated pharmacy that can ship your prescription directly to you, or you can go to any retail pharmacy. Additionally, data from the German healthcare setting (presented at the European Crohn’s and Colitis Organisation (ECCO) 2020 conference) concludes that total patient drug costs were 1.6x higher for treatment with IV iron compared with Feraccru. Shield Therapeutics plc. Our revised valuation is £505.7m or 234p/share versus £471.4m or 218p/share (derived from an rNPV model). Austin, Texas 78759 Found inside â Page 383Shield Therapeutics Ltd. Accrufer (Ferric Maltol) [prescribing information] . Revised July 2019. https:// www.accessdata.fda.gov/drugsatfda_docs/label/2019/ 212320Orig1s000lbl.pdf 33. Schrier SL . So you know how to treat. This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person. Shield Therapeutics plc ("Shield or the "Company" or the "Group") Jose A. Menoyo MD Appointed as Chief Medical Officer. You should receive a response within 2 business days. Shield Therapeutics PLC (LSE:STX, FRA:1JS) (LSE:STX) new CEO Greg Madison talks to Proactive London about his strategy for the company and focus on driving the iron deficiency product Accrufer … "With Accrufer now available in the US, and Feraccru available in Europe, I am excited about the long-term prospects for our product(s) and Shield," added Madison. Thu, 12th Aug 2021 12:25. Explore section. Shield Therapeutics Plc: LSE:STX: London: Ordinary Share: GB00BYV81293: ORD 1.5P Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade : 0.50 : 0.96%: 52.50: 52.00: 53.00: 53.80: 52.50: 52.50: 1,878,639: 15:39:01: Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m) Pharmaceuticals & Biotechnology: 0.7-9.1 … You can read more above this on our Privacy Policy page. The Accrufer Simple Savings Program provides support for your treatment journey, including prescription savings for commercially insured patients. ("Shield Therapeutics" or the "Company") PDMR Transaction Notification. Its initial focus is Feraccru®, a supplement for iron deficiency with or without anaemia. Carl Sterritt, Chief Executive Officer +44 (0)20 7186 8500. The US opportunity alone could be worth in excess of US$1bn, … Shield is a de-risked, specialty pharmaceutical company focused on commercialising its lead product, Feraccru (R) /Accrufer (R), a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia. Our Strategy and Values; People; Lead Products. The Gateshead Design Centre based company's main drug treats iron deficiency anaemia and is available in the UK and Europe where it is known as Ferracru, and in the US as Accrufer. Keep a list of them to show your doctor and pharmacist when you get a new medicine. There are both prescription drugs and over-the-counter iron supplements for treating ID and IDA. Sign up to receive the latest information about Accrufer, For more information on iron deficiency and Accrufer, download the patient brochure. Following completion of a capital increase in March 2021 to raise the necessary funds, momentum … Edison Investment Research Limited, 280 High Holborn, London, WC1V 7EE UK. (Sharecast News) - Commercial-stage pharmaceutical company Shield Therapeutics … Management expects this is sufficient to take it to the point at which it is cash flow positive, which it expects to reach on a monthly basis within 15–18 months after US launch. The US opportunity alone could be worth in excess of US$1bn, … We expect rapid margin expansion and forecast operating margins could reach 52% by 2024, given 90% gross margins and that the main operating costs for the business will likely relate to US SG&A. It will not be used for any other purpose unless you register for Shield Therapeutics separately. London, UK, 3 June 2020: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru ® /Accrufer ® (ferric maltol), notes the recent publication of two papers concerning Feraccru ® /Accrufer … Following the post period share placing (raising £27.8m net) STX reported an unaudited cash balance of £28.2m at 31 March 2021. In the near term management expects initial SG&A costs of $25–30m per year (2021/22), increasing to $40–45m in year three to fund US operations to the critical mass required. Shield is a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru®/Accrufer® (ferric maltol), a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia. View company profile. Importantly, STX market research demonstrates that US prescribers believe there is unmet need and Accrufer’s profile is viewed positively in terms of a clinically meaningful profile and improvement versus existing oral iron salts (good tolerability and efficacy). London, UK, 27 September 2021: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer(R)/ Feraccru(R) (ferric maltol), announces that Jose A. Menoyo, M.D., is joining Shield's Senior Executive Team as Vice President and Chief Medical Officer with immediate effect. Our Strategy and Values; People; Lead Products. Lead Products. We note that the withdrawal of Teva Pharmaceutical’s European patent challenge means Feraccru’s patent protection will continue to October 2035. Exhibit 1: Major work streams in US commercialisation process. Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. For the treatment of iron deficiency with or without anaemia in adults. Consequently, … Shield Therapeutics plc (LON:STX) is a commercial-stage pharmaceutical company delivering specialty products that address patients’ unmet medical needs, with an initial focus on treating iron deficiency (ID). In March 2021, STX raised net funds of £27.8m, which will be utilised to support the US launch and commercialisation of Accrufer (iron deficiency). Shield Therapeutics (Shield) is a commercial-stage pharmaceutical company delivering specialty products that address patients’ unmet medical needs, with an initial focus on treating iron deficiency (ID). Accrufer (ferric maltol) capsules is an FDA-approved treatment for adults with iron deficiency, Finally, an oral iron treatment that is both effective and tolerable. Our underlying assumptions for STX remain unchanged and reflect STX-led US commercialisation. Coverage and out-of-pocket costs may vary. Profitability in FY23 is achievable on the basis of our current forecast revenue streams ex-US (royalties of £16.2m and milestones of £13.1m) plus a minimum US sales contribution of c $25m. Before you take Accrufer, tell your doctor about all your medical conditions, including if you have inflammatory bowel disease (IBD); are pregnant or plan to become pregnant (it is not known if Accrufer will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if Accrufer passes into your breast milk); talk to your doctor about the best way to feed your baby if you take Accrufer. Shield Therapeutics PLC (LSE:STX, FRA:1JS) new CEO Greg Madison talks to Proactive London about his strategy for the company and focus on driving the iron deficiency product Accrufer in … Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. Do not take Accrufer if you are allergic to ferric maltol or any of the ingredients in Accrufer; have any illness that causes you to store too much iron in your body or if you have a problem with how your body uses iron; are receiving repeated blood transfusions; are experiencing an active IBD flare. We also use analytical cookies to help us improve our website by collecting and reporting information on it's usage. Carl Sterritt, Chief Executive Officer +44 (0)20 7186 8500. Following completion of a capital increase in March 2021 to raise the necessary funds, momentum … This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). Your information will only be used to respond to your information request. The product was launched in the US on 1 July, so the only impact it had on the company’s results for the first six months of the year was as an expense as the company prepared for the launch. reported total revenue of £10.4m reflecting an $11.4m (£9.7m) upfront payment received from ASK Pharm (Feraccru out-licensing deal that covers China) and £0.7m from royalties on Feraccru sales from European partner Norgine. The Design Centre based pharmaceutical company’s main drug treats iron deficiency anaemia and is called Ferracru in the UK and Europe, where it has been available since 2016, and Accrufer in the US. I agree that Shield Therapeutics may use the information I provide to send me health related materials, as well as information on Shield Therapeutics products and services, including marketing programs. Cookie Policy. Royalties received from early sales of the product in the UK and Germany by partner Norgine are encouraging. We've put some small files called essential cookies on your device to help our site work on your browser. Shield Therapeutics, a commercial-stage pharmaceutical company with a focus on addressing iron deficiency, remains ‘on track' to launch Accrufer in the US by end of June 2021. Shield Therapeutics (STX) has placed c 83m shares at a deep discount (30.0p/share) to the market price, resulting in a gross raise of £25m. Through development and commercialisation of lead assets such as Feraccru®/Accrufer™ and PT20, Shield continues to build an integrated and ultimately profitable speciality pharmaceutical business. This Patient Information has been approved by the U.S. Food and Drug Adminstration. Quick facts: Shield Therapeutics PLC. In March 2021, STX raised net funds of £27.8m, which will be utilised to support the US launch and commercialisation of Accrufer (iron deficiency). This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Nominated Advisor and Joint Broker The study is expected to complete in 2022, leading to potential approval and launch in 2023. The pharmaceutical company, which focuses on addressing … Shield Therapeutics’ (STX) FY20 results reported total revenue of £10.4m reflecting an $11.4m (£9.7m) upfront payment received from ASK Pharm (Feraccru out-licensing deal that covers China) and £0.7m from royalties on Feraccru sales from European partner Norgine. Shield Therapeutics plc ('Shield' or the 'Group' or the 'Company') Feraccru®/Accrufer ® publications. Shield Therapeutics plc, announces that it has entered into an exclusive licence agreement for Accrufer® with KOREA PHARMA CO.,LTD (“Korea Pharma”) in the Republic of Korea (“South Korea” or “Korea”). This site is intended for U.S. residents only. ACCRUFER is a registered trademark of the Shield group of companies. Shield Therapeutics plc (LON:STX) is a commercial-stage company delivering specialty products that address patients’ unmet medical needs, with an initial focus on treating iron deficiency (ID). All other forecasts are unchanged. 815041270, Register to receive research on Shield Therapeutics as it is published. This book covers the pathophysiology and treatment of anemia in inflammatory bowel diseases and discusses controversial aspects specifically when it comes to iron therapy. STX expects to reach break-even on a monthly basis within 15–18 months after US launch. Copyright: Copyright 2021 Edison Investment Research Limited (Edison). The product was launched in the US on 1 July, so the only impact it had on the company’s results for the first six months of the year was as an expense as the company prepared for the launch. To receive information about Accrufer ® (ferric maltol), please complete the form below. North East pharmaceutical firm Shield Therapeutics has sealed a licence deal worth up to £6 million that will see its lead product launch in South Korea. Accrufer ® (ferric maltol) is indicated for the treatment of iron deficiency in adults. Its proprietary product, Feraccru, is approved by the EMA and FDA for the treatment of iron deficiency. Following completion of a capital increase in March 2021 to raise the necessary funds, momentum … Tim Watts, Chief Financial Officer. Edison Investment Research is authorised and regulated by the Financial Conduct Authority. The placing is to raise funds to market it's Accrufer iron deficiency treatment in the US. Shield Therapeutics plc. Carton Label - ACCRUFER ® (ferric maltol) capsules 30 … Feraccru®/Accrufer® has been approved by the regulators in both Europe and the US. Lead Products. The funds will be utilised to support the US launch and commercialisation of Accrufer (iron deficiency), and thus clarify the strategy in this territory for its key asset. Shield out-licences Accrufer in South Korea. Since the company's fundraise in March, Shield said preparatory work has accelerated dramatically with five key workstreams underway. About Shield Therapeutics | Specialty Pharmaceutical Company This book presents a road map of the interactions among metabolic, electrolyte, acid-base and endocrine problems and suggesting clear lines of action for the ICU clinician. This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. Cash and equivalents at beginning of period, Increase/(decrease) in cash and equivalents, Source: Shield company accounts, Edison Investment research. The focus for STX now is to establish and expand its US-based operations ahead of a Q221 launch; management will provide an update on progress in mid-May. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. Feraccru/Accrufer has been approved by the regulators in both Europe and the US. Accrufer is a prescription medicine used in adults to treat low iron stores in your body. I certify that I am at least 18 years of age, and want to receive information from Shield Therapeutics, and third parties working on behalf of Shield Therapeutics. concludes that total patient drug costs were 1.6x higher for treatment with IV iron compared with Feraccru. We also use analytical cookies to help up improve our website by collecting and reporting information on it's usage. Shield Therapeutics PLC confirmed it will launch its Accrufer product in the US on 1 July. www.shieldtherapeutics.com. Opinions contained in this report represent those of the research department of Edison at the time of publication. Additional terms and conditions apply. This resulted in an operating loss for the period of £2.2m (FY19: £9.0m). Accrufer is contraindicated in patients with a history of: Hypersensitivity to Accrufer or any of its inactive components. Shield Therapeutics’ present drive for US launch success of iron deficiency product Accrufer; Quick facts: Shield Therapeutics PLC Follow. Shield Therapeutics plc (LON:STX) is a commercial-stage pharmaceutical company delivering specialty products that address patients’ unmet medical needs, with an initial focus on treating iron deficiency (ID). Accrufer is different because it protects iron within the maltol (sugar) complex, preventing it from breaking down in the stomach. Terms of Use. London, UK, June 24, 2021: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru (R)/Accrufer (R) (ferric maltol), confirms that, in line with prior guidance, it will launch Accrufer (R) in the US on July 1, 2021. excluding amortisation of acquired intangibles. Accrufer is a prescription medicine used in adults to treat low iron stores in your body. Tim Watts, Chief Financial Officer. Shield Therapeutics (LON: STX) shares have fallen on Friday after the company said it is to raise £25 million through a share placing and subscription. About Shield Therapeutics plc Shield is a de-risked, specialty pharmaceutical company focused on commercialising its lead product, Feraccru®/Accrufer®, a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia. It has also recently appointed Hans-Peter Rudolf as the group’s CFO. The investment or investment activity to which this document relates is available only to such persons. Shield Therapeutics is a commercial-stage speciality pharmaceutical company based in the UK. Shield Therapeutics plc ("Shield" or the "Company" or the "Group") US launch of Accrufer® confirmed for July 1, 2021. The directors of Gateshead pharma firm Shield Therapeutics have hailed a pivotal six months in the business after launching its lead drug in the US. 11 Mar 2021. Shield Therapeutics (LON: STX) share price is rallying after it said it is on track for the US launch of Accrufer by the end of June. Shield Therapeutics PLC. BONUS: This edition includes an excerpt from James A. Michener's Hawaii. Company no. ASK Pharm has submitted the IND application to the. Our NPV calculation is based on Feraccru achieving peak sales of €130m in Europe, $256m in the United States and $126m in China, Major work streams in US commercialisation process, The commercialisation of Feraccru in Europe, Australia (, ) and New Zealand is in the hands of partner Norgine, and the product is now marketed by Norgine in Germany, the UK, Scandinavia (since Q420, previously AOP) and Belgium (since January 2021). Shield received $11.4m upfront. Looking ahead, Shield has agreed a Feraccru/Accrufer Paediatric Investigational Plan (PIP)/Pediatric Development Plan (PDP) with the EMA/FDA, which will culminate in a study to evaluate the safety, tolerability and efficacy of the product in infants, children and adolescents. Explore section . Shield Therapeutics is a well-funded, high potential, commercial stage specialty-pharma company. This report has been commissioned by Shield Therapeutics and prepared and issued by Edison, in consideration of a fee payable by Shield Therapeutics. The ASK Pharm deal covers China, Hong Kong, Macau and Taiwan, Shield received $11.4m upfront. The US commercialisation of Accrufer is key to unlocking value and FDA approval (2019) led to the broadest possible label to encompass iron deficiency of any cause. Its primary focus is the commercialisation of Feraccru/Accrufer (oral ferric maltol), approved by the EMA and FDA for the treatment of iron deficiency in adults, with or without anaemia. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest. STX reported FY20 revenues of £10.4m (FY19: £0.7m), which included the £9.7m ($11.4m) upfront licence payment from ASK Pharm and £0.7m in royalty revenue from Norgine relating to Feraccru sales in Europe. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research. STX expects to reach break-even on a monthly basis within 15–18 months after US launch. Shield Therapeutics plc Licence agreement secured in Republic of Korea for Accrufer® Exclusive licence agreement... | October 20, 2021 Fees are paid upfront in cash without recourse. Accrufer® has just been launched in the US by Shield, where the initial aim is to greatly improve market awareness of its differentiating characteristics as an oral ID drug. We've put some small files called essential cookies on your device to help our site work on your browser. To activate your savings card or download a new card click below to enroll and save on your next prescription. Shield Therapeutics pleased with progress to date on US launch of Accrufer; Shield Therapeutics’ present drive for US launch success of iron deficiency product Accrufer ; Quick facts: Shield Therapeutics PLC Follow. STX is preparing to launch prescription iron replacement treatment Accrufer in the US, a market estimated to be worth US$1.2bn pa, the largest global market for iron replacement treatment. STX is eligible to receive a further $11.4m milestone upon regulatory approval in China, plus royalties of 10% or 15% on net sales (depending on the level), and up to $40m in cumulative sales-related milestones. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. Iron helps your body make hemoglobin, a protein in your blood that carries oxygen from your lungs throughout your body, Iron deficiency (ID) is a condition of too little iron in the body. ASK Pharm is responsible for all clinical and regulatory costs and activities in addition to all manufacturing and distribution costs of goods sold in the territory. ©2021 Shield Therapeutics Inc. All rights reserved. The product was launched in the US on 1 July, so the only impact it had on the company’s results for the first six months of the year was as an expense as the company prepared for the launch. Additionally, data from the, presented at the European Crohn’s and Colitis Organisation (ECCO) 2020 conference. ) What Shield does. Feraccru®/Accrufer® has been approved by the regulators in both Europe and the US. Shield Therapeutics PLC (LON:STX) Chief Executive Tim Watts joins Proactive London's Katie Pilbeam to discuss their financial and operational update. Shield Therapeutics PLC (LSE:STX) said in its half-year results that the focus in the second half will be on the roll-out of its iron deficiency product Accrufer in the US. About Shield Therapeutics plc. Shield Therapeutics (STX) is a commercial-stage pharmaceutical company delivering specialty products that address patients’ unmet medical needs in renal and gastrointestinal disorders. Carl Sterritt, CEO of Shield Therapeutics said: “We have been pleased with the levels of interest and engagement shown by third parties in commercialising Accrufer in … View company profile. ASK Pharm has submitted the IND application to the Chinese regulatory authority (CDE), the agency has indicated it is likely to require a short Phase III study in inflammatory bowel disease patients before approval. An unexpected reanalysis of the AEGIS-H2H data confirmed Feraccru as a credible alternative to IV therapy over the long term and will be used to negotiate pricing and reimbursement in the key markets of France, Italy and Spain. AHFS® DI® contains the most trustworthy drug information available--all in one place. It is the most comprehensive evidence-based source of drug information complete with therapeutic guidelines and off-label uses. Our Strategy and Values; People ; Lead Products. Timely launch (and subsequent market access coverage) is critical, as the product could offer an improved value proposition to patients and payors versus existing oral treatments or the alternative, an IV treatment in the hospital setting. Specialty UK pharma company Shield Therapeutics has entered into an exclusive licence agreement for Accrufer/Feraccru…. Accrufer may cause serious side effects including: The most common side effects of Accrufer include gas, diarrhea, constipation, discolored stools, stomach pain, stomach area discomfort or bloating, and nausea or vomiting. Since the fundraise in mid-March 2021, preparatory work has accelerated dramatically. ("Shield" or the "Company" or the "Group") Half-year Report. It is not known if Accrufer is safe and effective for use in children. US Patents 7459569, 9248148, 9802973, 10179120. Take one 30-mg capsule of Accrufer twice a day on an empty stomach. Adding reported net cash at 31 March 2021 of £28.2m and using a discount rate of 10% for Europe, where the product is launched, and 12.5% for the United States and China, we reach our risk-adjusted NPV of 234p/share. Shield Therapeutics may also use my information for market research, or to evaluate and improve the company’s programs and services. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Hardman & Co Research: Accrufer launch on schedule. In a clinical trial, Accrufer was found to be non-inferior in treatment effect to an IV iron therapy.4 Accrufer launch date and pricing are pending. Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.
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