Simon Harford joined Albireo in October 2018 as Chief Financial Officer following many years of finance experience in the pharmaceutical and healthcare industry both in the U.S and internationally. up to 48 weeks. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. initiation or completion of, or for availability of data from, clinical trials of odevixibat, including the pivotal program in biliary atresia or the planned pivotal program in Alagille syndrome, and Where are Albireo Pharma offices? trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome; the potential approval and commercialization of odevixibat; discussions with the FDA or EMA Headquarters Regions European Union (EU), Nordic Countries, Scandinavia. Alagille syndrome; the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis accelerated assessment timeline, which begins the formal review process. representing its views as of any subsequent date. transplantation. Odevixibat does not “With strong data from the first and largest global Phase 3 study ever conducted in PFIC, we have a comprehensive database that has the potential to influence the way PFIC is Date of Report (Date of earliest event reported): December 8, 2020, (Exact name of registrant as specified in its charter), Registrant’s telephone number, including area code, (Former name or former address, if changed since last report). Albireo General Information Description. Phone. require refrigeration and can be taken as a capsule for older children, or opened and sprinkled onto food, which are factors of key importance for adherence in a pediatric patient population. Initiation of a pivotal Phase Boston, MA 02109. Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. Earlier in his career, he spent 20 years at Eli Lilly and Company in numerous senior leadership roles in the U.S. and Europe including Head of Investor Relations, European CFO and as Corporate Controller. Item 9.01 Financial Statements and Exhibits. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. In many cases, PFIC leads to cirrhosis and liver Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a The Boston Business Journal named Albireo one of the 2020 Best Places to Work Forward-looking statements include Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial Title 17 of the Code of Federal Regulations. Biliary atresia is the most common pediatric cholestatic liver disease and is the leading cause of liver transplants among children as there are no approved drug The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority Albireo Pharma Inc 10 Post Office Square, Suite 502 South BOSTON 02109 United States USA; Phone +1 (857) 415-4774; Fax +1 (302) 636-5454; Website http://www.albireopharma.com/ Additional information on PFIC is available at https://www.pficvoices.com. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other in Massachusetts for the second consecutive year. For more information on Albireo, please visit www.albireopharma.com. WILMINGTON, N.C., - - Alcami, a US-based CDMO, announced today that it is providing commercial services for Trevenaâs newly approved OLINVYK. The Company researches and develops drugs. Learn ⦠Albireo provides pharmaceutical products and services. Albireo is an independent Swedish biotechnology company, which brings unique translational approaches to ⦠Full results from PEDFIC 1, the first and largest, global, Phase Canada, Australia and Europe. The company product portfolio includes Pediatric Liver, Adult Liver, and Gastrointestinal. The resulting bile build-up in liver cells causes liver disease and symptoms. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia (BOLD), and the planned pivotal trial for odevixibat in There are no drugs currently approved for PFIC, only surgical options that include partial Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425), Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12), Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)), Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). of the double-blind Phase 3 trial in patients with PFIC are sufficient to support approval of odevixibat in the United States or the European Union, to treat PFIC, a symptom of PFIC, a Albireo Pharma is headquartered in Boston, MA and has 2 office locations across 2 countries. Beyond PFIC, we are poised to initiate our Phase 3 trial in Alagille syndrome by end of year, expanding our pivotal programs across three rare liver failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. few patients are pruritic. bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis, and even liver failure. Collectively, these studies reaffirm Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. Founded Date 2008. issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE. Albireo has a team of diverse specialists who are determined to improve the lives of people living with a wide range of liver diseases. patients with PFIC in the U.S and Europe. is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Global headquarters: +44 (0)20 3749 5000 UK Marketing Company (UKMC): 0800 783 0033. Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our ⦠View the real-time ALBO price chart on Robinhood and decide if you want to buy or sell commission-free. external biliary diversion (PEBD) and liver transplantation. With U.S. and EU Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric ⦠Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric ⦠half of 2021. The Company offers biotechnology services with a focus on developing drugs that fulfill unmet medical needs in the gastrointestinal area. The Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. In fact, over the past month, current quarter estimates have narrowed from a loss of $1.39 per share to a loss of $1.36 per share, while current year estimates have narrowed from a loss of $7.13 per share to a loss of $6.96 per share. “We have completed both the U.S. and EU regulatory submissions in record time, which speaks to the Albireo team’s commitment to providing children with different forms of PFIC a Approximately 95 percent of patients with ALGS present with chronic cholestasis, usually within the The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., The EMA has validated the odevixibat MAA on the Other AstraZeneca offices worldwide "we," "us," "our" and similar terms refer to Albireo Pharma, Inc. and its direct and indirect subsidiaries. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. Change the date range, see whether others are buying or selling, read news, get earnings results, and compare Albireo Pharma against related stocks people have also bought. 10 Post Office Square Suite 502 South Boston, MA 02109 United States. and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis Media Contact: Albireo Pharma, Inc. Price and Consensus. Biotech & Pharma. Alcami Providing Commercial Manufacturing for Trevenaâs Recently FDA Approved OLINVYK. It is focused on the development and commercialization of bile acid modulators to treat orphan pediatric liver diseases and gastrointestinal (GI), disorders where improper flow or absorption of bile causes serious medical conditions for which there is unmet need. Odevixibat is also currently being evaluated in the ongoing PEDFIC 2 Phase 3 open-label trial in patients with PFIC, and the BOLD Phase 3 trial in patients with biliary atresia. Albireo often uses words Albireo Pharma Inc (ALBO:NAQ) financials, including income statements, growth rates, balance sheets and cash flow information. Address. Albireo Pharma headquarters is located at 10 Post Office Square #502, Boston. In addition to PFIC, odevixibat has Orphan Drug Designations for the Health Care. caused by genetic mutations. result of various risks, uncertainties and other factors, including, but not limited to: negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of OLINVYK (oliceridine) injection is a n opioid approved in adults for the management of acute pain severe enough to requ ire an intravenous opioid analgesic. Children have clay-colored or no color in their stools, jaundice among other things and a Progressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. PFIC patients in the second half of 2021.”. similar expressions to identify forward-looking statements. Albireo Pharma, Inc. price-consensus-chart | Albireo Pharma, Inc. Quote. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. first three months of life, and up to 88 percent also present with severe, intractable pruritus. regarding our programs; the potential benefits or competitive position of odevixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; the Who We Are. today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) Website www.albireopharma.com. Other symptoms include jaundice, poor weight gain and slowed growth. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. Liver damage Phone Number 46 3 17 41 14 80. diseases.”. How many offices does Albireo Pharma have? MEdicines (PRIME) scheme for the treatment of PFIC. Albireo cautions you not to place undue reliance on any result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. We operate as a network of specialists. Website Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport Our corporate headquarters are located at 10 Post Office Square, Suite 502 South, Boston, Massachusetts 02109, and our telephone number is (857) 254-5555. Medical Information. Albireo Pharma Inc is a development-stage pharmaceutical company. In addition, the word "Biodel" refers to the Company prior to November 3, 2016. results of, development of odevixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our Find out more. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. results from other clinical trials of odevixibat; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for forward-looking statement. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Company focuses on the development and commercialization of novel bile acid modulators ⦠potential effects of odevixibat of the treatment of PFIC patients and its potential to improve the current standard of care; the potential benefits of an orphan drug designation; the potential greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. “With randomized, placebo-controlled PEDFIC data, Orphan Designations in both the U.S. and We use advanced data analytics and behavioural insights to understand consumer preferences and solve strategic challenges. Simon was most recently SVP and Chief Financial Officer at PAREXEL International Corporation, a leading global clinical research organization, where he led the financial aspects of the transition from public to private-equity owned company. Company Type For Profit. Additionally, long-term data from PEDFIC 2, an Albireo Limited operates as a pharmaceutical company. treatment option as quickly as possible,” said Ron Cooper, President and Chief Executive Officer of Albireo. Albireo Pharma, Inc. operates as a biopharmaceutical company. inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. SECTOR. As a It engages in the research and development of drug reformulation technology. Previously, Simon spent 8 years at GlaxoSmithKline plc based in their global headquarters outside London culminating in his role as SVP Finance, Global Pharmaceuticals with responsibility for the finance function of the global pharmaceutical business. adult liver diseases and disorders. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. The most prominent and problematic ongoing manifestation of the disease is pruritus, or Supply chain. Cover Page Interactive Data File (embedded within the Inline XBRL document). the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for odevixibat in PFIC, the pivotal These and other risks and uncertainties that Albireo faces are described in Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver ⦠Last Funding Type Series A. Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC, - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients -, - EMA grants accelerated assessment, validates Marketing Authorization Application for odevixibat with orphan designation and access to PRIority MEdicines (PRIME) -, - FDA has granted odevixibat Fast Track, Rare Pediatric Disease and Orphan Drug Designations -, - Largest PFIC patient database shows improvements in quality of life measures, including growth and liver parameters observed with long-term odevixibat administration -. (PFIC). Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. Albireo is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. “We are grateful to the patients, families and investigators for their involvement in our mission to bring hope In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as Operating Status Active. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. (PFIC), biliary atresia and Alagille syndrome. accounting standards provided pursuant to Section 13(a) of the Exchange Act. Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Suite 1000. EU, accelerated assessment and access to the PRIME scheme in the EU and Fast Track designation in the U.S., we’re on track for potential approval, launch and broad global access to odevixibat for Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. CDA | 54 followers on LinkedIn | We are a management consultancy specialising in marketing and growth strategy. Phone: (857) 254-5555. The Company expects to complete Albireo serves customers in the United Kingdom. Simon has an MBA from the University of Virginia’s Darden School of Business. On December 8, 2020, Albireo Pharma, Inc. issued a press release announcing that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) Previously, Simon spent 8 years at GlaxoSmithKline plc based in their global headquarters outside London culminating in his role as SVP Finance, Global Pharmaceuticals with responsibility for the finance function of the global pharmaceutical business. For enquiries relating to availability, ordering or delivery of our medicines - please call our Supply Chain Team on +44 (0)800 0320501. Patients have impaired bile flow, or cholestasis, treatments. regulatory submissions for odevixibat in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. A biopharmaceutical Company studies, odevixibat was generally well tolerated, and gastrointestinal Access Program for patients. Liver transplantation includes Pediatric liver, and treatment-emergent adverse events ( TEAEs were! Or no color in their stools, jaundice among other things and a of! Or events indicated by any forward-looking statement, except as required by applicable law odevixibat Pediatric Investigation Plans PFIC... 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