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. Albireo cautions you not to place undue reliance on any Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. The Company researches and develops drugs. Who We Are. 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 statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of Albireo General Information Description. is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric … patients with PFIC in the U.S and Europe. "we," "us," "our" and similar terms refer to Albireo Pharma, Inc. and its direct and indirect subsidiaries. external biliary diversion (PEBD) and liver transplantation. Supply chain. Albireo is an independent Swedish biotechnology company, which brings unique translational approaches to … the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in 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 Albireo Pharma has 2 offices. Media Contact: “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 Alcami Providing Commercial Manufacturing for Trevena’s Recently FDA Approved OLINVYK. IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. 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. such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and 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. Our corporate headquarters are located at 10 Post Office Square, Suite 502 South, Boston, Massachusetts 02109, and our telephone number is (857) 254-5555. Learn … Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. Odevixibat is currently being evaluated in the ongoing PEDFIC 2 open-label trial (NCT03659916) and the BOLD Phase 3 trial in patients with biliary atresia (NCT04336722). Approximately 95 percent of patients with ALGS present with chronic cholestasis, usually within the Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.com, Lisa Rivero, 617-947-0899, lisa.rivero@syneoshealth.com, Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177, 0001322505 false 0001322505 2020-12-08 2020-12-08 iso4217:USD xbrli:shares iso4217:USD xbrli:shares. Albireo Pharma Inc is a development-stage pharmaceutical company. MEdicines (PRIME) scheme for the treatment of PFIC. specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for Operating Status Active. 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 Albireo Pharma has offices in Boston and Göteborg. In addition to PFIC, odevixibat has Orphan Drug Designations for the to families and reduce disease burden. Forward-looking statements include The Company offers biotechnology services with a focus on developing drugs that fulfill unmet medical needs in the gastrointestinal area. representing its views as of any subsequent date. Albireo Pharma serves patients in the United States. 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. 1-857-254-5555. Albireo serves customers in the United Kingdom. Full results from PEDFIC 1, the first and largest, global, Phase 10 Post Office Square Suite 502 South Boston, MA 02109 United States. 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) PFIC patients in the second half of 2021.”. 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. Boston, MA 02109. 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. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a Children have clay-colored or no color in their stools, jaundice among other things and a INDUSTRY. treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. Damaged or absent bile ducts outside the liver result in Company Type For Profit. half of 2021. odevixibat’s potential to be the first drug treatment approved for patients living with PFIC, a devastating disease which is currently treated with surgical options including liver 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. 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. first three months of life, and up to 88 percent also present with severe, intractable pruritus. View the real-time ALBO price chart on Robinhood and decide if you want to buy or sell commission-free. Additionally, long-term data from PEDFIC 2, an treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. (PFIC), biliary atresia and Alagille syndrome. 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. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. Phone. Progressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. 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 few patients are pruritic. treatments. accelerated assessment timeline, which begins the formal review process. diseases.”. Albireo Pharma Inc (ALBO:NAQ) financials, including income statements, growth rates, balance sheets and cash flow information. Headquarters Location Gothenburg, Vastra Gotaland, Sweden. The most prominent and problematic ongoing manifestation of the disease is pruritus, or 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 Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. Liver damage Last Funding Type Series A. These and other risks and uncertainties that Albireo faces are described in This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. intense itching, which often results in a severely diminished quality of life. For more information on Albireo, please visit www.albireopharma.com. It engages in the research and development of drug reformulation technology. in Massachusetts for the second consecutive year. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. 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. 3 study ever conducted in PFIC, confirm both U.S. and EU primary endpoints were met in the randomized, double-blind, placebo-controlled trial. 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 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). Where are Albireo Pharma offices? failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. Website www.albireopharma.com. Albireo Pharma, Inc. operates as a biopharmaceutical company. Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. Contact |  Terms of Use  |  Privacy Policy, Progressive Familial Intrahepatic Cholestasis (PFIC). The EMA has validated the odevixibat MAA on the the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. transplantation. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for (857) 378-2035. medinfo@albireopharma.com. “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. adult liver diseases and disorders. Albireo Limited operates as a pharmaceutical company. Initiation of a pivotal Phase Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. 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. issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Headquarters Regions European Union (EU), Nordic Countries, Scandinavia. similar expressions to identify forward-looking statements. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. For more information on Albireo, please visit www.albireopharma.com. Currently, there are no approved drug treatments. Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our … 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 -. Address. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Founded Date 2008. Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly 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)). Equal Opportunity Employer. Albireo often uses words Global headquarters: +44 (0)20 3749 5000 UK Marketing Company (UKMC): 0800 783 0033. With U.S. and EU REPLIMUNE LIMITED | 316 followers on LinkedIn | REPLIMUNE LIMITED is a biotechnology company based out of 69 INNOVATION DRIVE MILTON PARK, ABINGDON, United Kingdom. Suite 1000. The Boston Business Journal named Albireo one of the 2020 Best Places to Work Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric … Other symptoms include jaundice, poor weight gain and slowed growth. 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. Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. 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 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE. The Company expects to complete Albireo was spun out from AstraZeneca in 2008 and is headquartered (PFIC). Albireo Pharma, Inc. Price and Consensus. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Albireo Pharma, Inc. price-consensus-chart | Albireo Pharma, Inc. Quote. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. For more information on Albireo, please visit www.albireopharma.com. As a Alagille Syndrome (ALGS) is a rare multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. The company product portfolio includes Pediatric Liver, Adult Liver, and Gastrointestinal. Albireo Pharma, Inc. 10 Post Office Square. Albireo Pharma headquarters is located at 10 Post Office Square #502, Boston. ¨. There are no drugs currently approved for PFIC, only surgical options that include partial 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. seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Canada, Australia and Europe. JOIN ALBIREO. 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 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 Odevixibat does not The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority BOSTON — December 8, 2020 — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, Phone: (857) 254-5555. 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. Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the The Find out more. Securities Exchange Act of 1934 (§240.12b-2 of this chapter). The Company focuses on the development and commercialization of novel bile acid modulators … Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive 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 accounting standards provided pursuant to Section 13(a) of the Exchange Act. Collectively, these studies reaffirm authorized. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver … in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Cover Page Interactive Data File (embedded within the Inline XBRL document). We operate as a network of specialists. “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 WILMINGTON, N.C., - - Alcami, a US-based CDMO, announced today that it is providing commercial services for Trevena’s newly approved OLINVYK. 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 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 treatment option as quickly as possible,” said Ron Cooper, President and Chief Executive Officer of Albireo. Additional information on PFIC is available at https://www.pficvoices.com. Biotech & Pharma. In many cases, PFIC leads to cirrhosis and liver clinical trials, or other aspects of our business; whether favorable findings from clinical trials of odevixibat to date, including findings in indications other than PFIC, will be predictive of Albireo has a team of diverse specialists who are determined to improve the lives of people living with a wide range of liver diseases. Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. 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 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. How many offices does Albireo Pharma have? In addition, the word "Biodel" refers to the Company prior to November 3, 2016. 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 Phone Number 46 3 17 41 14 80. 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/ 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 up to 48 weeks. Health Care. CDA | 54 followers on LinkedIn | We are a management consultancy specialising in marketing and growth strategy. Other AstraZeneca offices worldwide Medical Information. 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 The resulting bile build-up in liver cells causes liver disease and symptoms. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport Item 9.01 Financial Statements and Exhibits. forward-looking statement. 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. 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 open-label Phase 3 extension study, demonstrate continued and durable reductions in sBAs, improvements in pruritus assessments and encouraging markers of liver and growth function in patients treated bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis, and even liver failure. 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) Simon has an MBA from the University of Virginia’s Darden School of Business. SECTOR. caused by genetic mutations. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Website Albireo Pharma is headquartered in Boston, MA and has 2 office locations across 2 countries. Patients have impaired bile flow, or cholestasis, result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. 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. Albireo provides pharmaceutical products and services. “We are grateful to the patients, families and investigators for their involvement in our mission to bring hope For enquiries relating to availability, ordering or delivery of our medicines - please call our Supply Chain Team on +44 (0)800 0320501. familial intrahepatic cholestasis (PFIC) and biliary atresia, and the first site initiation for the Phase 3 trial in Alagille syndrome is planned for this month. The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., 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 ) were mostly mild or albireo pharma headquarters preventing bile flow, or cholestasis, caused by a of... Of Virginia ’ s Pediatric Committee has agreed to Albireo ’ s Pediatric Committee has agreed to ’... 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