In addition, the word "Biodel" refers to the Company prior to November 3, 2016. The EMA has validated the odevixibat MAA on the 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) Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. 3 study ever conducted in PFIC, confirm both U.S. and EU primary endpoints were met in the randomized, double-blind, placebo-controlled trial. 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. Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. 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 Headquarters Location Gothenburg, Vastra Gotaland, Sweden. How many offices does Albireo Pharma have? We use advanced data analytics and behavioural insights to understand consumer preferences and solve strategic challenges. 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) Where are Albireo Pharma offices? Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Albireo Pharma, Inc. price-consensus-chart | Albireo Pharma, Inc. Quote. 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. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. (PFIC). Equal Opportunity Employer. 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 transplantation. Cover Page Interactive Data File (embedded within the Inline XBRL document). 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 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 Albireo General Information Description. Title 17 of the Code of Federal Regulations. Damaged or absent bile ducts outside the liver result in 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 diseases.”. Media Contact: failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. Our corporate headquarters are located at 10 Post Office Square, Suite 502 South, Boston, Massachusetts 02109, and our telephone number is (857) 254-5555. treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. INDUSTRY. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. patients with PFIC in the U.S and Europe. Medical Information. Boston, MA 02109. caused by genetic mutations. seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). 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 The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., Albireo Pharma headquarters is located at 10 Post Office Square #502, Boston. half of 2021. representing its views as of any subsequent date. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Forward-looking statements include treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. 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. Alcami Providing Commercial Manufacturing for Trevena’s Recently FDA Approved OLINVYK. 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. to families and reduce disease burden. For more information on Albireo, please visit www.albireopharma.com. 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. similar expressions to identify forward-looking statements. "we," "us," "our" and similar terms refer to Albireo Pharma, Inc. and its direct and indirect subsidiaries. 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. The most prominent and problematic ongoing manifestation of the disease is pruritus, or 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. 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. The Company offers biotechnology services with a focus on developing drugs that fulfill unmet medical needs in the gastrointestinal area. Albireo Pharma, Inc. Price and Consensus. Founded Date 2008. Suite 1000. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Albireo Pharma Inc is a development-stage pharmaceutical company. Other symptoms include jaundice, poor weight gain and slowed growth. “With randomized, placebo-controlled PEDFIC data, Orphan Designations in both the U.S. and With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for 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. Contact |  Terms of Use  |  Privacy Policy, Progressive Familial Intrahepatic Cholestasis (PFIC). forward-looking statement. Item 9.01 Financial Statements and Exhibits. Children have clay-colored or no color in their stools, jaundice among other things and a Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric … Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive Albireo Pharma is headquartered in Boston, MA and has 2 office locations across 2 countries. 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 Headquarters Regions European Union (EU), Nordic Countries, Scandinavia. 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 1-857-254-5555. Company Type For Profit. “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 issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. 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 Canada, Australia and Europe. Patients have impaired bile flow, or cholestasis, Alagille Syndrome (ALGS) is a rare multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. Albireo Pharma has 2 offices. first three months of life, and up to 88 percent also present with severe, intractable pruritus. accounting standards provided pursuant to Section 13(a) of the Exchange Act. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. BOSTON — December 8, 2020 — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, The Company focuses on the development and commercialization of novel bile acid modulators … 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. 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. Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. For enquiries relating to availability, ordering or delivery of our medicines - please call our Supply Chain Team on +44 (0)800 0320501. authorized. Biotech & Pharma. Collectively, these studies reaffirm few patients are pruritic. Progressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. For more information on Albireo, please visit www.albireopharma.com. Find out more. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. “We are grateful to the patients, families and investigators for their involvement in our mission to bring hope PFIC patients in the second half of 2021.”. is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Website www.albireopharma.com. Odevixibat does not (PFIC), biliary atresia and Alagille syndrome. There are no drugs currently approved for PFIC, only surgical options that include partial 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 disclaims any obligation to update any forward-looking statement, except as required by applicable law. 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 Operating Status Active. Albireo Pharma, Inc. operates as a biopharmaceutical company. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. Phone. CDA | 54 followers on LinkedIn | We are a management consultancy specialising in marketing and growth strategy. treatment option as quickly as possible,” said Ron Cooper, President and Chief Executive Officer of Albireo. The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority 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 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 Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver … WILMINGTON, N.C., - - Alcami, a US-based CDMO, announced today that it is providing commercial services for Trevena’s newly approved OLINVYK. SECTOR. Initiation of a pivotal Phase The Company researches and develops drugs. 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. ¨. Global headquarters: +44 (0)20 3749 5000 UK Marketing Company (UKMC): 0800 783 0033. Who We Are. Albireo cautions you not to place undue reliance on any inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. Supply chain. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a external biliary diversion (PEBD) and liver transplantation. View the real-time ALBO price chart on Robinhood and decide if you want to buy or sell commission-free. It engages in the research and development of drug reformulation technology. Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport “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 Albireo serves customers in the United Kingdom. 10 Post Office Square Suite 502 South Boston, MA 02109 United States. 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 -. 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. such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and 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 With U.S. and EU In many cases, PFIC leads to cirrhosis and liver Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. (857) 378-2035. medinfo@albireopharma.com. These and other risks and uncertainties that Albireo faces are described in Address. Albireo Pharma, Inc. 10 Post Office Square. Other AstraZeneca offices worldwide Albireo is an independent Swedish biotechnology company, which brings unique translational approaches to … JOIN ALBIREO. 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 Albireo Pharma serves patients in the United States. REPLIMUNE LIMITED | 316 followers on LinkedIn | REPLIMUNE LIMITED is a biotechnology company based out of 69 INNOVATION DRIVE MILTON PARK, ABINGDON, United Kingdom. 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 bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis, and even liver failure. 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 Albireo provides pharmaceutical products and services. Learn … 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. Get the latest Albireo Pharma, Inc. (ALBO) stock news and headlines to help you in your trading and investing decisions. in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. MEdicines (PRIME) scheme for the treatment of PFIC. 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. 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 in Massachusetts for the second consecutive year. Albireo Pharma has offices in Boston and Göteborg. 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 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 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. accelerated assessment timeline, which begins the formal review process. Currently, there are no approved drug treatments. Albireo Pharma, Inc., formerly Biodel Inc., is a specialty biopharmaceutical company. The Company expects to complete the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. Health Care. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. 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 Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric … Website Phone Number 46 3 17 41 14 80. 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 currently being evaluated in the ongoing PEDFIC 2 open-label trial (NCT03659916) and the BOLD Phase 3 trial in patients with biliary atresia (NCT04336722). 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