Albireo neuer big player im Pharma-Milliardenmarkt
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This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding: the progress or scope of development of A4250, elobixibat or any other Albireo product candidate or program, including regarding a planned Phase 3 clinical trial of A4250 in patients with PFIC, the timing for initiation of such planned Phase 3 clinical trial of A4250 or the timing for meeting with the European Medicines Agency regarding the planned Phase 3 program for A4250 in patients with PFIC, the target indication(s) for development, the size, design, population, location, conduct, objective, duration or endpoints of any clinical trial or the timing for initiation or completion of or reporting of results from any clinical trial; EA Pharma's plans with regard to the development or commercialization of elobixibat; the competitive position of any Albireo product candidate or the commercial opportunity in any target indication; any milestone or other payments that EA Pharma may make to Albireo; the sufficiency of Albireo's cash resources; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to, risks and uncertainties relating to: the conduct and results of Albireo's ongoing clinical trial of A4250 in children with chronic cholestasis; whether such ongoing clinical trial of A4250 will be sufficient to support advancement of A4250 into a planned Phase 3 clinical trial in patients with PFIC in the United States and Europe; the outcomes of meetings with the FDA and EMA regarding Albireo's planned Phase 3 clinical trial in patients with PFIC; the outcome of the ongoing long-term safety clinical trial of elobixibat in Japan; the discretion that EA Pharma has in the development and potential commercialization of elobixibat in Japan; and the timing and success of acceptance and approval of the new drug application submitted by EA Pharma with the Japanese Pharmaceuticals and Medical Devices Agency for elobixibat for the treatment of chronic constipation in Japan. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.
ir.albireopharma.com/releasedetail.cfm?ReleaseID=1017279
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1st Annual H.C. Wainwright & Company NASH Investor Conference
Location: St. Regis New York in New York City (Versailles Room)
Presentation date / time: Monday, April 3, 2017, at 11:00 a.m. ET
Presenter: Paresh N. Soni, MD, PhD, Chief Medical Officer
16th Annual Needham Healthcare Conference
Location: Westin Grand Central Hotel in New York City
Presentation date / time: Tuesday, April 4, 2017, at 3:00 p.m. ET
Presenter: Ron Cooper, President and Chief Executive Officer
A live audio webcast of the Needham conference presentation will be accessible from the Investors page of Albireo's website, ir.albireopharma.com. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo's website for at least two weeks following the event.
About Albireo
Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo's clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.
Source: Albireo Pharma, Inc.
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
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BOSTON, April 05, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that clinical data from the ongoing Phase 2 study of its lead product candidate A4250 in children with cholestatic liver disease has been selected by the European Association for the Study of the Liver (EASL) for an oral presentation during the late breaker session at The International Liver Congress™ (ILC) 2017 being held April 19-23, 2017, at the RAI Amsterdam in Amsterdam.
Details of the presentation are as follows:
Title: The Ileal Bile Acid Transport inhibitor A4250 decreases pruritus and serum bile acids in cholestatic liver diseases - an ongoing multiple dose, open-label, multicentre study
Session: Late Breaker
Date / Time: Saturday, April 22, 4:45 p.m. - 5:00 p.m. CET
Location: Hall 5
Presenter: Dr. Ulrich Baumann, Professor of Pediatric Gastroenterology and Hepatology at Hannover Medical School, Germany
EASL's ILC, now in its 52nd year, is a multi-disciplinary scientific Congress which brings more than 10,000 clinicians and scientists together annually to discuss clinical innovation and research. For more information about the conference, visit https://ilc-congress.eu/.
About Albireo
Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo's clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit http://www.albireopharma.com.
Source: Albireo Pharma, Inc.
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
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Albireo to Host KOL Meeting on Rare Pediatric Liver Diseases on April 12
BOSTON, April 10, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that it will host a Key Opinion Leader breakfast meeting focused on rare pediatric liver diseases at the Lotte New York Palace in New York City on Wednesday, April 12, 2017, from 8:00 a.m. to 9:30 a.m. ET.
The meeting will feature a presentation by Philip Rosenthal, MD, an internationally renowned pediatric liver disease specialist. Dr. Rosenthal will discuss the current treatment landscape and unmet medical need in the treatment of children with progressive familial intrahepatic cholestasis (PFIC) and be available to answer questions following the breakfast.
Additionally, Albireo executives will provide an overview of the clinical program for A4250, an ileal bile acid transporter (IBAT) inhibitor in development to treat patients with PFIC and potentially other rare pediatric cholestatic liver diseases.
Dr. Rosenthal is the Director of Pediatric Hepatology, Medical Director of Pediatric Liver Transplant Program and a Professor of Pediatrics and Surgery at the University of California, San Francisco (UCSF). He is board certified in Pediatrics and Pediatric Gastroenterology and has a certificate of added qualification in Transplant Hepatology. Dr. Rosenthal completed his medical training at Downstate Medical Center and the Albert Einstein College of Medicine in New York and a fellowship in pediatric gastroenterology at UCSF. He joined the UCSF faculty in 1995 after serving as Professor of Pediatrics at the University of California, Los Angeles. Dr. Rosenthal's current research includes several NIH-funded studies (CHiLDReN, NASH CRN, HBV CRN, PALFSG, iWITH) and several industry-sponsored hepatitis B and C research trials.
To confirm your attendance at the KOL breakfast meeting, email or contact LifeSci Advisors, LLC at Mac@LifeSciAdvisors.com. Please RSVP in advance if you plan to attend, as space is limited.
A live and archived webcast of the event, with slides, will be available at http://lifesci.rampard.com/20170412/reg.jsp and on the Investors section of Albireo's website at http://ir.albireopharma.com. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. The archived version of the webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo's website for at least two weeks following the event.
About Albireo
Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo's clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit http://www.albireopharma.com.
Source: Albireo Pharma, Inc.
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
link:
http://ir.albireopharma.com/releasedetail.cfm?ReleaseID=1020682
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link:
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BOSTON, April 10, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that it will host a Key Opinion Leader breakfast meeting focused on rare pediatric liver diseases at the Lotte New York Palace in New York City on Wednesday, April 12, 2017, from 8:00 a.m. to 9:30 a.m. ET.
The meeting will feature a presentation by Philip Rosenthal, MD, an internationally renowned pediatric liver disease specialist. Dr. Rosenthal will discuss the current treatment landscape and unmet medical need in the treatment of children with progressive familial intrahepatic cholestasis (PFIC) and be available to answer questions following the breakfast.
Additionally, Albireo executives will provide an overview of the clinical program for A4250, an ileal bile acid transporter (IBAT) inhibitor in development to treat patients with PFIC and potentially other rare pediatric cholestatic liver diseases.
Dr. Rosenthal is the Director of Pediatric Hepatology, Medical Director of Pediatric Liver Transplant Program and a Professor of Pediatrics and Surgery at the University of California, San Francisco (UCSF). He is board certified in Pediatrics and Pediatric Gastroenterology and has a certificate of added qualification in Transplant Hepatology. Dr. Rosenthal completed his medical training at Downstate Medical Center and the Albert Einstein College of Medicine in New York and a fellowship in pediatric gastroenterology at UCSF. He joined the UCSF faculty in 1995 after serving as Professor of Pediatrics at the University of California, Los Angeles. Dr. Rosenthal’s current research includes several NIH-funded studies (CHiLDReN, NASH CRN, HBV CRN, PALFSG, iWITH) and several industry-sponsored hepatitis B and C research trials.
To confirm your attendance at the KOL breakfast meeting, email or contact LifeSci Advisors, LLC at Mac@LifeSciAdvisors.com. Please RSVP in advance if you plan to attend, as space is limited.
A live and archived webcast of the event, with slides, will be available at http://lifesci.rampard.com/20170412/reg.jsp and on the Investors section of Albireo’s website at http://ir.albireopharma.com. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. The archived version of the webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo's website for at least two weeks following the event.
About Albireo
Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo’s clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit http://www.albireopharma.com.
Source: Albireo Pharma, Inc.
Quelle:
http://finance.yahoo.com/news/...host-kol-meeting-rare-120000587.html
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Die deutschen Boersen sind heute geschlossen (kein Handel).
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Apr 21, 2017
Form Def 14A / Definitive Proxy Statement, link:
http://ir.albireopharma.com/...lingid=1564590-17-6827&CIK=1322505
Form Defa14a / Definitive Additional Proxy Materials, link:
http://ir.albireopharma.com/...lingid=1564590-17-6829&CIK=1322505
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Data supports advancement of A4250 into a planned Phase 3 trial in patients with progressive familial intrahepatic cholestasis
Pruritus improvement and reduction in serum bile acid levels in most patients in Phase 2 clinical trial in children with cholestatic liver disease
BOSTON, April 22, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced that the embargo on its late-breaker abstract discussing preliminary data from a Phase 2 clinical trial of its lead product candidate A4250 in children with cholestatic liver disease has been lifted and the data will be presented today at The International Liver Congress™ 2017 in Amsterdam. The data demonstrated improvement in pruritus and reduction in serum bile acids (sBA) in most patients, particularly patients with progressive familial intrahepatic cholestasis (PFIC), after four weeks of treatment with A4250.
"This study represents the first time we have studied A4250 in children and we are very pleased with the data, especially the responses seen in patients with the rare, life-threatening liver disease PFIC," said Ron Cooper, President and Chief Executive Officer of Albireo. "We are currently engaging with regulatory authorities in the United States and Europe with the objective to design a coordinated Phase 3 program in patients with PFIC, which we expect to initiate in the second half of 2017."
A4250 is a highly potent and selective inhibitor of the ileal bile acid transporter (IBAT) that has minimal systemic exposure. The open label, multicenter, dose finding Phase 2 trial assessed the safety and tolerability of A4250 and explored changes in sBA levels and pruritus. Nineteen patients aged one to 17 years old with a pediatric cholestatic liver disease, including PFIC (subtype 1, 2 or 3), Alagille syndrome, biliary atresia or intrahepatic cholestasis, were enrolled in the trial's first five cohorts. Five different doses of A4250 were evaluated, ranging from 10 µg/kg to 200 µg/kg.
A4250 reduced mean levels of sBA in all five dose groups, with substantial sBA reductions observed in seven of nine PFIC patients (ranging from 43 percent to 98 percent). In addition, 14 of 19 patients showed improvement in pruritus using a visual analogue scale (VAS-Itch 0-10). The dose with the greatest improvement showed a mean decrease of 2.86 points from baseline. The trial was not powered for formal statistical analyses.
"The findings in this study illustrate the potential for A4250 to improve the treatment of children with PFIC or other rare cholestatic liver diseases," said Ulrich Baumann, MD, an investigator in the A4250 Phase 2 clinical trial and professor at Hannover Medical School in Germany. "There is no drug proven to be effective in treating these devastating diseases, and surgery, with its associated limitations and drawbacks, is often the only viable alternative. A safe and effective new treatment option for these patients is greatly needed."
The data showed a significant correlation between reduction in sBA and improvement of pruritus. In addition, no treatment-related serious adverse events were observed, and A4250 was well tolerated.
Subsequent to the submission date for ILC, the trial's remaining patients completed the study.
About A4250
A4250 is a first-in-class product candidate in development for progressive familial intrahepatic cholestasis (PFIC) and potentially other orphan pediatric cholestatic liver diseases. A4250 is a highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), has minimal systemic exposure and acts locally in the gut. Albireo anticipates initiating a Phase 3 clinical trial of A4250 in patients with PFIC in the second half of 2017.
A4250 has been granted orphan drug designation for PFIC in the United States and the European Union and has been granted access to the PRIority MEdicines (PRIME) program of the European Medicines Agency (EMA) for the treatment of PFIC.
About Albireo
Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo's clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding: the progress or scope of development of A4250, including regarding a planned Phase 3 clinical trial of A4250 in patients with PFIC; the timing for initiation of such planned Phase 3 clinical trial of A4250; the competitive position of A4250 or the commercial opportunity in any target indication; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to, risks and uncertainties relating to: whether preliminary data from the Phase 2 trial of A4250 in children with chronic cholestasis will be confirmed following database lock; whether the FDA, EMA or other regulatory authorities will determine clinical results for A4250 to be sufficient to support advancement into a planned Phase 3 clinical trial in patients with PFIC in the United States and Europe; whether favorable findings from clinical trials of A4250 to date will be predictive of results from future clinical trials, including the planned Phase 3 PFIC trial; the designs, endpoints, sizes and durations for trials that will be required to support approval of A4250 to treat patients with PFIC or any other orphan pediatric liver disease; whether Albireo's cash resources will be sufficient to advance A4250 through completion of a planned Phase 3 PFIC trial; the timing for initiation or completion of, or for availability of data from, ongoing or future trials of A4250, including the planned Phase 3 PFIC trial, and the outcomes of such trials; and delays or other challenges in the recruitment of patients for the planned Phase 3 PFIC trial. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.
Source: Albireo Pharma, Inc.
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com
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BOSTON, April 27, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that clinical data from a Phase 2 study of elobixibat in chronic constipation conducted by EA Pharma Co., Ltd. in Japan is scheduled to be presented at Digestive Disease Week (DDW) 2017.
Elobixibat is a once-daily, orally available ileal bile acid transporter (IBAT) inhibitor that is believed to improve both secretion and motility in the large bowel. EA Pharma, a subsidiary of Eisai Co., Ltd. focused in the gastrointestinal disease space, is the exclusive licensee of elobixibat for the treatment of gastrointestinal disorders in Japan and other select countries in Asia.
Subsequent to completion of the Phase 2 clinical trial being presented at DDW, EA Pharma conducted a Phase 3 trial of elobixibat in chronic constipation with positive results and submitted an application for regulatory approval in Japan. Subject to receipt of regulatory approval, EA Pharma plans to co-market elobixibat in Japan with Mochida Pharmaceutical Co., Ltd.
Details of the DDW presentation are as follows:
Title:§ Determining a clinical optimal dose of elobixibat, a novel
IBAT inhibitor, in Japanese patients with chronic
constipation: a multicenter, randomized, double-blind,
placebo-controlled study
Abstract Number: 172
Session:§ Constipation and Colorectal Disorders
Session Number: 2445
Date / Time: Saturday, May 6, 4:00-4:12 p.m. CDT
Location:§ S406b, McCormick Place in Chicago
Presenter:§ Atsushi Nakajima, MD, PhD; Division of
Hepatogastroenterology, Yokohama City University Graduate
School of Medicine, Japan
Digestive Disease Week® is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
About Elobixibat
Elobixibat is a first-in-class product candidate to treat chronic idiopathic constipation (or, in Japan, chronic constipation). Elobixibat is an inhibitor of the ileal bile acid transporter (IBAT, and also sometimes referred to as the apical sodium-dependent bile acid transporter) in the terminal ileum to increase secretion and motility in the large bowel without negatively affecting important functions in the small intestine. Elobixibat has been evaluated to date in more than 1,000 healthy volunteers and chronic constipation patients worldwide. A new drug application has been submitted to the Japanese Ministry of Health, Labour and Welfare for elobixibat for the treatment of chronic constipation in Japan.
About Albireo
Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo's clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit http://www.albireopharma.com.
Forward-Looking Statements
This press release includes "forward-looking statements." Forward-looking statements include statements, other than statements of historical fact, regarding Albireo's intentions, plans, beliefs, expectations or forecasts for the future, including regarding regulatory approval or marketing of elobixibat in Japan. Albireo uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to: the outcome of the ongoing long-term safety clinical trial of elobixibat in Japan; the discretion that EA Pharma has in the development and potential commercialization of elobixibat in Japan; and the timing and success of acceptance and approval of the new drug application submitted to the Japanese Ministry of Health, Labour and Welfare for elobixibat for the treatment of chronic constipation in Japan. These and other risks and uncertainties are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.
Source: Albireo Pharma, Inc.
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
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;) außer Dir schreibt hier niemand...
Weißt eh, wir sind im Forum gleich um's Eck! ;)
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Albireo reported a net loss of $6.7 million for the quarter ended March 31, 2017, compared with a net loss of $3.2 million for the corresponding 2016 period. As of March 31, 2017, cash and cash equivalents totaled $20.1 million.
"In the first part of 2017, we continued to make significant progress toward our goal of bringing A4250 to children suffering from progressive familial intrahepatic cholestasis (PFIC). We were delighted to have had clinical data from our Phase 2 study in children with cholestatic liver disease selected for a recent oral presentation at The International Liver Congress™ 2017," said Ron Cooper, President and Chief Executive Officer of Albireo. "Following consultation with regulatory authorities in both the United States and Europe, we are currently finalizing the design of our Phase 3 program for A4250, which we plan to initiate in the second half of 2017."
Recent Highlights and Corporate Update
A4250
Following meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Albireo is finalizing the design of a Phase 3 program for A4250 in patients with PFIC with the objective of supporting approval of A4250 in both regions. Albireo expects to initiate its planned Phase 3 clinical trial of A4250 in patients with PFIC in the second half of 2017.
Data from Albireo's Phase 2 open label, dose-finding clinical trial of A4250 in children with cholestatic liver disease and pruritus were presented in April in the late-breaker session at The International Liver Congress™ 2017 in Amsterdam. The data, from the trial's first five cohorts, showed that four weeks of treatment with A4250 reduced serum bile acid levels in a substantial majority of participating patients, particularly PFIC patients, with improvement in pruritus across multiple assessment scales and a significant correlation between reduction in serum bile acids and reduction in pruritus. There were no serious adverse events determined to be treatment-related observed in the trial, and most adverse events, including some increased transaminases, were transient. A4250 exhibited a favorable overall tolerability profile in the trial.
Albireo hosted a Key Opinion Leader breakfast meeting focused on rare pediatric liver diseases in New York City in April 2017.
Elobixibat
Data from a Phase 2 clinical trial of elobixibat in chronic constipation conducted by licensee EA Pharma Co., Ltd. (EA Pharma) in Japan was presented at Digestive Disease Week® 2017. Following completion of subsequent Phase 3 clinical development, EA Pharma submitted an application for regulatory approval of elobixibat to treat chronic constipation in Japan.
Financial Results for the Quarter ended March 31, 2017
Cash Position: Cash and cash equivalents totaled $20.1 million as of March 31, 2017.
Revenue: For the quarter ended March 31, 2017, revenue totaled $1,000 compared with $124,000 for the corresponding 2016 period, a decrease of $123,000. The decrease was due to a reduction in procurement services performed for EA Pharma.
R&D Expenses: For the quarter ended March 31, 2017, research and development expenses totaled $2.8 million compared with $1.6 million for the corresponding 2016 period, an increase of $1.2 million. The higher research and development expenses were principally due to increased costs associated with the development of A4250.
G&A Expenses: For the quarter ended March 31, 2017, general and administrative expenses totaled $3.2 million compared with $1.3 million for the corresponding 2016 period, an increase of $1.9 million. The higher general and administrative expenses were principally attributable to increases of $1.4 million in stock-based compensation expense and $500,000 in other compensation expense resulting from the hiring of additional executive personnel in the last nine months of 2016.
Interest expense, net: For the quarter ended March 31, 2017, interest expense, net totaled $249,000 compared with $526,000 for the corresponding 2016 period, a decrease of $277,000. The decrease was attributable to the conversion of convertible loan notes issued in 2014 and 2015 into equity in connection with the completion of Albireo's share exchange transaction with Biodel Inc. in November 2016 and a reduction in the amount of interest paid under an existing loan facility.
Other (income) expense, net: For the quarter ended March 31, 2017, other expense, net totaled $74,000 compared with other income, net of $155,000 for the corresponding 2016 period, a difference of $229,000. The difference resulted from changes in currency exchange rates between the two periods.
Non-operating expense, net: For the quarter ended March 31, 2017, non-operating expense, net totaled $325,000 compared with $89,000 for the corresponding 2016 period, an increase of $236,000. The increase reflected a change in the mark-to-market adjustments on warrants.
About Albireo
Albireo Pharma is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo's clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding: the progress or scope of development of A4250, elobixibat or any other Albireo product candidate or program, including regarding a planned Phase 3 clinical trial of A4250 in patients with PFIC, the timing for initiation of such planned Phase 3 clinical trial of A4250, the target indication(s) for development, the size, design, population, location, conduct, objective, duration or endpoints of any clinical trial, or the timing for initiation or completion of or reporting of results from any clinical trial; EA Pharma's plans with regard to the development or commercialization of elobixibat; the competitive position of any Albireo product candidate or the commercial opportunity in any target indication; any milestone or other payments that EA Pharma may make to Albireo; the sufficiency of Albireo's cash resources; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to, risks and uncertainties relating to: whether preliminary data from the Phase 2 trial of A4250 in children with chronic cholestasis will be confirmed following database lock; whether the results of Albireo's clinical trial of A4250 in children with chronic cholestasis will be sufficient to support advancement of A4250 into a planned Phase 3 clinical trial in patients with PFIC in the United States and Europe; whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from future clinical trials of A4250, including the trials comprising the planned Phase 3 PFIC program; the outcome of the ongoing long-term safety clinical trial of elobixibat in Japan; the discretion that EA Pharma has in the development and potential commercialization of elobixibat in Japan; and the timing and success of acceptance and approval of the new drug application submitted by EA Pharma with the Japanese Pharmaceuticals and Medical Devices Agency for elobixibat for the treatment of chronic constipation in Japan. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.
Source: Albireo Pharma, Inc.
Albireo Pharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited) §
March 31, 2017 December 31, 2016
ASSETS§
Current assets:
Cash and cash equivalents $ 20,143 $ 29,931
Trade receivables 1 26
Prepaid expenses and other assets 553 560
Other receivables 640 344
Total current assets 21,337 30,861
Property and equipment, net 111 21
Intangible assets 150 150
Goodwill§ 18,110 18,110
Other noncurrent assets 594 518
Total assets $ 40,302 $ 49,660
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Trade payables $ 1,309 $ 972
Accrued expenses 3,949 7,548
Long-term debt, current portion 2,488 3,075
Warrant liability 1,202 844
Other liabilities 126 269
Total current liabilities 9,074 12,708
Long-term liabilities 21 —
Total liabilities 9,095 12,708
Stockholders' Equity:
Common stock, $0.01 par value per share — 200,000,000 authorized at March 31, 2017 and December 31, 2016; 6,292,644 issued and outstanding at March 31, 2017 and December 31, 2016 63 63
Additional paid in capital 62,743 61,338
Accumulated other comprehensive income 1,017 1,496
Accumulated deficit (32,616 ) (25,945 )
Total stockholders' equity 31,207 36,952
Total liabilities and stockholders' equity $ 40,302 $ 49,660
Albireo Pharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited) §
Three Months Ended March 31,
2017 2016
Revenue§ $ 1 $ 124
Operating expenses:
Research and development 2,812 1,597
General and administrative 3,212 1,306
Other (income) expense, net 74 (155 )
Total operating expenses 6,098 2,748
Operating loss (6,097 ) (2,624 )
Interest expense, net (249 ) (526 )
Non-operating expense, net (325 ) (89 )
Net loss before income taxes (6,671 ) (3,239 )
Income tax — —
Net loss $ (6,671 ) $ (3,239 )
Net loss per share - basic and diluted $ (1.06 ) $ (12.20 )
Weighted-average shares outstanding - basic and diluted 6,292,644 265,560
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com
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Gebt mal ein bisschen Gas!
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Aber es ist wohl offensichtlich zuviel verlangt, dass die Herren die einfachsten Kurstreiber in die Wege leiten.
Hoffnung alleine bringt einen nicht weiter. Ergebnisse sind gefragt!
BOSTON, May 16, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that the United States Patent and Trademark Office (USPTO) has allowed U.S. Patent Application No. 15/276,446, "IBAT inhibitors for the treatment of liver diseases" (‘446 patent). The ‘446 patent claims a method of treatment for Albireo's lead product candidate A4250 in progressive familial intrahepatic cholestasis (PFIC) and other specified liver diseases. Upon issuance, the regular term of the ‘446 patent will expire in November 2031.
A4250 is an ileal bile acid transporter (IBAT) inhibitor initially in development for the treatment of patients with PFIC, a rare and life-threatening genetic liver disorder for which there are currently no approved therapies. In addition to the ‘446 patent, Albireo has issued composition of matter coverage for A4250 in more than 50 countries, as well as a method of use patent in Europe and Japan corresponding to the ‘446 patent. A4250 has also been granted orphan designation in the U.S. and the European Union.
"The allowance of this patent further fortifies our intellectual property protection for our lead product candidate, providing expected exclusivity into 2031 for A4250 in the treatment of PFIC among other indications," said Ron Cooper, President and Chief Executive Officer of Albireo. "This patent allowance is another step forward in our efforts to bring a pharmacological treatment option for children with PFIC who greatly need it. We plan to initiate a Phase 3 clinical program for A4250 in PFIC patients in the second half of this year."
Additionally, the USPTO allowed U.S. Patent Application No. 15/069,355, "IBAT inhibitors for the treatment of liver diseases," which claims a method of treatment for A4250 in nonalcoholic steatohepatitis (NASH). Albireo previously generated promising preclinical data with A4250 in an animal model of NASH and is currently conducting a preclinical program directed towards novel bile acid modulators to treat NASH.
About A4250
A4250 is a first-in-class product candidate in development for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC) and potentially other orphan pediatric cholestatic liver diseases. A4250 is a highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), has minimal systemic exposure and acts locally in the gut.
A4250 has been granted orphan drug designation for PFIC in the United States and the European Union and has been granted access to the PRIority MEdicines (PRIME) program of the European Medicines Agency (EMA) for the treatment of PFIC.
About Albireo
Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo's clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding: the progress or scope of development of A4250, including regarding the planned Phase 3 clinical program for A4250 in patients with PFIC; the timing for initiation of the planned Phase 3 PFIC program for A4250; the exclusivity provided by the allowed method of use patent for A4250 in the treatment of PFIC among other indications or the duration of the exclusivity; the competitive position of A4250 or the commercial opportunity in any target indication; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to, risks and uncertainties relating to: Albireo's ability to protect and maintain its allowed method of use patents for A4250, when issued, and to expand its intellectual property estate for A4250; whether or for how long Albireo's allowed method of use patents for A4250, when issued, will provide market exclusivity for A4250, if approved by applicable regulatory authorities, in the treatment of PFIC or any other indication; whether preliminary data from the Phase 2 trial of A4250 in children with chronic cholestasis will be confirmed following database lock; whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from future clinical trials of A4250, including the trials comprising the planned Phase 3 PFIC program; whether either or both of the FDA and EMA will determine that the primary endpoint and duration of a clinical trial included in the planned Phase 3 PFIC program is sufficient, even if such primary endpoint is met with statistical significance, to support approval of A4250 in the United States or the European Union, to treat PFIC, a symptom of PFIC or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study sponsored by Albireo pooling and analyzing long-term PFIC patient data; whether Albireo's cash resources will be sufficient to advance A4250 through completion of the planned Phase 3 PFIC program; the timing for initiation or completion of, or for availability of data from, ongoing or future trials of A4250, including the trials comprising the planned Phase 3 PFIC program, and the outcomes of such trials; and delays or other challenges in the recruitment of patients for the planned Phase 3 PFIC program. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. 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 representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.
Source: Albireo Pharma, Inc.
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com
Optionen
| Boardmail an "RoStock" |
Wertpapier: Albireo Pharma |