New Data Show ELOCTATE® and ALPROLIX® May Help Control Target Joint Bleeds in People with Hemophilia A and B
New data demonstrate ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] (marketed as ELOCTA® in Europe) and ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] may effectively manage target joint bleeding and maintain low annualized bleeding rates (ABRs) in people with severe hemophilia A and B. The data, which were presented by Biogen (NASDAQ:BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla., continue to reinforce the value of extended interval prophylactic dosing of ELOCTATE and ALPROLIX.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20151208005809/en/
“As the first prolonged half-life therapies, ELOCTATE and ALPROLIX have shown low rates in both joint bleeding and overall annualized bleeding episodes,” said Kate Dawson M.D., vice president, U.S. Medical at Biogen. “Their ability to reduce bleed rates, which may translate into the potential for reducing some joint disease, continues to reaffirm their clinical value for people living with hemophilia A and B.”
For people with severe hemophilia A and B, most bleeding events occur in joints. When bleeding events occur repeatedly in the same joint (known as a target joint), it is often a precursor to chronic joint disease, marked by progressive deterioration of the joint.1 These post-hoc analyses aimed to assess the frequency of bleeding events and the dosing of ELOCTATE and ALPROLIX in study participants who had one or more target joint bleeds [major joint (e.g., knee, elbow, ankle) with three or more bleeding episodes in a three-month (hemophilia B) or six-month (hemophilia A) period].2,3
“Understanding the impact of ELOCTATE and ALPROLIX on people with target joint bleeds provides further insight into their value in a real-world setting,” said Birgitte Volck, M.D., Ph.D., senior vice president of Development and chief medical officer of Sobi. “These new results from the post hoc analyses highlight the value of extended half-life therapy in managing and controlling bleeds, adding to the body of robust clinical data and the longest real-world experience of any extended half-life therapy to date."
Results Highlight Therapies’ Potential for Reducing Bleed Rates in
In this ASPIRE (an ongoing extension of Phase 3 pivotal trials A-LONG and Kids A-LONG) post-hoc analysis, for people with hemophilia A taking ELOCTATE prophylactically, on-study annualized bleeding rates (ABRs) overall and in target joints were lower than pre-study bleeding rates. Data from ASPIRE showed that nearly half of the adult and adolescent participants in the weekly prophylaxis, individualized prophylaxis and modified prophylaxis arms (n=26, n=82, n=12, respectively) did not have any target joint bleeds (42.3, 47.6 and 41.7 percent, respectively). For children, 53.8 percent of participants in the individualized prophylaxis group (n=13) did not have any target joint bleeding episodes. In addition, nearly all (97.4 percent) target joints in adult and adolescent participants taking ELOCTATE were resolved during the follow-up period, suggesting that the therapy may be equally effective for preventing target joint bleeding episodes in weight-bearing and non-weight-bearing joints. The median dosing intervals for ASPIRE participants with target joints at baseline were similar to those for the A-LONG and Kids A-LONG overall population.2
In the B-LONG (the pivotal Phase 3 study) post-hoc analysis, for people with hemophilia B taking ALPROLIX prophylactically, the therapy was shown effective in reducing the frequency of bleeding episodes overall and in target joints. The analysis found that 48.6 percent of participants receiving weekly prophylaxis (n=35) and 37.5 percent of participants on individualized interval prophylaxis (n=8) did not have any target joint bleeds at the end of B-LONG. Overall, participants’ target joint, spontaneous target joint and traumatic target joint median ABRs were low for participants in the weekly prophylaxis arm (1.03, 0.00 and 0.00 respectively) and the individualized interval prophylaxis arm (2.20, 2.20 and 0.00 respectively). Additionally, among B-LONG participants entering the trial with target joints (n=43), the on-study median dosing intervals were longer (6.98 days in the weekly prophylaxis arm and 10.25 in the individualized interval prophylaxis arm) than the pre-study dosing interval with a traditional factor therapy, suggesting that target joint bleeds may be effectively managed and controlled with an extended prophylactic dosing regimen.3
About Hemophilia A and B
Hemophilia is a rare, genetic disorder in which the ability of a person’s blood to clot is impaired. Hemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. Hemophilia B occurs in about one in 25,000 male births annually, and more rarely in females. Worldwide, it is estimated that more than 400,000 people are living with hemophilia. Hemophilia A is caused by having substantially reduced or no factor VIII activity, while hemophilia B is caused by having substantially reduced or no factor IX activity; factor VIII and factor IX are needed for normal blood clotting.
People with hemophilia A or B experience prolonged bleeding episodes that can cause pain, irreversible joint damage and life-threatening hemorrhages. Prophylactic infusions of factor VIII or IX can temporarily replace the missing clotting factors that are needed to control bleeding and prevent new bleeding episodes.4 The Medical and Scientific Advisory Council of the National Hemophilia Foundation recommends prophylaxis as the optimal therapy for people with severe hemophilia A or B.5
ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein], the first recombinant clotting factor VIII therapy with prolonged circulation in the body, is approved in the United States, Canada, Australia and Japan. In the European Union, it was recently approved and marketed under the trade name ELOCTA®. It is indicated in the United States for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A. ELOCTATE is not indicated for the treatment of a bleeding disorder called von Willebrand disease. ELOCTATE was developed by fusing B-domain deleted factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). It is believed that this enables ELOCTATE to use a naturally occurring pathway to prolong the time the therapy remains in the body.
Common adverse reactions (incidence of greater than or equal to 1 percent) reported in the registrational A-LONG study were arthralgia (joint pain) and malaise (general discomfort). For important safety information, and the United States full prescribing information, please visit www.ELOCTATE.com.
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant clotting factor therapy with prolonged circulation in the body, is approved in the United States, Canada, Australia and Japan. It is indicated in the United States for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B. ALPROLIX is not indicated for immune tolerance induction therapy, which is a treatment for people with inhibitors, and should not be used in individuals with a known history of serious allergic reactions. ALPROLIX was developed by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1. It is believed that this enables ALPROLIX to use a naturally occurring pathway to prolong the time the therapy remains in the body.
Common adverse reactions (incidence of greater than or equal to 1 percent) from the registrational B-LONG study were headache and oral paresthesia (an abnormal sensation in the mouth). For additional important safety information, and the United States full prescribing information, please visit www.ALPROLIX.com.
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter.
Sobi is an international specialty healthcare company dedicated to rare diseases. Sobi’s mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. Sobi also markets a portfolio of specialty and rare disease products for partner companies across Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion (USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.
Biogen Safe Harbor
This press release contains forward-looking statements, including statements about the potential benefits and efficacy of ELOCTATE and ALPROLIX. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that unexpected concerns may arise from additional data or analysis, regulatory authorities may require additional data or information or further studies, or may fail to approve, or refuse to approve, or may delay approval of our drug candidates, or we may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
1. Hemophilia Federation of America. Joint Damage. Available at: http://www.hemophiliafed.org/bleeding-disorders/complications/joint-damage/. Accessed: November 2015.
2. Kerlin, BA, et al. (December 2015). Long-term Efficacy of rFVIIIFc Prophylaxis in Pediatric, Adolescent, and Adult Subjects With Target Joints and Severe Hemophilia A. Poster session presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla.
3. Shapiro, AD, et al. (December 2015). Analysis of Target Joint Bleeding With Prophylactic Use of Recombinant Factor IX Fc Fusion Protein in Patients With Severe Hemophilia B. Poster session presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla.
4. Hemophilia Federation of America. What is Hemophilia? Available at: http://www.hemophiliafed.org/bleeding-disorders/hemophilia/treatment/ . Accessed: November 15.
5. Hemophilia Federation of America. MASAC Recommendation Concerning Prophylaxis. Available at: https://www.hemophilia.org/Researchers-Healthcare-Providers/Medical-and-Scientific-Advisory-Council-MASAC/MASAC-Recommendations/MASAC-Recommendation-Concerning-Prophylaxis . Accessed: November 2015.
Kate Niazi-Sai, +1-781-464-3260
Investor Relations Contact:
Benjamin Strain, +1-781-464-2442
Oskar Bosson, +46-70-410-71 80
Jörgen Winroth, +1-347-224-0819, +46-8-697-2135
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
EUSA Pharma Announces Acquisition of Global Rights to SYLVANT® (siltuximab) from Janssen Sciences Ireland UC for $115 Million18.7.2018 06:00 | Pressemelding
EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, announced today that it has entered into a definitive agreement with Janssen Sciences Ireland UC, a subsidiary of Janssen R&D Ireland (Janssen) to acquire the global rights to SYLVANT® (siltuximab) for $115 million in cash. The transaction is subject to review under the United States Hart–Scott–Rodino Antitrust Improvements Act of 1976, as amended, and the parties expect to close following completion of this regulatory review period and the mutual satisfaction of other remaining closing conditions. SYLVANT® is approved in more than 40 countries worldwide, including the United States, the European Union, the Republic of Korea and Canada, for the treatment of idiopathic multicentric Castleman’s disease (iMCD), a rare, life threatening and debilitating orphan condition. Idiopathic MCD is an inflammatory lymphoproliferative disorder, which causes the abnormal overgrowth of immune cells and shares many sym
The Best User Interface in Mobile and Web Tracking Just got Better18.7.2018 06:00 | Pressemelding
ThriveTracker, a leading web and mobile tracker for media buyers and performance marketers, today announced the general availability of its latest release featuring an all-new user interface (UI). Inspired by feedback from customers and partners, ThriveTracker designed the new UI to accelerate user adoption, improve usability and increase productivity. ThriveTracker focused on the user experience for all users regardless of device, (Desktop, Mobile, etc.), making it more intuitive and accessible. Improved navigation provides simplified access to frequently used functions in the platform, increases customer awareness of more advanced functionality and delivers fast access to detailed content when necessary. Cleaner, simpler, modern UI Clear, consistent navigation focuses your attention on where you are and what you can do Improved layout delivers common functions intuitively Simplified views provide faster access to relevant content Mobile Friendly Mobile responsive based on device New
JPMorgan Chase Bank announces the placement of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 19:40 | Pressemelding
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the placement of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest. The Bonds will be issued with an issue price of 100% and will redeem at par on 30 December 2020. The initial exchange price (the “Initial Exchange Price”) will
Boston Capital Announces Closing of Boston Capital Income & Value U.S. Apartment Fund17.7.2018 14:00 | Pressemelding
Boston Capital, the third largest owner of apartments in the U.S. with over $19.6 billion invested, is pleased to announce the final investor closing of Boston Capital Income and Value U.S. Apartment Fund (“BCIV”). BCIV, a discretionary multi-investor Luxembourg based fund vehicle, includes financial institutions, insurance companies, pensions, and family offices among its investors and will acquire over $350 million in apartment properties throughout the U.S. “We are very pleased to close BCIV, the latest in a succession of institutional investment vehicles through Boston Capital’s conventional apartment investment arm, Boston Capital Real Estate Partners (“BCRE”),” said Jeff Goldstein, COO and Director of Real Estate at Boston Capital. The Fund generates high current dividends and capital growth by acquiring and renovating Class B apartment properties located in major and secondary U.S. markets and by targeting a renovated rental price point well below new construction rates, which a
Amobee Wins Auction Process to Acquire Videology Assets17.7.2018 13:13 | Pressemelding
Singtel subsidiary Amobee, a leading global digital marketing technology company serving brands and agencies, today announced that it has emerged as the winner in the court supervised auction to acquire certain assets from Videology, a software provider for advanced TV and video advertising, for purchase price of approximately US$101 million1. The purchase price is subject to adjustments for accounts receivable at closing, estimated to be approximately US$20.9 million. The acquisition, following Videology’s voluntary Chapter 11 restructuring proceedings, includes Videology’s technology platform, intellectual property and certain other assets of estimated net book value of US$5.3 million2. Over the past decade, Videology has emerged as a leading provider of software that empowers advertisers and publishers to use data to optimize campaigns and spend across digital platforms and television. The addition of Videology’s capabilities will be a further boost to Amobee’s omni-channel platform
Lenovo Leaps Forward with Next-Generation ThinkAgile Composable Cloud Platform17.7.2018 12:00 | Pressemelding
Lenovo Data Center Group (HKSE: 992) (ADR: LNVGY), one of the fastest growing hyperconverged infrastructure (HCI) vendors according to IDC, – with HCI revenue growing at almost twice the market growth rate in Q1 2018 (149.1% compared to 76.3%)—is further expanding its ThinkAgile portfolio to provide an innovative solution for customers who desire the agility of the public cloud and the security of a private cloud. To address this growing customer trend, Lenovo – together with Cloudistics – has developed the ThinkAgile CP Series composable cloud platform, a ‘cloud-in-a-box’ that offers all of the conveniences and ease-of-use of a public cloud environment secured behind the customer’s own data center firewall. Lenovo ThinkAgile CP Series – with fully-integrated infrastructure, application marketplace and end-to-end automation of software-defined network, compute and storage – delivers a turnkey cloud experience that can be easily and centrally managed from anywhere through a software-as-