The Rosen Law Firm Announces Filing of Securities Class Action Lawsuit Against Biogen Inc. to Recover Investor Losses
Aug 18 15
The Rosen Law Firm announced that a class action lawsuit has been filed on behalf of all purchasers of Biogen Inc. securities from January 29, 2015 through July 23, 2015, inclusive. The lawsuit seeks to recover investors’ losses under the federal securities laws. According to the lawsuit, Biogen and certain of its executive officers and directors misrepresented the financial benefits that Biogen would receive from the sale of its drug TECFIDERA. On multiple occasions during the first half of 2015, the defendants projected 2015 revenue growth between 14% and 16% over 2014. Specifically, the market was told that ‘TECFIDERA will represent the large contributor to overall revenue growth.’ However, on July 24, 2015, Biogen revealed a correction to its earlier announced revenue growth guidance, decreasing its projected growth by half ‘based largely on revised expectations for the growth of TECFIDERA.
Biogen Inc. Announces Results from B-YOND Extension Study Reinforce Long-Term Clinical Profile of ALPROLIX for the Treatment of Hemophilia B
Aug 17 15
Biogen announced new clinical data support the long-term safety and efficacy of ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein] in people with severe hemophilia B treated for up to two years. Participants in the Phase 3, open-label extension study, B-YOND, maintained low bleeding rates with one to two week prophylaxis regimens, according to data from an interim analysis. Investigators presented these interim results for the first time at the 67th Annual Meeting for the National Hemophilia Foundation (NHF) in Dallas. B-YOND is a multi-year study for people with severe hemophilia B who completed the Phase 3 pivotal B-LONG or Kids B-LONG studies. In this interim analysis, the median time on ALPROLIX during B-YOND was 27.6 months for adults and adolescents (n=93), and 47.7 weeks for children under age 12 (n=23). The study’s primary endpoint is inhibitor development, and no inhibitors have been reported to-date. There were three prophylactic dosing options for adult, adolescent, and pediatric participants in the B-YOND trial – weekly, individualized, and modified prophylaxis. An episodic treatment arm was also available for adult and adolescent patients. ALPROLIX is a recombinant clotting factor IX therapy designed to have prolonged circulation in the body. According to the interim analysis, adults and adolescents treated prophylactically maintained protection against bleeding episodes with infusions every one to two weeks. These participants had overall median annualized bleeding rates (ABR) of 2.28 for weekly prophylaxis (20-100 IU/kg of ALPROLIX every seven days), 2.25 for individualized prophylaxis (100 IU/Kg of ALPROLIX every 8 to 16 days, or twice-monthly) and 2.42 for modified prophylaxis (personalized dosing if optimal prophylaxis could not otherwise be achieved). In contrast, people receiving on-demand therapy, or treatment when a bleeding episode occurred, had a median ABR of 11.27. The median overall ABR was zero for children under age six who received weekly prophylaxis (n=9). For children between six to 12 years old, median overall ABRs were 2.65 (n=10), 2.37 (n=5) and 3.13 (n=1) in weekly, individualized and modified prophylaxis regimens, respectively. In each age group, the median average weekly dose for participants previously on prophylaxis was similar for individuals in the weekly and individualized treatment arms. Safety results were typical of the hemophilia B populations studied. The most common adverse events (incidence of greater than or equal to five percent) included headache, common cold and vomiting for adults and adolescents. For children under age 12, falls, common cold and seasonal allergy were the most common adverse events. In B-YOND, participants can change between treatment groups at enrollment, and at any time during the study. Most adult and adolescent participants remained in the same treatment group during B-YOND that they had participated in during B-LONG. The majority of children under age 12 stayed on once-weekly treatment (78 percent). Adults and adolescents were able to achieve a median dosing interval of 6.9 days in the modified prophylaxis arm, and 13.7 days in the individualized prophylaxis arm, while maintaining low ABRs. From the beginning of B-LONG or Kids-B-LONG until the B-YOND interim data analysis, the cumulative median time on ALPROLIX was 171.6 weeks for adults and adolescents, and 95.3 weeks for children under age 12. B-YOND enrolled 116 males, including 93 participants (81 percent) who completed B-LONG, and 23 (100 percent) of those who completed Kids B-LONG. Secondary endpoints of the B-YOND study include ABRs (including spontaneous joint bleeding rates) per participant and treatment exposure days per participant. Additional outcomes are incidence of adverse events and serious adverse events, and evaluation of treatment of a bleeding episode (number of infusions, dose per infusion).
Biogen and Swedish Orphan Biovitrum AB (publ) Announce the Interim Results of Phase 3, Open-Label Extension Study Called ASPIRE
Aug 10 15
Biogen and Swedish Orphan Biovitrum AB (publ) announced the interim results of Phase 3, open-label extension study called ASPIRE were published in the online edition of Haemophilia, the journal of the World Federation of Hemophilia, the European Association for Haemophilia and Allied Disorders, and the Hemostasis & Thrombosis Research Society. Study participants completing the Phase 3 A-LONG and Kids A-LONG studies were eligible to participate in ASPIRE. The results to-date show the majority of participants in ASPIRE, maintained or extended their dosing intervals between treatments compared to the A-LONG and Kids A-LONG studies. As of the interim analysis, the median time in the ASPIRE study was 80.9 weeks for adults and adolescents completing the A-LONG study, and 23.9 weeks for children completing the Kids A-LONG study. Inhibitor development is the primary endpoint of ASPIRE and no inhibitors were reported in any treatment groups. Through the interim ASPIRE analysis, adults and adolescents experienced annualized bleeding rates (ABRs) of 0.66, 2.03 and 1.97 in the individualized, weekly and modified prophylaxis arms, respectively. Children on individualized prophylaxis also experienced low bleeding rates, with an overall median ABR of 0.0 in children less than 6 years of age, and 1.54 for children ages 6 to 12. These results were consistent with data from the Phase 3 A-LONG and Kids A-LONG studies. In addition to efficacy and safety endpoints, the publication also reports changes in prophylactic infusion frequency from the end of the A-LONG study through the interim analysis. Of the adults and adolescents who had previously been treated prophylactically and who remained in the study through the interim analysis (n=128), 72% maintained their prophylactic dosing interval and 22% lengthened and 6% shortened the time between infusions. Extension study participants could change treatment group at any time. In ASPIRE, most participants received prophylactic treatment and were able to maintain protection against bleeding episodes with ELOCTATE consumption that was consistent with that observed in A-LONG and Kids A-LONG.