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Baxter Announces Phase III Data Evaluating Prophylaxis Treatment of FEIBA NF for Hemophilia Patients with Inhibitors

Pivotal study to form basis for upcoming biologic license application to the FDA

DEERFIELD, Ill., JANUARY 8, 2013 — Baxter International Inc. (NYSE:BAX) today announced pivotal Phase III study results evaluating the efficacy and safety of routine prophylaxis compared to on-demand treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors. Top-line results from the study showed a reduced median annual bleed rate (ABR) from 28.7 during FEIBA NF on-demand treatment to 7.9 during FEIBA NF prophylactic treatment (a 72.5% reduction). The Phase III study will form the basis of a biologics license application (BLA) to be filed with the U.S. Food and Drug Administration (FDA) in the first quarter of 2013.

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Bayer Leadership Program

December 28, 2012 — Apply to be an intern through the Bayer Hemophilia Leadership Development Program (BHLDP) and experience a unique opportunity to build foundational leadership skills AND deepen your connection to the hemophilia community!

Bayer is looking for students enrolled full-time in college who are touched by hemophilia and have a strong interest in and commitment to becoming a future leader in the hemophilia community. Interns will travel to Bayer’s U.S. headquarters in New Jersey, where they will spend eight weeks participating in activities that aim to help them grow personally and professionally.

Through the program, selected interns will have the opportunity to:

  • Participate in formal training on communication skills, effective problem solving, leadership and compliance
  • Spend time working with mentors within Bayer to gain insights into the inner workings of the various corporate departments–emphasizing the importance of collaboration
  • Work with hemophilia organizations in the area to learn about the work done to support the hemophilia community and how business professionals can support these efforts
  • Engage in hands on projects that will build on the skills developed during the program

The program will also include a meeting with healthcare public policy professionals in Washington D.C. where interns will see first-hand how effective advocacy relations impacts legislative decisions.

This is an eight-week, paid internship program (June through August 2013). All housing, travel and related activities will be organized and underwritten by Bayer.

Interns will be selected based on an application form and interview process. Applications are due no later than Friday, February 8, 2013, at 11:59 pm ET.

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Baxter Presents Phase I/III Data Evaluating Safety and Efficacy of BAX 326, An Investigational Recombinant Factor IX for Hemophilia B, Showing More Than 40 Percent of Patients Experienced No Bleeds

BAX 326 Granted Orphan-drug Designation by U.S. FDA

DEERFIELD, Ill., December 10, 2012 — Baxter International Inc. (NYSE:BAX) today announced pivotal Phase I/III study results evaluating the safety and efficacy of BAX 326, an investigational recombinant factor IX (rFIX) protein, for the treatment and prophylaxis of bleeding episodes for patients with hemophilia B over 12 years of age. The data were presented at the 54th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Atlanta. BAX 326 was recently granted orphan-drug designation by the U.S. Food and Drug Administration (FDA), a special status given to a product that when approved, will address an unmet need for people with a rare disease or condition. Data supporting the prophylaxis indication, which is the basis for the orphan drug designation, was included in the biologics license application (BLA).

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Novo Nordisk Announces U.S. Results
of Largest Multinational Psychosocial Study of Living with Hemophilia

November 7, 2012 — Orlando, Fla. — U.S. patient and caregiver results derived from the largest multinational psychosocial study of the hemophilia community are being presented at the National Hemophilia Foundation (NHF) 64th Annual Meeting. In total, four posters were accepted from the Hemophilia Experiences, Results and Opportunities (HERO) study, a comprehensive analysis of the experience of living with hemophilia. One of the posters will be featured in an oral presentation at the meeting.

HERO examined the disorder’s effect on interpersonal relationships, careers, access to care and quality of life. The HERO initiative aims to improve outcomes in hemophilia by calling for and enabling enhanced psychosocial support based on increased understanding and awareness of the issues.

“We worked with key physicians and advocacy groups to develop a comprehensive study that, for the first time, examines the impact of living with hemophilia on all aspects of a family’s life, including interpersonal relationships, access to care, employment, and the quality of life,” said Robert Gut, MD, PhD, VP Clinical Development & Medical Affairs Biopharmaceuticals, Novo Nordisk.

In the United States, 189 adults with hemophilia and 190 parents of children with hemophilia participated in the quantitative arm of the HERO research.

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Biogen Idec & Sobi Announce Study Results
Positive Top-Line Results From Phase 3 Study Investigating Long-Lasting Recombinant Factor VIII Fc Fusion Protein In Hemophilia A

  • Individualized and weekly prophylactic regimens resulted in low single-digit median annualized bleeding rates
  • 98% of bleeding episodes were controlled with one or two injections of rFVIIIFc
  • No patients developed inhibitors to rFVIIIFc
  • The primary efficacy and safety objectives were met and Biogen Idec plans to submit an application to US FDA in first half 2013

October 31, 2012 — Weston, Mass. & Stockholm, Sweden — Biogen Idec and (Sobi) today announced positive results from A-LONG, a clinical study that evaluated a new long-lasting clotting factor candidate in people with hemophilia A. Hemophilia A is a rare inherited disorder that impairs blood coagulation. Top-line results from A-LONG, a global, multi-center, Phase 3 clinical study of the companies’ long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc), showed that rFVIIIFc was effective in the control and prevention of bleeding, routine prophylaxis and perioperative management. Recombinant FVIIIFc was generally well-tolerated. Additional analyses of the A-LONG study are ongoing, and the companies anticipate presenting detailed results at a future scientific meeting.

Biogen Idec plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2013. Consistent with guidelines published by theEuropean Medicines Agency (EMA) that require a study in children less than 12 years of age prior to filing, Biogen Idec and Sobi expect to file a Marketing Authorization Application with the EMA upon completion of the ongoing Kids A-LONG study.

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Biogen Idec & Sobi Announce Positive Top-Line Results for Hemophilia B

Biogen Idec and Sobi Announce Positive Top-Line Results from Phase 3 Study Investigating Long-Lasting Recombinant Factor IX Fc Fusion Protein in Hemophilia B

September 26, 2012 — Prophylactic regimens resulted in low single-digit annualized bleeding rates:

  • Median dosing interval was 14 days in the individualized interval prophylaxis arm during the last 6 months on study
  • Greater than 90% of bleeding episodes were controlled by a single injection of rFIXFc
  • No patients developed inhibitors to rFIXFc
  • The primary efficacy and safety objectives were met and Biogen Idec plans to submit a BLA to US FDA in first half 2013

Read the complete press release .

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