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Japan’s Ministry of Health, Labour and Welfare (MHLW) Approves CSL Behring’s IDELVION® -- The First and Only Hemophilia B Therapy with Up to 14-day Dosing Intervals

TOKYO — 29 September 2016

  • IDELVION® delivers high-level protection from bleeds by maintaining factor IX activity levels at an average of 20 percent in patients treated prophylactically every 7-days and an average of 12 percent every 14-days
  • Median annualized spontaneous bleeding rate (AsBR) of zero in IDELVION patients age twelve and older
  • IDELVION® approval in Japan follows recent approvals in the European Union, United States, Switzerland, Australia and Canada

Global biotherapeutics leader CSL Behring announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved IDELVION® [Albutrepenonacog Alfa], its innovative, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the prevention of bleeding tendency in patients with factor IX deficiency. IDELVION can be used for all age groups (children and adults). The approved treatment regimen includes routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand control; and the perioperative management of bleeding (around the time of surgery).

IDELVION is the first and only factor IX therapy that delivers high-level protection from bleeds by maintaining factor IX activity levels at an average of 20 percent in patients treated prophylactically every 7-days and an average of 12 percent when treated every 14-days. This results in excellent bleeding control and reduces the monthly number of units needed for prophylaxis therapy.

The approval of IDELVION is based on results from the PROLONG-9FP clinical development program. PROLONG-9FP includes Phase I through Phase III open-label, multicenter studies evaluating the safety and efficacy of IDELVION in children and adults (ages 1 to 61 years) with hemophilia B (factor IX levels ≤ 2%).

IDELVION provides excellent bleeding control by maintaining a high factor IX activity level over a prolonged period of time,” said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. “IDELVION delivers on CSL’s 100 year promise to develop and provide innovative specialty biotherapies that patients need and want. We look forward to bringing IDELVION to the Japan market and are particularly excited about the positive impact this long-acting therapy can have on the lives of patients with hemophilia B as CSL enters its next century.”

About PROLONG-9FP
The data from PROLONG-9FP showed median annualized spontaneous bleeding rates (AsBR) of zero and factor IX activity levels at an average of 20 percent in patients treated prophylactically every 7-days and an average of 12 percent every 14-days. The data for on-demand therapy showed that 94 percent of bleeds were controlled with one infusion, while 99 percent were controlled with one or two infusions. The most common adverse reaction in clinical trials was headache. Data from PROLONG-9FP were published in the American Society of Hematology’s publication Blood.

About Hemophilia B
Hemophilia B is a congenital bleeding disorder characterized by deficient or defective factor IX; nearly all affected patients are male. People with hemophilia B may experience prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Based on the 2011 National Survey of Coagulation Disorder, hemophilia B occurs in approximately 1 to 2 of every 100,000 male births in Japan.

About IDELVION®
IDELVION®, (Albutrepenonacog Alfa), is indicated in children and adults with factor IX deficiency for the treatment and prophylaxis of bleeding.

The approved treatment regimen includes routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand control; and the perioperative management of bleeding (around the time of surgery). IDELVION is not indicated for induction of immune tolerance in patients with hemophilia B. IDELVION is contraindicated in patients who have had life-threatening hypersensitivity to the product or its components, including hamster proteins.

CSL Behring engineered IDELVION® to extend the half-life of recombinant factor IX through fusion with recombinant albumin. CSL Behring selected recombinant albumin as its fusion partner for its coagulation factor proteins due to its long physiological half-life. Additionally, recombinant albumin has been shown to have a good tolerability profile, low potential for immunogenic reactions and a well-known mechanism of clearance.

IDELVION® is now approved in the United States, European Union, Australia, Japan, Switzerland and Canada.

About CSL Behring
CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs more than 16,000 people with operations in more than 30 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring.

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Japan Media:
Hidemi Akazawa
CSL Behring K.K.
Phone: +81 3 3534 5735
Mobile: +81 80 1359 2853
Email: Hidemi.Akazawa@cslbehring.com

All Other Media:
Greg Healy
CSL Behring
Office: 610-878-4841
Mobile: 610-906-4564
Email: Greg.Healy@cslbehring.com

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