FDA Approves a New Factor IX Treatment for Hemophilia B!

The following is a paid public awareness notice from Emergent BioSolutions about a recently approved FIX treatment.
Earlier this year I spotlighted the Emergent-sponsored mentorship program for teens and adults with hemophilia B (Calling All B’s—Be Part of the Generation IX Project! Or, way back in May 2014, when I shared my admiration for John Taylor, co-founder of the Coalition for Hemophilia B, and his work with Emergent BioSolutions to help bring a new factor IX to market (A Promising Future with Hemophilia B). 
 Well, our era of expanding treatment choices for hemophilia continues with the FDA-approval of Emergent’s IXINITY® [Coagulation Factor IX (Recombinant)] for people with hemophilia B. Now there’s more than one recombinant factor IX for hemophilia B people to rely on. 
More choice means more product differences to consider. That means it’s now more  important than ever to educate ourselves and understand differences among treatments. It also puts more power in the hands of patients to select a treatment that fits their needs and their lifestyles. 
Another great thing about the expansion of treatment choice is that it stresses how important it is for manufacturers to create a more positive treatment experience by offering additional programs that help individual people and the whole hemophilia B community.
More information about IXINITY is below. You can visit the site at IXINITY.com for more on what they call the IXINITY IXperience™. 
 With IXINITY, you define the IXperience. 
Predictable bleed control for your active, unpredictable life. 
• 98% average incremental recovery.Higher recovery may allow lower doses.1* 
• Third-generation† factor IX with no inhibitors developed in a clinical study.1‡ 
• 24-hour half-life for peak factor levels when you need them.1 

Start your FREE trial. Call 1-855-IXINITY (1-855-494-6489) to talk with your IXperience Concierge™. 

    • With your FREE trial of IXINITY, you’ll receive 1 month of free treatment up to 20,000 IU. 

    • After that, if you’re covered by commercial insurance, you may continue to   
    pay nothing out-of-pocket for IXINITY regardless of income. 
The IXINITY Savings Program: You can save up to $12,000 annually.§ 
    • NO income requirements 

    • NO out-of-pocket costs∥ 

    • NO monthly limits 
If you have commercial health insurance, you can save up to $12,000 a year for treatment with no income requirements or caps and no monthly limit over the $12,000 annual maximum. 

*The pharmacokinetics of IXINITY have been evaluated in 32 previously treated patients ≥12 years of age with severe to moderately severe hemophilia B.1 
†Third-generation product is defined by the National Hemophilia Foundation Medical and Scientific Advisory Council as recombinant factor IX (rFIX) produced in Chinese hamster ovary cells; no human or animal plasma-derived proteins are used in the manufacturing process2
‡The efficacy (n=68) and safety (n=77) of IXINITY has been evaluated in a prospective, open-label, uncontrolled, multicenter trial in which previously treated patients (PTPs) between 7 and 64 years of age received IXINITY in either a routine or on-demand regimen.1 
§Program does not cover government healthcare costs (Medicare, Medicaid, and TRICARE) or costs associated with therapy administration. Other restrictions may apply, and a US prescriber and pharmacy are required. Emergent BioSolutions reserves the right to rescind, revoke, or amend this offer without notice. 
∥May depend on your individual health insurance. 
IXINITY INDICATIONS AND IMPORTANT SAFETY INFORMATION 
What is IXINITY®? 
IXINITY [coagulation factor IX (recombinant)] is a medicine used to replace clotting factor (factor IX) that is missing in adults and children at least 12 years of age with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents clotting. Your healthcare provider may give you IXINITY to control and prevent bleeding episodes or when you have surgery. 
IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B. 
IMPORTANT SAFETY INFORMATION FOR IXINITY® 
 You should not use IXINITY if you are allergic to hamsters or any ingredients in IXINITY. 
 You should tell your healthcare provider if you have or have had medical problems, take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies, have any allergies, including allergies to hamsters, are nursing, are pregnant or planning to become pregnant, or have been told that you have inhibitors to factor IX. 
 You can experience an allergic reaction to IXINITY. Contact your healthcare provider or get emergency treatment right away if you develop a rash or hives, itching, tightness of the throat, chest pain, or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting. 
 Your body may form inhibitors to IXINITY. An inhibitor is part of the body’s defense system. If you develop inhibitors, it may prevent IXINITY from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for development of inhibitors to IXINITY. 
 If you have risk factors for developing blood clots, the use of IXINITY may increase the risk of abnormal blood clots. 
 Call your healthcare provider right away about any side effects that bother you or do not go away, or if your bleeding does not stop after taking IXINITY. 
 The most common side effect that was reported with IXINITY during clinical trials was headache. 
 These are not all the side effects possible with IXINITY. You can ask your healthcare provider for information that is written for healthcare professionals. 


Please see full Prescribing Information for IXINITY. 

You are encouraged to report side effects of prescription drugs to the Food and Drug Administration. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. 

References: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Winnipeg, MB, Canada; Emergent BioSolutions Inc.; April 2015. 2. National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. MASAC Document #230. September 2014. 

Manufactured by Cangene Corporation, a subsidiary of Emergent BioSolutions Inc. and distributed by Cangene bioPharma, Inc., a subsidiary of Emergent BioSolutions Inc. 
IXINITY® [Coagulation Factor IX (Recombinant)] and any and all Emergent BioSolutions Inc. brand, product, service and feature names, logos, slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All rights reserved. 
©2015 Emergent BioSolutions Inc. 

A Promising Future with Hemophilia B

I’ve always been an admirer of John
Taylor, and I’ve known him since both our boys with hemophilia were born in the
1980s. His story is so inspiring! I am pleased to share some of his trials and
triumphs, as well as his outlook on hemophilia B and the factor IX product he
is helping to bring to market. 
————————————————————————
John Taylor Sr.

by John Taylor Sr.

Nearly 25 years ago when our son, John Taylor Jr., was
born, my wife Joyce and I were informed that he had hemophilia B. This
diagnosis changed our lives. When your child has hemophilia, it’s all encompassing.
As a family, you struggle through it every day. But what started as an unknown,
daunting journey has developed into an expedition of hope.

In 1990, we were told
that there were few treatment options for John. Determined to find the right
treatment and support for ourselves and other families coping with hemophilia
B, we reached out to the scientific community. This quest led me to incredible passages in life—founding the
Coalition for Hemophilia B in 1990, becoming an activist for FDA approval of additional
factor treatments, and starting a company dedicated to advancing access to
hemophilia B treatment.
That company was called Inspiration Biopharmaceuticals, which our family co-founded with Scott
Martin, another father of a son with hemophilia. Our mission was to bring product choice and access to the hemophilia B
community. Because we understood the impact of this condition on our own families—as well as many other
families we met also coping with hemophilia—we were determined to start a
company that would address the concerns we were all living with. Thanks in part to our work, a lot has changed for families living
with hemophilia B.
When Emergent BioSolutions, a
company whose goal is to improve the lives of people with rare conditions, acquired
the recombinant Factor IX we were developing, families
felt empowered knowing that there was now a company that was working directly
for us. 
One demand that is finally being addressed by
pharmaceutical companies is treatment choice. Soon, people with hemophilia B
will have even more product choices for bleed control and prevention than ever
before.
One product I am particularly excited about is IB1001,
from Emergent BioSolutions. IB1001 is a recombinant factor IX product that began
development at Inspiration Biopharmaceuticals.

I am so proud to see Emergent continue the work we began at Inspiration, and to
know that they are seeking to gain approval for IB1001. Emergent’s focus on
developing treatments for rare conditions and blood disorders and their experience
in addressing the needs of small patient populations makes them a welcomed
addition to the companies serving the hemophilia B community.

Emergent’s mission is simple—to protect and enhance
life.  Although they are new to the
hemophilia community, their commitment to IB1001 and to improving the lives of
patients with hemophilia B makes me eager to see them bring to market a product
I believe in so strongly.
When I reflect on this journey, I can honestly say that every stop along
the way—and every person I’ve met from our community—have added incredible
value to my life. My son and this amazing community have given me the drive and
determination to keep going. When a company like Emergent comes along and
commits to understanding and responding to the needs of the hemophilia B
community, I can confidently say that my journey has been worthwhile. With dedication and the commitment that come
from having lived with the condition, and a thorough knowledge of our
community, we are proud to have been part of the development of a new
recombinant factor IX product. Standing with you, from a family like yours.
This is a journey we are taking with all of you.
 John’s work
on behalf of the hemophilia B community continues to make a positive impact. If
you’d like to learn more about IB1001, the product he helped develop, and
Emergent BioSolutions’ efforts to finish the work John began, please visit
www.ebsi.com/hemophiliab. To learn more about the Coalition for Hemophilia B, visit http://coalitionforhemophiliab.org


This is a sponsored public awareness notice.
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