Coalition for Hemophilia B

FDA Approves a New Factor IX Treatment for Hemophilia B!

Laurie Kelley June 7, 2015

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. 

Calling All B’s—Be a Part of the Generation IX Project!!

Laurie Kelley January 25, 2015
Back in July, I blogged about a new adventure opportunity called the Generation IX
Project. A mentorship program for teens and young adults with hemophilia B,
this program kicked off in October with an adventure retreat outside of Portland, Oregon (my kind of fun!).
From the looks of it, the guys had a great time! Check out the video  from the weekend.  
The next program is scheduled for June 9–14, 2015, and the Coalition for Hemophilia B is now accepting applications. If you are between the ages of 14 and 30 and
have hemophilia B, don’t miss your chance to be part of this great experience! The
program is proudly sponsored by Emergent BioSolutions.
Download the application for mentors or for teen participants for your age group and send it to Kim Phelan at hemob@ix.netcom.com at
the Coalition for Hemophilia B to reserve your spot today.
More about the Generation IX Project
The Generation IX Project is an adventure education program created by the Coalition for Hemophilia B with the support of Emergent BioSolutions. Led by Pat “Big Dog” Torrey and his company, GutMonkey, this national
mentoring program for young adults and teens with hemophilia B provides participants the opportunity to learn tangible mentoring skills through experiential learning in an unforgettable environment.
Check out what participants had to say about Generation IX:

“I really enjoyed being able to meet a group of complete strangers
with hemophilia B, and at the end of the program feeling like I have known them
for much longer than a week.”

 
“Even though we came from different places, we came together and
supported strangers as if we knew them our entire lives.”
 
“The part that will stick with me is knowing to trust the people around me.”
For more information about the Generation IX Project, check out the Generation IX Project Facebook page.
To learn more about how Emergent BioSolutions is making a difference for people living with hemophilia B, register for updates at www.ebsi.com/hemphiliab.
This announcement was sponsored by Emergent BioSolutions.


Great Book I Just Read

Surviving Survival: The Art and Science
of Resilience 
Laurence Gonzales

Perfect book to accompany those Gen IX adventurists! An expert in studying the field of survival, Gonzales examines through a variety of real-life tragedies, disasters and situations, why some people survive, the strategies they use and more importantly, how they continued their lives despite the PTSD and other after effects. How the brain is biologically altered after a trauma, and what successful survivors share in common by way of thinking, personality, life strategies. Four/five stars!

Hemophilia B: Explore, Branch Out, Give Back!

Laurie Kelley July 6, 2014
Anyone who reads my blog—even occasionally—knows I love adventure. In fact, I am on my way today to go white water rafting in Maine… class IV and V rapids! I love adventure, and thankfully for me, I was motivated and influenced by some incredible people—starting with my six
brothers! Based on those positive experiences, I’m motivated to share with my readers a new adventure opportunity that I recently discovered.

Pat “Big Dog” Torrey
Please read below about this great opportunity from the Coalition for Hemophilia B and
Emergent BioSolutions!
The Generation IX Project is a new adventure education program being offered by the Coalition for Hemophilia B, with the support of Emergent BioSolutions. This national mentoring training program for young adults and teens with
hemophilia B will provide them the opportunity to escape the everyday routine and learn some adventure skills in an experiential program. The Generation IX Project is designed to develop specific and tangible skills that will enhance the quality of life and give a better sense of self to young adults with hemophilia B.
The leadership of the project is being guided by Patrick Torrey, president and founder of Physis, Inc. Pat “Big
Dog” Torrey has been designing and delivering innovative experiential education programs and trainings for over 15 years.  Pat started and runs Physis.  Physis offers unconventional, adaptable, relationship-centered
adventure education programs that teach those with chronic medical conditions how
to lead rock-star lives.  He challenges and inspires people to explore
outside of their perceived limits and strive for excellence in their lives.
He and his staff run trainings and consult within the bleeding disorder
community for camps, foundations, and conferences.  Physis has been
running some of the most successful, fun, and sought after programs in the
bleeding disorder community for close to a decade.
Since its inception, Physis has worked to serve the bleeding disorder community and seeks to continue developing programming that empowers teens and young adults. This dynamic collaboration from Physis, the
Coalition, and Emergent is sure to create a life-changing experience for all involved.
Calling All Mentors
If you are an adult between the ages of 18 and 29 with hemophilia B, you have already experienced a lot of bumps in the road on your way through your transition to independence. As a Generation IX mentor, you’ll share your experience and the insights you’ve gained with a group of teen mentees and have an amazingly important impact on their lives. You will begin your training as soon as your application is accepted. You’ll be flown to a
multi-day retreat at beautiful Camp Collins, a state-of-the-art camp facility just outside Portland, OR.  Camp Collins is home to villages of ‘out of the ordinary’ cabins that are perched in the forest canopy connected by a walkway, and contains one of the nation’s most diverse high ropes challenge courses. There, you’ll
participate in intensive onsite training and then host a mentorship retreat for your teen mentees. The leadership skills and volunteer experience you will gain will look great on your resume!
As a mentor, you will participate in a two-day experiential training program in interpersonal skill development and group dynamics, as you find your personal leadership style while you learn and live with a group of other motivated mentors. This is all in preparation for when you help deliver a challenging and meaningful residential weekend program for a group of teen mentees. The instructor team will help guide the process as you get to immediately practice the skills learned.
Calling All Teens
The Generation IX Project gives you and other teens (age 14-17 years) with hemophilia B an adventure and the experience of a lifetime. You’ll learn solid skills from Generation IX mentors a few years older, who also have hemophilia B and are familiar with the many changes teens experience, such as heading off to college, going off on their own, and taking more responsibility for their treatment. These mentors will guide you
through a weekend of high ropes challenge course experiences, living in a temperate rainforest, and connecting with other participants living with
hemophilia B from around the country. This is a chance to expand your life experiences, improve your quality of life, and build your self-esteem—you might just be amazed at what you can do!
Living with hemophilia B is an ever-changing journey, and teens and young adults with hemophilia B are becoming more independent than ever and
taking responsibility for their own care. The Generation IX Project sounds to me like a fantastic opportunity to meet some of your peers and share your experiences.
Download additional
information and an application form here:

Teen Application

Send your completed application to Kim Phelan at hemob@ix.netcom.com at the Coalition for Hemophilia B to lock in your spot. Applications are due  August 1st! Get moving!
To learn more about how Emergent BioSolutions is making a difference for people living with hemophilia B, register for updates at www.ebsi.com/hemophiliab.
This announcement was sponsored by Emergent Biosolutions.

A Promising Future with Hemophilia B

Laurie Kelley May 4, 2014

 

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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