Emergent BioSolutions

Together we can FACTOR IT FORWARD™

Laurie Kelley June 19, 2016

The following is a paid public service announcement.
LA Kelley Communications always advises you
to be a savvy consumer when contacting any company; do not reveal personal
information (PI) or protected health information (PHI) carelessly or against
your will.
Every day, I’m reminded of how much I have to be thankful for. Like
the life-changing support I’ve had the privilege to both give and receive within
the hemophilia community.
As a parent personally touched by a
bleeding disorder, I’ve witnessed first-hand the power a strong support system
can provide.
This truly is a community that cares, and I’m proud to be a part
of it.
That’s why today, I’m excited to spread the word about a program that
embraces the spirit of this community—FACTOR IT FORWARD.
With FACTOR IT FORWARD, the people behind IXINITY® [coagulation
factor IX (recombinant)] have partnered with AmeriCares, a non-profit global
health organization, to donate IXINITY to people with hemophilia B who can’t
afford to be without it right here at home.
And it doesn’t end there. Visit www.factoritforward.com or read on to find out how you can help.
FACTOR IT FORWARD and help lead
the way
As part of their commitment to the hemophilia B community, the
makers of IXINITY will donate 10% of IXINITY used to nines who need it most
here in the U.S. That means:
For
every 10 units of IXINITY used, 1 unit is donated to those in need in the United
States.
So when you use IXINITY, you help
give back to the hemophilia B community. You can try IXINITY for free to see how it works for you. With
your IXINITY FREE Trial, you’ll receive 1 month of treatment up to 20,000 IU. Learn more about the FREE Trial, download the FREE Trial Form, and talk to your doctor. 
Plus, there are even more ways to join in and help FACTOR IT
FORWARD in addition to using IXINITY.  
Get involved today, right now, when you take the giving quiz at www.FactorItForward.com. You’ll earn points that will contribute to
factor donations just by answering a few quick questions.
Or chat with an IXINITY rep
at a local chapter event and snap a
selfie with your giving pledge. Share the pic on your favorite social media
channel to get points just for posting.  
More points equal more factor donated, making it even easier for
everyone to do their part!
And since there’s no limit to the number of IUs donated, every IU
of IXINITY used and every point earned count toward that end goal: to leave no
nine behind.
Visit www.FactorItForward.com
 today
to learn more about the program and how you can participate, and talk to your
doctor to find out how you can try IXINITY for free.   
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.
For more information about IXINITY,
please see accompanying full Prescribing Information, including
Important Patient Information.
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.
 
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)], FACTOR IT FORWARD, 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.
©2016 Emergent BioSolutions Inc. CM-FIX-0048

Hear About Nathan’s “IXperience” With His Factor IX

Laurie Kelley April 4, 2016
Last year I told you about the FDA approval of IXINITY® [coagulation factor IX (recombinant)] for people with hemophilia B (FDA Approves a New Factor IX Treatment for Hemophilia B!).  Now people are sharing their firsthand experiences with this factor IX. Watch Nathan’s full video to see more of his story on IXINITY.com.
Be sure to speak with your doctor about any new treatment that you’re considering. This is Nathan’s experience and it may not be typical. 
(The following is a paid placement of product information by Emergent BioSolutions.)
Nathan
Here’s what Nathan says about his IXINITY IXperience™. 
I’m 19 now and have severe hemophilia B. Over the years I’ve had a lot of bleeds. What interested me in IXINITY was that there were no inhibitors found in the clinical trials, the recovery rate was 98%,* and it’s not a plasma-derived product.1 

My hematologist and I collaborated and thought that with a 98%* recovery rate, we should be able to at least try to lower the dosage. Now I’m infusing 4,000 IU per infusion—less than in the past. 
Since I started IXINITY in July of 2015, I’ve experienced no bleeds. I also like the IXINITY reconstitution device. It’s so simple, and there’s really nothing to it. It’s just right there in front of you. 

Nathan’s experience with IXINITY may not be typical. Speak with your doctor to see if IXINITY may be a good option for you. 

*IXINITY recovery is an average based on lab tests of patients in the clinical study.1 Your actual recovery and dose may be different. Speak with your healthcare professional about the right dose for you. 
Visit IXINITY.com to learn more about IXINITY and the FACTOR IT FORWARD program. You can also call an IXINITY IXperience Concierge™, toll-free, at 1-855-IXINITY (1-855-494-6489). 
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 here.
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. 
Reference: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Winnipeg, MB, Canada; Emergent BioSolutions Inc.; April 2015. 
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)], IXperience, 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. 
©2016 Emergent BioSolutions Inc. All rights reserved. CM-FIX-0024 

An Opportunity to “B” Educated!

Laurie Kelley August 30, 2015

Education is important to me. I’ve always encouraged people with hemophilia to not let hemophilia stop them from getting the best education they can get.

The B More ScholarshipTM helps deliver a brighter future to people with hemophilia B by assisting with the cost of
post high school education. And that goes beyond college—B More Scholarships cover undergraduate, graduate,
and doctoral programs, trade schools, and certificate programs in the United States. Student can be enrolled full
time or part time. There is no age limit, and scholarships are awarded on a number of criteria.

The application period for the 2015-2016 school year is open NOW. If you have hemophilia B and will be pursuing a
higher degree this fall, apply now at  BMoreScholarship.com. The deadline for your completed application is
September 30, 2015, so don’t put it off!

This announcement was sponsored by Emergent BioSolutions.

Great Book I am Reading

Little Princes: One Man’s Promise to Bring Home the Lost Children of Nepal [Kindle]
Conor Grennan

I’m in Nepal this week, and found the perfect book to read while here. This powerful memoir begins with a nice young man infected with wanderlust who decides to travel around the world for a year in 2004. He volunteers at an orphanage in Nepal for three months during this time, and humorously shares his first exposure to Asia, and apparently to children! What starts off as light and whimsical writing gets serious, as Conor becomes attached to the children, becomes their advocate and then learns, with the ongoing Maoist rebellions flare ups, that these children had parents—they were trafficked. Sold. He begins a quest to find the parents. He faces bankruptcy and sacrificing his personal life at a time when his peers are partying and enjoying careers, to help these children. He forms a nonprofit, Next Generation Nepal, and dedicates his life to helping these victims of civil war in Nepal. To date he has helped 400 children become reunited with their families. Not only is this a fascinating story of how one young man discovers his purpose in life, it’s a very well written book! (And I can be critical of that) Read this and get inspired. Four/five stars.

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!

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