Novo Nordisk

Coming Changes: Kogenate® FS Discontinued

It was bound to happen sooner or later: in a community flush with hemophilia A therapies, one of them would have to give.

This past week Bayer announced that it would discontinue production of Kogenate® FS (Antihemophilic Factor (Recombinant), which has been in use since 1993. I’m nostalgic about it leaving; when it appeared, my second born was only 3. We used it at one point. We educated the community that it was the exact same product as Helixate®FS… though many parents tried to argue with me that they had different names and were from different companies, and were therefore different. They were not.

But times are truly changing. We have extended half-life (“long lasting”) products now; we have products made from a human cell line, and not hamster cell lines. We even have transgenic animal therapies. And we have Hemlibra, an injectable with a half-life of over 600 hours.

But above all, we have probably too many factor products for hemophilia A patients, who number around 20,000 in the US. How will the market justify all the products?

Our factor chart below shows 12 products for hemophilia A that are recombinant, and five products that are plasma-derived (from human blood). Some manufacturers, like Bayer, Novo Nordisk and Takeda, have multiple factor VIII products. It’s like they are in competition with themselves. Some are standard factor products and others are extended half-life.

Bayer’s press release says: “Recognizing the growing shift in patient use toward more recent products, such as Kovaltry® (Antihemophilic Factor (Recombinant)) and Jivi® (Antihemophilic Factor (Recombinant), PEGylated-aucl), Bayer has made the decision to discontinue Kogenate® FS (Antihemophilic Factor (Recombinant)) in the United States.  

“Keeping the needs of patients in mind, Bayer is keenly aware that they will need sufficient time to work with their HCP to make decisions about their next treatment. The timing of discontinuation will vary by Kogenate FS vial size. Customer demand may lead to depletion of the larger vial sizes of Kogenate FS during the fall of 2022. Remaining Kogenate FS vial sizes are anticipated to be available into 2023.

“As Kogenate FS patients and their caregivers embark on the next step of their journey, Bayer is committed to supporting them. Attached, please find our discontinuation announcement for your reference. Additionally, we have set up a website (explore.bayer.com) and a dedicated Kogenate FS hotline for anyone who has questions regarding this discontinuation, (1-833-40-BAYER), which is available Monday – Friday, 8:30am – 8:00pm ET.” See the full press release here.

If you are a Kogenate FS user, it’s time to contact your HTC staff and discuss next steps. We’ve been through this before over the decades: we know that some patients want to stay with the manufacturer, and will switch to their other products. Other patients will take this as an opportunity to learn more about other products from other manufacturers. Whichever you are, be sure you make your decision with your HTC staff… not the internet! Not even with me. Call the manufacturer and speak with your HTC staff, learn more about these products, and then choose which is right for you.

And probably more change is coming, in products, manufacturers… and eventually gene therapy.

Resolve to be a master of change rather than a victim of change.— Brian Tracy

Egyptian Bull God in Hemophilia

I’m in Egypt, first to visit a patient with hemophilia (read this story in last week’s blog!) and second to vacation and learn all I can about ancient Egypt. It’s an incredible tour, complete with lectures and a visit from the famous Dr. Zahi Hawass!

As I am learning about the ancient gods and pharaohs, one symbol keeps appearing on the carvings on the temples and tombs. A bull with the sun sign between his horns. Where have I seen that before? It’s the logo for the pharmaceutical company Novo Nordisk, which is a Danish company.

Who was this god? He is Apis, one of the sacred animals of ancient Egypt. He represents strength and fertility. His mother is sometimes listed as Hathor, an extremely important goddess, whose temples are everywhere. I visited some and carvings everywhere show the cow and bull.  

Our guide, Mohammed, tells me Hathor is the goddess of health and motherhood, and was also the mother of the god Horus, one of the most important gods of ancient Egypt.

I just found this all so interesting. The word “logo” is defined as “meaning,” so it’s always important to choose a logo (image, color, size and intensity) that has specific meaning to the company. I think Novo Nordisk chose well!

Celebrating Life at NHF

With my heroes Vaughn Ripley and
Barry Haarde
 

The beautiful speech given at NHF by chair Jorge de la Riva stressed caring, and the dangers of indifference. Jorge, the father of a teen with hemophilia, deftly drummed home by a quotation from Holocaust survivor Elie Weisel, whose book Night, I just reread a few weeks ago:

 

“The opposite of love is not hate, it’s indifference. The opposite of art is not ugliness, it’s indifference. The opposite of faith is not heresy, it’s indifference. And the opposite of life is not death, it’s indifference.” ― Elie Wiesel

 
How appropriate to use Weisel to remind our community that if we do not watchdog our own interests, we may be hurt–again. And this is why the theme of this year’s meeting was “Nothing about us, without us.” More and more, NHF (and HFA and other groups) are steering the interests of the community, from research, to data collection, to blood supply safety, to genotyping. We’ve come a long way in 20 years, and paid a hard price.
 
Derek Nelson and Chris Bombardier

Val Bias, CEO of NHF and person with hemophilia, gave a speech on the many and exemplary accomplishments of not only the NHF but of various groups and individuals in our community. During the videos shown, I thought instead of two people who have done extraordinary, history-making things in our community, just this year—Chris Bombardier, the first person with hemophilia in the world to conquer four of the seven summits. And Barry Haarde, who has now ridden his bike three times across America, to bring attention to the public of hemophilia and HIV. It’s nice that we showcased who we did, but Chris and Barry volunteered weeks of their lives to do something no one else has ever done, which are extraordinary feats even without hemophilia!

We did acknowledge them, at the Save One Life Celebration on September 17 at the Intercontinental Hotel in Washington DC, just before NHF kicked off. It was a lovely event, with about 77 attendees, including donors and sponsors. We honored special people who have helped make Save One Life a success so far:

 Over 1,300 people with hemophilia in 12 countries who live in poverty supported directly with financial aid 80 scholarships to foreign individuals since 2012 8 micro enterprise grants in 2014
Over $1.5 million in direct aid!
 
Laurie with friend and colleague Val Bias, CEO of NHF
 

All this goes to people who live on the fringe of life, the poor, the suffering, in places like India, Zimbabwe, Pakistan and Honduras. And we honored Chris and Barry who have raised so much money for us. And our Inspiration Award went to Mark Skinner, former NHF president, WFH president and current WFH USA president (and personal friend) who has inspried me for many years with his brilliant insights, his compassion for the poor and his endless volunteerism. Accepting the award for him was Mike Rosenthal, executive director of WFH USA. We were surprised and pleased to see Doug Loock in attendance, who, back when he worked for the American Red Cross in 2000, gave us our first grant, and was the first supporter to help us!

 

Thanks to NHF for allowing us to hold the even at their event (thanks, Val!); and to ASD Healthcare (thank you, Neil  Herson!) for being our major supporter of the event. Also thanks to Baxter, Novo Nordisk and CVS Health for supporting the event.

 
Best news of all? We picked up 30 more sponsored children as a result! 
 
If you want to learn more or support a child, please visit http://www.saveonelife.net
 
 
 
 

 

Laurie with Neil Herson, president of ASD Healthcare, accepting award for Chris Bombardier
Usha Parasarathy accepting award for Program Partner of Year
 

Great Book I Just Read
Blood Meridian [Kindle]
Cormac McCarthy

The author of No Country for Old Men does it again. This is a masterpiece, an American classic, written with such skill and depth that you cannot skim, cannot rush; it has to be savored, thought about, explored. The main character, a young man only referred to as “the kid,” runs away from home in the south and heads west in the 1800s. He meets many groups and characters, but ultimately joins a scalping posse, intent on capturing as many Indian scalps to sell as possible.  Like many of McCarthy’s stories, the theme is bleak, desperate, dusty and desolate, like the land the kid crosses. The main theme seems to be that evil lurks everywhere: there are no good guys or bad guys in the Wild West: just survival. And every single person, whether Indian, white, male or female, harbors evil deep within in the quest for survival. It’s a somber read, but the writing style alone is like a delicate fabric of words, woven so that you see no seams, only a beautiful, dark, and captivating cloth; worth reading if you want to read something by a master. Five our of five stars.

Be a Hero!

To continue with our updates of programs and services from Pharma, here’s a new and exciting one!

Jeffrey Leiken Master Trainer at Evolution Mentoring

Remember when you were evolving from a teenager to a young adult – trying to assert your independence, work through all the social politics of high school, and figure out the direction of your life? Then consider the challenges of living with hemophilia on top of that – it can add a whole other layer of complexity. That’s why Novo Nordisk is offering HeroPath™ to help youths between ages 15 and 20 better navigate this transitional life stage.

HeroPath will be led by Jeffrey Leiken, Master Trainer at Evolution Mentoring and creator of HeroPath – you may remember his passionate speech about life transitions and personal growth at National Hemophilia Foundation’s 2013 Annual Meeting. HeroPath  will focus on helping participants grow their skills for success in areas including relationships, education, and careers.

Here’s the exciting part: Up to 25 selected US participants with hemophilia A or B* between ages 15-20 will have the opportunity to work directly with Leiken, his team of expert coaches, and their peers at a kickoff weekend in Chicago from August 22-24, as well as continue to receive personalized monthly coaching for the following year.

Visit http://www.changingpossibilities-us.com/HeroPath to complete your official HeroPath™ application, including several multiple-choice questions and an up to 150-word explanation of why you are a great fit for the program. Prefer not to write? Provide a 60-second video explanation instead – just upload your video to YouTube™ and paste the URL into the application form!

All entries must be received by 11:59 p.m. EDT on Thursday, July 17, 2014. Leiken will select up to 25 participants based on responses to the multiple-choice questions and the level of creativity and original thought conveyed through the essay or video entry.

What parents need to know: HeroPath™ isn’t just a weekend retreat – it’s a yearlong program designed to help offer teens or young adults the tools to identify:
·        What direction to move in professionally based on interests, strengths, talents, and natural proclivities
·        What kind of people to associate with personally and professionally (Leiken and his team will help participants give voice to their own values)
·        What kind of person they want to be

HeroPath™ is also structured to help develop their ability to manage their state, stay focused, and perform under pressure to help make better decisions.

Questions? See Complete Official Rules at www.changingpossibilities-us.com/HeroPath for details.

*Participants cannot be on a federal health care program.

This sevice announcement was sponsored by Novo Nordisk.

Inhibitor Summits are Coming!

I was present way back at the first ever inhibitor summit meetings, brainchild at the time of George McAvoy of Novo Nordisk, and funded by Novo Nordisk. Now run by National Hemophilia Foundation (NHF) with funding from Novo Nordisk, NHF is pleased to announce the 2014 Inhibitor Education Summits, designed to specifically cater to your inhibitor educational needs. Come join this dynamic event and interact with expert healthcare professionals as well as other patients and their families for a weekend of education designed to improve your overall health and quality of life.

The Summits provide:

• Travel and lodging financial assistance provided for eligible patients and their caregiver(s)

• Both locations accessible to wheelchairs and other mobility devices

• Four different educational tracks tailored to suit your needs as a patient or caregiver

• An Interactive Education Camp for Youths, including an off-site activity (Ages 4-12)

• Childcare for infants-3 years old

To learn more, contact NHF:  877-560-5833 or inhibitorsummits@hemophilia.org

or go to https://www.nhfinhibitorsummits.org/register.aspx

ADVERTISEMENT
HemaBlog Archives
Categories