Novo Nordisk

Coming Changes: Kogenate® FS Discontinued

Laurie Kelley June 5, 2022

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

Laurie Kelley March 8, 2022

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!

iPhone App Helps in Diagnosis

Laurie Kelley February 20, 2011

Here is the latest in very cool applications for the iPhone. I don’t think I have yet seen one that helps in the diagnosis; I believe this is the first. This is from Novo Nordisk. This app does hematologic testing, including prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests. This resource has been developed to help you diagnose coagulation disorders. Here, you have access to the following features:

Lab Value Analyzer: Input the patient’s coags, and the clinician receives a list of possible diagnoses
Diagnostic Algorithm: this walks a clinician through step by step to narrow the possibilities of the diagnosis
Acquired Hemophilia

Check it out at http://www.coagsuncomplicated.com/Home.aspx

Great Book I Just Read
Annapurna: A Woman’s Place by Arlene Blum

Annapurna is the 10th highest peak, and renowned for avalanches. It takes extreme mental toughness and physical endurance. Of the 4 successful ascents of Annapurna only 2 men had reached the top each time. Arlene Blum became the first woman to ever summit it, and led an all woman team. She was met with skepticism and ridicule, and also great enthusiasm. This book details the preparation and the journey, and her struggles as a leader. It’s a great book about leadership. I had my own doubts reading it, as Arlene seems so insecure. But she is candid, and in the end, her leadership really shines. “My scientific training contributes to a natural tendency to see all sides of an issue. I tend to agonize about the full range of possibilities, and even after I’ve made a decision, to worry interminably about whether it was the right one.” Sadly, two women climbers on the team died when they chose to strike out on their own, against the wishes of the others to summit after Arlene.

Arlene Blum has played a groundbreaking role in US women’s mountaineering. She led the first women’s team up Mt. McKinley; was the first American woman to attempt Mt. Everest; and has played a leading role in more than 20 mountain expeditions worldwide. Three stars.

World’s First Inhibitor Book Published

Laurie Kelley November 1, 2010

Three years in the making, and it’s finally here–Managing Your Child’s Inhibitor, the world’s first book on inhibitors. At 279 pages, this is a comprehensive look at everything parents and patients need to know about so many aspects of inhibitors. From ITI to pain management, from insurance to attending school, this book weaves together advice from over 40 families with hemophilia, and includes the latest research and knowledge to give you a guidebook through every stage of inhibitor management.

The book is authored by me and my friend and colleague Paul Clement, who also has a son with hemophilia. The idea for the book was born during the Novo Nordisk Consumer Council meeting of 2005, after I heard the anguish, the suffering and saw the tears of so may families with inhibitors. I couldn’t believe what I was hearing. It was as though inhibitors were a separate disorder. I didn’t know people with hemophilia still suffered like that in the US.

As you may know, an inhibitor is an antibody the blood makes, directed against factor VIII or IX. The body doesn’t recognize the infused factor as belonging to the body–it sees it as a foreign invader and mounts an attack. The body produces antibodies which latch on and neutralize the infused factor. It renders it useless, and the blood continues to bleed. Very scary.

I learned so much creating this book: about pain management, different protocols, and the different products. But most of all, the incredible strength of people with inhibitors and their families. They are truly heroic people. I hope the book is a testament to their courage, and also helps give guidance to families new to inhibitors, so they can learn from their peers, and find the best route to elimination or at least management of the inhibitor.

My thanks to Novo Nordisk, which gave us an unrestricted grant to research write and publish this book. Novo Nordisk is the manufacturer of NovoSeven® RT, a bypassing agent used in the treatment of acute bleeds in patients with hemophilia and inhibitors.

You can order the inhibitor book via our website at https://www.kelleycom.com/books.html

From Diabetes to Hemophilia

Laurie Kelley August 23, 2010

Novo Nordisk is best known throughout the world as the leading manufacturers of insulin to treat diabetes; in the hemophilia community, it is best known for NovoSeven®RT, an inhibitor bypassing agent, a miracle drug to many. (Photo: with Lars Sørensen and Stephanie Seremetis)

I visited Novo Nordisk’s headquarters in Copenhagen, Denmark on Friday, to speak with CEO Lars Rebien Sørensen, arguably the most famous businessman in Denmark. The country is very small, about the size of my home state Massachusetts, and Novo Nordisk is its biggest company. Denmark is very pretty, a haven and heaven for cyclists, as everyone seems to bicycle everywhere. It doesn’t take long to get to Novo Nordisk from my hotel; indeed, it wouldn’t take long to get anywhere in this diminutive and charming country.

I am struck by how understated Novo Nordisk is. The buildings, designs, interiors are all minimalist, low key, humble even. Entering the executive suites, I am surprised to see that no one has offices per se; just desks, no walls, no glass, only hip-high borders to segregate one work area from another. Quite the opposite of the US and most other places, where executives usually prefer to have corner offices with glass, big cherry furniture, and doors for privacy. Here, everything is open, transparent.

Lars Sørensen came to the US in March (see blog.kelleycom.com/2010/03/spotlight-on-inhibitors-novo-nordisk.html#comments) to meet for the first time the key opinion leaders in the hemophilia community, and to also meet some patients. This meeting now was to follow up on points we touched upon, including products in the pipeline and the company’s policies for international humanitarian donations of product.

I first had lunch with Lise Kingo, executive vice president, Corporate Relations, and Charlotte Ersbøll, corporate vice president, who graciously filled me in on their programs. Next, a meeting with Charlotte and Trine Thomsen; Trine is heading the HERO project, a massive multicounty research that will attempt to quantify and publish responses about the psychosocial aspects of life with hemophilia. (Watch our blog for more news about this)

Last, a meeting with Lars and Dr. Stephanie Seremetis, formerly with a New York HTC. I had heard of Stephanie for so many years and each of us couldn’t quite believe we had never yet met! Lars is an energetic and welcoming executive, and we spoke for an hour about:

1. New products. We spelled out some of Novo Nordisk’s new products in research in the February issue of PEN: long-acting FVIIa; recombinant FVIII (to take on Advate and now Xyntha); a long-acting rFIX product; and a FXIII (13) product. We spoke about causes of inhibitors, patients’ personal experiences and what physicians are requesting (nonimmunogenic factor VIII—in other words, factor that does not cause inhibitors, although it’s not clear yet if how and why factor causes inhibitors)

2. Hemophilia in developing countries. One of my passions is to increase product donations to developing countries, and Novo Nordisk as of yet is not a big donor—although they donate a lot of product in the US, its main market. One problem is production itself: a specialty product for such a rare complication of such a rare disorder means not a whole lot of product sits on the shelf anywhere in the world. In other words, there isn’t much to donate. At Project SHARE we are over the moon when a rare donation of NovoSeven reaches us from some patient, HTC or homecare company, and usually it’s only a few boxes. It will be a while before donations become a routine thing and for now we will be dependent on third parties who donate NovoSeven to us. Novo Nordisk supports Project SHARE’s operating expenses, as do quite a few other pharmaceutical companies and others, and for this we are glad, but we look forward to the day when we and others can also expect product donations.

One interesting insight is Novo Nordisk’s take on product donations. As you can imagine, donating tons of products (just like doling out money to charities without expectation of anything in return) into a poor country can lead to dependency, which only perpetuates a bad situation; this is a constant threat to donations of anything in the humanitarian field. Lars explained that right now, the Novo Nordisk diabetes model has been extremely successful throughout the developing world, and perhaps this is the model to be followed in the future with hemophilia, when emerging markets like India and China start to purchase products. In diabetes, Novo Nordisk’s biggest single financial commitment is its annual donation to the World Diabetes Foundation. At the company’s Annual General Meeting in 2002, the shareholders made an agreement obliging the company over a 10-year period to make an annual donation of 0.25% of the net insulin sales for the preceding financial year (not to exceed approximately $12 million or 15% of taxable income).

In diabetes, the company’s donation policy is tied to product sales: higher sales mean a higher donation to the World Diabetes Foundation, and you can see where this would make good business sense. Also, clinics get established in this model; I saw some of these while traveling in Africa this year. Novo Nordisk is big in Africa, and does a lot to help those with diabetes.

In hemophilia, Novo Nordisk donates about $3 million to the Novo Nordisk Haemophiia Foundation (NNHF). NNHF supports sustainable local and regional projects as well as the advancement of relations between healthcare professionals, patient associations and authorities within the hemophilia community.

In hemophilia, a model like the diabetes model will take a long time to develop. But there are signs: patients in developing countries are integrating and speaking up like never before, thanks to information’s and resource exchange on the internet, and entities like the World Federation of Hemophilia, which brings patients, physicians and nonprofits together to learn and network, and to institute programs that train medical staff. Even at Project SHARE we sometimes, often, dangle product donations like a carrot to get patients organized and to take action. It works, no doubt. But people are still dying, weekly, and we will always need to donate life-saving products with no strings attached sometimes.

Hemophilia is a rare disorder, an expensive one, and we are a small community. Changing the current situation in poor countries will take a long time, and I plan to stick around for as long as humanly possible to ensure that change happens. Just so happens that Novo Nordisk’s slogan is “Changing Possibilities in Haemophilia®” and that needs to be believed no where more importantly than in hemophilia, by the patients, governments, humanitarians and very companies that provide the product. (Photo: Hartnell of Jamaica, who died of inhibitor complications in August 2009 at age 20)

Thanks to Lars and his team for welcoming me, for partnering with us, for sharing so much of their time and ideas. Let’s count on changing possibilities in the near future and make some dreams come true for those patients in countries where no treatment is available now.

Great Book I Just Read
Lord Jim
By Joseph Conrad
This classic was the basis for the movie “Apocalypse Now.” A young sailor, Jim, runs from his past by taking job after mundane job in far ports in the 1800s. He had served as first mate on the Patna, a ship carrying 800 Muslim pilgrims, which hit something in the dark waters one night during his watch and threatened to sink. Jim and the rest of the crew abandoned ship, thinking there is no hope of saving the passengers. The ship does not sink, and when Jim and the crew are rescued, their reputations are ruined. This story within a story is narrated by Marlow, an old sailor, who is fascinated by Jim, and spends the rest of his life trying to help the young man find redemption. Eventually Jim is offered a job to run a trading post in the far reaches of Southeast Asia, so remote few white people have ever visited. Eventually, his leadership and good deeds earns him the title “Lord Jim,” and he is beloved by the people. Soon his honor and character are tested as never before, earning him a last chance at redemption. The writing is amazing, the structure complex, superb, but difficult: some paragraphs are three pages long, and the story within a story can be confusing at times (think of the movie “Inception”!), but a great read; not to be missed. Four stars.