What’s Happening with Helixate® FS?

We’ve had a tremendous number of factor products enter the US hemophilia market the past few years. in fact, we have exploded from under 10 to about 26 now, not including inhibitor products! 
Rarely do we speak of a product exiting the market. But as of December 31, one will no longer be manufactured—Helixate® FS (Antihemophilic Factor (Recombinant)). 
I’ve read on Facebook some conspiracy-theory explanations!  But here are the facts:
1. Helixate® FS is the exact same product as Kogenate® FS. Exactly.
2. Both products are made by Bayer Corporation. The therapy that makes Kogenate FS has been sold to CLS Behring annually as part of a lawsuit settlement many years ago. CSL then markets the product as Helixate® FS. This was good for CSL, which at the time did not have a recombinant factor VIII product.
3. The resultant contract is coming to an end; CSL Behring and Bayer will no longer partner to product and market Helixate FS.
4. And CSL now has recombinant FVII products that it has created, namely Afstyla (Antihemophilic Factor [Recombinant], Single Chain, a next-generation factor VIII with twice-weekly dosing available).As with Helixate FS, Afstyla uses the Mix2Vial® system, which will keep patients’ reconstitution process consistent. 
5. CSL wants to assure the community that it will update patients, prescribers and specialty pharmacies with updated supply information. Community members can sign up here for direct updates.
6. The products that are already manufactured will still be in the distribution pipeline, probably through to early 2019. This gives patients and their families plenty of time to consider treatment options. 
If you currently use Helixate FS, you should speak with your HTC hematologist soon about what treatment options you have, given your insurance policy and specialty pharmacy. You can also contact a  CSL Behring My SourceSM Care Coordinator at 1-800-676-4266 Monday–Friday, 8 AM to 8 PM ET–but please speak with your hematologist, who can help you find the right therapy for you.
Helixate FS is a great product, and there are many more also great to choose from. Use our factor chart here to start looking. Good luck and always Factor Up!

This is an unpaid public service announcement.

Name Game, Game Change?

I’m thinking “game” this weekend because the Patriots are in the Super Bowl, again, and I will need to watch it like the rest of Boston. I only watched my first football game two years ago when, surprise surprise, the Patriots were in the Super Bowl. Every sports fan knows the Patriots, I am told. It’s easy to cheer for your home teams when the names (Red Sox, Patriots, Bruins, Celtics) endure for decades. It’s harder when it’s the drug companies that make your factor concentrate. There’s a lot of game changing going on lately.

The news was announced just three days ago: Biogen, maker of Eloctate and Alprolix, has spun off its hemophilia division, which has now become an entirely separate and new company called Bioverativ.

Biogen’s two revolutionary products, the first ones with a longer half-life, were game changers. Now there are a few more choices for longer half-life products, but these were the first and were rolled out with much fanfare. Then boom! Three years later, Biogen doesn’t want them anymore.

This is just a reminder to us patients that this is a marketplace, and we are consumers. And companies need to make business decisions—hence the “game.” As consumers, it’s up to us to understand how the game is played, and who are the players. The names have been changing, more rapidly than I can keep up with in the specialty pharmacy arena, and those are truly game changers.

In the factor concentrate manufacturing arena, we had two name changes just in the last few months: Biogen to Bioverativ, and Baxalta to Shire. But this has been happening for years in our community, so here’s a review. It’s worth knowing the players—of which YOU, the consumer, are the most important!

Remember Alpha? Those of you who use Alphanate or Alphanine may wonder why these drugs are called that when sold by the Spanish company Grifols. Simple: Grifols bought Alpha Therapeutics hemophilia therapies years ago and simply kept the drugs’ names the same. (It’s hard to change a drug’s name.) In 2011, Grifols also bought Talecris, making it the third-largest global manufacturer of plasma-derived therapies. Oh, and Talecris? It was a spin-off from Bayer, which didn’t want to keep plasma-therapies anymore. Bayer’s plasma-product Koate-DVI went to Talecris, and Bayer kept Kogenate FS. If you look at the Koate-DVI packaging, you’ll still see the Bayer primary color line around the box!

Baxter Healthcare produced factor concentrates like Recombinate, Advate, Hemofil M and FEIBA. It spun off its hemophilia division, which became an independent company called Baxalta. That didn’t last long. Shire, an Irish pharmaceutical company, liked what it saw and scooped it up. All the former Baxter/Baxalta products now belong to Shire.

The biggest name changer is CSL Behring. I knew it in 1987 as Armour Pharmaceutical. Then in 1996, Armour and Behringwerke (a Geman company) formed a joint venture known as Centeon. Things happen fast: in 1999, Centeon became Aventis Behring. Why? Armour’s parent companies (Rhone-Polenc Rorer and Hoechst) merged to become Aventis. Meanwhile, CSL (an Australian plasma therapies manufacturer) acquired ZLB Blood Transfusion Services. In 2004, CSL acquired Aventis Behring, to form ZLB Behring, later called CSL Behring.

(There’s a comprehensive timeline of this interesting company here.)

Genetics Institute: anyone remember that? They developed BeneFIX and ReFacto (no longer on the market). It evolved into Wyeth, and then was bought by pharma giant Pfizer Inc.

Bayer is one that seems to have stayed the same, but it’s had name changes too. Bayer bought Cutter Labs in 1978 and Miles Labs in 1979. In 1995, they all became Bayer. I think Novo Nordisk (Denmark) has stayed the same… so far!
And some companies dropped out altogether, like the American Red Cross.  And new ones entered, like Octapharma (Switzerland) and Kedrion (Italy), tapped to distribute Koate DVI for Grifols. And Aptevo Therapeutics… oh, which was owned by Cangene (Canada) first, then Cangene was bought by Emergent Biosolutions in 2014! And they all originated from Inspirational Biopharmaceuticals, which in 2013 sold all its product rights to them, and dropped out of the game.

More passes than Tom Brady!

Whew! It’s amazing tracking the history of just the name changes: but we also need to know products. We are tracking who makes what on our website Hemophilia Factor Chart by Brand, available as a download. We are updating it all the time… a necessity to keep track of this ever-changing game, and business.

Ice Ice Baby: Hockey and Hemophilia

Janet Reimund (CSL), David Quinn, Laurie Kelley

We’ve all been told not to let our kids with hemophilia play hockey. One kid had no choice—he grew up in Rhode Island surrounded by sports lovers, and gravitated toward hockey. He excelled at it. So much so that he tried out for the US Olympics team in 1988.

Meet David Quinn, now head coach of one of the country’s best college hockey teams, the Boston University Terriers.
How can all this be? A guy with hemophilia, playing hockey?
David shared his remarkable story Saturday evening at Boston University, at a “Common Factors” event hosted by CSL Behring. In the audience were families with hemophilia B, some of whom came from as far away as New York to see David, and to attend a hockey match after the presentation.
Key to note is that David went undiagnosed most of his life, until he tried out for the Olympics. He knew he got bruised bigger and harder than his teammates; his ankles and elbows would ache. But he somehow avoided any broken bones and major contusions. That in itself is miraculous, given the brutal nature of the sport.
During the tryouts for the 1988 Olympics, he developed compartment syndrome, which happens when blood seeps into the fascia surrounding muscle tissue and is essentially trapped. This can result in nerve damage and even amputation. But David had excellent care, and had to wait six weeks to recover from surgery. When he healed, he was back on the ice. His doctor made him get a blood test, where they discovered he had mild hemophilia B.
Even knowing all this, he eventually was drafted professionally, in 1992 by the New York Rangers, and in 1992-3 with the Cleveland Lumberjacks. He never made it to the nationals, as he admits he had missed too much practice and training. Instead, he turned to coaching and never looked back.
David easily engaged with the audience, was witty and warm, and his message was: find your passion, take your factor, live your life.
He has a major position now as head coach, and so with a smile and wave, he had to dash out to coach that night’s game. The families stayed a bit longer to hear Gina Perez, mother of two boys with hemophilia B, and final words from Janet Reimund of CSL Behring.
Gina Perez

It  was a great evening of learning and motivation, and socialization. I  got to see so many friends that I rarely get to see anymore as our hemophilia meetings become more numerous and frequent. In particular Jessica Graham and Wayne Cook—hey guys! And I had actually met David 20 years ago, when I wrote an article about him for one of my children’s magazines. I can actually say I knew him way back when.
Thanks to CSL Behring for hosting this, and having it in my backyard practically.  
My apologies to David but I’m not into hockey (I kind of like boxing, actually) so I skipped the game but kept the memories. Wonderful evening!

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News from Pharma

So much has been happening in the hemophilia community lately, I decided to post some news releases about new products and new services from three different pharma manufacturers. Last week we shared the news about Biogen Idec’s Eolctate approval; below are more interesting items, straight from the horses’ mouths.

From CSL Behring
New–CSL Behring’s world-class biotechnology manufacturing facility in Broadmeadows, Australia. The facility is for late-stage production of hemophilia therapies and is one of the largest and most advanced of its kind in the world. Leading-edge science is at the core of the $250 million expansion, which is expected to drive long-term growth in CSL Behring’s promising bleeding disorders portfolio.
In particular, the facility will produce novel recombinant therapies on a large scale for international clinical trials. Our recombinant technology uses a unique recombinant-albumin-fusion platform, which we believe could offer distinct clinical advantages and improve patient experiences.  Suffice it say, CSL Behring’s steadily-rising research and development spending has played a key role in developing these and other new technologies. For example, in 2011/2012 we spent $368 million on R&D (about 8% of total sales). And over the last 5 to 10 years, we have advanced an enviable pipeline with exciting product candidates that may offer enormous treatment benefits. 



From Baxter Healthcare

Mobile video gamers looking for the next app for their smartphone or tablet now have an option developed specifically for the hemophilia community. Baxter Healthcare Corporation has created a free multi-game app, called Eco-Trek, primarily for people between the ages of 15 and 32. Yet based on the reactions of pre-release product testers, Baxter expects that Eco-Trek will appeal to people of all ages, from adolescents waiting to be seen at hemophilia treatment centers, to older adults that enjoy competing in video games. Eco-Trek, which is available to everyone regardless of their treatment, is the first socially connected video game designed for the hemophilia community. With hemophilia-specific content and Facebook score-sharing built into the game, Eco-Trek is a first-of-its-kind mobile app. A national leaderboard will create competition among players in Eco-Trek’s three online adventures, each of which have 10 levels:
·     Bushwhacked! – Find your way through a forest maze without losing supplies from your backpack
·     Alpine Summit – Compete in an uphill race against the clock, dodging obstacles along the trail
·     Roughin’ It – Set up camp and complete specific tasks while pesky critters try to get in your way

“We are really excited about Eco-Trek because it’s simple, interactive, and offers important educational information about hemophilia A and ADVATE [Antihemophilic Factor (Recombinant)], while you’re competing in fun activities,” said Jeff Schaffnit, senior director of US Hemophilia Marketing. “For teens and young adults with hemophilia, this type of format can make it a lot more fun to gain knowledge on hemophilia.”

Eco-Trek is a free app available for download from the Apple App Store and Google Play. For more information, contact your Baxter representative.

From Pfizer

Pfizer understands that health care costs can be a challenge for those with hemophilia and their families, and strives to provide access and patient-centered support. Therapy is just one part of the equation, which is why we offer financial support for eligible patients as well as educational programs for patients with hemophilia who infuse with Pfizer Hemophilia Recombinant Factor products.

We’re pleased to share with you three program updates and hope that you will help us share this news with the hemophilia community. As of April 1:

•    Pfizer increased the maximum cap on its Pfizer Factor Savings Card
Program. Eligible patients can now save up to $5,000 annually on copay, deductible and coinsurance costs. Terms and conditions apply. Visit PfizerFactorSavingsCard.com to learn more and fill out a brief registration form. If you have any questions about the use of this Pfizer Factor Savings Card, please call 1-888-240-9040 or send questions to: Pfizer Factor Savings Program, 6501 Weston Parkway, Suite 370, Cary, NC 27513.

•    To continue to meet the changing needs of today’s patients, Pfizer is consolidating its various prescription assistance programs, formerly known as Pfizer Helpful Answers, into a new comprehensive program called Pfizer RxPathways. Pfizer RxPathways is a family of prescription assistance programs that provides eligible patients with financial support and reimbursement support services. Access the program today by visiting PfizerRxPath.com.

•    The Soozie Courter Hemophilia Scholarship Program, a tuition assistance program
for students with either hemophilia A or hemophilia B, is now accepting applications for the 2014-2015 school year. To apply, please visit http://www.hemophiliavillage.com/resources-support/scholarship-assistance 

NOW, CSL

I was unable to attend the fabulous NOW conference in Arizona this weekend, for women with bleeding disorders, where I was supposed to give a speech on Saturday. This assumes you have a voice. Which I did not. Returning from the Caribbean with a devastating chest cold (I think I inhaled mold from the AC system in the old hotel I slept in) and a voice that made me sound like a serial killer with laryngitis, I opted sadly to stay home and recover. So now (NOW) I don’t have a report on this great event, funded by the way by CSL Behring.

Speaking of which, here’s a book review by our colleague Richard Atwood in North Carolina about a book about CSL, or CSL Behring as we know it now. Even if you don’t read the book, the facts below are interesting. Having a business background, I’m always interested in knowing how these companies formed, and became what they are. Especially while I was in Barbados, a country which imports factor VIII from two companies, CSL Behring being one of them. Some of the there doctors didn’t realize it’s an Australian-based multinational company. 


Committed to Saving Lives: A History of the Commonwealth Serum Laboratories
A.H. Brogan, 1990,  Melbourne, Victoria, Australia: Hyland House Publishing Pty Limited. 301 pages.
SUMMARY: The government of Australia formed the Federal Serum Institute in 1916 and subsequently changed its name to the Commonwealth Serum Laboratories the following year. Despite its name, CSL had the mission to prepare vaccines, serums, and anti-toxins. As a pioneering public-sector manufacturer, CSL was prepared for the 1918 influenza pandemic by providing the diphtheria and tetanus immunizations. Subsequent public health achievements were the extraordinarily quick provisions of insulin in 1923, penicillin in 1944, Salk antipoliomyelitc vaccine in 1956, anti-D antiserum to prevent Rh disease in 1966, and tuberculosis vaccine. Although CSL had the statutory authority to run a pharmaceutical business, tension persisted for the next 75 years as to whether CSL was a commercial manufacturer or a national public health and research organization. Regardless, the government wanted a profit from a company that provided pharmaceuticals for both humans and domesticated animals.
   CSL conducted blood typing research, and then for the Second World War preserved whole blood and dried human serum for blood proteins. Whereas the UK, USA, and Canada used plasma for war casualties, CSL used serum to prevent spreading hepatitis. The war stimulated blood fractionation around the world beginning in 1941, using either the ethanol method developed by Cohn at Harvard or the ether method developed by Keswick in the UK. CSL implemented the Cohn method in 1945 using voluntary non-paid blood donors through the Australian Red Cross. Production began in 1953 for globulin, albumin, and fibrinogen, then in 1961 for AHG using the Cohn method modified by the Blombacks of Sweden, followed by cryoprecipitate until 1969, AHF in 1970, AHF HP (high purity) in 1972, Improved Intermediate Purity AHF in 1979, PPSB (Prothrombin, Proconvertin, Stuart Factor, Haemophilia B Factor) in 1968, and Prothrombinex in 1972. After learning from America in 1982 about the virus that was later to be called HIV, CSL began experiments in 1983 of heating AHF products and then implemented heat sterilization of FVIII products in 1984. CSL also produced the confirmatory Western blotting test for HIV-I beginning in 1984. Meanwhile, CSL upgraded and expanded the facilities for plasma fractionation.
COMMENT: The history of CSL for its first 75 years up to 1990, whose book title has the same acronym, was written by its recently retired personnel director. As an insider, the author confesses to be a partisan, and rightfully highlights the many medical accomplishments, but also includes some of its misfortunes. The book, which includes 121 photographs, 17 pages of Notes, 3 appendices, and a 9-page Index, ends with several questions regarding an uncertain future, whether CSL would continue to be owned by the government or be a candidate for privatization. CSL is a model for a government-owned commercial enterprise in the public health sector that accomplished its mission. It is also a case study for the continual difficulties imposed by government meddling in the public health research, development, and commercial activities that hindered its mission. Blood and blood substitutes were only a small part of the many commercial activities performed by CSL for the citizens of Australia and world-wide.

Great Book I Read
The Greatest Salesman in the World by Og Mandino [Kindle]

Published in 1968, this has become a timeless classic not just for sales, but for business, for life. A very simple story, set in the time of the birth of Christianity, with profound principles about being your best, making your life, not being a victim to chance but defining who you are, what you are and what you are to become. You can finish this in one sitting, but guaranteed it will stay withyou a long time. You can read this as a business self-help book, or as a way to build better character and life. I read it a long time ago for one and now read it for the other. Much in the style of Paolo Coelo, though Og came first! Five/five stars.
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