CSL Behring

NOW, CSL

Laurie Kelley February 23, 2014

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.

The Time is NOW!

Laurie Kelley February 27, 2012

I’m writing from Phoenix, where a weekend of education and networking for people with von Willebrand disease just wrapped up. The Arizona Hemophilia Association hosted the first annual national von Willebrand conference. Cindy Komar, the very capable executive director of the AHA and her team assembled a great cast of speakers and facilitators, and provided entertainment for the kids for the weekend-long event. It was a tremendous conference and hugely successful.

Saturday morning started with a rousing speech by Jerry Ervin, who shared his hard-luck story and how he overcame many environmental challenges to become educated and a motivational speaker. Then Drs. di Paola and Kouides shared latest developments in VWD treatment. Afterwards came break out sessions, in which I presented the changing insurance climate and how we can protect our access to treatment. Other sessions included dental care, financial planning, parenting and atypical VWD.

25 states were represented at the event, and I saw many friends in the community, from patients and families, and even my dear friend Julie Winton, with whom I climbed Kilimanjaro last August!

This morning we had two great speakers, Jeff Leiken, who spoke about attitude and removing bias from our way of looking at the world, and Pamela Crim, who shared her personal story, from a stroke at age 19 while just a newlywed, to adopting two little orphans from Juarez, Mexico–truly an incredible life story!

Outside the teens were treated to a demonstration by a hot air balloon pilot, Michael Glen. His inspiring talk about ballooning focused not on the fact that he’s a paraplegic (the only one in the world who is also a balloonist) but on how nothing can stop you from achieving your dreams. He was fantastic! I’d highly recommend him for teen workshops (www.rollingpilot.com)

We closed the event by paying our respects to the lady who was the pioneer in VWD advocating and educating, Renee Paper, my co-author and friend. We keenly felt her absence, but we’re pretty sure her spirit was with us.

Thanks to CSL Behring for the funding for making this fantastic event happen, and to the Arizona Hemophilia Association for their time and dedication.

Lucky Number 13 part 2

Laurie Kelley March 14, 2011

Just last week I blogged about CSL Behring’s new factor XIII concentrate Corifact. Now I’ve learned that Novo Nordisk announced that a Biologic License Application (BLA) has been submitted to the US Food and Drug Administration (FDA) requesting the approval of a recombinant factor XIII compound for those with congenital Factor XIII (FXIII) deficiency.

Corifact is made from human blood plasma. This new drug is made from recombinant technology, which uses genetic engineering.

Factor XIII deficiency has a prevalence of one case per two million people, with an estimated 600 diagnosed patients worldwide, making it one of the rarest bleeding disorders.

A press release from Novo Nordisk states: “Positive results from a phase III trial examining the efficacy and safety of recombinant factor XIII for the prevention of bleeds associated with congenital FXIII deficiency showed that when compared to a historic control group of individuals who did not receive routine FXIII infusions, preventive treatment with monthly recombinant FXIII injections significantly decreased the number of bleeding episodes requiring treatment. These data were presented at the American Society of Haematology (ASH) meeting in December 2010, and marked the first completed phase III study conducted to study the use of a recombinant FXIII treatment to prevent bleeding episodes in congenital FXIII deficiency patients.”

It’s all great news for those who have factor XIII deficiency, and with the sad news from around the world, especially Japan, we need good news.

Good Book I Just Read

No One Here Gets Out Alive
Jerry Hopkins and Danny Sugerman

I’m continuing my reading streak on The Doors, the 1960s band that took America by storm. In this book, Jerry Hopkins (Rolling Stone) and Danny Sugerman (then teen office boy for Doors) profile the madness and magnificence of Jim Morrison, front man and silky-voice singer, whose depravity and self-destruction eventually upstaged the music itself and his three talented band members. The book details Morrison’s schizophrenic adolescence in which he, with an IQ of 150, devoured sophisticated philosophy and poetry books, and wrote poetry himself, but yet immaturely and cruelly harassed his younger brother, scared the elderly and openly mocked cripples. The first few chapters alone might end any hero worship of The Lizard King. The book recounts chronologically how the Doors formed, their skyrocketing rise to fame, and the toll of fame on the unstable Morrison. They were only 21-23 years old, in a music industry and culture awash in drugs, but why did only Morrison succumb to the pressure? The book is insightful into the music industry of the 1960s. It’s incomplete in that no other character is truly explored: Manzarek, Densmore and Krieger are barely mentioned. They were together for six intense years: how did they cope with Morrison’s descent into madness? The book also sheds little insight into Morrison’s state of mind, or why he acts as he does other than the drugs or alcohol, but factually states a portrait of a seeming sociopath: the dozens of paternity suits, his wanting his child to be aborted because he simply didn’t want one, his cruelty to his mother when he performed, his promiscuity and debauchery.

It’s hard to reconcile the deep thinker with the raging drunk. Perhaps the book doesn’t go deep enough into Morrison’s psyche, but then, Morrison didn’t seem to let anyone in. He internalizes his pain, which seeps out in frightening rages, and then is dampened by alcohol. One only needs to look at his photo progression in just six years: from sleek, sexy rock star to bloated, bearded drunk. I don’t think the pain was from being a frustrated poet or even a rock star; that’s putting the cart before the horse. His pain was chronic, malignant. Poetry was one expression; rage and cruelty was another. Adoration from the masses was one treatment; alcohol, maybe heroin, was another, and became the final exit.

Morrison helped put the Doors on the map, and he destroyed the Doors by destroying himself. Forty years later, it seems we will never know what drove Morrison to the edge, and then over. The authors skim over any analysis by comparing his angst to being like the Greek god Dionysus, or part of the Beat generation, or expressing himself like the Indian shamans he revered. But this is shallow. Looking back today, Morrison was an emotionally disturbed artist who sought to medicate his pain through alcohol, and expressed himself through rage. Incredibly, he left a legacy of beautiful, mystical music that captured a unique time in America, and the black hole of his inner life. And we are drawn to such people, scared of them, and yet worship them. Despite the incomplete picture the book paints, it was a great read and I could not put it down. Three stars.

Lucky Number 13

Laurie Kelley March 4, 2011

When is the number 13 lucky?

We now have a factor concentrate for people with factor XIII deficiency. CSL Behring, makers of Helixate FS, Monoclate P and Mononine, was granted FDA approval for their factor XIII concentrate Corifact, indicated to treat congenital factor XIII deficiency. This is the first and only U.S. approved treatment for factor XIII-deficiency and the fourth new product that CSL Behring has brought to the U.S. market in the past two years. Corifact is already available for use in 12 countries throughout the world under the trade name Fibrogammin- P.

Factor XIII deficiency, also known as fibrin-stabilizing factor deficiency, is rare, affecting one in two million, with an incidence in the U.S. of approximately 150 people.

Symptoms include bleeding from the umbilical cord after birth, poor wound healing, miscarriages, subcutaneous bleeding, and excessive bleeding in joints and muscles following trauma. Patients lacking the FXIII protein are also at high-risk for intracranial hemorrhage (ICH), bleeding inside the skull that can be life threatening. Studies have shown that between 25- 60% of factor XIII deficient patients will experience an ICH at least once during their lifetime.

This is great news for those with factor XIII deficiency. For more information, please see www.corifact.com and contact your HTC staff.

Great Book I Just Read
Riders on the Storm by John Densmore

“There’s the Beatles, the Stones, and the Doors,” says Paul Rothschild, producer of one of the greatest bands of the sixties. Drummer John Densmore was only 21 when he joined with three other California students to form a band that would soon skyrocket to the top at a time when the US was a nation at war in Vietnam, and with itself. With quiet Robby Krieger on guitar, methodical and rational Ray Manzarek on keyboard and Adonis-look-a-like singer Jim Morrison, the band was like no other. With no bass player, they combined blues, jazz and psychedelic rock, with some Indian strings and often very dark lyrics, about death, murder and rage. And no wonder: Not long after forming, Densmore writes about their iconic lead singer, “I’m in a band with a psychotic.”

The book is captivating. It starts in Paris, 1975, with Densmore visiting Morrison’s grave, four years after his death at age 27 on July 3, 1971 from an overdose. Returning to the hotel, he pours his feelings out in a “letter” to Morrison on the hotel stationery, which then gets interspersed throughout the book with his recollections. His memoir details his time in the band, returning now and then to the ongoing letter, and towards the end, “updates” Morrison on events of the 1980s and 1990s. Interspersed are appropriate lyrics from their songs, so that the book itself becomes quite artsy. The book gives excellent insight into what the 60s were like, what it’s like being in a band on the rise and what it was like to survive the onslaught of Jim Morrison. What’s missing, though, is what “The Lizard King” was really like. We get snapshots, snippets, and stories, but it’s as if Densmore viewed Morrison at arm’s length, even though he intensely shared six years with him. He was in awe of Morrison—who wasn’t?—and scared of him, and rightly so. Though he feels guilty at not being able to help Morrison, we have to remember he was only a young man from a humble Catholic background, ill equipped to cope with sudden stardom, wealth and the phenomenally complex, creative and self-destructive Morrison.

As if to highlight the detachment Densmore had with Morrison, Densmore dedicates the book to John Lennon of the Beatles, one of Densmore’s heroes, and also mentions Lennon’s assassination in his “letter” to Morrison, yet doesn’t mention or maybe doesn’t even know that Lennon was assassinated on Morrison’s birthday, a fact he should know as Morrison and Densmore were born only a week apart.

“We sensed rage and a possible explosion too near the surface to mess with in dealing with you,” Densmore writes in his letter to the now dead Morrison. “It seemed to have a lid on it—Pandora’s box with all the demons that wanted to be released. We never opened the box… we had to deal with your demons seeping out the side.” They seeped out and poisoned everything; the Doors had to cancel a 20-city tour when Morrison was arrested in Miami for indecent exposure at a concert (he was just pardoned this past December!). The charisma, lyrics and stunning voice of Morrison helped make the Doors a success; his addiction, rage and irresponsibility destroyed them. The book was published in 1990 and Densmore writes, “Well, we’re going on 20 years and there’s no end in sight” of the fascination people have with the Doors. On July 3, it will be 40 years since Morrison’s death, and the Doors are almost as popular as ever. I picked this book up and finished it 5 hours later—it’s compelling, honest, shocking and eye opening. A great book about one of my favorite bands and my favorite singer—for no one could sing like Jim Morrison. Three stars.

Do Not Pass Go; Do Not Collect $3.1 Billion

Laurie Kelley June 22, 2009

The game of “Monopoly” is over– at least that’s what the Federal Trade Commission would have called it. Worried that CSL Behring would become too big after acquiring Talecris, and concerned that there was some antitrust issues, the FTC slapped the wrists of these two billion dollar plus companies and announced it would oppose the merger through the US courts, if necessary. Talecris management decided to withdraw from the $3.1 billion takeover deal by CSL Behring.

The US FTC opposed the proposed merger by alleging that the US plasma market was a tightly-controlled oligopoly, and that the merger would violate antitrust laws. CSL Behring has rejected these claims. The merger would have left CSL Behring the biggest plasma manufacturer in the world.

I read that CSL, Talecris and market leader Baxter International of Illinois have 83% of the US market for blood-based drugs; hemophilia plasma-derived products are included in this.

Just a little history: Talecris is the company formed in 2005 when Bayer spun off its plasma division. Bayer produced a plasma-derived factor VIII product called Koate DVI. Talecris inherited it and still produces it. It’s a big company, with 2008 sales of over $1.4 billion. It’s not big in hemophilia in the US, but it is a major player in the immune deficit disorders community.

The proposed sale to CSL Behring is no surprise. I’ve heard from the get-go that management at Talecris would expand the company, and then sell it and reap the profits. Private equity companies Cerberus Capital Management and Ampersand Ventures together bought the plasma division of Bayer for more than $300 million. And now it’s up for $3.1 billion.

So what happens now?

Well, we still have seven licensed manufacturers of factor on the US: Baxter, Bayer, CSL Behring, Grifols, Novo Nordisk, Wyeth and of course, Talecris. I wouldn’t be surprised if more mergers are proposed down the road but the FTC ruling might make it impossible to accomplish. Our community, our industry, is small and carefully watched. And the Obama climate seems to be very antitust-conscious.

Neal R. Stoll and Shepard Goldfein, in the New York Law Journal (November 19, 2008) note, “In his September 2007 statement to the American Antitrust Institute (AAI), President-elect Obama noted that ‘[a]ntitrust is the American way to make capitalism work for consumers.’ President-elect Obama emphasized that, ‘the [Bush] administration has what may be the weakest record of antitrust enforcement of any administration in the last half century,’ and he specifically cited lax merger enforcement for the rising cost of health insurance.” The authors then go on to say that antitrust laws are not good tools to effect economic engineering.

Read more about plasma derived products–their role in hemophilia history and today, in the next issue of PEN.