August 2008

Register with PNS Now!

It’s been a long time since I’ve seen a withdrawal or recall of factor. About six years ago we had a lot of them, and not everyone got word that their particular product was recalled. Then along came the Patient Notification System (PNS), a program that allows you to register to get alerted via email, telephone, fax or snail mail to any recalls or withdrawals. It’s a good time now to ask yourself if you have registered with PNS.

Here’s why: Just this week we had a voluntary recall of factor.

NHF’s Medical Advisory #407 of August 20 announced that CSL Behring initiated a voluntary recall of four lots of Monoclate-P
that were distributed beginning on August 4, 2008. It reads: “This action is being taken with the knowledge of the United States Food and Drug Administration (FDA). These lots are being voluntarily recalled as a precautionary measure because they do not meet the potency specification when stored for three months at 5 degrees C. No specific safety issues have been identified and neither have adverse incidents been reported. CSL Behring is requesting that the use of these lots be immediately discontinued and the product be returned to the company.”

When you register with PNS, you will be notified only about the product you use, so if you change brands, you may need to update your registration. If you are not registered, you may not hear at all about recalled brands. Please sign up with PNS today. Go to http://www.patientnotificationsystem.org to register. Don’t be the last to know!

Needless to say you should also register with NHF’s eNews, which will keep you updated with recalls and all news related to hemophilia.


Book I Just Read
Fifty Things to Do When You Turn Fifty by Ronnie Sellars (ed). This is a compilation of 50 essays by 50 authors, doctors, celebrities about turning 50 and what you need to know. It was pretty good, a general summary on changes you will face in areas like fitness, attitude, career and friendship. Thing is, most of us at age 50 are already aware of these things! So I guess it’s a good book to read when you are 45. Best part is that all profits are donated. Two stars.

Shopping Spree: CSL Limited to Buy Talecris

The hemophilia world is buzzing with the latest acquisition announcement: CSL Limited will buy Talecris Biotherapeutics Holdings Corp., one of the world’s leading manufacturers of plasma-derived protein therapies. One of these therapies is Koate-DVI, a plasma-derived factor VIII clotting concentrate. The move will make CSL a stronger competitor in the $15 billion global plasma products market. Selling price? US $3.1 billion.

How will this affect the US market, with so many changes underfoot?

One concern is what will happen to Koate DVI. CSL Behring already has two plasma derived factor VIII concentrates, Monoclate P and Humate P. Will it need three? We may be jumping the gun in speculating. Talecris is reaching out to its customers to assure them that the acquisition will not affect production for the foreseeable future. Below is a letter from Talecris, which I am reprinting with permission. We’ll be watching developments closely, and will let you know more in the near future. And let me add: we’ve been predicting consolidations, both in homecare and in pharma, for the past four years, and so they continue. We will monitor industry and as always, try to discern how consolidations and acquisitions, and product changes, will affect you, the consumer.

August 13, 2008

Dear Hemophilia friends, partners, and patients:

You may have heard Talecris Biotherapeutics and CSL have entered into a definitive agreement for CSL to purchase Talecris, pending the necessary regulatory approvals.

Please note that our commitment to provide high quality and effective products to our customers remains our paramount concern, and that has not changed — nor will a transaction affect any of our existing contracts to supply Koate-DVI Antihemophilic Factor (Human).

While the transaction moves through regulatory review, we will continue to serve our customers and the patients who rely on us by providing a reliable supply of safe and effective protein therapies. Additionally, we will continue to invest in improving our products, increasing the availability of our therapies, and developing innovations to enhance the lives of our patients. In short, you can rely on us now and in the future, however that future unfolds.

Talecris Biotherapeutics recognizes that the availability of Koate-DVI, is a paramount issue for the patients around the world. It is an issue of extreme importance to us, and one in which we have invested heavily to resolve for the patients we serve. In the past several years, we’ve invested over $150 million in the vertical integration of our plasma supply chain to enable long-term reliable supply, and tremendous progress has been made in taking the necessary steps to ultimately increase the supply of Koate-DVI.

* Talecris has invested significantly in our Clayton manufacturing facility, which operates nearly 24 hours a day, 365 days a year. In fact, we are completed an extended planned maintenance in order to significantly upgrade portions of our facility where Koate-DVI is produced. These upgrades will allow us to support increased worldwide demand and meet current commitments to supply Koate-DVI to our patients.

* Talecris Plasma Resources, Inc. (TPR), will further ensure a reliable, consistent supply of plasma for the long-term and we continue to invest significantly in improving the output of these centers and opening new centers.

* CSL, like Talecris, is a key global player in the plasma biotherapeutics industry dedicated to treating rare and serious diseases, and is passionate about improving the quality of life for patients throughout the world. We believe a combined entity would accelerate our ability to develop and deliver therapies that enhance the lives of patients who depend on us.

Thank you for your continued support.

Sincerely,

John Cutter
General Manager Intercontinental
Talecris Biotherapeutics, Inc.

Book I Just Read: How Elizabeth Barrett Browning Saved My Life by Mameve Mamwed
I don’t usually read fiction, especially not romantic fiction, but this book was a gift, and personalized by the author at that, so I could not avoid reading it. And I am glad I did: a little charmer of a book, easy to read and very well done. The real story’s about love, wrapped up in a plot about how an antique chamber pot turns the life of a struggling, young, intelligent antiques dealer with poor self-esteem upside down. Abby thinks her life is about to get better when the pot is appraised at $75,000, as it was once owned by poet Elizabeth Barrett Browning. But it’s the beginning of a lot of trouble, and a lot of introspection as to the nature of relationships when relatives and friends come out of the woodwork to get a piece of Abby’s fortune. I loved all the literary references and as it takes place in Cambridge, Massachusetts, hearing about places well known to us Yanks. Three stars.

On Vacation!

No blog this week! I am on vacation with my daughters Tara (17) and Mary (14) in Orlando but will return next week. Have a great week! We sure will!

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New Factor VIII Product

It’s not too often that a new factor VIII product comes along. I don’t pitch products, but I do announce new products and developments to keep our readers educated and up to date. So you should know there is a new factor VIII product called “Xyntha.” It’s pronounced “ZIN tha” and it’s manufactured by Wyeth.

Why another recombinant factor VIII? This one will replace ReFacto, Wyeth’s only recombinant FVIII product. ReFacto is first-generation recombinant FVIII; Xyntha is third generation, and will be competing with Advate, the first third-generation FVIII product.

So in a nutshell, hemophilia A factor VIII concentrate users have:

PLASMA DERIVED
Alphanate (Grifols)
Monoclate-P (CSL Behring)
Koate DVI (Talecris)

RECOMBINANT
First generation
Recombinate (Baxter)

Second generation
Kogenate FS (Bayer)
Helixate FS (CSL Behring)

Third generation
Advate
Xyntha

Which is best? How do you choose? Questions about Xyntha? That you need to discuss with your doctor! Please remember to go see your HTC at least once a year for clinic, more if you are under age 18 or have any complications of hemophilia bleeds.

Book I Just Read: Untamed Seas by Deborah Scaling Kiley

I went sailing this weekend, and most of the trip was haunted by a foreboding thunderstorm that seemed to chase the chartered ship. As thunder cracked right over our heads and lightening split the sky, I thought about this book I had just read. Untamed Seas tells the amazing story of five people who tried to sail the Trashman, a yacht owned by a wealthy businessman, to Florida in the fall of 1982. They never got passed the northern east coast. Caught in a gale, the ship sank and there the remarkable story of survival begins. Who lives and who dies? This is a study in discipline, leadership, teamwork and crisis over a span of only 5 days. Hard to put down, you might finish this in one night yet the story will never leave you. And us? We made it back fine, back to Gloucester harbor, where the true story (As told in the excellent 2000 movie “The Perfect Storm,” starring George Clooney) of the sinking of the Andrea Gail begins and was filmed. Three out of four stars.

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