Fall 2005 - Factor Nine News

TOPICS IN HEMOPHILIA

-Hemophilia B Gathering, Friday, October 28th
-Joe Caronna Workshops, October 26th & 27th
-Hemophilia B Product Update - USA
-Novo Nordisk – Inhibitor Education Meeting
-Survey Mailing Reminder

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The Coalition for Hemophilia B Social Gathering

Friday, October 28, 2005San Diego Mariott Hotel & Marina
333 West Harbor Drive
San Diego, California
(619) 234-1500

Marina Ballroom E
(3rd Floor- South Tower)

Coffee, Tea and Soft Drinks
Cheese & Crackers
Fresh Fruit
Assorted Baked Goods

Raffle Prizes!

Sponsored by a Grant from Wyeth Pharmaceuticals

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Please join us Friday evening for an informal social gathering for people with hemophilia B and their families to share concerns, gain support and knowledge.We have been very successful in bringing people together with hemophilia B from all walks of life. New families can learn a lot from the families who have already been through the ropes.

For more information please call Kim at (212) 554-6898 or email: Hemob@ix.netcom.com

We look forward to seeing you!

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INALEX COMMUNICATIONS WORKSHOPS FOR MEN

Workshops will be held at the:

Mariott Gaslamp Quarter Hotel
666 K Street
San Diego, CA
(619) 696-0234
(4 blocks from Marriott Hotel & Marina)

“Letting Go of the Anger”
Wednesday, October 26, 2005
5:00 pm – 10:00 pm
(Dinner will be served from 5:00-6:00 pm)

This workshop will provide interaction with Dr. Ron Potter-Efron, PhD, a renowned psychotherapist and author of twelve books on managing anger and resentment. You will learn techniques and useful guidelines that will make it possible to overcome the anger that may be hindering us and harming others.

RSVP:

JOE CARONNA
Telephone: (201) 493-1399
Toll Free: (866) 802-1399
Email: Joe_Caronna@inalex.com
Web: INALEX.COM

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Inalex Communications, 28 E Ridgewood Ave. #244, Ridgewood, NJ 07450“Building a Strong Relationship with your Partner”

Thursday, October 27, 2005
8:00 am – 1:00 pm
(Breakfast & Lunch will be served)This workshop is facilitated by Rob Berkley, a Master Certified executive coach and author who works with men on leadership, personal vision and relationships. Men will learn practical tools and techniques to connect more closely with the one they love. It is for men in a new relationship who want tools to start off successfully, as well as those in long-term, committed relationships who want a deeper connection.Complementary Workshops are hosted by Hemophilia Association of San Diego & The Hemophilia Foundation of Southern California, for men living with a bleeding disorder in their life.

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FACTOR IX PRODUCTS - USA

There are three basic types of factor IX products currently available in the U.S. for treatment of hemophilia B: Factor IX Complex, Coagulation Factor IX (Human) and Coagulation Factor IX (Recombinant). The products are shown in the table below.Factor IX Complex, a low purity product that contains other clotting factors, was the first product developed for treatment of hemophilia B. Its introduction, starting in 1959, radically transformed the lives of hemophilia B patients. However, Factor IX Complex can produce thrombosis when used in large amounts for extended periods of time, for instance as support for surgery. Thrombosis is unnecessary clotting within the bloodstream that can plug up blood vessels, cutting off the blood flow. This can have serious, even fatal, consequences if the blood flow to important organs such as the heart or lungs is affected.

This problem led to the development of Coagulation Factor IX (Human), a more highly purified concentrate that contains no other clotting factors and does not appear to cause thrombosis. Both Coagulation Factor IX products available in the U.S. are produced from Factor IX Complex concentrates, which are then further purified by chromatography to separate the factor IX from the other clotting factors. Although produced by different methods, both products have similar purities; both are essentially pure factor IX with only insignificant amounts of other plasma proteins.

Coagulation Factor IX (Recombinant) is a highly purified factor IX concentrate produced by genetic engineering, not purified from plasma. Recombinant Factor IX is produced by special animal cells that have been engineered to contain the gene for human factor IX. The cells are grownin large tanks, suspended in a nutrient broth that
contains everything that the cells need to grow and produce factor IX. The factor IX they produce is secreted into the broth, from which it is purified to produce the product.

Recombinant products are considered to be safe from the risk of transmission of viral diseases because they are not produced from plasma. However, over the two decades since the AIDS crisis in the early 1980’s tremendous advances have been made improving the viral safety of products made from human plasma. Today’s plasma-derived products are considered extremely safe, even though the risk of disease transmission cannot be completely ruled out. The National Hemophilia Foundation and many physicians recommend that patients be treated with recombinant products whenever possible. However, other physicians and organizations believe that all of the products currently available in the U.S. have such high levels of viral safety that the decision can be made based on other criteria such as cost. Product cost is a major factor for many patients. As expected, the more highly purified products cost more, with the recombinant product being the most expensive.

There are many factors to consider in the selection of the appropriate product for an individual patient. In addition to the differences among the products, there are also physiological differences among patients. As with any medication, some products will work better than others for a given patient. The best recommendation is for the patient and his family to have an informed discussion with his physician to choose the best products for his particular situation. A list of Factor IX Products currently available in the USA are listed on the next page.

Factor IX Products Currently Available in the United States 

Company	Product Name	Purity	Purification Methods	Viral Inactivation/ Removal Methods
Factor IX Complex (Human)
Baxter	Bebulin® VH	Low	Chromatography	Vapor heating
Baxter	Proplex® T	Low	Adsorption PEG precipitation	20% ethanol Dry heating
Grifols	Profilnine® SD	Low	Chromatography	Chromatography Solvent/detergent
Coagulation Factor IX (Human)
CSL Behring	Mononine®	High	Chromatography	Chromatography Chemical treatment Ultrafiltration
Grifols	AlphaNine® SD	High	Chromatography	Chromatography Solvent/detergent Nanofiltration
Coagulation Factor IX (Recombinant)
Wyeth	BeneFix®	High	Chromatography	Nanofiltration

 

Vial Sizes Available:
Alphanine: 500  , 1000, 1500
BeneFIX:  250 ,  500, 1000
Mononine: 500 ,  1000

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NOVO NORDISK LEADS INHIBITOR PATIENT EDUCATION EFFORTS

Novo Nordisk is sponsoring a first-of-its-kind Inhibitor Patient Education Summit. With an agenda developed by national and local hemophilia leaders-including physicians, nurses, advocates, individuals with hemophilia and inhibitors, and representatives from social work and physical therapy – the meeting topics promise to be relevant and timely.

“It may be rare to develop an inhibitor, but it shouldn’t be a rare occurrence to sit down with others and discuss how to overcome the challenges of an inhibitor,” says Mike Sumner, MD, Senior Director, Clinical Affairs, Novo Nordisk”

The first Inhibitor Patient Education Summit will take place in Philadelphia, PA, on November 5-6 2005 at the Courtyard Marriott Downtown .
For more information about this educational event, including available on-site childcare and travel grants please call 1-888-706-6867 or visit Novo’s site www.inhibitorsummits.com

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REMINDER

SURVEY FORMS WENT OUT ON OCTOBER 11.  PLEASE REMEMBER TO FILL THEM OUT AND RETURN THEM TO US IN THE ENVELOPE ENCLOSED ASAP.  RESULTS OF THE SURVEY WILL BE PUBLISHED IN AN UPCOMING NEWSLETTER ISSUE. WE THANK YOU FOR YOUR TIME!

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For back issues of Factor Nine Newsletter of for more information on research please call or write to:
Kim Phelan, 825 Third Ave., Suite 226, New York, New York 10022, Telephone (212) 520-8272
E-mail: hemob@ix.netcom.com Website: www.coalitionforhemophiliab.org