Advancing Treatment For Real Life Protection

As the year comes to a close, Bayer HealthCare remains focused on our commitment to the same mission we had at the beginning of 2008:  to help meet the real life needs of families in the hemophilia community by providing real protection through safe, effective and convenient treatment as well as new, innovative programs and services.

We are proud of the collective accomplishments that the hemophilia community has made and that Bayer HealthCare has made together with your support in 2008 – real advancements that will continue to benefit the hemophilia community. One of the community's milestones in 2008 was the FDA approval of Kogenate^® FS Antihemophilic Factor (Recombinant) for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with severe hemophilia A with no pre-existing joint damage. This FDA approval represents a first in the hemophilia community.  

One of the things we value most at Bayer HealthCare is the continued dialogue and input from the hemophilia community. With that in mind, one of our new programs for 2008 was the development of the Hispanic Advisory Board & Latino Alliance (HABLA). Discussed in this issue of Kogenate Connections, we hope that the creation of HABLA allows us to gain a deeper and broader understanding of the hemophilia community's needs based on direct feedback from the HABLA members.

We have many exciting programs planned for 2009 and would like to keep you consistently informed on updates that affect you. If you haven't already requested to Stay Informed, please visit www.kogenatefs.com to receive email alerts with information about breaking news and the hemophilia programs from Bayer HealthCare. As you encounter or experience new programs, please provide your insights to us so that we can adapt based on your invaluable feedback.

Enjoy the beginnings of another wonderful holiday season with your loved ones, and please know that Bayer HealthCare values each of you as an integral part of our family who are dedicated to pursuing and delivering real treatment advancements and helpful programming for people living with hemophilia.

Sincerely,

Paul Bedard
Vice President, General Manager
Hematology
Bayer HealthCare

FDA Approves Kogenate^® FS for Routine Prophylaxis in Children with Hemophilia A

Bayer HealthCare proudly celebrates the FDA approval of Kogenate FS for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with severe hemophilia A with no pre-existing joint damage. This important approval provides these patients with the only factor VIII treatment that the FDA has determined safe and effective for routine prophylaxis.

"The FDA approval of Kogenate FS as the first factor VIII treatment product in the U.S. to be used to replenish factor VIII levels in a prophylactic manner marks a significant milestone in the care of patients, especially young children, with hemophilia A," said Craig Kessler, M.D., Georgetown University Hospital and Chair, National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC).

This approval is based on the clinical data from a multicenter trial in the U.S. that included 65 boys with severe hemophilia A less than 30 months of age at study entry.  Study participants were followed for up to 5.5 years.  This Joint Outcomes Study (JOS) was led by Marilyn J. Manco-Johnson, M.D., Professor of Pediatrics and Associate Professor of Pathology in the Department of Pediatrics, University of Colorado at Denver and Health Science Center, and Director of the Mountain States Regional Hemophilia & Thrombosis Center at the University of Colorado.

"The value of prophylaxis for hemophilia A patients has been understood for many years, but until today we have not had the combination of clinical evidence, pharmaceutical indication and the alignment of healthcare professionals, patients and regulators needed to ensure this treatment option is available," said Val Bias, CEO, National Hemophilia Foundation. "Bayer HealthCare's pursuit of this approval shows leadership and commitment to providing the scientific evidence that proves the benefits of prophylactic use for joint health in pediatric hemophilia patients."

This FDA approval may positively affect the prophylactic use of Kogenate FS in certain developing markets, including countries in Asia and South and Central America, where the product is approved based on the U.S. label.

"From the beginning, our goal in pursuing this indication was to provide treatment options that would reduce bleeding episodes and protect the joint health of children with hemophilia A, which are the everyday concerns of patients," said Paul Bedard, Vice President, General Manager, Hematology, Bayer HealthCare.

INDICATIONS

Kogenate^® FS,Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate^® FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.

IMPORTANT SAFETY INFORMATION

The most serious adverse reactions are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating alternative treatments to AHF.Themost common adverse reactions observed in clinical trials (frequency ≥ 4% of patients) were skin-associated hypersensitivity reactions (rash, pruritus, urticaria), inhibitor formation in previously untreated or minimally treated patients, infusion site reactions, and central venous access device (CVAD) line-associated infections. Kogenate^® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.

For important risk and use information, please see the full prescribing information.

New Program Provides LINK for Patients and Caregivers

Searching for programs and tools to help manage hemophilia treatment? Your local Bayer HealthCare Hematology Account Executive could be the missing LINK.

LINK programs provide learning, insights, and knowledge for patients and caregivers in an open forum format to provide feedback on important treatment and lifestyle issues. These interactive meetings are designed to form an even stronger link between the needs of the community and Bayer HealthCare's ongoing efforts to meet them.

LINK programs include interactive presentations on the following topics:

• New videos featuring hemophilia experts
• Exciting new product updates
• Living Beyond Hemophilia, a new community for young people and mentors
• New EZ-Log Web-based tracking system

For more information on LINK, contact a local Bayer HealthCare Hematology Account Executive near you. To locate a representative, go to www.kogenatefs.com.

Hola to HABLA

The first meeting of the Hispanic Advisory Board & Latino Alliance (HABLA) kicked-off with resounding success on September 22nd – 23rd in Chicago!

To develop HABLA, Bayer HealthCare enlisted the ongoing advice of patients, caregivers, community advocates and social workers to best meet the needs of the Hispanic hemophilia community.

"We work with Hispanic patients with hemophilia and their families on a daily basis, and they are always asking for resources in Spanish," said Debbi Adamkin, Executive Director for the Florida Hemophilia Association. "I'm excited to be a part of the HABLA advisory board and am looking forward to working with the group. I think that the development of this information will be very helpful and is much needed."

The group of nine HABLA members represented key cities from across the nation with large Hispanic populations. Each board member was encouraged to ask questions and to offer ideas on how to continue improving support for people living with hemophilia and their caregivers.

The group will reconvene in April 2009 in Scottsdale, Arizona to review progress and to determine the next steps in Bayer HealthCare's continued commitment to the Hispanic hemophilia community.

NOW SHOWING ONLINE: www.SaludablesconHemofilia.com

Bayer HealthCare is proud to present SaludablesconHemofilia.com. The site provides culturally relevant information for the Hispanic hemophilia community.

The site features expert advice, practical tips and user-friendly tools for patients and families living with hemophilia. Educational components of the site include the following categories:

• Essentials of managing care
• Managing life at home
• Staying safe and active on the go
• Transitioning or growing up with hemophilia

Patients and their parents are also given the opportunity to subscribe to future communications from Bayer HealthCare and SaludablesconHemofilia.com.

Team Hemophilia visits Camp Bond.

Team Hemophilia Parks for '08 with Plans to Push Forward in '09

The 2008 Team Hemophilia program crossed the finish line on September 6th to complete the third year of this exciting and interactive educational program. With the participation of ambassadors from NHF's National Youth Leadership Institute, Team Hemophilia traveled the country to visit 12 local chapters this year and hosted more than 500 participants.

"We were able to discuss with families that becoming involved in your local chapters really makes a difference in helping to find the joys of living with a bleeding disorder. Given the choice, I would never choose to have my bleeding disorder taken away from me. That is the power of becoming involved," said NYLI ambassador Julia McDougal of her participation at the Team Hemophilia event in Detroit, Mich.

 An open forum regarding the program was also held this year at NHF's June Leadership, where chapter executives and board members provided valuable feedback and suggestions. This input has been extremely important to the current planning process for the 2009 season.

"The 2008 Team Hemophilia program was a great success," said John Indence, Vice President, Marketing & Communications, National Hemophilia Foundation. "Not only did we use Team Hemophilia to encourage youth leadership at chapters across the country, but we exceeded our fundraising goals. The National Hemophilia Foundation is grateful for the support Bayer HealthCare provided throughout the 2008 Team Hemophilia season and we are looking forward to an even better program in 2009."

For more information about Team Hemophilia or to provide additional feedback for next year, please visit www.TeamHemophilia.org.

The panel of experts for the Living with Hemophilia® symposium included Kimberly Baumann, PT; Donald Molter, MS; and Marianne McDaniel, RN.

Mile-High Excitement at Camp Kogenate

Like many of you, the team at Bayer HealthCare was actively involved in this year's National Hemophilia Foundation annual meeting in Denver. More than 2,000 members of the hemophilia community experienced the fun and excitement at Camp Kogenate. Congratulations to Seth S., Kyle M., Josh M., Stephen W., Robert W., Jeff C., Rider K., Joshua H., Katrina G., and Laura W., all of whom won an iPod^® touch media player just for visiting their local hemophilia treatment center (HTC) for a comprehensive care exam.

Visitors to Camp Kogenate also participated in virtual sports activities, experienced an interactive demonstration on Kogenate FS with BIO-SET^® needless reconstitution system, and completed a quiz for a chance to win a new Nintendo^® Wii™. Congratulations to all of the winners: Cynthia R., Jessica S., and Aaron R.

Thank you to the many participants who joined our panel of experts for Living with Hemophilia^®: Practical Tips for You and Your Family. This interactive patient symposium provided patients and their caregivers with important information about hemophilia basics, physical activity, and educational advocacy.

These activities along with conversations with patients, caregivers, and community advocates provided the Bayer HealthCare team with valuable insights and feedback. Thank you to all who contributed to this successful convention.

To find out more about the products, programs, or services offered by Bayer HealthCare, visit www.kogenatefs.com.

Maria Sanchez and her son Bernardo find real life solutions with Kogenate FS with BIO-SET®

Words of Wisdom from a Real Mom

Maria Sanchez and her husband Victor head a busy southern California household.  They are raising two daughters and six sons, five of whom have hemophilia A.  

When Kogenate FS with BIO-SET^® was introduced to Maria at the hospital; she decided it was a product worth trying.  "I liked Kogenate FS with BIO-SET.  They offered it to me in the hospital, and I said 'ok, I'm going to try it.'  It is always nice to know what is better for your children and what helps them more.  The sooner they are healthy, the better.  I am delighted with it."

Bernardo, the Sanchez's 16-year-old son is an avid soccer fan who has experienced the benefits of Kogenate FS with BIO-SET.  "I like to play soccer, and I practice with my brothers and my dad.  I have hemophilia A, and thanks to Kogenate FS with BIO-SET, it has helped me to have a normal life."

Not only is Kogenate FS with BIO-SET an effective product, it is safe and offers its users real protection.  "For me, it is very important to know that the product Kogenate FS with BIO-SET is delivered to the door of my house completely sealed, said Maria. "I am sure that what I'm giving my children is something good and healthy for them without the problem of contamination."

Maria shares more words of wisdom for parents of children with hemophilia.  "We just need to stay calm and seek appropriate help.  Everything will be fine as long as we follow the instructions that the doctors give us, and we do our job 100 percent so that our children will be well."

Paul Bedard, Vice President, General Manager Hematology Bayer HealthCare

Bedard Returns to Bayer HealthCare Hematology Division

Bayer HealthCare recently announced that Paul Bedard would return to the Hematology division as Vice President and General Manager. The Bayer HealthCare Hematology team is proud to welcome Bedard back to the hemophilia community and looks forward to his leadership as Bayer HealthCare continues to work to meet the real needs of patients and caregivers in the hemophilia community. Welcome back, Paul!