February 3, 2009
A Message from Wyeth Hemophilia:
As a valued member of the hemophilia community, we want to ensure that you are aware that on Monday, January 26, Pfizer announced that it agreed to acquire Wyeth, creating the world’s premier global biopharmaceutical company with the strongest assets, pipeline and capabilities within health care. The diversity, agility and scale of the combined company will enable us to more effectively address the health, wellness and unmet medical needs of patients around the world.
For more information, we encourage you to visit www.premierbiopharma.com where you can hear Jeff Kindler, Chairman and Chief Executive Officer, Pfizer, and Bernard Poussot, Chairman, President and Chief Executive Officer, Wyeth. We expect the transaction to close during the second half of 2009. More...
Baxter Preclinical Data of Longer-Acting Factor VIII for Hemophilia A Presented at International Congress
Preclinical data on new partially humanized hemophilia A mouse model and characterization of investigational recombinant therapy for von Willebrand disease also shared
Istanbul, Turkey, June 4, 2008 – Baxter International Inc. (NYSE: BAX) announced data on three key areas of preclinical research in hemophilia: a releasable PEG conjugate for recombinant factor VIII (rFVIII), a potential longer-acting alternative therapy candidate for hemophilia A; a new partially humanized mouse model for hemophilia A; and preclinical characterization of an investigational recombinant blood-free von Willebrand factor (VWF). Preclinical data presented in both oral presentations and poster sessions were part of the scientific forum at the XXVIII International Congress of the World Federation of Hemophilia (WFH) held June 1-4. More...
Leverkusen / Redwood City, California, USA, July 2, 2008 – Bayer HealthCare is expanding its commitment to hemophilia with the acquisition of Maxygen’s hemophilia program assets, including a next-generation recombinant Factor VIIa protein known as MAXY-VII. The lead therapeutic candidate is expected to enter Phase 1 clinical testing in the third quarter of 2008. The total transaction is valued at US-Dollar 90 million upfront with a final, potential milestone payment of US-Dollar 30 million. This agreement includes a license to use Maxygen’s MolecularBreeding™ technology, a novel research platform, for exploiting gene targets. More...
NovoSeven® (Recombinant Coagulation Factor VIIA) Approved in Secondary Prophylaxis for Haemophilia A or B Patients with Inhibitors
Sydney, Australia, 21 May, 2008 – Novo Nordisk announced approval in Australia and New Zealand for the use of NovoSeven® (eptacog alfa (activated) (bhk)) for secondary prophylaxis in patients with haemophilia A or B complicated by inhibitors following the results of a trial recently published in the Journal of Thrombosis and Haemostasis1. This means that patients with haemophilia A or B with inhibitors and a high bleeding frequency can now be treated with once-daily NovoSeven® for up to three months, to reduce the frequency of bleeding.
Read more...
BERKELEY, Calif. (Feb. 26th, 2008) – New data published in Thrombosis and Haemostasis shows that formation of inhibitors – antibodies against factor VIII – occurred in only 8 percent of previously untreated patients (PUPs) with hemophilia A who received the recombinant factor VIII therapy KOGENATE® Bayer. With the addition of these results, the safety and efficacy of KOGENATE® Bayer has been studied in more than 1,000 patients in clinical and post marketing studies.
For more information, please click here.
FDA Approves New Roche West Nile Virus Blood Screening Test
Automated test helps ensure safety of blood supply by detecting virus earlier in infection cycle. Roche Diagnostics announced that the US Food & Drug Administration (FDA) approved its biologics license application for the company's test for direct detection of West Nile Virus in donated human blood and plasma. News release.
Source: AABB smartbrief
Maxygen has licensed technology for its dengue virus antigen with the Sanofi-Aventis group and will transfer a portfolio of preclinical antigens to the pharmaceutical company for development and commercialization for a vaccine. Total payments to Maxygen could total $24.5 million. Am erican City Business Journals/San Francisco Source: AABB smartbrief
The World Economic Forum has given Oxitec Ltd. a Technology Pioneer 2008 award for its development of a technique to fight a mosquito that spreads dengue fever. The technology makes the male mosquitoes sterile through molecular biology and genetics, and one scientist says the approach is more effective and cheaper than the traditional radiation therapy method. BBC Source: AABB smartbrief
Cerus Corp. has spun off its immunotherapy division to focus on marketing its Intercept blood-safety system, a device used to destroy viruses and bacteria in donated blood. Cerus' David Cook and Thomas Dubensky will assume responsibilities as chief executive and chief scientific officer of the new company. The Boston Globe/Associated Press Source: AABB smartbrief
Nektar Therapeutics and Baxter International have extended a partnership to develop improved hemophilia drugs. The new pegylated forms of the drugs improve the duration and performance of activity. Nektar sa ys the program will start preclinical development in 2008. Reuters Source: AABB smartbrief
Baxter's Advate Receives Room Temperature Storage Approval
In its efforts and continuous commitment to make hemophilia A therapy more
user-friendly, Baxter has achieved another milestone.
At the beginning of this year the recombinant factor VIII concentrate
ADVATE received approval in Europe for storage at room temperature.
Approval permits the one-time storage of the preparation at room
temperature (up to 25 °C) for a maximum of 2 months within the approved
shelf life (24 months at 2 °C to 8 °C). After storage at room temperature
the product must not be refrigerated again.
The positive opinion of the European Medicines Agency (EMEA) is based on a
comprehensive stability study demonstrating that the quality of the product
is not impaired if ADVATE is stored at room temperature for up to 2 months.
This provides the patients and their caregivers with additional flexibility
and facilitates treatment during travel.
NovoSeven (recombinant facto VIIa) launched in single dose regimen for patients with haemophilia A or B with inhibitors.
NovoSeven® stops bleeding in over 90% of cases with a single dose
[Add place, add date] – Novo Nordisk announced today that NovoSeven®, the only recombinant activated factor VII product available for the treatment of bleeding episodes in people with haemophilia with inhibitors, is now available in [add country] for use as a single 270 μg/kg dose.
Treatment with the new single dose is convenient for patients because it can reduce the need for multiple intravenous infusions, thereby minimising the interruption to patients’ lives and helping to preserve the status of the vein.
“In practical terms, approval of a single dose regimen of NovoSeven® means less time spent redosing, less interruptions to daily life and fewer concerns relating to injection for patients, thereby enhancing their quality of life,” commented [Add local KOL spokesperson].
In a randomised, double blind, cross over clinical study, treatment with a single 270 µg/kg dose of NovoSeven® controlled bleeding within 9 hours in 90.5% of episodes, compared with 85.7% of episodes treated with three doses of 90 µg/kg.1 The new single-dose regimen offers an efficacy and safety profile similar to that of the established regimen of three doses of 90 μg/kg.1,3 In randomized clinical trials, the single 270 μg/kg dose was well tolerated and was not associated with thromboembolism or other serious adverse events.1,2
“The use of single dose NovoSeven® is a significant step forward, and one that may help to improve the quality of life for people who have haemophilia with inhibitors. This development will be welcomed by those involved in the management of haemophilia, and demonstrates Novo Nordisk’s ongoing commitment to making a significant difference in inhibitor management,” added [Add Novo Nordisk spokesperson].
CSL Behring Makes Annual Start-Up Grants Available to Next Generation of Coagulation Researchers
Awards Named in Honor of Professor Norbert Heimburger, Pioneer of Modern Coagulation Research
Geneva, Switzerland — 07/09/2007
CSL Behring, a global leader in the protein biotherapeutics industry, announced today at the International Society on Thrombosis and Haemostasis (ISTH) XXIst Congress that it will award five annual grants to support new research projects in the area of coagulation. The start-up grants of 20,000 euros each ($26,780 U.S) will be awarded to young medical researchers for preclinical and/or clinical coagulation projects based on the scientific merit of their work.
The grant is named in honor of Professor Norbert Heimburger, a pioneer of modern coagulation therapy and a CSL Behring employee for over three decades. Among his many achievements was the development of virus-safe plasma products based on pasteurization. Due to his research efforts, Behring launched the first effectively virus-inactivated FVIII concentrate in 1981.
“CSL Behring is committed to advancing research that furthers our understanding of coagulation and improves the treatment of bleeding disorders such as hemophilia and von Willebrand disease,” said Roland Martin, Head of Research and Development at CSL Behring. “Supporting the next generation of specialists to medically and scientifically establish themselves is important to have continued progress in this therapeutic area.”
Grant applications must be received by February 1, 2008. They will be reviewed by a special selection committee of four scientifically renowned clinicians in the coagulation field: Erik Berntorp, MD, PhD, Malmö University Hospital, Sweden; Jorge DiPaola, MD, Great Plains Regional Hemophilia Treatment Center, USA; David Lillicrap, M.D., FRCPC, Queen’s University, Canada; and Johannes Oldenburg, M.D. PhD, University of Bonn, Germany.
For more information regarding the Professor Norbert Heimburger Grant and specific criteria for applications, please go to www.cslbehring.com/ProfHeimburgerAward.
Collegeville, Pa., July 3, 2007 —Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that it has assumed all marketing and distribution rights to BeneFIX* nonacog alfa Coagulation Factor IX (Recombinant) in Europe. This transfer of responsibility follows the planned June 30, 2007 conclusion of a 10-year distribution rights agreement between Baxter Healthcare Corporation and Genetics Institute. Genetics Institute was acquired by Wyeth in 1996. Representatives of Wyeth and Baxter have worked closely together to ensure a structured transition between companies and an uninterrupted supply of BeneFIX to people with hemophilia B.
In May 2007, Wyeth Pharmaceuticals received a positive opinion from the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, on new convenience enhancements to BeneFIX. The product enhancements are: a 2000 IU dosage strength vial, a needleless reconstitution device, a prefilled diluent syringe and a low 5 mL diluent volume for all dosage strengths.
