Volume 8, Number 2
WFH statement on H1N1 pandemic and vaccination
The WFH has posted a new statement on the H1N1 pandemic and vaccination including advice for people with bleeding disorders and those who are immune compromised. http://www.wfh.org
President Obama lifts US HIV travel ban
On 30 October, 2009, President Obama announced the publication of the rule ending the HIV immigration and travel ban. The lifting of the ban will go into full effect on 4 January 2010, after a 60-day waiting period. This means that, starting in the new year, non-US citizens who are HIV positive will have the same rights as anyone else to enter the US for meetings and congresses, tourism or education. The ban has been in effect since since 1987. The WFH participated with many other patient groups to lobby for this change.
President Obama's statement: http://www.whitehouse.gov/
The detailed rule can be accessed here: http://www.gpo.gov/fdsys
Canadian Blood Services in court battle over donor deferral policy
On 28 September 2009, a trial between Canadian Blood Services (CBS) and Kyle Freeman began in the Superior Court of Ontario in Ottawa, Canada. The Court will determine whether Freeman is liable for lying about his sexual history, as well as whether the MSM (men having sex with men) deferral policy is discriminatory under the Canadian Charter of Rights and Freedoms. Freeman lied on his donor questionnaire and then later informed CBS that he had made donations that would not have been accepted under current donor deferral policies. The trial will last until mid-December.
CBS statement on the case: http://www.bloodservices.ca
CHS statement: PDF
Elsewhere on this same issue, the UK Advisory Committee on the Safety of Blood, Tissues and organs (SABTO) was due to meet on October 27th to discuss evidence for and against lifetime exclusion of MSM donors as part of an official review of the UK policy.
New technique for cleaning prions from surgical instruments
Novapharm Research has regulatory approval in Australia and the Europe Union (EU) for its enzyme-based technology to deactivate the protein molecules of prions which cause Creutzfeldt-Jakob disease (CJD). Researchers at the University of Melbourne have created a solution to deactivate prions, which are the infectious proteins that cause Creutzfeldt-Jakob disease (CJD) and can be transmitted via surgical instruments. The human prion is resistant to both heat and chemicals and is reported to be much more difficult to deactivate than the animal form of the infective agent which causes well-known diseases, such as mad cow disease in cattle and scrapie in sheep. A paper describing the technique was published earlier this year. http://vir.sgmjournals.org/cgi
Biogen advances long-acting hemophilia B therapy into a registrational trial
Biogen has announced that it plans to advance the company’s long-acting, fully recombinant factor IX Fc fusion protein into a registrational clinical trial in hemophilia B patients. This comes after a successful phase I/IIa open-label, multi-centre, safety dose-escalation and pharmacokinetic study of intravenous rFIXFc in severe, previously treated hemophilia B patients. The product demonstrated a prolonged half-life compared to historical data for existing therapies, supporting advancement of the program. The potential to prolong protection from bleeding and reduce the frequency of injections for both prophylaxis and on-demand therapy will be evaluated in the new trial. http://investor.biogenidec.com
Novel treatment for hemophilia caused by nonsense mutation
New Jersey, U.S.A.-based PTC Therapeutics has initiated a ohase IIa clinical trial of ataluren in patients with nonsense mutation hemophilia type A and B (nmHA and nmHB). Ataluren is a powder that is taken orally three times a day and has been used to treat other disorders caused by a nonsense mutation. The trial is a multi-centre, open label, dose escalation study. The main goals of the trial are to determine whether treatment with ataluren can result in an increase in factor VIII or IX levels and whether the drug can safely be given to people with severe hemophilia caused by a nonsense mutation. http://www.ptcbio.com
Helixate approved for prophylaxis in children under 16
CSL Behrings’s Helixate FS recombinant factor VIII concentrate has been approved by the US Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia aged 16 or younger who do not have pre-existing joint damage. This approval was based on a multi-centre trial of 65 boys younger than 30 months, in which magnetic resonance imaging (MRI) of joints documented that prophylactic use of the product resulted in less joint damage (7%) than did an on-demand therapy strategy (42%). http://www.cslbehring.com
Wyeth merges with Pfizer
On October 16, 2009 Pfizer announced that it has initiated joint operations with Wyeth following the legal close of the acquisition process. Wyeth manufactures the recombinant treatment products, Refacto (also called Xyntha) for hemophilia A and Benefix for hemophilia B. http://www.pfizer.com/news/press_releases/pfizer
CSL acquisition of Talecris called off
In June CSL Behring and Talecris announced that they have mutually agreed to terminate their merger agreement, announced on 12 August 2008, under which CSL agreed to acquire Talecris for US$3.1 billion. The US Federal Trade Commission (FTC) had concerns that the merger would harm competitiveness in the plasma fractionation industry. Brian McNamee, CEO and Managing Director of CSL, said "We are disappointed that the US Federal Trade Commission (FTC) resolved to block the transaction. As we have previously stated we fundamentally disagree with the FTC case and matters included in their complaint." But the CSL board has decided not to continue to fight for the merger. (Since the decision was made, Talecris has raised close to a billion dollars in an initial public offering.) http://www.cslbehring.com
Sixth WFH Global Forum
The WFH hosted its Sixth Global Forum on the Safety and Supply of Treatment Products for Bleeding Disorders with participants from 35 countries at the end of September. With 175 representatives of patient groups, regulators, commercial and not-for-profit fractionators, as well as doctors who treat people with bleeding disorders participating, it was the biggest WFH Global Forum ever. The theme of the 2009 Forum was "Making the Case for Clotting Factor Concentrates" and issues covered included: projected trends in plasma production and supply; prophylaxis models around the world; threats to hemophilia care in a tightening economy; new concentrates for rare factor deficiencies; and the risk of variant Creutzfeldt-Jakob disease.
Click here to view the presentations from this year's Forum. We will soon be posting the proceedings of the Forum.
The World Federation of Hemophilia thanks the sponsors who supported this event: Canadian Blood Services; Héma-Québec; Ministère des Relations Internationales, Gouvernement du Québec; Ministère de la Santé et des Services Sociaux, Gouvernement du Québec; and the Public Health Agency of Canada.
Events
2010 International Plasma Protein Congress (IPPC)
16-17 March 2010 – Berlin
Internet: http://www.ippc2010.com/
International Plasma Fractionation Association (IPFA)/PEI 17th Workshop on “Surveillance and Screening of Blood Borne Pathogens”
26-27 May 2010 – Croatia
Internet: http://www.ipfa.nl
Hemophilia 2010 World Congress
Saturday, July 10 – Wednesday, July 14, 2010 – Buenos Aires, Argentina
Internet: http://www.hemophilia2010.org
Safety & Supply News
Published bi-monthly by the World Federation of Hemophilia.
Next issue: May 2010
Editorial Board: Claudia Black, WFH (Canada); Keith Hoots, MD (U.S.A.); Elizabeth Myles, WFH (Canada); Brian O’Mahony (Ireland); David Page (Canada), Mark Skinner (U.S.A.); Mike Soucie, PhD (U.S.A.); Alok Srivastava, MD (India); Alison Street, MD (Australia)
Editor: Mark Brooker, WFH World Federation of Hemophilia
1425 René Lévesque Blvd. West, Suite 1010
Montréal, Québec H3G 1T7 Canada
Tel.: +1 (514) 875-7944 Fax: +1 (514) 875-8916
E-mail: wfh@wfh.org
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Permission to translate and/or reprint all contents of the Safety and Supply News is granted to interested non-profit hemophilia organizations, with prior approval and appropriate acknowledgment of the WFH. Permission does not extend to reproduction, in whole or in part, for sale or use in conjunction with commercial purposes.
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