EAPB newsletter - European Association of Pharma Biotechnology

EAPB newsletter http://www.eapb.org/newsletter/newsletter.html
EAPB Newsletter January 2008
Dear colleagues,
Pharma Biotechnology today has delivered many innovative options for therapy,
diagnostics, and prevention with a worldwide turnover of > 60 billion US$ (2006)
and with an annual growth rate of abt. 20%. With this, Pharma Biotechnology is an
increasingly important economical factor in the EU with excellent prospects for the
future. For keeping pace with this outstanding growth while saving economical
resources, networking is of eminent importance.
It is the mission of EAPB, as a non-profit organization, to link and to facilitate the
cooperation between the players in Pharma Biotechnology, especially between its
members. Our major goal is to enhance the economical output of scientific results
and findings to foster public health and increase the competitiveness of the
European Pharma Biotechnology. To achieve this we organize workshops,
conferences and partnering events (see below).
This newsletter, which will appear every other month, is a new addition to our
services. It shall contribute to meet our goals by providing actual scientific,
technological and business news in the field of Pharma Biotechnology. I invite all
members to submit relevant information which they consider to be of interest for the
EAPB to one of the addresses below.
In the name of the Board of EAPB I wish all members a happy, healthy and
successful New Year and hope to meet you on one of our events in 2008!
Wieland W. Wolf
General news in Pharma Biotechnology
By Inge Mühldorfer and Wieland Wolf
The Council of the European Union approved the Regulation setting up the
Innovative Medicines Initiative (http://www.imi-europe.org) which is a partnership
between the European Community and the European Federation of Pharmaceutical
Industries and Associations (EFPIA). IMI will embody a new approach to research
financing at the European level, bringing together public and private funds, involving
industry, SMEs, and non-profit research institutions. The first call of the IMI is
planned for February 2008.
Events and initiatives organized by EAPB
By Karoline Bechtold-Peters
In April EAPB and EUFEPS, supported by AAPS and FIP, organized its first
two-days Workshop on Monoclonal Antibodies in summerly Amsterdam with active
participation from industry and university. The scientific program was formidable
and was outstandingly judged. Both organizations will continue this expert meeting
at annual basis. The 2nd Workshop on Monoclonal Antibodies - Cutting Edge
Science for new Medicines will take place June 3 to 5, 2008 in Heidelberg.
Again internationally acknowleged speakers in the areas Antibody Design, Pharma
Development, Process Development, Analytics, Clinics and Regulatory Affairs could
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be recruited. There will be the possibility for product and service exhibitions and
poster presentations.
See the first announcement: (187 KB)
See the 2nd announcement: (888 KB)
More informations: www.EUFEPS.org
In connection with the Biotechnica in Hannover a meeting “Science to
Market” is planned from October 7 to 8, 2008. For research centers close to
market and young technology companies in Europe the opportunity will be given to
present itself with consideration of the limited financial budget of such groups. On
the other hand possible European users from the Pharma biotech industry will be
addressed, which are interested in the offered technologies. European Life Science
Clusters will be supporting the event. A sound scientific program and poster
presentations will round off the meeting.
Business News in Pharma Biotechnology
By Sven Stegemann
The major Antibody deals in 2007
Antibodies remained one of the main areas of interest for the pharmaceutical
industry in 2007. The major five deals represent at least > 800 mio USD (546 mio
€) if all milestones are achieved.
Ablynx, the Ghent (Belgium) based company signed a collaboration deal with
Germany’s Boehringer Ingelheim to discover, develop and commercialize 10
biotherapeutics against cancer, immunological and respiratory diseases using its
Nanobody technology platform.
Regeneron from Tarrytown, NY (USA) has signed a partnership with Sanofi-Aventis
on the discovery, development and commercialization of human antibodies using its
proprietary VelociSuite and VelocImmune MAb technologies. The deal will run over
5 years.
A 10 year collaboration agreement was signed between German’s MorphoSys and
Novartis from Switzerland to use Morphosys’s HuCAL Gold library to discover and
optimize several antibodies against targets defined by Novartis.
Also GlaxoSmithKline entered into an agreement to get access to innovative
antibodies. OncoMed based in Redwood City, CA (USA) will use its xenograft
cancer models to identify and develop antibodies directed against cancer stem
cells. OMP-21M18 will is one of the lead candidates covered by this deal that is
expected to enter into phase 1 clinical for solid tumors this year.
Genentech (South San Francisco, CA, USA) has signed an exclusive license
agreement with Seattle Genetics based in Bothell, WA (USA) to get access to
SGN-40, a humanized antibody against multiple myeloma, Hodgkin’s and
non-Hodgkin’s lymphoma and leukemia.
Regulatory News
By Axel Wenzel, axel.wenzel@p-ss-t.de.
New Biotech Legislation and guidances in EU:
EUDRAPharm is online: all products approved by centralized procedure are now
searchable and SPC, PIL, Label texts, pack sizes, strenghts etc are published.
see: www.eudrapharm.eu.
Products approved by the MRP or DCP can be found in the MRI product Index
http://www.hma.eu/mri.html
Readability guideline updated:
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„Target patient population consultation“ is now also a must before filing a MRP or
DCP and even also often for national procedures. Readability testing is one
possible solution to fulfil these requirements. This is the reason why the guidance
originating from 1998 for CPs was now updated.
Medicines for children
The European Commission (EC) published early 2007 in the Official Journal (L 378
volume 49, 27 December 2006) Regulation (EC) No 1901/2006 of the European
Parliament and of the Council of 12 December 2006 on medicinal products for
paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC,
Directive 2001/83/EC and Regulation (EC) No 726/2004. Incl. its amendments:
http://eurlex.europa.eu/LexUriServ/site/en/oj/2006/l_378
/l_37820061227en00010019.pdf
http://eurlex.europa.eu/LexUriServ/site/en/oj/2006/l_378
/l_37820061227en00200021.pdf
EMEA has now a specific page for medicines for children, see
http://emea.europa.eu/htms/human/paediatrics/introduction.htm
Pharmacovigilance
Eudralex Volume 9 was newly organized. It contains now all legislation and
Guidelines on Pharmacovigilance for Medicinal Products for Human Use,
Regulations, Authority guidances etc. Volume 9B contains the respective data for
Pharmacovigilance for Medicinal Products for Veterinary Use
BioSimilars:
In summary, EMEA approved 2007 more than 40 products, many of them were
manufactured by means of Biotechnology. Other than the US FDA, the European
Union has a legislation that clearly allows and regulates „Biosimilars“ (US definition:
Follow-on biologicals). This new category of products is defined as „.off-patent
Biopharmaceutical products developed and filed for a MA by a non-originator
company”. Biosimilars need – other than “classical Generic products” – more than a
Bioequivalence study: Beside the pharmaceutical data, pre- and clinical trials have
to be performed on a case-by-case base to support a regulatory approval.
Reasons for such efforts are the complexity of Biotech derived products (10 to
1000 fold bigger molecules), the impurities related to the manufacturing process
and the immunogenicity.
In 2006, two Biosimilar products were approved, 2007 yielded in four further
Erythropoetins and one recombinant h Insulin.
Contact details and address of EAPB:
European Association of Pharma Biotechnology
Kelchstraße 31
12169 Berlin
Phone: ++49-30-838 506 96
Fax: ++49-30-838 506 16
www.EAPB.org
President
Wieland W. Wolf
Dr. Rentschler Holding GmbH & Co. KG, Germany
1st Vice President
Karoline Bechtold-Peters
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
2nd Vice President
Sven Stegemann
Capsugel AG, Belgium
Scientific Secretary I
Barry Moore
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XstalBio Ltd., United Kingdom
Scientific Advisor and Treasurer
Jörg Knäblein
Bayer Schering Pharma AG, Germany
General Secretary
Rainer H. Müller
Freie Universität Berlin, Germany
Board Members
Heiko von der Leyen, Hannover Clinical Trial Center GmbH
Karl Michaelis, AAI Pharma GmbH
Inge Mühldorfer, Rentschler Biotechnologie GmbH
Henrik Luessen, Tytonis
Kai Lahtonen, Hormos Medical
Filiz Öner, Hacettepe University
Fabio Carli, Remedia
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