Market watch
EU OK's bird flu vaccine
The European Commission has, for the first time, given the go ahead for a vaccine that could provide protection against an
avian influenza pandemic. GlaxoSmithKline's Prepandrix vaccine is reportedly already being stockpiled by several countries,
including Switzerland and the US.
http://www.gsk.com/PerkinElmer positively expands
PerkinElmer has acquired LabMetrix Technologies, a provider of metrology-based multivendor analytical instrument qualification
solutions. The company generated approximately €3.2 million in 2007 and will provide PerkinElmer with new technology, tools,
processes and compliance expertise. Both companies are positive at the prospect of combining their skills and resources.
http://www.perkinelmer.com/
Industry
Barrier to generic medicines exposed
Is the patent system to blame?
A report from the European Generic medicines Association (EGA) claims that weaknesses in the European patent system are the
major barriers preventing cheaper medicines from reaching the public.
The report highlights several hurdles to generic medicines, many of which appear to result from weaknesses in the European
patent system, including failings in the system for granting quality patents, patent thickets and follow-on patents, and patent
litigation procedures. Related barriers also include patent linkage, statements to the authorities and the use of marketing
campaigns to shift consumer demand. Greg Perry, Director General of EGA, believes that "the introduction of patent linkage
presents the single biggest barrier to generic competition."
Patent linkage prohibits the granting of market authorization or price and reimbursement status to a generic medicine until
all patents have expired, or until it has been determined that the patents are not being infringed, or are invalid or unenforceable.
According to the report, the practice forces authorities to make ill-informed judgements on complex patent issues that can
normally only be determined in specialized courts. "Patent linkage is inconsistent with European law and must not be allowed
to become ensconced in practice," says Perry.
The report believes that patent linkage is just one of the many ways that patents are being used to prevent innovation and
competition, forming an almost insurmountable barrier to the entry of generic medicines.
http://www.egagenerics.com/
R&D
Human microdosing the way forward?
The gap between the laboratory and the clinic could be bridged by human microdosing, a practice that appears to offer a faster
and more accurate method of developing drugs. According to trials conducted by Xceleron (UK), microdose data for 25 candidates
proved more than 80% predictive of pharmacokinetics compared with pharmacological dose.
"Microdosing is gaining acceptance as it is a new and more precise method for evaluating a drug candidate's profile earlier
than traditional practices," says Colin Garner, CEO of Xceleron. "With only one out of every 5000 compounds making it from
bench to bedside, the intrinsic value of microdosing is that it enables companies to select and advance only those compounds
to clinical trials that demonstrate optimal drug profiles predictive of success."
Xceleron was asked to lead the EU's Microdose Accelerator Mass Spectrometer Partnership Programme (EUMAPP) consortium in January
2006, which aims to accelerate drug development. In April 2008, Malcolm Rowland, Chairman of Xceleron's Scientific Advisory
Board, presented information on Fexofenadine, one of seven drugs tested in the EUMAPP study. The findings established linear
pharmacokinetics between a microdose of Fexofenadine and its therapeutic dose. Prior to the study, it had not been possible
to administer the drug intravenously. The absolute bioavailability was previously estimated to be 11%, based on unchanged
drug in urine, but microdosing showed oral absolute bioavailability to be 33%, implying a higher degree of biliary excretion
than originally thought.
"Past studies suggest that in vivo animal modes are not necessarily reliable predictors of drug absorption and elimination
in humans, and we have found human microdosing to be highly predictive," says Garner. "The benefits of microdosing in terms
of cost savings, improved candidate selection, pipeline productivity and risk mitigation are significant."
http://www.eufeps.org/
News bites
FDA's foreign reign?
Plans have been made to provide FDA with the equivalent of €178 million, which the agency will use to expand the agency's
reach beyond its American borders. More inspections of foreign and domestic facilities are expected, and FDA says other measures
will be implemented to ensure greater foreign compliance.
http://www.fda.gov/
