Almac outlines rapid response for drug distribution in German E
5 January 2012
Almac has outlined its response last year to an urgent request
from its client partner, Alexion Pharmaceuticals, Inc. for packaging and
distribution of Soliris (eculizumab) for patients with STEC-HUS during
the E. coli outbreak in Germany earlier this year.
Beginning in May and lasting through the summer, Germany
experienced a historically large outbreak of food-borne E. coli
infection, which resulted in more than 800 cases of STEC-HUS
(Shiga-toxin producing E. coli haemolytic uremic syndrome),
an ultra-rare and life-threatening complication of the infection. As
the crisis grew, Alexion initiated an access program to provide
Soliris free of charge in response to requests from physicians
treating patients with STEC-HUS. Subsequently, Alexion commenced a
clinical study with Soliris in STEC-HUS patients, in collaboration
with the German healthcare authorities and leading physicians.
Although Alexion continuously maintains more than 18 months of
Soliris inventory in addition to its two manufacturing sources, the
need for Soliris specifically packaged for use at various centers in
Germany was greater than the normal use of Soliris for patients with
paroxysmal nocturnal hemoglobinuria (PNH) in that country.
Alexion contacted Almac for assistance in delivering the drug,
packaged and labelled, to the EU, and requested an extremely short
turnaround time to package and distribute their drug product.
Soliris is approved for the treatment of paroxysmal nocturnal
hemoglobinuria (PNH), an ultra-rare and life-threatening blood
disorder, in the U.S., European Union, Japan and other countries.
Soliris is also approved for the treatment of patients with atypical
hemolytic uremic syndrome (aHUS), a debilitating, ultra-rare and
life-threatening genetic disorder, in the United States.
The German physicians were using Soliris in STEC-HUS on an
investigational basis. The study evaluating the safety and efficacy
of Soliris for the treatment of patients with STEC-HUS is ongoing.
“Almac understood the importance of meeting this critical
timeline to Alexion and ultimately the German patients. Because of
this, the project had visibility to the highest levels at Almac and
meetings were held daily to ensure that nothing was missed or
allowed to cause delay,” said Donna Christopher, VP of Operations at
Almac’s Durham, North Carolina facility. “This was a very gratifying
collaboration for Almac to be involved in, as we were able to make
an immediate impact to a highly publicized public health crisis.
This was satisfying to everyone who worked on this project.”
Almac’s overall approach was to quickly process (within 48 hours)
the current commercial Soliris drug product stock held at Craigavon,
UK (licensed for the treatment of PNH — paroxysmal nocturnal
hemoglobinuria) on a Named Patient basis to German physicians to
treat this life threatening condition. When the initial urgent
requirement was met, Almac was then able to scale up the packaging
and distribution of the clinical trial product.
The product was successfully delivered to patients in the time
requested due to the careful planning and constant communication of
all parties involved. “Almac was very pleased to be able to deliver
the drug to Germany within the timeframe,” said Robert Dunlop,
President of Almac Clinical Services. “Given the nature of our
industry, there are occasions when we all have to pull together to
address a critical patient need. The supply of Soliris to patients
in Germany is a great example of what can be achieved when different
stakeholders combine their respective strengths for the common