Almac collaborates with Alexion for packaging and distribution of Soliris during German E. coli outbreak

Almac, a leading provider of contract services to the global pharmaceutical and biotech industries, responded earlier this year to an urgent request from their client partner, Alexion Pharmaceuticals, Inc., a global biotechnology company, for packaging and distribution of Soliris® (eculizumab) for patients with STEC-HUS during the E. coli outbreak in Germany earlier this year.

“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 good.”

Background

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 hemolytic 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 labeled, 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 good."