Conference Reports
2nd BIO-Europe Spring, Madrid, Spain
7th-9th April 2008
The Palacio Municipal de Congresos in Madrid played host to the 2nd BIO-Europe Spring conference, showcasing its partnering event for 850 biotechnology, pharmaceutical and professional service companies from across the globe, which included 1400 attendees, 5000 partnering meetings and 150 company presentations, workshops and panels. The conference also aspired to display the importance of raising awareness of the biotechnology industry in Madrid.
With the main objectives of striking licensing deals and coordinating strategic partnerships, companies ensured quality and integrity within their presentations. Of particular interest was Canadian-based Zelos’ injectable parathyroid hormone analogue, which is in Phase III trials for osteoporosis. With 10 million patients diagnosed with the disease in the US, Ostabolin-C is designed to prevent the “silent epidemic of bone loss” by targeting postmenopausal women, who are mainly at risk. Zelos aims to develop it for inhaled and transdermal delivery, but its subcutaneous application is currently the most advanced. Results from a recent Phase II trial in 261 post-menopausal patients showed a significant, doseresponsive increase in mean lumbar spine bone mineral density, keeping it well on track for an NDA filing in 2010. Zelos is seeking a development and marketing partner and expects to collaborate with a peptide delivery company for the development of an oral formulation.
In the cardiovascular arena is Sanofi-Aventis’ icatibant, for which Jerini has full responsibility for global commercialization for the treatment of hereditary angioedema. Whilst this bradykinin B2 antagonist has shown good results in trials in hepatic cirrhosis and burns, Jerini confirmed that FAST-1 and –2 studies showed it was safe, with a faster median time to onset of symptom relief compared with placebo and tranexamic acid. An EU MAA is already filed, with approval recommended by the CHMP. However, it received a non-approvable letter in the US, although Jerini plans to meet with the FDA as early as possible to address the agency’s concerns.
As well as some of the heavyweights, including Genzyme, Procter & Gamble, Nektar and Boehringer Ingelheim, it was a good opportunity for next-generation companies to display their pipelines to potential investors and licensees. With a collection of stem cell therapies in active development, Aastrom Biosciences hopes to attain licensing deals for treatments in the cardiac, neural and vascular areas, as well as its most advanced candidate for osteonecrosis. Phase III trials are ongoing in 120 patients with the disorder receiving the tissue repair cells derived from cryopreserved small aspirate bone marrow cells placed in a bone matrix carrier, administered into the femoral head via a core tract. The elimination of the progression or delay of the disease will be observed.
Another cellular therapy company, Cellerix, which is following the same route as Aastrom, with four stem cell/cellular candidates presented data on its lead product CX-401. This autologous treatment is in a Phase III trial in 207 patients with perianal fistula without inflammatory bowel disease. With EU orphan drug status granted, Cellerix plans to bring it to market in 2010. Its epidemolysis bullosa agent, CX-501, is in Phase II trials and also has EU orphan drug status, with launch planned in 2008-2011.
The conference once again lived up to its expectations of imprinting its mark on the biopartnering calendar within the healthcare industry, providing success and productivity and key links between companies of various therapeutic focuses.
The 3rd BIO-Europe Spring will be held in Milan, Italy, 16th - 18th March 2009
Paul D'Souza
Pharmaprojects Analyst
