Actelion AG, the Swiss biopharmaceutical company, reported higher third quarter sales and earnings largely as a result of expanding sales of Tracleer (bosentan), its treatment for pulmonary arterial hypertension (PAH).
The Roche Group said that its pharmaceutical research and development pipeline consisted of 65 new molecular entities and 54 additional indications at the end of the 2008 third quarter. Since the start of the year, 10 major projects have entered Phase 3. Roche gave the R&D update on 21 October with the release of its earnings for the first nine months of the year.
MediGene AG said that the final results of a Phase 2 study of its treatment for pancreatic cancer, EndoTAG-1, showed a median overall survival of up to 9.4 months for patients who were administered the treatment, together with the chemotherapy drug gemcitabine. The median survival for patients receiving gemcitabine alone was 7.2 months.
Pharming Group NV said that it is on course to make regulatory filings for its lead drug, Rhucin, with the US Food and Drug Administration and the European Medicines Agency. An FDA filing is expected to take place before the end of 2008 with a new submission to the EMEA shortly thereafter.
Vernalis Plc said its oncology collaboration with the privately-owned French pharmaceutical company, Servier, has reached a milestone triggering the payment to it of €500,000.
Governments in the industrialised world have revolutionized drug development over the past 25 years with the introduction of orphan legislation encouraging companies to invest in new products to treat rare diseases. Legislation in the US, Europe, Japan and elsewhere gives incentives to companies to start looking after the medical needs of patients with rare, but life-threatening diseases. The concept of ‘orphan’ derives from the fact that these patients had previously been ‘orphaned’ by the pharmaceutical industry.
The number of new applications for marketing authorisations in the first half of 2008 was steady compared with a year earlier, but requests for scientific advice increased by 28% over the same period, the European Medicines Agency said in its latest statistical overview of the pharmaceutical market.
The European Medicines Agency and the US Food and Drug Administration have agreed to expand the number of occasions on which they exchange confidential commercial data to include information about advanced-therapy medicines and medicines derived from nanotechnology as well as pharmacovigilance information.
Oxford BioMedica Plc said that it has reached agreement with the US Food and Drug Administration to amend the design of a Phase 3 study of its gene-based therapeutic vaccine for renal cancer, TroVax.
Advances in technology have led to an increase in the number of business models being employed by biotechnology companies in Europe. But not all of these models will survive, according to Valérie Sabatier of the University of Grenoble.