Few Big Pharma companies have done as much as Sanofi to change the game plan in R&D. And if you drill down into the company's second quarter report today, you'll find a snapshot of just how successful the company has been at restructuring the pipeline.
At the beginning of February, Sanofi Aventis portfolio included 55 projects in clinical development, 13 in Phase III or submitted for approval. Today, Sanofi reported that it has 65 new molecular entities in its pipeline, with 17 either in Phase III or up for an approval. And over the next 9 months, the pharma giant says it expects to file for approval on 6 new treatments.
While Sanofi added four new compounds to its Phase I program, its mid-stage drug celivarone flunked a Phase IIb study and has been discontinued for the prevention of shocks and major clinical outcomes in patients with an implanted cardiac defibrillator. Sanofi also has some big plans for the regulatory team.
Kynamro (mipomersen), obtained in the Genzyme buyout after it was originally in-licensed from Isis, Sanofi says its application will be ready for the FDA in the fourth quarter for homozygous familial hypercholesterolemia; Mulsevo (semuloparin), ready for U.S. and EU regulators in the third quarter for venous thrombo-embolism events in cancer patients initiating a chemotherapy regimen; Aubagio (teriflunomide), another third quarter U.S. filing for relapsing multiple sclerosis; Lemtrada (alemtuzumab), another MS drug, headed to EU and U.S. regulators in the fourth quarter; Zaltrap (aflibercept), in collaboration with Regeneron for colorectal cancer, third quarter filing; Lyxumia (lixisenatide), a Type 2 diabetes treatment licensed from Zealand Pharma, is slated for a fourth quarter EU filing.
Still missing from the Sanofi snapshot is fresh insight into the stem cell partnerships it has with Osiris, which the Big Pharma company also picked up in the Genzyme buyout. Analysts have been looking closely for any signs that indicate how committed Sanofi is to the developer.
CEO Chris Viehbacher, who took the helm vowing an "open innovation" development strategy after its R&D division had failed to deliver, has a lot riding on the outcome of its upcoming applications. In order for Sanofi to get investors excited again, it needs new products to gin billions in fresh revenue. These drugs are at the front line of that fight.
- here's the quarterly report, R&D on page 9