sanofi (SNYNF) Key Developments
Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis
May 17 13
Sanofi announced that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR302503 for myelofibrosis (MF), met its primary endpoint in both dose groups. The primary endpoint assessed the proportion of patients achieving >/=35% reduction of spleen volume. Consistent with data reported in previous trials, the most common adverse events were anemia, diarrhea, nausea and vomiting. Full results will be presented at an upcoming medical congress. SAR302503 is a novel, investigational, selective JAK2 inhibitor. Sanofi Oncology is developing SAR302503 for the treatment of the three main types of myeloproliferative neoplasms: primary myelofibrosis, including those previously treated with ruxolitinib; polycythemia vera; and essential thrombocythemia. Conducted in 24 countries, the randomized, double-blind, placebo-controlled Phase III JAKARTA study evaluated once-daily oral SAR302503 versus placebo in 289 patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis. Eligible patients with platelet counts >/=50,000/ul were randomized to receive a once-daily oral dose of either 400mg of SAR302503, 500 mg of SAR302503 or placebo for twenty-four weeks (six cycles). The normal functioning of the JAK/STAT pathway is key to blood cell development. Dysregulated JAK/STAT signaling is associated with the development of MF and other related myeloproliferative neoplasms (MPN), such as Polycythemia Vera (PV) and Essential Thrombocythemia (ET). Dysregulation of the JAK/STAT pathway in these diseases occurs with mutations of the JAK2 and MPL genes (notably JAK2V617F and MPLW515L). In addition, up to 50% of patients with MF are considered wild-type, meaning there is no detectable JAK2 or MPL mutations, yet do demonstrate dysregulated JAK2 signaling. SAR302503 is a novel, investigational, JAK2 kinase inhibitor that selectively inhibits the JAK2 kinase, and in preclinical studies it has demonstrated activity against MF cells containing either JAK2V617F or MPLW515L mutation. As demonstrated in earlier Phase I and II studies, SAR302503 demonstrated activity in MF patients with both wild-type and mutated JAK2 (JAK2V617F). Another Phase II study in ruxolitinib-exposed patients who are either resistant or intolerant to ruxolitinib is ongoing.
Sanofi Reportedly Eyes Adcock
May 12 13
Sanofi (ENXTPA:SAN) reportedly eyes Adcock Ingram Holdings Limited (JSE:AIP). Insiders say a number of multinational companies have been looking to carve up Adcock ever since The Bidvest Group Limited (JSE:BVT made an opportunistic ZAR 6.2-billion bid for it in March 2013, an offer that has sat on the shelf since Adcock’s board refused to present it to shareholders a few weeks ago. Sources say Sanofi had been looking at making a bid for Adcock for a while, and Bidvest spurred it into action. Adcock said that it had received non-binding proposals that could lead to an offer to buy either 100% of it, or a controlling stake on May 9, 2013.
Regeneron Acquires Full Rights to Two Novel Ophthalmology Development Programs from Sanofi
May 6 13
Regeneron Pharmaceuticals Inc. announced that it has expanded its ophthalmology portfolio by acquiring full exclusive rights to two families of novel antibodies invented at Regeneron and previously included in Regeneron's antibody collaboration with Sanofi. Regeneron acquired full rights to antibodies targeting the PDGF (platelet derived growth factor) family of receptors and ligands in ophthalmology and all other indications and to antibodies targeting the ANG2 (angiopoietin2) receptor and ligand in ophthalmology. Antibodies to PDGF and ANG2 are currently in preclinical development for use in ophthalmology. With respect to PDGF antibodies, Regeneron will pay Sanofi $10 million upfront, up to $40 million in development milestone payments, and royalties on sales. With respect to ANG2 antibodies in ophthalmology, Regeneron will pay Sanofi $10 million upfront, a potential $5 million development milestone payment, and royalties on sales. Antibodies to ANG2 outside of ophthalmology will continue to be developed by Regeneron and Sanofi under their antibody collaboration agreement, including REGN910 (SAR 307746), an antibody to ANG2 that is currently in Phase 1 development in patients with advanced malignancies.
Sanofi Inaugurates New Corporate Head Office in Laval, Quebec
May 6 13
Sanofi inaugurated its new Canadian corporate head office in Laval, Quebec. The new offices, together with a new Canadian center for distribution in Kirkland, Quebec, form a renewed investment of $12 million by Sanofi in the province. Sanofi companies in Canada include Sanofi Canada (pharmaceuticals), Sanofi Pasteur (vaccines), Sanofi Consumer Health (health and beauty), Genzyme (rare diseases) and Merial (animal health). Together they employ more than 1,700 Canadians and, in 2012, invested $122 million in R&D in Canada, creating jobs, business and opportunity throughout the country. The new head office, which includes large open concept areas designed to encourage collaboration, innovation and cross-functional partnership between teams, will continue to house Sanofi's Canadian Clinical Study Unit (CSU) currently overseeing close to 70 clinical trials across the country. The Kirkland distribution center brings together the company's consumer health products and pharmaceuticals under one roof. It will also house a new cosmeceutical laboratory for the purposes of continuing innovation in Sanofi Consumer Health's NeoStrata(R) brand and bringing new health and beauty products to market.
Sanofi Inaugurates Canadian Head Office Located in 2905 Place Louis-R. Renaud in Laval, Quebec
May 6 13
On May 6, 2013, Sanofi inaugurated Canadian head office located in 2905 Place Louis-R. Renaud in Laval, Quebec.