Sanofi SA is looking at a year of transition as it faces the loss of exclusivity for blockbuster drugs Plavix (clopidogrel) and Avapro (irbesartan) – losses that alone will drag net income down €1.4 billion ($1.86 billion). But management highlighted the silver lining during a year-end sales and earnings call Feb. 8: the acquisition of Genzyme, which will mitigate damage, and the company’s pipeline, which could yield 18 product launches from 2012 through 2015.

Nonetheless, there is no sugar coating the fact that 2012 will be a difficult year for Sanofi. The company expects earnings per share to be 12% to 15% lower than 2011 at constant exchange rates. The forecast is in line with the mid-term return to growth strategy laid out by management last September, a plan that anticipates sales growth of at least 5% per year between 2012 and 2015 Also see "After The Patent Cliff, "New" Sanofi Will Deliver Steady, Modest, Growth" - Pink Sheet, 12 September, 2011..

Optimistic On R&D

Sanofi is broadly recognized as having one of the weaker pipelines among big pharma, but management is trying its best to change that image. How successful Sanofi will ultimately be at delivering on its drug launch goals remains to be seen, but the company is targeting a high number of regulatory filings in the next four years. CEO Christopher Viehbacher pointed to the company’s filing of five new drugs with regulatory authorities within nine months as positive momentum. “For a company that most people don’t think has a pipeline, I think it’s a pretty strong achievement,” he said.

Among the five filings are Kynamro (mipomersen) for severe homozygous familial hypercholesterolemia, filed in July in Europe; Aubagio (teriflunomide) for relapsing forms of multiple sclerosis, filed in the U.S. in August and in February in Europe; Visamerin (semuloparin) for venous thromboembolism prevention in chemotherapy-treated patients, filed in September in the U.S. and Europe; Lyxumia (lixisenatide) for type 2 diabetes in October in Europe; and Zaltrap (aflibercept) for metastatic colorectal cancer, re-filed in the U.S. in February and in Europe in December. U.S. filings for Kynamro, an RNA interference agent, and Lyxumia, a once-daily GLP-1, are planned for the first quarter and the fourth quarter, respectively, the company announced.

Those five filings could yield drug launches in 2012. An additional three drugs could launch in 2013, the firm said. Lemtrada (alemtuzumab), an anti-CD52 monoclonal antibody for multiple sclerosis, will be filed in the U.S. later this year. The filing timeline for the drug, gained through the acquisition of Genzyme, slipped from the first quarter to the second quarter, the firm acknowledged. Two other potential 2013 launches are vaccines: Fluzone quadrivalent influenza vaccine and Hexaxim, a DTP-HepB-Polio-Hib vaccine.

Further out, six additional launches are targeted for 2014, including eliglustat, another drug acquired through Genzyme and the first oral therapy for Gaucher disease. The rare disease is currently treated with twice monthly infusions, including with Genzyme’s Cerezyme (imiglucerase). Three Phase III trials evaluating the drug, ENCORE, ENGAGE and EDGE, are fully enrolled. Other potential launches in 2014 are SAR302503, a JAK-2 inhibitor in Phase III trials in myelofibrosis; iniparib, a PARP inhibitor for non-small cell lung cancer; otamixaban, a direct Xa inhibitor for acute coronary syndromes; and ombrabulin, a vascular disrupting agent for sarcoma.

In 2015, the company expects to launch SAR236553, an anti-PCSK-9 for hypercholesterolemia, FOV1101 for allergies and two vaccines.

Global R&D President Elias Zerhouni acknowledged that investors are likely to be skeptical about the mid-stage pipeline for now. “I’m told that there’s a lot of discounting whatever R&D chiefs say in terms of their early portfolio,” he said. “But I think we have here tangible, measurable outcomes of R&D you can check us on.”

Genzyme Gives Sanofi A Hand In 2011

The acquisition of Genzyme in April helped Sanofi’s fourth quarter and annual sales performance. Fourth quarter sales of €8.51 billion ($11.3 billion) were up 8.8%, and sales for the year were up 3.2% to €33.39 billion ($44.32 billion), despite the loss of €2.2 billion ($2.92 billion) in sales due to generic competition. Pharmaceutical sales increased 10.5% in the fourth quarter to €7.22 billion ($9.58 billion), with a positive €831 million ($1.1 billion) contribution from Genzyme offsetting the negative effect of generic competition to Lovenox, Ambien CR and Taxotere in the U.S. Full year pharmaceutical sales increased 6.7% to €27.89 billion ($37.02 billion). Earnings per share for the year were €6.65 ($8.83), down 5.8% on a reported basis.

The diabetes business continued its strong sales performance, driven by Lantus (insulin glargine), which surpassed €1 billion in quarterly sales for the first time in the fourth quarter. Lantus sales for the year were up 15% to €3.92 billion ($5.2 billion). With the loss of exclusivity of Plavix, Lantus has become an increasingly vital brand for Sanofi, but the drug could soon be facing competition from Novo Nordisk AS, which filed a competing long-acting insulin, Degludec, in the U.S. and EU in September Also see "More Insulin Innovation To Come, Says Novo CEO Sorensen" - Pink Sheet, 14 December, 2011.).

Sanofi is looking to develop its own new formulation of insulin glargine. The company said it began recruiting patients in two Phase III trials at the end of 2011. The EDITION I trial compares the new formulation to Lantus in patients with type II diabetes on basal plus meal-time insulin. The EDITION II trial compares the new formulation of insulin with Lantus in patients with type II diabetes on oral anti-diabetic agents.

Sanofi is also experiencing some infusion of cash from its win in patent infringement litigation with Apotex. The generic firm, which launched an at-risk version of Plavix in 2006, paid $442.2 million in damages to Sanofi and partner Bristol-Myers Squibb Co., the firms announced Feb. 8. The October 2011 federal appeals court ruling also awarded Sanofi and Bristol $1.3 million in post-judgment interest and $900,000 in costs in addition to the damages award Also see "Apotex To Retain About $300 Million From Its At-Risk Launch of Generic Plavix" - Pink Sheet, 20 October, 2010..

Sanofi Targets 18 Drug Launches From 2012 To 2015

More from Clinical Trials

More from R&D