Full Press Release Details
Q1 2014 Business EPS(1) up 5.8% at CER
Total Group sales(2) increased 3.5% to 7,842 million while our growth platforms(3) sales grew 7.9% to 5,776 million and accounted for 73.7% of total sales in Q1 2014.
First quarter business net income(1) and business EPS(1) were 1,547 million (+5.6% at CER) and 1.17 (+5.8% at CER, -3.3% on a reported basis), respectively.
Free Cash Flow after capital expenditures increased by 20.6% to 1,396 million.
The first dengue vaccine Phase III study in Asia met its primary endpoint with a 56% reduction of dengue disease cases.
Positive results from the Phase III ODYSSEY MONO study with alirocumab were presented at the ACC medical congress; we expect top line readouts from 9 additional Phase III studies by the end of Q3 2014.
Positive Phase IIa study results evaluating dupilumab in Atopic Dermatitis were presented at the AAAAI medical meeting. Top line Phase IIb data are anticipated to report in the second quarter followed by an expected Phase III initiation in Q3 2014.
The Phase III program for LixiLan, the Fixed-Ratio combination of Lantus /Lyxumia , was recently initiated.
Genzyme is expected to resubmit the LemtradaTM sBLA for FDA review in Q2 2014.
Chattem launched Nasacort OTC nasal spray in February 2014 while Merial launched NexGardTM, our next generation flea and tick product, in Q1 2014 in the U.S.
Sanofi will use the equity method to account for its 20% ownership interest in Regeneron from April 4, 2014.
The performance of the first quarter is in line with the full year guidance announced on February 6, 2014. The continued performance of growth platforms, expenses in new product launches and the late-stage pipeline is expected to lead to 2014 business EPS(1) growth between 4% and 7% at CER, barring major unforeseen adverse events.
Sanofi Chief Executive Officer, Christopher A. Viehbacher commented:
The Group s financial performance in the first-quarter continued the growth trajectory that emerged at the end of 2013. Our Business EPS(1) grew 5.8% at CER which is in line with our full-year financial guidance. Importantly, our pipeline showed steady progress. We presented study results for alirocumab, dupilumab, initiated the LixiLan Phase III program and announced plans to resubmit the sBLA for LemtradaTM. In addition, the first dengue vaccine Phase III study met its primary endpoint. During the next three quarters of 2014, we expect important development milestones for multiple high potential pipeline projects including ToujeoTM (U300), the Dengue vaccine, alirocumab, Cerdelga and dupilumab.
(1) See Appendix 6 for definitions of financial indicators; (2) Growth in net sales is expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 6 for a definition); (3) See page 2.
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2014 first-quarter key figures
| Q1 2014 | Change (reported) | Change (CER) | ||||||
| Net sales | 7,842m | -2.7 | % | +3.5 | % | |||
| Business net income(1) | 1,547m | -3.2 | % | +5.6 | % | |||
| Business EPS(1) | 1.17 | -3.3 | % | +5.8 | % |
In order to facilitate an understanding of our operational performance, we comment on our business net income statement. Business net income(1) is a non-GAAP financial measure. The consolidated income statement for Q1 2014 is provided in Appendix 4 and a reconciliation of business net income to consolidated net income in Appendix 3. Consolidated net income for Q1 2014 was 1,084 million, compared to 989 million for Q1 2013. Consolidated EPS for Q1 2014 was 0.82 versus 0.75 for Q1 2013.
2014 first-quarter net sales
Unless otherwise indicated, all sales growth figures in this press release are stated at constant exchange rates(1).
In the first quarter of 2014, Sanofi generated sales of 7,842 million, a decrease of 2.7% on a reported basis. Exchange rate movements had a negative effect of 6.2 percentage points primarily reflecting the depreciation of the U.S. Dollar, Japanese Yen, Brazilian Real, Russian Ruble, Argentine Peso, Turkish Lira and the Australian Dollar against the Euro.
In the first quarter, sales of the Group s growth platforms totaled 5,776 million, an increase of 7.9%, driven by the performance of Diabetes (up 13.2%), CHC (up 18.6%), Genzyme (up 21.5%) and Other Innovative Products (up 22.6%). The Group s growth platforms accounted for 73.7% of total consolidated sales in the first quarter, up from 71.0% in the first quarter of 2013.
| million | Q1 2014 net sales | Change at CER | |||
| Diabetes | 1,662 | +13.2 | % | ||
| Consumer Healthcare (CHC) | 885 | +18.6 | % | ||
| Vaccines | 628 | -4.2 | % | ||
| Genzyme | 566 | +21.5 | % | ||
| Animal Health | 517 | -1.6 | % | ||
| Other Innovative products(a) | 190 | +22.6 | % | ||
| Emerging Markets(b) | 2,590 | +5.5 | % | ||
| of which Diabetes, Vaccines, CHC, Animal Health, Genzyme and Other Innovative Products | 1,262 | +12.4 | % | ||
| of which other products | 1,328 | -0.3 | % | ||
| Total Growth Platforms | 5,776 | +7.9 | % |
(a) Includes products launched since 2009 which do not belong to the other Growth Platforms listed above: Multaq , Jevtana , Zaltrap , Auvi-QTM/Allerject and Mozobil
(b) World excluding the U.S. and Canada, Western Europe, Japan, Australia and New Zealand
Sales for Pharmaceuticals increased 4.7% to 6,697 million in the first quarter of 2014 driven by Genzyme, Diabetes and CHC.
(1) See Appendix 6 for definitions of financial indicators
| million | Q1 2014 net sales | Change at CER | |||
| Lantus | 1,448 | +13.5 | % | ||
| Amaryl | 86 | 0.0 | % | ||
| Apidra | 75 | +19.7 | % | ||
| Insuman | 32 | +3.0 | % | ||
| Blood Glucose Monitoring | 16 | +45.5 | % | ||
| Lyxumia | 5 | ||||
| Total Diabetes | 1,662 | +13.2 | % |
The Diabetes division generated sales of 1,662 million in the first quarter, an increase of 13.2%. Lantus sales were up 13.5% to 1,448 million driven by the U.S. (+14.5% to 951 million) and Emerging Markets (+17.9% to 225 million). In the U.S., Lantus volume sell-in was down this quarter given unfavorable trade inventory fluctuations (around 70 million). Lantus SoloSTAR represented 60.8% of total Lantus sales in the quarter in the U.S., versus 57.0% in the first quarter of 2013. In China, Lantus sales grew 39.4% to 45 million. Sales of Lantus in Western Europe grew 5.6% to 208 million.
Lyxumia (lixisenatide), a once-daily prandial GLP-1 receptor agonist is now available in a number of countries such as Italy, Spain, Japan, Mexico, with additional launches expected in 2014. First-quarter sales of Lyxumia were 5 million. In Germany, Sanofi suspended in-country distribution of lixisenatide on April 1, 2014 given unsuccessful pricing negotiation with the National Association of Statutory Health Insurance Funds (SpiBu). An arbitration process is ongoing and after the completion of this process, Sanofi will reassess the situation.
Sales of Apidra increased 19.7% to 75 million in the first quarter driven by Western Europe (+21.1% to 23 million) and Emerging Markets (+28.6% to 17 million).
First-quarter sales of Amaryl were stable at 86 million reflecting 6.0% growth in Emerging Markets ( 65 million) offset by generic competition in Japan where sales decreased 19.0% to 15 million.
| million | Q1 2014 net sales | Change at CER | |||
| Allegra | 104 | +14.1 | % | ||
| Doliprane | 88 | +7.2 | % | ||
| Essentiale | 66 | +45.1 | % | ||
| Enterogermina | 38 | +5.1 | % | ||
| Nasacort | 42 | ||||
| No Spa | 28 | +3.3 | % | ||
| Maalox | 27 | +20.0 | % | ||
| Lactacyd | 25 | +11.1 | % | ||
| Dorflex | 23 | +7.7 | % | ||
| Other CHC Products | 444 | +11.8 | % | ||
| Total Consumer Healthcare | 885 | +18.6 | % |
First-quarter sales of Consumer Healthcare products (CHC) grew 18.6% to 885 million. At the beginning of February, Nasacort Allergy 24HR nasal spray was available over-the-counter (OTC) in the U.S. to relieve nasal allergy symptoms. Nasacort Allergy 24HR is the first and only medicine in its class to be available at full prescription strength without the need for a prescription. U.S. sales of Nasacort were 36 million in the first quarter. In addition, Lactacyd and Maalox recorded double-digit growth in sales in the first quarter.
Some products previously recorded in prescription pharmaceuticals in the first quarter of 2013 were transferred to Consumer Healthcare products and totaled 68 million. Excluding this change of perimeter, sales of CHC grew 9.4% reflecting the success of the Nasacort Rx-to-OTC switch in the U.S. and strong performance in Emerging Markets (+13.7%).
| million | Q1 2014 net sales | Change at CER | |||
| Cerezyme | 168 | +5.8 | % | ||
| Myozyme / Lumizyme | 121 | +7.8 | % | ||
| Fabrazyme | 98 | +13.0 | % | ||
| Aldurazyme | 41 | +16.2 | % | ||
| Total Rare Diseases | 483 | +8.5 | % | ||
| Aubagio | 78 | +305.0 | % | ||
| Lemtrada TM | 5 | ||||
| Total Multiple Sclerosis | 83 | +330.0 | % | ||
| Total Genzyme | 566 | +21.5 | % |
Genzyme first-quarter sales increased 21.5% to 566 million, driven by Aubagio with sales of 78 million versus 20 million in the first quarter of 2013. Genzyme recorded double digit growth in all regions with +31.0% in the U.S. ( 212 million), +18.2% in Emerging Markets ( 112 million), +14.8% in Western Europe ( 194 million) and +19.6% in the rest of the world ( 48 million).
First-quarter sales of Cerezyme , the leading therapy for Gaucher disease, were 168 million, an increase of 5.8% driven by Emerging Markets (+10.0% to 56 million) and the U.S. (+7.0% to 45 million).
Sales of Myozyme /Lumizyme reached 121 million in the first quarter, an increase of 7.8%, supported by strong growth in Emerging Markets (+64.3% to 20 million).
First-quarter sales of Fabrazyme increased 13.0% to 98 million due to patient accruals globally. Fabrazyme continued to record strong growth in Western Europe (+25.0% to 25 million) reflecting market share gains. Fabrazyme sales grew 12.8% to 51 million in the U.S.
Sales of Aubagio were 78 million in the first quarter of which 59 million were in the U.S. The launch of the product in the first Western European countries (specifically Germany, Switzerland and Nordic countries) started in the fourth quarter of 2013 and sales reached 17 million in the first quarter of 2014.
Following its approval by the European Commission in September, Lemtrada (alemtuzumab, developed in collaboration with Bayer HealthCare to treat relapsing forms of multiple sclerosis) was launched in Germany in October 2013 with further roll-out across Europe expected in 2014. Lemtrada is also approved in Canada, Australia, Mexico and Brazil. First-quarter sales of the product were 5 million.
Other Innovative Products(4)
| million | Q1 2014 net sales | Change at CER | |||
| Multaq | 73 | +21.0 | % | ||
| Jevtana | 66 | +30.8 | % | ||
| Mozobil | 25 | 0.0 | % | ||
| Zaltrap | 16 | +45.5 | % | ||
| Auvi-Q /Allerject | 10 | +25.0 | % | ||
| Total Other Innovative Products | 190 | +22.6 | % |
(4) Includes products launched since 2009 which do not belong to the other Growth Platforms
First-quarter sales of Multaq grew 21.0% to 73 million driven by the U.S. ( 60 million, up 26.5%). Sales of Jevtana increased 30.8% to 66 million in the first quarter, reflecting recent launches in Western Europe ( 38 million, up 58.3%). In the first quarter, sales of Zaltrap (aflibercept, collaboration with Regeneron) reached 16 million, an increase of 45.5% driven by recent launches in Western Europe ( 7 million vs. 1 million in Q1 2013) which offset lower sales in the U.S. First-quarter sales of Mozobil were stable at 25 million. Sales of Auvi-Q /AllerjectTM(5) which was launched in the U.S. in January 2013, were 10 million (+25.0%) in the first quarter.
(5) Sanofi US licensed the North America commercialization rights to Auvi-Q from Intelliject,Inc.
Established Pharmaceutical Products
| million | Q1 2014 net sales | Change at CER | |||
| Plavix | 487 | +18.2 | % | ||
| Lovenox | 416 | +1.4 | % | ||
| Aprovel /Avapro | 179 | -22.8 | % | ||
| Renvela /Renagel | 172 | +5.3 | % | ||
| Allegra | 80 | -46.2 | % | ||
| Myslee /Ambien /Stilnox | 78 | -14.9 | % | ||
| Synvisc / Synvisc One | 70 | -3.9 | % | ||
| Taxotere | 69 | -28.7 | % | ||
| Eloxatin | 46 | -15.3 | % |
In the first quarter, sales of Plavix grew 18.2% to 487 million. In Japan, sales were up 48.5% to 215 million reflecting strong underlying volume growth and favorable buying patterns in anticipation of an increase in the consumption tax. In Emerging Markets, sales grew 4.4% to 204 million. In China, sales reached 114 million, an increase of 6.4%. In Western Europe, sales of Plavix decreased 4.6% to 62 million.
Sales of Lovenox were 416 million in the first quarter (up 1.4%), reflecting good performance in Western Europe (+7.5% to 229 million), in Emerging Markets (+4.2% to 135 million) and generic pressure in the U.S. where sales of the branded product declined 32.7% to 32 million.
First-quarter sales of Aprovel /Avapro decreased 22.8% to 179 million, due to generic competition in Western Europe where sales decreased 45.5% to 54 million. Sales of the product in Emerging Markets were relatively stable at 95 million.
Sales of Renvela /Renagel totaled 172 million in the first quarter (up 5.3%) reflecting good performance in Emerging Markets (sales of 22 million vs. 13 million in Q1 2013) and slightly lower sales in the U.S. (down 2.5% to 114 million).
In the first quarter, sales of Allegra as a prescription drug were 80 million, down 46.2% and sales of the Ambien family of products were 78 million, down 14.9%, reflecting generic competition in Japan for both products.
Sales of Synvisc /Synvisc One were 70 million (down 3.9%) in the first quarter, impacted by lower sales in the U.S. (down 12.7% to 53 million).
First-quarter sales of Taxotere decreased 28.7% to 69 million, reflecting generic erosion in the U.S. and Western Europe and lower sales in Emerging Markets ( 39 million, down 23.2%). Sales of Eloxatin decreased 15.3% to 46 million in the first quarter of 2014.
In the first quarter, sales of Generics totaled 421 million, an increase of 8.0%, reflecting the recovery in Brazil where sales grew to 52 million partially offset by lower sales of the authorized generics of Lovenox and of Taxotere in the U.S. In Emerging Markets, sales of generics increased 23.6% to 244 million due to the strong improvement in Brazil.
| million | Q1 2014 net sales | Change at CER | |||
| Polio/Pertussis/Hib Vaccines (incl. Pentacel , Pentaxim and Imovax ) | 211 | -15.9 | % | ||
| Influenza Vaccines (incl. Vaxigrip and Fluzone ) | 135 | +19.3 | % | ||
| Adult Booster Vaccines (incl. Adacel ) | 81 | 0.0 | % | ||
| Travel and Other Endemics Vaccines | 75 | +10.8 | % | ||
| Meningitis/Pneumonia Vaccines (incl. Menactra ) | 56 | -25.0 | % | ||
| Other Vaccines | 70 | +4.3 | % | ||
| Total Vaccines (consolidated sales) | 628 | -4.2 | % |
First-quarter consolidated sales of Sanofi Pasteur were 628 million, a decrease of 4.2%, reflecting a phasing effect in Pentaxim deliveries in Emerging Markets and strong sales for Imovax in Japan and Menactra in the previous year period. In the U.S., sales grew 23.8% to 279 million, driven by the continued gradual Pentacel recovery. In Emerging Markets, sales were 261 million, a decrease of 15.0% due to Pentaxim phasing.
First-quarter sales of Polio/Pertussis/Hib vaccines reached 211 million, a decrease of 15.9%. The first-quarter performance was impacted by timing of supply of Pentaxim in Mexico and China and lower sales of Imovax in Japan due to the end of the catch-up cohort following its launch in September 2012. As expected, the first quarter performance reflected continued gradual Pentacel recovery in the U.S.
Sales of influenza vaccines increased 19.3% to 135 million in the first quarter and included 16 million of H7N9 flu vaccines in the U.S. Sales of influenza vaccines were 21 million in the U.S., an increase of 40.0% (including H7N9 flu vaccines). In Emerging Markets, sales of influenza vaccines grew 17.2% to 105 million.
Sales of Adult booster vaccines were stable at 81 million in the first quarter. Sales of Adacel were 63 million, an increase of 4.8%, reflecting a gradual supply recovery from Adacel in the U.S.
First-quarter sales of travel and other endemic vaccines increased 10.8% to 75 million driven by higher Typhim Vi sales.
First-quarter sales of Menactra were 48 million, a decrease of 23.9%, reflecting a strong baseline in the first quarter of 2013 which benefited from a meningitis outbreak in Latin America and lower sales in Middle East.
First-quarter sales of Sanofi Pasteur MSD (not consolidated), the joint venture with Merck & Co. in Europe, were 158 million (a decrease of 8.8% on a reported basis), reflecting strong baseline for Gardasil due to the catch up program in Nordic countries in the first quarter of 2013 and lower sales for pediatric vaccines tied to changes in the vaccine schedule implemented in April 2013 in France.
| million | Q1 2014 net sales | Change at CER | |||
| Companion Animal | 344 | -3.7 | % | ||
| Production Animal | 173 | +2.8 | % | ||
| Total Animal Health | 517 | -1.6 | % | ||
| of which fipronil products | 171 | -8.2 | % | ||
| of which NexGard TM | 23 | ||||
| of which avermectin products | 114 | -14.8 | % | ||
| of which Vaccines | 154 | -1.2 | % |
First-quarter sales of Animal Health were 517 million, down 1.6%. In Emerging Markets, sales grew 3.9% to 121 million.
Sales of the Companion Animals segment were 344 million, a decrease of 3.7% in the first quarter. Merial started to prepare for the flea and tick season by introducing NexGardTM for dogs in the U.S. and in France in the first quarter. BroadlineTM, a unique product in the fight against external and internal parasites for cats and kittens, was also launched in France. Sales of NexGardTM were 23 million while sales of the anti-parasiticide
Frontline /fipronil family of products were down 8.3% to 169 million. Furthermore, in the first quarter of 2013, Heartgard (avermectin products line) benefited from a competitor supply issue in the U.S.
First-quarter sales of the Production Animals segment were 173 million, an increase of 2.8% driven by the performance of the swine business.
Net sales by geographic region
| million | Q1 2014 net sales | Change at CER | |||
| Emerging Markets(a) | 2,590 | +5.5 | % | ||
| of which Latin America | 734 | +13.1 | % | ||
| of which Asia | 734 | +4.0 | % | ||
| of which Eastern Europe, Russia and Turkey | 604 | +4.0 | % | ||
| of which Africa | 233 | -11.0 | % | ||
| of which Middle East | 253 | +10.9 | % | ||
| United States | 2,415 | +7.5 | % | ||
| Western Europe(b) | 1,998 | -0.3 | % | ||
| Rest of the world(c) | 839 | -4.0 | % | ||
| of which Japan | 587 | -2.5 | % | ||
| TOTAL | 7,842 | +3.5 | % |
(a) World less the U.S., Canada, Western Europe, Japan, Australia and New Zealand
(b) France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark
(c) Japan, Canada, Australia and New Zealand
First-quarter sales in Emerging Markets were 2,590 million, an increase of 5.5%. Double-digit growth was recorded for Diabetes (+16.1%), CHC and Genzyme (+18.2%). Latin America reported double-digit sales growth over the period driven by the performance in Brazil. Sales in Brazil grew 19.9% to 359 million, reflecting a recovery of Generics (+113.3% to 52 million), strong performance of Diabetes (+25.0%) and vaccines (up 39.1%). Sales in China increased 10.3% to 377 million driven primarily by the performance of Diabetes and CHC partially offset by lower sales of vaccines due to timing of supply of Pentaxim . Sales in Eastern Europe/Russia and Turkey increased 4.0% to 604 million driven by Russia (+8.8% to 195 million) and Turkey (+15.5%). Sales in Africa were 233 million, down 11.0%, reflecting changes in buying patterns and inventory policies by some customers in Algeria and Morocco.
First-quarter sales in the U.S. grew 7.5% to 2,415 million driven by strong performances from Diabetes (+14.4%), Genzyme (+31.0%), Vaccines (+23.8%) and CHC (+18.1%) supported by the success of the Nasacort Rx-to-OTC switch.
First-quarter sales in Western Europe were stable (-0.3%) at 1,998 million, reflecting continued growth of Diabetes (+8.3%) and Genzyme (+14.8%) offset by generic competition to Aprovel .
Sales in Japan were 587 million, a decrease of 2.5%, reflecting generic competition to Allegra , Myslee and Amaryl and lower sales of Imovax .
Consult Appendix 5 for full overview of Sanofi s R&D pipeline
Regulatory updates since the publication of the Full-year 2013 results on February 6, 2014 include the following:
In April, Sanofi and its subsidiary Genzyme announced that following constructive discussions with the U.S. Food and Drug Administration (FDA) the company plans to resubmit in the second quarter its supplemental Biologics License Application (sBLA) seeking approval of LemtradaTM (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. The resubmission will provide information to
specifically address issues noted by the FDA in its December 2013 Complete Response Letter. Once the filing is accepted, the FDA will assign either a two month or six month review timeframe. Genzyme had previously announced its intention to appeal the FDA s Complete Response Letter. In light of the planned resubmission, the company does not expect to pursue an appeal at this time.
In March, SAR650984, a monoclonal antibody anti-CD38, obtained a designation as an orphan medicinal product from the European Medicines Agency for the treatment of myeloma.
In February, the European Commission approved NexGardTM (afoxolaner) for the treatment of flea and tick infestations in dogs. NexGardTM can also be used as part of a treatment strategy for the control of Flea Allergy Dermatitis.
At the end of April 2014, the R&D pipeline contained 50 projects (excluding Life Cycle Management) and vaccine candidates in clinical development of which 12 are in Phase III or have been submitted to the health authorities for approval.
Sanofi Pasteur announced in April that the first of two pivotal Phase III efficacy studies with its dengue vaccine candidate has achieved its primary clinical endpoint. The efficacy study showed a significant reduction of 56% of dengue disease cases. Initial safety data are consistent with the good safety profile observed in previous studies. Full analysis of the data will be undertaken in the coming weeks and reviewed by external experts prior to disclosure at an upcoming international scientific congress and publication in a peer-reviewed journal later this year. The results of this first, large-scale efficacy study will be further complemented by results in the third quarter of 2014 from a second, large-scale study currently conducted in Latin America, including more than 20,000 volunteers.
The first full data results from the Phase III ODYSSEY MONO study with alirocumab, an investigational monoclonal antibody targeting PCSK9 (collaboration with Regeneron), were presented at the American College of Cardiology s 63rd Annual Scientific Session held in March. ODYSSEY is the global Phase III trial program for investigational compound alirocumab. ODYSSEY currently comprises 14 clinical trials enrolling more than 23,500 patients with hypercholesterolemia. We expect to report additional top-line Phase III data, beginning in June 2014 through the third quarter of 2014. All ongoing Phase III studies that are part of the ODYSSEY program are now fully enrolled (except ODYSSEY OUTCOMES).
The filing of alirocumab in hypercholesterolemia in EU is expected in the fourth quarter of 2014.
In April, Sanofi and Regeneron Pharmaceuticals, Inc. announced that the first Phase II study with alirocumab in Japanese patients met its primary endpoint. The results demonstrated that the mean low-density lipoprotein-cholesterol (LDL-C, or bad cholesterol) percentage reduction from baseline to week 12, the primary efficacy endpoint of the study, was significantly greater in patients randomized to receive one of three doses of alirocumab administered every other week (Q2W) - 150 milligrams (mg), 75 mg, and 50 mg, in combination with statin therapy, compared to patients receiving placebo. The Phase III program has now started in Japan.
The Phase III program for LixiLan, the Fixed-Ratio combination of Lantus /Lyxumia , was recently initiated.
ALN-TTRsc/SAR438714 (collaboration with Alnylam) is in Phase II development for the treatment of Familial Amyloidotic Cardiomyopathy (FAC). Furthermore, in April, the European Medicines Agency (EMA) Committee for Orphan Medicinal Products adopted a positive opinion recommending ALN-TTRsc for designation as an orphan medicinal product.
In March, at the American Academy of Allergy, Asthma and Immunology Annual Meeting held in San Diego, positive data from a Phase IIa trial evaluating dupilumab, a human monoclonal antibody targeting the IL-4R subunit, administered for 12 weeks in patients with moderate-to-severe atopic dermatitis poorly controlled by topical agents were presented. At 12 weeks, the dupilumab group achieved statistically superior clinical outcomes compared to the placebo group in all measures of disease activity and pruritus. Updated data including a follow-up assessment up to 78 days from a smaller Phase II trial evaluating dupilumab co-administered with topical steroid (TCS) treatment were also presented. Relative
to TCS alone, concomitant treatment with dupilumab and TCS provided marked, sustained, and significant improvement in clinical efficacy measures, despite use of less TCS.
Sanofi has decided not to pursue the development of SAR 339658, an anti-VLA 2 monoclonal antibody, in ulcerative colitis and will instead focus on evaluating the use of this compound in multiple sclerosis by initiating a clinical Phase II study.
The development of SAR3419 in Acute Lymphocytic Leukemia has been discontinued.
Sanofi has decided not to exercise the licence option for RetinoStat .
In March, Sanofi and UCB announced they had entered into a scientific and strategic collaboration for the discovery and development of innovative anti-inflammatory small molecules, which have the potential to treat a wide range of immune-mediated diseases in areas such as gastroenterology and arthritis. UCB NewMedicines, the research arm of UCB, has used an innovative approach to identify small molecule modulators of a biological pathway, for which parenterally administered biologic therapies have proven highly efficacious in patients. A dedicated team of scientists will be formed under the leadership of Sanofi and UCB, and will join forces in a discovery and development based collaboration to characterize and identify new potential therapies.