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`SANOFI
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`Lantus®/Apidra® SoloSTAR® help to improve patient satisfaction
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`Paris, France - June 27, 2011 - Sanofi (EURONEXT: SAN and NYSE: SNY) announced today, at
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`the 71 st Scientific American Diabetes Association Sessions 2011 , the results of three studies
`showing that people with diabetes using Sanofi insulins Lantus® and/or Apidra® with the insulin
`delivery device SoloST AR® experienced greater treatment satisfaction, better quality of life and
`lower fear of hypoglycemia vs those using a premixed insulin product.
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`The goal of the first study1, involving 586 patients with uncontrolled type 2 diabetes on oral agents,
`was to evaluate any changes in physical and psychological well-being, diabetes-related symptoms,
`and patient satisfaction with diabetes-related care and treatment over the study period and from
`baseline to endpoint.
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`It showed that, compared with those on twice-daily premixed 70/30 insulin aspart (premix) , patients
`on the combination of Lantus®- and Apidra®-based regimens experienced better quality of life as
`measured by the Diabetes Quality of Life (DQoL) questionnaire, which evaluates personal
`perception of improvements as a result of treatment:
`• DQoL improved significantly for all groups at all wks; average improvement was greater for
`basal Lantus® (insulin glargine) + 1 prandial Apidra® (insulin glulisine) dose (GLARG+1) and
`stepwise addition of prandial glulisine (GLARG+0-3) vs premix (P::;;0.0002)
`• Compared to the glargine group, patients on premix also showed significantly greater
`hypoglycemic fear from week 12 to study end (P<0.05).
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`The goal of the second study2, conducted with 220 type 1 and type 2 patients from 32 sites in
`Canada, was to evaluate the change in diabetes treatment satisfaction in people treated with insulin
`glargine. It showed that 96% of patients experienced significant treatment satisfaction upon
`switching to Lantus® SoloST AR® from their previous treatment: Diabetes Treatment Satisfaction
`Questionnaire at 6 months= 12.0 (SD= 5.4), compared to overall satisfaction at baseline.
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`The objective of the third study, LANSOLEAP3
`, involving 143 adults with either type 1 or type 2
`diabetes in Mexico, was to evaluate satisfaction with the SoloST AR® insulin pen by adult patients.
`It showed that:
`• 83% rated SoloST AR® as excellent
`• 78% found SoloSTAR® easier to use overall, compared with their previous device
`• 87% preferred SoloST AR® to their previous device
`• Of those who had never used a pen device, 83% felt confident about using SoloST AR® on
`the same day they received the pen.
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`Patient satisfaction is key to improving compliance, and therefore treatment outcomes. As a patient(cid:173)
`centric company focused on the needs of people with diabetes Sanofi is committed to improving
`treatment satisfaction and quality of life.
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`Mylan v. Sanofi
`IPR2018-01676
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`Notes to editors
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`About the studies
`Polonsky et al (referred as the first study) was a 60-week randomized , open-label study compared
`adding BID premixed 70/30 insulin aspart (PREMIX), basal insulin glargine + 1 prandial insulin
`glulisine dose (GLARG+1), or stepwise addition of prandial glulisine (GLARG+0-3) in 586 patients
`with uncontrolled type 2 diabetes on oral agents. The objective was to evaluate any within- and
`between-group changes in 1) physical and psychological well-being, 2) diabetes-related symptoms,
`and 3) patient satisfaction with diabetes-related care and treatment over the study period and from
`baseline to endpoint. While achieving similar glycemic control and body weight changes , GLARG+1
`and GLARG+0-3 were more effective than PREMIX in FBG reduction and reaching A 1 C <7%, while
`causing less overall hypoglycemia. Patient reported outcomes were measured at baseline, 6, 12, 24,
`36, 48, and 60 weeks to assess overall quality of life, diabetes-specific quality of life (DQoL),
`hypoglycemic fear and adjustment to illness.
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`Garon et al (referred as the second study) evaluated the change in diabetes treatment satisfaction
`in 220 patients with type 1 or type 2 diabetes treated with Lantus® SoloST AR®. This 6-month
`Canadian, observational, multicenter, prospective registry collected data in 220 T1&T2 Diabetes
`patients
`from 32 sites treated with any combination of unmixed basal
`insulin, oral anti(cid:173)
`hyperglycemic drugs or short-acting insulins who had HbA1c > 7% or HbA1c :5 7% with severe or
`frequent symptomatic hypoglycemia were enrolled
`in the study. Treatment satisfaction was
`measured by using the standard Diabetes Treatment Satisfaction Questionnaire at baseline
`(DTSQs) and after 6 months (DTSQc). Patients acceptance of SoloSTAR® pen was assessed using
`8-item pen use questionnaire having scores from 1 =excellent to 5=very poor. 56 T1 DM and 164
`T2DM pts were on average 39.7 (SD=12.4) and 59.3 (SD=11.0) years old and had BMls of 26.9
`(SD=4.7) and 33.4 (SD=8.0) kg/m2, respectively.
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`LANSOLEAP (referred as the third study) was a multicenter, prospective, one-arm, six to eight
`week observational study, involving adults with either type 1 or type 2 diabetes (who were either
`insulin users, or insulin na"fve and taking oral medications and candidates for insulin therapy). The
`primary objective was to evaluate satisfaction with SoloST AR®, evaluated by a self-assessment
`questionnaire pertaining to overall acceptance (rating of SoloST AR®) and ease and continuation of
`use. In a second questionnaire, insulin users assessed their preference for SoloSTAR® compared
`with their previous device.
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`A total of 206 patients were enrolled, with 56 excluded for failing to meet the minimum time of 30
`days between visits. The mean age of the 150 patients whose data could be analyzed was 53.3
`years (range 18-90 yrs); 58.7% were female, 86.6% had type 2 diabetes, 68% had a BMI >25, and
`70% had used insulin previously. The 7 patients who did not inject insulin themselves were
`excluded from the satisfaction evaluation .
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`About Lantus®
`Lantus® (insulin glargine) is the first 24-hour once-daily basal insulin analog. Lantus® is as effective
`as NPH insulin with similar reductions in HbA10 , but is associated with lower fasting blood glucose
`concentrations. People with Type 2 diabetes experience a consistent and significant reduction in the
`incidence of nocturnal hypoglycemia with Lantus®.4
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`About Apidra®
`Apidra® is a fast-acting insulin analog of human insulin with a zinc-free molecular structure that
`maintains a rapid onset and a short duration of action, indicated for the treatment of adults with type
`1 and type 2 diabetes. Apidra® offers mealtime dosing flexibility - it can be taken 15 minutes before
`or within 20 minutes after starting a meal, and in a variety of body types, from lean to obese.
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`About SoloSTAR®
`SoloSTAR® is Sanofi's prefilled, multi-purpose, disposable insulin pen for the administration of
`Lantus®, Apidra® and lnsuman®. SoloSTAR®is the winner of a GOOD DESIGN™ Award.
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`About the Sanofi Diabetes Division
`Sanofi strives to help people manage the complex challenges of diabetes by delivering innovative,
`integrated and personalized solutions. Driven by valuable insight that comes from listening to and
`engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics,
`therapies, services, and devices. Sanofi markets both injectable and oral medications for people
`with type 1 or type 2 diabetes. lnvestigational compounds in the pipeline include an injectable GLP-
`1 agonist being studied as a single agent, in combination with basal insulins, and/or in combination
`with oral antidiabetic agents.
`
`About Sanofi
`Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic
`solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven
`growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer
`healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in
`New York (NYSE: SNY).
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`References
`1. Polonksy et al. Patient Reported Outcomes Using Twice-Daily Insulin Aspart Premixed vs Insulin Glargine Plus 1
`Prandial Insulin Glulisine or Stepwise Addition of Glulisine to Glargine in Type 2 Diabetes Uncontrolled With Oral Agents
`(2316-PO) ADA 2011
`2. Garon et al. Significant Improvement in Treatment Satisfaction for Patients (pts) With Type 1 and Type 2 Diabetes
`Mellitus (T1 & T2DM) After 6 Months Following the Initiation of Insulin Glargine (Lantus SoloSTAR®) (2223-PO) ADA 2011
`3. Arellano SM, Campuzano RR, Santoyo JC, Mauricio GL. Patient Satisfaction with the SoloSTAR® Insulin Pen Device in
`Medical Practice in Mexico: The LANSOLEAP Study (2218-PO) ADA 2011
`4. Wang Fetal. Insulin glargine: a systematic review of a long-acting insulin analogue. Clin Ther 2003 25:1541-77
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`Forward Looking Statements
`This press release contains fonvard-looking statements as defined in the Private Securities Litigation Reform Act of 1995.
`as amended Fonvard-looking statements are statements that are not historical facts. These statements include
`projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and
`expectations with respect to future financial results, events, operations, services, product development and potential, and
`statements regarding future performance. Forward-looking statements are generally identified by the words "expects"",
`""anticipates"", ""believes", "intends''. "estimates"', "plans" and similar expressions. Although Sanofi's management believes
`that the expectations reflected in such fonvard-looking statements are reasonable, investors are cautioned that fonvard(cid:173)
`looking information and statements are subject to various risks and uncertainties. many of which are difficult to predict and
`generally beyond the control of Sanofi. that could cause actual results and developments to differ materially from those
`expressed in, or implied or projected by, the fonvard-looking information and statements. These risks and uncertainties
`include among other things, the uncertainties inherent in research and development, future clinical data and analysis,
`including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when
`to approve any drug, device or biological application that may be filed for any such product candidates as well as their
`decisions regarding labeling and other matters that could affect the availability or commercial potential of such products
`candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future
`approval and commercial success of therapeutic alternatives.
`the Group 's ability to benefit from external growth
`opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi,
`including those listed under "Risk Factors" and "Cautionary Statement Regarding Fonvard-Looking Statements" in
`Sanofi's annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law,
`Sanofi does not undertake any obligation to update or revise any fonvard-looking information or statements.
`
`Contacts:
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`Global Diabetes Division Communications
`Yanyan Chang
`Tel: +49 - 173 - 689 6295
`E-Mail: yanyan.chang@sanofi.com
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