Sanofi : Announces Soliqua™ 100/33 Now Available in the U.S. ​

Paris, France - January 4, 2017 - Sanofi announced today that Soliqua™ 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) is now available by prescription in U.S. pharmacies. Soliqua 100/33 is indicated for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.

'We are encouraged by the potential of Soliqua 100/33, which has demonstrated superior HbA1c lowering versus Lantus,' said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. 'By offering Soliqua 100/33 - a product containing both a basal insulin and a GLP-1 therapy - at a competitive price while facilitating patient access, we believe we are providing value to patients and the healthcare system.'

In the labeled clinical trial, once-daily Soliqua 100/33 demonstrated statistical superiority for the change in HbA1c from baseline to week 30 (p<0.0001) versus Lantus, the most prescribed basal insulin in the world. The most common side effects reported in the clinical program included low blood sugar, nausea, stuffy or runny nose and sore throat, diarrhea, upper respiratory tract infection and headache. Soliqua 100/33 is delivered in a single pre-filled SoloStar pen with a dose range covering from 15 to 60 Units and two starting doses to support patients' insulin needs. Soliqua 100/33 was approved by the U.S. Food and Drug Administration (FDA) on November 21, 2016.

The daily Wholesale Acquisition Cost (WAC) price of Soliqua 100/33 is $127 for a 300 Unit pen, which equals $19.90 per day at the average final dose of 47 Units used in the labeled clinical trial.

Sanofi is offering Soliqua 100/33 at a $0 co-pay for eligible U.S. patients with commercial insurance and is working to secure coverage for Soliqua 100/33 on health plans nationwide. Sanofi is also offering a tailored support program, Soliqua 100/33 COACH, at no cost to adults living with type 2 diabetes who have been prescribed Soliqua 100/33 by their doctor.

'Healthcare professionals need a broad range of treatments to individualize a patient's diabetes care, particularly for the many adults living with diabetes who continue to face challenges in controlling their blood sugar levels even after treatment with basal insulin,' said George Grunberger, M.D., FACP, FACE, Chairman, Grunberger Diabetes Institute. 'This combination product provides a new option for many patients uncontrolled on basal insulin therapy or lixisenatide.'

Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com.

With the SOLIQUA 100/33 Savings Card, patients may be eligible for the $0 CO-PAY offer for the next 12 months. Restrictions apply. This offer is for commercially insured patients and is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, or TRICARE, or similar federal or state programs including any state pharmaceutical programs. Void where prohibited by law. Savings card carries maximum savings of $700 off per pack for the duration of the program. Savings may vary depending on patient's out-of-pocket costs. Upon registration, patient receives all program details. Sanofi US reserves the right to rescind, revoke, or amend the program without notice.

References

1. Data on file: IMS Q_Global Q4/2015, V.Kircher.
2. Rosenstock J, et al. Presentation 186-O presented at American Diabetes Association (ADA) 76th Scientific Sessions, New Orleans, LA, U.S., 2016. Available from Date accessed: November 2016.
3. Aroda V, et al. Presentation 238-O presented at American Diabetes Association (ADA) 76th Scientific Sessions, New Orleans, LA, U.S., 2016. Available from Date accessed: November 2016.