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Myriad RBM Announces an Agreement with Sanofi to Measure Predictive Cardiovascular Biomarkers in Patients with DiabetesSALT LAKE CITY, Utah, Oct. 25, 2016 – Myriad RBM, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN), today announced that it will work with Sanofi, a global and diversified healthcare leader, to perform a biomarker analysis of blood samples from the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial (NCT01147250).
“We know that cardiovascular risk is higher in people with diabetes and that cardiovascular disease negatively affects treatment outcomes,” said Riccardo Perfetti, head of Global Diabetes Medical Team, Sanofi. “Sanofi is committed to further exploring cardiovascular disease in this patient population. The biomarker work with Myriad RBM will allow us to further develop a molecular understanding of the cardiovascular risks in people with type 2 diabetes. Biomarker profiling supports our goal of developing potentially innovative new treatments for patients.”Under the agreement, Sanofi will provide approximately 5,300 serum samples from the ELIXA trial. Myriad RBM will use its CustomMAP® platform to measure biomarkers that can predict cardiovascular and microvascular (renal and retinal) risk in people with type 2 diabetes. Financial terms of the deal were not disclosed.
“Biomarker profiling can support the accelerated development of potentially innovative, targeted treatments for people with diabetes,” said Marc Pfeffer, M.D., Ph.D., Dzau Professor of Medicine at Harvard Medical School, senior physician in the Division of Cardiovascular Medicine at Brigham and Women’s Hospital. “As the chair of the ELIXA Steering Committee, I am pleased that Sanofi is supporting this work, which will provide new insights for better predicting cardiovascular risk in people with diabetes and hopefully improve the beneficial effects of therapies.”Myriad RBM’s DiscoveryMAP® platform was used with Sanofi’s ORIGIN1 trial to successfully identify biomarkers associated with cardiovascular events or death in people with pre-diabetes or early type 2 diabetes. The performance of these biomarkers was confirmed using Myriad RBM’s CustomMAP platform and samples from Sanofi’s HOPE trial.1
“In prior studies, we demonstrated the power of DiscoveryMAP to identify panels of biomarkers that have important diagnostic and prognostic applications for people at a higher risk of a cardiovascular event. This new agreement with Sanofi will expand upon that experience,” said Ralph McDade, Ph.D., president of Myriad RBM. “Our ultimate goal is to provide accurate estimates of the risk of a future cardiovascular event in patients so that drug developers and physicians can tailor care and achieve better health outcomes.”
About Human DiscoveryMAP®DiscoveryMAP is for those who seek a thorough understanding of a compound’s biological activity, efficacy and safety profile, as well as the disease or condition being addressed. The DiscoveryMAP service products help increase the odds of identifying novel protein biomarker patterns in drug development or diagnostic discovery projects. These data can support critical go/no-go decisions or identify candidate panels for potential companion diagnostics. Once a pattern is discovered, it can be seamlessly converted into a CustomMAP for high volume sample processing resulting in better, more efficient clinical trials. More info »
About Myriad RBMMyriad RBM is a wholly owned subsidiary of Myriad Genetics, Inc. Myriad RBM’s biomarker discovery platform provides clinical researchers and healthcare providers with reproducible, quantitative, multiplexed data for hundreds of proteins to advance drug development and patient care. The Company’s proprietary Multi Analyte Profiling (MAP) technology offers preclinical and clinical researchers with broad, cost-effective analyses of multiple proteins from a single, small sample volume. MAP technology also supports Myriad RBM’s drive to develop companion diagnostics in areas of unmet medical need such as neuropsychiatry, nephrology and immunology. More information about Myriad RBM can be found at www.myriadrbm.com.
About Myriad GeneticsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com. Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prolaris and GeneSight are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G
About Sanofi’s Lixisenatide
What is lixisenatide injection?Lixisenatide is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise.
- Lixisenatide is not insulin and should not be used instead of a long-acting insulin.
- Lixisenatide is not for people with type 1 diabetes or people with diabetic ketoacidosis.
- Lixisenatide has not been studied in people with a history of pancreatitis.
- Lixisenatide has not been studied in people who use short-acting insulin.
- It is not known if Lixisenatide is safe and effective in children.
Important Safety Information for Lixisenatide injectionWhat is the most important information I should know about Lixisenatide? Do not share your Lixisenatide pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Lixisenatide can cause serious side effects, including:
- inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Stop using Lixisenatide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel pain from your abdomen to your back.
- are allergic to lixisenatide or any of the other ingredients in Lixisenatide.
- have or have had pancreatitis, stones in your gallbladder, or a history of alcoholism.
- have or have had kidney problems.
- have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
- are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Lixisenatide will harm your unborn baby.
How should I use Lixisenatide?
- Check the label on the pen each time you give your Lixisenatide injection to make sure you are using the correct medication.
- You must activate each Lixisenatide pen before you use it for the first time.
- Do not re-use or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
- Inject your dose of Lixisenatide under the skin (subcutaneously) of your abdomen, thigh, or upper arm. Do not inject into a vein.
- Change (rotate) your injection
What are the possible side effects of Lixisenatide?Lixisenatide may cause serious side effects including:
- severe allergic reactions. Severe allergic reactions can happen with Lixisenatide. Stop taking Lixisenatide and get medical help right away if you have any symptoms of a severe allergic reaction.
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you use Lixisenatide with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin medicine may need to be lowered while you use Lixisenatide. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, hunger, fast heartbeat, dizziness, confusion, irritability, sweating, and feeling jittery.
- kidney problems (kidney failure).In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
- nausea, vomiting, headache, diarrhea and feeling dizzy.
What is Lantus (insulin glargine injection) 100 Units/mL?Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.
- Do not use Lantus to treat diabetic ketoacidosis.
- Shortness of breath
- Sudden weight gain
- Swelling of your ankles or feet
- A rash over your whole body
- Swelling of your face, tongue, or throat
- Trouble breathing
- Shortness of breath
- A fast heartbeat
- Extreme drowsiness, dizziness, or confusion