Myriad RBM Announces an Agreement with Sanofi to Measure Predictive Cardiovascular Biomarkers in Patients with Diabetes

SALT LAKE CITY, Oct. 25, 2016 (GLOBE NEWSWIRE) — 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.  For more information visit: http://rbm.myriad.com/discoverymap/

About Myriad RBM
Myriad 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 Genetics
Myriad 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 injection

What 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.

Do not use Lixisenatide if you:

  • are allergic to lixisenatide or any of the other ingredients in Lixisenatide.

Symptoms of severe allergic reaction with Lixisenatide may include swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

Before using Lixisenatide, tell your healthcare provider if you:

  • 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.

Tell your healthcare provider about all the medicines you take, including prescription medicines (especially antibiotics and birth control pills) and over-the-counter medicines (especially acetaminophen), vitamins, herbal supplements or other medicines to treat diabetes, including sulfonylureas or insulin.

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.

Talk with your healthcare provider about how to treat low blood sugar.

  • 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.

The most common side effects of Lixisenatide include:

  • nausea, vomiting, headache, diarrhea and feeling dizzy.

Please see full prescribing information for Lixisenatide here http://products.sanofi.us/Lixisenatide/Lixisenatide.pdf.

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.

Important Safety Information For Lantus (insulin glargine injection) 100 Units/mL
Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the inactive ingredients in Lantus.

Do not share needles, insulin pens, or syringes with others. Do NOT reuse needles.
Before starting Lantus®, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant or if you are breast-feeding or planning to breast-feed.

Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you already have heart failure, it may get worse while you take TZDs with Lantus®. Your treatment with TZDs and Lantus® may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms of heart failure, including:

  • Shortness of breath
  • Sudden weight gain
  • Swelling of your ankles or feet

Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, including herbal supplements.

Lantus should be taken once a day at the same time every day. Test your blood sugar levels while using insulin, such as Lantus. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix Lantus with any other insulin or solution.
It will not work as intended and you may lose blood sugar control, which could be serious. Lantus must only be used if the solution is clear and colorless with no particles visible. Always make sure you have the correct insulin before each injection.

While using Lantus®, do not drive or operate heavy machinery until you know how Lantus® affects you. You should not drink alcohol or use other medicines that contain alcohol.

The most common side effect of insulin, including Lantus, is low blood sugar (hypoglycemia), which may be serious and life threatening.
It may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.

Lantus may cause serious side effects that can lead to death, such as severe allergic reactions. Get medical help right away if you have:

  • 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
  • Sweating

Other possible side effects may include swelling, weight gain, low potassium levels, injection site reactions, including changes in fat tissue at the injection site, and allergic reactions.
Please see full prescribing information for Lantus at http://products.sanofi.us/lantus/lantus.html.

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the scope, timing, completion and success of Myriad RBM’s agreement with Sanofi to measure prognostic cardiovascular biomarkers in patients with diabetes; Myriad RBM’s goal 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; and the Company’s strategic directives under the captions “About Human DiscoveryMAP,” “About Myriad RBM,” and “About Myriad Genetics.”  These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire, including but not limited to our acquisition of a healthcare clinic in Germany and Sividon Diagnostic and our planned acquisition of Assurex Health; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our Annual report on Form 10-K for the fiscal year ended June 30, 2016, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.

US.LIX.16.10.011

[1] Outcome Reduction Intervention (ORIGIN) and the Heart Outcomes Prevention Evaluation (HOPE) trials.

CONTACT: Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com

Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com