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 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
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/mLDo 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 StatementThis 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.
Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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