BMS-663068 is the first investigational antiretroviral
designed to prevent HIV attachment to and entry into CD4+ T
cells
FDA Breakthrough Designation recognizes the need for new
therapies for heavily treatment-experienced HIV-1 patients and may
expedite the development and review of BMS-663068
Designation granted for investigational agent BMS-663068 in
combination with other antiretroviral agents for treatment of HIV-1
in heavily treatment-experienced patients
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the
U.S. Food and Drug Administration (FDA) has granted Breakthrough
Therapy Designation to the investigational compound BMS-663068 when
used in combination with other antiretroviral (ARV) agents for the
treatment of HIV-1 infection in heavily treatment-experienced adult
patients. BMS-663068 is an oral prodrug of the molecule BMS-626529
and first-in-class HIV-1 attachment inhibitor. The attachment
inhibitor is designed to work differently than entry inhibitors, a
current class of drugs that targets co-receptors’ activity or
fusion after HIV attaches to the CD4+ host cell. BMS-663068 is
thought to work at an earlier point in the replication process to
prevent the virus’ initial interaction with immune cells entirely,
and thus blocks its entry into the cell.
The designation is based on data from the Phase IIb clinical
study comparing BMS-663068 to a boosted protease inhibitor
(Reyataz® (atazanavir sulfate) and ritonavir) in
treatment-experienced patients, with a treatment backbone across
all arms of raltegravir, in addition to tenofovir disoproxil
fumarate. Week 48 results from the Phase IIb trial were presented
earlier this year at the 22nd Conference on Retroviruses and
Opportunistic Infections (CROI) and supported the continued
clinical development of the attachment inhibitor. A Phase III trial
in heavily treatment-experienced patients (defined as individuals
who can no longer formulate a viable three-drug treatment regimen
due to accumulation of drug resistance, past intolerabilities or
antiretroviral contraindications) began in February 2015 and is
ongoing.
“We are now 30-plus years into the AIDS epidemic, and there is
an ever-increasing number of long-term survivors of the condition,
many of whom are facing issues of drug resistance and are in need
of new treatment options,” said Douglas Manion, M.D., Head of
Specialty Development, Bristol-Myers Squibb. “The Breakthrough
Designation recognizes the unmet need for novel therapies for this
growing group of heavily treatment-experienced patients, and is
evidence of Bristol-Myers Squibb’s continued focus on meeting that
need.”
Breakthrough Therapy Designation expedites the development and
review of new therapies meant to treat serious or life-threatening
conditions. The criteria for Breakthrough Therapy Designation
require preliminary clinical evidence that the drug may demonstrate
substantial improvement over existing therapies on one or more
clinically significant endpoints. The Designation for BMS-663068 is
a significant milestone and will help speed development of the
investigational compound for heavily treatment-experienced
patients.
About Bristol-Myers Squibb in HIV
For more than 20 years, Bristol-Myers Squibb has focused on
delivering innovative medicines to help meet the needs of patients
living with HIV-1. Our goal is to help individuals living with
HIV-1 to live longer and healthier lives by achieving and
maintaining viral suppression, and by managing challenges
associated with treatment resistance. We are investigating new ways
to attack the HIV virus, and studies are ongoing for innovative
treatments including the HIV-1 attachment inhibitor (BMS-663068)
and an HIV-1 maturation inhibitor (BMS-955176).
INDICATION and IMPORTANT SAFETY INFORMATION
aboutREYATAZ (atazanavir) 200mg/300mg Capsules:
INDICATION:
REYATAZ® (atazanavir) is a prescription HIV-1 (Human
Immunodeficiency Virus) medicine that is used with other
antiretroviral medicines to treat HIV-1 infection in adults and
children 3 months of age and older and who weigh at least 10 kg (22
pounds).
- REYATAZ should not be used in children
less than 3 months of age.
REYATAZ does not cure HIV infection or AIDS (Acquired
Immunodeficiency Syndrome). You must stay on continuous HIV therapy
to control HIV infection and decrease HIV-related
illnesses.
IMPORTANT SAFETY INFORMATION:
Do not take REYATAZ (atazanavir) if you are:
- Allergic to REYATAZ or to any of its
ingredients
- Taking certain medicines with REYATAZ
that may affect how REYATAZ works. REYATAZ may cause
serious, life-threatening side effects or death if taken with the
following medicines: alfuzosin (Uroxatral®), cisapride
(Propulsid®), ergot medicines (refer to Patient Information for
complete list of these medicines), indinavir
(CRIXIVAN®),irinotecan (Camptosar®), lovastatin (Advicor®,
Altoprev®, Mevacor®), midazolam (Versed®) when taken by mouth for
sedation, nevirapine (Viramune®, Viramune
XR®), pimozide (Orap®), rifampin (Rimactane®, Rifadin®,
Rifater®, Rifamate®), sildenafil (Revatio®) when used for pulmonary
arterial hypertension, simvastatin (Zocor®, Vytorin®,
Simcor®), St. John's wort (Hypericum perforatum), triazolam
(Halcion®)
Before taking REYATAZ, tell your healthcare provider if
you:
- Have heart problems
- Have liver problems including hepatitis
B or C infection
- Have phenylketonuria (PKU). REYATAZ
oral powder contains phenylalanine as part of the artificial
sweetener aspartame and can be harmful to people with PKU
- Are receiving dialysis treatment
- Have diabetes
- Have hemophilia
- Have any other medical conditions
- Are pregnant or plan to become
pregnant. It is not known if REYATAZ will harm your unborn baby.
When taking REYATAZ with other HIV medicines called nucleoside
analogues, pregnant women have developed a serious condition called
lactic acidosis
- Hormonal forms of birth control,
such as injections, vaginal rings or implants, contraceptive patch,
and some birth control pills, may not work when you are taking
REYATAZ
- After your baby is
born, tell your healthcare provider if your baby's skin or
the white part of his/her eyes turns yellow
- Are breastfeeding or plan to
breastfeed. Do not breastfeed if you have HIV. It is not known if
REYATAZ passes into your breast milk
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins and herbal supplements. REYATAZ may affect the
way other medicines work and other medicines may affect how REYATAZ
works and may cause serious side effects. DO NOT take the
following medicines while taking REYATAZ: boceprevir
(VICTRELIS®), salmeterol (SEREVENT DISKUS®) and
salmeterol with fluticasone (ADVAIR DISKUS®, ADVAIR
HFA®), voriconazole (VFEND®).
Tell your healthcare provider right away if you take
sildenafil (VIAGRA®), tadalafil (CIALIS®, ADCIRCA®) or vardenafil
(LEVITRA®, STAXYN®). People who take REYATAZ with these medicines
may increase their chance of having the following side effects:
lightheadedness (especially when standing), fainting, changes in
vision, an erection that lasts more than 4 hours.
The above list of medicines is not complete. Please refer to
the Patient Information for a list of medicines that may require
your therapy to be monitored more closely or may require a change
in dose or dose schedule of REYATAZ (atazanavir) or the other
medicine. Know the medicines you take. Keep a list of your
medicines and show it to your healthcare provider and pharmacist
when you get a new medicine.
REYATAZ can cause serious side effects. Call your healthcare
provider right away if you have any of the following:
- A change in the way your heart
beats. You may feel dizzy or lightheaded as these could be
symptoms of a heart problem
- Skin rash is common with
REYATAZ and usually goes away within 2 weeks. Skin rash can
sometimes be severe and may develop with other symptoms which can
be serious. If you develop a severe rash with any of the
following symptoms stop taking REYATAZ and call your healthcare
provider right away: general feeling of discomfort, fever,
muscle or joint aches, red or inflamed eyes, blisters, mouth sores,
swelling of your face, painful, warm or red lump under the
skin
- Yellowing of your skin or the white
part of your eyes is common but may be a symptom of a
serious problem. This may occur due to increases in bilirubin
levels in the blood (bilirubin is made by the liver)
- Liver problems including
hepatitis B or C may get worse when taking REYATAZ. Your healthcare
provider will do blood tests before and during treatment with
REYATAZ. Liver problem symptoms may include: your skin or the white
part of your eyes turning yellow, dark tea colored urine, light
colored stools, nausea, itching, or stomach area pain
- Kidney stones have happened
in some people taking REYATAZ. Symptoms may include pain in your
back or low stomach area, blood in your urine, pain when you
urinate
- Gallbladder problems have
happened in some people who take REYATAZ. Symptoms may include pain
in the right or middle upper stomach area, fever, nausea and
vomiting, and your skin or the white part of your eyes turning
yellow
- Diabetes and high blood
sugar have happened or worsened in some people who take
protease inhibitor medicines like REYATAZ. Some people may need to
start diabetes medicine or change their diabetes medicine
- Changes in your immune system
(Immune Reconstitution Syndrome) can happen when you start
taking HIV medicines. Tell your healthcare provider if you have any
new symptoms after starting your HIV medicine
- Changes in body fat can
happen in people taking HIV medicines. The cause and long-term
health effects are not known.
The most common side effects of REYATAZ include:
nausea, headache, stomach-area pain, vomiting, trouble sleeping,
numbness, tingling, or burning of hands or feet, dizziness,muscle
pain, diarrhea, depression, and fever
You should take REYATAZ capsules and oral powder once
daily with food. Swallow the capsules whole; do
not open the capsules. REYATAZ oral powder must be mixed with
food or liquid and taken with ritonavir. Take REYATAZ exactly
as your healthcare provider tells you to.
Visit www.reyataz.com for full product information.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit http://www.bms.com or follow us
on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that clinical trials of BMS-663068 will support regulatory filings,
or that BMS-663068 will receive regulatory approval in the United
States, or if approved, that it will become a commercially
successful product. Forward-looking statements in this press
release should be evaluated together with the many uncertainties
that affect Bristol-Myers Squibb's business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2014, in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20150721005824/en/
Bristol-Myers Squibb CompanyMedia:Robert Perry,
609-419-5278Cell: 407-492-4616rob.perry@bms.comorShelly Mittendorf,
609-897-2055Cell:
609-480-2951shelly.mittendorf@bms.comorInvestors:Ranya
Dajani, 609-252-5330ranya.dajani@bms.com
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