Bristol-Myers Squibb Receives U.S. FDA Breakthrough Therapy Designation for Investigational HIV-1 Attachment Inhibitor for Heavily Treatment-Experienced Patients

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

Tuesday, July 21, 2015 9:00 am EDT
"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"
PRINCETON, N.J.--(BUSINESS WIRE)--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 about
REYATAZ (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.

Contact:

Bristol-Myers Squibb Company
Media:
Robert Perry, 609-419-5278
Cell: 407-492-4616
[email protected]
or
Shelly Mittendorf, 609-897-2055
Cell: 609-480-2951
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]

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