Bristol-Myers Squibb, Gilead Sciences and Merck & Co. Submit Marketing Authorisation Application for ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) to European Medicines Agency.PRINCETON, N.J. & FOSTER CITY, Calif. & WHITEHOUSE STATION, N.J. -- Bristol-Myers Squibb Company (NYSE NYSE See: New York Stock Exchange :BMY BMY Bristol Myers Squibb ), Gilead Sciences, Inc. (Nasdaq:GILD) and Merck & Co., Inc. (NYSE:MRK MRK Merck & Company (stock symbol) MRK Mayer-Rokitansky-Kuster (anomaly) MRK Manual Remote Keying ) today announced the submission of a Marketing Authorisation Application (MAA MAA abbr. macroaggregated albumin ) for ATRIPLA(TM) (efavirenz efavirenz /ef·a·vi·renz/ (ef´ah-vi?renz) an antiretroviral, inhibiting reverse transcriptase; used in the treatment of HIV infection. e·fa·vir·enz n. 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate tenofovir disoproxil fumarate Viread Pharmacologic class: Nucleoside analog reverse transcriptase inhibitor Therapeutic class: Antiretroviral Pregnancy risk category B 300 mg) in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to theEuropean Community to the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ). The MAA will be reviewed by the Committee for Medicinal Products for Human Use “CHMP” redirects here. For French language Canadian radio station, see CHMP-FM. CPMP, Committee for Proprietary Medicinal Products, now CHMP Committee for Medicinal Products for Human Use (CHMP CHMP Committee for Medicinal Products for Human Use CHMP Cultural Heritage Management Plan CHMP Centrale Humanitaire Médico-Pharmaceutique CHMP Certified Hazardous Materials Practitioner (Institute of Hazardous Materials Managers) ), subject to validation by the EMEA. The MAA for ATRIPLA in the European Union was filed jointly by the three companies through a newly established three-way joint venture based in Ireland, Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited. Review of the MAA will be conducted by the EMEA under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all member states of the European Union. Discussions among the three companies regarding agreements for manufacturing, commercialization and distribution of ATRIPLA in the European Union are ongoing. ATRIPLA is a once-daily single tablet regimen approved in the United States for the treatment of HIV-1 infection in adults for use either as stand-alone therapy or in combination with other antiretroviral agents. The product contains 600 mg of efavirenz, a non-nucleoside reverse transcriptase inhibitor Noun 1. non-nucleoside reverse transcriptase inhibitor - an antiviral drug used against HIV; binds directly to reverse transcriptase and prevents RNA conversion to DNA; often used in combination with other drugs NNRTI (NNRTI NNRTI Non-nucleoside reverse transcriptase inhibitor, see there ), 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, both nucleoside reverse transcriptase inhibitors (NRTIs). Efavirenz is marketed by Bristol-Myers Squibb under the tradename SUSTIVA([R]) in the United States, Canada and six European countries (France, Republic of Ireland, Germany, Italy, Spain and the United Kingdom). In other territories, including all other countries of the European Union, efavirenz is commercialized by Merck & Co., Inc., (also known as MSD (MicroSoft Diagnostics) A utility that accompanied Windows 3.1 and DOS 6 that reported on the internal configuration of the PC. A variety of information on disks, video, drivers, IRQs and port addresses was provided. outside of the United States and Canada) and is marketed in most of these countries under the tradename Stocrin([R]). Emtricitabine and tenofovir disoproxil fumarate emtricitabine and tenofovir disoproxil fumarate Truvada Pharmacologic class: Nucleoside/nucleotide reverse-transcriptase inhibitor combination Therapeutic class: Antiretroviral Pregnancy risk category B are commercialized by Gilead Sciences under the tradenames Emtriva([R]) and Viread([R]), respectively. The compounds are commonly prescribed together as a once-daily, fixed-dose tablet, marketed under the tradename Truvada([R]) for use as part of combination therapy. ATRIPLA was approved by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) on July 12, 2006. In the United States, the product is commercialized by Bristol-Myers Squibb and Gilead Sciences through a joint venture. The FDA also granted approval of an alternate tradedress of ATRIPLA for developing countries, where ATRIPLA will be made available as a white-colored tablet to distinguish it from the salmon-colored version currently available in the United States. Gilead and Merck established a separate agreement in August 2006 for distribution of the product in developing countries. "Bristol-Myers Squibb is committed to delivering effective HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. therapies to patients worldwide and is pleased to work with Gilead and Merck to realize this goal with ATRIPLA," said Lamberto Andreotti, president, Worldwide Pharmaceuticals, Bristol-Myers Squibb. "With the filing of ATRIPLA in Europe, we are one step closer to making available another effective treatment option for European adult patients living with HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome ." "As the first and only once-daily single tablet regimen, ATRIPLA may help to simplify therapy for many HIV-infected adults. Gilead is pleased to have established this partnership with Bristol-Myers Squibb and Merck, and we look forward to working with colleagues at both companies to make this product available to people living with HIV in Europe as quickly as possible," said Kevin Young, Executive Vice President, Commercial Operations, Gilead Sciences. "ATRIPLA has the potential to offer an important new tool to patients and physicians in Europe for treating HIV infection in adults," said Stefan J. Oschmann, President, Europe, Middle East, Africa, Canada, Merck & Co., Inc. "This new single tablet regimen exemplifies our commitment to putting patients first. We look forward to collaborating with BMS BMS abbr. Bachelor of Marine Science , Gilead and national health authorities to deliver ATRIPLA to those who need it as soon as possible." Important Safety Information About ATRIPLA, Truvada, Viread and Emtriva Lactic acidosis Lactic acidosis A serious condition caused by the build up of lactic acid in the blood, causing it to become excessively acidic. Lactic acid is a by-product of glucose metabolism. and severe hepatomegaly hepatomegaly /hep·a·to·meg·a·ly/ (hep?ah-to-meg´ah-le) enlargement of the liver. hep·a·to·meg·a·ly n. The abnormal enlargement of the liver. Also called megalohepatia. with steatosis steatosis /ste·a·to·sis/ (ste?ah-to´sis) fatty change. ste·a·to·sis n. See fatty degeneration. steatosis fatty degeneration. See also muscular steatosis. , including fatal cases, have been reported with the use of nucleoside analogues Nucleoside analogues The first group of effective anti-retroviral medications. They work by interfering with the AIDS virus' synthesis of DNA. Mentioned in: AIDS alone or in combination with other antiretrovirals. ATRIPLA, Truvada, Viread and Emtriva are not indicated for the treatment of chronic hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis B virus (HBV HBV hepatitis B virus. HBV abbr. hepatitis B virus ) infection and the safety and efficacy of these drugs have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic have been reported in patients who have discontinued Emtriva or Viread (components of ATRIPLA and Truvada). Hepatic function hepatic function (h  ·paˑ·tik funkˑ·sh should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue ATRIPLA, Truvada, Emtriva or Viread and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted. Antiretroviral therapies do not cure HIV infection or AIDS and have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination. Additional Important Information About ATRIPLA in the United States In the United States, ATRIPLA is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Coadministration of ATRIPLA with astemizole, cisapride, midazolam, triazolam triazolam /tri·a·zo·lam/ (tri-a´zo-lam) a benzodiazepine used as a sedative and hypnotic in the treatment of insomnia. tri·a·zo·lam n. , ergot ergot (ûr`gət), disease of rye and other cereals caused by the fungus Claviceps purpurea. The cottony, matlike body, or mycelium, of the fungus develops in the ovaries of the host plant; it eventually turns into a hard pink or purple derivatives, or voriconazole is contraindicated. Concomitant use of ATRIPLA with St. John's wort St. John’s wort indicates animosity. [Flower Symbolism: Flora Symbolica, 177] See : Hatred St. John’s wort defense against fairies, evil spirits, the Devil. [Br. (Hypericum perforatum Hypericum perforatum, n See St. John's wort. Hypericum perforatum Popularly, St John's wort, see there ) or St. John's wort-containing products is not recommended. Since ATRIPLA contains efavirenz, emtricitabine, and tenofovir disoproxil fumarate, ATRIPLA should not be coadministered with SUSTIVA, EMTRIVA, VIREAD, or TRUVADA. Due to similarities between emtricitabine and lamivudine, ATRIPLA should not be coadministered with drugs containing lamivudine, including Combivir([R]), Epivir([R]), Epivir-HBV([R]), Epzicom([TM]), or Trizivir([R]). Serious psychiatric adverse experiences, including severe depression (2.4%), suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%), and manic reactions (0.2%) have been reported in patients receiving efavirenz. In addition to efavirenz, factors identified in a clinical study that were associated with an increase in psychiatric symptoms included a history of injection drug use, psychiatric history, and use of psychiatric medication. There have been occasional reports of suicide, delusions, and psychosis-like behavior, but it could not be determined if efavirenz was the cause. Patients with serious psychiatric adverse experiences should be evaluated immediately to determine whether the risks of continued therapy outweigh the benefits. Fifty-three percent of patients reported central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ) symptoms including dizziness (28.1%), insomnia (16.3%), impaired concentration (8.3%), somnolence somnolence /som·no·lence/ (som´no-lens) drowsiness or sleepiness, particularly in excess. som·no·lence n. 1. A state of drowsiness; sleepiness. 2. (7.0%), abnormal dreams (6.2%), and hallucinations Hallucinations Definition Hallucinations are false or distorted sensory experiences that appear to be real perceptions. These sensory impressions are generated by the mind rather than by any external stimuli, and may be seen, heard, felt, and even (1.2%) when taking efavirenz compared to 25% of patients receiving control regimens. These symptoms usually begin during the first two days of therapy and generally resolve after the first two to four weeks of therapy; they were severe in 2.0% of patients and 2.1% of patients discontinued therapy. After four weeks of therapy, the prevalence of CNS symptoms of at least moderate severity ranged from 5% to 9% in patients treated with regimens containing efavirenz. Nervous system symptoms are not predictive of the less frequent psychiatric symptoms. ATRIPLA should not be given to patients with creatinine clearance less than 50 mL/min. Renal impairment, including cases of acute renal failure acute renal failure Acute kidney failure Nephrology An abrupt decline in renal function, triggered by various processes–eg, sepsis, shock, trauma, kidney stones, drug toxicity-aspirin, lithium, substances of abuse, toxins, iodinated radiocontrast. and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of tenofovir disoproxil fumarate. Renal impairment occurred most often in patients with underlying systemic or renal disease, or in patients taking concomitant nephrotoxic nephrotoxic /neph·ro·tox·ic/ (nef´ro-tok?sik) destructive to kidney cells. Nephrotoxic Toxic, or damaging, to the kidney. agents. Some cases have occurred in patients with no identified risk factors. ATRIPLA should be avoided with concurrent or recent use of a nephrotoxic agent. ATRIPLA may cause fetal harm when administered during the first trimester to a pregnant woman. Women should not become pregnant or breastfeed breast·feed or breast-feed v. breast-fed , breast-feed·ing, breast-feeds v.tr. To feed (a baby) mother's milk from the breast; suckle. v.intr. To breastfeed a baby. while taking ATRIPLA. Barrier contraception must always be used in combination with other methods of contraception (e.g., oral or other hormonal contraceptives). If the patient becomes pregnant while taking ATRIPLA, she should be apprised of the potential harm to the fetus. Mild to moderate rash is a common side effect of efavirenz. In controlled clinical trials, 26% of patients treated with efavirenz experienced new-onset skin rash compared with 17% of patients treated in control groups. Skin discoloration dis·col·or·a·tion n. 1. a. The act of discoloring. b. The condition of being discolored. 2. A discolored spot, smudge, or area; a stain. Noun 1. , associated with emtricitabine, may also occur. ATRIPLA should be discontinued in patients developing severe rash associated with blistering, desquamation desquamation /des·qua·ma·tion/ (des?kwah-ma´shun) the shedding of epithelial elements, chiefly of the skin, in scales or sheets.desquam´ative des·qua·ma·tion n. 1. , mucosal involvement, or fever. Liver enzymes should be monitored in patients with known or suspected hepatitis B or C and when ATRIPLA is administered with ritonavir ritonavir /ri·to·na·vir/ (ri-to´nah-vir) an HIV protease inhibitor used in treatment of HIV infection and AIDS. ri·ton·a·vir n. or other medications associated with liver toxicity. Decreases in bone mineral density bone mineral density n. See bone density. bone mineral density A measurement of bone mass, expressed as the amount of mineral–in grams divided by the area scanned in cm2. See Bone densitometry. (BMD BMD In currencies, this is the abbreviation for the Bermudian Dollar. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. ) have been seen with tenofovir disoproxil fumarate. Use ATRIPLA with caution in patients with a history of seizures. Convulsions Convulsions Also termed seizures; a sudden violent contraction of a group of muscles. Mentioned in: Heat Disorders have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures. Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of ATRIPLA. Coadministration with ATRIPLA and atazanavir is not recommended due to concerns regarding decreased atazanavir concentrations. Atazanavir and lopinavir/ritonavir have been shown to increase tenofovir concentrations. Patients on atazanavir or lopinavir/ritonavir plus ATRIPLA should be monitored for tenofovir-associated adverse events. ATRIPLA should be discontinued in patients who develop tenofovir-associated adverse events. Coadministration of ATRIPLA with didanosine didanosine /di·dan·o·sine/ (-dan´o-sen) 2, an analogue of dideoxyadenosine; an antiretroviral agent used for the treatment of advanced HIV-1 infection and acquired immunodeficiency syndrome, administered orally. should be undertaken with caution. Patients receiving this combination should be monitored closely for didanosine-associated adverse events. See Full Prescribing Information for complete list of drug-drug interactions. In Study 934, the most frequently reported grades two to four adverse events through 48 weeks in patients receiving efavirenz, emtricitabine and tenofovir disoproxil fumarate were dizziness (8%), nausea (8%), diarrhea (7%), fatigue (7%), headache (5%), rash (5%), sinusitis sinusitis Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. (4%), depression (4%), insomnia (4%), and abnormal dreams (4%). The dose of ATRIPLA is one tablet (containing 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate) once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms. ATRIPLA is not recommended for use in patients younger than 18 years of age. Important Information About Efavirenz Efavirenz in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. This indication is based on two clinical trials of at least one year duration that demonstrated prolonged suppression of HIV RNA. Coadministration with astemizole, cisapride, midazolam, triazolam, ergot derivatives, or voriconazole is contraindicated. Concomitant use of efavirenz and St. John's wort (Hypericum perforatum) or St. John's wort-containing products is not recommended. This list of medications is not complete. Serious psychiatric adverse experiences, including severe depression (2.4%), suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%) and manic reactions (0.2%) have been reported in patients treated with efavirenz. In addition to efavirenz, factors identified in a clinical study that were associated with an increase in psychiatric symptoms included history of injection drug use, psychiatric history, and use of psychiatric medication. There have been occasional reports of suicide, delusions, and psychosis-like behavior, but it could not be determined if efavirenz was the cause. Patients with serious psychiatric adverse experiences should be evaluated immediately to determine whether the risks of continued therapy outweigh the benefits. Fifty-three percent of patients reported central nervous system symptoms including dizziness (28.1%), insomnia (16.3%), impaired concentration (8.3%), somnolence (7.0%), abnormal dreams (6.2%) and hallucinations (1.2%) when taking efavirenz compared to 25% of patients receiving control regimens. These symptoms usually begin during Days 1-2 of therapy and generally resolve after the first 2-4 weeks of therapy. After four weeks of therapy, the prevalence of central nervous system symptoms of at least moderate severity ranged from 5% to 9% in patients treated with regimens containing efavirenz. Nervous system symptoms are not predictive of the less frequent serious psychiatric symptoms. Efavirenz may cause fetal harm when administered during the first trimester to a pregnant woman. Women should not become pregnant or breastfeed while taking efavirenz. Barrier contraception must always be used in combination with other methods of contraception (e.g. oral or other hormonal contraceptives). If the patient becomes pregnant while taking efavirenz, she should be apprised of the potential harm to the fetus. Mild to moderate rash is a common side effect of efavirenz. In controlled clinical trials, 26% of patients treated with efavirenz experienced new-onset skin rash compared with 17% of patients treated in control groups. Efavirenz should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever. Rash is more common and often more severe in pediatric patients. Liver enzymes should be monitored in patients with known or suspected hepatitis B or C, in patients treated with other medications associated with liver toxicity, and when efavirenz is administered with ritonavir. Use efavirenz with caution in patients with a history of seizures. Convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures. Redistribution and/or accumulation of body fat have been seen in patients receiving antiretroviral therapy. A causal relationship has not been established. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including efavirenz. It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime. The increased concentrations following administration of efavirenz with food may lead to an increase in frequency of adverse events. Dosing at bedtime may improve the tolerability of nervous system symptoms. Additional Important Information About Truvada Truvada is a fixed-dose combination product that combines 200 mg of Emtriva([R]) (emtricitabine) and 300 mg of Viread([R]) (tenofovir disoproxil fumarate) in one tablet, taken once a day. In the United States and the European Union, Truvada is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors Definition This type of drug interferes with an enzyme that is key to the replication (reproduction) of the human immunodeficiency virus (HIV). or protease inhibitors) for the treatment of HIV-1 infection in adults. Truvada should not be coadministered with Emtriva, Viread or lamivudine-containing products and it is not recommended that Truvada be used as a component of a triple nucleoside regimen. In treatment-experienced patients, the use of Truvada should be guided by laboratory testing and treatment history. Clinical Study 934 supports the use of Truvada tablets for the treatment of HIV-1 infection. Additional data in support of the use of Truvada are derived from Study 903, in which Viread and lamivudine were used in combination in treatment-naE[macron ma·cron n. 1. A diacritical mark placed above a vowel to indicate a long sound or phonetic value in pronunciation, such as (  ) in the word make.2. ]ve adults, and clinical Study 303, in which Emtriva and lamivudine demonstrated comparable efficacy, safety and resistance patterns as part of multidrug regimens. No drug interaction studies have been conducted using Truvada. Drug interactions have been observed when didanosine, atazanavir, or lopinavir/ritonavir is co-administered with Viread, a component of Truvada, and dose adjustments may be necessary. Data are not available to recommend a dose adjustment of didanosine for patients weighing less than 60 kg. In the European Union, the co-administration of tenofovir disoproxil fumarate and didanosine is not recommended unless judged strictly necessary. Patients on atazanavir or lopinavir/ritonavir plus Truvada should be monitored for Truvada-associated adverse events that may require discontinuation. When co-administered with Truvada, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Truvada. Four-hundred and forty-seven HIV-1 infected patients have received combination therapy with Emtriva and Viread with either a non-nucleoside reverse transcriptase inhibitor (Study 934) or protease inhibitor for 48 weeks in clinical studies. Adverse events observed in Study 934 were generally consistent with those seen in other studies in treatment-experienced or treatment-naE[macron]ve patients receiving Viread and/or Emtriva. Adverse events observed in more than 5% of patients in the Viread/Emtriva group in Study 934 include diarrhea, nausea, fatigue, headache, dizziness and rash. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported among patients taking Viread, a component of Truvada (emtricitabine and tenofovir disoproxil fumarate). Renal impairment occurred most often in patients with underlying systemic or renal disease or in patients taking concomitant nephrotoxic agents, though some cases have appeared in patients without identified risk factors. Decreases in bone mineral density (BMD) at the lumbar spine and hip have been seen with the use of Viread. The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future risk fracture are unknown. Redistribution and/or accumulation of body fat have been observed in patients receiving combination antiretroviral therapy. The cause and long term health effect of these conditions are unknown. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy including Truvada, Viread and Emtriva. Skin discoloration, manifested by hyperpigmentation Hyperpigmentation Definition Hyperpigmentation is the increase in the natural color of the skin. Description Melanin, a brown pigment manufactured by certain cells in the skin called melanocytes, is responsible for skin color. on the palms and/or soles, has been reported with the use of Emtriva, a component of Truvada. Skin discoloration was generally mild and asymptomatic and its mechanism and clinical significance are unknown. The parent compound of Viread was discovered through a collaborative research effort between Dr. Antonin Holy, Institute for Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic The Academy of Sciences of the Czech Republic Czech: Akademie věd České republiky, abbr. AV ČR (IOCB IOCB Institute of Organic Chemistry and Biochemistry (founded 1960; Prague, Czech Republic) IOCB Input Output Control Block ) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research The Rega Institute for Medical Research is a Belgian scientific establishment that is part of the Catholic University of Leuven (Leuven) in central Belgium. The Rega Iinstitute is an interfacultary biomedical research institute of the Catholic University of Leuven and consists of , Katholic University in Leuven, Belgium. About Bristol-Myers Squibb Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company. Visit Bristol-Myers Squibb on the World Wide Web at www.bms.com. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California
About Merck Merck & Co. Inc., which operates as Merck Sharp & Dohme (MSD) in countries outside of the United States, is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but also help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com. Forward-Looking Statements 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 regarding product development. 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 the combination product will receive regulatory approval in the European Union or other geographies, or, if approved, will be commercially successful. Nor is there any guaranty that discussions among the three companies regarding agreements for manufacturing, commercialization and distribution of ATRIPLA in the European Union will be successfully concluded or implemented. 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, 2005 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Gilead Forward-Looking Statement This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that ATRIPLA may not be approved in the European Union or other markets and the risk that physicians and regulatory agencies may not see advantages of ATRIPLA over other antiretrovirals and may therefore be reluctant to prescribe the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2005, filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements. Merck Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference. Full U.S. prescribing information for ATRIPLA is available at www.atripla.com. Full U.S. prescribing information for SUSTIVA is available at www.bms.com. Full U.S. prescribing information for Truvada, Viread and Emtriva is available at www.gilead.com. EU Summary of Product Characteristics for Truvada, Viread, Emtriva, SUSTIVA and Stocrin are available at http://www.emea.eu.int/humandocs/Humans/EPAR/a-zepar.htm. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control . SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company. Stocrin is a registered trademark of Merck & Co., Inc. Truvada, Viread and Emtriva are registered trademarks of Gilead Sciences, Inc. |
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