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GlaxoSmithKline (GSK) HIV Drug Gets Approval


10/19/2005 5:12:31 PM

Issued : Wednesday 22 December 2004, London, UK --GlaxoSmithKline (GSK) announced today it has received marketing approval from the European Commission for Kivexa, a new HIV medication. Kivexa combines two antiretrovirals in one tablet dosed once a day with no food or fluid requirements. Kivexa is comprised of two widely used nucleoside reverse transcriptase inhibitors (NRTIs), Epivir® (lamivudine, 3TC) and Ziagen® (Abacavir sulfate, ABC), for the treatment of HIV infection in combination with other antiretroviral medications in adults and adolescents from 12 years of age.

Kivexa is administered as one pill, once-daily as the backbone of a combination treatment regimen. Studies have shown that patients are more likely to adhere to their antiretroviral medication if they have to take fewer pills less frequently and if there are no food restrictions.1,2 Adherence is vital for achieving maximal viral suppression3, thereby increasing the patient’s chances of survival3. Kivexa provides potent and durable virological control and is compatible with multiple recommended third agents, including non-nucleoside reverse transcriptase inhibitors (NNRTIs) and boosted protease inhibitors (PI). In treatment-naïve patients, Kivexa is associated with a low risk of cross-resistance with other NRTIs, thus helping preserve future treatment options.

"Kivexa is an important advance in GSK’s ongoing commitment to provide new options in antiretroviral therapy for HIV patients," commented Didier Lapierre, M.D., Vice President of Infectious Diseases, GSK Europe. "Kivexa will provide clinicians and HIV-infected patients with a flexible, welltolerated and potent combination of two NRTIs that have been widely used in antiretroviral therapy for years. Prescribers are familiar with these medications, which have an established resistance and long-term safety profile."

Clinical Data The components of the Kivexa tablet have proven efficacy and safety profiles, as well as a favourable resistance profile. Epivir and Ziagen have no known pharmacokinetic interactions with PIs or NNRTIs; therefore, Kivexa can be combined with PIs or NNRTIs. Epivir and Ziagen have each been well-studied in both once and twice-daily dosing regimens and in multiple combinations with other classes of antiretroviral drugs. In clinical trials, Kivexa has demonstrated its ability to reduce the concentrations of HIV in plasma in both antiretroviral treatment-naïve and experienced patients. Clinical trials have demonstrated the use of Epivir and Ziagen in more than 5,800 patients as a dual-NRTI backbone of multi-drug HIV regimens. Current experience with the two components includes more than 509,000 patient years’ experience with regimens containing Ziagen and 2.6 million patient years with regimens containing Epivir.

In study CNA300244, Ziagen 300mg twice-daily + Epivir 150mg twice-daily was as effective as Retrovir twice-daily + Epivir 150mg twice-daily in combination with efavirenz (EFV) at 48 weeks. Virological response within this study was equivalent to the current standard of care and was combined with significantly greater increases in CD4+ cell count from baseline with Ziagen + Epivir compared with Retrovir + Epivir. Sustained virological response was demonstrated over 120 weeks with ABC + 3TC twicedaily in the SOLO/APV30005 study5 with 75 percent of patients who rolled over from the SOLO study achieving a plasma HIV-1 RNA of ¡Ü400 copies/mL of blood at this time point. In a multi-centre double-blind, controlled study (CAL30021, ZODIAC)6 in 770 adult patients, comparable efficacy and tolerability were demonstrated after 48 weeks between Ziagen dosed 300mg twice-daily and 600mg once-daily, when given in combination with Epivir 300mg once-daily and efavirenz 600mg once-daily. Virological failure in clinical trials with treatment-naïve subjects receiving ABC/3TC/EFV firstline therapy was infrequent. 4,6 A low rate of lipoatrophy was observed over 120 weeks with the ABC + 3TC backbone.7

Abacavir hypersensitivity reactions (HSR) were reported in approximately 5 percent of patients across all Abacavir clinical trials. In clinical trials using an Abacavir once-daily regimen, the reported rate of HSR remained within the range recorded for Abacavir given twice-daily. The hypersensitivity reaction is characterized by fever, rash, gastrointestinal symptoms, such as nausea, vomiting, diarrhea or abdominal pain, symptoms such as generalized malaise, fatigue or achiness and/or respiratory symptoms such as dyspnea, pharyngitis or cough. Symptoms of this reaction usually occur within the first six weeks of treatment although these reactions can occur at any time during therapy.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK developed the first two combination products to treat HIV infection. COMBIVIR ® (lamivudine/zidovudine, AZT) was approved in the EU in 1998, and TRIZIVIR® (Abacavir sulfate, lamivudine, zidovudine/AZT) was approved in 2001. GSK is an industry leader in HIV research and therapies and is engaged in research programs designed to investigate new targets to treat HIV/AIDS.

For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.

NOTES: EPIVIR was discovered by Shire Pharmaceuticals and was licensed to Glaxo Wellcome in 1990.

1. Stone VE. Strategies for optimizing adherence to highly active antiretroviral therapy: lessons from research and clinical practice. Clin Infect Dis. 2001; 33: 865 872.

2. Stone V. Enhancing adherence to antiretrovirals: Strategies and regimens. Medscape General Medicine 2002; 4 (3). Available at: http://www.medscape.com/viewarticle/438193

3. Wood E, Hogg RS, Yip B et al . Effect of medication adherence on survival of HIV-infected adults who start highly active antiretroviral therapy when the CD4+ cell count is 0.200 to 0.350 x 10(9) cells/L. Ann Intern Med. 2003;139(10): 810 — 816.

4. DeJesus E et al . Abacavir Versus Zidovudine Combined With Lamivudine And Efavirenz , for the Treatment Of Antiretroviral-Naive HIV-Infected Adults. Clinical Infectious Diseases, 2004; 39: 1038—46. 5. Gathe J et al. HIV DART 2004: Frontiers in Drug Development, for antiretroviral therapies, Montego Bay, Jamaica, December 12-16, 2004

6. Moyle G et al . Abacavir 600mg Once Daily Versus 300mg Twice Daily, Combined With Lamivudine And Efavirenz Once Daily, For The Treatment Of Antiretroviral-Naive HIV-Infected Adults: Results of The Zodiac Study. JAIDS, in press.

7. Walmsley S et al. Fosamprenavir/ritonavir and Nelfinavir have Comparable Effects on Body Fat Distribution in Antiretroviral-naïve Patients: 48-Week Results from the SOLO. International Workshop on Adverse Drug Reactions and Lipodystrophy, Washington DC USA, 25-28 October 2004 Poster L-787

8. Walmsley S et al. No Change in Fat Redistribution between Week 48 and Week 120 in Subjects receiving Fosamprenavir/ritonavir in Study APV30005. International Workshop on Adverse Drug Reactions and Lipodystrophy, Washington DC USA, 25-28 October 2004 Poster L-790

Enquiries:

UK Media enquiries: Philip Thomson (020) 8047 5502 David Mawdsley (020) 8047 5502 Chris Hunter-Ward (020) 8047 5502

European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540 Anita Kidgell (020) 8047 5542

Updated December 22, 2004 - © 2001-2005 GlaxoSmithKline - All Rights Reserved Legal Notices - Privacy Statement - Accessibility


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