Gilead Sciences, Inc. Announces Favorable Results from Phase III HIV-1 Infection Studies
Mar 2 15
Zahur Cotton Mills Limited reported earnings results for the half year ended December 31, 2014. For the period, the company reported loss after tax of was PKR 929,958 or PKR 0.09 per share.
Gilead Sciences Inc. has announced a detailed 48-week results from two Phase III studies, or studies 104 and 111, evaluating its investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naive adults. A regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF) was found to be statistically non-inferior to Gilead's Stribild (containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), based based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. A second analysis found that patients receiving the TAF regimen also had significantly better renal and bone laboratory parameters than those treated with Stribild. TAF is a novel nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead's Viread (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters in clinical trials. In the combined analyses of Studies 104 and 111, a total of 1,733 treatment-naive adults with HIV were randomized to receive E/C/F/TAF or Stribild. At 48 weeks, 92.4% (n=800/866) of patients taking E/C/F/TAF and 90.4% (n=784/867; CI -0.7% to +4.7%, p=0.13) of patients taking Stribild achieved HIV RNA levels less than 50 copies/mL (Abstract 113LB/Wohl). These analyses found that the rate of virologic success between the two regimens was similar across patient subgroups (age, gender, race, baseline HIV-1 RNA level and baseline CD4 count). Discontinuations due to adverse events were low in both treatment arms (0.9% (n=8) for E/C/F/TAF vs. 1.5% (n=13) for Stribild), with the most common side effects being diarrhea, nausea, headache and upper respiratory tract infection. Based on initial data from Studies 104 and 111 announced in September 2014, Gilead filed a New Drug Application for E/C/F/TAF with the FDA on November 5, 2014. In addition to Studies 104 and 111, several other E/C/F/TAF study results were presented. Notably, these include an open-label 48-week study (Study 112) supporting the efficacy and safety of E/C/F/TAF for use among HIV-infected patients with mild-to-moderate renal impairment (CrCL greater than or equal to 30mL/min) (Abstract 795/Pozniak). The study included 242 virologically suppressed patients whose treatment regimens were switched from both TDF- and non-TDF-containing regimens to E/C/F/TAF. The study found that 92% of study participants remained virologically suppressed at week 48. There was no significant change in eGFR compared to baseline, and significant improvements were observed in other markers of renal function, including proximal renal tubular laboratory parameters and decreased proteinuria (UPCR >200 mg/g) and albuminuria (UACR greater than or equal to 30mg/g). Improvements in BMD (hip and spine) were also observed from baseline to week 48 (median percentage change of 0.9% and 1.9%, respectively). Finally, lipid values among patients taking non-TDF-containing regimens prior to the study decreased, while fasting lipids increased among those who were taking TDF-containing regimens prior to study enrollment. Twenty-four-week data from another Phase III study (Study 106) of E/C/F/TAF in treatment-naive adolescents also were presented. Two other studies on emergent resistance in treatment-naive adult and adolescent patients taking E/C/F/TAF were presented. E/C/F/TAF is an investigational product and has not been determined to be safe or efficacious. Studies 104 and 111, originally planned for 96 weeks but recently extended to 144 weeks, are randomized, double-blind, controlled Phase III trials conducted among 1,733 treatment-naive adults living with HIV. At study enrollment, 15% of subjects were women, 43% were non-white and 23% had viral loads greater than or equal to 100,000 copies/mL. Patients were randomized 1:1 to receive a single tablet regimen of E/C/F/TAF or Stribild. Baseline median CD4 counts were 404 cells/µL for patients in the E/C/F/TAF arm and 406 cells/µL for those in the Stribild arm. The primary endpoint was Week 48 virologic response by FDA Snapshot Algorithm in a pre-specified analysis of the combined studies. The primary endpoint was met, as E/C/F/TAF was non-inferior to Stribild, with respect to the proportion of patients having HIV RNA less than 50 copies/mL at Week 48. Median change in CD4 count at Week 48 was 211 cells/µL in the E/C/F/TAF arm vs. 181 cells/µL in the Stribild arm (p=0.024). Virologic failure with resistance occurred in 0.8% in the E/C/F/TAF arm and 0.6% in the Stribild arm. There were no reports of proximal renal tubulopathy (including Fanconi Syndrome) in either arm. No single adverse event led to discontinuation of more than one subject on E/C/F/TAF. The most commonly reported adverse events (any grade) were: diarrhea (17% vs. 19%), nausea (15% vs. 17%), headache (14% vs. 13%) and upper respiratory infection (11% vs. 13%) in the E/C/F/TAF and Stribild arms, respectively. The studies are ongoing in a blinded fashion. After week 96, patients will continue to take their blinded study drug until treatment assignments have been unblinded, at which point all will be given the option to participate in an open-label rollover extension and receive E/C/F/TAF.
Natco Pharma Limited Signs Non-Exclusive Licensing Agreement with Gilead Sciences to Manufacture and Sell Generic Versions of Chronic Hepatitis C Medicines
Mar 2 15
Natco Pharma Limited announced that it has signed a non-exclusive licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic hepatitis C medicines. The medicines include sofosbuvir, ledipasvir/sofosbuvir and the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. This agreement allows Natco to expand access to these chronic hepatitis C medicines in 91 developing countries. Under the license, Natco can set its own price for the generic products it produces, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities.
Gilead Sciences Inc. Presents at The 9th Annual Daiwa Investment Conference 2015, Mar-04-2015 11:30 AM
Feb 27 15
Gilead Sciences Inc. Presents at The 9th Annual Daiwa Investment Conference 2015, Mar-04-2015 11:30 AM. Venue: The Prince Park Tower, 4-8-1, Shibakoen, Minato-ku, Tokyo, Japan. Speakers: Robin L. Washington, Chief Financial Officer, Principal Accounting Officer and Executive Vice President.