Key Developments: Gilead Sciences Inc (GILD.O)
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Latest Key Developments (Source: Significant Developments)
Gilead Sciences Inc Announces Response Data From Phase 2 Study Of Idelalisib For Previously Untreated Chronic Lymphocytic Leukemia
Gilead Sciences Inc announced results from a Phase 2 study (Study 101-08) evaluating idelalisib (formerly GS-1101), an investigational, targeted, oral inhibitor of PI3K delta, in combination with rituximab for older patients with treatment-naïve chronic lymphocytic leukemia (CLL). This regimen achieved a complete response (CR) rate of 19% and an overall response rate (ORR) of 97%, with estimated progression-free survival (PFS) at 24 months of 93%. Among the 64 patients in study, Kaplan-Meier estimated PFS at 24 months was 93%. The median time on treatment was 14 months, with 33 patients remaining on treatment. The median time to response was two months. No relapses on study have been reported. The nine patients with chromosome 17p deletion (del 17p) (n=6) or mutation in the TP53 gene (n=3), which have been linked to poor prognosis, all responded to therapy including three with a complete response. 94% of patients with thrombocytopenia at baseline responded to treatment (16/17), as did all patients with anemia at baseline (17/17). Of patients with systemic symptoms such as extreme fatigue, fever, night sweats or weight loss (known as B symptoms) at baseline, 77% (20/26) were asymptomatic by eight weeks. Patients completing 48 weeks of therapy without progression could continue to receive idelalisib in an extension study. 43 patients completed 48 weeks of treatment (21 discontinued - 17 due to adverse events, three due to death and one due to other reasons). Full Article
Gilead Sciences Inc Reiterates FY 2013 Product Sales Guidance
Gilead Sciences Inc reiterated its fiscal 2013 guidance which it provided on February 4, 2013 and expects net product sales of $10.000 - $10.200 billion. Full Article
FDA Rejects Two Gilead Sciences Inc's HIV Drugs As Standalone Products-Reuters
Reuters reported that Gilead Sciences Inc said that U.S. health officials rejected two of its HIV drugs as standalone therapies, citing deficiencies in documentation and validation of certain quality testing procedures. Gilead said it is working with the U.S. Food and Drug Administration to address the questions raised in the rejection letter in order to prove the application forward. The Company is seeking approval for its drug elvitegravir for people with HIV, the virus that causes AIDS, who have already been treated with other products. The drug blocks the enzyme integrase which is needed for the HIV virus to replicate. Full Article
Gilead Sciences Inc Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C
Gilead Sciences Inc announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection. Chronic HCV infection affects up to four million Americans, particularly individuals born between 1946 and 1964. The disease is the leading cause of liver cancer and liver transplantation in the United States. Treatment for HCV currently includes 24-48 weeks of therapy with peg-IFN, which has to be injected and is associated with significant side effects, leaving some patients unable to complete therapy. If approved, sofosbuvir would shorten HCV therapy to 12 to 16 weeks, and depending on the genotype, would either eliminate or reduce the duration of peg-IFN injections. Full Article
Gilead Sciences Inc Announces Update On Phase 3 Study Of Oral Fixed-Dose Combination Of Sofosbuvir And Ledipasvir For Genotype 1 Hepatitis C Patients
Gilead Sciences Inc announced an update on ION-1, a Phase 3 clinical trial evaluating a once-daily fixed-dose combination of the nucleotide sofosbuvir and the NS5A inhibitor ledipasvir with and without ribavirin (RBV) for 12 or 24 weeks among treatment-naïve genotype 1 patients with hepatitis C virus (HCV) infection (n=800). A planned review by the study's Data and Safety Monitoring Board (DSMB) of safety data from 200 patients in all four arms and of SVR4 rates (sustained virologic response four weeks after completion of therapy) from 100 patients in the two 12-week duration arms concluded that the trial should continue without modification. This recommendation is based upon the observed SVR4 rates exceeding the predefined threshold of 60% and the absence of safety issues. Enrollment of the remaining 600 patients in ION-1 is underway. Sofosbuvir/ledipasvir is also being evaluated in a second Phase 3 study, ION-2, initiated in January 2013, which is now fully enrolled. ION-2 is evaluating sofosbuvir/ledipasvir with RBV for 12 weeks, and with and without RBV for 24 weeks, among 400 treatment-experienced genotype 1 HCV patients. Participants in this study failed to respond to past therapy containing pegylated interferon (peg-IFN) or peg-IFN plus a protease inhibitor. Full Article
European CHMP Adopts Positive Opinion For Gilead Sciences Inc's Stribild, Once-Daily, Integrase Inhibitor-Based, Single Tablet Regimen For Treatment Of HIV-1 Infection
Gilead Sciences Inc announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the Company's Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. Stribild combines elvitegravir, an integrase inhibitor, and cobicistat, a pharmacoenhancing agent, with Truvada (emtricitabine and tenofovir disoproxil (as fumarate)). The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicines for use in the 27 countries of the European Union (EU). The regulatory filing for Stribild is supported by 48-week data from two Phase 3 double-blind, active-controlled, randomized studies in which Stribild met primary objective of non-inferiority compared to Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 300 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada (Study 103). In all studies, Stribild was well tolerated and most adverse events were mild to moderate. The most common adverse events observed were nausea, diarrhea, upper respiratory tract infection and headache. Full Article
Gilead Sciences Inc's Ranexa Reduces Angina Frequency in Study of Chronic Angina Patients With Type 2 Diabetes
Gilead Sciences Inc announced data from the Phase 4 TERISA (Type 2 Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) study, which demonstrated that the addition of ranolazine to background antianginal therapy in chronic angina patients with type 2 diabetes significantly reduced the frequency of weekly angina episodes compared to placebo and background antianginal therapy. Ranexa (ranolazine) is indicated for the treatment of chronic angina. Ranexa is not indicated for the treatment of diabetes and should not be considered a treatment for diabetes. Chronic angina, the most common symptom of coronary artery disease, can be a debilitating heart condition. Angina typically manifests as recurrent pain or tightness in the chest upon exertion or emotional stress. Patients with diabetes have more extensive coronary artery disease and a propensity for greater angina burden compared to patients without diabetes. Following a single-blind, four-week placebo run-in phase, 927 randomized patients received ranolazine (twice-daily 500 mg up-titrated to twice-daily 1,000 mg on Day 8) (n=462) or matching placebo (n=465) in addition to background antianginal therapy for eight weeks. Patients were asked to document the number of angina episodes and sublingual (under the tongue) nitroglycerin doses taken on a daily basis using an electronic diary. Full Article
Gilead Sciences Inc And Teva Pharmaceuticals Reach Settlement Agreement In Viread Patent Litigation
Gilead Sciences Inc announced that Gilead and Teva Pharmaceuticals have reached an agreement in principle to settle the ongoing patent litigation concerning the patents protecting Viread (tenofovir disoproxil fumarate), a treatment for HIV infection and chronic hepatitis B. Under the terms of the settlement, Teva will be allowed to launch a generic version of Viread on December 15, 2017. The trial in this litigation, which was scheduled to begin on Wednesday, February 20 in the District Court for the Southern District of New York, has been adjourned pending completion of activities necessary to finalize the settlement. Full Article
Gilead Sciences Inc's Subsidiary Completes Acquisition Of YM BioSciences
Gilead Sciences Inc's Subsidiary announced that it has completed its acquisition of YM BioSciences Inc. On February 8, 2013, a subsidiary of Gilead acquired all of the outstanding common shares of YM pursuant to the terms of a plan of arrangement. As a result, YM has become a wholly-owned subsidiary of Gilead and it is anticipated that the common shares of YM will no longer be listed for trading on the NYSE MKT LLC or the Toronto Stock Exchange, on or about February 12, 2013. Shareholders of YM on this date will be entitled to receive U.S. $2.95 per common share in cash, and holders of warrants and stock options will be entitled to receive a cash payment equal to the difference between U.S. $2.95 and the exercise price of such warrant or stock option. Full Article
YM BioSciences Inc Announces Receipt of Final Court Order Approving Plan of Arrangement with Gilead Sciences Inc
YM BioSciences Inc announced that the Supreme Court of Nova Scotia has issued a final order approving the previously announced plan of arrangement (the Arrangement) involving the Company, Gilead Sciences Inc (Gilead) and 3268218 Nova Scotia Limited, a wholly-owned subsidiary of Gilead (the Purchaser). Under the Arrangement, the Purchaser will acquire all of the issued and outstanding common shares (Common Shares) of the Company for cash consideration of USD2.95 per Common Share. In addition, holders of warrants and options will each receive a cash payment equal to the difference between USD2.95 and the exercise price of such warrants or options. Assuming all other closing conditions are satisfied or waived, it is anticipated that the Arrangement will become effective on February8, 2013 (the "Effective Date"). Full Article
FDA grants priority review status to Gilead's hepatitis C drug
June 7 - Biotechnology company Gilead Sciences Inc said the U.S. Food and Drug Administration (FDA) granted priority review to its experimental hepatitis C drug sofosbuvir.
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