Gilead Sciences, Inc.(GILD)- NASDAQ
  • Mon, Apr. 4, 7:31 AM
    • March monthly performance was: +8.07%
    • AUM of $331M
    • 52-week performance vs. the S&P 500 is: -11%
    • No dividends were paid in March
    • Top 10 Holdings as of 12/31/2015: Teva Pharmaceutical Industries Ltd ADR (TEVA): 2.13%, Sky PLC (OTCQX:BSYBF): 1.98%, Gilead Sciences Inc (GILD): 1.8%, Apple Inc (AAPL): 1.78%, Newell Rubbermaid Inc (NWL): 1.54%, Amcor Ltd (OTC:AMCRF): 1.48%, CGI Group Inc Class A (GIB): 1.47%, Avago Technologies Ltd (AVGO): 1.46%, CK Hutchison Holdings Ltd (OTCPK:CKHUF): 1.43%, RELX PLC (OTC:RLXXF): 1.43%
    | Mon, Apr. 4, 7:31 AM
  • Thu, Mar. 31, 7:12 AM
    • Gilead Sciences (NASDAQ:GILD) submits a New Drug Application (NDA) to the Japanese Pharmaceutical and Medical Devices Agency (PMDA) seeking clearance of tenofovir alafenamide (TAF) for the treatment of hepatitis B virus (HBV) infection.
    • TAF has similar efficacy as Viread (tenofovir disoproxil fumarate, TDF) at one-tenth the dose while being less stressful on bones and kidneys. Viread is marketed in Japan for the treatment of HBV by GlaxoSmithKline (NYSE:GSK) under the brand name Tenozet.
    • More than 1M Japanese are chronically infected with HBV.
    | Thu, Mar. 31, 7:12 AM | 32 Comments
  • Tue, Mar. 29, 1:02 PM
    • Thinly traded nano cap ContraVir Pharmaceuticals (CTRV +20.1%) is up on a whopping 61x surge in volume in response to its announcement of results from a third-party laboratory (in vitro) study that showed greater antiviral activity in a hepatitis B virus (HBV) cell culture for product candidate CMX157 compared to Gilead Sciences' (GILD -0.9%) tenofovir alafenamide fumarate (TAF).
    • The study evaluated the anti-hepatitis B activities of CMX157 and other tenofovir prodrugs, including Gilead's Viread (tenofovir disoproxil fumarate), in order to profile CMX157. The ability of each to shut down HBV replication was determined by a parameter called effective concentration (EC), which measures the degree to which viral replication is inhibited for a given concentration of drug. EC50, for example, is the concentration of drug that reduces viral replication by 50%. EC50 values for CMX157 and TAF were 9.3 (range: 5.7 - 12.9) and 32.4 (range: 15.3 - 49.5), respectively. A lower value implies that the drug is more potent, although not necessarily more efficacious. EC90 (HBV viral replication inhibited 90%) values were 186 (range: 133 - 239) and 474 (range: 213 - 735), respectively. No values for Viread are provided.
    • ContraVir recently initiated a Phase 1/2a study assessing CMX157. The 2a portion, expected to commence in Q2, will compare it against Viread.
    • Tenofovir is a compound called a lipid acyclic nucleoside phosphonate. It is an effective antiviral agent but is limited by low oral bioavailability, renal toxicity and poor cell penetration.  According to the company, CMX157's novel formulation enables it to deliver high intracellular concentrations of tenofovir thereby making it more effective at permanently suppressing HBV replication than existing drugs.
    • Gilead is currently transitioning its TDF (tenofovir disoproxil fumarate) products to TAF because its has equivalent efficacy at one tenth the dose and is easier on the bones and kidneys. The FDA cleared TAF for HIV-1 on March 1. Its marketing applications for hep B are currently under review in the U.S. and Europe.
    • Previously: ContraVir Pharma adds to up move, shares rise 22% (March 22)
    | Tue, Mar. 29, 1:02 PM | 25 Comments
  • Thu, Mar. 24, 10:16 PM
    • A jury has ordered Gilead Sciences (NASDAQ:GILD) to pay $200M to Merck (NYSE:MRK) for patent infringement in a case over hepatitis C drugs -- that vs. Merck's demand for more than $2B in damages.
    • Jurors had sided with Merck in ruling its patents related to sofosbuvir that were infringed by Gilead were valid. But they rejected a call for a 10% royalty on some $20.7B in revenue that Gilead's drugs (Sovaldi and Harvoni) earned between 2013 and 2015.
    • The jury settled on a 4% royalty for $5B in sales, after subtracting a Gilead investment of $15B from the revenues.
    • Gilead says it will appeal the amount if a judge upholds it: “Since Merck made no contribution and assumed none of the risk in the discovery and development of sofosbuvir, we do not believe Merck is entitled to any amount of damages,” says Gilead's Michele Rest.
    • Previously: Ionis Pharma to receive 20% of Gilead patent infringement damages; shares up 11% premarket (Mar. 23 2016)
    • Previously: Merck +0.9%, Gilead -2.1% as jury rules Merck's patents valid (Mar. 22 2016)
    | Thu, Mar. 24, 10:16 PM | 92 Comments
  • Wed, Mar. 23, 8:23 AM
    • Ionis Pharmaceuticals (NASDAQ:IONS) is up 11% premarket on increased volume in response to yesterday's jury verdict in California that Gilead Sciences' (NASDAQ:GILD) HCV meds Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) infringe on two patents invented by Merck (NYSE:MRK) and Ionis. The next phase of the trial will determine the amount of the damages.
    • Ionis will receive 20% of the amount awarded to Merck that exceed its litigation costs and 20% of all future payments.
    • Previously: Merck +0.9%, Gilead -2.1% as jury rules Merck's patents valid (March 22)
    | Wed, Mar. 23, 8:23 AM | 32 Comments
  • Tue, Mar. 22, 5:37 PM
    • Merck (NYSE:MRK) is up 0.9% after a quick 3.7% spike after hours, and Gilead Sciences (NASDAQ:GILD) down 2.1%, as a jury has decided that Merck's 2002 patents related to sofosbuvir are valid, lending credence to Merck's argument that Gilead is infringing via its Pharmasset unit, acquired in 2011.
    • Gilead's Sovaldi and Harvoni were ruled last month to infringe on Merck patents, and the next step was to decide the validity of the Merck patents.
    • The case now proceeds to damages owed. Sovaldi and Harvoni brought $19.2B in global sales last year.
    • Merck has demanded more than $2B in damages and 10% of Gilead's sales of the products going forward.
    • Previously: Merck after a big slice of Gilead's sofosbuvir pie (Mar. 08 2016)
    | Tue, Mar. 22, 5:37 PM | 123 Comments
  • Tue, Mar. 22, 1:21 PM
    • Thinly traded nano cap ContraVir Pharmaceuticals (CTRV +21.6%) is up again today on a 6x surge in volume. Shares have jumped over 42% since the company announced the initiation of a Phase 1/2a clinical trial assessing CMX157 for the treatment of hepatitis B virus (HBV) infection.
    • The Phase 1 portion will evaluate ascending doses of CMX157 in 50 healthy volunteers for safety, tolerability and pharmacokinetics.
    • Phase 2a will enroll 60 treatment-naive patients with chronic HBV infection and will compare CMX157 to Gilead Sciences' (GILD +1%) Viread (tenofovir disoproxil fumarate)(TDF). It will also consist of a sequential dose escalation with 10 participants per cohort receiving four weeks of once-daily 5, 10, 25, 50 or 100 mg of CMX157 and two participants who will receive 300 mg of CMX157 daily, the standard dose of Viread.
    • Patient dosing in the Phase 1 should commence in the next several weeks. The Phase 2a will commence in Q2.
    • Tenofovir is a compound called a lipid acyclic nucleoside phosphonate. It is an effective antiviral agent but is limited by low oral bioavailability, renal toxicity and poor cell penetration. According to the company, CMX157's novel formulation enables it to deliver high intracellular concentrations of tenofovir thereby making it more effective at permanently suppressing HBV replication than existing drugs.
    | Tue, Mar. 22, 1:21 PM | 12 Comments
  • Fri, Mar. 18, 3:41 PM
    • Despite its statement that the events are unrelated, the future of Gilead Sciences' (GILD +1.1%) cancer programs is under more scrutiny after cancer chief Philippe Bishop, M.D., SVP of Hematology and Oncology Therapeutics, resigned after only 15 months on the job. Chief Scientific Officer Norbert Bischofberger, Ph.D., says his departure was by mutual consent, but it comes only a few days after the company disclosed that it stopped six clinical trials assessing cancer med Zydelig (idelalisib) due to an increase rate of adverse events, including deaths. The FDA alerted healthcare professionals on Monday.
    • Dr. Bishop joined Gilead in December 2014 from Roche's Genentech, where he was VP, Product Development, and oversaw the development of blockbuster cancer drug Avastin (bevacizumab).
    • The FDA approved idelalisib with a "black box" warning in July 2014 for the treatment of chronic lymphocytic leukemia, in combination with Genentech's Rituxan (rituximab), in addition to certain lymphomas. The European Commission cleared it in September 2014.
    • The company is relying on the cancer space to drive growth outside of its hepatitis business.
    | Fri, Mar. 18, 3:41 PM | 78 Comments
  • Tue, Mar. 8, 1:14 PM
    • Gilead Sciences (GILD +0.4%) and Merck (MRK +0.2%) are in the midst of a courtroom spat over sofosbuvir patents. Merck claims Gilead is infringing on its intellectual property and owes it 10% of the $31.7B it has made to date on the hepatitis C med. Unsurprisingly, Gilead disagrees with Merck's assertion saying sofosbuvir was invented by Pharmasset, which it acquired in 2011 for $11B.
    • Last month, a judge ruled that Gilead's Sovaldi and Harvoni do, indeed, infringe on Merck's patents. Now a jury will decide if they remain valid and how much Gilead owes to the Kenilworth, NJ-based drug firm.
    • The dispute centers on a patent published in 2002 by Merck, who alleges that Pharmasset used it to develop sofosbuvir. Gilead says Pharmasset's development work on sofosbuvir began in 2001, a year before Merck secured patent rights.
    • The rhubarb began in 2013 when Gilead sued Merck over what it called a "threat" by Merck to sue Gilead over two of its patents registered in 2002 in an attempt to extract a "prohibitive" royalty on sofosbuvir.
    • In a worse case scenario, Gilead would hardly miss a step if it had to disgorge $3B considering its cash horde of over $26B. Nevertheless, it won't do so without a fight. If it loses the current case, expect an appeal.
    | Tue, Mar. 8, 1:14 PM | 89 Comments
  • Tue, Mar. 8, 9:13 AM
    • Sydney, Australia-based Benitec (NASDAQ:BNTC) announces that its DNA-directed RNA interference (ddRNAi) candidate, BB-HB-331, showed robust and durable hepatitis B virus (HBV) suppression in vivo following a single administration.
    • The HBV suppression activity of BB-HB-331 was assessed in the Phoenix mouse model in which murine liver cells were replaced by human hepatocytes which made them susceptible to HBV infection. Once infected, the mice received a single systemic injection of BB-HB-331. Serum antigen levels, HBV viral proteins and extracellular HBV DNA were measured once per week for the duration of the eight-week study.
    • Results showed a 1.83 log knockdown of serum HBV DNA, equivalent to a 98.5% reduction of circulating HBV. In addition, intracellular HBV DNA was reduced 94.9% while HBV surface antigen (HBsAg) and e antigen (HBeAg) were reduced by 97.6% and 92.6%, respectively. The results validated the previously reported in vitro findings.
    • BB-HB-331 combines the gene silencing of RNA interference with the therapeutic potential of gene therapy. It is comprised of an AAV8 capsid (protein shell of a virus) and recombinant DNA engineered to express three short hairpin RNAs that target and inhibit viral RNA expressed from three regions across multiple HBV genotypes. The company plans to advance BB-HB-331 to clinical development.
    • Previously: Benitec Biopharma's ddRNAi therapeutic candidate shows potent anti-HBV antigen activity in preclinical testing; shares up 14% (Dec. 7, 2015)
    • HBV-related tickers: (NASDAQ:GILD)(OTCQB:COCP)(NYSE:GSK)(NASDAQ:IONS)(NASDAQ:DVAX)(NYSE:JNJ)(NASDAQ:ARWR)(NYSE:MRK)(NASDAQ:CTRV)(NASDAQ:ABUS)(NYSE:SNY)(NASDAQ:ALNY)(NYSE:BMY)
    • Update: Shares up 26% in early trading.
    | Tue, Mar. 8, 9:13 AM | 8 Comments
  • Wed, Mar. 2, 10:06 AM
    • February monthly performance was: +1.02%
    • AUM of $328M
    • 52-week performance vs. the S&P 500 is: -2%
    • No dividends were paid in February
    • Top 10 Holdings as of 12/31/2015: Teva Pharmaceutical Industries Ltd ADR (TEVA): 2.13%, Sky PLC (OTCQX:BSYBF): 1.98%, Gilead Sciences Inc (GILD): 1.8%, Apple Inc (AAPL): 1.78%, Newell Rubbermaid Inc (NWL): 1.54%, Amcor Ltd (OTC:AMCRF): 1.48%, CGI Group Inc Class A (GIB): 1.47%, Avago Technologies Ltd (AVGO): 1.46%, CK Hutchison Holdings Ltd (OTCPK:CKHUF): 1.43%, RELX PLC (OTC:RLXXF): 1.43%
    | Wed, Mar. 2, 10:06 AM | 2 Comments
  • Tue, Mar. 1, 3:16 PM
    • The FDA approves Gilead Sciences' (GILD +2.2%) Odefsey (emtricitabine 200mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg)(R/F/TAF) for the treatment of HIV-1 infection in certain patients. Rilpivirine is from Janssen Sciences Ireland UC (JNJ +1.8%).
    • Odefsey, the company's second TAF-based regimen cleared in the U.S., is indicated for antiretroviral treatment-naive patients at least 12 years old with HIV-1 RNA levels no greater than 100K copies/mL. It is also indicated as replacement for a stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.
    • The company is transitioning its HIV product line to TAF because it is shows antiviral efficacy at one tenth the dose of TDF (tenofovir disoproxil fumarate) while being less stressful on the bones and kidneys.
    • The FDA approved TAF-based Genvoya (E/C/F/TAF) in November 2015.
    • Previously: Gilead submits NDA for single tablet HIV med (July 1, 2015)
    • Previously: FDA clears Gilead's Genvoya for HIV-1 infection (Nov. 5, 2015)
    | Tue, Mar. 1, 3:16 PM | 31 Comments
  • Fri, Feb. 26, 8:13 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of two doses of Gilead Sciences' (NASDAQ:GILD) F/TAF for the treatment of HIV-1 infection in patients at least 12 years old.
    • The two doses of the product, branded as Descovy, are emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg.
    • The company is transitioning its product line to TAF from TDF (tenofovir disoproxil fumarate) (Viread) because it is just as effective at a dose less that one tenth that of TDF and is less stressful on the bones and kidneys.
    • A final decision by the European Commission usually takes ~60 days.
    | Fri, Feb. 26, 8:13 AM | 24 Comments
  • Thu, Feb. 25, 11:10 AM
    • The European Medicines Agency (EMA) accepts for review Gilead Sciences' (GILD +0.5%) Marketing Authorization Application (MAA) seeking clearance for tenofovir alafenamide fumarate (TAF) 25 mg for the treatment of adults with chronic hepatitis B virus (HBV) infection.
    • The company is transitioning its product line to TAF from TDF (tenofovir disoproxil fumarate) (Viread) because it is just as effective at a dose less that one tenth that of TDF and is less stressful on the bones and kidneys.
    • Gilead submitted its NDA in the U.S. in early January.
    • Previously: Gilead submits TAF NDA for hepatitis B (Jan. 12)
    | Thu, Feb. 25, 11:10 AM | 11 Comments
  • Wed, Feb. 24, 1:40 PM
    • ViiV Healthcare, the HIV-focused joint venture between GlaxoSmithKline (GSK -1.1%), Pfizer (PFE -0.5%) and Shionogi Limited (OTC:SGIOF)(OTCPK:SGIOY), announces the results from a 41-week Phase 2a study, ECLAIR, assessing the safety, tolerability, dosing and satisfaction with long-acting, injectable cabotegravir as monotherapy for the prevention of HIV infection in adult males not at high risk of acquiring HIV. The data were presented at the Conference on Retroviruses and Opportunistic Infections in Boston.
    • ECLAIR randomized 127 HIV-negative subjects 5:1 to cabotegravir or placebo beginning with a safety assessment on oral cabotegravir 30 mg or placebo tablet for four weeks followed by an intramuscular injection of 800 mg cabotegravir or placebo (sterile saline) every 12 weeks for three cycles.
    • The proportions of participants who completed three injections for cabotegravir and placebo were 93% (n=87/94) and 95% (n=20/21), respectively. The incidences of Grade 2 (moderate) to Grade 4 (life-threatening or disabling) adverse events during the injection phase were 80% (n=75/94) and 48% (n=10/21), respectively. The most common Grade 2-4 AE was injection site pain (59% and 5%, respectively). The incidences of all grades of adverse events during the injection phase were 98% (n=92/94) and 90% (n=19/21), respectively.
    • Following repeat injections, 74% (n=67/91) favored long-acting cabotegravir over the oral version.
    • ViiV intends to advance cabotegravir to Phase 3 development later this year.
    • Related tickers: (NASDAQ:GILD)(NYSE:ABT)(NYSE:BMY)(NYSE:JNJ)(NYSE:MRK)(OTCQX:RHHBY)
    | Wed, Feb. 24, 1:40 PM | 14 Comments
  • Mon, Feb. 22, 1:53 PM
    • Results from a 159-subject Phase 3 clinical trial assessing Bristol-Myers Squibb's (BMY) all-oral HCV regimen, daclatasvir (Daklinza) combined with asunaprevir, in Asian patients positive for genotype 1b showed cure rates as high as 99%. The data were presented today at the Asian Pacific Association for the Study of the Liver Conference in Tokyo.
    • The trial was an open-label design that evaluated daclatasvir 60 mg once daily and asunaprevir 100 mg twice daily for 24 weeks. 80% of patients (n=127) were from mainland China, 11% (n=17) from Korea and 9% (n=14) from Taiwan.
    • Cure rates, defined as sustained virologic response at week 24 (SVR24), were 91% among all Chinese patients and 98% in those without NS5A resistance-associated variants (RAVs) at baseline. SVR24 rates were high among HCV-1b subgroups including those with cirrhosis (90%), Koreans (94%) and Taiwanese (87%). Japanese patients were not part of the study.
    • In all patients, the SVR24 rate was 99% (n=137/139) in those without NS5A RAVs, regardless of the presence (98%) or absence (99%) of cirrhosis, and 42% (n=8/19) in those with baseline NS5A RAVs.
    • The daclatasvir/asunaprevir regimen is currently cleared in Japan, Korea, Taiwan and certain countries in Latin America and Eastern Europe. More than 13M Chinese are HCV-positive so approval there is a priority for the company.
    • Related tickers: (GILD +2.2%)(ABBV +0.7%)(MRK +0.8%)(JNJ +0.5%)
    | Mon, Feb. 22, 1:53 PM | 48 Comments
Company Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Its primary areas of focus include primary areas of focus include human immunodeficiency virus (HIV), liver diseases such as... More
Sector: Healthcare
Industry: Biotechnology
Country: United States