Gilead Sciences, Inc. (Public, NASDAQ:GILD)

[Michael Scally MD]

Gilead Sciences, Inc. (Public, NASDAQ:GILD) Home
IR: http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-irhome

GF: Gilead Sciences, Inc.: NASDAQ:GILD quotes & news - Google Finance
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SA: Gilead Sciences, Inc. (GILD) Stock - Seeking Alpha

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Since 1987, Gilead Sciences has worked to discover, develop and commercialize medications to advance the care of patients suffering from life-threatening diseases in areas of unmet medical need.

In just over 20 years, Gilead has become a leading biopharmaceutical company with a portfolio of 14 marketed products, a growing pipeline of investigational drugs and approximately 4,200 employees in offices across four continents.

Gilead’s primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular/metabolic and respiratory conditions.


Our Marketed Products - http://www.gilead.com/corporate_overview

Following is a summary of Gilead’s product portfolio. See our Products section for full prescribing information, including BOXED WARNINGS and Important Safety Information.

HIV/AIDS

Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is a once-daily single-tablet regimen for the treatment of HIV infection in adults. Atripla combines three HIV medicines in a single pill: Viread (tenofovir disoproxil fumarate), Emtriva (emtricitabine) and Sustiva® (efavirenz), manufactured by Bristol-Myers Squibb Company. (U.S. approval, 2006; EU approval, 2007.)

Complera™ (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a once-daily complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. Complera combines three medicines in a single pill: Viread (tenofovir disoproxil fumarate), Emtriva (emtricitabine) and Edurant™ (rilpivirine), manufactured by Tibotec Pharmaceuticals Ltd. (U.S. approval, 2011; EU approval,pending.)

Emtriva® (emtricitabine) is a once-daily oral nucleoside reverse transcriptase inhibitor (NRTI) used in combination with other antiretroviral agents for the treatment of HIV infection. An oral solution is available for use in pediatric patients. (U.S. and EU approval, 2003.)

Truvada® (emtricitabine and tenofovir disoproxil fumarate) is a fixed-dose once-daily combination pill containing Viread and Emtriva. It is used in combination with other antiretroviral agents for thetreatment of HIV infection in adults. (U.S. approval, 2004; EU approval, 2005.)

Viread® (tenofovir disoproxil fumarate) is a once-daily oral nucleotide reverse transcriptase inhibitor (NtRTI) for the treatment of HIV infection in patients 12 years of age and older in combination with other antiretroviral agents. (U.S. approval, 2001; EU approval, 2002.) Viread is also approved as a treatment for chronic hepatitis B in adults. (U.S. and EU approval, 2008.)

Liver Disease

Hepsera® is a once-daily oral NtRTI for the treatment of chronic hepatitis B in patients 12 years of age and older. (U.S. approval, 2002; EU approval, 2003.)

Viread® (tenofovir disoproxil fumarate) (tenofovir disoproxil fumarate) is a once-daily oral NtRTI for the treatment of chronic hepatitis B infection in adults with compensated and decompensated liver disease. (U.S. and EU approval, 2008.) As noted above, Viread is also approved for the treatment of HIV infection in patients 12 years of age and older.

Cardiovascular

Letairis® (ambrisentan) is a once-daily treatment to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (PAH, WHO Group 1) patients with predominantly WHO Functional Class II-III symptoms. (U.S. approval, 2007; EU approval, 2008, as Volibris®. GlaxoSmithKline PLC holds rights to commercialize the product outside of the United States.)

Lexiscan® (regadenoson) injection is the first A2A adenosine receptor agonist approved for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging studies. The product has been designed to target the A2A adenosine receptor, which is the adenosine receptor subtype responsible for coronary vasodilation. (U.S. approval, 2008; EU approval, 2010, as Rapiscan®. Astellas Pharma US, Inc. commercializes the product in the United States. Rapidscan Pharma Solutions, Inc. commercializes the product in Europe.)

Ranexa® (ranolazine) is an extended-release tablet for the treatment of chronic angina. Ranexa may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors and angiotensin receptor blockers. (U.S. approval, 2006; U.S. indication updated to include first-line treatment for chronic angina, 2008; EU approval, 2008.)

Respiratory

Cayston® (aztreonam for inhalation solution) is an inhaled antibiotic indicated to improve respiratory symptoms in cystic fibrosis (CF) patients 7 years of age and older with Pseudomonas aeruginosa infection. Cayston is administered with the Altera® Nebulizer System, a portable, drug-specific delivery device using the eFlow® Technology Platform, developed by PARI Pharma GmbH. (EU conditional approval, 2009; U.S. approval, 2010.)

Tamiflu® (oseltamivir phosphate) is the first neuraminidase inhibitor tablet for the treatment and prevention of influenza A and B. Developed by Gilead, Tamiflu is commercialized globally by F. Hoffmann-La Roche Ltd. (U.S. approval for influenza treatment, 1999; U.S. indication expanded to include influenza prevention, 2000; EU approval, 2002.)

Other

AmBisome® (amphotericin B liposome for injection) is a treatment for life-threatening, systemic fungal infections in adults. (EU approval, 1990; U.S. approval, 1997. Astellas Pharma US, Inc. commercializes the product in the U.S. and Canada.)

Macugen® (pegaptanib sodium injection) is an injection for the treatment of neovascular age-related macular degeneration (also known as "wet" AMD), an eye disease that destroys central vision in elderly patients. (U.S. approval, 2004; EU approval, 2006. Macugen is marketed in the U.S. by Eyetech Inc., and by Pfizer Inc. outside the U.S.)

Vistide® is an antiviral injection for the treatment of cytomegalovirus retinitis in adult patients with AIDS. (U.S. approval, 1996; EU approval, 1997.)

 

[Michael Scally MD]

U.S. Food and Drug Administration Approves Gilead Sciences' Complera(TM), a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults
- Complera Combines the Most-Prescribed HIV Product in the United States with the Newest Antiretroviral Agent Approved by the FDA -
- Approval Marks Gilead's Second Successful Collaboration to Develop a Complete Single-Tablet Regimen for HIV/AIDS -
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1595280&highlight=

 

[zkt]

Damn! You`ve been a busy boy. :tiphat

 

[Michael Scally MD]

Gilead's Investigational Antiretroviral Quad Regimen Meets 48-Week Primary Objective in Pivotal Phase 3 Clinical Study 102
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1596378&highlight=

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that a Phase 3 clinical trial (Study 102) of its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective, which was non-inferiority at week 48 as compared to Atripla(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). The primary endpoint analysis indicated that 88 percent of patients in the Quad arm compared to 84 percent in the Atripla (95% CI for the difference: -1.6% to 8.8%) achieved HIV RNA (viral load) of less than 50 copies/mL through week 48. The predefined criterion for non-inferiority was a lower bound of a two sided 95% CI of -12 percent.

 

[Michael Scally MD]

The success of Quad in the ‘102’ study is pretty big news for GILD, IMO. In the ‘102’ study, the comparator arm was Atripla, so the comparison was effectively between Elvitegravir and BMY’s Sustiva. In a second phase-3 Quad study called ‘103’ due to report data soon, the comparator arm is Truvada + boosted Reyataz, so the comparison is effectively between Elvitegravir and Reyataz.

Thus, the two phase-3 Quad studies will effectively compare Elvitegravir to, respectively, the leading HIV non-nuke (Sustiva) and the leading HIV protease inhibitor (Reyataz). If both studies show statsig non-inferiority, Quad will be a near lock to obtain FDA approval and will be well on its way toward achieving commercial success. In that case, Quad not only will soften the blow from the eventual patent expiration of Truvada and Atripla, but also will generate a substantially higher profit margin for GILD than either Atripla or Complera.

 

[Michael Scally MD]

Gilead: Deutsche Bank Sees Big Potential for New HIV Drug
http://blogs.barrons.com/stockstowa...che-bank-sees-big-potential-for-new-hiv-drug/

AUGUST 16, 2011

The Street is underestimating Gilead’s (GILD) ability to take market share among new HIV patients with its HIV drug QUAD, which contains four medicines in one pill, writes Deutsche Bank analyst Robyn Karnauskas. Gilead expects to seek approval for QUAD in the first quarter of 2012.

After evaluating the potential market for QUAD, Karnauskas called Gilead the “top value stock” she covers and raised her price target to $53 from $45.

Gilead is competing with GlaxoSmithKline (GSK) to treat HIV patients, and investors are concerned that a new pill from GSK called 572-Trii will take market share from Gilead. But those concerns appear overblown, Karnauskas argues, as Gilead’s new pill should be able to hold its own against GSK’s new offering. And if the GSK pill never comes to market — it hasn’t been approved yet, Gilead shares could jump even higher.


“Our model assumes GSK takes 50% of potential QUAD share. If we assume QUAD takes 100% of potential share from Atripla & Truvada regimens we see fair valuation at $67/share.”

 

[CubbieBlue]

When do these stocks typically hit their peak? When FDA approval is gained? When sales figures come back?

 

[Michael Scally MD]

When do these stocks typically hit their peak? When FDA approval is gained? When sales figures come back?

If anyone knew the answer, they would be very wealthy. Also, once something is known or revealed it is typically too late to make money on the information.

BTW: I am in at $38.85.

 

[Michael Scally MD]

The premium is almost 100% to Friday close.

Gilead Sciences to Acquire Pharmasset, Inc. for $11 Billion
http://finance.yahoo.com/news/gilead-sciences-acquire-pharmasset-inc-120000407.html

 

[Michael Scally MD]

Gilead Board Approves Two-for-One Stock Split
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1765916&highlight=

On December 10, 2012, the Board of Directors of Gilead Sciences, Inc. (the Company) declared a two-for-one stock split of the Company's outstanding common stock to be effected through a stock dividend. Stockholders of record as of the close of business on January 7, 2013 will receive a stock dividend of one additional share of common stock for every share of common stock they own. The stock dividend will be distributed on or about January 25, 2013.

 

[Michael Scally MD]

IMO, GILD will increase significantly in 2013, possibly even DOUBLING.
If you are not in GILD, BUY!!!

Now, GILD has expanded into the Cancer arena with YM purchase.
BTW: A look at YM financials shows over $125 MILLION in cash.

Gilead Sciences to Acquire YM BioSciences
- Adds Selective JAK Inhibitor to Growing Oncology and Inflammation Pipeline -
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1766528&highlight=