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Posts Tagged ‘HIV’

BioLineRx Signs Exclusive License Agreement for BL-8020, an Oral Treatment for Hepatitis C

Tuesday, January 24th, 2012

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JERUSALEM — 01/24/2012 (CRWENEWSWIRE) — BioLineRx (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today it has signed a worldwide, exclusive license agreement with Genoscience, a French company focused on viral disease therapeutics, to develop and commercialize BL-8020, an orally available treatment for Hepatitis C.

BL-8020 has been developed for anti-viral therapy by Professor Philippe Halfon, Co-Founder and President of Genoscience. Prof. Halfon is a founder of several biotechnology companies and is world renowned for his work on HIV (AIDS virus), HPV (human papilloma virus causing cervical cancer) and Hepatitis.

BL-8020 acts via a unique mechanism of action, by inhibiting Hepatitis C virus (HCV)-induced autophagy, which differs from the mechanism of currently used anti-HCV agents. BL-8020’s safety and efficacy were demonstrated in pre-clinical studies. These studies have shown that BL-8020, when combined with other anti-Hepatitis C virus (HCV) agents, has a synergistic effect. BL-8020’s synergistic effect on other therapies is likely to increase their potency and reduce the numerous adverse effects often associated with these drugs, by enabling utilization of lower dosages. In addition BL-8020 may reduce therapy duration, which is currently up to 48 weeks. The use of two drugs acting by different mechanisms is also likely to be beneficial for patients who have developed resistance to current treatments and is an effective strategy used against other viruses such as HIV.

Dr. Kinneret Savitsky, CEO of BioLineRx, said, “We are excited about entering the field of Hepatitis C therapeutics, which is a very important field in the pharmaceutical market today. The current global Hepatitis market is estimated at approximately $6.5 billion and is growing steadily. Current therapies are characterized by numerous severe side effects, long treatment duration and development of resistance. In these respects, BL-8020 has a demonstrated safety and efficacy profile, may shorten therapy duration and may combat resistance by acting as an add-on platform which can potentially be combined with other oral Hepatitis C therapies to increase their efficacy.”

“We were impressed by the drug development expertise of the BioLineRx team and are very pleased to collaborate with them for the further development of our product for the treatment of Hepatitis C,” said Prof. Philippe Halfon, Co-Founder and President of Genoscience. “There is clearly a huge unmet medical need in finding a safe and effective treatment for the disease, and based on pre-clinical results, its unique mechanism of action and synergistic effect, we believe that our product, especially when combined with other available Hepatitis C drugs, has the potential to bring remedy to millions worldwide.”

About Hepatitis C

Hepatitis C infection is a blood borne infection of the liver caused by the Hepatitis C virus (HCV) which becomes chronic in about 85% of cases. According to the World Health Organization (WHO), more than 170 million people worldwide are chronically infected with HCV. In addition, HCV infection is the leading cause of liver transplantation and is a risk factor for liver cancer. The global Hepatitis market was estimated at $6.5 billion in 2010 and is forecasted to grow to $11.5 billion in 2016.

About BioLineRx

BioLineRx Ltd. is a publicly-traded biopharmaceutical development company. It is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx’s current portfolio consists of five clinical stage candidates: BL-1020 for schizophrenia has commenced a Phase II/III study; BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, is currently undergoing a pivotal CE-Mark registration trial and has been out-licensed to Ikaria Inc. for a total deal value of $282.5 million, in addition to sales royalties; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-1021 for neuropathic pain is in Phase I development and BL-7040 for treating Inflammatory Bowel Disease (IBD) has completed Phase I. In addition, BioLineRx has 12 products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, oncology, infectious diseases, cardiovascular and autoimmune diseases.

BioLineRx’s business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government’s Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization. For more information on BioLineRx, please visit www.biolinerx.com.

The estimates and judgments with respect to BL-8020 included in this release are considered forward-looking statements, which involve certain risks and uncertainties, and are based on information available to the Company at the time of this release. Such estimates may not be realized or may be only partially realized, due to the significant uncertainty characterizing research and development activities in general, particularly those of drug development, including changes in regulation or uncertainty relating to the application of regulation, unexpected delays in obtaining regulatory approval, unexpected delays in patient recruitment for clinical trials, unexpected delays in other clinical trial preparatory activities, inefficiencies, inability to manufacture, toxicity, a high level of risk/reward in comparison. Any forward-looking statements represent the Company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Source: BioLineRx Ltd.

Contact:
KCSA Strategic Communications
Garth Russell / Todd Fromer
1 212-896-1250 / 1 212-896-1250
grussell@kcsa.com / tfromer@kcsa.com
or
BioLineRx Ltd.
Tsipi Haitovsky, Public Relations
+972-3-6240871
tsipih@netvision.net.il

 

 

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THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
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GILD (VIDEO!), CRWE, XEC, NR, CRS - Market Update From DrStockPick.com!

Sunday, September 25th, 2011

 

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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.

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Gilead Sciences, Inc. (Nasdaq:GILD) recently announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera®, combining Gilead’s Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) with Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor Edurant® (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in antiretroviral-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL.

The CHMP’s positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union (EU). Gilead expects the European Commission to issue its decision on the marketing authorization for the Eviplera single-tablet regimen later this year.

“There is a need for the simplification of treatment regimens featuring co-formulated, fixed-dose medicines as patients stay on therapy longer,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “We are pleased to move one step closer to making this potentially important new simplified treatment option available to physicians and patients in Europe.”

The regulatory filing for the Eviplera single-tablet regimen is supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) conducted by Tibotec evaluating the safety and efficacy of rilpivirine compared to efavirenz in treatment-naïve HIV-1 infected adults. Both arms of the studies were administered with a background regimen, in which the majority of patients in the rilpivirine arm received Truvada. A bioequivalence study conducted by Gilead demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.

More about GILD at www.gilead.com

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crwenew

The main benefits of Internet marketing is that it can allow a business to reach a larger audience than other marketing methods. Websites are accessible to anyone in the world with an Internet connection so long as they are not blocked by network administrators (some countries and workplaces block certain websites). This means that a website devoted to promoting a company or ads placed on popular websites can potentially be seen by millions of customers across the world.

Crown Equity Holdings Inc. (OTC:CRWE), together with its digital network, currently provides electronic media services specializing in online publishing, which brings together targeted audiences and advertisers.

Crown Equity Holdings Inc. offers internet media-driven advertising services, which covers and connects a range of marketing specialties, as well as search engine optimization for clients interested in online media awareness.

CRWE’s digital network is designed, on behalf of its clients, to bring together targeted high-income audiences and advertisers on its financial websites that include, among others, DrStockPick.com, PennyOmega.com, BestOtc.com, CRWEFinance.com, CRWESelect.com, CRWEPicks.com and StockHotTips.com.

Crown Equity Holdings Inc. is pleased to announce that it has entered into a joint venture to deploy VoIP (Voice over Internet Protocol) technology delivering voice, video and data services to residential and commercial customers. The joint venture company is Crown Tele Services Inc. which was a wholly-owned subsidiary of Crown Equity Holdings Inc. Crown Equity Holdings Inc. will own fifty percent (50%) interest in the joint venture.

Commenting on the joint venture, Kenneth Bosket, President of Crown Equity Holdings Inc., said: “We are excited to deliver VoIP communications solutions specifically designed to meet the business and residential market needs in this fast-growing global market.”

For more information, please visit: http://www.crownequityholdings.com

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Cimarex Energy Co. (NYSE:XEC) has declared a regular cash dividend on its common stock of 10 cents-per-share. The dividend is payable on December 1, 2011 to stockholders of record on November 15, 2011. Denver-based Cimarex Energy Co. is an independent oil and gas exploration and production company with principal operations in the Mid-Continent, Permian Basin and Gulf Coast areas of the U.S.

Cimarex Energy Co. operates as an independent oil and gas exploration and production company primarily in Texas, Oklahoma, New Mexico, Kansas, and Wyoming.

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Newpark Resources, Inc. (NYSE:NR) announced that it will release its third quarter 2011 results on Thursday, October 27, 2011 after the market closes. In conjunction with the release, the Company has scheduled a conference call, which will be broadcast live over the Internet, for Friday, October 28, 2011 at 10:00 a.m. Eastern / 9:00 a.m. Central. Newpark Resources Third Quarter 2011 Earnings Conference Call. Friday, October 28, 2011 at 10:00 a.m. Eastern / 9:00 a.m. Central. Live via phone — By dialing 480-629-9771 and asking for them. Newpark Resources call at least 10 minutes prior to the start time, or Live over the Internet By logging onto the web at the address, http://www.newpark.com.

Newpark Resources, Inc., together with its subsidiaries, provides fluids management, waste disposal, and well site preparation products and services primarily to the oil and gas exploration and production industry in the United States and internationally.

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Carpenter Technology Corporation (NYSE:CRS) announced a major expansion of its Carpenter Powder Products facility in Sweden (CPP AB). Located in Torshälla, CPP AB is a joint venture operation with Sandvik Materials Technology and is one of three powder metal manufacturing sites associated with Carpenter Powder Products (CPP), a subsidiary of Carpenter Technology Corporation. CPP is the leading global producer of gas atomized powder metal products serving a variety of industries and has additional locations in Pennsylvania and Rhode Island.

Carpenter Technology Corporation engages in the manufacturing, fabrication, and distribution of specialty metals. The company Advanced Metals Operations segment offers metal alloys, stainless steels, and titanium in the form of small bars and rods, wire, narrow strip, and powder.

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THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. DrStockPick.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold DrStockPick.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://drstockpick.com/disclaimer) . Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

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U.S. Food and Drug Administration Approves Gilead Sciences’ Complera™, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults

Wednesday, August 10th, 2011

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– 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 –

FOSTER CITY, Calif.–(CRWENewswire)– Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Complera™ (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. Complera combines three antiretroviral medications in one daily tablet – Gilead’s Truvada®, which is a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate, and Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor, rilpivirine (marketed as Edurant™ in the United States by Janssen Therapeutics, Division of Janssen Products, LP). Truvada and rilpivirine were approved by the FDA in August 2004 and May 2011, respectively, for use as part of HIV combination therapy.

“In the 30 years since the first AIDS cases were reported, we’ve made incredible strides in the treatment of this disease,” said Tony Mills, MD, Director of Medical Research, Anthony Mills MD, Inc. and a participating investigator in ongoing Complera studies. “The concept of a single-tablet regimen has become a goal in HIV drug development, and the standard of care in medical practice in the United States. However, no one therapy is appropriate for all patients. Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy.”

The approval of Complera is supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) conducted by Tibotec that evaluated the safety and efficacy of rilpivirine compared to efavirenz among treatment-naïve HIV-1 infected adults. Both arms of the study were administered with a background regimen, in which the majority of patients in the rilpivirine arm received Truvada. A bioequivalence study, conducted by Gilead, demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.

“Complera is the second complete single-tablet regimen that Gilead has introduced, and it represents a collaboration between two organizations that share a vision of simplifying HIV therapy for patients,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Tremendous progress has been made in the field of HIV, but we recognize new therapies are still needed, and we continue to work to advance options that address the needs of patients.”

Complera is the second complete antiretroviral treatment regimen for HIV-1 available to treatment-naïve patients in a single once-daily pill. The first, Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), is marketed by Gilead and Bristol-Myers Squibb. Complera does not cure HIV-1 infection or help prevent the transmission of HIV to others. Complera has Boxed Warnings including lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B; see below for additional important safety information. The following points should be considered when initiating therapy with Complera:

* More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy.

* The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz.

* More subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz.

* Complera is not recommended for patients less than 18 years of age.

Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of Complera in July 2009. Under the terms of the agreement, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of Complera in the United States, Canada, Brazil, the European Union, Australia and New Zealand. Tibotec will be responsible for the commercialization of rilpivirine as a stand-alone product and will hold rights to co-detail Complera in these territories. A marketing application for the emtricitabine/rilpivirine/tenofovir disoproxil fumarate single-tablet regimen is currently pending in the European Union.

The companies also have finalized an agreement for the development and commercialization of the single-tablet regimen for the rest of world, including the developing world. Gilead will be responsible for the registration, distribution and commercialization of the single-tablet regimen in certain European countries, Latin America and the Caribbean. Tibotec will be responsible for all countries outside of the Gilead territories, the most significant of which include Asia Pacific, including Japan, the Middle East, Eastern Europe and all of Africa.

Important Product Safety Information About Complera, Including Boxed Warnings

BOXED WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of Complera, in combination with other antiretrovirals.

Complera is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Complera have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of Complera. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Complera. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

CONTRAINDICATIONS

Complera should not be co-administered with the following drugs, as significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to Complera or to the class of NNRTIs:

* the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin

* the antimycobacterials rifabutin, rifampin, rifapentine

* proton pump inhibitors, such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole

* the glucocorticoid systemic dexamethasone (more than a single dose)

* St John’s wort (Hypericum perforatum)

WARNINGS AND PRECAUTIONS

* New onset or worsening renal impairment
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir disoproxil fumarate. Assess creatinine clearance (CrCl) before initiating treatment with Complera. Monitor CrCl and serum phosphorus in patients at risk for renal impairment, including patients who have previously experienced renal events while receiving Hepsera® (adefovir dipivoxil). Avoid administering Complera with concurrent or recent use of nephrotoxic drugs. Patients with CrCl below 50 mL per minute should not receive Complera.

* Drug Interactions
Complera should be used with caution when given with drugs that may reduce the exposure of rilpivirine.

Complera should be used with caution when co-administered with a drug with a known risk of Torsade de Pointes.

* Depressive Disorders
The adverse reaction depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) has been reported with rilpivirine. During the Phase 3 trials (N = 1,368), the incidence of depressive disorders (regardless of causality, severity) reported among rilpivirine (N = 686) or efavirenz (N = 682) was 8% and 6%, respectively. Most events were mild or moderate in severity. The incidence of Grade 3 and 4 depressive disorders (regardless of causality) was 1% for both rilpivirine and efavirenz. The incidence of discontinuation due to depressive disorders among rilpivirine or efavirenz was 1% in each arm. Suicide attempt was reported in 2 subjects in the rilpivirine arm while suicide ideation was reported in 1 subject in the rilpivirine arm and in 3 subjects in the efavirenz arm. Patients with severe depressive symptoms should seek immediate medical evaluation to assess the possibility that the symptoms are related to Complera, and if so, to determine whether the risks of continued therapy outweigh the benefits.

* Decreases in bone mineral density
Bone mineral density (BMD) monitoring should be considered for patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Cases of osteomalacia (associated with proximal renal tubulopathy and which may contribute to fractures) have been reported in association with the use of tenofovir disoproxil fumarate.

* Co-administration with other products
Complera should not be administered concurrently with other medicinal products containing any of the same active components, emtricitabine, rilpivirine, or tenofovir disoproxil fumarate (Emtriva, Edurant, Viread, Truvada, Atripla), with medicinal products containing lamivudine (Epivir, Epivir-HBV, Epzicom, Combivir, Trizivir), or with adefovir dipivoxil (Hepsera).

* Fat redistribution
Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.

* Immune reconstitution syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of Complera. Further evaluation and treatment may be necessary.

ADVERSE REACTIONS

The most common adverse drug reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2-4) were insomnia and headache.

The most common adverse drug reactions to emtricitabine and tenofovir disoproxil fumarate (incidence ? 10%) were diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

DRUG INTERACTIONS

* Complera should not be used with drugs where significant decreases in rilpivirine plasma concentrations may occur (See CONTRAINDICATIONS).

* Complera is a complete regimen for the treatment of HIV-1 infection; therefore Complera should not be administered with other antiretroviral medications for the treatment of HIV-1 infection.

* Drugs inducing or inhibiting CYP3A enzymes: Rilpivirine is primarily metabolized by cytochrome P450 (CYP) 3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of rilpivirine. Coadministration of rilpivirine and drugs that induce CYP3A may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs. Coadministration of rilpivirine and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine.

* Drugs increasing gastric PH: Coadministration of rilpivirine with drugs that increase gastric pH may decrease plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs.

* Drugs affecting renal function: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, coadministration of Complera with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine, tenofovir, and/or other renally eliminated drugs. Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir and valganciclovir.

* QT prolonging drugs: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and drugs that prolong the QTc interval of the electrocardiogram. In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the electrocardiogram. Complera should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes.

DOSAGE AND ADMINISTRATION

Adults: The recommended dose of Complera is one tablet taken orally once daily with a meal.

Renal Impairment: Because Complera is a fixed-dose combination, it should not be prescribed for patients requiring dose adjustment such as those with moderate or severe renal impairment (creatinine clearance below 50 mL per minute).

Important Safety Product Information About Truvada, Including Boxed Warnings

Truvada, a combination of Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate [DF]), is indicated in combination with other antiretroviral agents (such as non nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection.

The following points should be considered when initiating therapy with Truvada for the treatment of HIV-1 infection:

It is not recommended that Truvada be used as a component of a triple nucleoside regimen.
Truvada should not be coadministered with Atripla (efavirenz/emtricitabine/tenofovir DF), Emtriva, Viread, or lamivudine-containing products.
In treatment-experienced patients, the use of Truvada should be guided by laboratory testing and treatment history.

WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread, a component of Truvada, in combination with other antiretrovirals.

Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

WARNINGS AND PRECAUTIONS

New Onset or Worsening Renal Impairment

* Emtricitabine and tenofovir are principally eliminated by the kidney. Renal impairment, including acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir DF.

* Assess CrCl before initiating treatment with Truvada. Routinely monitor CrCl and serum phosphorus in patients at risk for renal impairment, including patients who have previously experienced renal events while receiving Hepsera (adefovir dipivoxil).

* Dosing interval adjustment of Truvada and close monitoring of renal function are recommended in all patients with CrCl 30–49 mL/min. No safety or efficacy data are available in patients with renal impairment who received Truvada using these dosing guidelines, so the potential benefit of Truvada therapy should be assessed against the potential risk of renal toxicity. Truvada should not be administered in patients with CrCl <30 mL/min or patients requiring hemodialysis.

* Avoid administering Truvada with concurrent or recent use of nephrotoxic drugs.

Coadministration With Other Products

* Since Truvada contains emtricitabine and tenofovir DF, Truvada should not be coadministered with Atripla, Emtriva or Viread. Due to similarities between emtricitabine and lamivudine, Truvada should not be coadministered with other drugs containing lamivudine, including Combivir (zidovudine/lamivudine) Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine).

* Truvada should not be administered with Hepsera.

Bone Mineral Density

* Decreases in bone mineral density (BMD): BMD monitoring should be considered for HIV-1 infected patients who have a history of pathologic bone fracture or who are at risk for osteopenia. Cases of osteomalacia (associated with proximal renal tubulopathy and which may contribute to fractures) have been reported in association with the use of Viread.

Fat Redistribution

* Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Immune Reconstitution

* Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Truvada, which may necessitate further evaluation and treatment.

Early Virologic Failure

* Triple nucleoside-only regimens: Early virologic failure has been reported in HIV-infected patients on regimens containing only 3 nucleoside reverse transcriptase inhibitors (NRTIs). Monitor carefully and consider treatment modification.

ADVERSE REACTIONS

* The most common (incidence ?10%, any severity) and/or treatment-emergent (Grade 2–4, occurring in ?5% of subjects) adverse reactions occurring in subjects treated with efavirenz, emtricitabine and tenofovir DF in Study 934 through 144 weeks include diarrhea, nausea, fatigue, sinusitis, upper respiratory tract infections, nasopharyngitis, headache, dizziness, depression, insomnia, abnormal dreams and rash.

DRUG INTERACTIONS

* Didanosine (ddI): tenofovir disoproxil fumarate increases ddI concentrations. Use with caution and monitor for evidence of ddI toxicity (eg, pancreatitis, neuropathy) when coadministered. The ddI dose should be reduced to 250 mg for patients weighing >60 kg. Data are not available to recommend a dose adjustment of ddI for patients weighing <60 kg. Coadministration of didanosine buffered tablet formulation with Truvada should be under fasted conditions.

* Atazanavir (ATV): coadministration decreases ATV concentrations and increases tenofovir concentrations. ATV 300 mg should be boosted with ritonavir 100 mg only and taken with food when administered with Truvada. Monitor for evidence of tenofovir-associated adverse reactions and discontinue Truvada if appropriate. ATV without ritonavir should not be coadministered with Truvada.

* Lopinavir/ritonavir (LPV/r): coadministration increases tenofovir concentrations. Patients receiving LPV/r and Truvada should be monitored for tenofovir-associated adverse reactions and discontinue Truvada if appropriate.

DOSAGE AND ADMINISTRATION

* Recommended dose: one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food in adults and pediatric patients 12 years of age and older with body weight greater than or equal to 35 kg (greater than or equal to 77 lb.).

Renal dosing guidelines
Creatinine clearance (mL/min)a
(>=)50 30-49
<30 (including patients requiring hemodialysis)
Recommended dosing
Every 24 hours Every 48 hours
Truvada should not be administered
aCalculated using ideal (lean) body weight.

* The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment; clinical response to treatment and renal function should be closely monitored in these patients.

Please see full Prescribing Information for Complera and Truvada (including BOXED WARNINGS).

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that physicians may not see advantages of Complera over other therapies and may therefore be reluctant to prescribe the product, and payers may be reluctant to approve or provide reimbursement for the product. In addition, pending marketing applications such as those in the European Union may not be approved or approval may be delayed, and marketing approval, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Complera is available at www.Gilead.com.

U.S. full prescribing information for Truvada is available at www.Truvada.com.

U.S. full prescribing information for Atripla is available at www.Atripla.com.

Complera, Truvada, Viread, Emtriva and Hepsera are trademarks or registered trademarks of Gilead Sciences, Inc. or its related companies.

Edurant is a trademark of Tibotec Pharmaceuticals.

Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact:

Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Erin Rau, 650-522-5635 (Media)

Source: Gilead Sciences, Inc.

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a newswire as well as an IR and PR firm. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
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ICON, MSLP, BRKR, ORFG, OXPS - Stock Report From DrStockPick.com!

Wednesday, December 15th, 2010

 

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MusclePharm Corporation (OTCBB:MSLP) one of the fastest growing nutritional supplement companies in the United States, announced that it will begin a clinical research program with the Metabolic and Body Composition Laboratory in the department of Health and Exercise Science at the University of Oklahoma to determine the effects of MusclePharm Assault(R) beginning in January 2011.

The clinical research program will be led by Jeffrey R. Stout, Ph.D, MusclePharm’s Scientific Advisor, who is an Associate Professor and Director of the OU lab. Stout, along with other faculty in the department, will study the effects of MusclePharm’s products on high-intensity interval training, on aerobic and anaerobic power, repeated sprint ability, body composition, training volume and strength levels.

MusclePharm Assault(R) is rated as a top pre-workout supplement on numerous, premier websites. Scoring 9.2 out of 10 on bodybuilding.com proves Assault(R) to be at the top of its category. With previous assessments and reviews performed by thousands of satisfied customers in conjunction with the research team at the University of Oklahoma, MusclePharm is once again proving themselves as an industry leader.

“We are excited to be working with the University of Oklahoma and such an esteemed team focused on health and exercise science to further understand the results of MusclePharm Assault(R),” commented, Brad Pyatt, MusclePharm’s Chief Executive Officer. “As one of the leading developers and manufacturers of nutritional supplements we continue to focus on safe and scientific product formulations that will benefit the global healthy living and wellness industry as we strive to increase sales and profitability long-term.”

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Orofino Gold Corp. (ORFG.PK) is a US (Nevada) company established for the purpose of creating a significant exploration and mining group to operate in Colombia.

Orofino has major criteria by which they select properties that includes:

* Significant historical production
* Favorable geology for hosting major ore bodies
* Significant property area for large target exploration
* Recent results available
* Favorable infrastructure and access to allow mine development
* Receptive local government and populace.

In addition, Orofino has acquired a database comprised of exploration and mining results from previous operators who left when the global mining sector experienced a major downturn in the three year period from 1997-2000.

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optionsXpress Holdings, Inc. (Nasdaq:OXPS) announced recently that it launched Target Markers for Streaming Charts on December 8, allowing customers to quickly identify desired entry or exit points for their trades. The feature was one of 8,000 product ideas submitted by customers.

optionsXpress Holdings, Inc. provides brokerage and education services in the United States and internationally. The company offers Internet-based options, stock, bond, mutual fund, and futures brokerage services to retail customers. Its brokerage platform delivers various trading tools, which allow retail and professional investors to identify, analyze, and execute a range of investment strategies.

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Bruker Corporation (Nasdaq:BRKR) announced on December 13, 2010, the first order for a novel and unique 527 GHz Solid State DNP-NMR system, based on an ultra-high field NMR system. Dynamic Nuclear Polarization (DNP) has been shown to greatly increase solid-state NMR sensitivity for numerous bio-solids and advanced materials research applications.

Bruker Corporation designs and manufactures life science and materials research systems, and related products. The company operates through two segments: Scientific Instruments, and Energy & Supercon Technologies. The Scientific Instruments segment engages in the design, manufacture, and distribution of advanced instrumentation and automated solutions based on X-ray technology, spark-optical emission spectroscopy technology, atomic force microscopy, magnetic resonance technology.

*********************************************

Iconix Brand Group, Inc. (Nasdaq:ICON) announced its first international partnership with Hudson’s Bay Company for its junior brand, Material Girl. The Material Girl collection of apparel and accessories will be exclusively available in all Bay stores this spring 2011. This is the first license outside of the United States for “Material Girl” and marks the beginning of an international expansion strategy for the brand. The “Material Girl” collection was inspired and designed in collaboration with Madonna and her daughter Lourdes, along with Iconix Brand Group’s in-house fashion department.

Iconix Brand Group, Inc. operates as a brand management company that engages in licensing, marketing, and providing trend direction for a portfolio of owned consumer brands. The company owns 17 brands through its subsidiaries: Candie’s, Bongo, Badgley Mischka, Joe Boxer, Rampage, Mudd, London Fog, Mossimo, Ocean Pacific/OP, Danskin, Rocawear, Cannon, Royal Velvet, Fieldcrest, Charisma, Starter.

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THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

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Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. DrStockPick.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold DrStockPick.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://drstockpick.com/disclaimer) .Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings, Inc. (CRWE.OB) is a newswire as well as an IR and PR firm. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

Crown Equity Holdings Inc. (CRWE.OB) has received five thousand dollars and anticipates receiving another forty five thousand dollars in cash from a third party for 30 (thirty) days of advertising for MusclePharm Corporation (MSLP.OB).

Crown Equity Holdings Inc. (CRWE.OB) has received 500,000 shares of 144 stock in Orofino Gold Corp. (PINK SHEETS: ORFG) valued at sixty five thousand dollars, and 500,000 shares of free trading shares valued at sixty five thousand dollars from a third party (QU CUI You) for 30 days advertising .

 
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SMTC, MSLP, SNPS, SAVW, AVGO - Market Update From DrStockPick.com!

Wednesday, December 15th, 2010

 

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MusclePharm Corporation (OTCBB:MSLP) one of the fastest growing nutritional supplement companies in the United States, announced the appointment of Michael R. Stevens, PharmD as Director of Therapeutic Nutrition.

Dr. Stevens joins MusclePharm with over twenty years of well diversified experience in the healthcare and pharmaceutical industry. In addition to his current role as Chief Strategy Officer for Virostatics, Dr. Stevens spent 17 years at Bristol-Myers Squibb, where he held positions of increasing responsibility in the areas of Market Research (Oncology and HIV), Marketing (Oncology), and Medical Affairs (HIV).

“We are extremely pleased to have Dr. Stevens join the MusclePharm team and further strengthen our position in working to add MusclePharm’s Re-con(R) and MuscleGel(R) nutritional supplements to the New York State Medicaid list of prescription medications,” commented Dr. Roscoe Moore, former United States Surgeon General, and Chief Science Director for MusclePharm. “With Dr. Stevens’ extensive experience and assistance, we plan to further MusclePharm’s support of therapeutic nutritional supplementation in the medical community.”

Nutritional Supplementation has long been utilized within the HIV community to maintain and support muscle mass and help strengthen the immune system. Whey protein has been shown through various credible studies to aid in the growth of muscle mass. Unlike other Medicaid available proteins, MusclePharm’s Re-con helps to burn fat while building muscle. This is a factor essential to people living with HIV, especially those on antiviral regimens where unwanted fat may be an issue in those who often battle muscle depletion.

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SavWatt USA, Inc. (SAVW.PK), pioneers in LED lighting — announced today the partnership with Pro-EcoSolutions. Under the agreement, Pro-EcoSolutions will be a subsidiary of SavWatt. Pro-EcoSolutions is a New Jersey based implementation firm specializing in comprehensive support services for all energy services companies and performance contractors. Pro-EcoSolutions provides a single source for project support and installation. The Company excels in identifying savings opportunities through the use of the most efficient energy technologies. Pro-EcoSolutions professionals will then develop design/build specifications, manage construction, and provide post-installation performance evaluations. Past clients include: Trump Plaza Hotel and Casino, Vitamin Shoppe, Albert Einstein Medical Center, Duane Reade, Radio City Music Hall, Loews Cineplex, Johnson & Johnson, Citibank Branches and others.

John Romano, President of Pro-EcoSolutions, commented, “Our association with SavWatt and their products will give our firm an advantage in the Energy saving environment. We are looking forward in this relationship and being able to provide our clients with quality LED products.”

SavWatt is leading the LED lighting revolution and setting the stage to obsolete the incandescent light bulb through the use of energy-efficient, environmentally friendly LED lighting.

*******************************************

Avago Technologies Limited (Nasdaq:AVGO) announced on December 08, 2010, two new low-power optical sensors for wireless mouse applications. The ADNS-2080 and ADNS-3000 LED-based sensors leverage an advanced low-power architecture and automatic power management modes to enable over a year of battery life for cordless mice using a single AA battery. The ADNS-2080 and ADNS-3000 optical sensors provide precise, high-speed tracking for wireless mice, with high-speed motion detection of up to 30 inches per second (ips) and 20g acceleration detection. The sensors also feature selectable resolution of up to 2000 counts per inch (cpi) for highly accurate, sensitive navigation.

Avago Technologies Limited engages in the design, development, and supply of analog semiconductor devices worldwide. The company offers RF amplifiers, RF filters, RF front end modules, ambient light sensors, light emitting diodes, low noise amplifiers, mm-wave mixers, optical finger navigation, diodes, fiber optic transceivers, serializer/deserializer ASICs, motion control encoders and subsystems, optocouplers, and optical mouse sensors.

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Synopsys Inc. (Nasdaq:SNPS) announced it has received the Corporate Award from the IEEE Standards Association (IEEE-SA) for its contribution to semiconductor and Electronic Design Automation (EDA) standards and its role in fostering innovation and collaboration in the standards community. The award is presented annually to an IEEE-SA member who demonstrates outstanding leadership and contributions to the organization.

Synopsys, Inc. and its subsidiaries provide electronic design automation software and related services for semiconductor design companies worldwide. It delivers semiconductor design and verification software platforms and integrated circuit (IC) manufacturing software products to the electronics market; intellectual property (IP), system-level design hardware and software products, and design services; and software and services that help prepare and optimize designs for manufacturing.

*******************************************

Semtech Corp. (Nasdaq:SMTC) announced it has entered into an agreement in principle to settle all claims asserted against all defendants in the putative class action concerning the Company’s stock option accounting practices captioned In re Semtech Corporation Securities Litigation, Case No. 2:07-cv-07114-CAS (C.D. Cal). The agreement in principle provides for the payment of $20 million by the Company. The agreement in principle contemplates the negotiation and execution of a final settlement agreement. The proposed settlement would fully resolve all claims against the Company, all current officers and directors of the Company named in the lawsuit, and certain former officers and directors of the Company named in the lawsuit. No parties admit any wrongdoing as part of the proposed settlement. The settlement also is subject to preliminary approval by the Court, notice to the putative class and subsequent final approval by the Court.

Semtech Corporation, together with its subsidiaries, engages in the design, development, manufacture, and marketing of analog and mixed-signal semiconductor products. Its product lines include power management products comprising switching voltage regulators, combination switching and linear regulators, smart regulators, and charge pumps; protection devices consisting of filter and termination devices that provide protection for electronic systems from voltage spikes; and wired communication.

***************************************************************************

 

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

drstbc

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. DrStockPick.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold DrStockPick.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://drstockpick.com/disclaimer) .Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings, Inc. (CRWE.OB) is a newswire as well as an IR and PR firm. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

Crown Equity Holdings Inc. (CRWE.OB) has received five thousand dollars and anticipates receiving another forty five thousand dollars in cash from a third party for 30 (thirty) days of advertising for MusclePharm Corporation (MSLP.OB).

Crown Equity Holdings Inc. (CRWE.OB) has received five thousand dollars and anticipates receiving another forty five thousand dollars in cash from a third party for (thirty) days of advertising for SavWatt USA, Inc. (SAVW.PK)

 
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