Panel backs Gilead Sciences' Truvada for HIV-1 prophylaxis (GILD)

Gilead Sciences, Inc. (NASDAQ:GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, Gilead seeks to improve the care of patients suffering from life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation. Their portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-daily single pill – Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), approved in 2011.

BioCentury.com reports that the FDA's Antiviral Drugs Advisory Committee has concluded that "the benefit-risk profile for Truvada emtricitabine/tenofovir...supports the drug's use as pre-exposure prophylaxis (PrEP) to reduce risk of HIV-1 infection in uninfected adults." 

Committee members voted 19-3 "in favor of recommending approval of the drug for high-risk men who have sex with men and 19-2, with one abstention, in favor of recommending approval in serodiscordant heterosexual couples. For other individuals at risk of acquiring HIV through sexual activity, the panel voted 12-8, with two abstentions, in favor of Truvada as PrEP."

According to the article,

"Panel members echoed the concerns of FDA briefing documents about inadequate adherence and the risk of resistance development. The panel recommended HIV testing at baseline and every few months thereafter should be part of Gilead's proposed REMS. 

An sNDA for Truvada is under Priority Review with a June 15 PDUFA date. The fixed-dose combination of the nucleoside analog reverse transcriptase inhibitors (NRTI) emtricitabine and tenofovir is approved to treat HIV infection. The votes occurred after market close. Gilead was up $0.61 to $51.25 on Thursday."

Read more at BioCentury.com. 

FDA Advisory Committee Supports Approval of Gilead’s Truvada® for Reducing the Risk of Acquiring HIV (GILD)

Gilead Sciences, Inc. (Nasdaq:GILD) 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.

The Company announced that the FDA's Antiviral Drugs Advisory Committee "has voted to support approval of once-daily oral Truvada® (emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP. If the FDA decides to approve Truvada for PrEP, it would be the first agent indicated for uninfected individuals to reduce their risk of acquiring HIV."

In response to questions posed to the committee, "members voted 19 to 3 in favor of approval for Truvada for PrEP in men who have sex with men; 19 to 2 (with 1 abstaining) in support of use in HIV-uninfected partners in serodiscordant couples; and 12 to 8 (with 2 abstaining) in other individuals at risk for acquiring HIV through sexual activity."

Although the committee's recommendations are not binding, the FDA will consider them as the agency completes its six-month priority review of Gilead’s supplemental New Drug Application (sNDA) of Truvada for PrEP. Gilead submitted the sNDA on December 15, 2011 and the FDA has established a target review date under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012.

The committee’s positive recommendation followed presentations today of efficacy and safety data from several clinical studies of Truvada for PrEP, including two large placebo-controlled Phase 3 trials sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. Several other clinical studies support the use of Truvada for HIV risk reduction.

Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States. Truvada is not indicated for HIV prevention.

Read more at investors.gilead.com. 

Gilead Sciences Announces First Quarter 2012 Financial Results ($GILD)

Gilead Sciences, Inc. (Nasdaq: GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate,  they seek to improve the care of patients suffering from life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation. Their portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-daily single pill – Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), approved in 2011.

Gilead Sciences has announced their first quarter financial results for 2012.  Total revenues for the first quarter of 2012 increased 19 percent to $2.28 billion,  with a net income of $442.0 million.  The increased revenue is attributed to product sales driven by Gilead's antiviral franchise, including sales of Atripla^(R), Truvada^(R), and the launch of Complera^(R)/Eviplera^(R) in 2011.

Read the full press release here.

Market watchers have commented on this announcement and the success of The Company's antiviral sales. Brean Murray Carret & Co. commented,

"Gilead’s HIV franchise had a strong quarter, with newly launched Complera

contributing to the strength of core products Atripla and Truvada. However, investor

focus remains on the Hepatitis C opportunity and the development plans for GS‐7977.

We continue to believe Gilead represents a compelling investment opportunity and

see the strong quarter as a reaffirmation of the value of the company’s current suite of

commercial products. We believe further upside will be derived from the approval and

commercialization of GS‐7977 for Hepatitis C next year.  Gilead’s HIV franchise had a strong quarter, with newly launched Compleracontributing to the strength of core products Atripla and Truvada. However, investorfocus remains on the Hepatitis C opportunity and the development plans for GS‐7977.We continue to believe Gilead represents a compelling investment opportunity andsee the strong quarter as a reaffirmation of the value of the company’s current suite ofcommercial products. We believe further upside will be derived from the approval andcommercialization of GS‐7977 for Hepatitis C next year."

Read the Brean Murray full report here.  

Gilead ($GILD) announces early sustained Virologic response rates for GS-7977 plus Ribavirin in genotype 1 Treatment-Navee hepatitis C patients

Gilead Sciences, Inc. (NASDAQ: GILD) announced interim data from the Phase 2 ELECTRON study examining the investigational once-daily oral agent GS-7977 plus ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection.

• Of the 25 patients who completed 12 weeks of treatment with the GS-7977-based regimen, 88 percent of patients (n=22/25) remained HCV RNA undetectable four weeks after completion of treatment.
• Three patients experienced viral relapse.
• These findings are being presented this week during a poster session (Poster #1113) at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain.
• Overall, GS-7977 was well tolerated and exhibited a favorable safety profile. No patients experienced viral rebound during treatment. No patients discontinued therapy due to an adverse event. The most common adverse events were fatigue, dizziness and headache, and two grade 3/4 laboratory abnormalities were reported.
• Results from three additional arms of the ELECTRON study examining GS-7977-based therapy in various patient populations are also being presented this week at the International Liver Congress. These include null responder genotype 1 patients, and genotype 2 and genotype 3 patients, both treatment-naïve and prior non-responders.

Gilead today also announced interim results from a second Phase 2 trial (QUANTUM) examining a 12- and 24-week duration of GS-7977 plus RBV in treatment-naïve patients. Twenty-five patients were randomized to the 12-week treatment arm: 19 genotype 1 patients; four genotype 3 patients; and two genotype 2 patients.

• Two genotype 1 patients discontinued therapy prematurely during the 12-week treatment period. At the four-week post-treatment time period, data were available for 17 genotype 1 patients.
• Of these, 10/17 (59%) remained HCV RNA undetectable.
• Seven patients (41%) experienced viral relapse.
  • The seven patients who relapsed in the QUANTUM study either had IL28B C/T (n=4) or IL28B T/T (n=3) genetic polymorphisms.
• Additionally, seven of the patients who have reached the eight week post-treatment time period, and who achieved SVR4, remain HCV RNA undetectable.
• The overall safety and efficacy profile of GS-7977 was consistent with that seen in ELECTRON. No patients experienced viral rebound while on treatment and no patients discontinued therapy due to an adverse event.

Eleven of the 25 patients (44%) in ELECTRON and three of 19 patients (16%) in QUANTUM had the IL28B C/C genetic polymorphism.

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Cell Therapy - Is there value for stock market investors?

The cell therapy space has been hit hard over the past year triggered by a perfect storm of events from the macro-economic environment:

• Biotechnology has come under pressure, where investors fear not only dilution but extinction; and
• Companies in the Small-Cap Biotech space often operate with a years worth of cash, and this has made investors nervious.

We have been down this road in the past, can anybody say Y2K?

Dendreon's (NASDAQ: DNDN) rise became the rallying cry for investors so its subsequent plunge became the proof for the bears that cell therapy just doesn't work. Both examples are in our opinion false. Provenge, like so many biotech products before it, is the first in a new therapeutic category. We lived through the monoclonal antibodies in the 90's, and then the HIV market in Y2K. Most recently the success of the nucleosides (Pharmasset) is now destined to be acquired by Gilead (GILD). We hope our followers saw the run up in Inhibitex (INHX) that resulted.

What's the connection? A pattern has emerged, and Provenge is not just a cell therapy but the first of a cell based approach to immunology/cancer. The follow-on products will be better. Take a look at the work that PrimaBioMed (ASX: PRR) is doing or even better, Coronado (OTCBB: CNDO) (which we have been following for some time).

What we want to begin discussing today is cell therapy on the regenerative medicine side of the equation. Oncology has always had tough hurdles but on the regenerative side the unmet medical need is often just as great, in fact, greater in some places. 

No one yet has been able to explain Mesoblast (MSB-Australia) to us but Cephalon and now Teva are in partnership and the stock has a market cap approaching $2 billion. This is an allogenic (other peoples cells) model, which pharma likes. It is the so called pills in a bottle model. Peer companies include Pluristem (PSTI) and Athersys (ATHX), at much lower valuations ($100 million or lower). On the autlogous side no one seems to be paying any attention to NeoStem (AMEX: NBS). This company acquired Progenitor Cell Therapy the contract manufacturing company that worked on Provenge and today is working with many of the cell therapy companies we are following.

Can an autlogous model work?  Baxter thinks so, and has been highlighting their autlogous cells for cardiac ischemia. Interesting because the Baxter product is very similar to the NeoStem product - both are CD34+ cells with some differences. NeoStem is begining their Phase 2 trial for a cell therapy that promises to stabilze failing hearts after a heart attack.

We recently attended the Stem Cell Therapy on the Mesa conference, and we were "blown away" with the number of products in clinical trials. We saw companies from all over the world - some had revenues with approved products, and others had great data and proof of concept with thereapies that can work for everything from cardiovascular disease to healing damaged muscles and tendons.

Going Forward: We will be actively following the "Cell Therapy Space" now. That means we will be watching the developments on two fronts:

• Oncology/Immunology side, and
• Regenerative Medicine side.

We will be commenting on the trials, the news developments in the space, the competitive landscape, talking with managment, and posting our articles on where we believe the ground breaking science, product profiles, and catalysts lie that can trigger the next paradigm shift in the space.

Remember, Lipitor is going to leave a big hole in Pfizer's pipleine as it goes generic. Pharma and Biotech have to act. Early signs abound that cell therapies are no longer a case of if, but when, and the answer to that is tied to clinical trials, which represent a highly defined process.