GILD: Gilead Sciences Hepatitis C Pipeline ($70.97)

Gilead Sciences hepatitis C (HCV) drug sofosbuvir with ribavarin is currently under review with the FDA for stage 2 and 3 genotype infection.  Also under consideration, is sofosbuvir in combination with ribavarin and peglated interferon for the treatment of chronic hepatitis C in treatment naive adult patients with genotype 1 and 4 infection.  Approximately 75% of patients with HCV fall into the genotype 1 catagory.
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GILD is currently conducting a phase 3 trial called ION-3 for treatment naive genotype 1 infected patients. This phase 3 study was initiated from the positive results of the phase 2 study called LONESTAR.

LONESTAR Phase 2 Results

Treatment                      Duration         Population                  Results

Sofosbuvir + ledipasvir  8 weeks  GT-1 treatment naive  95%  (19/20) SVR 8

Sofosbuvir + ledipasvir  8 weeks  GT-1 treatment naive 100% (21/21) SVR 8

+ RBV            

Sofosbuvir + ledipasvir 12 weeks GT-1 treatment naive 100% (19/19) SVR 4
Sofosbuvir + ledipasvir 12 weeks GT-1 treatment exp.   95%  (18/19) SVR 4
Sofosbuvir + ledipasvir 12 weeks GT-1 treatment exp.   95%  (21/21) SVR 4
+ RBV

The phase 2 Lonestar trial results above suggest that a once daily all oral therapy of sofosbuvir + ledipasvir may have the potential to cure most genotype 1 HCV infected patients 100% at 12 weeks naive.

ION-3  Phase 3 Current Study Design

Sofosbuvir + ledipasvir 8 weeks GT-1 treatment naive
Achieved 95% from LONESTAR.
Sofosbuvir + ledipasvir + RBV 8 weeks GT-1 treatment naive
Achieved 100% from LONESTAR.
Sofosbuvir + ledipasvir 12 weeks GT-1 treatment naive
Achieved 100% from LONESTAR.

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GILD has just posted results of their PHOTON-1 phase 3 trial for patients with HCV and HIV.

76% SVR 12 for genotype 1 Hpc/HIV patients after 24 wks of sofosbuvil + ribavirin (no interferon)

88% SVR 12 for genotype 2 Hpc/HIV patients after 12 wks of sofosbuvil + ribavirin

67% SVR 12 for genotype 3 Hpc/HIV patients after 12 wks of sofosbuvil + ribavirin

The phase 3 PHOTON-1 trial results above are impressive given the fact that patient cohorts (Hep C + HIV) were the most refractory among drug therapy, most of them have failed prior treatment. 

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Bottom Line:  The $20 billion hepatitis C market has grabbed the attention of several companies attempting to enter with new and improved products.  From data researched, I believe GILD has the best product and safety profile coming to the market and the best pipeline for HCV.  Thank you for reading.

GILD: Reports 3rd Quarter Earnings

GILD - Gilead Sciences is a top selection for 2014. Today after the close, the company comfortably beat top and bottom line analyst 3rd quarter estimates and guided higher for the remainder of 2013.  Here are some highlights and future potential catalyst.
*  Today's earnings beat on the revenue side of 2.78 versus a 2.72 estimate and earnings per share was .52 cents versus an estimate of .48 cents. GILD also raised year end guidance numbers.
*  Stock buybacks will continue into next year.
*  On Friday October 25th, the FDA advisory panel voted unanimously in favor to approve Sofosbuvir to treat several forms of Hepatitis C.  The total HCV market is 10 billion dollars annually.
*  The final FDA approval could come at anytime from here through December.
*  Analyst are forecasting $1.85 billion in sales alone for Sofosbuvir in 2014, if it prices around $85,000 per patient.  I think that is rather conservative and I expect the company to beat the numbers throughout 2014.
The weekly chart below is near all time highs and appears to be overbought in the short term.  I expected to see some profit taking post report, but we will have to see how that plays our tomorrow.

Bottom Line:  GILD looks ready to have a strong 2014 with the launch of HCV drug Sofosbuvir. The key to the approval expected in December is how the FDA allows for the labeling on approval. Thank you for reading.