Below is Roche's 2/3/98 press release on Fortovase.
The data in the Crixivan vs Fortovase head to head study and the data in the Fortovase + Viracept study (Fortovase vs Viracept vs Fortovase + Viracept, all in combination with I think AZT + 3TC) clearly show Fortovase (saquinavir soft gel cap) to be a well-tolerated, highly potent PI ... with anti-viral potency on a par with Crixivan and Viracept.
As I've mentioned in a previous post, this changes the dynamic of the Roche AGPH marketing deal. How, I don't know, but it has to. Roche now has a PI that performs comparable to Viracept (Invirase - saquinavir hard gel cap - was inferior in anti-viral potency to Viracept, as well as the others). This reduces Roche's incentive to sell Viracept as a single PI. Of course, AGPH has somewhat of an insurance policy to cover this eventuality, with their royalty structure with Roche. Apparently, there's a lower rate on Roche sales of their own PI, a higher rate on Roche sales of Viracept, and they pay AGPH the greater of the two.
Other relevant data were that Fortovase + Viracept perform better than either alone.
A last point is that Roche's press release is fairly aggressive ... out of the 50 + papers that cite either formulation of saquinavir, they've chosen to focus on their head to head results vs. Crixivan. These guys want their PI to win in the marketplace. It's worth watching how aggressively they market Viracept in Europe.
Just something for us AGPH longs to keep an eye on.
New Data from First Head-to-Head Protease Inhibitor Study Show FORTOVASE(TM) Saquinavir) Challenges Market Leader, Crixivan (Indinavir Sulfate)
New Data Shifts Focus to Immune Recovery
CHICAGO, Feb. 3 /PRNewswire/ -- In the first-ever head-to-head trial comparing two HIV protease inhibitors, six-month data presented today show that FORTOVASE(TM), the newest protease inhibitor, has antiviral activity comparable to Merck & Co.'s Crixivan(R) (indinavir) and an increased rate of CD4 cell recovery when either drug is taken in combination with AZT and 3TC. These data were presented at the 5th Conference on Retroviruses and Opportunistic Infections.
Six-month data from the "Cheese" Study (M61003) show that HIV-RNA levels dropped to below the limit of detection in 93 percent of patients (400 copies/mL) in the FORTOVASE arm (n=14) and 92 percent of patients in the Crixivan arm (n=12) for whom data are available. A 16-week analysis in a larger number of patients shows that the FORTOVASE arm (n=20) increased CD4 counts by 163 cells over baseline (301 cells/mL), while the Crixivan arm (n=17) increased CD4 counts by 8 cells over baseline (337 cells/mL). The "Cheese" Study is a Comparative trial in HIV infected patients Evaluating the Efficacy and Safety of saquinavir Enhanced oral formulation and indinavir given as part of a triple therapy.
"These results demonstrate an interesting and curious phenomenon," said Jan Borleffs, M.D., Ph.D., of the University Hospital at Utrecht, The Netherlands, and lead investigator of the "Cheese" Study. "We don't know why the CD4 cell count is increasing faster in the FORTOVASE arm when FORTOVASE and Crixivan are demonstrating an equal reduction in viral load. We also don't yet know how effective these new cells are. We must conduct further research into immune recovery to answer these questions."
Hoffmann-La Roche, the makers of FORTOVASE, acknowledges the need to compare the safety and efficacy of drugs within a given class to provide patients and physicians with the facts to make informed treatment decisions. While developing FORTOVASE, which was made available in November 1997, Roche conducted clinical trials to compare its efficacy to that of the original formulation of saquinavir, INVIRASE(R). Sixteen-week data using an on-treatment analysis from a trial (NV 15355) comparing FORTOVASE and INVIRASE in 171 HIV-infected, treatment-naive patients, show that 80 percent of those on the FORTOVASE arm had viral loads below the level of quantification, compared to 43 percent in the INVIRASE arm. Twenty-four week data presented today at the Conference, which show 79 percent of patients in the FORTOVASE arm below the level of quantification, are consistent with the response seen at 16 weeks.
About the CHEESE Study
The "Cheese" study (M61003) is an open-label, randomized, parallel study designed to compare the antiviral efficacy of a triple drug regimen including AZT plus 3TC plus either FORTOVASE or Crixivan. Sixty-three treatment-naive patients or previous AZT users (<12 months) with more than 10,000 copies of HIV-RNA/mL of blood and/or CD4 counts less than 500 cells were randomized to receive AZT at 200 mg three times daily (tid), 3TC at 150 mg twice daily (bid), plus either FORTOVASE at 1200 mg tid or Crixivan at 800 mg every eight hours (q8h). Patients in both groups had a mean baseline viral load of approximately 80,000 copies/mL. Patients in the FORTOVASE group (n=30) and the Crixivan group (n=33) had a mean baseline CD4 count of 301 cells and 337 cells, respectively. FORTOVASE and Crixivan were both generally well tolerated. Reported adverse events were mostly of mild intensity.
More About FORTOVASE
FORTOVASE, given at 1200 mg three times daily (tid), with meals or within two hours after a meal, offers increased drug exposure over the original formulation of saquinavir, INVIRASE given at 600 mg tid. Introduced in 1995, INVIRASE was the first protease inhibitor to become available to people with HIV and AIDS.
FORTOVASE has been well tolerated in clinical trials. The most frequently reported adverse events in a FORTOVASE study with 442 patients were diarrhea (19.9 percent), nausea (10.6 percent) and abdominal discomfort (8.6 percent). Forty-eight week data from this safety study (NV 15182) show that only eight percent of patients (n=35) discontinued drug use due to clinical adverse events (primarily related to the GI system), and less than one percent discontinued due to laboratory toxicities. Patients received FORTOVASE at 1200 mg three times daily, with meals or within two hours after a meal, in combination with two nucleoside analogues. Median duration of treatment was 52 weeks.
About Roche Laboratories Inc.
Roche Laboratories Inc. is the marketing and sales subsidiary of Hoffmann-La Roche Inc., a leading research-intensive pharmaceutical company. Roche Laboratories markets more than 35 medications in major therapeutic areas including AIDS, oncology, transplantation, infectious diseases, cardiovascular diseases and dermatology.
FORTOVASE is a trademark of Hoffmann-La Roche Inc. INVIRASE is a registered trademark of Hoffmann-La Roche Inc. Crixivan is a registered trademark of Merck & Co., Inc.
For more information about FORTOVASE, please visit the web-site at: fortovase.com.
SOURCE Hoffmann-La Roche Inc.
CO: Hoffmann-La Roche Inc.
ST: Illinois
IN: MTC
SU:
02/03/98 16:43 EST prnewswire.com |
