Analysts jolted by Pharmasset's stellar data on combo hep C treatment
March 9, 2011 — 9:12am ET | By John Carroll
n one of the worst kept secrets of the year, new data shows that Pharmasset's combo oral approach to hepatitis C triggered the complete elimination of the virus in 15 of 16 patients after only 14 days of treatment. And the startling results, which were supposed to be kept under wraps in a blanket embargo lowered by the European Association for the Study of the Liver, spurred a quick spike in Pharmasset shares as word of the outcome spread swiftly among investors.
As Adam Feuerstein at TheStreet notes, this is the best such early-stage data released on an oral drug for hepatitis C. And the PSI-938 and PSI-7977 one-two punch eliminates the need for interferon, which is linked to a number of side effects among patients. That's the kind of news investors like to hear about early on, and the data--which is easily available online--spurred an increase of more than 32 percent in Pharmasset shares ($VRUS) over the first two days of the week.
Sign up for our FREE newsletter for more news like this sent to your inbox!
Quoting analysts at BMO Capital Markets, Bloomberg notes that Pharmasset's data indicates it may be on track to eventually gain an approval for a new hepatitis C therapy that will be able to compete with Vertex, which is widely expected to gain approval for telaprevir in the spring. Jason Zhang says that a combination of telaprevir and VX-222 didn't generate data that was good enough to follow up in additional patient studies, leaving Vertex open to a later challenge if Pharmasset can duplicate these early results in larger trials.
"The hepatitis C treatment landscape subsequent to the initial phase of telaprevir dominance is tilting away from Vertex to companies such as Pharmasset that have potent combinations," Zhang wrote. Vertex shares slid about five percent.
"We believe the full data of a 14-day combination of PSI-7977 / PSI-938 to be presented at the upcoming EASL could show proof of principle for a nuc-nuc combination and position Pharmasset as one of the front runners in the race to develop an interferon-free regimen, which is considered a Holy Grail in hepatitis C treatment," noted Leerink Swann analyst Howard Liang.
Read more: Analysts jolted by Pharmasset's stellar data on combo hep C treatment - FierceBiotech http://www.fiercebiotech.com/story/analysts-jolted-pharmassets-stellar-data-combo-hep-c-treatment/2011-03-09#ixzz1G7qrJyRm
http://www.fiercebiotech.com/story/analysts-jolted-pharmassets-stellar-data-combo-hep-c-treatment/2011-03-09
Somewhat dated article - since the company that holds the patent is no longer called "Chiron'.
http://hepcproject.typepad.com/hep_c_project/2004/06/chirons_hepatit.html
"Chiron holds over 100 patents related to the HCV genome, which won't expire until 2015. Any company that develops a new drug targeting hepatitis C (such as a protease inhibitor), or a diagnostic test to detect and measure HCV (viral load; test for screening the blood supply), needs to license Chiron's patents, typically by negotiating a licensing fee and royalties on product sales. Chiron typically charges each company millions of dollars in licensing fees during research and development alone, and makes millions more each year in royalties from HCV tests.
Chiron's enforcement of its patent rights has slowed the pace of HCV drug development considerably, as other companies struggled to reach reasonable terms for licensing -- with Chiron filing several lawsuits beginning in the late 1990s that effectively halted much of the research into HCV protease inhibitors. Nobody can say how close we'd be today to having an effective HCV protease inhibitor on the market, were it not for Chiron's use (or abuse) of its patent position. But it's arguable that Chiron's actions -- or, put differently, greed -- will result in thousands of needless deaths from HCV-related liver disease over the next several years.
Under the new arrangement, companies can license Chiron's HCV patents without paying any up-front costs. Companies only have to make payments to Chiron when they reach certain milestones in their research, and then pay royalties on any sales for approved products."