Thomas Weisel conference, 9/9/09
There is never any big news at one of these conferences, but responses in the Q & A usually provide some tidbits. This conference was typical in that regard. Barry Labinger, EVP, CCO did the presentation today.
From the presentation itself:
-- Reaffirmed the November release of the second P3 data for LSB several times.
-- The “low hanging fruit” target patients for LSB are a segment of the 320,000 lupus patients in the US under the care of a Rheumatologist (thus easier to get to by a sales force). Of these patients, 200,000 have moderate to severe dz, and this is the initial target group. Labinger estimates there are 1.5 million US lupus sufferers and 5 million worldwide.
-- “Feverishly” working on BLA for Albuferon.
-- If all goes well, LSB approval by end of 2010 and Albuferon by fall 2010.
-- Hopefully, will get to present full data set of first P3 for LSB at ACR in October. (From the Q & A: the full data set will show that LSB worked well according to multiple measures of lupus activity).
-- Early 2010 for results of the P2b for q monthly dosing of Albuferon in genotypes 2/3 pts. States type 2/3 pts. comprise about one-third of all Hep C pts. Further states, (and this is new to me) that if the data in type 2/3 pts is good, they might consider q month in type 1 pts (harder to treat) along with the new protease inhibitors.
-- Discussing Abthrax with “other parts” of the USG and foreign countries (From the Q & A: said “Yes and yes” when asked if Middle Eastern and W. European countries were interested in Abthrax. Labinger did say that foreign government sales would be smaller than those to the USG).
From the Q & A:
-- Re question about initial market for LSB: First, in 2 groups of moderate/severe lupus patients. Those who get worse/not controlled by Plaquenil + low dose steroids and those already on high dose steroids in attempt to lessen dose of steroids. In the future, perhaps early in the course of lupus to prevent progression of disease.
-- Re question about price of LSB: Labinger stated that LSB is likely to be used as a chronic medication with pts on it indefinitely. He envisions the price per year to be in the range of other chronic meds used for similar dzs: the range of prices for chronic biologics is $15,000-$20,000 per year for Rheumatoid Arthritis and $20,000-$30,000 for Multiple Sclerosis (note: LSB already has passed a P2 for RA and has been mentioned as a tx for MS).
-- Re question about HGSI’s expectations for the second P3 results: “Hard to believe the effect (as seen in the first P3) isn’t real.” He stated that the probability of success in the second P3 is “high” but not certain. In an interesting aside, Labinger said that HGSI was more nervous about the first P3 that was done with Asian/Latin American patients, since there has been little work with Asians/Latin Americans who suffer from lupus. He believes that the second P3 done with European and North American patients should resemble the positive data seen in the P2 with patients from the same area.
-- Editorial note: TRAIL was not discussed at all.
(Note: I also post on the Yahoo board, but since that is way too crazy for most, I have a nice group board on Yahoo (HGSIdiscussiongroup) that has been good lately. If anyone is interested just navigate to the group board and ask to be invited..anyone can join to discuss but you will be thrown out for any bashing or disrespect -- Steve) |
