LOL 'blockbuster status' from FDA. You refer to breakthrough therapy designation - blockbusters and megablockbusters, the latter of which GILD has two and soon to be a third, are adjectives to describe product sales.
I can't see GILD having any interest in ACHN.
Of course the FDA approval of the single pill is already baked into GILD share price. Approval is a 99% certainty.
What isn't fully realized, I believe, is the massive market for this drug. With the chance to be cured of HepC with a ribavarin- and interferon-free regimen, take a single pill once a day, and do so for as little as 8 weeks, patients will be breaking down their physician's doors to get prescribed the combo pill.
Couple the increase in demand even over the mega-blockbuster Sovaldi with approval in Japan and a ramping up of sales in the major European markets, and the combo pill can be expected to top the record set by Sovaldi for most successful product launch in Pharm/Biotech history.
One price cut is already upcoming in October. When the sovaldi/ledipasvir once-a-day pill is FDA approved, it will be priced at a small premium to sovaldi, but given the requirement of only 8 weeks of use for most patients and obviation of the need to add ribavirin, the treatment will cost less per patient than the current sovaldi regimen does now.
The noise being made by the insurers is a joke.
The most important presentation for affecting share price in the short-term was the NSCLC oral presentation.
"The data show that patients in the predefined adenocarcinoma subgroup treated with the vintafolide plus docetaxel combination had a 27 percent reduction in risk of the disease worsening or death (HR=0.73, p=0.0899, one-sided test), and a 30 percent reduction in the risk of death (HR=0.70, p=0.1018) compared to docetaxel monotherapy. Stratified analysis, which adjusts for pre-defined patient characteristics in the trial, reflect a 49 percent reduction in the risk of death in patients with adenocarcinoma (HR=0.51, p=0.0147). These data include approximately 78 percent of the targeted number of events in the overall survival analysis."
At first glance, the trial result looks pretty good (3-4). Vintafolide added to doxil improves OS in a subgroup of NSCLC patients after stratification and selection of the adenocarcinoma subtype. The effect is statistically significant and comes without any major safety concerns compared with doxil alone.
- Interim Update of Overall Survival Analysis Shows 30 Percent Reduction of Risk of Death in Pre-Defined Adenocarcinoma Patient Subgroup -
WEST LAFAYETTE, Ind., Sept. 27, 2014 (GLOBE NEWSWIRE) -- Endocyte, Inc. ECYT, -1.61% today announced that the small molecule drug conjugate (SMDC) vintafolide in combination with docetaxel extended overall survival (OS) for patients with folate receptor (FR) positive recurrent non-small cell lung cancer (NSCLC) compared to patients receiving monotherapy docetaxel in its TARGET Phase 2b clinical trial. The late-breaking TARGET trial data will be presented today at the European Society for Medical Oncology Congress (ESMO), by Rohit Lal, M.D., consultant medical oncologist at Guys and St Thomas' Hospital and an Honorary Consultant Medical Oncologist for Kings College Hospital, London.
The data show that patients in the predefined adenocarcinoma subgroup treated with the vintafolide plus docetaxel combination had a 27 percent reduction in risk of the disease worsening or death (HR=0.73, p=0.0899, one-sided test), and a 30 percent reduction in the risk of death (HR=0.70, p=0.1018) compared to docetaxel monotherapy. Stratified analysis, which adjusts for pre-defined patient characteristics in the trial, reflect a 49 percent reduction in the risk of death in patients with adenocarcinoma (HR=0.51, p=0.0147). These data include approximately 78 percent of the targeted number of events in the overall survival analysis. Overall survival in all patients, including those with squamous disease, reflect a 12 percent reduction in the risk of death (HR=0.88, p=0.2874) or 25 percent reduction when stratified (HR=0.75, p=0.1066). The primary endpoint of the study, as presented previously, showed that risk of disease worsening or death (progression-free survival, or PFS) was reduced by 25 percent for patients who received vintafolide plus docetaxel (HR=0.75, p=0.0696).
You don't get a slot in a late-breaking oral presentation session with 'just safety'.
Lol, it's a name we're going to be hearing a whole lot about over the next few years.
An expected European approval, but still nice to get in an accelerated time frame. FDA approval should be coming within the next two weeks.
I'm really looking forward to sovaldi/ledipasvir sales figures for November and December. I suspect there is something of a backlog of HepC patients waiting for the single pill approval so they could forego ribavarin.
"If abstract was good then we'd be flying"
The abstract has old data on the effects of vintafolide + doxil on progression-free survival, but at the time it was written there were insufficient deaths in the vintafolide + doxil treatment arm to draw conclusions. Now, they have the OS data in hand. The fact that the abstract was moved to the prestigious late-breaking oral session raises the possibility that the combo produced a statistically significant prolongation of OS.
We'll find out on the 27th.
I just had to quote this gem from earlier:
"if control was 16, the trial would have likely been stopped for fertility"
For futility, yes.
I bought shares on today's dip.
Anybody ever hear about medical insurance? It's what prevents someone in the US from needing to go to a poor country, where the price of a drug might be far less.
'No need to guess which one they will cover'
Insurance will cover both Ledivaldi and the ABBV multi-pill treatment, so your post is garbage.
Ledivaldi will be the dominant HepC treatment owing to its ease of use (which promotes patient compliance and, hence, real-world cure rates), benign side-effect profile, 8 week curative course for most patients, efficacy for those co-infected with HIV, and extraordinarily high cure rate.
Flip and not hold, that's your advise? Funny to the longs who bought GILD shares at 50, 65, and up to 90 over the past 18 months. Their held positions have quite a bit more profit accumulated in them than any short-term trade for at best a couple of points a share.
Plus, since you've been advocating shorting the stock since 15 points ago, your stance doesn't have much credibility.
The low dropout rate on Sovaldi will be rendered irrelevant by Ledivaldi within a month. The latter doesn't need to be paired with ribavarin or IFN for most HepC patients, is a once-a-day pill, and in most cases will require only 8 and not 12 weeks of dosing.
The ABBV multi-pill, twice-a-day regimen, on the other hand, will be more prone to causing dropouts before completion of a course of treatment.
Since you consider the pancreatic cancer trial failure as material bad news for GILD, please enlighten us with how much you estimated that success in this indication was going to add to the bottom line.
The ongoing trials of this drug in NASH are far more impactful to the GILD revenue projections than any of its potential oncology indications.
You missed the 75% stock price appreciation over the past 18 months, and the reaching of all-time highs on nearly a daily basis over the past month.
The stock is up over 50% since you started with the homophobic ranting.
Are you going to be a sore ex-employee permanently?
Source for your claim that it will be half the price of Sovaldi?
At such a price, they would have to outpace Sovaldi sales to garner a decent share of the HepC market revenue. It isn't in their best interest to discount.
A contract to provide Imbruvica to patients of the VA does not specify how many patients will require treatment. The 'size' of the contract is the maximum amount the VA is committed to spending to provide the drug to veterans in need.