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It will be interesting to see how fast they can push cabazitaxel into the established Taxotere holes. With that toxicity profile, it ought to be difficult.
IMGN has exactly one success out of almost a dozen tries. SGEN has one success out of one try. IMGN has far more TAP compounds in trials by partners currently. SGEN has two or three.
This is an argument people can legitimately have differences of opinion over. Remember I think TAP works, too.
IMGN/DNA linekr tech
Options are created out of thin air for the transaction at hand, so the seller more than likely previously was not a buyer. This is especially true on high volume and when a new strike is created.
This is (theoretically) not true for stocks, where the only shares available to be sold are shares previously purchased. Short selling disconnects this completely through the creation of new shares, but short sale levels are usually a small percentage of overall float so you're likely buying a stock from someone who was previously a buyer.
re: SGEN vs IMGN
I said the technology hasn't been validated "but" (except) for DM-1. All other attempts at using TAP have failed, some miserably. Whether that is learning cruve due to being first or something wrong with TAP is a valuation question. We cover them, and think they are suitable for investment capital over the long term. I think use of TAP with previously validated MAbs will likely be successful, though I think it will take more fiddling with TAP to get it right than I do with SGEN's ADC technology.
I wasn't asked about SGEN's valuation, though you assume I think it's immediately going higher. I think it can go higher, but that will wait until we know pricing and indication for SGN-35. I think their relative valuation gains (from a post ALCL-baseline) are likely to be the same until we know pricing on SGN-35 and 2nd line results on T-DM1.
When comparing technology, let's look at the prime examples:
SGN-30 was a a single-digit response rate MAb. The same MAb empowered by SGEN's ADC technology has a 75% ORR with durability likely approaching a year in the same population.
Herceptin in third line has varying repsonse rates depending on the protocol, but I think we can agree it is also single-digit response rates. T-DM1 has a 32.7% response rate.
Like any indirect data set comparisons, this only goes so far -- particularly since they are completely separate diseases and one can argue T-DM1 was used in a more heavily pre-treated population that essentially excluded any MAb-specific baseline response.
This is what potential partners and potential acquirers are looking at, however, which partically explains the price differential between the two companies. The other explanation is the TAP technology has failed more often than it has succeeded (again, not necessarily the technology's fault). The remainder (majority) of the price differential is IMGN gets ~5% of T-DM1 sales and SGEN gets 100% in NA and double-digits ex-NA.
SGEN - ALCL and EMEA and ODAC
Management said on the conference call Millenium was taking this trial to the EMEa and had already spoken with them about design and potential approvability. That said, I'd be a little surprised if the EMEA approved based on one uncontrolled Phase II trial.
In ALCL, the company said if the data were of comparable strength to the HL data AND the FDA agreed it was OK, they would file for both indications jointly. 55 patient is enough size for that population. In the Phase I, 7/8 r/r pts had a CR. If they can duplicate that or even the 75% rate in HL I think the FDA will entertain a dual indication application.
I was surprised to hear SGEN mgmt describe ODAC as optional. Apparently the new code has an out for the agency where they can waive the requirement for a panel for a first-in-class drug. I either forgot about that or missed that in the code. I don't think an ODAC would be a worry for SGEN, but no requirement to have one might quicken approval.
Because nobody looks at HR, they look at median survival. You and I can agree this is silly, but it reality.
Additionally, HRs typically shrink P2 to P3 in oncology.
Finally, the HR difference is probably not enough to have insurers force zibo use ahead of Provenge because of the big differential in 3-year survival.
If they are going to do labels for GMO, they need to mandate how long the product has included the GMO material be on the label. I think if American's realized they've been eating food with GMO grains in them for over a decade, the nonsense we see in Europe on this issue would disperse quickly.
Actually, Genmab is trying and if they succeed SGEN gets to participate.
Somewhat ironic Genmab selects the ADC tech from SGEN instead of Medarex's linker tech.
ZGEN/BMY a dirty deal done dirt cheap
10b5 programs should have fixed action dates and/or stock prices. Too many of them include a holder's option. No idea why such things are to actionable, but I gave up a long time ago thinking the SEC actually does anything useful to control fraud.
T-DM1 -- The docs really let them have it. It was nice to get some more detailed commentary from Roche other than the press release.
It is interesting now that Pazdur has turned people back both because they did not account for approved drugs that are not standard care AND for non-approved drugs that are standards of care.
He continues to make ish up as he goes to the detriment of cancer patients.
Those interested in the T-DM1 issue should grab this week's copy of BioCentury and "flip" to A10. Interesting reading...
We expect small-cap bios to trade more with an the macro market in relation to their percevied risk. Lower risk = more with the macro. Alpha will only be found in riskier bets, which sounds good until we remind ourselves alpha is not inherently positive.
Bio investors are increasingly afraid of everything regulatory. The toxic political environment is also adversely affecting bio investing. Nowhere is the conspiracy theory situation more rampant than ascribing every bobble in the regulatory process to some black helicopter (hmmm, red socialist helicopter?) interference from up the administration power chain.
"It's different this time" is always a sure way to start a loser of a theory, but I wonder if household America -- esp baby boomers closing in on retirement -- have said enough is enough with stocks. They realized Wall Street is largely geared towards separating the average investors from their money, through means fair and foul. Given that realization, they don't want to play any longer.
The kink in the theory is that money is piling into bond mutual funds. This suggests it isn't that people are adverse to investing, they are just adverse to (perceived) risk. That sort of aversion usually resolves itself.
I do wonder whether we're to the point where boomers are going to largely exit from equities...
Ixebepilone, which sees very little use in 3rd line BCa from what I'm told, is likely the reason why this got hung up.
Of course.
Since there has been no listed approval for 3rd line I'm aware of, having the FDA say there are approved thereapies USED in 3rd line as a reson for the RTF would be a significant change in interpretation of accelerated approval rules.
I'll note Pazdur has precedent for this. His requirement that confirmatory trials be "substantially" underway prior to granting accelerated approval is nowhere in the regs. In fact, it goes against Congressional intent.
I think we won't know unless Roche decides to tell us. We've been trying to understand what went on in that meeting from the angle of Roche filing a BLA and the FDA granting a SPA for SGEN under a NDA. Not many folks are talking, but I don't get the impression Roche walked into this one unprepared or not listening.
My only guess is maybe Roche was working the BLA/NDA angle too hard and didn't read some fine print. Or, that the FDA had said they might consider this a panel issue and changed their mind.
Dew -
I'm interested in hearing what Tx you think Roche missed in the P2 trial. Patients had to have failed Herceptin, Tarceva, an anthracycline, taxanes, and capecitabine. Of the 120 pts in the trial, all met these criteria save one person who did not have a taxane. The emdian number of therapies for M+ disease was 7, the median number of all BCa therapies was 8.
The FDA seemed to indicate that Roche missed some non-targeted therapy. I'd be interested to hear what you think that therapy(ies) might be.
I'm not sure it's viable for most non-profits. They don't usually understand how expensive and complicated it is to get a new drug approved. Most models have the non-profit funding basic research and driving patients to clinical trials. Others try to get some ownership of IP so they can generate a revenue stream for the non-profit. The only advantage a non-profit has over pharma is the ability to connect with patients for trials. No intelligent drug developer excludes patient advocacy groups from their trial recruitment process, however, so even that advantage is minimal.
Non-profits will try this route if they believe drug companies are not interested in bringing candidates forward because teh disease is "too small" to deal with. I'm not sure I can think of an example where this has worked when it's a small non-profit. They're usually better off cajoling the pharma into doing something.
This has been proposed and tried before. It is essentially the model underway now at the US-based world health NGOs for bringing vaccine and AIDS drugs to the 3rd world.
Did they mention anything about their P3 trial for ipi in prostate?
Since we don't typically cover operating companies, we won't cover the biogenerics. We continue to focus on dev-stage biotechs we find interesting, undercovered, and (in most cases) suitable for investment. With a closed IPO window and too often the best science being picked up by pharma in early-stage private deals, it's getting harder and harder to find companies. We'd hoped to be back towards 22-25 companies under coverage at this point but we're just not finding stuff that fits.
We've outlined specific stock price projections for Subscribers starting last March with a significant update at the end of last month.
Part of their CoG. There is no signfiicant cost other than Provenge.
You have to look in the earlier reports. I'll see if I can dig up the citation for you. NICE uses not only drug cost, but total cost of treatment. A recent analysis in US dollars put Taxotere use at about $7900/month all in. TAX-321 did 10 cycles (210 days or about 7 months or about $55,300.
NICE approves Taxotere for 6 cycles or about 180 days or about six months or $47,400.
David
30,000 is the number.
Patients have to be M+, asymptomatic or minimally symptomatic, and refractory to hormone therapy. Most insurers are requiring a minimum period of hormone therapy to prove refractory (30-60 days or one shot) and castrate levels of T. This is in line with the enrollment criteria for IMPACT.
In today's screened population, very few men present with symptomatic, M+, CRPC. Those are the patients of the 30,000 that Provenge would theooretically miss. One thing we learned during the online chat I did with Higano and again at ASCO was oncs will treat guys (who are willing) with Taxotere (or clinical trial) first to bring them into line with the Provenge label and then give them Provenge.
That's the nice thing about the FDA not specifying order of treatment in the label.