I do think that MM-398 has great potential - and that's one reason why i'm long MACK. But pirfenidone has much higher sales potential than $1 billion. I personally know of several estimates that place the drug at $2-3 billion per year because it will be essentially the only drug for IPF. That said, pirfenidone has a weak patent estate. There is no composition of matter coverage and the secondary patents covering the drug look weak to me.
There is a huge market opportunity if TGR1202 maintains its efficacy profile along with its safety profile. Below are comments from Citi which highlight these issues in relation to Gilead's drug.
We met with a prominent academic hematologist who was very bullish on Pharmacyclics' (PCYC) Imbruvica, fairly positive on ABT-199 but bearish on Gilead's Zydelig. The physician was very positive on Imbruvica due to its ease of use and good tolerability. In his view, there are no safety issues with the drug and it can be tolerated for very long periods of time. With regards minimal residual disease (MRD) he indicated that for many CLL patient segments the potential advantage are less clear based on the favorable safety/efficacy profile of ibrutinib. The physician was bearish on Zydelig relative to Imbruvica as he is not interested in dosing either drug in combination with Rituxan. He does not believe that Zydelig is more potent than Imbruvica in NHLas there is no head-to-head data and does not want to deal with diarrhea. In
addition, Zydelig's black box warning on LFT and warning for fatal bowel perforations are concerning especially as the incidence of serious adverse events is more pronounced now that there is more experience with the drug. In his view, the drug's label actually understates the extent of toxicity as much of it is seen with long-term therapy. He believes that there is risk of colitis with Zydelig with a median onset of 9 months based on mouse data. He expects that the risk of colitis may limit the duration of therapy. He believes that the rate of diarrhea is greater than 14% seen in the label as that was based on immature data and high dose Imodium does not help in these patients. He prefers Imbruvica as it does not have any safety issues.
there were no offers at 3.50 - hence it didn't get filled. if bad news breaks pre-market open, you are stuck with the price at the open.
And Abbvie is paying $275 M upfront and up to $530 M in additional payments to license Infinity's IPI-145 which i see as not as good as TGTX's 1202
I think this stock could go over $45 if both drugs work as i hope, especially after the valuation that Roche agreed to pay for Intermune for a drug with a #$%$ patent estate
I can't rule it out. MACK has several viable ongoing clinical programs which is good, but expensive and, without a partner(s), certain to result in a financing. Commercialization of MM-398, without a partner, would lead to the same result. I know you don't have faith in Mulroy - i'm hoping he can pull one out of his #$%$ and cobble a few deals together.
Neither 1101 nor 1202 will take sales from ibrutinib - maybe you are not suggesting that - but would be used with and be complementary to ibrutinib. Frankly, it's all hard to tell - it will be driven by the data. For example, if 1101 + ibrutinib ends up being the standard of care for CLL, then sales of that could be substantially higher. And if 1202 is combined with various drugs - due to it's safety profile - that could really ramp too. So, i think your projections are fine, but we really need to see what the data yields in the months ahead - that could blow off the top for these drugs.
Galeterone may be better than Zytiga - that's my expectation - but i'm not so sure about being better than Xtandi. Yes - galeterone has a broader, arguably better, mechanism of action - but i'm not aware of any clinical data as yet that supports the contention that galeterone is better than Xtandi. If you are aware of such data, i'll gladly change my view.
Yeah - i fully understand the mechanism - AR degradation is the differentiating hook - and they do have data on 4 patients but they were treatment naive. I do think galeterone will differentiate from Xtandi but the question is degree, and that will be borne out in the forthcoming ph II data. Also - another concern - they don't have composition of matter patent coverage for galeterone, instead they rely on secondary patents. That shouldn't weigh down the stock too much - if ph II data looks great, the stock will ramp - but it will be a point of concern for potential partners (trust me - i'm in this business and this is an issue all the time). But even with these concerns - i'm a cautious TKAI bull although i haven't bought shares just yet. I'm waiting to see if it settles down further.