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.
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.
KOLs Optimistic on Zydelig & Imbruvica in CLL, Zydelig Black Box a Risk
We hosted chronic and acute leukemia specialists Dr. Nicole Lamanna and Mark Frattini, both associate professors of medicine at the Hematology/Oncology Division of Columbia University Medical Center. The key takeaways were: Despite several champions for chemo-free regimens, chemotherapy should be expected to remain the front-line standard in CLL for some time to come. In keeping with her discussion talk at ASCO following the presentation of the RESONATE trial, Dr. Lamanna reiterated the compelling efficacy of front-line chemotherapy (~50% CR, 20% MRD negativity), particularly among younger patients where remissions can
last 15-20 years. While the field in recent years has seen a significant shift from FCR to the gentler BR as front-line chemo, Dr. Lamanna remained dubious of the move to dispense with it altogether in favor of novel oral therapy prior to definitive comparative data. Dr. Lamanna pointed out that the new oral regimens are being welcomed broadly in both the community as well as in the tertiary care setting. While, Pharmacyclics’ Imbruvica and Gilead's Zydelig are ‘game changers’, she did not view them as ‘panaceas’.
What to do with watch-and-wait will ultimately be decided by the data. Effectively tabling the debate on the utility of therapy (chemo, oral small molecule or otherwise) in the low-risk, watch-and-wait CLL setting, docs referred to several studies concluding that conventional chemotherapy in patients did not have an impact on overall survival. While trials revisiting this question are ongoing, in the absence of data, treating watch-and-wait patients was seen as unwarranted by the risk/benefit. Dr. Lamanna did offer a hopeful comment about the future possibility of effective, well-tolerated and convenient oral regimens in this population.Black box warning with Zydelig (idelalisib) represents a real risk with meaningful implications for compliance and continued trea
Exactly - i had a good year in the market in 2012, my wife found out (around tax time in 2013), and spent essentially all the profit building a new house.
Let me see - i own 70,000 of MACK so i am up about $10k today alone. See Brad - i didn't have to wait a week or more like you? Isn't that awesome? You'd be up too if you hadn't sold.
i am long as well, and very confident that both their clinical candidates work and will lead to appreciation of the stock. But i'm not sure about the timing. The next data release - which may be the ASH conference - could be December of this year. We'll probably see the stock remain volatile until then unless there is an additional development before December. So - the bottom line is that the stock could remain more or less range bound until at least December - and given the volatility of TGTX "range bound" could be in the 6-8 range. I wish i could be more positive - although note that i do own alot of TGTX, bought at an average of $4.7 and will continue to hold - likely through the end of this year at a minimum.
possible that Deutsch Bank may be initiating coverage on the stock, advising on a potential partnership, or (and this is a long shot) advising on a potential take out - who knows. Better not be to advise on a secondary.