binary- I thought the trials were only for platinum resistant OC? That's about 4300 cases per year. Are you saying this will be used for all OC?
igonber, binary - I now have 7000 ITEK and 12000 OXGN. Ignber, I didn't mention ITEK because it was a very busy trading day - sorry! The other ones you were thinking about were ONCE and CLDN in addition to AAVL. Lost a bunch on those! I got into OXGN at binary's suggestion. OXGN got a favorable trial design from FDA for phase 3 in ovarian cancer. Their drug plus avastin doubled PFS against avastin alone, and could become the new paradigm for treating platimum restistance ovarian cancer. The p3 will test fosbretabulin and avastin in combination against chemo, and a separate mono arm for avastin as a point of reference. Also, exciting stuff testing fosbretabulin in AML and other cancers.
do your own research, but the drugs you used were a beta-blocker and a prostaglandin, which both enhance uveoscleral outflow, or the drainage of ocular aqueous humor from the anterior chamber into the anterior chamber angle other than through the trabecular meshwork. Trabodenoson on the other hand moves aqueous humor through the trabecular meshwork by enzymatically clearing out the tubes of proteins so that the eye works as it is supposed to. Far fewer side effects by enhancing the natural metabolism of the eye, rather than forcing it to do things that it normally doesn't!
that should have read: "That makes it a first-in-class drug, and given the 7 mmHg reduction in eye pressure compared to Aerie's Rhopressa 5 mmHg reduction, may also make it best of any class.
What's remarkable about this drug, trabodenoson, is that it has a mechanism of action that out of all other drugs existing or in development, most resembles the natural metabolic action of the eye in controlling ocular pressure and fluid outflow. That makes it a first-in-class drug, and given the 7 mmHg reduction in eye pressure compared to Aerie's Rhopressa #$%$ mmHg reduction, may also make it best of any class. Trabodenoson binds to epithelial cells in the trabecular meshwork and increases the presence of proteolytic enzymes that break down proteins that block the flow of aqueous humor through the trabecular meshwork. Put another way, it is enhancing the eye's natural infrastructure and metabolic action that an otherwise healthy eye would have. I think ophthalmologists will find this to be the best monotherapy first-line choice for the long-term health of the eye.
Trabodenoson is a first-in-class, highly selective A1 subtype adenosine mimetic for glaucoma and ocular hypertension that binds to epithelial cells in the trabecular meshwork, up-regulating gelatinases that clean out and remodel the meshwork, increasing outflow and restoring a healthier IOP.
“These Phase 2 trabodenoson results are highly encouraging, with the efficacy and safety data suggesting the potential for a glaucoma treatment with a profile superior to currently approved drugs,” said Rudolf A. Baumgartner, MD, Inotek’s Executive Vice President, Chief Medical Officer. “Additionally, based on pharmacodynamics observed in this study, we are also encouraged by the possibility of once-daily dosing, and look forward to exploring this profile in future trials.”
In the Phase 2 study, trabodenoson was found to be safe and well tolerated. Trabodenoson demonstrated: very good ocular and systemic tolerability; reduced hyperemia compared with the current first-line treatment for glaucoma, prostaglandin-based drugs; and no iris pigmentation. Patients receiving trabodenoson experienced IOP reductions of approximately 7 mmHg at 28 days (p-value
The analyst provided an upside scenario of $80/share on "approval of trabodenoson monotherapy and FDC and then acquired."
The phase 2 data had nothing to do with the meteoric rise. It's that the FDA has allowed a placebo control instead of a head to head with standard of care. The drug will generate between $300-900 mill, and if acquired the company could g for 600 mill to 2 billion.
"Cowen analyst Ken Cacciatore aggressively boosted his price target on Inotek Pharmaceuticals (NASDAQ: ITEK) to $40.00 (from $15.00) after the company announced that the Phase III study for trabodenoson will have a placebo comparator for evaluating the primary endpoint. The firm maintained an Outperform rating.
Cacciatore commented, "This appears unprecedented and we and our consultants believe that the clinical and regulatory risk is now significantly lowered. Phase II data have been compelling – and consistent – and this morning's disclosure provides us with even greater conviction. Add aggressively."
The analyst highlighted the following:
Importantly, the study will be powered such that the primary efficacy endpoint will be the reduction in intraocular pressure (IOP) relative to placebo, while the timolol comparator arm will only serve to ensure study validation and not statistical comparison. To our knowledge, this is the first time that the FDA has allowed a glaucoma product to use placebo as its key comparator in pivotal studies (as confirmed by our consultants)...
Stated more clearly, based on the compelling efficacy/safety profile of trabodenoson – combined with the significant unmet need for novel mechanisms of action for the treatment of glaucoma – it does appear that the FDA has significantly reduced the regulatory hurdle for trabodenoson approval to what we would categorize as an unprecedented level...
Given what we and our consultants now view as lowered clinical and regulatory risk, we have lowered the discount rate in our valuation model, and are correspondingly moving our price target to $40.
I got in with 4000 shares at 8, still in. I think this is going to double again. The drug has market potential of 900 mill, 4X the market cap! I'd hate to be one of those shorts holding 6% of the float. They are getting their heads ripped off today.
...and one day later we are now at 27,119 open interest calls at 240-290, aug-sept. Plus a new 5500 vol on dec, which will be about 8500 open interest tomorrow on dec.
TEVA is in phase 3 for Laquinimod for relapsing MS, but look at the difference in phase 2 data:
"Laquinimod, a new type of immumodulatory agent for relapsing-remitting multiple sclerosis, led to a 40% reduction in lesions, according to results of a multicenter, placebo-controlled phase IIb trial."
"Patients treated with RPC 1063 showed significant reduction of 86 percent in GdE lesions in both 0.5 milligram and 1.0 milligram dosages compared to patients medicated with a placebo."
neaghan, I couldn't agree with you more. I was completely dumbfounded when I saw the $232 price. The only way this makes sense is if management bought into a heavy discount since this is still phase 2 data, albeit very robust phase 2 data. But if that's the case, then, as you said, WHY SELL NOW? I'd rather wait for phase 3 to get final data, then go for $11-12 billion. In any case, I think I've said before that I never felt good about how the company went about this. They said they went looking for a partner, and they would only partner with a serious entity willing to pony up big bucks and a large percentage of revenue share. That was their big mistake. They should have hired an investment bank like GS or Morgan BEFORE looking, then they should have shopped this as a buyout to create a bidding war, and accept a partnership if that ultimately looked better than a buyout. I say that because, as they proved now, they were ALWAYS willing to sell and not just partner, so why not do this the right way? I'm convinced that their process is what screwed this valuation up. And that's why I feel confident that another buyer will emerge. TEVA, AZN, GILD, NVS, etc. are probably shaking their heads in wonder as much as we are. 1063 has such a better safety profile it will BLOW AWAY GILENYA and their $2.6 billion in revenues along with it. This is a $4 billion drug, no ifs ands or buts. That's why I thought an $11 billion price tag was reasonable, even at phase 2.
That's about double what it was a few days ago. This tells quite a story.
Broad and south, I'm beginning to notice you have a habit of saying things before you've actual done the research to substantiate what you are saying. Go read the 8K summary of the merger agreement! Then talk!