Well that explains a lot. Now he's probably sharing his short calls in advance with hedge funds with impunity. I've never seen an "analyst" reiterate his short call as many times as Chardan has on ESPR. Somehow, someway, Chardan is profiting from this call.
"Simeprevir is primarily metabolized via CYP3A enzymes and thus administering simeprevir with medications that have moderate or strong induction of CYP3A may significantly reduce levels of simeprevir (examples include rifampin, St. John's Wort, and most anticonvulsants). In contrast, medications that have moderate or strong inhibition of CYP3A may significantly increase levels of simeprevir, including clarithromycin, ketoconazole, ritonavir, and Silybum marianum (milk thistle). Accordingly, simeprevir should not be given with moderate or strong inducers or inhibitor of CYP3A. Simeprevir is an inhibitor of CYP1A2 and intestinal CYP3A, but not hepatic CYP3A4. Levels of medications that undergo primary metabolism via CYP3A4 may increase if coadministered with simeprevir."
Simeprevir is an inhibitor of CYP1A2 and intestinal CYP3A, but not hepatic CYP3A4. Got that Macugen?
You must make chef-boy-ar-dee quality spaghetti and meatballs. There just no nuance at all to your thinking.
absolutely bio. If JNJ comes out with an 8 week cure with a good safety profile they will capture half this market in a year. If they come out with a 6 week cure, they could capture much more of it. But let's say they get half of 20 billion, with 3102 in the cocktail. That's $2 billion a year for ACHN in royalties. If they see that kind of payout scenario, they will happily pay $4-6 billion to take ACHN out. And why do I think a better product will take over the market in less than a year? Look at what happened to Olysio. US run rate 2014: $2 billion. Run rate 2015: $250 million. Olysio was cut to one tenth of peak revenues in one year. All due to Harvoni, which essentially replaced Olysio in the sovaldi + PI cocktail. So if a 6 week cure, or even an 8 week cure is commercialized, JNJ will take 50% - 75% of the market in a year. And the royalty stream for ACHN will simply be too rich for JNJ not to buy it out, and if they hesitate, GILD or MRK or some other company will happily buy the royalty stream for $3-4 billion. Oddly enough, this strategy of partnering with JNJ now for a big payoff later may have been the better path. We would have all been jumping up and down on a $3 bill buyout. But now it might be a $5-6 bill buyout (if the revenues pan out the way I think they will if things go with the trials go well. Remember, there's still the breakthrough therapy designation if they hit a 6 week cure!)
oh right, forgot all about those guys - LPath , another loser. I've been in several this year! (Maybe I should change my name to Agosto!)
For those shorts who have been touting for over a year that the HepC market would dry up soon, I rthink Gilead effectively blew a large hole through that theory yesterday:..."the company has only "touched the tip of the iceberg," of available patients. "We see that there are still a lot of patients in the U.S., in Europe, around other countries in the world to be treated.
Gilead enjoys a 90% market share in the space and he expects payers to loosen restrictions on covering the drugs as they understand the benefits, enabling more patients to get the drugs.
EVP Paul Carter explained that the 130,000 patients starting the drugs in H1 was equal to all of the patients added in 2014. And the dip in new prescriptions didn't hurt the drugmaker's bottom line. It reported total revenue from Sovaldi and Harvoni as $4.9 billion. In the U.S., hep C drug revenue totaled $3.4 billion..."
That says a few things: First, Harvoni/Sovaldi are producing $20 billion in annual revenues. Second, all areas on the world outside of the US in this quarter produced a mere $1.5 billion, meaning that globally the market has barely been tapped. Third, if a successful cocktail emerges from the collaboration with JNJ and a 6 or 8 week cure is commercialized, what part of 20 billion do the shorts not understand? ACHN should see anywhere from $400-$1+ billion in annual revenues I would think.
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.