If senators are going to get into the drug business then they had better educate themselves on the macro view of healthcare costs per disease. Traditional hep c treatments have a 50% cure rate at best, and up to 20% of chronic carriers develop cirrhosis. Liver transplants are $550,000 each. One liver transplant = 6-7 cured individuals. And if they believe in letting the market work this out, then they should do nothing. Once a couple more treatments are approved, there will be a price squeeze, but Gilead will still do fine.
"The company reports that the FDA has granted priority review to a New Drug Application (NDA) for idelalisib for the treatment of relapsed CLL. A target review date under the Prescription Drug User Fee Act (PDUFA) has been set for August 6, 2014. Previously, the FDA granted idelalisib a Breakthrough Therapy designation in relapsed CLL. The designation is given to drug candidates that may offer major advances in treatment over existing options.Separately, the FDA has accepted an NDA for idelalisib for the treatment of patients with iNHL. The FDA has granted a standard review for the iNHL NDA, with a target review date under PDUFA set for September 11, 2014."
I'm surprised that no one is talking about this date. It's the PDUFA for Idelalisib for CLL. When this is approved, Pharmacyclics will drop $5 and Gilead will be up $3-4. Idelalisib, for all indications, will be a $5+ billion drug.
Sentiment: Strong Buy
and last but not least, GSK I think would want ISIS for all three of their potential blockbusters: diabetes drug Triglycerides drug, and thrombosis drug.
Wow, I'm long and I got a thumbs down for saying a Shire buyout would mean the deal's off to buy NPSP? Is anyone else concerned about potentially losing our acquirer?
I'm long NPSP, Ibl4, but I disagree with you. If sHire accepts a bid, the possibility of Shire buying NPSP drops to zero, and we could see a $7 fall back to $27. Why do you think a bidding war per se is good for NPSP?
...or about 2.38 Billion. And I continue to thihnk Gilead will pull the trigger and buy these drugs as backup and to extend their portfolio and patent suite.
"R. W. Baird's Brian Skorney noted that Merck's (NYSE:MRK) official tender offer statement Friday indicated that there was another bidder for Idenix Pharmaceuticals (NASDAQ:IDIX), which accepted Merck's $3.85 billion bid last week. In Skorney's view, this means that somebody's still on the prowl for a nucleoside hepatitis C drug, which Achillion has."The company draws many similarities to Idenix from an asset perspective and has the only unpartnered nuc left in development, which makes it an attractive target," he wrote in his research note Friday."
With the CEO saying that ISIS's drug ISIS-APOCIIIRx that targets the APOC3 protein to reduce triglyceride levels by up to 71% "is the most important drug in our pipeline," with positive phase 2 data coming on the back of the Thrombosis drug and the diabetes drug, my guess is Biogen, which already has a partnership with ISIS, will buy them out for about $75 a share, or over $8 billion. Could go as high as $10 billion. This is reminiscent of Pharmacett, except that ISIS has at least three multi-blockbuster drugs in development. Hopefully they didn't grant too many rights to ALNY in that collaboration deal, but ISIS has a goldmine.
Abbott could be another suitor, since they also have a deal with Biogen who in turn has a partnership with ISIS, and they have a strong cardiovascular division.
Because no one wants to get left out of a weekend deal, understandably so!
There's a nice article by a guy named Austolib (The Israeli Libertarian) today on tech platforms. Here's what he said about Achillion:
"What we can say about Achillion's platform is that it is certainly highly computerized. First, there is the Achillion Automated Chemistry Platform, software that automates some of the steps in synthesizing small molecules, basically the building blocks of any of these antivirals. From there is the Compound Acquisition and Repository Tracking, which streamlines and categorizes the building blocks into different chemical groups. Then data mining software takes these categorized building blocks and cross references them with known biological activity by category. With this information, Achillion can start piecing together the building blocks like a jigsaw puzzle. Then, the Competitive Intelligence and Data Mining system sifts through publicly available information about preclinical and clinical activities around the world and any that may overlap with the compounds Achillion pursues at this stage. Achillion's software continues to follow the development process step by step, including organizing preclinical results to spot candidates."
Here's what I imagine the CEO said: "Mr. Kolbert, I am not willing to answer that question on the record, but I can tell you OFF THE RECORD there is intense interest in Achillion from other players."
So Feuerstein writes an article that leads with this: "The prestigious MD Anderson Cancer Center issued a stern rebuke to Northwest Biotherapeutics (NWBO_) for making promotional, unjustified claims about results from an ongoing clinical trial of an experimental cancer vaccine known as DCVax-Direct.
From that opener, you'd think Adam F got ahold of a letter or email from MD Anderson - perhaps one that was leaked to him - that was addressed to Northwest Bio and that contained the "stern rebuke," right? After all, he's reporting that the HOSPITAL issued this rebuke. Here's the headline: "Prestigious Cancer Hospital Rebukes Northwest Bio for 'Inappropriate' Data Disclosures." But wait - that doesn't seem to be the case. MD Anderson, it turns out, hasn't filed anything. They hadn't even said anything, until Mr. F called. And then only a cancer doc name Buzdar decided to shoot off his mouth to a reporter to get his name in lights, likely without clearing his statements with the chief administrator of the hospital, or the in-house legal counsel. But Feurstein decided to intentionally mislead his readers by making the strong inference that MD Anderson has a real problem with Northwest Bio, perhaps because the personal opinions of Buzdar were made as a vice president of the hospital. That makes it an institutional matter in Feuerstein's mind, because as a VP, Buzdar is an officer of the hospital and therefore represents the hospital in an official capacity. However, even officers can speak out of turn and get both themselves and their employer in deep trouble by doing so. But here's what bad journalism causes - lawyers that now take the misleading headline and run with it: "The investigation is related to an article...alleging that the MD Anderson Cancer Center “issued a stern rebuke to Northwest Bio..." Snowball effect. I would not at all be surprised if this one triggers a lawsuit by Powers. Feustein caused MD Anderson to publicly defame and discredit their sponsor!
Well I'm sorry but the caterer was packing the bundt cakes with Gattex. So that's zero for 2!
who says he had access and who says there were letters? There had better been correspondence between MD Anderson and NWBO expressing concern over the PR releases of data, or NWBI will be justifiably very #$%$ off at MD Anderson for not airing these concerns in private, at the very least. But I don't think MD Anderson said anything about the PR releases to anyone - this is a lone doc being a hotshot who is not involved with the trials and who is going to get more than his hand slapped. Those statements cost NWBO over $50 million in market cap (its abating), so unless MD Anderson corrects the misperception NWBO may have legal recourse against their service provider for defamation.
This definitely should not be a press release from NWBO solely. It either should come from MD Anderson as someone else just pointed out, or a joint release, which is the strongest IMHO. My preliminary draft: "Recently a reporter quoted a doctor who practices in the oncology department of MD Anderson, regarding a phase1/2 cancer trial being conducted at two MD Anderson sites on behalf of Northwest Biotherapeutics. The quotes, which were taken out of context, suggested that the data disseminated by Northwest Bio thus far may be misleading, or that disseminating the data itself is inappropriate for the protocols of the trial. As the supervising physician at MD Anderson overseeing these trials and the primary contact with Northwest Bio in sharing data as it becomes available, I can say without reservation that all data presented to the public to date has been accurate and in accordance with an unblinded, open label study that is primarily observational by design. MD Anderson will provide a complete set of data to NW Bio at the conclusion of this trial, which at the time will be framed within traditional efficacy measurements."
I'm long NWBO, but I have to say I had the same reaction about the weekly updates on how patients are doing on DCVAX direct without really getting a clear picture on efficacy. I've never seen anything like it either, and it looks like NWBO intentionally made this an open label unblinded study so they could promote-as-you-go. Having said that, I have to repeat: this is an open label unblinded study. That makes this more of an observational study with a statistical conclusion at the end. Secondly, we're not talking about tumors that can be treated in different ways, where DCVAX is in a placebo-controlled trial to test relative efficacy, or in a head-to-head trial against another drug. We are talking about inoperable tumors that have not responded to chemo, radiation , or other drug regimens. So the observational aspect of this trial is both valid and meaningful: ANY measurable response to this regimen, AT THE VERY LEAST, demands further investigational inquiry to determine how to maximize efficacy, either as an adjunct therapy to other drugs or on its own. If DCVAx is slowing progression and adds months on to the lives of these patients in a double blind, placebo controlled trial, this could be a very significant therapy.
here you go again Malph...now I see why you call yourself Malph; you couldn't get far enough down the alphabet to get to R - oh, wait, I said I wouldn't do that - BUT GEEZ, will you shorts go take a break and learn how to read financial statements or do something contsructive for a change? They have 0 million in CASH and their have a negative burn of $53 million. Do the math - at current burn that 2.6 years of cash requirements. NO SECONDARY - CAPICHE? And that's not including any partnering revenue they might get (which I hope they don't go for - they should sell the company)
Sentiment: Strong Buy