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POPSBiotech Buzz Kills Adam Feuerstein over at TheStreet.com always has smart things to say about biotech stocks. In his column today, he makes both Onyxx, which has a big-selling cancer drug, and Exelixis, which is testing cancer drugs, sound very risky. With the markets a mess, it's hard to see how the extremely risky world of cash-hungry biotechs is going to appeal to investors.
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POPSWill Pfizer Buy Bayer? A Pfizer-Bayer deal is the unsubstantiated market rumor of the day. There are reasons to doubt the rumors. Pfizer's previous mega-deals haven't exactly paid off. And buying a European drug firm isn't exactly appealing given the current state of the dollar. But one stumbling block listed by Reuters, that Bayer is a healthcare-chemicals conglomerate, not just a drug company, doesn't seem that big a deal for me. In fact, Pfizer might be excited to get Bayer's diagnostics business. Being a mix of medical devices, diagnostics, and drugs has worked pretty well for Abbott Laboratories and Johnson & Johnson, after all.
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POPSGilead Drug Approved Viread gets approved for hepatitis B on its PDUFA date. A nice win for Gilead. For investors, the big questions about the company come down to valuation. Most analysts love the company; doubters just think shares are overpriced.
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POPSD-Mab Does It Amgen's osteoporosis drug met its goals, and serious infections may be less of a problem than expected. But the devil will be in the details -- it's hard to gauge the potential for the drug without more information on safety and efficacy. This is a medicine that will compete with long-marketed drugs and cheap generics. Still, this is good news for Amgen, which is why the stock is up 15% in after-hours trading. Quotes from the press release are below; click the link to read the whole thing.
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POPSFDA Looking Into Safety of RA Drugs TNF blockers like Remicade, Enbrel, Humira, and Cimzia are big sellers for drug companies. The FDA's investigation is preliminary -- part of the agency's effort to let consumers know about potential problems earlier. This was partly a response to the Avandia controversy. Click the link for the FDA's Early Communication.
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POPSVertex Beats Schering-Plough In Hep C Race That's the takeaway from both Bernstein analyst Geoffrey Porges and Adam Feuerstein, who has been following this battle closely over at TheStreet.com. Click the link to read the whole story.
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POPSGlaxo Buys Sirtris For $720 Million A bit unexpected, as big pharma's have been mostly involved in buying up drugs that are close to market. Sirtris' medicines, famously based on a supposedly life-prolonging chemical in red wine, are very early stage. Still, this emphasizes the trend of foreign-based pharmaceutical firms buying up U.S. companies, which are cheap because of the weakness of the dollar.
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POPSFinally. Who would have thought a combo of two already marketed drugs would take forever and a day to approve?
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POPSBrain Doping? An online survey in Nature says scientists and engineers are taking concentration-enhancing drugs. Via the WSJ Health Blog.
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POPSFDA Panel Backs Suggamadex Not a huge surprise, but still very important to Schering-Plough. It's also nice to see unanimity from the panelists. Suggamadex has been touted by some anesthesiologists as an important advance in their field. The next hurdle for the company is dealing with the continuing controversy over the cholesterol drugs, Zetia and Vytorin, which it sells with Merck.
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POPSWyeth and Elan: Reinventing the Wheel? Adam Feuerstein at TheStreet.com is asking a pointed question about the way Wyeth and Elan are conducting a big study of their Alzheimer's drug. Why, exactly, are the companies trying to design a new way to measure Alzheimer's symptoms, and is doing so really such a good idea?
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POPSMr. State Trooper The Wall Street Journal has a nice profile of the Rep. Bart Stupak, the former state trooper who is fast becoming one of the drug industry's most outspoken adversaries. Click on the highlighted text to read the whole story.
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POPSRelief For Genentech The data released today doesn't make an approval of Avastin for breast cancer on February 23 a sure thing. But it does make it more likely that Avastin will eventually notch an approval for this indications, and it increases the likelihood that doctors will use the drug off-label in the meantime.
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POPSWhat Causes Alzheimer's? The leading hypothesis is that the disease is caused by the buildup of plaques of a protein called amyloid. Drug researcher Derek Lowe does his usual fine job explaining an elegant experiment that gets to the heart of whether that's true. Want final proof? Wait for the big trials of Alzheimer's drugs being tested by Wyeth, Elan, Eli Lilly, and others.
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POPSPfizer Anti-Smoking Drug Gets Warning File this under "drugs have risks." Pfizer's anti-smoking drug Chantix has been one of the company's biggest recent successes. Today, it's getting a warning that patients should watch for agitation, dpressed mood, or suicidal thoughts. This change upgrades a "precaution" that was previously put in the label to a "warning." Pfizer chief medical officer Joe Feczko said in a statement that Chantix is "a real breakthrough" and that he hopes the change helps doctors have a "dialogue" with patients.
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POPSJudah Folkman Dies Folkman's ideas helped lead to lots of important cancer drugs including Genentech's Avastin and Celgene's Thalomid.
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POPSNice Bump For Amicus Shares in Amicus Therapeutics have been trading near a fifty-two week low thanks to data from another study that was less positive than investors hoped. This new data is only looking at blood test results, but it does give some confidence that the basic idea behind the company -- pills to replace the expensive biotech enzyme drugs sold by companies like Genzyme to treat rare diseases -- shows some promise. Shares are up 14% in pre-market trading.
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POPSEpix Soars 50% On Alzheimer's Data These are promising results, but investors should be cautious: The Alzheimer's field is littered with failed attempts at developing a treatment. Late-stage results often don't match the promise seen in mid-stage trials. Still, this is better than the approved drugs in this field can do, and a reason to watch Epix.
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POPSWeak Knees On Avandia The nuclear receptors triggered by Avandia and Actos, are really complicated, and lots of drugs that hit them have been non-starters because of side effects. Derek Lowe, a pharmaceutical chemist, takes a look at the latest worrisome result in mice -- by PPAR guru Ron Evans -- on his blog.
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POPSFDA Panel Pans Avastin The panel voted by a margin of one vote that the FDA should not approve Genentech's Avastin as a treatment for breast cancer. This is bad for Genentech, but it also likely to hurt the stocks of biotechnology companies in general. This decision reinforces the view that the FDA is getting tougher in approving new drugs. Every medicine has risks and benefits, but many in the drug industry complain that the risks are starting to weigh more heavily in that equation than they did before. This has more symbolic weight because Genentech is often seen as biotech's standard bearer, and because Avastin is one of the first targeted therapeutics. Of course, the drug is still on the market saving lives -- this decision applies only to the question of whether or not Genentech can market Avastin as a breast cancer treatment. The final word will rest with the FDA early next year.
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POPSMulling Over Bristol's Cuts Bristol-Myers is cutting its work force by 10% and manufacturing by 50%, and its talking about selling off businesses including its nutrition unit and medical imaging business. Generally these are seen as good moves, but buying and selling non-core businesses isn't what makes pharmaceutical stocks move. Last time Bristol did a bunch of spinning off and purchasing was at the nadir of the tenure of its previous chief executive, Peter Dolan. The real question is whether the pipeline of new medicines Bristol is touting can deliver, not what it can do to control costs.
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POPSMerck's Big Risk: High Expectations So much has gone so right for so long. Merck has executed well, but it has also gotten very lucky. For instance, its diabetes pill Januvia would not be such a big product were it not for both the safety problems plaguing GlaxoSmithKline's Avandia and the regulatory delay of Novartis' Galvus. Earnings forecasts have just kept going up. Should investors start to feel cautious? Or can Merck really keep delivering when other drug stocks are not?
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POPSNot So Fast This great investigation The Cleveland Plain Dealer illustrates how the badly named Fast Track designation many drug companies brag about often doesn't result in faster drugs or better outcomes, either for long-term investors or patients. Found via Pharmalot.
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POPSWhy The AIDS Vaccine Quest Must Go On As World AIDS Day approaches, Arthur Caplan, the University of Pennsylvania bioethicist, takes a look at the fallout from Merck's experimental HIV vaccine. The vaccine, for unknown reasons, actually made patients more likely to contract the virus. But Caplan says stopping the search for an AIDS vaccine would be a giant mistake.
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POPSIs Medicine Haunted? The WSJ's Health Blog does a great job sussing out a suspected case of ghostwriting on the part of a communications firm hired by drugmaker Forest Laboratories. These kinds of cases crop up every so often, and they are disturbing because they make you wonder how much of the medical literature is written by drug companies and then foisted on scientific journals under the guise of more independent research. This just isn't how science is supposed to work. The names on the paper are supposed to accurately reflect the people who did the research.
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POPSCelgene Buying Pharmion For $2.9 Billion This is a sensible move for Celgene, maker of the multiple myeloma drugs Thalomid and Revlimid, and a big payday for holders of Pharmion shares, which had already doubled this year.
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POPSCrestor Approved To Clear Artery Plaque It will be interesting to see how this impacts sales. Clearing plaque out of the arteries is a nice indication a drug is working, but it doesn't mean for sure that the medicine is preventing heart attacks or saving lives.
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POPSAmgen, J&J: It Could Have Been Worse The consensus here: After the battering these drugs have taken in the press and in the market, this could have been much worse. The companies and their investors can breathe a little sigh of relief.
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POPSFDA Rejects Generic Lovenox This is a defeat for Momenta and its partner Novartis, of course, but it is also a setback for the prospect of generic knockoffs of biotech protein drugs. Biogenerics, or biosimilars, whatever you want to call them, look as if they'll have a long road to market in the U.S.
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POPSAbbott Posts Good Cholesterol Data The question for this Simcor, which is basically a combo pill of Niaspan and Zocor, is how Merck's results on its niacin combo will compare. Merck's version is aimed at causing less flushing, a side effect that caused 6% of patients on Simcor to discontinue treatment.
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POPSIt Seems The FDA Was Right An FDA panel asked for more data after seeing interim results of GPC Biotech's study of the prostate cancer drug satraplatin. Looks like they had a point. It failed to increase survival.
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