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I have extensive knowledge on drug discovery, also I am interested in fundamental analysis of biotech/pharma stocks. See Seeking Alpha's policy on anonymous authors:
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  • Delcath Systems (DCTH)

    DCTH is at the front of regional treatment of cancer with a promising therapy to shrink tumors in the liver. Delcath’s Percutaneous Hepatic Perfusion (PHP™) technology allows physicians to deliver significantly higher doses of anti-cancer drugs to the liver without exposing the patient's entire body to those same potent levels of drug. PHP™ is an investigational treatment currently undergoing testing in Phase III and Phase II clinical trials.

    administered via the hepatic artery and the venous effluent of the liver is collected and filtered using a percutaneously placed catheter and filtration system. The treatment is investigational, but observed benefits of the procedure include:

    Minimally invasive – PHP™ utilizes a series of catheters and extracorporeal filters to infuse high doses of chemotherapeutic agents to tumors in the liver with minimal systemic exposure.

    Higher Dosing – PHP™ allows infusion doses exceeding those of systemic or intra-arterial administration.

    Treatment Flexibility - PHP™ can be performed in an operating room or in a radiology suite under local or general anesthesia.

    Repeatable Procedure - Unlike surgical isolated hepatic perfusion (IHP), which can be performed only once, PHP™ can be repeated several times. Patients within the trial usually receive the treatment at four-week intervals and up to ten treatments have been administered to a patient.

    Decreased Toxicity - Filtration of the hepatic venous effluent can reduce systemic exposure of chemotherapy by 80% to 90% compared to hepatic artery infusion alone.

    Today, DCTH started to analyze Phase III data:

    Company On Track For April 2010 FDA Submission

    NEW YORK, Feb. 4 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment system for metastatic cancers to the liver, announced today that sufficient events have been reached to allow data analysis to begin on its Phase III trial.  The trial uses the drug melphalan to treat patients with metastatic melanoma in the liver.  

    "We remain very optimistic that the Phase III trial will achieve a successful endpoint," said Eamonn P. Hobbs, President and CEO of Delcath. "Assuming a successful trial endpoint, we remain committed to filing our NDA with the FDA in April," Mr. Hobbs added.

    The 92 patient, randomized, multi-center, Phase III study commenced patient enrollment in February 2006.  Patients were randomly assigned to receive treatments with ultra-high doses of the chemotherapeutic drug melphalan infused directly into the liver via the Delcath PHP System™ or to a control group, where they were provided with best alternative care (NYSE:BAC).  BAC included alternative regional or systemic therapies.  Patients assigned to the Delcath arm were eligible to receive up to six cycles of treatment at approximately four to six week intervals.  Patients randomized to the non-PHP arm were permitted to cross-over into the Delcath arm at documentation of hepatic disease progression.

    The study's primary objective was to demonstrate a statistically significant improvement in the hepatic progression free survival (HPFS) of patients with metastatic melanoma (ocular or cutaneous) to the liver treated with the Delcath PHP System™ versus patients in the control arm. Secondary endpoints include response rate, duration of response and overall survival.

    DCTH Sequence of events from here on:

    Data complete in February 2010

    FDA submission April 2010

    Endpoints are much more than double that of control group

    Coincident with FDA submission, or maybe before, expect a paper published in JAMA or NEJM after all Trial Center heads (including NCI) unanimously agree on findings which will be a big event

    Partnering discussions are being held in over 3 countries for exclusive geographic marketing rights and once the first agreement is established DCTH’s stock price will be moving north

    Reference to active negotiations should not have been mentioned in Hobb’s November press release as its set up an expected time certain and a concomitant stream of worries for unsophisticated or impatient investors who assume “the negative” when no press release has been made according their own mental and unjustified timetable

    Stock pressure is to be expected with some parties understandably cashing-in to lock in realized gains. Actually, weak hands are relinquishing to strong investors who are picking DCTH up for steal. Yes, downward stock movement is worrisome, but unjustified.

    Nothing is wrong but the company wants to insure tight lips and DCTH will not issue a press release just to calm the price of its stock.

    Expect a partner, either Asian or US, next year to expand on platform technology and expedite trials and front all costs for Hepatitis and Colorectal indications

    When there is a release it will be legitimate and with positive news

    Do your own homework, your money, your decision.

    Tags: DCTH, Healthcare
    Feb 04 6:12 PM | Link | Comment!
  • Ironwood Gears Up for Biotech’s Biggest IPO in Years, Sending Ripple Effect Through Industry
    Watch out IBS drugs and incoming IRWD IPO this Wedsday. Irritable bowel syndrome (IBS) has a potentially multi-billion market and currently there is NO IBS drug (Novartis used to have one with annual sell of close to one billion, but withdraw from market due to severe side effect). Now only three companies have mid-to-late stage drug candidate on IBS. They are IRWD, SLXP and LXRX. IRWD has a poly-peptide in Phase III, SLXP has a polyketide antibiotic(antibiotic for IBS?) in phase III, LXRX has a small molecule in Phase II.

    Ironwood Gears Up for Biotech’s Biggest IPO in Years, Sending Ripple Effect Through Industry

    Everybody with a financial stake in biotechnology will be watching Ironwood Pharmaceuticals this week, as it attempts to pull off the biggest initial public offering the industry has seen in years.

    The Cambridge, MA-based company, which filed its original IPO prospectus on Nov. 20, is now primed to go ahead and start selling its first shares on the NASDAQ market this week under the ticker IRWD, according to Renaissance Capital. If the company and its investment bankers pull the trigger, this will be a monster deal for a biotech company still in the product development phase. Ironwood could raise as much as $306 million if it can command the high end of its forecasted price range of $14 to $16 a share, which would establish an initial market valuation of more than $1.5 billion.

    Biotech has been itching for someone to come along and whet the appetite of Wall Street for new companies, so that venture capitalists and entrepreneurs can realize the big paydays they need to justify the risks of drug development. Only one biotech company in the drug development stage, Seattle-based Omeros (NASDAQ: OMER), has gone public in the past two years, and that was a dud. So if Ironwood can find demand for its shares at the high end of its range, and the stock price rises on the first couple days of trading, it could provide a lift to the entire industry, including both public and private companies, according to three veteran market watchers I spoke with on Friday.

    “There is huge buzz about it, and it could be bigger than most biotech IPOs in recent memory. The whole industry is waiting with baited breath and watching how it trades,” says Bob Nelsen, managing director of Arch Venture Partners in Seattle. “There is no question they will get a good price and get out, so the big question is what happens post-IPO. If it goes out strong, the number of followers will be much larger. If it goes out weak, only a few super-high-quality deals will get through the window. My fingers are crossed.”

    Then again, a couple others I spoke with said that Ironwood is clearly a different beast than the average biotech. So while it will have an impact on the sector as a whole, it won’t necessarily re-ignite the IPO market.

    “It’s a great story, but it’s more of a singularity,” says Richard Pops, the CEO of Cambridge, MA-based Alkermes (NASDAQ: ALKS), a longtime market watcher with no ties to Ironwood. “There aren’t five other Ironwoods teed up behind them.”

    What’s different about Ironwood? The company has an oral pill in development that has already passed two pivotal clinical trials, so much of the clinical trial risk has been removed. The product is for a potentially vast market of millions of people who suffer from chronic constipation and irritable bowel syndrome, and who don’t have good treatment options. And Ironwood already has big partners to market the drug in North America, Europe, and Asia.


    The product, linaclotide, has made it possible for Ironwood to raise more than $300 million since it was founded in 1998. The company still had $98 million in cash in the bank at the end of September, so it’s not doing an IPO because it needs more cash to keep the doors open. The company is led by CEO Peter Hecht, a former scientist at the Whitehead Institute for Biomedical Research in Cambridge, MA, and one of its newest directors is David Ebersman, the highly regarded former chief financial officer of Genentech. Wall Street’s big name underwriters are lined up behind Ironwood—JP Morgan Securities, Morgan Stanley, Credit Suisse, Bank of America/Merrill Lynch, and Wedbush PacGrow Life Sciences.

    “This is going to be a large, liquid stock from the beginning, and that right there makes it different from a lot of others,” Pops says.

    The more typical kind of biotech IPO would be for a company with an exciting platform technology, and products that face far more risks ahead than Ironwood, Pops says. That kind of company is more likely to command a $300 million to $400 million market capitalization, not $1.5 billion, he says.

    Many venture capitalists, even though they know their portfolio companies don’t have the same kind of profile as Ironwood, are drawing up their IPO prospectuses based on the assumption that Ironwood will pry open the window of opportunity, says Doug Fambrough, a general partner with Oxford Bioscience Partners in Cambridge. One reason is the sense that Ironwood might be one of those rare opportunities that has crossover appeal into the wider world of investors who control a lot of capital, but don’t normally get involved in the life sciences.

    It’s widely expected to draw general investors who otherwise won’t play in the biotech space,” Fambrough says, noting that if Ironwood does well, the generalists might look for more opportunities like it. And that would help guys like him. “If Ironwood performs well, that will affect the mood of investors in the more specialized biotech community,” Fambrough says.

    Of course, if Ironwood flops, it could throw a lot of cold water on all this optimism. “If [Ironwood] goes public at $9, it will suggest the valuation pressure is more intense than everybody thought, and if Ironwood can’t justify a $1 billion valuation, then it’s really open season on valuations,” Fambrough says. “It will be hard to see how an Aveo Pharmaceuticals can get an aggressive valuation if Ironwood can’t.”

    Disclosure: No current positions in stocks mentioned
    Feb 01 6:32 PM | Link | 1 Comment
  • Vanda Pharma, Novartis To Develop, Sell Schizophrenia Drug

    Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) has entered into an agreement with Swiss drug maker Novartis AG (NYSE:NVS) to commercialize and develop its schizophrenia drug Fanapt in the U.S. and Canada.

    Novartis said it expects to launch the drug in the U.S. early next year.

    In May, Vanda pulled off an upset by winning U.S. regulatory approval to sell a drug most investors had abandoned. The U.S. anti-psychotic market is about $14 billion.

    Shares of the tiny Rockville, Md., company jumped 14% to $13 after-hours. The stock is up more than 10 times in the past year.

    Novartis shares rose 1 cent to $50.63 in after-hours trading. That stock is up 15% in the past year.

    Under the agreement, which amended a prior deal between the companies, Novartis will have exclusive rights to commercialize Fanapt for the U.S. and Canada. Novartis will develop and commercialize a long-acting injectable version of the drug.

    Vanda will receive an upfront payment of $200 million and will be eligible for more payments totaling up to $265 million at certain milestones. Vanda also will receive royalties on the U.S. and Canadian net sales of Fanapt.

    The deal is expected to receive the required approvals by the end of the year.

    Vanda will retain rights to commercialize Fanapt oral and depot formulations outside the U.S. and Canada. At Novartis' option, the companies will discuss the commercialization of Fanapt outside of the U.S. and Canada or Novartis will receive a royalty on net sales.

    "With the launch of Fanapt in early 2010, we will broaden our presence in psychiatry and build on the heritage of Novartis in offering innovative treatments for devastating psychiatric diseases," said Ludwig Hantson, chief executive of Novartis Pharmaceuticals Corp.

    Oct 12 6:55 PM | Link | Comment!
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