Cell Therapeutics vor Tounaround?
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Expected FDA Decision Dates added for CTIC, DDSS, CRXX and CADX
Laurel, MD (PRWEB) January 30, 2010 -- www.profeticconsult.com Prophetic Consulting LLC a leading provider of independent investment research and biotech stocks news on small and micro-cap biotechnology and pharmaceutical companies provides latest event updates on its FDA & Biotech calendar for (CRXX), (CTIC), (DDSS), (CADX), The following updates were made:
Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that on February 10, 2010 the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).
Labopharm's novel formulation of trazodone is currently under regulatory review in the U.S. with an action date under the Prescription Drug Users Fee Act (PDUFA) of February 11, 2010. Labopharm received a complete response letter from the FDA on July 17, 2009 indicating the Company's new drug application (NDA) for its novel trazodone formulation could not be approved in its present form due to the deficiencies at the API supplier's manufacturing facility. The letter did not raise any efficacy or safety issues.
CombinatoRx, Incorporated(NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months. The extended Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of the Exalgo NDA has been set for February 22, 2010. The FDA stated in its letter extending the PDUFA date that the purpose for the extension is to allow the FDA more time for a full review of Neuromed’s submission, including a recent amendment by Neuromed to the Exalgo NDA.
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Wieso 24.04.? Für mich steht noch der 10. Februar als erste FDA Termin fest...
Luke Timmerman 2/3/10
Seattle-based Cell Therapeutics will find out in seven days whether it has a legitimate shot at getting a new cancer drug on the U.S. market. This company has a long and controversial history, and it is guaranteed to generate noise over the next week from stock market bulls and bears. So I figured it might be useful to gather some of the relevant facts in advance of this modern version of Roman theater, otherwise known as an FDA advisory panel.
The main event starts at 8 am Eastern time/5 am Pacific on February 10. That’s when the Oncologic Drugs Advisory Committee, a panel of cancer drug experts that advises the FDA, will gather in a suburban Washington, DC, hotel. There, they’ll hear testimony about, and likely vote on, Cell Therapeutics’ application to market pixantrone (Pixuvri) as a new therapy for patients with relapsed, aggressive forms of non-Hodgkin’s lymphoma. The FDA isn’t required to follow the public advice of its expert panels, although it usually does.
Cell Therapeutics (NASDAQ: CTIC) has survived more than one near-death experience in the past, and CEO Jim Bianco has described 2009 as a “tight-wire act.” So pretty much the whole farm is riding on this panel vote. The company, which ran down to less than a couple of weeks of cash at one point last year, doesn’t have any marketed products generating cash at the moment and nothing besides pixantrone with a legitimate shot at imminent FDA approval. Amazingly, it has burned through more than $1.4 billion of capital since its founding in 1991 without ever becoming profitable. Yet the company has been so prodigious at convincing investors to keep writing checks, and so popular with the fast-money crowd, that it now has an astonishing 574 million shares outstanding. That’s more than Celgene (NASDAQ: CELG), a profitable maker of blood cancer drugs, which has a market capitalization of $26 billion.
James Bianco
James Bianco
The question of little Cell Therapeutics, and whether it will ever get within hailing distance of profitability, really hinges on a single study of 140 patients that doctors review next week.
“We do expect U.S. approval,” Cell Therapeutics president Craig Phillips told investors on January 14, during a presentation at the JP Morgan Healthcare Conference in San Francisco.
Before diving into the nitty-gritty of the medical evidence, a little bit of business background is necessary. Cell Therapeutics obtained pixantrone in 2003 when it paid $236 million to acquire Italy-based Novuspharma. The drug is a modified form of an anthracycline chemotherapy. Anthracyclines are potent cell-killing agents commonly used in patients newly diagnosed with lymphomas. They can induce long-term remissions, but they also can cause heart failure if they are used more than once. Novuspharma designed pixantrone to have the cell-killing power of an anthracyline infusion, without damaging the heart.
If the treatment is approved, Cell Therapeutics officials estimate the company can tap into a market of about 10,000 U.S. patients each year who are on at least their third round of treatment for aggressive non-Hodgkin’s lymphoma. Cell Therapeutics uses Cephalon’s bendamustine (Treanda), which costs $44,000 per patient, as a comparable benchmark on price, Phillips told investors last month. Assuming Cell Therapeutics captures one-third of the patient population, pixantrone could generate …Next Page »
Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.
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