SEATTLE, March 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that the U.S. Food and Drug Administration ("FDA") has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures the CTI's drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product. CTI has a New Drug Application ("NDA") under review at the FDA for pixantrone to treat relapsed/refractory aggressive non-Hodgkin's lymphoma. As previously announced, the FDA's Oncologic Drugs Advisory Committee ("ODAC") will review the NDA for pixantrone on March 22, 2010 and the FDA is expected to make a final decision on approval by April 23, 2010.
"FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved," said Craig W. Philips, President of CTI.
About Nerviano Medical Sciences (NMS)
Nerviano Medical Sciences is the largest pharmaceutical R&D facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.celltherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA (including ODAC), that the FDA may postpone the ODAC meeting again, that the FDA may not approve the NDA for pixantrone, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 F: 206.272.4434 E: deramian@ctiseattle.com www.celltherapeutics.com/press_room
Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T: 206.272.4347 F: 206.272.4434 E: invest@ctiseattle.com www.celltherapeutics.com/investors
SOURCE Cell Therapeutics, Inc.
Contacts:
Media Dan Eramian 206-272-4343 cell 206-854-1200 fax 206-272-4434 deramian@ctiseattle.com
Investors, Ed Bell 206-272-4345 Lindsey Jesch Logan 206-272-4347 fax 206-272-4434 invest@ctiseattle.com
all of Cell Therapeutics, Inc.
Public Companies Associated with this story: CTIC
Knobias Subject Codes Associated with this story: FDA/R&D
Paradigm Partner Completes FDA Submission for Retimax
Paradigm Medical Industries, Inc. announced that it has been notified by its Italian partner, Costruzione Strumenti Oftalmici, that all necessary documents have been completed and submitted to the United States Food and Drug Administration (FDA) for the Retimax, also known as the Paramax. http://www.fdanews.com/newsletter/article?articleId=125112&issueId=13495 CNNMoney
FDA Decision Expected Soon For ParaMax, Paradigm Medical (OTC:PDMI)
Written by Staff and Wire Reports Daily Profiles, Small and Micro Cap Mar 7, 2010
The FDA decision on Paradigm Medical Industries, Inc. (OTC: PDMI) lead device candidate ParaMax for Glaucoma early detection is expecting anytime soon.
Paradigm team has been very busy these last months, preparing the release of fantastic new devices, auditing in regards to the FDA visit of their facility, all the while continuing talks of securing a financial and marketing partner.
With the mistakes of the old management, things were a little slow in getting back on track. The new management has been in place for one year now, the progress and the reorganization is nearly completed. Paradigm is still in talk with different partners but now they are being very selective in selecting the right one that will benefit the company the most.
CEO said that things are coming along very well right now and they are back on track. The next level should be right in the corner with their new device ParaMax awaiting FDA approval and with a coming financial partner secured; this could be the real new start for Paradigm.
CEO said in a recent phone call interview that he is expecting to receive the FDA approval for their ParaMax any day now and it is going to revolutionize the glaucoma world.
Paradigm has many products to address the optometrist market but we will focus here on the 3 new products with the biggest potential.
Products:
Corneal topography — also known as videokeratography or corneal mapping — represents a significant advance in the measurement of the corneal curvature. Most corneal topographers evaluate 8,000 to 10,000 specific points across the entire corneal surface. By contrast, the Paravue processes more than 100,000 points. It also offers corneal wave front analysis with 2, 3 or 4 maps available for comparison.
1. Paravue 300 is a corneal topographer, (measures the curvature of cornea). The Paravue is a sophisticated topographer utilizing Placido Disk Technology and an advanced software to provide accurate and detailed analysis of the anterior corneal surface. It is FDA approved and is manufactured by CSO, (Italy). Paradigm will begin promoting it as soon as funding issues are resolved. It’s a very impressive piece of equipment!
1. Surveyor 500 is also a corneal topographer, but also included is a Scheimpflug rotating camera. This was first of its kind. The rotating camera was a big hit for Occulus with its Pentacam. It had no competitors and sold for over $55,000 USD. The Surveyor has same camera and includes one of finest topographers with it at approximately the same price to physicians! Release is same situation as Paravue 300.
According to the World Health Organization, approximately 60 million people suffer from glaucoma, making it one of the leading causes of blindness. It is estimated that the market is growing by approximately 10% per year, and it is expected to reach a value of $4 billion in 2010 (Decision News Media). Steve Davis, CEO of Paradigm believes that they have the product that will capture the bulk of that market with their FDA approved ParaMax device.
1. Paramax is also from CSO and is being sold as Retimax outside the US. Paradigm has exclusive arrangement to represent this early glaucoma detection device in the US! It is in review by the FDA. Latest information states that all paperwork has been submitted and work completed for submission. It’s now up to the FDA as to the release date. Paradigm is very anxious to add this piece to their product line and look forward to the opportunities it creates.
Glaucoma:
Everyone is at risk for glaucoma. According to the Glaucoma Research Foundation, approximately 1 out of every 10,000 babies in the U.S. is born with glaucoma. Certain groups also posses an increased risk, such as senior citizens. In fact, the Glaucoma Research Foundation found that people over the age of 60 are 6 times more likely to develop glaucoma than younger people. This group alone represents a very large number of people, especially as the baby boomer population is reaching these later ages.
Financial:
The CEO stated many times that we will not have to worry about the company doing a reverse split. Steve Davis is against this method.
November last year, shareholders have approved the increase in the authorized number of shares, although the Board of Directors has no immediate plans to issue a significant number of additional shares of common stock.
About Steve Davis, new CEO of Paradigm:
Mr. Davis brings over 25 years of experience in global healthcare and medical devices markets and over 14 of those in the ophthalmic arena to Paradigm Medical Industries, Inc. Stephen has also served as the President and CEO for Zinetics Medical, Inc. Salt Lake City, Utah for nine years. Stephen was successful in raising over $2.7 million for Zinetics Medical and spearheaded the purchase of Zinetics Medical by Medtronic for over $50 million. He served as Site Director for Medtronic Functional Diagnostics for a year after the conclusion of the sale of Zinetics Medical. Prior to those responsibilities, Stephen was the Western Area Director for Barnes-Hind Hydrocurve and held additional responsibilities as a Regional Vice-President and District Sales Manager. He possesses a stellar background in the areas of strategic planning, start-up ventures, P&L and has a successful record in developing business in preparation for acquisition. Mr. Davis also has an extensive knowledge of the International markets. Stephen has a B.S. from Brigham Young University and additional studies in International Business and Finance.
Conclusion:
These are the best times of the company; Paradigm could soon emerge from their past difficulties and gain investors attraction as soon as ParaMax is approved and a financial partner is secured. We have also been told that a new designed company website is coming very soon and that Paradigm will be more devoted to their shareholders by providing regular updates and information.
Clever investors would do their own due diligence and discover that it might be the good time to invest and take a long position on this company poised for a recovery.
Disclosure: No Positions TheMarketFinancial is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.
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