La Jolla bricht um 60% ein


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3186 Postings, 7344 Tage lancerevo7La Jolla bricht um 60% ein

 
  
    #1
15.10.04 17:35
La Jolla Pharmaceutical Company Receives Letter From FDA About Riquent SAN DIEGO, Oct 14, 2004 /PRNewswire-FirstCall via COMTEX/ -- La JollaPharmaceutical Company (Nasdaq: LJPC) announced today that the Company hasreceived a letter from the United States Food and Drug Administration (FDA)indicating that its lupus drug candidate, Riquent(R) (abetimus sodium), isapprovable, but that an additional randomized, double-blind study demonstratingthe clinical benefit of Riquent would need to be completed prior to approval.The FDA letter indicated that the ongoing clinical trial initiated in August2004 would appear to satisfy this requirement.The Company continues to review the letter and has requested a meeting with theFDA to discuss the next steps in the development of Riquent. Until that meetingis held, the Company will be able to provide only limited guidance.The Company will host a conference call tomorrow, Friday, October 15, 2004, at8:00 a.m. Eastern Time. The dial in number is 800-329-9097 for U.S. callers and617-614-4929 for international callers. The passcode is 44429115. A live audiowebcast of the conference call will be available through La Jolla PharmaceuticalCompany's Web site at www.ljpc.com. A replay of the conference call can beaccessed for approximately one week by dialing (888) 286-8010 (US) or (617)801-6888 (International). The passcode for the replay is 49457212.La Jolla Pharmaceutical Company is a biotechnology company developingtherapeutics for antibody-mediated autoimmune diseases and inflammationafflicting several million people in the United States and Europe. The Companyis developing Riquent(R) for the treatment of lupus kidney disease, a leadingcause of sickness and death in patients with lupus. The Company is alsodeveloping LJP 1082 for the treatment of antibody-mediated thrombosis, acondition in which patients suffer from recurrent stroke, deep-vein thrombosis,miscarriage and other thrombotic events, and is in the early stage of developingsmall molecules to treat various other autoimmune and inflammatory conditions.The Company's common stock is traded on The Nasdaq Stock Market under the symbolLJPC. For more information about the Company, visit its Web site:http://www.ljpc.com.The forward-looking statements in this press release involve significant risksand uncertainties, and a number of factors, both foreseen and unforeseen, couldcause actual results to differ materially from our current expectations.Forward-looking statements include those that express a plan, belief,expectation, estimation, anticipation, intent, contingency, future developmentor similar expression. The analyses of clinical results of Riquent(R),previously known as LJP 394, our drug candidate for the treatment of systemiclupus erythematosus ("lupus"), and LJP 1082, our drug candidate for thetreatment of antibody-mediated thrombosis ("thrombosis"), including the resultsof any trials that are ongoing or that we may initiate in the future, couldresult in a finding that these drug candidates are not effective in largepatient populations, do not provide a meaningful clinical benefit, or may reveala potential safety issue requiring us to develop new candidates. The analysis ofthe data from our Phase 3 trial of Riquent showed that the trial did not reachstatistical significance with respect to its primary endpoint, time to renalflare, or with respect to the secondary endpoint, time to treatment withhigh-dose corticosteroids or cyclophosphamide. The results from our clinicaltrials of Riquent, including the results of any trials that are ongoing or thatwe may initiate in the future, may not ultimately be sufficient to obtainregulatory clearance to market Riquent either in the United States or Europe,and we may be required to conduct additional clinical studies to demonstrate thesafety and efficacy of Riquent in order to obtain marketing approval. There canbe no assurance, however, that we will have the necessary resources to completeany additional trial or that any additional trial will sufficiently demonstratethe safety and efficacy of Riquent. Our blood test to measure the bindingaffinity for Riquent is experimental, has not been validated by independentlaboratories and will likely be reviewed as part of the Riquent approvalprocess. Our other potential drug candidates are at earlier stages ofdevelopment and involve comparable risks. Analysis of our clinical trials couldhave negative or inconclusive results. Any positive results observed to date maynot be indicative of future results. In any event, regulatory authorities mayrequire clinical trials in addition to our current clinical trial, or may notapprove our drugs. Our ability to develop and sell our products in the futuremay be adversely affected by the intellectual property rights of third parties.Additional risk factors include the uncertainty and timing of: our clear needfor additional financing; obtaining required regulatory approvals, includingdelays associated with any approvals that we may obtain; our ability to pass allnecessary FDA inspections; the increase in capacity of our manufacturingcapabilities for possible commercialization; successfully marketing and sellingour products; our lack of manufacturing, marketing and sales experience; ourability to make use of the orphan drug designation for Riquent; generatingfuture revenue from product sales or other sources such as collaborativerelationships; future profitability; and our dependence on patents and otherproprietary rights. Readers are cautioned to not place undue reliance uponforward-looking statements, which speak only as of the date hereof, and weundertake no obligation to update forward-looking statements to reflect eventsor circumstances occurring after the date hereof. Interested parties are urgedto review the risks described in our Annual Report on Form 10-K for the yearended December 31, 2003, and in other reports and registration statements thatwe file with the Securities and Exchange Commission from time to time.SOURCE La Jolla Pharmaceutical CompanyCONTACT:          Andrew Wiseman, Ph.D., Sr. Director of Business Development and                  Investor Relations, La Jolla Pharmaceutical Company, +1-858-646-6615,                  andrew.wiseman@ljpc.com; or Virginia Amann, +1-608-274-6046, vamann@irpr.com,                  or Trista Morrison, +1-858-527-3490, tmorrison@irpr.com, both of Atkins +                  Associates, for La Jolla Pharmaceutical CompanyURL:              http://www.ljpc.com http://www.prnewswire.comCopyright (C) 2004 PR Newswire.  All rights reserved.**************************************************FNWU: La Jolla Receives Letter from FDA and Pfizer to Launch Generic Neurontin Oct 15, 2004 (M2 PRESSWIRE via COMTEX) -- City of Industry, CA - La JollaPharmaceutical Company (Nasdaq: LJPC) announced today that the Company hasreceived a letter from the United States Food and Drug Administration indicatingthat its lupus drug candidate, Riquent (abetimus sodium), is approvable, butthat an additional randomized, double-blind study demonstrating the clinicalbenefit of Riquent would need to be completed prior to approval. Pfizer Inc.(NYSE: PFE) said a federal court in the District of Columbia cleared the way forits launch of a generic version of its own blockbuster anticonvulsant drugNeurontin. The launch is aimed at countering competition from Alpharma Inc.(NYSE: ALO) and Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA), whichlaunched a generic version of the drug last week despite an unresolved patentdispute with Pfizer.U.S. BioDefense, Inc. (OTCBB: UBDF) announced recently that the company hadretained the business planning services of TriTech. TriTech is a Small BusinessDevelopment Center centered on helping Southern California people withhigh-tech/high-growth business concepts learn how to bring their ideas tomarket. U.S. BioDefense also recently announced the Defense Logistics Agencypartnership, a tier of the Department of Defense for the United States ofAmerica. Partners with a Central Contractor Registration number have exclusiveaccess to contract with various US Government Agencies which in turn increasespotential sales opportunities for U.S. BioDefense.About Financial News USAFinancial News USA (OTC: FNWU) is a Next Generation Financial Communicationsfirm that is performance driven and has a proven track record of award winningsuccess. We can enhance the liquidity of your stock by using a unique approachto the mass distribution of news releases through our proprietary wire serviceprogram. Our services include but are not limited to OTCBBWire service,GlobalWire services, Copywriting services to help you create news worthy pressreleases, and Investor Relations and Venture Capital services to assist you ifyou are looking for more customers or funding. Our goal is to create a long-termrelationship with you and your company so we can work together on a regularbasis to raise your stock price where it deserves to be. Financial News USA andits affiliates charge each client $10,000 in cash for news distribution and mayhave up to a 4.9% equity position in the companies mentioned herein, pleasevisit the disclaimer at www.financialnewsusa.com.CONTACT: FNWU Tel: +1 626 961 8041 e-mail: info@financialnewsusa.comM2 Communications Ltd disclaims all liability for information provided within M2PressWIRE. Data supplied by named party/parties. Further information on M2PressWIRE can be obtained at http://www.presswire.net on the world wide web Inquiries to info@m2.com.(C)1994-2004 M2 COMMUNICATIONS LTD***********************************************Oct 15, 2004 (streetinsider.com via COMTEX) -- Pacific Growth downgrades LaJolla Pharmaceutical (Nasdaq: LJPC) from 'equal-weight' to 'underweight' Theanalyst says the FDA "Approvable Letter" creates significant uncertainty andthey do not believe that LJPC has sufficient financing to complete the ongoingstudy.  

2718 Postings, 7340 Tage IDTEmehr text bitte o. T.

 
  
    #2
15.10.04 17:49

3186 Postings, 7344 Tage lancerevo7hier noch der chart

 
  
    #3
15.10.04 17:49

3186 Postings, 7344 Tage lancerevo7sorry für das chaos oben :(

 
  
    #4
15.10.04 17:51
hier könnt ihr euch alle infos holen: http://quotes.freerealtime.com/rt/frt/M?SA=quotes|News&IM=quotes&symbol=LJPC&type=News&

intraday:
 

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