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  2. [verwijderd] 18 oktober 2005 13:57

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    Riquent(R)
    Tuesday October 18, 7:30 am ET

    SAN DIEGO, Oct. 18 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company (Nasdaq: LJPC - News) today provided a summary of the status of the Company's development program for Riquent® (abetimus sodium), its drug candidate for lupus renal disease. In October 2004, following a review of the Company's New Drug Application for Riquent, the U.S. Food and Drug Administration (FDA) informed the Company that Riquent was "approvable" pending the successful completion of a clinical benefit trial.

    biz.yahoo.com/prnews/051018/latu064.h...
  3. [verwijderd] 18 oktober 2005 15:30

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    La Jolla Pharmaceutical Company Provides Update on Riquent(R)

    All PRNewswire News
    SAN DIEGO, Oct. 18 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company LJPC today provided a summary of the status of the Company's development program for Riquent(R) (abetimus sodium), its drug candidate for lupus renal disease. In October 2004, following a review of the Company's New Drug Application for Riquent, the U.S. Food and Drug Administration (FDA) informed the Company that Riquent was "approvable" pending the successful completion of a clinical benefit trial.

    A Phase 3 clinical benefit trial designed to meet this requirement was initiated in August 2004 under a Special Protocol Assessment (SPA). The trial is ongoing, although the Company delayed additional patient enrollment in March 2005 to conserve cash. To date, 37 sites in the United States have been initiated and 27 patients have enrolled in the study.

    On Friday, October 7, 2005, the Company announced that it had entered into a definitive agreement for the sale of common stock and warrants to purchase common stock to selected institutional and other accredited investors for gross proceeds to the Company of approximately $66 million. The financing is intended to fund the continued development of Riquent in a Phase 3 trial. The transaction is expected to close in December 2005 and is subject to stockholder approval and other closing conditions.

    Subject to the closing of the financing, the Company plans to expand the Phase 3 trial of Riquent to countries in Europe and Asia. Prior to reactivating enrollment, the Company expects to seek approval from the FDA for amendments to the current SPA. Several proposed amendments, which are detailed below, were discussed with the FDA in July 2005. It is estimated that it will take approximately one year to complete enrollment once enrollment is reactivated and then another year for the last patient enrolled to complete the study.

    Trial overview

    In the current Phase 3 clinical benefit study, the Company has refined the primary endpoint, added two higher dose groups, added more patients, restricted the use of immunosuppressive agents, and changed the treatment duration to 12 months. These changes were incorporated into the approved SPA and are based on results of the previous Phase 2/3 and Phase 3 trials of Riquent.

    The primary endpoint, time to renal flare, was refined in order to eliminate the hematuria component, which appears to be less specific for lupus renal disease. Two additional Riquent dose groups were added to the study so that, following the amendment of the SPA, 80% of the drug-treated patients will be treated with a higher dose than the 100 mg dose used in the previous Phase 3 trial. In the drug-treated group, 20% of patients will receive 100 mg per week, 40% will receive 300 mg and 40% will receive 900 mg per week. The trial will evaluate three different doses of Riquent in lupus patients with a history of renal disease, and twice as many patients will be treated with drug as placebo.

    The number of patients to be enrolled in the study is expected to be between 500 and 600, which is greater than the approximately 300 patients in the previous Phase 3 study. The trial is designed to be successful based on the results from the last Phase 3 study, where all drug-treated patients were treated with 100 mg per week of Riquent. In deciding how many patients should be enrolled, no additional clinical benefit from treatment with the higher doses was assumed. In animal studies of Riquent, higher doses further reduced antibody levels and increased survival.

    To assess the tolerability of higher doses, the Company recently completed a safety study in healthy volunteers who received a single dose of Riquent at 600 mg, 1200 mg, or 2400 mg. The drug appeared to be well tolerated in these subjects.

    The study entry criteria will restrict the use of immunosuppressive agents which, in the previous Phase 3 study, may have reduced the renal flare rate, especially in placebo-treated patients. Lastly, the current design was changed to a fixed 12-month patient evaluation period to reduce the potential for a survivor effect in patients treated with placebo. In the previous Phase 3 trial, patients were treated for up to 22 months.

    Regulatory update

    The Company is continuing regulatory discussions with the FDA. In May 2005, the Company received Fast Track designation for Riquent, which is intended to facilitate the FDA's ability to respond to questions and to review additional data. In July 2005, the Company met with the Cardio-Renal Division of the FDA to discuss further refinements to the trial design including selection of the higher dose, addition of an interim analysis to measure antibody levels and addition of a potential interim analysis for efficacy.

    Based on these discussions with the FDA, the Company currently intends to propose several revisions to the current SPA, including designating the 900 mg per week as the highest dose to be used in the study. The Company also expects to assess the dose response of the treatment with Riquent on antibodies to dsDNA by conducting an interim analysis in the Phase 3 study to evaluate the effect of higher doses on the reduction of these antibodies. The antibody assessment is currently expected to occur approximately one year after reinitiating patient enrollment. The FDA has indicated that no statistical penalty would be needed as a result of conducting this analysis.

    The Company also expects to be able to conduct an interim analysis for efficacy at a point in time when approximately 70% of the projected number of renal flares has been observed. This formal interim analysis, if conducted, would result in an adjustment in the measure of statistical significance for the primary endpoint required for approval. The Company is working to complete its review of the protocol and expects to submit the amended protocol to the FDA in the next few months.

    In August and September 2005, the Company evaluated potential clinical research organizations and physicians in India and in other countries in Asia to refine plans for the study.

    In Europe, the Company is planning to file a Medical Marketing Authorization (MAA) application in the first quarter of 2006 and, in such event, would expect an initial response with questions from the European Medicines Agency (EMEA) in the third quarter of 2006. In May 2005, the Company met with the Rapporteur assessment team in England and, in September, met with the Co-Rapporteur assessment team in Germany.

    Goals

    The Company has several key goals for the next twelve months. First, the Company is focused on completing the recently announced financing in December 2005. Second, the Company expects to restart enrollment in the United States for Phase 3 trial early in 2006, after a final review of the revised protocol by the FDA. After the review, the Company expects to expand the study to Europe and Asia. Third, the Company plans to file the MAA application for Europe in the first quarter of 2006, to receive feedback and questions from the EMEA in the third quarter of 2006, and finally, to obtain data on the ability of higher doses of Riquent to reduce further the levels of antibodies to dsDNA late next year.

    "There continues to be a significant unmet need in the treatment of lupus and we remain dedicated to providing a potentially safer treatment
  4. [verwijderd] 20 oktober 2005 15:29

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    Duurt me allemaal te lang; bovenstaand verhaal staat me ook niet echt aan.

    Ben gisteren uitgestapt op 0,73; zul je zien dat ze uiteraard vanaf vandaag gaan stijgen.
  5. [verwijderd] 20 oktober 2005 16:37

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    quote:

    Dachthetwelhe schreef:

    Duurt me allemaal te lang; bovenstaand verhaal staat me ook niet echt aan.

    Ben gisteren uitgestapt op 0,73; zul je zien dat ze uiteraard vanaf vandaag gaan stijgen.
    spread 73-74
  6. [verwijderd] 26 oktober 2005 14:17

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    SAN DIEGO, Oct. 26 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company LJPC announced today that it received a letter from the Nasdaq Listing Qualifications Department on October 25, 2005 indicating that the Company is not in compliance with the minimum $1.00 bid price requirement for continued listing pursuant to Nasdaq Marketplace Rule 4450(a)(5) and is subject to delisting. The Company intends to make a timely request for a hearing before a Nasdaq Listing Qualifications Panel, which will automatically stay the delisting of the Company's common stock pending the Panel's review and determination. The Company, however, can give no assurances that the Panel will grant its request for continued listing.

    Until the Panel's final determination and the expiration of any exception granted by the Panel, the Company's common stock will continue to be traded on the Nasdaq Stock Market.

    La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent(R) for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing small molecules to treat various other autoimmune and inflammatory conditions. The Company's common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: www.ljpc.com.

    The forward-looking statements in this press release involve significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause 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 development or similar expression. The analyses of clinical results of Riquent, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus") and any other drug candidate that we may develop, including the results of any trials that are ongoing or that we may initiate in the future, could result in a finding that these drug candidates are not effective in large patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety issue requiring us to develop new candidates. The analysis of the data from our Phase 3 trial of Riquent showed that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare, or with respect to the secondary endpoint, time to treatment with high-dose corticosteroids or cyclophosphamide. The results from our clinical trials of Riquent, including the results of any trials that are ongoing or that we may initiate in the future, may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United States or Europe, and we may be required to conduct additional clinical studies to demonstrate the safety and efficacy of Riquent in order to obtain marketing approval. There can be no assurance, however, that we will have the necessary resources to complete any current or future trials or that any such trials will sufficiently demonstrate the safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is experimental, has not been validated by independent laboratories and will likely be reviewed as part of the Riquent approval process. Our other potential drug candidates are at earlier stages of development and involve comparable risks. Analysis of our clinical trials could have negative or inconclusive results. Any positive results observed to date may not be indicative of future results. In any event, regulatory authorities may require clinical trials in addition to our current clinical trial, or may not approve our drugs. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: our clear need for additional financing or a collaborative agreement; obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; our ability to pass all necessary FDA inspections; the increase in capacity of our manufacturing capabilities for possible commercialization; successfully marketing and selling our products; our lack of manufacturing, marketing and sales experience; our ability to make use of the orphan drug designation for Riquent; generating future revenue from product sales or other sources such as collaborative relationships; future profitability; and our dependence on patents and other proprietary rights. Readers are cautioned to not place undue reliance upon forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time.

    © 2005 PRNewswire
  13. [verwijderd] 28 oktober 2005 21:51

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    Aandeel volgens mij nog steeds in dalende trend. Pas als koers boven 1.06 uitbreekt dan kan groter dat aandeel verder in waarde zal stijgen. Delisting kandidaat en kan iemand beoordelen of ze ondersteund zullen worden om boven de 1 usd te worden geholpen ??
  14. [verwijderd] 28 oktober 2005 21:55

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    quote:

    DeGroeneGigant schreef:

    Aandeel volgens mij nog steeds in dalende trend. Pas als koers boven 1.06 uitbreekt dan kan groter dat aandeel verder in waarde zal stijgen. Delisting kandidaat en kan iemand beoordelen of ze ondersteund zullen worden om boven de 1 usd te worden geholpen ??
    In december wordt besloten tot een eventuele reverse split 5:1. Het zal dan 3.00-3.50 doen. Ze hebben net maandag de 180 dagen gekregen om weer boven de $1 te komen (delisting over 180 dagen indien niet lukt). Vooralsnog hebben ze geld genoeg.

    Psycho
  15. [verwijderd] 4 november 2005 12:33

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    Als er wordt besloten tot een aandelen split, hoe zit het dan met je uitstaande orders? stel dat je dit aandeel tot maart volgend jaar te koop hebt staan op $ 1,00 en in bijvoorbeeld in december is die split, ben je ze dan allemaal kwijt voor die prijs?
  16. [verwijderd] 4 november 2005 18:31

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    quote:

    domus muris schreef:

    Als er wordt besloten tot een aandelen split, hoe zit het dan met je uitstaande orders? stel dat je dit aandeel tot maart volgend jaar te koop hebt staan op $ 1,00 en in bijvoorbeeld in december is die split, ben je ze dan allemaal kwijt voor die prijs?
    Bij een 5:1 rs wordt de door jou gewenste prijs $5 aangezien het aandeel ipv 0.60 dan $3 doet en jouw vraagprijs dan geldt voor de optelsom van 5 aandelen. Het zou ook nog kunnen, dat alle laatprijzen opnieuw ingezet moeten worden. Je bank geeft jou daar mededeling over.

    Psycho

  21. Bel-chin 15 december 2005 19:40

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    quote:

    Maximaal! schreef:

    blijkbaar positief bericht geweest

    vr.gr. berry
    Inderdaad. En komt daarbij een goede financiële deal en/of insider buying ....

    P.
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