Calypte und die Zeit nach AIDS2004 in Bangkok
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Thursday July 8, 12:00 pm ET
EL DORADO HILLS, Calif.--(BUSINESS WIRE)--July 8, 2004--J.M. Dutton & Associates continues coverage of Calypte Biomedical (OTCBB:CYPT - News) with a neutral rating. The 9-page report by J.M. Dutton senior analyst Sherry Grisewood, CFA is available at www.jmdutton.com as well as from First Call, Bloomberg, Zacks, Multex, and other leading financial portals.
Calypte Biomedical has taken a series of significant steps over the past six months that have resulted in the addition of highly respected senior management, substantial reduction in the toxic debt on its balance sheet, improvement in its overall financial condition and early signs of stabilization of product revenues. Furthermore, in the past few months the Company has moved ahead on its strategic plan for the commercialization of its rapid HIV detection tests in international markets and appears to be making progress in implementing its plan to have commercial rapid tests for sale in selected markets. These are among a number of critical elements the Company needs to become positioned for a viable future. We are encouraged by the progress the Company has made in recent months. However, we believe several additional steps need to be taken before investors will put the Company on a footing equal to its peers. These steps include a successful transition of its manufacturing to its Maryland facility, further signs of sales stabilization in its core products -- including producing a manufacturing profit (gross margin) on sales -- and steady, timely progress on the commercialization of its rapid test products. Therefore, we are maintaining our Neutral rating.
und das bei diesem wert. wann ist es zeit, zu erkennen, dass man sich verzockt hat???
bei sun gebe ich ohne wenn und aber zu, mich verzockt zu haben. trotz aller lippenbekenntnisse von insidern trotz aller bm von welchen, die angelbich mehr wussten, trotz aller hintertupfinger börsenbriefe mit kurszielen von 0,06€....
coleman hat alles sunnies verarscht, bis der arzt kommt, einschließlich mich. nur habe ich irgendwann bei 0,02€ die reissleine gezogen, wurde dafür verhöhnt und verspottet...und genau diese gleichen jammer jetzt am lautesten bei 0,007€. haben aber auch schon dafür ihr fett von mir wegbekommen....
es sollte euch bei caly nicht genauso gehen.
wo sind die vielgepriesenen aufträge aus dem august?
Massenmord? wegen Caly? warum denn?
verzockt? wo denn?
Aufträge August? wer sagte das?
das Ding in die Hose geht? in welche Hose?
Grüße Lucky
zock.überleg mal wie lange man schon investiert ist.wenn ich zocke, bin ich nach 48h spätestens wieder draussen und da bin ich mittlerweile konsequent.wie konsequent bist du beim zocken.würde mich echt interessieren, ob du noch in augrid bist?war ich auch drin und bin mit 10% minus ganz konsequent wieder raus.bei caly ist das für mich anders, weil ich ganz einfach der überzeugung bin, das die sich durchsetzen werden.also kein zock, sondern ein investment. Source: PR Newswire
Calypte Biomedical Corporation (OTC Bulletin Board: CYPT), a company engaged in developing rapid
tests for HIV diagnosis and the developer and marketer of the only two FDA-approved HIV-1 antibody
tests that can be used on urine samples, as well as an FDA-approved serum HIV-1 antibody Western Blot
supplemental test, announced today that it has executed a CRADA -- a Cooperative Research and
Development Agreement -- with the Centers for Disease Control and Prevention (CDC) for the
development of a unique new HIV rapid blood assay. Like current rapid test assays, the proposed device
will be for diagnostic use to detect HIV antibodies, but it will also be for use in population studies to
estimate the proportion of HIV-1 infections that have occurred in the last six months. This assay will use a
proprietary recombinant protein that will include the amino acid sequences identified from the
immunodominant regions of the transmembrane glycoprotein (gp41) identified from multiple subtypes of
HIV-1 group M.
The CRADA between Calypte and the CDC provides for the development of a test to estimate the incident
HIV infections (of less than 6 months duration) in a population survey. The purpose of the test is to provide
a simplified and rapid format that can be performed in resource poor settings and remote outreach locations
as a public health surveillance tool. The test should be particularly suitable for settings with limitations in
blood collection capacity, laboratory facilities, or specimen transport. The test will be designed to provide
invaluable information to Public Health agencies concerning the course of the HIV pandemic, such as
identifying populations where new infections are occurring most frequently, allowing agencies to measure
the effectiveness of prevention efforts in specific risk groups, and identifying high-incidence cohorts for
prevention trials (e.g. microbicide, vaccine etc).
Calypte recently announced that it had obtained a non-exclusive license from the CDC to manufacture a
serum enzyme Immunoassay test that can measure the proportion of infections that are recently acquired
(less than 6 months) for use in estimating HIV incidence. This assay is a laboratory based technology that is
performed on samples from individuals previously tested and found to be positive for HIV antibodies. Such
a test could have applications in helping public health officials to determine which populations have the
highest rate of new infections, and by extension, where they need to focus their intervention efforts.
Dr. Richard George, President and CEO of Calypte commented that "A simplified and rapid format for
serologic assays to estimate HIV incidence is a logical progression and refinement of the currently used,
laboratory based EIA. The ability to perform tests for recent infection for public health surveillance
purposes in all types of environments will dramatically expand the use and reduce the cost of incidence
testing used to monitor the effectiveness of HIV prevention programs."
Tony Cataldo, Executive Chairman of Calypte, stated, "Calypte is pleased to have completed this second
agreement with the CDC and to provide science that will allow Public Health agencies to focus their
resources on HIV and AIDS prevention measures that can be shown by empirical data to be effective."
About Calypte Biomedical:
Calypte Biomedical Corporation, headquartered in Alameda, California, is a public healthcare company
dedicated to the development and commercialization of in vitro diagnostic tests, primarily for the detection
of antibodies to Human Immunodeficiency Virus (HIV), and other sexually transmitted and infectious
diseases. Calypte's currently marketed laboratory-based tests include an enzyme immunoassay (EIA) HIV-
1 antibody screening test and an HIV-1 antibody western blot supplemental test, the only two FDA-
approved HIV-1 antibody tests for use on urine samples, as well as an FDA-approved serum HIV-1
antibody western blot supplemental test. Calypte is actively engaged in developing new test products for
the rapid detection of HIV and other infectious diseases. Calypte believes that there is a significant need
for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed
countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that
testing for HIV and other infectious diseases may make important contributions to public health.
Statements in this press release that are not historical facts are forward-looking statements within the
Page 9
9
meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the
intent, belief or current expectations of the Company and its management. Such statements reflect
management's current views, are based on certain assumptions and involve risks and uncertainties. Actual
results, events, or performance may differ materially from the above forward-looking statements due to a
number of important factors, and will be dependent upon a variety of factors, including, but not limited to,
the Company's ability to obtain additional financing and access funds from its existing financing
arrangements that will allow it to continue its current and future operations and whether demand for its test
products in domestic and international markets will continue to expand. The Company undertakes no
obligation to publicly update these forward-looking statements to reflect events or circumstances that occur
after the date hereof or to reflect any change in the Company's expectations with regard to these forward-
looking statements or the occurrence of unanticipated events. Factors that may impact the Company's
success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and
Exchange Commission ("SEC"), including its annual report on Form 10-KSB for the year ended December
31, 2003 and its subsequent filings with the SEC.
Company Contact:
Dr. J. Richard George, President and CEO
(510) 749-5100
rgeorge@calypte.com
Investor Relations Contact:
Tim Clemensen
Rubenstein Public Relations
212-843-9337
tclemensen@rubensteinir.com
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WHO Regional Conference Opens in Shanghai
By CHRISTOPHER BODEEN
Associated Press Writer
SHANGHAI, China (AP) -- The head of the World Health Organization called on Monday for steps to narrow growing inequality in medical care between rich and poor, saying the gap is undermining health security for all, especially in efforts to combat AIDS.
Tackling challenges ranging from the new - avian flu and SARS - to the familiar - tuberculosis, AIDS, smoking - WHO opened its annual regional session in Shanghai with a call for more robust spending on public health.
The meeting follows warnings that avian flu could spark a global pandemic if more is not done to detect and eradicate it. So far, 39 cases of the disease have been detected among humans, killing 28 people.
WHO's director for the Western Pacific warned that new diseases originating in animals similar to SARS and avian flu - known as zoonotic diseases - are almost certain to appear.
To help deal with the threat, WHO must work more closely with the United Nations' Food and Agriculture Organization, which deals with livestock, Dr. Shigeru Omi said.
"We can be virtually certain that zoonotic diseases will continue to emerge. We must be ready for them," he said.
WHO Director General Dr. Lee Jong-wook stressed the threat to public health due to the shortage of health resources for the poor.
"Equity has to be strongly reasserted as the health effects of extreme disparities between communities become more and more evident," Lee said.
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The world's response to AIDS provided a key illustration, he said.
"Lack of access to AIDS treatment and prevention methods continues to be a glaring example both of insecurity and inequality," Lee said.
Still, Lee said lower prices for AIDS drugs - as little as US$140 (euro 114) a year per patient for triple-drug treatments - make it more likely WHO will meet its goal of ensuring 3 million people are on antiviral drugs by 2005.
"HIV treatment is now finally within reach for more countries, and more people, than ever before," Lee said.
Work to combat tuberculosis has seen progress through broad use of the "directly observed treatment, short course," or DOTS, strategy, Lee said. The strategy relies on multiple use of inexpensive antibiotics, which must be taken every day for six to nine months.
However, increased surveillance is needed to detect TB earlier in the very poor and marginalized groups, Lee said. Drug resistance and co-infection with HIV also pose new challenges, he said.
Lee also outlined progress against malaria, and said nine countries have now ratified the WHO Framework Convention on Tobacco Control. But he warned of the growing dangers of obesity and diabetes arising from higher incomes and richer diets.
Lee said responses to avian flu have been "timely and well-managed" but much work remained to build a global alert and response system. The ultimate goal will be to smother the virus' spread before it can develop the ability to jump from human to human, he said.
"This will require a sustained effort of investment," Lee said.
To help meet those goals, WHO is pushing for a 12 percent increase in its budget, all of which is to be allocated to programs in its member countries and regions, Lee said.
The five-day WHO regional conference is also due to discuss the need for more cooperation to ensure food safety, including regulations on the sale of live animals for food. It will also discuss prospects for eliminating measles from the Western Pacific region, along with expanding vaccinations for Hepatitis B.
© 2004 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed
umsätze sehen top aus. bis jetzt schon über 53.000.000 stücke gehandelt. wenn es hochging, dann immer sehr schnell.
mal sehen, ob ich in den nächsten tagen den guten kade nicht mit top-kursen "beglücken" kann und ihm die schadenfreude austreibe...
2004 Releases
Date Title (click to view the full text)
16-Aug-2004 Calypte Biomedical Approved for Listing on AMEX: HIV
12-Aug-2004 Calypte Biomedical Announces Second Quarter and Six-Month Financial Results
10-Aug-2004 Calypte Biomedical to Host 2nd Quarter Conference Call
9-Aug-2004 Calypte Biomedical Announces Signing of Sublicense Agreement with Abbott Laboratories
21-Jul-2004 Calypte Biomedical To Host Conference Call
19-Jul-2004 Calypte Biomedical Issues Update on Informal SEC Inquiry
15-Jul-2004 Calypte Biomedical Presents Results of Its Rapid HIV-1/2 Field Trial Tests at the XV International AIDS Conference in Bangkok
13-Jul-2004 Calypte Biomedical Raises an Additional $1.5 Million in Private Placement
1-Jul-2004 Calypte Biomedical Announces Board Member Resignation
24-Jun-2004 Calypte's Rockville, Maryland Facility Receives Quality System Certification to ISO 13485:1996
16-Jun-2004 Calypte Files Registration Statement
1-Jun-2004 Calypte Biomedical Raises $9.3 Million in Private Placement
25-May-2004 Calypte Developing HIV-1/2 Oral Fluid Rapid Tests
13-May-2004 Calypte Announces First Quarter Financial Results
13-May-2004 Calypte Biomedical Corporation: First Quarter Earnings Conference Call
13-May-2004 Calypte Enters Into Memorandum of Understanding with Beijing Tiantan Biological Products
11-May-2004 Calypte Finalizes Manufacturing Agreement for Rapid Tests
14-Apr-2004 Calypte Announces Execution of a Research and Development Agreement With CDC for Rapid HIV Incidence Test
12-Apr-2004 Calypte Announces License From CDC for HIV Incidence Test
6-Apr-2004 Calypte Appoints New Board Member
1-Apr-2004 Calypte Launches International Manufacturing Initiative of its Rapid HIV Type 1 and HIV Type 2 Tests
23-Mar-2004 Calypte Announces Fourth Quarter and Year End Results
19-Mar-2004 Calypte Biomedical Corporation 2003 Fourth Quarter/Year-End Conference Call
27-Jan-2004 Calypte Biomedical to Host Conference Call On January 29th; Newly Appointed CEO Dr. Richard George and VP of Operations Richard VanMaanen to Speak
20-Jan-2004 Calypte Biomedical Appoints Dr. Richard George as President and CEO and Richard Van Maanen as Vice President of Operations
2003 Releases
Date Title (click to view the full text)
2-Dec-2003 Calypte Biomedical and Earvin 'Magic' Johnson Commemorate World AIDS Day December 1st
14-Nov-2003 Calypte Biomedical Announces Third Quarter and Nine-Month Financial Results
14-Nov-2003 Calypte Biomedical to Host 3rd Quarter Financial Results Conference Call On November 17
6-Nov-2003 Calypte Biomedical Submits Investigational Device Exemption Application for HIV-1 Rapid Blood Test
3-Nov-2003 Calypte Biomedical to File Form 8K
21-Oct-2003 Calypte Biomedical Corporation Announces 2004 Financial Guidance
17-Oct-2003 Calypte Biomedical to Present at Rodman & Renshaw Techvest Healthcare Conference
17-Oct-2003 Calypte's Urine Based HIV Test Receives Approval in the Republic of Kenya
16-Oct-2003 Calypte Biomedical Corporation and LabOne Sign Multi-Year Agreement
9-Oct-2003 Calypte Receives Initial Order From Botswana
8-Oct-2003 Calypte Completes China Clinical Trials
2-Oct-2003 Marr Technologies Increases Investment in Calypte Biomedical Corporation
1-Oct-2003 Calypte Biomedical Corporation Plans New Initiative With The AIDS Action Council In Africa
24-Sep-2003 Calypte Biomedical to Test its Urine Based HIV-1 Test in Tanzania, Rwanda, Burundi and Botswana
9-Sep-2003 Calypte's HIV-1 Antibody Tests Approved For Distribution in the Republic of Uganda
2-Sep-2003 Calypte Receives $10 Million Investment
12-Aug-2003 Calypte Biomedical Announces Resumption of Product Distribution in China
31-Jul-2003 Calypte Biomedical Announces $2.5 Million Investment
31-Jul-2003 Calypte Biomedical Announces Second Quarter and Six-Month Financial Results
30-Jul-2003 CEOcast Initiates Coverage of Calypte Biomedical
25-Jul-2003 Calypte Biomedical to Host 2nd Quarter Financial Results Conference Call On July 31
10-Jul-2003 Calypte Adds Second China Distributor
30-Jun-2003 Calypte Announces Dr. J. Richard George to Head Its Rapid HIV Business
27-Jun-2003 Calypte Announces Senior Management Change; Nancy Katz to Depart the Company
26-Jun-2003 Calypte Receives Another Order from Its Primary China Distributor for 150,000 Tests
25-Jun-2003 Calypte Adds Taiwan ROC Distributor; Enfield Medical Co. Ltd. Expands Calypte's Asian Coverage
24-Jun-2003 Calypte Receives Initial Order for the Middle East
13-Jun-2003 Calypte Biomedical Announces Symbol Change
3-Jun-2003 Calypte Names President and Chief Operating Officer to Ensure a More Efficient Transition into Its Marketing and Sales Phase
28-May-2003 Calypte Implements Reverse Stock Split; $15 Billion Emergency Plan for AIDS Relief Signed by President Bush
23-May-2003 Calypte Receives FDA Approvals on Revised Labeling for Urine Screening and Supplemental Tests; Provides Opportunity for Increased Marketing Opportunities
22-May-2003 Calypte Biomedical Partners with Planned Parenthood Federation of America to Fight the Spread of HIV
21-May-2003 Calypte Biomedical Corporation Holds Annual Meeting of Shareholders; Obtains Shareholder Approval for All Agenda Items
6-May-2003 FDA Authorizes Use of Calypte HIV-1 Serum Western Blot as Supplemental Test for HIV Rapid Products; Expands Market for Cambridge Biotech Western Blot Serum/Plasma Test
29-Apr-2003 Earvin ``Magic'' Johnson and Calypte Biomedical Team-up to Fight the Spread of AIDS
24-Apr-2003 Calypte Announces First Quarter Financial Results
23-Apr-2003 Calypte Biomedical Reschedules First Quarter Earnings Conference Call; First Quarter Financials Will Be Disseminated as Scheduled
21-Apr-2003 Calypte Biomedical to Announce First Quarter 2003 Financial Results
10-Apr-2003 Cambridge Biotech Serum Western Blot Update; Adaltis U.S. Inc. Grows Their Customer Base for Calypte Product
4-Apr-2003 Calypte Biomedical Corporation Files Preliminary Proxy Statement
3-Apr-2003 Calypte Expands Distribution into the Middle East; Mistaire LLC Selected to Distribute Calypte Products Throughout the GCC
19-Mar-2003 Harlem Congregations for Community Improvement Plans to Expand Use of Calypte's Urine HIV-1 Antibody Tests
10-Mar-2003 Calypte Biomedical Reports Three New Insurance Customers; Continues Insurance Market Penetration
4-Mar-2003 Calypte Receives an Additional Approval Eliminating FDA Lot Release Testing; Reduces Production-to-Market Time for HIV-1 Urine Western Blot Test
3-Mar-2003 Calypte's Urine HIV-1 Antibody Tests Selected for Important Faith-Based HIV Testing Initiative
27-Feb-2003 Calypte Announces Fourth Quarter and Year-End Financial Results; Adds Planned Parenthood Golden Gate to Customer Base
27-Feb-2003 Planned Parenthood Golden Gate to Offer Calypte's Urine HIV-1 Antibody Tests; Earnings Results Conference Call to be Conducted Today
19-Feb-2003 PathNet Laboratory to Offer Calypte Urine HIV Testing; Expands Urine Testing Access to Women's Health
18-Feb-2003 StockMac.com Focuses on Calypte Biomedical in its Market Awareness Newsletter
18-Feb-2003 Calypte Announces Results of Special Shareholder Meeting and Preliminary Unaudited Fourth Quarter 2002 Results
6-Feb-2003 Calypte Biomedical to Announce Fourth Quarter and Year-End 2002 Financial Results On February 27th
5-Feb-2003 Calypte Biomedical to Present at the Wall Street Analyst Forum 47Th Annual Institutional Investor Conference
3-Feb-2003 Calypte Comments On President Bush's Plans for AIDS Relief; Calypte's Safe Blood for Africa Relationship Focuses on HIV Testing
27-Jan-2003 Calypte HIV-1 Urine Tests Used in Study Led by Johns Hopkins for HIV Testing in High Risk Communities; Study Concluded Urine Tests are Effective Tools for HIV Screening
10-Jan-2003 J. Richard George, CDC and HIV Veteran Joins Calypte as VP of Government Affairs
8-Jan-2003 Calypte Receives Exemption from FDA Lot Release Testing; Production-to-Market Time for HIV-1 Urine EIA Test Significantly Reduced
6-Jan-2003 Calypte Receives Second Commercial Order from China Distributor and Payment for First Order; New Order for 160,000 Tests to Ship in February 2003
Seit Freitag kein Posting mehr von mir, und plötzlich kommt von Dir wieder ein dummer Text aus heiterem Himmel in meine Richtung.
Kommst Du Dir jetzt mächtig toll vor dass Augrid heute mal wieder steigt, nach 50% Verlust in den letzten Tagen ?! Respekt !
Du solltest vielleicht bei den Tatsachen bleiben und erwähnen, dass Du mit Augrid bei 0,0018 knapp 50% im Minus bist, und noch vor Kurzem als Augrid noch 50% höher war Kurse von 0,005 bis 0,01 in wenigen Wochen (die sind schon vorbei) in Aussicht gestellt hast.
Super Joelu. Vielleicht solltest Du dich einfach mal wieder etwas zurück halten und nicht ständig einen auf oberwichtig machen !?
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Wertpapier: Calypte Biomedical |
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ja immer noch am Hals !
er hat sich sogar angepaßt / schlechtes Zeichen für einen "Pay-Basher" !
wird wohl bald arbeitslos !
Gruß
leo
letztes Jahr September stieg der Kurs auf 1,75 US-Dollar, warum nicht wieder der September !!!!
Ich kann mir das gut feststellen, kann mir nicht vorstellen daß der Kurs einbricht oder so vor sich hindümpelt !!!
gruß werweiß
aber das werden wir am 1.Oktober feststellen, ihr könnt mich dann festnageln
mind. 0,75 US-Dollar am 30.9.2004
gruß werweiß
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Wertpapier: Calypte Biomedical |
FOR IMMEDIATE RELEASE
P04-76
August 3, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Approves Sculptra for HIV Patients
After an expedited review, the Food and Drug Administration (FDA) today approved an injectable filler to correct facial fat loss in people with human immunodeficiency virus (HIV) infection.
The filler, called Sculptra, is the first such treatment approved for a condition known as lipoatrophy, or facial wasting, a sinking of the cheeks, eyes and temples caused by the loss of fat tissue under the skin. Lipoatrophy is common among HIV patients. FDA expedited review of the product because of its importance to people with HIV/AIDS.
Sculptra was shown to produce significant increases in skin thickness, adding volume to facial tissue and restoring shape in areas of the face with fat loss. After an initial treatment series, repeat treatments may be needed to maintain the correction. Studies reported an improvement in the quality of life among those treated and less of the anxiety and depression often associated with lipoatrophy.
Sculptra is an injectable form of poly-L-lactic acid, a biodegradable, biocompatible synthetic polymer from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches, bone screws, and facial implants.
"Change in facial appearance is one of the emotionally devastating and stigmatizing side effects of HIV/AIDS and the drugs used to treat it,” said FDA Acting Commissioner Dr. Lester M. Crawford. “The AIDS community has been awaiting a product like this that can give patients a smoother, fuller face.”
FDA approval of Sculptra was based on a review of clinical studies of safety and effectiveness submitted by the manufacturer, Dermik Laboratories, of Berwyn, Pa.
Dermik reported on the use of Sculptra in 278, HIV-positive patients with severe facial lipoatrophy. The patients, who were all being treated with antiretroviral drugs, were primarily white males, mostly ages 41 to 45. Patients were given three to six injections of Sculptra at two-week intervals and were followed for two years.
The studies showed that the product was safe and significantly improved facial appearance. Most adverse events were related to the injection itself and included nodules, redness, swelling and bruising in the injection area.
Sculptra should only be used in patients with HIV by health care providers who are fully familiar with the product training materials provided by Dermik and the entire product package insert. The use of the product for other indications, such as to treat wrinkles, has not been approved by FDA.
As a condition of approval, Dermik has agreed to conduct an open-label registry study of 100 patients for five years to evaluate Sculptra’s long-term safety. The study will include at least 30 females and 30 people with dark skin types.
It is estimated that 900,000 to 1 million people in the United States are HIV-positive, although about one third are not diagnosed. Some 50 percent will develop lipoatrophy. An estimated 150,000 to 350,000 patients could potentially benefit from the new treatment.
For more information on HIV and AIDS go to http://www.fda.gov/oashi/aids/hiv.html
FOR IMMEDIATE RELEASE
P04-75
August 2, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Approves Two Fixed-Dose Combination Drug Products
For the Treatment of HIV-1 Infection
The Food and Drug Administration (FDA) today announced the approvals of Epzicom (abacavir/lamivudine) and Truvada (tenofovir disoproxil/emtricitabine), two fixed-dose combination treatments for HIV-1 infection. Control of HIV/AIDS generally requires simultaneous use of three or more drugs from different classes. Combination products bring together different HIV/AIDS drugs in a single medication or co-package and help make treatment regimens less complicated for patients to follow.
"We gained important scientific knowledge during the development of these products that will be especially useful in our efforts to speed the availability of safe and effective fixed-dose combination products to those who need them in this country and in developing countries under President Bush's Emergency Plan for AIDS Relief program," said Dr. Lester M. Crawford, Acting FDA Commissioner.
"Simplifying treatment regimens by reducing the number of pills and times per day patients need to take them provides significant public health benefits," Dr. Crawford added.
Epzicom and Truvada are indicated for use in combination with other antiretroviral drug products from different classes such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors for the treatment of adults with HIV-1 infection.
Epzicom is a fixed-dose combination of the antiretroviral drugs abacavir sulfate 600mg and lamivudine 300mg, both of which are approved individually under the brand names Ziagen (abacavir sulfate) and Epivir (lamivudine). Epzicomís approval is based on a large well-controlled clinical study which showed that abacavir dosed once daily had a similar antiviral effect as abacavir dosed twice daily both in conjunction with lamivudine and with efaviranz, another antiretroviral drug.
Truvada is a fixed-dose combination of the antiretroviral drugs tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, both of which are approved individually under the brand names Viread and Emtriva, respectively. The approval of Truvada is based on data demonstrating therapeutic equivalence between the combination product and the individual products.
FDA completed its review of Epzicom in 10 months and its review of Truvada in 4 months. GlaxoSmithKline submitted their New Drug Application (NDA) for Epzicom in October 2003. Gilead Sciences, Inc., submitted their New Drug Application (NDA) for Truvada in March 2004.
#69 von kade_I 27.08.04 12:19:31 Beitrag Nr.: 14.152.885 14152885
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joelu: Du wirst hier vom mir keine Fakten mehr sehen. Kannst ja nochmal nachlesen weshalb.
Trotzdem solltest Du mir gestatten zu posten, ohne dass ich zuvor jedes Mal auf deine Calypte-Einwände eingehe.
Augrid wird unter 0,002 gehen und das schon bald- glaube mir !
Bei 0,0015 steig ich auf ein 100 %-Zock ein. Mehr als 0,003 erwarte ich mir dann nicht.
im übrigen bleibe ich immer noch dabei, dass augrid eher auf 0,01 steigen wird, bevor caly die 0,50 blickt...