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ALKERMES INC - Nasdaq National Market: ALKS (NEW charting help)
mit deinem Link allerdings kam ich ins Nirwana
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| Alkermes's alcoholism drug wins OK |
Apr 14, 2006 (The Boston Globe - Knight Ridder/Tribune Business News via COMTEX) -- The Food and Drug Administration yesterday approved a new drug to treat alcoholism, a monthly injection that many analysts say could significantly change the way alcohol dependence is treated. The drug, Vivitrol, was developed by Alkermes Inc. of Cambridge and will be launched in June. According to a study published last year, patients on Vivitrol had fewer "heavy drinking days" per month than patients who did not get the drug. Although its mechanism is not well understood, it is believed to reduce the euphoria alcoholics feel when they drink. "There is a very real brain component to addiction, and society up to now has for the most part has viewed it as failure of will," said Alkermes chief executive Richard Pops. Yesterday's approval was a milestone for Alkermes, a 19-year-old company that has never had a profitable year. Analysts project sales of the drug to start slowly but build to as much as $300 million annually. "We think that 10 years from now people will look back and, hopefully, view Vivitrol as one of the first steps to a new approach to treating these diseases," said Pops. It will be sold in a joint deal with Cephalon Inc., a Pennsylvania company that specializes in neurological drugs. Patients who now take medication to treat alcoholism must take up to six pills a day. Despite the enthusiasm from many alcoholics and addiction psychiatrists about a once-a-month drug to help cut down on drinking, Vivitrol faces significant challenges to wide acceptance. One is the US alcohol-treatment system, which relies chiefly on clinics whose staff members are not doctors and cannot write prescriptions. The drug carries a warning of potential liver toxicity in high doses, and patients are supposed to refrain from drinking alcohol before receiving it. Vivitrol will likely be more expensive than other drugs and could face resistance from insurance companies. The company has not yet disclosed a price. The most significant hurdle, however, is how alcohol dependence is viewed by doctors: Few alcoholics are treated with medication of any kind. The handful of existing drugs have far lower sales numbers than what Vivitrol is aiming to reach. Cephalon has targeted 2,000 to 3,000 addiction specialists and psychiatrists around the country, said Shawn Ferry, who is in charge of marketing Vivitrol at Cephalon. Alkermes has assembled a separate 28-person team. Its members have traveled to cities throughout the United States to coordinate doctors, clinics, and nurses who can administer the regimen. "I think this really represents a qualitative advance. It's the only treatment that can be given once a month that's effective," said Dr. Michael Bohn, an addiction specialist at Aurora Healthcare in Wisconsin who worked with Alkermes on its latest Vivitrol study. Bohn said that among people in the study who stayed on the drug for six months, 85 percent asked to remain on the drug after the study ended. That level of popularity would be welcome news for Alkermes, which specializes in long-acting versions of existing drugs. Vivitrol is based on a generic compound called naltrexone, and the company has signed deals to work with other companies' drugs, including a possible inhaled insulin. Alkermess' stock jumped after the FDA decision was released late yesterday, gaining more than 4 percent to close at $21.96. "If we're right, and Alkermes now moves from one of several hundred money-losing biotech companies into one of the companies in the tier of profitability, then there's real opportunities for growth," Pops said. By Stephen Heuser To see more of The Boston Globe, or to subscribe to the newspaper, go to http://www.boston.com/globe. Copyright (c) 2006, The Boston Globe ************************************************** As of Monday, 04-10-2006 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 03-28-2006 for ALKS @ $23.52. (C) 2006 Comtex News Network, Inc. All rights reserved. |
"Die FDA ist der Meinung, dass bei einem generischen Wirkstoff, der bereits hinreichend am Menschen getestet wurde, ein Löslichkeitstest zur Ermittlung der Bioäquivalenz ausreicht."dahinter steht,dass es schon länger das Bestreben des FDA war,die Zulassung preiswerter Arzneien zu beschleunigen,die letzte Gesetzesänderung erfolgte 2003 wonach der Einspruch gegen die Produktion von Generika nur maximal zu einer Verzögerung von 30 Monaten führen konnte
www.fda.gov/cder/ogd/
www.fda.gov/cder/consumerinfo/generics_q&a.htm
ich nehme an,dass die erleichterte Zulassung kommen wird,was natürlich enorme Auswirkungen nicht nur auf Viropharma haben wird
www.fda.gov/cder/ogd/
www.fda.gov/cder/consumerinfo/generics_q&a.htm
ich nehme an,dass die erleichterte Zulassung kommen wird,was natürlich enorme Auswirkungen nicht nur auf Viropharma haben wird
Alkermes's alcoholism drug wins OK 
( Boston Globe, by Stephen Heuser, 2006/04/14 )
The Food and Drug Administration yesterday approved a new drug to treat alcoholism, a monthly injection that many analysts say could significantly change the way alcohol dependence is treated.
Das war die News im Globe.
Hilft nur, wie Kikky schrieb, wenn man aufhört mit Trinken.??
Also eine Spirzte, eine Ersatzdroge? Gegen die Sucht??
Favrille Announces $45 Million Financing to Support Clinical Development and Commercialization of Lead Product Candidate FavId
SAN DIEGO, March 7, 2006 /PRNewswire-FirstCall via COMTEX/ -- Favrille, Inc. (Nasdaq: FVRL), a biopharmaceutical company developing patient-specific immunotherapies for the treatment of cancer, announced today that it has entered into a binding agreement to raise approximately $45 million in a private placement of common stock and the concurrent issuance of warrants for the purchase of common stock. The private placement is being led by MPM BioEquities Adviser, LLC and also includes Federated Kaufmann Fund, T. Rowe Price Associates, Tang Capital Management, ProMed Management, Forward Ventures, Sanderling Ventures, Alloy Ventures and William Blair Capital Partners.
SAN DIEGO, March 7, 2006 /PRNewswire-FirstCall via COMTEX/ -- Favrille, Inc. (Nasdaq: FVRL), a biopharmaceutical company developing patient-specific immunotherapies for the treatment of cancer, announced today that it has entered into a binding agreement to raise approximately $45 million in a private placement of common stock and the concurrent issuance of warrants for the purchase of common stock. The private placement is being led by MPM BioEquities Adviser, LLC and also includes Federated Kaufmann Fund, T. Rowe Price Associates, Tang Capital Management, ProMed Management, Forward Ventures, Sanderling Ventures, Alloy Ventures and William Blair Capital Partners.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031013/LAM095LOGO)
"This financing should be sufficient to fund operations through the analysis of our primary endpoint, time to disease progression, in the pivotal Phase 3 clinical trial of FavId(R) during the second half of 2007," said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. "This will enable us to continue our clinical development of FavId for B-cell non-Hodgkin's lymphoma (NHL) while aggressively preparing for its commercial launch. We have also strengthened our shareholder base in the process and helped to position our company for long-term growth."
"Favrille is poised to provide a major advance in the treatment of non-Hodgkin's lymphoma patients. The MPM BioEquities team has been impressed with the quality of Favrille's management, the impressive results from previous trials of FavId, and the many near-term milestones to be achieved by this talented team," said Kurt von Emster, General Partner, MPM Capital.
Favrille completed enrollment in a Phase 3 clinical trial of its lead product candidate FavId in January 2006. The registration trial is designed to evaluate FavId following Rituxan(R), the current standard of care, for the treatment of follicular B-cell NHL. The Company also announced in January that it has received Fast Track designation from the U.S. Food and Drug Administration for FavId.
Under the terms of the agreement, Favrille will sell approximately 8.6 million shares of its common stock at a price of $5.26 per share, the closing bid price for the Company's common stock immediately preceding execution of the binding agreement for the transaction. The Company will also issue warrants to purchase approximately 3 million shares of its common stock at an exercise price of $5.26 per share. At the closing, investors in the financing will pay an additional purchase price equal to $0.125 for each share underlying the warrants. Favrille intends to use the net proceeds from the sale for clinical development and commercialization of FavId, working capital and general corporate purposes.
The shares of common stock and warrants to be issued by the Company in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commissions, or an applicable exemption from the registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission within 30 days after closing covering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon exercise of the warrants issued in the private placement. This press release is not an offer to sell or the solicitation of an offer to buy the shares of common stock or warrants to be issued in the private placement or any other securities of the Company.
About Favrille, Inc.
Favrille, Inc. is a biopharmaceutical company focused on the research, development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company's lead product candidate, FavId, is based upon unique genetic information extracted from a patient's tumor. FavId is currently under investigation in a pivotal Phase 3 clinical trial for patients with follicular B-cell NHL and Phase 2 clinical trials in other B-cell NHL indications. The Company is developing additional applications based on its immunotherapy expertise and proprietary cost-effective manufacturing technology, including a second product candidate, FAV-201, for the treatment of T-cell lymphoma.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to Favrille's product candidates, proprietary technologies and research programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Favrille's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to progress and timing of clinical trials for FavId, including difficulties or delays in development, testing, manufacturing and marketing FavId or Favrille's other product candidates; Favrille's ability to obtain marketing approval for FavId or Favrille's other product candidates and the timing of any such approvals; Favrille's ability to manufacture sufficient quantities of FavId for use in clinical trials and, if FavId receives marketing approval, for commercialization; risks associated with achieving projected operating metrics and financial performance or the anticipated number of patients using FavId; potential delays in patient enrollment; Favrille's ability to obtain additional financing to support its operations; and additional risks discussed in Favrille's filings with the Securities and Exchange Commission. In addition, conclusions regarding the safety and efficacy of Favrille's product candidates cannot be made until the results of future clinical trials of longer duration in more patients are known. All forward-looking statements are qualified in their entirety by this cautionary statement. Favrille is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
SOURCE Favrille, Inc.
CONTACT: Tamara A. Seymour, CFO and Vice President, Finance & Administration,
+1-858-526-8035, tseymour@favrille.com, or Pete De Spain, Associate Director,
Investor Relations & Corporate Communications, +1-858-526-2426,
pdespain@favrille.com, both of Favrille, Inc.
URL: http://www.prnewswire.com
Copyright (C) 2006 PR Newswire. All rights reserved.
KEYWORD: California
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SPM
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Riesen Insider Kauf von ca. 10 Mio US $
| mpare: | FVRL vs S&P Nasdaq Dow |
Dynavax to Advance Cancer, Hepatitis B and Hepatitis C Therapy Programs With $50 Million Funding
E-mail or 
Print this story 19 April 2006, 4:00pm ET
Collaborative Financing From Symphony Capital Partners, LP Designed to Advance Next-Generation TLR-Agonist PipelineBERKELEY, Calif., April 19 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) announced an agreement with Symphony Capital Partners, LP and its co-investors to provide $50 million of committed capital to advance Dynavax's ISS-based cancer, hepatitis B and hepatitis C therapeutic programs through clinical development.
Under the terms of the agreement, Symphony Capital, a private equity fund, has established Symphony Dynamo, Inc., which will be capitalized initially with $20 million and an additional $30 million within one year following closing to fund Dynavax's identified development programs in cancer and hepatitis therapeutics. Dynavax has granted a license to the intellectual property for the ISS compounds selected for the Symphony Dynamo programs. Through a purchase option, Dynavax retains the exclusive right, but not the obligation, to acquire certain of the programs at specified points in time, or the entire set of funded programs at specified prices during the term of the development period. The term of the agreement is up to five years. The implementation of the development plans will be led by Dynavax with support from RRD International, LLC, Symphony Capital's clinical development partner, to provide additional clinical development and regulatory capabilities for the advancement of Dynavax's cancer, hepatitis B and hepatitis C therapeutic programs.
"We believe that this collaborative financing arrangement is timely and opportune, and fulfills key strategic goals for our company. It will enable us to continue to focus critical resources on advancing our lead programs in ragweed allergy and hepatitis B vaccines and provide additional minimally dilutive funding for investment in our early-stage, second-generation programs. This approach should allow us to build additional value in our pipeline and expand our partnering opportunities, all in a risk-reduced manner," said Dino Dina, MD, president and chief executive officer.
Continued Dr. Dina: "We can now invest more robustly in our cancer and hepatitis therapeutics pipeline, optimize the potential of our second-generation ISS-based technology, and accelerate creation of a new set of partnering assets. With TOLAMBA and HEPLISAV having achieved proof-of-concept and advancing through late-stage clinical trials and potentially toward registration, we believe now is the right time to invest in our cancer, hepatitis B and hepatitis C therapeutic programs. This financing strategy is consistent with our overall corporate strategy to have a steady stream of product opportunities moving into and through the clinic, to advance next-generation programs that represent attractive therapeutic and commercial opportunities, and to generate a meaningful return on investment for our shareholders."
Financial Terms
Funds from the arrangement will be dedicated to Dynavax's cancer product candidate, currently in a Phase 2 trial in Non-Hodgkin's lymphoma and anticipated to advance into clinical trials in solid tumors in 2006, and its hepatitis B and C therapeutic product candidates, which are anticipated to enter the clinic in 2007.
Symphony Dynamo will be capitalized initially with $20 million and an additional $30 million within one year following closing. Dynavax will issue to Symphony Dynamo investors five-year warrants to purchase two million shares of Dynavax common stock at $7.32 per share, representing a 25% premium over the recent 60-day trading range average of $5.86 per share. The term of the warrants is five years and the exercise price is subject to reduction to $5.86 per share under certain circumstances.
Dynavax will have an exclusive option, exercisable at its sole discretion, to acquire all of the programs through the purchase of all of the equity in Symphony Dynamo, exercisable at any time beginning one year after the closing date of the transaction and ending either five years after the closing date or at a time when the funding balance remaining in Symphony Dynamo reaches a certain minimum level. The purchase price is based on a compounded annual rate of return of 27% calculated as of the time of exercise. The purchase option exercise price is payable in cash or a combination of cash and shares of Dynavax common stock, at Dynavax's sole discretion. Dynavax also has an option to purchase either the hepatitis B or hepatitis C program during the first year of the agreement.
Dynavax plans to consolidate the results of operations of Symphony Dynamo into its financial statements in the second quarter of 2006. To the extent that Dynavax contributes existing internal resources to the Symphony Dynamo programs as planned, the company currently estimates that the transaction may have a positive impact on both Dynavax's use of cash and the timing of future capital requirements.
Symphony Dynamo will be governed by a board of directors, comprised of one Dynavax representative, Dino Dina, MD, two representatives from Symphony Capital Partners, Harri Taranto and Mark Kessel, and two independent directors, one of whom is Ann Arvin, MD, the Lucile Salter Packard Professor of Pediatrics, Associate Dean of Research, Professor of Microbiology & Immunology and Chief of Pediatric Infectious Diseases at Stanford University School of Medicine.
JMP Securities LLC served as advisor to Dynavax in this transaction.
Conference Call Today
| Mentioned | Last | Change |
|---|---|---|
| DVAX | 5.56 |  0.01dollars or (0.18%) |
Dynavax will hold a conference call to discuss the Symphony Dynamo transaction today at 4:30 pm Eastern/1:30 pm Pacific. To access the live call, please dial 866.543.6403 (US) or 617.213.8896 (international), passcode 90694187. Interested parties may listen to the webcast live at http://www.dynavax.com by clicking on the "Events" tab under the heading, "Investors." The webcast is also being distributed over CCBN's Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through CCBN's individual investor center at http://www.fulldisclosure.com or by visiting any of the investor sites in CCBN's Individual Investor Network. Institutional investors can access the call via CCBN's password-protected event management site, StreetEvents, at http://www.streetevents.com . A telephonic replay will be available through April 24, 2006 by dialing 888-286-8010, access code 67463566. International callers can dial 617-801-6888, access code 67463566.
About Symphony Capital Partners, LP
Symphony Capital is a New York-based private equity firm that invests in development stage biopharmaceutical programs. Symphony has the most experienced team for project-specific financings and has $315 million in private equity capital dedicated to invest exclusively in the type of collaboration undertaken with Dynavax. Symphony Capital Partners is the lead investor in Symphony Dynamo. Additional information about Symphony is available at www.symphonycapital.com .
About RRD International, LLC
RRD International, LLC (RRD) is an innovative product development company dedicated to supporting the global regulatory, preclinical and clinical needs of biotechnology, pharmaceutical and medical device companies. RRD provides comprehensive strategic planning and operational support from program inception to product approval including the design, management and execution of clinical trials. RRD's team of highly experienced drug and device developers has a substantial record of favorable FDA interactions and outcomes. Through its customized and flexible business approach, RRD offers a unique risk-sharing model, enabling its goals and interests to be aligned with a partner company's success. Additional information about RRD is available at www.rrdintl.com .
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Dynavax's pipeline includes: TOLAMBA(TM), a ragweed allergy immunotherapeutic, that has completed a large-scale Phase 2/3 clinical trial, and is in a supportive clinical trial in ragweed allergic children; HEPLISAV(TM), a hepatitis B vaccine that is currently in a pivotal Phase 3 clinical trial; a cancer therapy currently in a Phase 2 clinical trial; and an asthma immunotherapeutic that has shown preliminary safety and pharmacologic activity in a Phase 2a clinical trial.
Dynavax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements regarding the agreement with Symphony Capital Partners, LP and its investors to provide $50 million of committed capital to advance Dynavax's ISS-based cancer, hepatitis B and hepatitis C therapeutic programs through clinical development; expectations that this agreement will build value in Dynavax's pipeline, accelerate the advancement of promising, early-stage development programs, will be minimally dilutive, reduce risk and provide a return on investment to shareholders; statements related to plans to advance its clinical programs in ragweed allergy, hepatitis B, hepatitis C and cancer and the commercial opportunities for those programs. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Dynavax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Dynavax's business including, without limitation, risks relating to: plans to advance its cancer, hepatitis B and hepatitis C programs into clinical development and the therapeutic and commercial potential of these programs; and other risks detailed in the "Risk Factors" section of Dynavax's Annual Report on Form 10-K filed on March 16, 2006. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Dynavax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
SOURCE Dynavax Technologies Corporation -0- 04/19/2006 /CONTACT: Jane M. Green, PhD, Vice President, Corporate Communications ofDynavax Technologies Corporation, +1-510-665-4630, orjgreen@dvax.com/ /Web site:http://www.rrdintl.com//Web site:http://www.symphonycapital.com//Web site:http://www.dynavax.com/(DVAX)CO: Dynavax Technologies Corporation; Symphony Capital Partners, LP; RRD International, LLCST: CaliforniaIN: MTC HEASU: FNCJA-HD-- SFW105 --2198 04/19/2006 16:00 EDThttp://www.prnewswire.comFree quote.com newslettersDVAX
Chart(s) drawn 22 Apr 06, 11:54 PM ET .
Try a streaming chart for DVAX< script type=text/javascript><!--//try{if (objAdMgr.isSlotAvailable('messagingunit'))objAdMgr.renderSlot('messagingunit');}catch(error){}//-->< /script><!-- catman: start 247 --><!-- catman: end 247 -->Overlay indicators
MCLONE SYSTEMS INC - Nasdaq National Market: IMCL (NEW charting help)
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| ELN - Elan Corporation, plc (NYSE) | 10:55 AM ET, 6/1/2006 |
kein Kurseinbruch!
godd news und good chance for Chart.
New Data for Investigational Hepatitis C Drug Telaprevir (VX-950) to be Presented at AASLD Meeting - Combination therapy with telaprevir and pegylated interferon suppressed both wild-type and resistant HCV -
BOSTON, Oct 27, 2006 /PRNewswire-FirstCall via COMTEX/ -- Researchers will
present new data this week suggesting that both wild-type hepatitis C virus and
resistant variants were suppressed in patients when pegylated interferon
(peginterferon alfa-2a; peg-IFN) was added to telaprevir (VX-950), Vertex's
investigational hepatitis C virus (HCV) protease inhibitor, in a Phase 1b
clinical study. In addition, clinical investigators will report that 24 of 26
patients who received telaprevir (VX-950) in two early-stage clinical trials had
undetectable HCV RNA after receiving follow-on combination therapy with peg-IFN
and ribavirin (RBV) through 24 weeks of treatment, a therapeutic regimen
following the conclusion of the clinical trials. Clinical investigators will
also report that some of these patients have stopped therapy, and that a
proportion of them continued to have undetectable HCV RNA after stopping
therapy.
The data will be presented while attending the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) and were released in accordance with media guidelines established by the conference. Telaprevir (VX-950) is an investigational drug candidate being developed as part of a global Phase 2b clinical development program by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) Combination of Telaprevir (VX-950) and Peg-IFN Suppressed Both Wild-type Virus and Resistance Variants in 14-day Clinical Study
Tara Kieffer, Ph.D., of Vertex will present data in a Presidential Plenary session on Monday, October 30, analyzing viral sequences isolated from patients receiving telaprevir (VX-950) as a single agent or in combination with peg-IFN in a Phase 1b 14-day clinical study. In this study, viral variants were suppressed when peg-IFN was combined with telaprevir, or when peg-IFN and RBV were administered subsequent to telaprevir dosing.
In one arm of the trial, resistant viral variants were isolated from six of eight patients who had detectable HCV RNA while receiving telaprevir as a single agent over a period of 14 days. Subsequently, clinical investigators reported that all patients who received follow-on therapy with peg-IFN and RBV had undetectable HCV RNA at 24 weeks. In a second arm of the study, resistant viral variants were isolated from two of eight patients who received a combination of telaprevir and peg-IFN for 14 days. Both patients subsequently had undetectable HCV RNA at week 12 of follow-on therapy.
Current Status of Patients Receiving Follow-On Peg-IFN and RBV Combination Therapy After a 14-day, Phase 1b Clinical Trial of Telaprevir (VX-950)
On Tuesday, October 31, Dr. Nicole Forestier of Saarland University Hospital in Homburg, Germany will review the current status of 20 patients from a Phase 1b study who received 14 days of telaprevir therapy either alone or in combination with peg-IFN, or peg-IFN alone, in a poster presentation titled "Current status of subjects receiving peg-interferon alfa-2a (peg-IFN) and ribavirin (RBV) after a 14-day study of the hepatitis C protease inhibitor telaprevir (VX-950), with peg-IFN." Clinical investigators previously reported that at the end of 14 days of dosing, one of eight patients receiving telaprevir as a single agent and four of eight patients receiving telaprevir in combination with peg-IFN had undetectable HCV RNA (less than 10 IU/mL, Roche Taqman(R)).
All patients who did not discontinue therapy at week 24 are expected to continue to receive peg-IFN+RBV for a total of 48 weeks of treatment. The current status of patients, as reported by the poster authors, is described in the following table:
HCV RNA results for patients receiving follow-on peg-IFN+RBV therapy following
14-day Phase 1b study of telaprevir (VX-950)
Initial Patients Patients Patients Patients who Patients
14-day with with with stopped continuing
regimen undetectable undetectable undetectable therapy at to receive
(number HCV RNA at HCV RNA at HCV RNA at week 24 who peg-
of end of 14 end of 12 end of 24 had IFN+RBV
patients) days of weeks of weeks of undetectable through 48
dosing follow-on follow-on HCV RNA 12 weeks of
treatment treatment weeks post- follow-on
New Data for Investigational Hepatitis C Drug Telaprevir (VX-950) to be Presented at AASLD Meeting - Combination therapy with telaprevir and pegylated interferon suppressed both wild-type and resistant HCV -
BOSTON, Oct 27, 2006 /PRNewswire-FirstCall via COMTEX/ -- Researchers will
present new data this week suggesting that both wild-type hepatitis C virus and
resistant variants were suppressed in patients when pegylated interferon
(peginterferon alfa-2a; peg-IFN) was added to telaprevir (VX-950), Vertex's
investigational hepatitis C virus (HCV) protease inhibitor, in a Phase 1b
clinical study. In addition, clinical investigators will report that 24 of 26
patients who received telaprevir (VX-950) in two early-stage clinical trials had
undetectable HCV RNA after receiving follow-on combination therapy with peg-IFN
and ribavirin (RBV) through 24 weeks of treatment, a therapeutic regimen
following the conclusion of the clinical trials. Clinical investigators will
also report that some of these patients have stopped therapy, and that a
proportion of them continued to have undetectable HCV RNA after stopping
therapy.
The data will be presented while attending the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) and were released in accordance with media guidelines established by the conference. Telaprevir (VX-950) is an investigational drug candidate being developed as part of a global Phase 2b clinical development program by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) Combination of Telaprevir (VX-950) and Peg-IFN Suppressed Both Wild-type Virus and Resistance Variants in 14-day Clinical Study
Tara Kieffer, Ph.D., of Vertex will present data in a Presidential Plenary session on Monday, October 30, analyzing viral sequences isolated from patients receiving telaprevir (VX-950) as a single agent or in combination with peg-IFN in a Phase 1b 14-day clinical study. In this study, viral variants were suppressed when peg-IFN was combined with telaprevir, or when peg-IFN and RBV were administered subsequent to telaprevir dosing.
In one arm of the trial, resistant viral variants were isolated from six of eight patients who had detectable HCV RNA while receiving telaprevir as a single agent over a period of 14 days. Subsequently, clinical investigators reported that all patients who received follow-on therapy with peg-IFN and RBV had undetectable HCV RNA at 24 weeks. In a second arm of the study, resistant viral variants were isolated from two of eight patients who received a combination of telaprevir and peg-IFN for 14 days. Both patients subsequently had undetectable HCV RNA at week 12 of follow-on therapy.
Current Status of Patients Receiving Follow-On Peg-IFN and RBV Combination Therapy After a 14-day, Phase 1b Clinical Trial of Telaprevir (VX-950)
On Tuesday, October 31, Dr. Nicole Forestier of Saarland University Hospital in Homburg, Germany will review the current status of 20 patients from a Phase 1b study who received 14 days of telaprevir therapy either alone or in combination with peg-IFN, or peg-IFN alone, in a poster presentation titled "Current status of subjects receiving peg-interferon alfa-2a (peg-IFN) and ribavirin (RBV) after a 14-day study of the hepatitis C protease inhibitor telaprevir (VX-950), with peg-IFN." Clinical investigators previously reported that at the end of 14 days of dosing, one of eight patients receiving telaprevir as a single agent and four of eight patients receiving telaprevir in combination with peg-IFN had undetectable HCV RNA (less than 10 IU/mL, Roche Taqman(R)).
All patients who did not discontinue therapy at week 24 are expected to continue to receive peg-IFN+RBV for a total of 48 weeks of treatment. The current status of patients, as reported by the poster authors, is described in the following table:
HCV RNA results for patients receiving follow-on peg-IFN+RBV therapy following
14-day Phase 1b study of telaprevir (VX-950)
Initial Patients Patients Patients Patients who Patients
14-day with with with stopped continuing
regimen undetectable undetectable undetectable therapy at to receive
(number HCV RNA at HCV RNA at HCV RNA at week 24 who peg-
of end of 14 end of 12 end of 24 had IFN+RBV
patients) days of weeks of weeks of undetectable through 48
dosing follow-on follow-on HCV RNA 12 weeks of
treatment treatment weeks post- follow-on
VERTEX PHARMACEUTICALS - Nasdaq National Market: VRTX (NEW charting help)
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Charttechnisch buy und ein Mittel zur Vogelgrippe:
| .S. Equity News: MedImmune's FluMist Sales Jump and CV Therapeutics Announces Presentations at American Heart Association Scientific Sessions 2006 |
Oct 27, 2006 (M2 PRESSWIRE via COMTEX) -- City of Industry, CA - Biotechnologyindustry alert provided by Equity IR News. MedImmune (Nasdaq: MEDI) is ready forflu season, and says sales of its FluMist flu vaccine helped boost revenue lastquarter. The Gaithersburg-based company had third-quarter revenue of $177million, up 15 percent from the same quarter a year ago. It reports a net lossof $55.8 million, or 23 cents per share, compared to a net loss of $64.1million, or 26 cents per share in the same quarter a year ago. U.S. BioDefense,Inc. (OTC BB: UBDE) subsidiary Emergency Disaster Systems (EDS) launches its newe-commerce site www.EDisasterSystems.com to expand its services and products andincrease its accessibility to current corporate clients and its retail customerbase. For the last ten years EDS has focused primarily on providing itscorporate clients like Toyota and Kaiser with innovative emergency preparednesstechnology. CV Therapeutics, Inc. (Nasdaq: CVTX) announced that data from threeranolazine-related studies will be presented at the American Heart Association(AHA) Scientific Sessions 2006, which will be held at McCormick Place inChicago, IL, on November 12 - 15, 2006. CV Therapeutics, Inc., headquartered inPalo Alto, California, is a biopharmaceutical company focused on applyingmolecular cardiology to the discovery, development and commercialization ofnovel, small molecule drugs for the treatment of cardiovascular diseases.Celgene Corporation (Nasdaq: CELG) announced adjusted net income of $59.4million, or adjusted earnings per diluted share of $0.15 for the quarter endedSeptember 30, 2006. Based on U.S. Generally Accepted Accounting Principles(GAAP), Celgene reported net income of $20.4 million, or diluted earnings pershare of $0.05 for the quarter ended September 30, 2006, including share-basedemployee compensation expense, compared to net income in the prior year periodof $0.7 million. About U.S. Equity News U.S. Equity News provides information, resources and news services for investorsof small-cap, micro-cap and emerging companies. U.S. Equity News distributes RSSnews feeds and a free subscription-based newsletter available through itswebsite at www.usequitynews.com. U.S. Equity News is a financial news distribution service by Equity Solutions,Inc. (www.equityirsolutions.com) that provides a platform for public companiesto disseminate important news to key Wall Street interest such as shareholdersand new investors. Equity Solutions, Inc. can assist by providing an effectiveincrease in the awareness of a public company's news, development and corporatestory through its proprietary network and its financial portal. CONTACT: U.S. Equity News Tel: +1 626 961 8039 e-mail: info@usequitynews.comEddie Cruz, President, Equity Solutions, Inc. Tel: +1 626 961 8039 Tel: +1 949394 7495 Tel: +1 626 961 8179 WWW: http://www.equityirsolutions.com WWW:http://www.USEquityNews.com M2 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)1994-2006 M2 COMMUNICATIONS LTD ************************************************** As of Monday, 10-23-2006 23:59, the latest Comtex SmarTrend(SM) Alert,an automated pattern recognition system, indicated an UPTREND on08-30-2006 for CVTX @ $11.89. For more information on Comtex SmarTrend? Alert, contact your market dataprovider or go to CSTADirect.com SmarTrend is a registered trademark of Comtex News Network, Inc.Copyright ? 2004-2006 Comtex News Network, Inc. All rights reserved. |
MEDIMMUNE INC - Nasdaq National Market: MEDI (NEW charting help)
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Friedman,Billings,Ramsey &Co - Alkermes "outperform"
07:56 19.01.07
Rating-Update:
Arlington (aktiencheck.de AG) - Die Analysten von Friedman, Billings, Ramsey & Co stufen die Aktie von Alkermes (ISIN US01642T1088/ WKN 882907) unverändert mit "outperform" ein. Das Kursziel werde bei 22 USD gesehen. (19.01.2007/ac/a/u)
Quelle: aktiencheck.de
07:56 19.01.07
Rating-Update:
Arlington (aktiencheck.de AG) - Die Analysten von Friedman, Billings, Ramsey & Co stufen die Aktie von Alkermes (ISIN US01642T1088/ WKN 882907) unverändert mit "outperform" ein. Das Kursziel werde bei 22 USD gesehen. (19.01.2007/ac/a/u)
Quelle: aktiencheck.de
www.rt.boerse-stuttgart.de/pages/details/...RX.STU&ChartHist=1
2nd UPDATE: Elan Up On Early Phase III For Alzheimer's Drug5-21-07 7:15 AM EDT
By Quentin Fottrell
Of DOW JONES NEWSWIRES
DUBLIN -(Dow Jones)- Shares in Elan Corp. PLC (ELN) surged Monday after the Irish drug group and U.S. partner Wyeth (WYE) said they will start early Phase III clinical trials of AAB-001, their treatment for mild to moderate Alzheimer's disease which analysts say could become a blockbuster drug.
With Phase III starting in mid-2007 rather than mid-2008 as previously expected, analysts say AAB-001 could potentially receive approval by the U.S. Food & Drug Administration by late-2008.
Investors liked the news, which indicates increased confidence in the Alzheimer's program. At 1050 GMT, Elan shares reached a daily high, rising nearly 13%, or EUR1.50, at EUR13.20 in Dublin, out performing the broader market with the ISEQ Overall Index up 0.9% at 9751. Although Phase II is not yet complete, the two drug companies said Phase III clinical trial design will be finalized with regulatory agencies, and subject to their approval, it will begin in the second half of 2007.
Davy Stockbrokers, which doesn't rate shares, raised its sum-of-the-parts valuation for Elan to $21.00 from $16.10 to reflect the "advance" in the Alzheimer's program. "This is a key catalyst for the shares," Davy's Jack Gorman said.
NCB Stockbrokers' Orla Hartford, who rates Elan a buy, said there was "real potential" for early filing of AAB-001, adding that interim analysis of Phase II over the next three months could "transform Elan's investment case."
She said that evidence of plaque reduction on the brain by AAB-001 with statistical evidence on quality of life improvements would provide a "compelling case" for filing AAB-001 for approval after Phase II is completed.
Goodbody Stockbrokers' Ian Hunter welcomed the early Phase III, but added, " The only frustrating element for the market is that, given that the Phase II trial is ongoing, we will not get a sight of the data until early 2008."
Hunter maintains a buy recommendation on Elan, predicting "conservative" peak annual sales for AAB-001 of $2.2 billion by 2014 should the treatment get final approval by the regulatory authorities.
"The Alzheimer's market is huge," Hunter said. "It has the potential to be the next big indication for pharmaceutical companies, especially as the baby boomers come into the Alzheimer's-prone age group."
Last month, Elan Corp's chief executive officer Kelly Martin told Dow Jones Newswires that there are about 10 million Alzheimer's patients in the U.S. and Europe, with tens of billions of dollars of potential revenue.
He also flagged a "series of Alzheimer's advancements" by year-end, shifting the focus away from Elan's multiple sclerosis drug Tysabri, which has up until now been the main focus for investors in the company.
Elan's share price has had a rollercoaster ride over the last five years: falling from its 2002 high of EUR50.27 due to revelation of now-resolved accounting troubles in 2002, and the temporary suspension of Tysabri in 2005.
In February 2005, Elan and joint venture partner Biogen Idec PLC (BIIB) suspended Tysabri in the U.S. on safety grounds. Tysabri was re-launched in the U.S. and launched for the first time in the E.U. in June 2006.
That temporary setback followed a long and arduous recovery for Elan, beginning with a change of senior management in 2002 when its former CEO and Chairman, the late Donal Geaney, resigned amid accounting troubles.
Company website: www.elan.com
-By Quentin Fottrell, Dow Jones Newswires; +353-1-6762189; quentin.fottrell@ dowjones.com
(END) Dow Jones Newswires
05-21-070715ET
Copyright (c) 2007 Dow Jones & Company, Inc.
________
Alles was ich hier poste, ist eine Satire.
Nichts ist wahr, Alles ist nur eine Geschichte.
Ähnlichkeit mit lebenden oder verstorbenen Personen sind rein zufällig.
Ähnlichkeit mit Tatsachen sind reiner Zufall.
Charts oder andere Meinungen sind keine Kaufempfehlungen.
Alles was ich hier schreibe sind reine Fiktionen.
Ein Bezug aus dieser virtuellen Welt zur realen Welt ist rein zufällig, nie intendiert und unterliegt der Täuschung des Lesers.
2nd UPDATE: Elan Up On Early Phase III For Alzheimer's Drug5-21-07 7:15 AM EDT
By Quentin Fottrell
Of DOW JONES NEWSWIRES
DUBLIN -(Dow Jones)- Shares in Elan Corp. PLC (ELN) surged Monday after the Irish drug group and U.S. partner Wyeth (WYE) said they will start early Phase III clinical trials of AAB-001, their treatment for mild to moderate Alzheimer's disease which analysts say could become a blockbuster drug.
With Phase III starting in mid-2007 rather than mid-2008 as previously expected, analysts say AAB-001 could potentially receive approval by the U.S. Food & Drug Administration by late-2008.
Investors liked the news, which indicates increased confidence in the Alzheimer's program. At 1050 GMT, Elan shares reached a daily high, rising nearly 13%, or EUR1.50, at EUR13.20 in Dublin, out performing the broader market with the ISEQ Overall Index up 0.9% at 9751. Although Phase II is not yet complete, the two drug companies said Phase III clinical trial design will be finalized with regulatory agencies, and subject to their approval, it will begin in the second half of 2007.
Davy Stockbrokers, which doesn't rate shares, raised its sum-of-the-parts valuation for Elan to $21.00 from $16.10 to reflect the "advance" in the Alzheimer's program. "This is a key catalyst for the shares," Davy's Jack Gorman said.
NCB Stockbrokers' Orla Hartford, who rates Elan a buy, said there was "real potential" for early filing of AAB-001, adding that interim analysis of Phase II over the next three months could "transform Elan's investment case."
She said that evidence of plaque reduction on the brain by AAB-001 with statistical evidence on quality of life improvements would provide a "compelling case" for filing AAB-001 for approval after Phase II is completed.
Goodbody Stockbrokers' Ian Hunter welcomed the early Phase III, but added, " The only frustrating element for the market is that, given that the Phase II trial is ongoing, we will not get a sight of the data until early 2008."
Hunter maintains a buy recommendation on Elan, predicting "conservative" peak annual sales for AAB-001 of $2.2 billion by 2014 should the treatment get final approval by the regulatory authorities.
"The Alzheimer's market is huge," Hunter said. "It has the potential to be the next big indication for pharmaceutical companies, especially as the baby boomers come into the Alzheimer's-prone age group."
Last month, Elan Corp's chief executive officer Kelly Martin told Dow Jones Newswires that there are about 10 million Alzheimer's patients in the U.S. and Europe, with tens of billions of dollars of potential revenue.
He also flagged a "series of Alzheimer's advancements" by year-end, shifting the focus away from Elan's multiple sclerosis drug Tysabri, which has up until now been the main focus for investors in the company.
Elan's share price has had a rollercoaster ride over the last five years: falling from its 2002 high of EUR50.27 due to revelation of now-resolved accounting troubles in 2002, and the temporary suspension of Tysabri in 2005.
In February 2005, Elan and joint venture partner Biogen Idec PLC (BIIB) suspended Tysabri in the U.S. on safety grounds. Tysabri was re-launched in the U.S. and launched for the first time in the E.U. in June 2006.
That temporary setback followed a long and arduous recovery for Elan, beginning with a change of senior management in 2002 when its former CEO and Chairman, the late Donal Geaney, resigned amid accounting troubles.
Company website: www.elan.com
-By Quentin Fottrell, Dow Jones Newswires; +353-1-6762189; quentin.fottrell@ dowjones.com
(END) Dow Jones Newswires
05-21-070715ET
Copyright (c) 2007 Dow Jones & Company, Inc.
________
Alles was ich hier poste, ist eine Satire.
Nichts ist wahr, Alles ist nur eine Geschichte.
Ähnlichkeit mit lebenden oder verstorbenen Personen sind rein zufällig.
Ähnlichkeit mit Tatsachen sind reiner Zufall.
Charts oder andere Meinungen sind keine Kaufempfehlungen.
Alles was ich hier schreibe sind reine Fiktionen.
Ein Bezug aus dieser virtuellen Welt zur realen Welt ist rein zufällig, nie intendiert und unterliegt der Täuschung des Lesers.
hat sich ja seit jahren nichts mehr getan. sollte sich das ändern? na ja, am pusch solls nicht hapern. schaun wer mal. es grüßt mcgeiz
nun tut sich eine ganze menge, am 28.4. entscheidet sich ob ein weiters medikament
in die produktion gehen darf, darum die anstiege.
Kursziele werden mit etwa 50€ prognostiziert.
in die produktion gehen darf, darum die anstiege.
Kursziele werden mit etwa 50€ prognostiziert.
NWBO.OB, BVTI.PK + ABPI.PK, IMUC.OB
am 23.5 ist es soweit.., die Us Gesundheitsbehörde beschließt ob das Medikament (telaprevir) auf den Markt darf oder nicht...hoffe mal alles geht gut und der kurs steigt weiter
Fokussiert man die Zahlen von Alkermes, geht es seit mehreren Quartalen nur bergab.
Die Anleger scheinen aktuell aber auf eine gute Zukunft zu hoffen.
www.erfolgreichinvestieren.ch/wp/...kermes-aktie-kein-hit-ist/
Die Anleger scheinen aktuell aber auf eine gute Zukunft zu hoffen.
www.erfolgreichinvestieren.ch/wp/...kermes-aktie-kein-hit-ist/
www.fool.com/investing/2018/04/02/...a-cellular-therapie.aspx
Es gibt keine neuen Beiträge.
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