Du wirst es einschätzen können, Gruss E.
chart.bigcharts.com/bc3/quickchart/...25&mocktick=1&rand=9677"
Spannende News von AELA:
AEterna reports positive Phase III Trial results with Impavido (miltefosine)
14:26 29.07.03
AEterna Laboratories Inc. reported today that results of a Phase III trial evaluating its drug Impavido(R) (miltefosine) for the treatment of cutaneous Leishmaniasis, a severe skin disease, showed that patients taking Impavido(R) had a 220% better cure rate compared with those in the placebo group. The average cure rate after treatment with Impavido(R) was 70%. This favourable data enables AEterna's subsidiary, Zentaris, which develops the drug, to immediately apply for a marketing authorization in South American countries where the cutaneous form of the disease is predominant.
"Impavido(R) is a breakthrough drug for the treatment of Leishmaniasis," said Prof. Jurgen Engel, Managing Director of Zentaris GmbH, Executive Vice President R&D and Chief Operating Officer at AEterna. "It has recently been approved in India as the first effective oral treatment for the life- threatening visceral form of Leishmaniasis. An even larger number of patients worldwide suffer from the cutaneous form of Leishmaniasis which can become a chronic, severely disfiguring condition. These patients are currently treated with toxic drugs that require hospitalization and intravenous administration which is often the source of new infections, like HIV. For that reason an effective orally administered drug is eagerly awaited."
Gilles Gagnon, President and Chief Executive Officer at AEterna added, "These results are another example of the depth and potential of our 12 product pipeline. Within the last three years, this pipeline has yielded three successful Phase III trials with Cetrotide(R) and Impavido(R), products which are already generating significant revenues."
About the Phase III trial
Impavido(R) was tested in a randomized, double-blind, placebo-controlled study in Colombia and Guatemala, involving 133 patients suffering from cutaneous Leishmaniasis. Of these patients, 89 were treated with Impavido(R), at a dosage of 150 mg/day for four weeks, while 44 received placebo. Cure from the disease was assessed six months after the end of treatment; all skin lesions had to be healed at that time and no new skin lesions were allowed to appear. Importantly, patients with newly diagnosed cutaneous Leishmaniasis responded to treatment equally well as patients who were not cured by prior therapy. The new treatment was well tolerated; side effects of Impavido(R) were limited to short episodes of vomiting or diarrhea, similar to earlier findings in patients with visceral Leishmaniasis.
About Leishmaniasis
Leishmaniasis is a tropical disease caused by the Leishmania parasite. According to the World Health Organization (WHO), more than 12 million people are affected worldwide, with an infection rate of 2 million new cases per year. Impavido(R) has recently been approved in India for the treatment of the visceral form of this disease.
About AEterna Laboratories Inc.
AEterna Laboratories has an extensive portfolio of marketed and development-stage biopharmaceutical products focused in oncology and endocrinology. Its lead oncology compound is Neovastat(R), a proprietary angiogenesis inhibitor with multiple mechanisms of action in a Phase III clinical trial for renal cell carcinoma (data available by year-end 2003) and in a Phase III trial for non-small cell lung cancer. Cetrotide(R), its lead compound in endocrinology is sold in the U.S. and Europe to the "in vitro" fertilization market, and is in clinical testing for endometriosis, uterus myoma and enlarged prostate (BPH). A further seven clinical programs are underway with various compounds. In addition, AEterna owns 62% of Atrium Biotechnologies, a profitable and growing developer, distributor and marketer of active ingredients, fine chemicals, cosmetic and nutritional products with sales exceeding $Cdn 100 million in 2002.
AEterna and its entities have 270 employees in Canada and Europe.
AEterna shares are listed on the Toronto Stock Exchange (AEL) and the NASDAQ National Market (AELA).
News releases and additional information about AEterna are available on its Web site at www.aeterna.com/. To find out more about the current Phase III trial in non-small cell lung cancer, call 1-888-349-3232.
Safe Harbor Statement
This press release contains forward-looking statements, which are made
pursuant to the safe harbor provisions of the U.S. Securities Litigation
Reform Act of 1995. Forward-looking statements involve known and unknown
risks and uncertainties which could cause the Company's actual results to
differ materially from those in the forward-looking statements. Such
risks and uncertainties include, among others, the availability of funds
and resources to pursue R&D projects, the successful and timely
completion of clinical studies, the ability of the Company to take
advantage of the business opportunities in the pharmaceutical industry,
uncertainties related to the regulatory process and general changes in
economic conditions. Investors should consult the Company's ongoing
quarterly and annual filings with the Canadian and U.S. securities
commissions for additional information on risks and uncertainties
relating to the forward-looking statements. Investors are cautioned not
to rely on these forward-looking statements. The Company does not
undertake to update these forward-looking statements.
For further information: CANADA: Media relations: Paul Burroughs, +1 (418) 652-8525 ext. 406, Cell.: +1 (418) 573-8982, Fax: +1 (418) 577-7671, E-mail: paul.burroughs@aeterna.com; Investor relations: Jacques Raymond, +1 (418) 652-8525 ext. 360, Cell.: +1 (514) 703-5654, Fax: +1 (418) 577-7671, E-mail:jacques.raymond@aeterna.com; USA: Investor relations: Lippert/Heilshorn & Associates, Kim Sutton Golodetz, +1 (212) 838-3777 E-mail: kgolodetz@lhai.com; GERMANY: Sales & Marketing: Dr. Mathias Pietras, +49 69 426023423, Fax: +49 69 426023444, E-mail: mathias.pietras@zentaris.de
Ausserdem gestern die Zulassung für ISTA Pharmaceuticals gelesen?
chart.bigcharts.com/bc3/quickchart/...46&mocktick=1&rand=7793"
ISTA Pharmaceuticals Announces FDA Approvable Letter for ISTALOL
MONDAY, JULY 28, 2003 7:01 AM
- PR Newswire
IRVINE, Calif., Jul 28, 2003 /PRNewswire-FirstCall via COMTEX/ -- ISTA Pharmaceuticals, Inc. (ISTA) today announced that the U.S. Food & Drug Administration (FDA) has issued an approvable letter for ISTALOL(TM), a once-a-day liquid formulation of timolol which has been developed for the treatment of glaucoma. Under an agreement between ISTA and Senju Pharmaceutical Co., Ltd., ISTA holds exclusive marketing rights to ISTALOL in the United States. In the letter, the FDA cited issues related to manufacturing methods and controls. No additional clinical studies were requested.
Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, "We're very pleased with the progress of the NDA submission for ISTALOL. We believe that the issues cited by FDA in the approvable letter are readily addressable. In addition, we are seeking to qualify an alternate manufacturing site. Based on this, we believe that the product remains on track for approval and launch in early 2004. We anticipate that the introduction of ISTALOL in the U.S. market, assuming FDA approval, would provide a significant improvement in patient care for the treatment of glaucoma."
ISTALOL was developed by Senju to be applied topically, once per day. Clinical trials of this new formulation have shown comparable efficacy and safety to timolol maleate ophthalmic solution, the leading beta-blocker, which is commonly applied twice a day. ISTALOL will compete in the glaucoma market, which according to published reports is valued at $1.1 billion per year in the United States.
ISTALOL is a branded, patent-protected product. ISTA believes that ISTALOL is eligible to receive certain FDA statutory exclusivity upon approval and therefore, if granted, ISTALOL will not be immediately substitutable by any of the generic timolol products currently on the market.
ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA's product candidates and programs seek to address serious diseases and conditions of the eye such as vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain and inflammation. Building on this pipeline, ISTA's goal is to become a fully integrated specialty pharmaceutical company by acquiring complementary products, either already marketed or in late-stage development.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. For example, statements in this press release regarding the timing and scope of any action with respect to the ISTALOL NDA or the timing and prospects of ISTALOL's approval or commercialization are forward-looking statements. ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially from current expectations. Important factors that could cause actual results to differ from current expectations include, among others: delays and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing, scope or outcome of product development efforts and the FDA or other regulatory agency approval or actions with respect to the ISTALOL NDA); uncertainties and risks related to the timing or outcome of resolving the issues cited in the FDA's approvable letter with respect to the ISTALOL NDA or qualifying an alternative manufacturer; uncertainties and risks regarding market acceptance of ISTALOL if approved and the impact of competitive products; uncertainties and risks regarding the continued timely performance by ISTA's strategic partners of their respective obligations under existing collaborations; the continued availability of third party sourced products and raw materials on commercially reasonable terms; the scope, validity, and enforceability of patents related to ISTA's products and technologies and the impact of patents and other intellectual property rights held by third parties; and, such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2002 and its Quarterly Report on Form 10-Q for the three month period ended March 31, 2003.
SOURCE ISTA Pharmaceuticals, Inc.
Vince Anido, +1-949-788-5311, vanido@istavision.com, or Lauren
Silvernail, +1-949-788-5302, lsilvernail@istavision.com, both of ISTA
Pharmaceuticals; Media - Justin Jackson, jjackson@ny.burnsmc.com, Investors -
Lisa Burns and E. Blair Clark, bclark@ny.burnsmc.com, all of Burns McClellan,
+1-212-213-0006, for ISTA Pharmaceuticals, Inc.
(ISTA)
Copyright (C) 2003 PR Newswire. All rights reserved.
Spannende News von AELA:
AEterna reports positive Phase III Trial results with Impavido (miltefosine)
14:26 29.07.03
AEterna Laboratories Inc. reported today that results of a Phase III trial evaluating its drug Impavido(R) (miltefosine) for the treatment of cutaneous Leishmaniasis, a severe skin disease, showed that patients taking Impavido(R) had a 220% better cure rate compared with those in the placebo group. The average cure rate after treatment with Impavido(R) was 70%. This favourable data enables AEterna's subsidiary, Zentaris, which develops the drug, to immediately apply for a marketing authorization in South American countries where the cutaneous form of the disease is predominant.
"Impavido(R) is a breakthrough drug for the treatment of Leishmaniasis," said Prof. Jurgen Engel, Managing Director of Zentaris GmbH, Executive Vice President R&D and Chief Operating Officer at AEterna. "It has recently been approved in India as the first effective oral treatment for the life- threatening visceral form of Leishmaniasis. An even larger number of patients worldwide suffer from the cutaneous form of Leishmaniasis which can become a chronic, severely disfiguring condition. These patients are currently treated with toxic drugs that require hospitalization and intravenous administration which is often the source of new infections, like HIV. For that reason an effective orally administered drug is eagerly awaited."
Gilles Gagnon, President and Chief Executive Officer at AEterna added, "These results are another example of the depth and potential of our 12 product pipeline. Within the last three years, this pipeline has yielded three successful Phase III trials with Cetrotide(R) and Impavido(R), products which are already generating significant revenues."
About the Phase III trial
Impavido(R) was tested in a randomized, double-blind, placebo-controlled study in Colombia and Guatemala, involving 133 patients suffering from cutaneous Leishmaniasis. Of these patients, 89 were treated with Impavido(R), at a dosage of 150 mg/day for four weeks, while 44 received placebo. Cure from the disease was assessed six months after the end of treatment; all skin lesions had to be healed at that time and no new skin lesions were allowed to appear. Importantly, patients with newly diagnosed cutaneous Leishmaniasis responded to treatment equally well as patients who were not cured by prior therapy. The new treatment was well tolerated; side effects of Impavido(R) were limited to short episodes of vomiting or diarrhea, similar to earlier findings in patients with visceral Leishmaniasis.
About Leishmaniasis
Leishmaniasis is a tropical disease caused by the Leishmania parasite. According to the World Health Organization (WHO), more than 12 million people are affected worldwide, with an infection rate of 2 million new cases per year. Impavido(R) has recently been approved in India for the treatment of the visceral form of this disease.
About AEterna Laboratories Inc.
AEterna Laboratories has an extensive portfolio of marketed and development-stage biopharmaceutical products focused in oncology and endocrinology. Its lead oncology compound is Neovastat(R), a proprietary angiogenesis inhibitor with multiple mechanisms of action in a Phase III clinical trial for renal cell carcinoma (data available by year-end 2003) and in a Phase III trial for non-small cell lung cancer. Cetrotide(R), its lead compound in endocrinology is sold in the U.S. and Europe to the "in vitro" fertilization market, and is in clinical testing for endometriosis, uterus myoma and enlarged prostate (BPH). A further seven clinical programs are underway with various compounds. In addition, AEterna owns 62% of Atrium Biotechnologies, a profitable and growing developer, distributor and marketer of active ingredients, fine chemicals, cosmetic and nutritional products with sales exceeding $Cdn 100 million in 2002.
AEterna and its entities have 270 employees in Canada and Europe.
AEterna shares are listed on the Toronto Stock Exchange (AEL) and the NASDAQ National Market (AELA).
News releases and additional information about AEterna are available on its Web site at www.aeterna.com/. To find out more about the current Phase III trial in non-small cell lung cancer, call 1-888-349-3232.
Safe Harbor Statement
This press release contains forward-looking statements, which are made
pursuant to the safe harbor provisions of the U.S. Securities Litigation
Reform Act of 1995. Forward-looking statements involve known and unknown
risks and uncertainties which could cause the Company's actual results to
differ materially from those in the forward-looking statements. Such
risks and uncertainties include, among others, the availability of funds
and resources to pursue R&D projects, the successful and timely
completion of clinical studies, the ability of the Company to take
advantage of the business opportunities in the pharmaceutical industry,
uncertainties related to the regulatory process and general changes in
economic conditions. Investors should consult the Company's ongoing
quarterly and annual filings with the Canadian and U.S. securities
commissions for additional information on risks and uncertainties
relating to the forward-looking statements. Investors are cautioned not
to rely on these forward-looking statements. The Company does not
undertake to update these forward-looking statements.
For further information: CANADA: Media relations: Paul Burroughs, +1 (418) 652-8525 ext. 406, Cell.: +1 (418) 573-8982, Fax: +1 (418) 577-7671, E-mail: paul.burroughs@aeterna.com; Investor relations: Jacques Raymond, +1 (418) 652-8525 ext. 360, Cell.: +1 (514) 703-5654, Fax: +1 (418) 577-7671, E-mail:jacques.raymond@aeterna.com; USA: Investor relations: Lippert/Heilshorn & Associates, Kim Sutton Golodetz, +1 (212) 838-3777 E-mail: kgolodetz@lhai.com; GERMANY: Sales & Marketing: Dr. Mathias Pietras, +49 69 426023423, Fax: +49 69 426023444, E-mail: mathias.pietras@zentaris.de
Ausserdem gestern die Zulassung für ISTA Pharmaceuticals gelesen?
ISTA Pharmaceuticals Announces FDA Approvable Letter for ISTALOL
MONDAY, JULY 28, 2003 7:01 AM
- PR Newswire
IRVINE, Calif., Jul 28, 2003 /PRNewswire-FirstCall via COMTEX/ -- ISTA Pharmaceuticals, Inc. (ISTA) today announced that the U.S. Food & Drug Administration (FDA) has issued an approvable letter for ISTALOL(TM), a once-a-day liquid formulation of timolol which has been developed for the treatment of glaucoma. Under an agreement between ISTA and Senju Pharmaceutical Co., Ltd., ISTA holds exclusive marketing rights to ISTALOL in the United States. In the letter, the FDA cited issues related to manufacturing methods and controls. No additional clinical studies were requested.
Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, "We're very pleased with the progress of the NDA submission for ISTALOL. We believe that the issues cited by FDA in the approvable letter are readily addressable. In addition, we are seeking to qualify an alternate manufacturing site. Based on this, we believe that the product remains on track for approval and launch in early 2004. We anticipate that the introduction of ISTALOL in the U.S. market, assuming FDA approval, would provide a significant improvement in patient care for the treatment of glaucoma."
ISTALOL was developed by Senju to be applied topically, once per day. Clinical trials of this new formulation have shown comparable efficacy and safety to timolol maleate ophthalmic solution, the leading beta-blocker, which is commonly applied twice a day. ISTALOL will compete in the glaucoma market, which according to published reports is valued at $1.1 billion per year in the United States.
ISTALOL is a branded, patent-protected product. ISTA believes that ISTALOL is eligible to receive certain FDA statutory exclusivity upon approval and therefore, if granted, ISTALOL will not be immediately substitutable by any of the generic timolol products currently on the market.
ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA's product candidates and programs seek to address serious diseases and conditions of the eye such as vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain and inflammation. Building on this pipeline, ISTA's goal is to become a fully integrated specialty pharmaceutical company by acquiring complementary products, either already marketed or in late-stage development.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. For example, statements in this press release regarding the timing and scope of any action with respect to the ISTALOL NDA or the timing and prospects of ISTALOL's approval or commercialization are forward-looking statements. ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially from current expectations. Important factors that could cause actual results to differ from current expectations include, among others: delays and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing, scope or outcome of product development efforts and the FDA or other regulatory agency approval or actions with respect to the ISTALOL NDA); uncertainties and risks related to the timing or outcome of resolving the issues cited in the FDA's approvable letter with respect to the ISTALOL NDA or qualifying an alternative manufacturer; uncertainties and risks regarding market acceptance of ISTALOL if approved and the impact of competitive products; uncertainties and risks regarding the continued timely performance by ISTA's strategic partners of their respective obligations under existing collaborations; the continued availability of third party sourced products and raw materials on commercially reasonable terms; the scope, validity, and enforceability of patents related to ISTA's products and technologies and the impact of patents and other intellectual property rights held by third parties; and, such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2002 and its Quarterly Report on Form 10-Q for the three month period ended March 31, 2003.
SOURCE ISTA Pharmaceuticals, Inc.
Vince Anido, +1-949-788-5311, vanido@istavision.com, or Lauren
Silvernail, +1-949-788-5302, lsilvernail@istavision.com, both of ISTA
Pharmaceuticals; Media - Justin Jackson, jjackson@ny.burnsmc.com, Investors -
Lisa Burns and E. Blair Clark, bclark@ny.burnsmc.com, all of Burns McClellan,
+1-212-213-0006, for ISTA Pharmaceuticals, Inc.
(ISTA)
Copyright (C) 2003 PR Newswire. All rights reserved.
