دورة المؤشرنت للتحليل الفني
50 دينار كويتي
توصية شراء .. عاجلة
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جزيل الشكر لك يابو عمر، على اخر الدقايق ظليت ابيع الف الف من 1.99 الى الأفتر اورز بعت اخر الفين على 2.35 وارتحت.
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عضو مبدع
- التسجيل
- 25 أبريل 2005
- المشاركات
- 394
السلام عليكم
هذي التوصية توها وصلتني بالايميل عن نفس الشركة ...
وخلاصة الخبر عن تركيبة دواء جديد والحديث عن بيع حق التركيبة والتوزيع وخلافه ...
المهم ... هل نتوقع صعود هالسهم في المستقبل في حال تمت صفقات على شراء التركيبة ؟؟؟
أتمنى من بو عمر أو أي واحد عنده فكرة يحلل لنا الموضوع
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هذي التوصية توها وصلتني بالايميل عن نفس الشركة ...
وخلاصة الخبر عن تركيبة دواء جديد والحديث عن بيع حق التركيبة والتوزيع وخلافه ...
المهم ... هل نتوقع صعود هالسهم في المستقبل في حال تمت صفقات على شراء التركيبة ؟؟؟
أتمنى من بو عمر أو أي واحد عنده فكرة يحلل لنا الموضوع
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(NASDAQ: AVNC) Is TheSUBWAY.com's Pick of the Day. Last Pick Traded Up 13% Intraday!
Advancis Pharmaceutical to Conduct Additional Adult Amoxicillin PULSYS Phase III Trial
Advancis Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it will conduct a new Phase III trial for its Amoxicillin PULSYS product candidate in adults and adolescents with pharyngitis/tonsillitis due to Group A strep infections. Enrollment in the clinical trial is expected begin in the fourth quarter of 2005. The Company believes it has the cash and resources to fund this trial through completion and to fund its research operations into early 2007.
Following extensive analysis of data from the Company's recently concluded unsuccessful Amoxicillin PULSYS clinical trials, Advancis has decided to extend the length of treatment in a new Phase III trial in adults and adolescents from seven days to 10 days for its product candidate.
"We are very eager to continue our development work on a once-daily Amoxicillin PULSYS product," said Edward M. Rudnic, Ph.D., chairman, president, and CEO of Advancis. "As a result of what we learned from our prior trials, we believe that our current once-a-day formulation dosed for 10 days has the potential to provide the efficacy required for product approval. In addition, we believe this therapy may yield eradication rates that are competitive with the most efficacious treatments for strep throat. This therapy would utilize Advancis' proprietary PULSYS technology and preserve the product's strongest marketing appeal of once-daily dosing."
Advancis' adult and adolescent pivotal trial is expected to be designed as a 600-patient, double-blind, double-dummy, non-inferiority trial to begin as early as November 2005. The Company anticipates comparing its Amoxicillin PULSYS dosage form for the treatment of pharyngitis/tonsillitis in adults and adolescents delivered in a once-daily, 775 milligram tablet for a period of 10 days to 250 milligrams of penicillin dosed four times daily, for a total of one gram per day, for 10 days.
Advancis' Amoxicillin PULSYS dosing of 775 milligrams for 10 days - or just under eight grams in total for this new therapy - compares to the most common amoxicillin therapy for pharyngitis that is dosed 500 milligrams three- times daily for a period of 10 days - or a total of 15 grams of amoxicillin over the full course of therapy. If successful, physicians prescribing Amoxicillin PULSYS would be able to dose approximately one-half the amount of amoxicillin in adult and adolescent patients with pharyngitis/tonsillitis, while at the same time providing the convenience of once-daily dosing.
Sale of Keflex Brand
Advancis also announced that it has reached an agreement in principle to sell the U.S. rights to the Keflex(R) brand of cephalexin to a private company. The Company has agreed to terms for the sale of its Keflex assets and has received a $1 million non-refundable upfront payment. Completion of the transaction is subject to negotiation of a definitive agreement and completion of necessary financing by the buyer. If the transaction is completed as expected by year-end, the Company anticipates receiving at least an additional $11 million in 2005 and a cumulative total of approximately $15 million could be realized over the next 12 months.
"We are very pleased with the terms of this agreement," said Dr. Rudnic. "We believe that we have built value in the Keflex franchise, which we have stewarded over the past 14 months. In selling the rights to Keflex, we are establishing a source of additional corporate funds that will provide us greater financial flexibility as we proceed with the continued development of our proprietary PULSYS technology."
Terms of the agreement include $3 million in potential milestone payments to Advancis following the approval of certain products currently under development, reimbursement of related development costs, and royalty income on subsequent net sales of such products.
Financial Guidance
Assuming the sale of Keflex closes as anticipated in 2005, full year 2005 financial results are expected to show total cash balance at December 31, 2005, in the range of $35 million to $38 million.
Advancis anticipates that its current funds along with proceeds from the sale of Keflex will be sufficient to support its new Phase III trial for Amoxicillin PULSYS and its other planned operations through 2006 and into early 2007. Assuming positive Phase III trial results and FDA approval of the Company's Amoxicillin PULSYS product in 2006, Advancis may consider raising additional capital to support the launch of Amoxicillin PULSYS and the potential development of additional PULSYS product candidates.
Total revenue for the 2005 is expected to be between $16 million and $18 million, resulting from sales of Keflex, reimbursed R&D payments, and recognition of license revenue during the year, and includes the recognition of $6 million of deferred revenue related to the termination of the Company's Amoxicillin PULSYS agreement with Par Pharmaceutical Companies, Inc. Net loss for the year is expected to be between $30 million and $35 million, or approximately $1.10 to $1.30 per diluted common share. Non-cash charges for 2005, consisting primarily of stock-based compensation expenses and depreciation and amortization, are expected to be approximately $6 million.
Conference Call
The Company has scheduled a conference call for today, September 15, 2005 at 10:30 AM ET. During the call, Dr. Edward Rudnic, chairman, president and CEO, and Steve Shallcross, senior vice president and CFO will discuss the expected clinical trial and other corporate activities. Investors can call 1- 800-813-8504 (domestic) and 1-706-643-7752 (international) prior to the 10:30 AM start time and ask for the Advancis Pharmaceutical conference call hosted by Dr. Rudnic. A replay of the call will be available on Thursday, September 15, 2005 beginning at 12:30 PM ET and will be accessible until Thursday, September 22, 2005 at 5:00 PM ET. The replay call-in number is 1-800-642-1687 for domestic callers and 1-706-645-9291 for international callers. The access number is 9542089.
The conference call will also be broadcast simultaneously on the Company's website, http://www.advancispharm.com. In addition, the Company will make slides available for viewing on the website in conjunction with the audio webcast. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary audio software. The call will also be archived on the Advancis website.
About Keflex:
Keflex(R) (cephalexin capsules, USP) is a first-generation cephalosporin antibiotic shown to be active against strains of both gram-positive and gram- negative aerobes in vitro and in clinical infections. Keflex is indicated for treatment of the following infections: respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections. More information on Keflex and prescribing information are available at http://www.advancispharm.com/products/keflex.
About Amoxicillin:
More than 54 million prescriptions for amoxicillin were written in 2004 with total retail sales of approximately $600 million. Amoxicillin is indicated for a broad range of infections, and is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis (sore throat), and sinusitis (sinus infection). According to data from IMS Health, a pharmaceutical research company, approximately one-quarter of amoxicillin prescriptions are written for pharyngitis, strep throat, and tonsillitis in adults and children.
About Advancis Pharmaceutical:
Advancis Pharmaceutical Corporation (NASDAQ: AVNC) is a pharmaceutical company focused on the development and commercialization of pulsatile drug products that fulfill substantial unmet medical needs in the treatment of infectious disease. The Company is developing a broad portfolio of anti- infective drugs based on its novel biological finding that bacteria exposed to antibiotics in frontloaded staccato bursts, or "pulses," are killed more efficiently and effectively than those under standard treatment regimens. Based on this finding, Advancis has developed a proprietary, once-a-day pulsatile delivery technology called PULSYS. By examining the resistance patterns of bacteria and applying its delivery technologies, Advancis has the potential to redefine infectious disease therapy and significantly improve drug efficacy, shorten length of therapy, and reduce drug resistance versus currently available antibacterial products. For more on Advancis, please visit http://www.advancispharm.com.
Advancis Pharmaceutical to Conduct Additional Adult Amoxicillin PULSYS Phase III Trial
Advancis Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it will conduct a new Phase III trial for its Amoxicillin PULSYS product candidate in adults and adolescents with pharyngitis/tonsillitis due to Group A strep infections. Enrollment in the clinical trial is expected begin in the fourth quarter of 2005. The Company believes it has the cash and resources to fund this trial through completion and to fund its research operations into early 2007.
Following extensive analysis of data from the Company's recently concluded unsuccessful Amoxicillin PULSYS clinical trials, Advancis has decided to extend the length of treatment in a new Phase III trial in adults and adolescents from seven days to 10 days for its product candidate.
"We are very eager to continue our development work on a once-daily Amoxicillin PULSYS product," said Edward M. Rudnic, Ph.D., chairman, president, and CEO of Advancis. "As a result of what we learned from our prior trials, we believe that our current once-a-day formulation dosed for 10 days has the potential to provide the efficacy required for product approval. In addition, we believe this therapy may yield eradication rates that are competitive with the most efficacious treatments for strep throat. This therapy would utilize Advancis' proprietary PULSYS technology and preserve the product's strongest marketing appeal of once-daily dosing."
Advancis' adult and adolescent pivotal trial is expected to be designed as a 600-patient, double-blind, double-dummy, non-inferiority trial to begin as early as November 2005. The Company anticipates comparing its Amoxicillin PULSYS dosage form for the treatment of pharyngitis/tonsillitis in adults and adolescents delivered in a once-daily, 775 milligram tablet for a period of 10 days to 250 milligrams of penicillin dosed four times daily, for a total of one gram per day, for 10 days.
Advancis' Amoxicillin PULSYS dosing of 775 milligrams for 10 days - or just under eight grams in total for this new therapy - compares to the most common amoxicillin therapy for pharyngitis that is dosed 500 milligrams three- times daily for a period of 10 days - or a total of 15 grams of amoxicillin over the full course of therapy. If successful, physicians prescribing Amoxicillin PULSYS would be able to dose approximately one-half the amount of amoxicillin in adult and adolescent patients with pharyngitis/tonsillitis, while at the same time providing the convenience of once-daily dosing.
Sale of Keflex Brand
Advancis also announced that it has reached an agreement in principle to sell the U.S. rights to the Keflex(R) brand of cephalexin to a private company. The Company has agreed to terms for the sale of its Keflex assets and has received a $1 million non-refundable upfront payment. Completion of the transaction is subject to negotiation of a definitive agreement and completion of necessary financing by the buyer. If the transaction is completed as expected by year-end, the Company anticipates receiving at least an additional $11 million in 2005 and a cumulative total of approximately $15 million could be realized over the next 12 months.
"We are very pleased with the terms of this agreement," said Dr. Rudnic. "We believe that we have built value in the Keflex franchise, which we have stewarded over the past 14 months. In selling the rights to Keflex, we are establishing a source of additional corporate funds that will provide us greater financial flexibility as we proceed with the continued development of our proprietary PULSYS technology."
Terms of the agreement include $3 million in potential milestone payments to Advancis following the approval of certain products currently under development, reimbursement of related development costs, and royalty income on subsequent net sales of such products.
Financial Guidance
Assuming the sale of Keflex closes as anticipated in 2005, full year 2005 financial results are expected to show total cash balance at December 31, 2005, in the range of $35 million to $38 million.
Advancis anticipates that its current funds along with proceeds from the sale of Keflex will be sufficient to support its new Phase III trial for Amoxicillin PULSYS and its other planned operations through 2006 and into early 2007. Assuming positive Phase III trial results and FDA approval of the Company's Amoxicillin PULSYS product in 2006, Advancis may consider raising additional capital to support the launch of Amoxicillin PULSYS and the potential development of additional PULSYS product candidates.
Total revenue for the 2005 is expected to be between $16 million and $18 million, resulting from sales of Keflex, reimbursed R&D payments, and recognition of license revenue during the year, and includes the recognition of $6 million of deferred revenue related to the termination of the Company's Amoxicillin PULSYS agreement with Par Pharmaceutical Companies, Inc. Net loss for the year is expected to be between $30 million and $35 million, or approximately $1.10 to $1.30 per diluted common share. Non-cash charges for 2005, consisting primarily of stock-based compensation expenses and depreciation and amortization, are expected to be approximately $6 million.
Conference Call
The Company has scheduled a conference call for today, September 15, 2005 at 10:30 AM ET. During the call, Dr. Edward Rudnic, chairman, president and CEO, and Steve Shallcross, senior vice president and CFO will discuss the expected clinical trial and other corporate activities. Investors can call 1- 800-813-8504 (domestic) and 1-706-643-7752 (international) prior to the 10:30 AM start time and ask for the Advancis Pharmaceutical conference call hosted by Dr. Rudnic. A replay of the call will be available on Thursday, September 15, 2005 beginning at 12:30 PM ET and will be accessible until Thursday, September 22, 2005 at 5:00 PM ET. The replay call-in number is 1-800-642-1687 for domestic callers and 1-706-645-9291 for international callers. The access number is 9542089.
The conference call will also be broadcast simultaneously on the Company's website, http://www.advancispharm.com. In addition, the Company will make slides available for viewing on the website in conjunction with the audio webcast. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary audio software. The call will also be archived on the Advancis website.
About Keflex:
Keflex(R) (cephalexin capsules, USP) is a first-generation cephalosporin antibiotic shown to be active against strains of both gram-positive and gram- negative aerobes in vitro and in clinical infections. Keflex is indicated for treatment of the following infections: respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections. More information on Keflex and prescribing information are available at http://www.advancispharm.com/products/keflex.
About Amoxicillin:
More than 54 million prescriptions for amoxicillin were written in 2004 with total retail sales of approximately $600 million. Amoxicillin is indicated for a broad range of infections, and is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis (sore throat), and sinusitis (sinus infection). According to data from IMS Health, a pharmaceutical research company, approximately one-quarter of amoxicillin prescriptions are written for pharyngitis, strep throat, and tonsillitis in adults and children.
About Advancis Pharmaceutical:
Advancis Pharmaceutical Corporation (NASDAQ: AVNC) is a pharmaceutical company focused on the development and commercialization of pulsatile drug products that fulfill substantial unmet medical needs in the treatment of infectious disease. The Company is developing a broad portfolio of anti- infective drugs based on its novel biological finding that bacteria exposed to antibiotics in frontloaded staccato bursts, or "pulses," are killed more efficiently and effectively than those under standard treatment regimens. Based on this finding, Advancis has developed a proprietary, once-a-day pulsatile delivery technology called PULSYS. By examining the resistance patterns of bacteria and applying its delivery technologies, Advancis has the potential to redefine infectious disease therapy and significantly improve drug efficacy, shorten length of therapy, and reduce drug resistance versus currently available antibacterial products. For more on Advancis, please visit http://www.advancispharm.com.
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Avnc
تتقدم - متجاوزة مقاومة الـــ 5,50
Last = 05.57
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Avnc
تتقدم - متجاوزة مقاومة الـــ 5,50
Last = 05.57
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دورة المؤشرنت للتحليل الفني
50 دينار كويتي