3SOF

AVNC had positive news today and sent the pps up nicely.  It is currently trading in the $2.20 range after hours.  Note on the 1 year chart below the small resistance between its current pps and $5.00.  Basically, it has the 200dma at $3.19, and then clear sailing.  I picked up a chunk in the $1.90's and will likely sell sometime before the stock ever reaches $5.00, but this is a very interesting looking chart.

Here is the news that got things started today:

Advancis Pharmaceutical to Conduct Additional Adult Amoxicillin PULSYS Phase III Trial
Thursday September 15, 7:00 am ET 
Company Signs Term Sheet to Sell Keflex Brand That Could Result in $15 Million and Royalties on New Product Sales; Updated Financial Guidance Provided for 2005 and 2006


GERMANTOWN, Md., Sept. 15 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation (Nasdaq: AVNC - News), 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® 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® (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 - News) 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.

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on Advancis' current expectations and assumptions. These statements are not guarantees of future performance and are subject to a number of risks and uncertainties that would cause actual results to differ materially from those anticipated. The words, "believe," "expect," "intend," "anticipate," and variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward- looking. Statements in this announcement that are forward-looking include, but are not limited to, statements about the Company's future development plans, clinical trials, and financial results. The actual results realized by Advancis could differ materially from these forward-looking statements, depending in particular upon the risks and uncertainties described in the Company's filings with the Securities and Exchange Commission. These include, without limitation, risks and uncertainties relating to the Company's financial results and the ability of the Company to (1) reach profitability, (2) prove that the preliminary findings for its product candidates are valid, (3) receive required regulatory approvals, (4) successfully conduct clinical trials in a timely manner, (5) establish its competitive position for its products, (6) develop and commercialize products that are superior to existing or newly developed competitor products, (7) develop products without any defects, ( have sufficient capital resources to fund its operations, (9) protect its intellectual property rights and patents, (10) implement its sales and marketing strategy, (11) successfully attract and retain collaborative partners, (12) implement, conduct, and successfully conclude its planned Phase III clinical trials for Amoxicillin PULSYS, and (13) retain its senior management and other personnel. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Advancis undertakes no obligation to update or revise the information in this announcement, whether as a result of new information, future events or circumstances or otherwise.




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Source: Advancis Pharmaceutical Corporation

here is my question.....

AVNC announced this news at 7am.  early morning.

why did it take till 3:30pm to run ?

[applaud] stocksquire. AVNC has a big gap down from a while ago that should get filled pretty fast.

I was finaly able to give that applaud for HYRF after I got my 50th post.

wow after hours up to 2.50.  to think started the day in the $1 range, if only we investors can pick stocks like this before they move!  good find, think it has legs still?

Thanks for the kind words, guys.  It has traded in the $2.60's pre-market, so it sure does looks like it stil has legs.  If I wanted in, I would probably wait for a morning dip -- I personally don't like to chase stocks, especially in the pre-market.  I will be selling some shares into this strength, and will likely reload if we get a nice dip.

I'm out with a 31% profit.  The chart doesn't show much resisitance and this can certainly go higher, but I couldn't resist taking the quick profits.  I will watch it today and may trade it again if we get a large dip.

This is a tempting buy again afer some healthy consolidation.  It held the $1.72 level on a number of tries.

Hi stocks.
I was looking at this stock on Friday and I knew if would feel the gap and possibly consolidate after a huge runup. I put a buy at 2.05 on Friday thinking it's a day order but it looks like it was a GTC so it triggered a buy this morning. I was pissed!
I really hope this is indeed a consolidation and it will go to its next resistance $3.
Let's see where it closes today.

This looks ready to bounce. Loaded up 20K shares at 1.30-1.31 this morning.

in other news, sold my axyx... (sigh) seems like it's going nowhere. Bought at 1.06, sold 1.13... oh well.

fwiw sold 20K avnc at 1.52 a few days back. may reenter axyx at 1.00.

Advancis Up on Clinical Trial Success
 

AVNC continued to make new highs after hitting the 50% Fibonacci Retracement....