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$AUXL DD Notes ~ http://www.ddnotesmaker.com/AUXL
bullish
$AUXL recent news/filings
## source: finance.yahoo.com
Thu, 20 Nov 2014 12:33:56 GMT ~ Endo Announces Early Termination of HSR Act Waiting Period in Connection with its Proposed Acquisition of Auxilium Pharmaceuticals
[at noodls] - DUBLIN and CHESTERBROOK, Pa., Nov. 19, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) and Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) today announced that the waiting period under ...
read full: http://www.noodls.com/view/82E0A8BE20DB7F00A8D4E78ED4729EB9D098E6D1
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Thu, 20 Nov 2014 12:19:14 GMT ~ Auxilium Pharmaceuticals, Inc. Presents STENDRA Data At SMSNA Scientific Meeting
[at noodls] - CHESTERBROOK, Pa., Nov. 20, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that data were presented regarding the use of STENDRA® ...
read full: http://www.noodls.com/view/4F5E51992A7C4D0F709AE7C0BF80A99C394ECABB
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Thu, 20 Nov 2014 12:19:14 GMT ~ Auxilium Pharmaceuticals, Inc. Presents XIAFLEX For Peyronie's Disease Data At SMSNA Scientific Meeting
[at noodls] - CHESTERBROOK, Pa., Nov. 20, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced presentations of data from new studies, as well as ...
read full: http://www.noodls.com/view/38A552BEC5DE413B8EF682309D15D868CCF6C83F
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Thu, 20 Nov 2014 12:02:15 GMT ~ AUXILIUM PHARMACEUTICALS INC Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits
read full: http://biz.yahoo.com/e/141120/auxl8-k.html
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Thu, 20 Nov 2014 12:00:00 GMT ~ Auxilium Pharmaceuticals, Inc. Presents XIAFLEX For Peyronie's Disease Data At SMSNA Scientific Meeting
[PR Newswire] - CHESTERBROOK, Pa., Nov. 20, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced presentations of data from new studies, as well as ...
read full: http://finance.yahoo.com/news/auxilium-pharmaceuticals-inc-presents-xiaflex-120000629.html
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$AUXL charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$AUXL company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/AUXL/company-info
Ticker: $AUXL
OTC Market Place: Not Available
CIK code: 0001182129
Company name: Auxilium Pharmaceuticals, Inc.
Incorporated In: DE, USA
$AUXL share structure
## source: otcmarkets.com
Market Value: $1,734,220,921 a/o Dec 01, 2014
Shares Outstanding: 51,021,504 a/o Oct 27, 2014
Float: Not Available
Authorized Shares: Not Available
Par Value: 0.01
$AUXL extra dd links
Company name: Auxilium Pharmaceuticals, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=AUXL+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=AUXL+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=AUXL+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/news - http://finance.yahoo.com/q/h?s=AUXL+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/AUXL/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=AUXL+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/AUXL
DTCC (dtcc.com): http://search2.dtcc.com/?q=Auxilium+Pharmaceuticals%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Auxilium+Pharmaceuticals%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Auxilium+Pharmaceuticals%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/AUXL
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001182129&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=AUXL&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=AUXL
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=AUXL+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=AUXL+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=AUXL
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=AUXL
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=AUXL+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/AUXL/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=AUXL+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/AUXL.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=AUXL
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/AUXL
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/AUXL
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/AUXL:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=AUXL
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=AUXL
$AUXL DD Notes ~ http://www.ddnotesmaker.com/AUXL
$AUXL DD Notes ~ http://www.ddnotesmaker.com/AUXL
bullish long term investor buy and hold
dollar cost averaging, buy some each month purchase methods, etc...
$AUXL recent news/filings
## source: finance.yahoo.com
Thu, 02 Oct 2014 15:10:26 GMT ~ Auxilium Pharma downgraded by R. F. Lafferty
read full: http://finance.yahoo.com/q/ud?s=AUXL
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Wed, 01 Oct 2014 21:16:03 GMT ~ Endo Finance Co. -- Endo's new mesh litigation accrual is credit negative
read full: http://www.moodys.com/page/viewresearchdoc.aspx?docid=PR_309732&WT.mc_id=AM~WWFob29fRmluYW5jZTQyX1NCX1JhdGluZyBOZXdzX0FsbF9Fbmc=~20141001_PR_309732
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Mon, 29 Sep 2014 12:53:00 GMT ~ Auxilium Pharma (AUXL) Upgraded From Sell to Hold
read full: http://www.thestreet.com/story/12894696/1/auxilium-pharma-auxl-upgraded-from-sell-to-hold.html?puc=yahoo&cm_ven=YAHOO
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Wed, 24 Sep 2014 14:06:01 GMT ~ Biotech Stock Roundup: Auxilium an Acquisition Target, Amgen Submits another BLA
read full: http://finance.yahoo.com/news/biotech-stock-roundup-auxilium-acquisition-140601450.html
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Tue, 23 Sep 2014 22:34:58 GMT ~ Moody's says may review M&As if new tax rules lead to altered terms
[Reuters] - Moody's Investors Service said it may review the credit implications for pending tax-inversion deals in the healthcare and pharmaceutical sector if U.S. "While there is no immediate ratings impact on these companies, we will assess the credit implications of any changes they might make to their deals' terms, some of which may be credit negative," Moody's said on Tuesday. Moody's also said the assessment of the credit implications could result in credit-negative ratings for some of the mergers. In a separate release, Fitch Ratings said the new tax inversions rules were unlikely to deter the deal between Burger King Worldwide and Canada's Tim Hortons Inc.
read full: http://finance.yahoo.com/news/moodys-says-may-review-m-223458958.html
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$AUXL charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$AUXL company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/AUXL/company-info
Ticker: $AUXL
OTC Market Place: Not Available
CIK code: 0001182129
Company name: Auxilium Pharmaceuticals, Inc.
Incorporated In: DE, USA
$AUXL share structure
## source: otcmarkets.com
Market Value: $1,510,643,640 a/o Oct 02, 2014
Shares Outstanding: 50,354,788 a/o Aug 01, 2014
Float: Not Available
Authorized Shares: Not Available
Par Value: 0.01
$AUXL extra dd links
Company name: Auxilium Pharmaceuticals, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=AUXL+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=AUXL+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=AUXL+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/news - http://finance.yahoo.com/q/h?s=AUXL+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/AUXL/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=AUXL+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/AUXL
DTCC (dtcc.com): http://search2.dtcc.com/?q=Auxilium+Pharmaceuticals%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Auxilium+Pharmaceuticals%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Auxilium+Pharmaceuticals%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/AUXL
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001182129&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=AUXL&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=AUXL
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=AUXL+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=AUXL+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=AUXL
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=AUXL
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=AUXL+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/AUXL/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=AUXL+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/AUXL.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=AUXL
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/AUXL/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/AUXL/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/AUXL
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/AUXL
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/AUXL:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=AUXL
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=AUXL
$AUXL DD Notes ~ http://www.ddnotesmaker.com/AUXL
BOOMBAAAAA!!!
Cowen Reiterates Market Perform On Auxilium Following Phase 2a Data In Cellulite http://www.smarteranalyst.com/2014/08/22/cowen-reiterates-market-perform-on-auxilium-following-phase-2a-data-in-cellulite/
Auxilium Pharmaceuticals to Merge with Canadian Biotechnology Company QLT
CHESTERBROOK, Pa. and VANCOUVER, Canada, June 26, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, and QLT Inc. (NASDAQ: QLTI) (TSX: QLT), a Canadian-based biotechnology company focused on developing innovative orphan ophthalmology products, today announced that they have entered into a definitive agreement under which Auxilium plans to merge with QLT. The transaction is expected to drive shareholder value creation by accelerating Auxilium's ongoing transformation into a leading diversified North American specialty biopharmaceutical company. As a result of the merger, Auxilium expects to have an expanded corporate platform that includes focused investments in research and development and the continued pursuit of new products and M&A due to cost and tax synergies. The companies also intend to continue to pursue a potential partnering agreement for QLT's promising late-stage retinoid program.
Under the terms of the agreement, a wholly-owned subsidiary of QLT will be merged with and into Auxilium. QLT will remain incorporated in British Columbia, Canada, and will be renamed "New Auxilium." Current shareholders of Auxilium will receive 3.1359 QLT shares for each Auxilium share, subject to certain adjustments. For QLT shareholders, the transaction represents a 25% premium based on a calculation of the closing NASDAQ stock prices of Auxilium and QLT on June 25, 2014, the last trading day prior to the announcement of the merger. When completed, Auxilium shareholders will own approximately 76% of the combined entity on a fully diluted basis, and current QLT shareholders will own approximately 24%, subject to certain adjustments.
Adrian Adams, Chief Executive Officer and President of Auxilium, stated, "Building on Auxilium's strong foundation and commercial expertise, the merger with QLT represents a unique opportunity to accelerate our desired strategic transformation into a leading, diversified North American specialty biopharmaceutical company. We are creating what we believe is a more competitive and efficient platform to capitalize on greater market opportunities and position Auxilium to deliver meaningful value for shareholders while enhancing our ability to invest in and offer innovative products that make a difference in the lives of underserved patients."
"We believe that this is an excellent transaction for QLT shareholders and provides them with the opportunity to benefit from the potential upside of the combined company," said Jason Aryeh, Chairman of QLT. "We believe that Adrian Adams and the Auxilium team have proven their ability to execute and deliver on a strategy for providing quality specialty biopharmaceutical products to fill significant unmet medical needs around the world. I am confident that under their leadership, and with the advantages presented by our combined organization, this transaction will leave the merged company well-positioned to achieve sustained growth."
The combined organization will be led by Auxilium's current leadership team and will maintain Auxilium's current offices in Chesterbrook, Pennsylvania. All current Auxilium directors are expected to join the merged company's board, joined by two current QLT directors. Auxilium does not expect any material changes to its current U.S. operations or employment as a result of this transaction, and expects to grow its presence in both the U.S. and Canada. Shares of the combined company are expected to trade on NASDAQ and QLT is expected to be delisted from the Toronto Stock Exchange.
Mr. Adams continued, "We believe this transaction will facilitate the continued build out of our current portfolio and provide us with the corporate platform and strong financial position to build on our strength in men's healthcare and enable expansion into new specialty therapeutic focus areas. The transaction aligns with Auxilium's well-defined growth strategy and our intention to build a more diversified global organization through the aggressive pursuit of product licensing and M&A. We expect Auxilium to create increased value for shareholders and patients for years to come."
QLT Retinoid Program
QLT's synthetic retinoid program is a replacement for 11-cis-retinal and is under development for the treatment of retinal diseases caused by gene mutations that interfere with the availability of 11-cis-retinal. QLT has conducted safety and proof of concept clinical studies to evaluate its oral synthetic retinoid in patients with Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP). The innovative ophthalmology program is nearing Phase 3 development. With its orphan drug designation, QLT's synthetic retinoid program augments Auxilium's existing orphan drug portfolio and allows Auxilium to expand its orphan drug reach outside of the U.S. Auxilium and QLT intend to continue to pursue discussions around a potential partnering agreement for this promising late-stage retinoid program.
Approvals and Further Details
The transaction, which has been unanimously approved by the Boards of both companies, is subject to certain conditions and approvals, including regulatory approvals in the U.S. and Canada, if necessary, the approval of both companies' shareholders, consents under Auxilium's senior secured credit facility required as a result of the transaction or, in lieu of such consents, the refinancing of such facility, receipt of an opinion of counsel to Auxilium that "New Auxilium" should not be treated as a U.S. domestic corporation for U.S. federal income tax purposes, and other negotiated closing conditions. Deutsche Bank has delivered a commitment letter for a $225 million facility for the refinancing of the senior secured credit facility (together with cash on hand) that is subject to the execution of definitive agreements and other conditions. The transaction is expected to close in the fourth quarter of 2014, and is expected to be taxable to Auxilium shareholders. Holders representing approximately 32% of QLT shares outstanding have agreed to vote in favor of the transaction.
Deutsche Bank, Skadden Arps and Morgan Lewis acted as advisors to Auxilium. Houlihan Lokey Financial Advisors, Inc. also acted as an advisor to Auxilium. Credit Suisse, McCullough O'Connor Irwin LLP, Nutter McClennen & Fish LLP and KPMG LLP acted as advisors to QLT.
Conference Call
Auxilium will conduct a conference call with financial analysts to discuss this news release today at 8:30 a.m. ET. The presentation slides to be used during the call will be available on the "Investors" section of Auxilium's web site under the "Presentations" tab at 8:30 a.m. ET. A question and answer session will follow the presentation. The conference call and the presentation slides will be simultaneously webcast on the "Investors" section of Auxilium's website under the "Events" tab. The conference call will be archived via webcast for future review until July 26, 2014. Investors and other interested parties may call 866-510-0712 and enter passcode AUXILIUM. Please dial in 10 minutes prior to the scheduled start time.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing innovative products for specialist audiences. With a broad range of first- and second-line products across multiple indications, Auxilium is an emerging leader in the men's healthcare area and has strategically expanded its product portfolio and pipeline in orthopedics, dermatology and other therapeutic areas. The Company now has a broad portfolio of 12 approved products. Among other products in the U.S., Auxilium markets edex® (alprostadil for injection), an injectable treatment for erectile dysfunction, Osbon ErecAid®, the leading device for aiding erectile dysfunction, STENDRA® (avanafil), an oral erectile dysfunction therapy, Testim® (testosterone gel) for the topical treatment of hypogonadism, TESTOPEL® (testosterone pellets) a long-acting implantable testosterone replacement therapy, XIAFLEX® (collagenase clostridium histolyticum or CCH) for the treatment of Peyronie's disease and XIAFLEX for the treatment of Dupuytren's contracture. The Company also has programs in Phase 2 clinical development for the treatment of Frozen Shoulder syndrome and cellulite. To learn more, please visit www.Auxilium.com.
About QLT
QLT is a biotechnology company dedicated to the development and commercialization of innovative ocular products that address the unmet medical needs of patients and clinicians worldwide. QLT is focused on developing its synthetic retinoid program for the treatment of certain inherited retinal diseases. QLT's head office is based in Vancouver, Canada and the Company is publicly traded on NASDAQ Stock Market (symbol: QLTI) and the Toronto Stock Exchange (symbol: QLT). For more information about the Company's products and developments, please visit our web site at www.qltinc.com.
No Offer or Solicitation
This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Additional Information
In connection with the proposed merger, QLT plans to file with the Securities and Exchange Commission ("SEC") a Registration Statement on Form S-4 that will include a joint proxy statement of Auxilium and QLT that also constitutes a prospectus of QLT. Auxilium and QLT will mail the joint proxy statement/prospectus to their respective stockholders. INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS WHEN IT BECOMES AVAILABLE BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION. You will be able to obtain the joint proxy statement/prospectus, as well as other filings containing information about Auxilium and QLT, free of charge, at the website maintained by the SEC at www.sec.gov and, in QLT's case, also at the website maintained by the Canadian Securities Administrators ("CSA") at www.sedar.com. You may also obtain these documents, free of charge, from Auxilium's website (www.Auxilium.com) under the heading "Investors – SEC Filings" or by directing a request to Auxilium, Attention: Investor Relations, 640 Lee Road, Chesterbrook, PA 19087. You may also obtain these documents, free of charge, from QLT's website (www.qltinc.com) under the tab "Investors" and then under the headings "Securities Filings" and "Proxy Circulars" or by directing a request to QLT, Attention: Investor Relations, 887 Great Northern Way, Suite 250, Vancouver, BC, Canada, V5T 4T5.
Participants in the Solicitation
The respective directors and executive officers of Auxilium and QLT and other persons may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information regarding Auxilium's directors and executive officers is available in its definitive proxy statement filed with the SEC by Auxilium on April 10, 2014, and information regarding QLT directors and executive officers is available in its Annual Report on Form 10-K/A filed with the SEC and applicable Canadian securities regulators by QLT on April 30, 2014. These documents can be obtained free of charge from the sources indicated above. Other information regarding the interests of the participants in the proxy solicitation will be included in the joint proxy statement/prospectus and other relevant materials to be filed with the SEC and the applicable Canadian securities regulators when they become available.
Cautionary Statement Regarding Forward-Looking Statements
To the extent any statements made in this press release contain information that is not historical, these statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information as defined under applicable Canadian securities legislation (collectively, "forward-looking statements").
These forward-looking statements relate to, among other things, the degree to which the transaction accelerates Auxilium's ongoing transformation into a leading diversified North American specialty pharmaceutical company; whether the combined company's profitability increases in the future; the degree to which the transaction enhances Auxilium's growth profile, expands its geographic reach or the efficiencies of Auxilium's platform to drive shareholder value creation through increased investments in research and development; whether Auxilium pursues or obtains a potential strategic or partnering agreement for QLT's late-stage retinoid program; whether the transaction enables Auxilium to create a more competitive and efficient global platform, capitalize on greater market opportunities, positions Auxilium to deliver value for its shareholders, or enhances Auxilium's ability to invest in or offer innovative products; whether this transaction will facilitate the continued build-out of Auxilium's current portfolio and further build out its men's healthcare portfolio and establish new specialty therapeutic areas; whether the reorganized company is positioned to achieve growth, sustained or otherwise; whether QLT or Auxilium shareholders will receive any of the anticipated benefits of the transaction; the degree to which the closing of the transaction results in any changes to Auxilium's current U.S. operations or employment agreements, whether Auxilium will grow its presence in either the U.S. or Canada; whether QLT's synthetic retinoid program augments Auxilium's existing orphan drug portfolio or allows Auxilium to expand its orphan drug reach outside of the U.S.; when the transaction will close, if at all; completion of the various steps of the transaction including filing and mailing of the joint proxy statement/prospectus; the expected benefits of the proposed transaction such as efficiencies, cost savings, tax benefits, enhanced cash management flexibility, growth potential, market profile and financial strength; the tax consequences to shareholders; the competitive ability and position of the combined company; the expected timing of the completion of the transaction; whether the transaction will be taxable to Auxilium shareholders; or the securities exchange on which shares of the new parent company of Auxilium will trade. Forward-looking statements can generally be identified by the use of words such as "believe", "anticipate", "expect", "estimate", "intend", "continue", "plan", "project", "will", "may", "should", "could", "would", "target", "potential" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Although certain of these statements set out herein are indicated above, all of the statements herein that contain forward-looking statements are qualified by these cautionary statements Although Auxilium and QLT believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, including, but not limited to, factors and assumptions regarding the items outlined above. Actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things, the following: the failure to receive, on a timely basis or otherwise, the required approvals by Auxilium and QLT stockholders and government or regulatory agencies (including the terms of such approvals); the risk that a condition to closing of the merger may not be satisfied; the possibility that the anticipated benefits and synergies from the proposed merger cannot be fully realized or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of Auxilium and QLT operations will be greater than expected; the ability of Auxilium and QLT to obtain consents of lenders or to obtain refinancing in connection with the transaction, and if the transaction is consummated, the adequacy of the capital resources of "New Auxilium;" the ability of the combined company to retain and hire key personnel and maintain relationships with customers, suppliers or other business partners; the impact of legislative, regulatory, competitive and technological changes, including changes in tax laws or interpretations that could increase "New Auxilium's" or Auxilium's consolidated tax liabilities, including, if the transaction is consummated, changes in tax laws that would result in "New Auxilium" being treated as a domestic corporation for United States federal tax purposes; the risk that the credit ratings of the combined company may be different from what the companies expect; and other risk factors relating to the biopharmaceutical and medical device industries, or the business and operations of either of Auxilium or QLT as detailed from time to time in each of Auxilium's and QLT's reports filed with the SEC and, in QLT's case, the applicable Canadian securities regulators. There can be no assurance that the proposed merger will in fact be consummated.
Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this press release, as well as under Item 1.A. in each of Auxilium's and QLT's respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2013, and Item 1.A in each of Auxilium's and QLT's most recent Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2014. Auxilium and QLT caution that the foregoing list of important factors that may affect future results is not exhaustive. When relying on forward-looking statements to make decisions with respect to Auxilium and QLT, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Neither QLT nor Auxilium undertakes any obligation to update or revise any forward-looking statement, except as may be required by law.
Auxilium Contacts:
Keri P. Mattox / SVP, IR & Corporate Communications
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
kmattox@auxilium.com
Nichol L. Ochsner / Senior Director, IR & Corporate Communications
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
nochsner@auxilium.com
For Media:
George Sard, David Reno, Alexandra LaManna
Sard Verbinnen and Co.
(212) 687-8080
QLT Contacts:
Investor & Media Relations
Andrea Rabney or David Pitts
Argot Partners
(212) 600-1902
andrea@argotpartners.com
david@argotpartners.com
SOURCE Auxilium Pharmaceuticals, Inc.
Copyright 2014 PR Newswire
Study Suggests Link Between Viagra And Melanoma
http://www.forbes.com/sites/larryhusten/2014/04/08/study-suggests-link-between-viagra-and-melanoma/
4/08/2014 @ 12:28PM |2,917 views
Larry Husten, Contributor -- I'm a medical journalist covering cardiology news.
In recent years researchers have uncovered a potentially important pathway whereby PDE5A inhibitors (which include sildenafil– Viagra– and other drugs used to treat erectile dysfunction and pulmonary hypertension) could potentially increase the risk of developing melanoma. Now a new study provides early evidence showing an association between sildenafil and melanoma, though, like all observational studies, it is unable to demonstrate a cause-and-effect relationship.
The study, published in JAMA Internal Medicine, analyzed data from more than 25,000 men who participated in the Health Professionals Follow-up Study. Men who had recently used sildenafil had nearly twice the risk of developing melanoma after adjusting for other risk factors (hazard ratio 1.84, CI 1.04 – 3.22). Men who had used sildenafil at any time had a similar increase in risk. No increase in risk was observed for other skin cancers (basal cell carcinoma and squamous cell carcinoma) without known links to PDE5A inhibitors. In addition, there was no significant association between erectile function by itself and melanoma.
The investigators did not explore whether other PDE5A inhibitors, including tadalafil (Cialis) and vardenafil (Levitra), were associated with melanoma, since these drugs were not available at the start of the study. But in their discussion they point out that because these drugs are longer-acting they may potentially result in an even greater increase in risk for melanoma.
Because the study was a retrospective, observational study, the authors cautioned that their findings “should be interpreted cautiously and are insufficient to alter current clinical recommendations.”
In an accompanying editorial, June Robinson agrees with the authors that a prospective study will be required before clinical recommendations should be changed. But she sees little reason why physicians should not perform melanoma screening when writing a sildenafil prescription for older men who have a history of sunburns. Early detection, she noted, “may make melanoma a curable disease.”
Auxilium Pharmaceuticals, Inc. Submits Application To The FDA Requesting Approval Of XIAFLEX® For Concurrent Treatment Of Mu...
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CHESTERBROOK, Pa., Dec. 20, 2013 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) requesting approval of XIAFLEX (collagenase clostridium histolyticum, or CCH) for the treatment of multiple Dupuytren's contracture (DC) cords concurrently. It is estimated that 35 to 40 percent of annual surgical procedures in the U.S. are performed to treat more than one DC cord at a time. XIAFLEX is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.
"We are pleased to present the multicord sBLA filing to the FDA ahead of schedule, especially given the estimated high prevalence of multiple cords among patients suffering from Dupuytren's contracture," said Adrian Adams, Chief Executive Officer and President of Auxilium. "This is an important milestone for Auxilium and, importantly, for patients, as we believe that a potential label expansion would provide a non-surgical option for treating multiple cords during one office procedure."
The sBLA, seeking expansion of the labeling for the concurrent treatment of multiple palpable cords, is based on positive results from a global, multicenter Phase 3b trial, together with data from the Company's earlier MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) studies (AUX-CC-861 and AUX-CC-864).
About Dupuytren's Contracture
Dupuytren's disease is a progressive condition affecting the hand, specifically the layer of tissue just under the skin of the palm and fingers. While this layer of tissue normally contains collagen, in patients with Dupuytren's there is an increase in the amount of collagen produced. Abnormal collagen build-up results in nodule and cord formation that worsens over time. Eventually, rope-like collagen cords may form, thicken and shorten, causing the fingers to be drawn in toward the palm. This thickening and shortening of the Dupuytren's cord can reduce the finger's range of motion (how much a person can move or straighten them). Once the Dupuytren's collagen cord can be felt, it is referred to as a "palpable cord." [ii],[iii]
About XIAFLEX
XIAFLEX (collagenase clostridium histolyticum, or CCH) is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's contracture patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX consists of a combination of two subtypes of collagenase, derived from Clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. XIAFLEX has been granted Orphan status in the U.S. by the FDA for DC and PD. Additionally, CCH is currently being studied in clinical trials in the following collagen-related conditions: frozen shoulder syndrome (Phase 2), cellulite (Phase 2), and lipoma (Phase 2).
About Auxilium
Auxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing products to predominantly specialist audiences. Auxilium markets Testim (testosterone gel) for the topical treatment of hypogonadism in the U.S. and XIAFLEX (collagenase clostridium histolyticum (CCH) for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy in the U.S., and XIAFLEX for the treatment of adult Dupuytren's contracture patients with a palpable cord in the U.S. Ferring International Center S.A. markets Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in Canada. Swedish Orphan Biovitrium AB has marketing rights for XIAPEX® (the EU tradename for CCH) in 71 Eurasian and African countries. Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. Auxilium also markets TESTOPEL®, a long-acting implantable testosterone replacement therapy, Edex®, the leading branded non-oral drug for erectile dysfunction, Striant®, a buccal system for testosterone delivery, Osbon ErecAid®, the leading device for aiding erectile dysfunction, and also has a non-promoted respiratory franchise, including Theo-24® and Semprex®-D, along with other non-promoted products, in the U.S. Auxilium has exclusive marketing rights in the U.S. and Canada for STENDRA™, an oral erectile dysfunction therapy. Auxilium has two projects in clinical development. CCH is in Phase 2 of development for the treatment of Frozen Shoulder syndrome (adhesive capsulitis) and Phase 2 of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.
Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2b Frozen Shoulder Syndrome Study of Collagenase Clostr...
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CHESTERBROOK, Pa., Dec. 13, 2013 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, today announced that the first patient was dosed in its Phase 2b study of collagenase clostridium histolyticum (CCH) for the treatment of adult patients with adhesive capsulitis, commonly known as Frozen Shoulder syndrome (FSS). FSS can be a prolonged, painful condition of the shoulder in which increased capsular collagen thickening and subsequent capsular contraction in the shoulder joint is thought to cause a loss of range of motion in the shoulder and pain. The condition is believed to affect approximately two to five percent of the general adult population and the full duration of the disease can last from approximately one year to up to 3.5 years. Some cases never completely resolve. The majority of cases are currently managed conservatively with prolonged physical therapy and occasionally with steroid injections. It is estimated that approximately 300,000 cases of FSS are diagnosed annually and approximately 10 percent are treated with an invasive intervention such as surgery or manipulation under anesthesia on an annual basis.[ii]
CCH is a biologic approved in the U.S., EU, Canada and Australia under the trade name XIAFLEX® for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord and in the U.S. as the first Food and Drug Administration approved non-surgical treatment of adult men with Peyronie's disease (PD) with a palpable plaque. XIAFLEX consists of a combination of two subtypes of collagenase, derived from Clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. XIAFLEX has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.
"The initiation of our Phase 2b Frozen Shoulder syndrome study represents another development milestone for Auxilium as we further evolve our pipeline and advance a fourth potential indication for CCH," explained Adrian Adams, Chief Executive Officer and President of Auxilium. "We believe that our continued measured investments in research and development, together with the upcoming product launches of XIAFLEX in Peyronie's disease and STENDRA™ in erectile dysfunction, position the Company well for growth and shareholder value creation."
The Phase 2b study is a double-blind, placebo-controlled study of the safety and efficacy of CCH for the treatment of Stage 2 (frozen stage) unilateral idiopathic FSS. The study will enroll approximately 300 adult men and women at approximately 35 sites in the U.S. and Australia. Subjects will be randomized 3:1 to receive CCH or placebo and will receive up to three ultrasound-guided injections of study drug. Each injection will be separated by a minimum of 21 days. All subjects will also perform home shoulder exercises after the first injection.
In a prior Auxilium Phase 2a FSS study, both the 0.58mg (1mL) and 0.58mg (2mL) dosing arms showed statistically significant improvement (p<0.05) from baseline in forward flexion versus the exercise-only group. The 0.58mg (1mL) dosing arm also showed statistically significant improvement (p<0.05) from baseline in shoulder abduction versus the exercise-only group. For this Phase 2b study, the dose selected will be 0.58 mg (1mL).
The Phase 2b study's primary endpoint is the change (degrees) from baseline to the Day 95 follow-up visit in active forward flexion in the affected shoulder compared to placebo. Patients will also be assessed using the American Shoulder and Elbow Surgeons (ASES) Scale for function and pain as well as additional patient reported outcome measures. Safety assessments will be made during all study visits and immunogenicity testing will be performed at screening and at the end of the study.
"We are very excited to be moving into this next phase of development for CCH in the potential treatment of Frozen Shoulder," said Dr. James Tursi, Chief Medical Officer of Auxilium. "FSS is a condition with no approved therapies and limited treatment options. Innovative treatment approaches such as CCH, if approved by the FDA, may allow patients quicker relief from limits in range of motion and associated pain."
About Frozen Shoulder Syndrome
FSS, also known as adhesive capsulitis, can be a prolonged, and painful disorder of diminished shoulder motion. The full duration of the frozen stage (Stage 2) of disease can last from 1 to 3.5 years with a mean of 30 months. Increased capsular collagen thickening and subsequent capsular contraction in the glenohumeral joint is thought to cause restriction in both active and passive range of motion in the shoulder.[iii] As the condition progresses, pain can become more severe and is accompanied by stiffness and decreased range of motion. The stiffening may increase to the point where the natural arm swing that accompanies normal gait is lost.[iv] The most common treatments for FSS are long-term intensive physical therapy, corticosteroids, manipulation under anesthesia and/or arthroscopic release and each treatment has differing associated risks. Drugs are often used to manage associated pain, but none have been demonstrated to have an impact on the course of FSS.
FSS is estimated to affect approximately two to five percent of the general adult populationi and has an increased incidence among patients with diabetes,[v] Dupuytren's contracture, and thyroid disease. It tends to occur in a patient's fourth to sixth decade of life. The condition occurs slightly more often in women than in men, often presents bilaterally and commonly affects the contralateral side years after onset of symptoms in the first shoulder, but it does not typically affect the same shoulder twice.[vi]
About XIAFLEX
XIAFLEX (collagenase clostridium histolyticum, or CCH) is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX consists of a combination of two subtypes of collagenase, derived from Clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. XIAFLEX has been granted Orphan status in the U.S. by the FDA for DC and PD. Additionally, CCH is currently being studied in clinical trials in the following collagen-related conditions: frozen shoulder syndrome (Phase 2), cellulite (Phase 2), and lipoma (Phase 2).
About Auxilium
Auxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing products to predominantly specialist audiences. Auxilium markets Testim (testosterone gel) for the topical treatment of hypogonadism in the U.S. and XIAFLEX (collagenase clostridium histolyticum (CCH) for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy in the U.S., and XIAFLEX for the treatment of adult Dupuytren's contracture patients with a palpable cord in the U.S. Ferring International Center S.A. markets Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in Canada. Swedish Orphan Biovitrium AB has marketing rights for XIAPEX (the EU tradename for CCH) in 71 Eurasian and African countries. Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. Auxilium also markets TESTOPEL®, a long-acting implantable testosterone replacement therapy, Edex®, the leading branded non-oral drug for erectile dysfunction, Striant®, a buccal system for testosterone delivery, Osbon ErecAid®, the leading device for aiding erectile dysfunction, and also has a non-promoted respiratory franchise, including Theo-24® and Semprex®-D, along with other non-promoted products, in the U.S. Auxilium has exclusive marketing rights in the U.S. and Canada for STENDRA™, an oral erectile dysfunction therapy. Auxilium has two projects in clinical development. CCH is in Phase 2 of development for the treatment of Frozen Shoulder syndrome (adhesive capsulitis) and Phase 2 of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, including statements made with respect to: the design, efficacy, safety and timing of the Phase 2b study for CCH for the potential treatment of FSS; whether CCH will be approved by the FDA and, if approved, whether it will be an effective or successful treatment option for FSS; if approved, whether CCH for the potential treatment of FSS will allow quicker relief for patients; whether Auxilium is well positioned for growth and increased shareholder value; the timing of Auxilium's launches of XIALFLEX for the treatment of Peyronie's disease and of STENDRA; Auxilium's other product candidates; and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Although forward-looking statements are based on Auxilium's current plans or assessments that are believed to be reasonable as of the date of this press release, they inherently involve certain risks and uncertainties. These forward-looking statements are subject to a number of risks and uncertainties, including those discussed under ''Risk Factors'' in Auxilium's Annual Report on Form 10-K for the year ended December 31, 2012 and in other public filings with the SEC, including, without limitation, as such Form 10-K was updated in Item 8.01 of the Current Report on Form 8-K filed on April 29, 2013 and Auxilium's Quarterly Reports for 2013. While Auxilium may elect to update the forward-looking statements made in this news release in the future, Auxilium specifically disclaims any obligation to do so. Auxilium's SEC filings may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov. There may be additional risks that Auxilium does not presently know or that Auxilium currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements.
Auxilium Contacts:
Keri P. Mattox / SVP, IR &
Nichol L. Ochsner / Senior Director, IR &
Corporate Communications
Corporate Communications
Auxilium Pharmaceuticals, Inc.
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
(484) 321-5900
Kmattox@auxilium.com
Nochsner@auxilium.com
Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elbow Surg. 2011 Mar;20(3):502-14.
[ii] SDI claims data.
[iii] Pal B, Anderson J, Dick WC, Griffiths D. Limitation of joint mobility and shoulder capsulitis in insulin and non-insulin dependent diabetes mellitus.Br J Rheumatol. 1986;25:147-51.
[iv] Rizk TE, Pinals RS. Frozen shoulder. Semin Arthritis Rheum. 1982 May;11(4):440–452.
[v] Pal B, Anderson J, Dick WC, Griffiths D. Limitation of joint mobility and shoulder capsulitis in insulin and non-insulin dependent diabetes mellitus.Br J Rheumatol. 1986;25:147-51.
[vi] Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elbow Surg. 2011 Mar; 20(3):502-14.
SOURCE Auxilium Pharmaceuticals, Inc.
Copyright 2013 PR Newswire
$AUXL - Auxilium Could Get Bought, But Not Right Away -- Market Talk
4:44 PM ET 12/6/13 | Dow Jones
16:44 EST - Auxilium (AUXL) CEO Adrian Adams is known for making his investors money, having sold three prior companies to firms like Merck (MRK) and Abbott (ABT). But don't expect an AUXL auction right away, even after it got FDA approval for Xiaflex to treat severe penis curvature. Potential buyers will want to see the rate of initial uptake and how the threat of generic competition for its testosterone gel Testim plays out, says RBC Capital's Michael Yee in an email. "I was brought to the company to create another growth story, and that's what I'm going to do," Mr. Adams said in interview. AUXL ended up 12%. (joseph.walker@wsj.com)
> Dow Jones Newswires
December 06, 2013 16:44 ET (21:44 GMT)
Copyright (c) 2013 Dow Jones & Company, Inc.
Auxilium Pharma confirms FDA approval for XIAFLEX for the treatment of Peyronie's disease
1:30 PM ET 12/6/13 | Briefing.com
Co announced that the FDA has approved XIAFLEX (collagenase clostridium histolyticum, or CCH), an in-office, biologic for the treatment of Peyronie's disease (PD). XIAFLEX is the first and only FDA-approved treatment proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy. XIAFLEX has already been approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord. XIAFLEX for the treatment of DC is marketed under the trade name XIAPEX in the EU.
7:09AM Auxilium Pharma beats by $0.03, beats on revs (AUXL) 17.29 : Reports Q3 (Sep) earnings of $0.17 per share, $0.03 better than the Capital IQ Consensus Estimate of $0.14; revenues rose 52.3% year/year to $108.1 mln vs the $102.94 mln consensus.
For the third quarter of 2013, XIAFLEX U.S. net revenues increased by 20% over the comparable 2012 period to $15.9 million and U.S. Testim net revenues decreased by 7% to $50.7 million.
"We are pleased with the overall momentum of the business and are delighted to deliver what we consider to be a strong third quarter of record revenues in addition to significant non-GAAP earnings per share growth... The recent in-licensing of STENDRA, a first line oral therapy for erectile dysfunction, further reflects a successful execution of our corporate development and licensing strategy which remains focused on diversifying and strengthening our product portfolio. This, together with the potential opportunity for XIAFLEX in Peyronie's disease, if approved by the FDA, and measured progress in research and development with the initiation of a Phase 2a study in cellulite and pending initiation of a Phase 2b study in frozen shoulder later this year positions us well, we believe, to drive increased shareholder value over time."
7:03AM Auxilium Pharma announces license agreement for the marketing rights to STENDRA in the US and Canada (AUXL) 17.20 : Co announced the signing of an agreement with VIVUS (VVUS) providing Auxilium with the exclusive right to market VIVUS's product, STENDRA (avanafil), in the United States and Canada. The parties also simultaneously signed a Commercial Supply Agreement pursuant to which VIVUS will be initially responsible for the manufacture and supply of STENDRA to Auxilium. STENDRA is an oral therapy approved by the FDA for the treatment of erectile dysfunction.
Under the license, Auxilium will pay VIVUS a one-time license fee of $30 mln. Auxilium may make a $15 mln regulatory milestone payment to VIVUS if the FDA approves the STENDRA label to reflect a 15 minute or less onset of action efficacy claim and up to $255 mln in potential milestone payments based on the achievement of certain sales targets. VIVUS will also receive royalties on product sales. Auxilium expects to begin its commercial launch of STENDRA by the end of 2013, first with shipments of STENDRA in Dec 2013, followed by promotional activities in early Jan 2014 by its PRIMERA sales force. The co also plans to leverage digital media to reach a broader audience online. Auxilium believes that the transaction will be accretive in 2015.
7:31AM Auxilium Pharma presented data at the ASSH Annual Meeting About XIAFLEX; 42% of joints previously treated successfully with XIAFLEX exhibited disease recurrence at year 4 (AUXL) 18.34 : Co announced results from Year 4 of the Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study. These data indicated that the overall recurrence rate at Year 4 was 42.1 percent for patients previously treated successfully with XIAFLEX for Dupuytren's contracture.
The study assessed 623 joints in adult Dupuytren's patients with a palpable cord from earlier Auxilium studies, indicating that 57.9 percent of patients previously successfully treated with XIAFLEX did not experience disease recurrence based on the study's definition.
In the CORDLESS study, recurrence was defined as a 20 degree change of contracture with a palpable cord or when the treated joint underwent medical/surgical intervention. These data were highlighted as an oral presentation on October 5, 2013, at the 68th Annual Meeting of the American Society for Surgery of the Handn San Francisco, California.
Of the 623 joints that were successfully treated with XIAFLEX, only 12.8 percent of those joints received medical or surgical intervention through Year 4. Of the joints that received medical or surgical intervention by Year 4 of the study, patients were most commonly retreated with XIAFLEX.
Additional highlights from Year 4 of the CORDLESS study include: The overall recurrence rate increased by 15.4 percent between year two and three (19.6 to 35 percent) and increased by 7.1 percent from year three to four (35 to 42.1 percent). This represents a slowing of the recurrence rate in XIAFLEX treated patients over time. At four years, 87.2 percent of the 623 joints that achieved clinical success did not have a further surgery or other medical intervention. High severity proximal interphalangeal joints (those with baseline contractures > 40 degrees) had a higher recurrence rate than low severity PIP joints (71 percent versus 58 percent, respectively) at four years. Recurrence rates in successfully treated metacarpophalangeal joints with low severity (those with baseline contractures < 50 degrees) and high severity were comparable at four years (36 percent and 29 percent, respectively).
7:54AM On The Wires (WIRES) : Auxilium Pharmaceuticals (AUXL) announced that data from multiple trials evaluating the use of XIAFLEX ("collagenase clostridium histolyticum" or "CCH") in adult patients with Dupuytren's contracture with a palpable cord will be presented at the upcoming 68th Annual Meeting of the American Society for Surgery of the Hand ("ASSH") being held in San Francisco on Oct 3 - 5, 2013.
7:02AM Auxilium Pharma raises $50 mln in additional financing (AUXL) 18.53 : Co announced it entered into an Incremental Assumption Agreement with Morgan Stanley Senior Funding under its existing Credit Agreement with MSSF. Under the Incremental Agreement, the Company raised an additional $50,000,000 from a syndicate of lenders, and this additional amount is on terms consistent with its existing ~$225 mln senior secured credit facility. The Company expects to use these proceeds for general corporate purposes, including potential corporate development and licensing activities.
6:03AM Auxilium Pharma receives notification of XIAFLEX PDUFA extension (AUXL) 17.51 : Co announced that the FDA has notified the Company that it is extending the Prescription Drug User Fee Act goal date for the Company's supplemental biologics license application for XIAFLEX for the treatment of Peyronie's disease from September 6, 2013 to December 6, 2013
AUXL News Today EPS surprise
It should start moving more now and break out of range bound as of today. jmho
Here's is why:
7:18AM Auxilium Pharma beats by $0.14, beats on revs; guides FY13 revs in-line (AUXL) : Reports Q2 (Jun) earnings of $0.22 per share, excluding non-recurring items, $0.14 better than the Capital IQ Consensus Estimate of $0.08; revenues rose 28.5% year/year to $100.5 mln vs the $90.59 mln consensus. Co issues in-line guidance for FY13, sees FY13 revs of $363-405 mln vs. $371.84 mln Capital IQ Consensus Estimate, prior range $360-415 mln.
This Stock Is Gonna Fly after the first conference call!!!!!!!!. Mark my words Testopel and Edax are gonna be huge winners for this company. Comments? Forget about Xiaflex. Its Testopel that will propel this stock
AUXL I had taken a small position at $15.37 on 6/6 and then increased it on the 10th due to momentum and this looks like a play into the $20 range hopefully, seems like there is plenty of love for this stock by investors..
Auxilium Pharmaceuticals, Inc. to Present at the Cowen and Company 33rd Annual Healthcare Conference
Press Release: Auxilium Pharmaceuticals, Inc. – Mon, Mar 4, 2013 7:00 AM EST
CHESTERBROOK, Pa., March 4, 2013 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (AUXL) today announced that executive management will participate in the Cowen and Company 33rd Annual Global Healthcare Conference to be held March 4-6, 2013 at the Marriott Copley Place in Boston. Mr. Adrian Adams, Chief Executive Officer and President, is scheduled to present an overview of the Company and its product pipeline at 11:20 a.m. ET on Wednesday, March 6, 2013.
(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO)
The presentation will also be webcast on the "For Investors" section of the Auxilium website under the "Events" tab on March 6, 2013. To access the live webcast, please log on to Auxilium's website approximately fifteen minutes prior to the presentation to register and download any necessary audio software. The presentation replay will be available for ninety days after the event.
7:00AM Auxilium Pharma: FDA accepts XIAFLEX supplemental biologics license application filing for the treatment of Peyronie's Disease (AUXL) 18.34 : Co announced that the FDA has accepted for filing and granted standard review status to its supplemental Biologics License Application for XIAFLEX, in-office biologic therapy for the potential treatment of Peyronie's disease. Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to take action on the application by September 6, 2013. XIAFLEX is currently approved in the U.S., EU, Canada and Switzerland for the treatment of adult Dupuytren's contracture patients with a palpable cord. XIAFLEX for the treatment of PD was granted orphan designation in the U.S. by the FDA in January 1996 and, if approved by the FDA, is expected to be the first and only biologic therapy indicated for the treatment of PD
7:01AM Auxilium Pharma announces 'Encouraging' top-line 30-day data from XIAFLEX (CCH) Phase Ib study in cellulite (AUXL) 17.81 : Co announced top-line Day 30 data for collagenase clostridium histolyticum or CCH for the potential treatment, if approved by the U.S. FDA, of adult patients with cellulite. The phase Ib study is a single site, open-label dose-escalation study that enrolled 99 women between 21 and 60 years of age. The objectives of the study are to assess the safety and effectiveness of a single injection of CCH for the treatment of EFP at 30, 60 and 90 days across multiple dosing arms. Across all dosing arms, 60 patients (63%) who were treated experienced some improvement in the volume of their target cellulite dimple at Day 30. Overall, 17% of patients had a greater than or equal to 30% improvement in their target dimple at Day 30; however, multiple CCH dosing arms had more than 40 percent of patients experience an improvement greater than or equal to 30% in their target dimple at Day 30. Treatment-related adverse events with CCH were mostly localized bruising, injection site discomfort and swelling, and all such events resolved without intervention, which are all consistent with XIAFLEX use in other indications. There were no new adverse events and no drug-related serious adverse events reported.
Auxilium's Management Presents at Lazard Capital Markets Healthcare Conference (Transcript)
http://seekingalpha.com/article/1009371-auxilium-s-management-presents-at-lazard-capital-markets-healthcare-conference-transcript?source=yahoo
7:04AM Auxilium Pharma announces 30 month XIAFLEX safety update; safety profile consistent with clinical trials after ~ 27,000 injections administered in U.S. through July 31, 2012 (AUXL) 23.99 : Co announced a safety update following 30 months of post-approval use in the U.S. of XIAFLEX for the treatment of adult Dupuytren's contracture patients with a palpable cord. After ~ 27,000 injections administered to ~ 21,000 patients in the U.S., there was no clinically meaningful change in the nature of events expected relative to the clinical trial safety profile. From February 2, 2010 through July 31, 2012, approximately 1,454 adverse events have been reported to the Company. Of those reported events, the most commonly reported events were laceration, peripheral edema and contusion. Adverse event reporting requirements post-approval are different from requirements for reporting such events during a clinical trial. In the phase III clinical trials for registration, three (0.3%) subjects experienced a tendon rupture and one (0.1%) subject experienced ligament damage (pulley rupture) following XIAFLEX treatment of 1,082 subjects in the safety database. In the U.S. post-marketing period, 19 tendon ruptures (0.09%) and 3 ligament injuries (0.01%) from approximately 21,000 patients treated with commercial drug were reported. Additionally, there has been a single report of complex regional pain syndrome (0.005%), that resolved within approximately 3 months, and a single case of residual stretch neuropraxia (0.005%) with full finger extension and remote from the injection site.
7:04AM Auxilium Pharma announces additional Phase III XIAFLEX data to be presented at SMSNA meeting; results from the open-label sub-study were consistent with the double-blind placebo-controlled studies (AUXL) 23.29 : Co announced that additional data will be presented from its IMPRESS trials, the phase III studies that assessed XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease. A baseline analysis from IMPRESS focuses on the psychosocial impact on men with PD, specifically the level of PD bother and distress associated with PD as related to the degree of penile curvature deformity. At baseline, results showed that all degrees of curvature deformity evaluated in the studies may be associated with high levels of bother and distress. Specifically, more than half (58%) of patients with lesser levels of curvature deformity (30 to 60 degrees) reported that they were "very bothered" or "extremely bothered" about their condition. Additional results showed that 73% of patients with curvature deformity of 60 to 90 degrees were also "very bothered" or "extremely bothered" about their condition. A high level of patient-reported moderate to severe distress over PD was also noted among subjects with curvature deformity of 30 to 60 or 60 to 90 degrees (80.5% and 90.5%, respectively). In addition, photographs and data will presented from a subset of IMPRESS patients involved in the first study ever to use 3-D photographic technology for 360 degree assessment of penile curvature deformity in PD patients. The sub-study was conducted as part of an open-label phase III study allowing physicians to visualize the changes in penile curvature deformity for a patient after each XIAFLEX treatment cycle, including images from the patient's perspective. Patients were followed for 36 weeks and penile curvature deformity was 3-D photographed prior to each treatment cycle and at the end of the study. The results from this open-label sub-study were consistent with the double-blind placebo-controlled studies.
7:01AM Auxilium Pharma announces 'positive' top-line data from XIAFLEX Phase IIIb Dupuytren's contracture multicord study (AUXL) 26.70 : Co enrolled 60 patients at eight sites throughout the U.S. and Australia. In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the co to seek FDA approval and expansion of the Dupuytren's label. In this phase IIIb multicord study, 60 patients received two concurrent injections of 0.58 mg of XIAFLEX per affected hand and efficacy was based on a single injection per contracted joint. At 30 days, 60% of all joints, 76% of metacarpophalangeal (MP) and 33% proximal interphalangeal joints achieved clinical success (defined as joint correction to 0 to 5 degrees) following this single injection when two 0.58 mg doses of XIAFLEX were administered concurrently into the same hand. These response rates are numerically higher than the response rates seen after the first single injection in the double-blind placebo controlled phase III studies. The most common adverse events reported in this phase IIIb trial were bruising, pain and swelling at the treatment site. These AE's were comparable to the previous trials with certain events being slightly higher with two concurrent injections; bruising, pain, pruritus, and lymphadenopathy. Co intends to present additional data from the trial at a future medical conference. There were two related serious adverse events reported in the phase IIIb trial: an A2-A4 pulley rupture/ligament injury of the middle finger after middle and ring finger MP joint injections and a 24 hour hospitalization for pain control after two injections into a little finger.
9:29AM Auxilium Pharma and Actelion announce approval of XIAFLEX in Canada (AUXL) 26.80 : Co and Actelion Pharmaceuticals Canada announced that Auxilium was granted a Notice of Compliance by Health Canada for XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, first-in-class biologic for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada. Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion received exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Pursuant to the Collaboration Agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in Canada and, upon approval, in the remainder of these countries. Actelion expects to make
7:02AM Auxilium Pharma and FCB I file lawsuit against Watson (WPI) for infringement of Testim patents (AUXL) 19.23 : Co announced today that they filed a lawsuit against Watson Laboratories (WPI) for infringement of FCB's ten patents listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations as covering Testim 1% testosterone gel. The lawsuit was filed in the United States District Court for the District of New Jersey on May 23, 2012.
7:02AM Auxilium Pharma and GlaxoSmithKline (GSK) enter into a co-promotion agreement for Testim in the U.S.; AUXL raises guidance as a result (AUXL) : Auxilium Pharma and GSK announced that they have entered into an agreement for the co-promotion of Testim 1% (testosterone gel), which is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. Under the terms of the agreement, Auxilium granted GSK the exclusive right to co-promote the sale of Testim with Auxilium in the U.S. through September 30, 2015. "While the Auxilium sales force has consistently performed well in an increasingly competitive environment, adding the strength and breadth of GSK's U.S. commercialization organization will further enhance our sales efforts with U.S. physicians who treat this condition."
Co raises FY12 rev guidance to $293-315 mln from $283-305 mln vs $299.31 mln Capital IQ Consensus Estimate; reduces net loss guidance to ($5)-(10) mln from ($5)-(15) mln. "As a result of this morning's announcement concerning the Testim U.S. co-promotion agreement, we are increasing Testim revenue guidance and trimming net loss guidance for 2012. While we have not changed our previously stated guidance for Selling, General & Administrative expense, it is likely that we will be near the top end of the range."
7:13AM Auxilium Pharma and FCB I LLC announce the issuance of composition of matter patent covering Testim (AUXL) 18.49 : Co and FCB I LLC announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,178,518 covering, among other things, Testim 1% testosterone gel, marketed by Auxilium under license from FCB. The newly issued patent, which claims certain pharmaceutical compositions comprising testosterone, is expected to expire in April 2023. Auxilium has also submitted the patent for listing in the Approved Drug Products with Therapeutic Equivalence Evaluations, published by the U.S. Food and Drug Administration.
Auxilium Pharmaceuticals (AUXL), a specialty biotech that develops branded pharmaceuticals for urology and sexual health, in which New York-based Invus Public Equities filed SEC Form SC 13G/A on Tuesday indicating that it holds 2.6 million shares, a decrease from the 2.9 million shares it held at the end of Q4; and
http://seekingalpha.com/article/497771-noteworthy-institutional-5-ownership-filings-last-week?source=yahoo
~ Monday! $AUXL ~ Earnings posted, pending or coming soon! In Charts and Links Below!
~ $AUXL ~ Earnings expected on Monday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.
http://stockcharts.com/h-sc/ui?s=AUXL&p=D&b=3&g=0&id=p88783918276&a=237480049
http://stockcharts.com/h-sc/ui?s=AUXL&p=W&b=3&g=0&id=p54550695994
~ Google Finance: http://www.google.com/finance?q=AUXL
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=AUXL#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=AUXL+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=AUXL
Finviz: http://finviz.com/quote.ashx?t=AUXL
~ BusyStock: http://busystock.com/i.php?s=AUXL&v=2
<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=AUXL >>>>>>
http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916
*If the earnings date is in error please ignore error. I do my best.
3. Auxilium Pharmaceuticals Inc. (AUXL): Operates as a specialty biopharmaceutical company primarily in the United States. Market cap of $960.76M. On 04/15/2011, UBS had a Buy rating on the stock. The stock is a short squeeze candidate, with a short float at 10.02% (equivalent to 7.27 days of average volume). The stock has had a good month, gaining 11.01%.
http://seekingalpha.com/article/320482-ubs-loves-these-12-healthcare-stocks?source=yahoo
Auxilium Pharma AUXL UBS Buy $30 » $27
Read more: http://www.briefing.com/investor/calendars/upgrades-downgrades/#ixzz1cTDzAEvp
Overvalued 10 biotechs/pharmas? ; is AUXL one of them?
http://seekingalpha.com/article/301838-10-overvalued-healthcare-stocks?source=yahoo
8-K Form in regard to officers:
Form 8-K for AUXILIUM PHARMACEUTICALS INC
31-Oct-2011
Change in Directors or Principal Officers
Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
The employment of Mr. Roger D. Graham, Jr., Executive Vice President, Sales and Marketing, by Auxilium Pharmaceuticals, Inc. (the "Company") will terminate on November 28, 2011. Mr. Graham's Amended and Restated Employment Agreement, dated December 23, 2010, provides for certain severance benefits subject to Mr. Graham's execution and non-revocation of a written release in a form provided by the Company (the "Release"). Mr. Graham and the Company are currently discussing the terms of such Release. The Company will make all necessary disclosures with respect to any such Release upon the conclusion of such discussions.
AUXL $15 with financial results:
Auxilium reports Q3 EPS (8c) vs. consensus (21c)
theflyonthewall
Companies:
o Auxilium Pharmaceuticals Inc.
On Monday October 31, 2011, 7:07 am EDT
Reports Q3 revenue $66.7M vs. consensus $66.83M.
7:02AM Auxilium Pharma beats by $0.12, reports revs in-line (AUXL) 17.22 : Reports Q3 (Sep) loss of $0.08 per share, $0.12 better than the Capital IQ Consensus Estimate of ($0.20); revenues rose 24.4% year/year to $66.7 mln vs the $66.8 mln consensus. As of September 30, 2011, co had $149.6 mln in cash and cash equivalents compared to $151.8 mln on June 30, 2011.
Auxilium Pharma AUXL Collins Stewart Neutral » Buy $23
Read more: http://www.briefing.com/investor/calendars/upgrades-downgrades/#ixzz1bEmkj3q0
7:03AM Auxilium Pharma announced a 17 month safety update of XIAFLEX (AUXL) 16.40 : Auxilium Pharmaceuticals (AUXL) announced a safety update following 17 months of post-approval use in the U.S. of XIAFLEX for the treatment of adult Dupuytren's contracture patients with a palpable cord. After ~11,000 injections administered to ~10,000 patients in the U.S., there was no clinically meaningful change in the nature of events expected relative to the clinical trial safety profile.
Auxilium Pharma AUXL Collins Stewart Neutral $26 » $23
Read more: http://www.breifing.com/investor/calendars/upgrades-downgrades/#ixzz1Tq6jtcMt
7:03AM Auxilium Pharma beats by $0.08, beats on revs; lowers Xiaflex guidance (AUXL) 18.74 : Reports Q2 (Jun) loss of $0.11 per share, $0.08 better than the Capital IQ Consensus Estimate of ($0.19); revenues rose 30.5% year/year to $65.9 mln vs the $64.5 mln consensus. The co is decreasing full year 2011 guidance for XIAFLEX U.S. revenues from the previously stated guidance of a range of $50 to $60 million to a range of $45 to $50 million. -- The decrease in XIAFLEX U.S. revenues guidance changes full year 2011 net loss guidance from the previously stated guidance of a range of $(31) to $(41) million to a range of $(40) to $(45) million for the year. "We believe that the progress we made in the second quarter of 2011 will drive long term shareholder value. XIAFLEX showed double-digit sequential growth over the first quarter of 2011 and we remain encouraged by the success stories on XIAFLEX use, reflecting a steady shift in the treatment paradigm. Testim continued to perform well, despite several new competitors entering the market, with prescriptions posting growth over the second quarter of 2010 and over the first quarter 2011."
6 Highly Shorted Stocks Being Bought Up by Insiders
4. Auxilium Pharmaceuticals Inc. (AUXL): Drug Related Products Industry. Market cap of $930.49M. Float short at 21.57%. Net insider purchases over the last 6 months at 973,072 shares, which is 2.22% of the company's 43.80M share float. The stock has performed poorly over the last month, losing 12.35%.
http://seekingalpha.com/article/276054-6-highly-shorted-stocks-being-bought-up-by-insiders?source=yahoo
Auxilium Pharmaceuticals Announces Results from Three Year CORDLESS Extension Study in Dupuytren's Contracture
- Nominal Recurrence Rate of 34.8% at Three Years for Joints Previously Treated Successfully with XIAFLEX®
-93% of joints that were successfully treated with XIAFLEX did not receive any medical or surgical intervention through three years of follow-up.
Press Release Source: Auxilium Pharmaceuticals, Inc. On Thursday June 30, 2011, 7:00 am EDT
MALVERN, Pa., June 30, 2011 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL - News), a specialty biopharmaceutical company, today announced three year recurrence data from the Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study (CORDLESS) for XIAFLEX® (collagenase clostridium histolyticum) in the treatment of adult Dupuytren's contracture patients with a palpable cord. This five year observational study was designed to assess the durability of response following treatment with XIAFLEX, as well as long-term safety and progression of disease in patients from earlier Auxilium studies. At three years, the nominal recurrence rate for the 623 joints previously treated successfully with XIAFLEX was 34.8%.
(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO )
"In my opinion, the recurrence rate seen with XIAFLEX is comparable with or better than other minimally-invasive treatment options. More importantly, the fingers I have treated with XIAFLEX do not appear to develop scar tissue, as opposed to surgically treated fingers. Scar slows recovery and complicates further treatment," said Dr. Tom Kaplan, of the Indiana Hand to Shoulder Center. "As a result, first-line use of XIAFLEX preserves all of my treatment options for those patients who do recur."
Data from the XIAFLEX Three Year Follow-up
At three years, 34.8% of joints that had achieved clinical success had experienced recurrence. Of those patients with affected MP joints, 26.6% of joints that had achieved clinical success had recurrence through three years, while 56.4% of PIP joints that had achieved clinical success had recurrence through three years.
Recurrence per protocol definition of >20 degrees or medical intervention
All Joints
MP Joints
PIP Joints
Patients from all phase III studies (n=950)
1,568
920
648
Patients enrolled in extension studies (n=643)
1,080
648
432
Patients successfully treated and enrolled in extension study (n=478)
623
451
172
Joints with recurrence at 1 year (n/%)
19/623 (3.0%)
8/451 (1.8%)
11/172 (6.4%)
Joints with recurrence at 2 years (n/%)
122/623(19.6%)
64/451(14.2%)
58/172(33.7%)
Joints with recurrence at 3 years (n/%)
217/623 (34.8%)
120/451 (26.6%)
97/172 (56.4%)
The study also tracks whether a joint successfully treated with XIAFLEX received any further medical intervention. Through year three of follow-up 93.1% of joints that were successfully treated with XIAFLEX did not receive any medical or surgical intervention. Of the 43 (6.9 %) successfully treated joints that received medical or surgical intervention through three years, 30 had surgery, seven received needle aponeurotomy (of which 2 subsequently received a third intervention), and six received XIAFLEX. XIAFLEX has been commercially available in the U.S. only since March 2010.
Other Top-Line Findings through Three Years:
High severity PIP joints (those with baseline contractures > 40 degrees) had a statistically significant higher recurrence rate than low severity PIP joints (71% versus 50%, respectively). Combined with data from the CORD I study this suggests that treatment of PIP joints, before they reach high severity, may be beneficial(1).
Recurrence rates in successfully treated MP joints with low severity (those with baseline contractures less than or equal to 50 degrees) and high severity were not statistically different.
Sixteen patients in this study have been retreated with XIAFLEX (6 in a previously successfully treated joint and the remainder in previously untreated joints) through three years follow-up, with a local adverse event profile similar to previous first-line clinical studies. One retreated patient had a serious adverse event of a motor vehicle accident, which was considered unrelated to drug.
The adverse event profile of XIAFLEX treated joints through three years follow-up revealed no new long-term adverse events.
Of the 74 serious adverse events reported through three years of follow-up, none were considered related to XIAFLEX and none occurred in the treated finger.
"While I am very impressed with the three year recurrence rate of 35% using a 20 degree change to define recurrence, the surgical literature has often defined recurrence as a 30 degree change. Using this definition, XIAFLEX demonstrates an even lower 22% recurrence rate at three years,” said Dr. Vincent Hentz, Professor Emeritus, Surgery - Plastic/Recon Surgery, Stanford Medical School. “With this longer term data, I believe that treatment with XIAFLEX of Dupuytren’s patients’ palpable cords can provide durable outcomes with a very acceptable rate of recurrence in the majority of patients.”
Recurrence with XIAFLEX as defined by greater than or equal to 30 degrees standard used in surgical literature
Although there is no standard methodology to measure recurrence, the literature(2,3,4), on surgical treatment does reference a definition of recurrence as a 30 degree worsening of contracture following an intervention. XIAFLEX recurrence was defined in the AUX-CC-860 clinical study as a 20 degree change in the presence of a palpable cord. In order to evaluate within the context of the existing surgical literature, the three year XIAFLEX data was examined using a criterion referenced in the literature. Specifically, for this post hoc analysis, the definition of recurrence was (a) a joint contracture that was successfully treated (had previously achieved a reduction in contracture to five degrees or less at the Day 30 evaluation after the last injection of XIAFLEX) that subsequently increases by at least 30 degrees compared with the reference value with a palpable cord present or, (b) a joint which underwent correction to treat contracture in that joint. By this definition of recurrence, only 22% of patients who had achieved clinical success had experienced recurrence at three years. The recurrence rate for MP joints was 16% and for PIP joints was 39%.
7:02AM Auxilium Pharma announces results from 3 year CORDLESS extension study in dupuytren's contracture (AUXL) 19.61 : Co says 34.8% of joints that had achieved clinical success had experienced recurrence. Of those patients with affected MP joints, 26.6% of joints that had achieved clinical success had recurrence through three years, while 56.4% of PIP joints that had achieved clinical success had recurrence through three years. In addition, -93% of joints that were successfully treated with XIAFLEX did not receive any medical or surgical intervention through three years of follow-up.
7:13AM Auxilium Pharma misses by $0.01, misses on revs; guides FY11 revs in-line (AUXL) 23.44 : Reports Q1 (Mar) loss of $0.25 per share, $0.01 worse than the Thomson Reuters consensus of ($0.24); revenues rose 28.6% year/year to $58.4 mln vs the $61.1 mln consensus. Co issues in-line guidance for FY11, sees FY11 revs of $259-281 mln vs. $268.66 mln Thomson Reuters consensus. Co sees R & D Expense of $60-70 mln. Additionally, as a result of the $30 mln in regulatory milestones received from Pfizer and the $15 mln in milestones received from Asahi Kasei Pharma, the co is increasing full year 2011 XIAFLEX contract and ex-U.S. revenues from the previously stated guidance of a range of $5-7 mln to a range of $9-11 mln. The increase in XIAFLEX contract and ex-U.S. revenues changes full year 2011 net loss guidance from the previously stated guidance of a range of ($5) -($35) mln to a range of ($41) to ($31) mln for the year
Where is everybody? time to wake up!!!
Huge January 2011 Call option volume today. This is going to head back up!!!!!!!!
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http://finance.yahoo.com/q/sec?s=AUXL
Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, focuses on developing and marketing products to urologists, endocrinologists, orthopedists, and primary care physicians primarily in the United States. The company markets Testim, a topical 1% testosterone gel for the treatment of hypogonadism. Its product pipeline also includes XIAFLEX, an injectable collagenase enzyme, which is in Phase III of development for the treatment of Dupuytren?s contracture; and in Phase II of development for the treatment of Peyronie?s Disease and Adhesive Capsulitis. The company?s product pipeline also comprises AA4010, which is in Phase I of development for the treatment of overactive bladder using its transmucosal film delivery system; and A Fentanyl, a pain product, which is in Phase I of development. It has agreement with Pfizer, Inc. for the development, commercialization, and supply of XIAFLEX in European and Eurasian countries. The company was founded in 1999 and is headquartered in Malvern, Pennsylvania.
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