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Down down down down
$60 come to daddy, earnings after the bell, facing shareholders days after every insiders dumped a ton of stock on the open market.
Good luck
Earnings tomorrow after the bell.
Wow never a good sign when you see all those insider transactions. All sells and disbursements.
Finally this trade is falling apart, this one took a long time. Stubborn little bastard.
damn calls 7/21
70 calls are at 2.30 up from .20 this morning
10 bags of happiness
Still runnin - this thing is incredible
Onyx Pharma ONXX Rodman & Renshaw Mkt Outperform $57 » $73
Read more: http://www.briefing.com/investor/calendars/upgrades-downgrades/#ixzz1yQcqmajR
2:38AM Onyx Pharma and Bayer HealthCare (BAYRY) Phase 3 MISSION trial of Nexavar in patients with non-small cell lung cancer Did Not Meet Primary Endpoint of improving overall survival (ONXX) 42.82 : Cos announce that a Phase 3 trial evaluating Nexavar tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival. An improvement in the secondary endpoint of progression-free survival was observed. The study compared Nexavar plus best supportive care to placebo plus best supportive care. The safety and tolerability data were generally as expected. The data will be presented at an upcoming scientific meeting.
~ Wednesday! $ONXX ~ Q1 Earnings posted, pending or coming soon! In Charts and Links Below!
~ $ONXX ~ Earnings expected on Wednesday *
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=ONXX&p=D&b=3&g=0&id=p88783918276&a=237480049
http://stockcharts.com/h-sc/ui?s=ONXX&p=W&b=3&g=0&id=p54550695994
~ Google Finance: http://www.google.com/finance?q=ONXX
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=ONXX#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=ONXX+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=ONXX
Finviz: http://finviz.com/quote.ashx?t=ONXX
~ BusyStock: http://busystock.com/i.php?s=ONXX&v=2
<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=ONXX >>>>>>
http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916
*If the earnings date is in error please ignore error. I do my best.
<<< $ONXX Links! >>> ~ MAC's Quick DD Links without the charts.
PennyStockTweets ~ http://www.pennystocktweets.com/stocks/profile/ONXX
OTC Markets Company Info ~ http://www.otcmarkets.com/stock/ONXX/company-info
OTC Markets Charts ~ http://www.otcmarkets.com/stock/ONXX/chart
OTC Markets Quote ~ http://www.otcmarkets.com/stock/ONXX/quote
OTC Markets News ~ http://www.otcmarkets.com/stock/ONXX/news
OTC Markets Financials ~ http://www.otcmarkets.com/stock/ONXX/financials
OTC Markets Short Sales ~ http://www.otcmarkets.com/stock/ONXX/short-sales
OTC Markets Insider Disclosure ~ http://www.otcmarkets.com/stock/ONXX/insider-transactions
OTC Markets Research Reports ~ http://www.otcmarkets.com/stock/ONXX/research
Google Finance Summary ~ http://www.google.com/finance?q=ONXX
Google Finance News ~ http://www.google.com/finance/company_news?q=ONXX
Google Finance Option chain ~ http://www.google.com/finance/option_chain?q=ONXX
Google Finance Financials ~ http://www.google.com/finance?q=ONXX&fstype=ii#
Google Finance Historical prices Daily ~ http://www.google.com/finance/historical?q=ONXX
Google Finance Historical prices Weekly ~ http://www.google.com/finance/historical?q=ONXX&histperiod=weekly#
Y! < Company >
Y! Profile ~ http://finance.yahoo.com/q/pr?s=ONXX+Profile
Y! Key Stat's ~ http://finance.yahoo.com/q/ks?s=ONXX+Key+Statistics
Y! Headlines ~ http://finance.yahoo.com/q/h?s=ONXX+Headlines
Y! Summary ~ http://finance.yahoo.com/q?s=ONXX
Y! Historical Prices ~ http://finance.yahoo.com/q/hp?s=ONXX+Historical+Prices
Y! Order Book ~ http://finance.yahoo.com/q/ecn?s=ONXX+Order+Book
Y! Message Boards ~ http://messages.finance.yahoo.com/mb/ONXX
Y! Market Pulse ~ http://finance.yahoo.com/marketpulse/ONXX
Y! Technical Analysis ~ http://finance.yahoo.com/q/ta?s=ONXX+Basic+Tech.+Analysis
Y! < Analyst Coverage >
Y! Analyst Opinion ~ http://finance.yahoo.com/q/ao?s=ONXX+Analyst+Opinion
Y! Analyst Estimates ~ http://finance.yahoo.com/q/ae?s=ONXX+Analyst+Estimates
Y! Research Reports ~ http://finance.yahoo.com/q/rr?s=ONXX+Research+Reports
Y! Star Analysts ~ http://finance.yahoo.com/q/sa?s=ONXX+Star+Analysts
Y! < Ownership >
Y! Major Holders ~ http://finance.yahoo.com/q/mh?s=ONXX+Major+Holders
Y! Insider Transactions ~ http://finance.yahoo.com/q/it?s=ONXX+Insider+Transactions
Y! Insider Roster ~ http://finance.yahoo.com/q/ir?s=ONXX+Insider+Roster
Y! < Financials >
Y! Income Statement ~ http://finance.yahoo.com/q/is?s=ONXX+Income+Statement&annual
Y! Balance Sheet ~ http://finance.yahoo.com/q/bs?s=ONXX+Balance+Sheet&annual
Y! Cash Flow ~ http://finance.yahoo.com/q/cf?s=ONXX+Cash+Flow&annual
FINVIZ ~ http://finviz.com/quote.ashx?t=ONXX&ty=c&ta=0&p=d
Investorshub Trades ~ http://ih.advfn.com/p.php?pid=trades&symbol=ONXX
Investorshub Board Search ~ http://investorshub.advfn.com/boards/getboards.aspx?searchstr=ONXX
Investorshub PostStream ~ http://investorshub.advfn.com/boards/poststream.aspx?ticker=ONXX
Investorshub Messages ~ http://investorshub.advfn.com/boards/msgsearch.aspx?SearchStr=ONXX
Investorshub Videos ~ http://ih.advfn.com/p.php?pid=ihvse&ihvqu=ONXX
Investorshub News ~ http://ih.advfn.com/p.php?pid=news&btn=s_ok&ctl00%24sb3%24tbq1=Get+Quote&as_values_IH=&ctl00%24sb3%24stb1=Search+iHub&symbol=ONXX&s_ok=OK&from_month=3&from_day=15&from_year=2012&order=desc&selsrc%5B%5D=prnca&selsrc%5B%5D=prnus&selsrc%5B%5D=zacks&selsrc%5B%5D=money2&selsrc%5B%5D=djn&selsrc%5B%5D=bw&selsrc%5B%5D=globe&selsrc%5B%5D=edgar&selsrc%5B%5D=mwus&force=1&last_ts=1331855999&p_n=1&p_count=&p_ts=1331794260
CandlestickChart ~ http://www.candlestickchart.com/cgi/chart.cgi?symbol=ONXX&exchange=US
Barchart Quote ~ http://barchart.com/quotes/stocks/ONXX?
Barchart Detailed Quote ~ http://barchart.com/detailedquote/stocks/ONXX
Barchart Options Quotes ~ http://barchart.com/options/stocks/ONXX
Barchart Technical Chart ~ http://barchart.com/charts/stocks/ONXX&style=technical
Barchart Interactive Chart ~ http://barchart.com/charts/stocks/ONXX&style=interactive
Barchart Technical Analysis ~ http://barchart.com/technicals/stocks/ONXX
Barchart Trader's Cheat Sheet ~ http://barchart.com/cheatsheet.php?sym=ONXX
Barchart Barchart Opinion ~ http://barchart.com/opinions/stocks/ONXX
Barchart Snapshot Opinion ~ http://barchart.com/snapopinion/stocks/ONXX
Barchart News Headlines ~ http://barchart.com/news/stocks/ONXX
Barchart Profile ~ http://barchart.com/profile//ONXX
Barchart Key Statistics ~ http://barchart.com/profile.php?sym=ONXX&view=key_statistics
OTC: American Bulls ~ http://www.americanbulls.com/StockPage.asp?CompanyTicker=ONXX&MarketTicker=OTC&TYP=S
NASDAQ: American Bulls ~ http://www.americanbulls.com/StockPage.asp?CompanyTicker=ONXX&MarketTicker=NASD&TYP=S
NYSE: American Bulls ~ http://www.americanbulls.com/StockPage.asp?CompanyTicker=ONXX&MarketTicker=NYSE&Typ=S
Marketwatch Profile ~ http://www.marketwatch.com/investing/stock/ONXX/profile
Marketwatch Analyst Estimates ~ http://www.marketwatch.com/investing/stock/ONXX/analystestimates
Marketwatch Historical Quotes ~ http://www.marketwatch.com/investing/stock/ONXX/historical
Marketwatch Financials ~ http://www.marketwatch.com/investing/stock/ONXX/financials
Marketwatch Overview ~ http://www.marketwatch.com/investing/stock/ONXX
Marketwatch SEC Filings ~ http://www.marketwatch.com/investing/stock/ONXX/secfilings
Marketwatch Picks ~ http://www.marketwatch.com/investing/stock/ONXX/picks
Marketwatch Hulbert ~ http://www.marketwatch.com/investing/stock/ONXX/hulbert
Marketwatch Insider Actions ~ http://www.marketwatch.com/investing/stock/ONXX/insideractions
Marketwatch Options ~ http://www.marketwatch.com/investing/stock/ONXX/options
Marketwatch Charts ~ http://www.marketwatch.com/investing/stock/ONXX/charts
Marketwatch News ~ http://bigcharts.marketwatch.com/news/symbolsearch/symbolnews.asp?news=markadv&symb=ONXX&sid=1795093&framed=False
The Lion ~ http://thelion.com/bin/aio_msg.cgi?cmd=search&msg=&si=1&tw=1&tt=1&rb=1&ih=1&fo=1&iv=1&yf=1&sa=1&fb=1&gg=1&symbol=ONXX
Search NYSE ~ http://www.nyse.com/about/listed/lcddata.html?ticker=ONXX
StockTA ~ http://www.stockta.com/cgi-bin/analysis.pl?symb=ONXX&num1=567&cobrand=&mode=stock
StockHouse ~ http://www.stockhouse.com/financialtools/sn_overview.aspx?qm_symbol=ONXX
StockHouse Delayed LII ~ http://www.stockhouse.com/financialtools/sn_level2.aspx?qm_page=46140&qm_symbol=ONXX
AlphaTrade ~ http://tools.alphatrade.com/index.php?t1=mc_quote_module&t2=mc_quote_module2&t3=historical&template=historical2html&sym=ONXX&client_id=2740&a_width=680&a_height=1000&language=english&showVol=1&chtype=8
Reuters ~ http://www.reuters.com/finance/stocks/companyOfficers?symbol=ONXX.PK&WTmodLOC=C4-Officers-5
StockWatch ~ http://www.stockwatch.com/Quote/Detail.aspx?symbol=ONXX®ion=U
Search NASDAQ ~ http://www.nasdaq.com/symbol/ONXX
NASDAQ Divy History ~ http://www.nasdaq.com/symbol/ONXX/dividend-history
NASDAQ Short Interest ~ http://www.nasdaq.com/symbol/ONXX/short-interest
NASDAQ Institutional Ownership ~ http://www.nasdaq.com/symbol/ONXX/institutional-holdings
NASDAQ FlashQuotes ~ http://www.nasdaq.com/aspx/flashquotes.aspx?symbol=ONXX&selected=ONXX
NASDAQ InfoQuotes ~ http://www.nasdaq.com/aspx/infoquotes.aspx?symbol=ONXX&selected=ONXX
NASDAQ After Hours Quote ~ http://www.nasdaq.com/symbol/ONXX/after-hours
NASDAQ Pre-Market Quote ~ http://www.nasdaq.com/symbol/ONXX/premarket
NASDAQ Historical Quote ~ http://www.nasdaq.com/symbol/ONXX/historical
NASDAQ Option Chain ~ http://www.nasdaq.com/symbol/ONXX/option-chain
NASDAQ Company Headlines ~ http://www.nasdaq.com/symbol/ONXX/news-headlines
NASDAQ Press Releases ~ http://www.nasdaq.com/symbol/ONXX/news-headlines
NASDAQ Sentiment ~ http://www.nasdaq.com/symbol/ONXX/sentiment
NASDAQ Analyst Summary ~ http://www.nasdaq.com/symbol/ONXX/analyst-research
NASDAQ Guru Analysis~ http://www.nasdaq.com/symbol/ONXX/guru-analysis
NASDAQ Stock Report ~ http://www.nasdaq.com/symbol/ONXX/stock-report
NASDAQ Competitors ~ http://www.nasdaq.com/symbol/ONXX/competitors
NASDAQ Stock Consultant ~ http://www.nasdaq.com/symbol/ONXX/stock-consultant
NASDAQ Stock Comparison ~ http://www.nasdaq.com/symbol/ONXX/stock-comparison
NASDAQ Call Transcripts ~ http://www.nasdaq.com/symbol/ONXX/call-transcripts
NASDAQ Annual Reports ~ http://www.nasdaq.com/aspx/annualreport.aspx?symbol=ONXX&selected=ONXX
NASDAQ Financials ~ http://www.nasdaq.com/symbol/ONXX/financials
NASDAQ Revenue & Earnings Per Share (EPS) ~ http://www.nasdaq.com/symbol/ONXX/revenue-eps
NASDAQ SEC Filings ~ http://www.nasdaq.com/symbol/ONXX/sec-filings
NASDAQ Ownership Summary ~ http://www.nasdaq.com/symbol/ONXX/ownership-summary
NASDAQ Institutional Ownership ~ http://www.nasdaq.com/symbol/ONXX/institutional-holdings
NASDAQ (SEC Form 4) ~
--------- All Trades ~ http://www.nasdaq.com/symbol/ONXX/insider-trades
--------- Buys ~ http://www.nasdaq.com/symbol/ONXX/insider-trades/buys
--------- Sells ~ http://www.nasdaq.com/symbol/ONXX/insider-trades/sells
The Motley Fool ~ http://caps.fool.com/Ticker/ONXX.aspx
The Motley Fool Earnings/Growth ~ http://caps.fool.com/Ticker/ONXX/EarningsGrowthRates.aspx?source=itxsittst0000001
The Motley Fool Ratios ~ http://caps.fool.com/Ticker/ONXX/Ratios.aspx?source=itxsittst0000001
The Motley Fool Stats ~ http://caps.fool.com/Ticker/ONXX/Stats.aspx?source=icasittab0000006
The Motley Fool Historical ~ http://caps.fool.com/Ticker/ONXX/Historical.aspx?source=icasittab0000004
The Motley Fool Scorecard ~ http://caps.fool.com/Ticker/ONXX/Scorecard.aspx?source=icasittab0000003
The Motley Fool Statements ~ http://caps.fool.com/Ticker/ONXX/Statements.aspx?source=icasittab0000009
MSN Money ~ http://investing.money.msn.com/investments/stock-ratings?symbol=ONXX
YCharts ~ http://ycharts.com/companies/ONXX
YCharts Performance ~ http://ycharts.com/companies/ONXX/performance
YCharts Dashboard ~ http://ycharts.com/companies/ONXX/dashboard
InsideStocks Opinion ~ http://www.insidestocks.com/texpert.asp?sym=ONXX&code=XDAILY
InsideStocks Profile ~ http://www.insidestocks.com/profile.asp?sym=ONXX&code=XDAILY
InsideStocks Quote ~ http://www.insidestocks.com/quote.asp?sym=ONXX&code=XDAILY
InsideStocks Projection ~ http://charts3.barchart.com/procal.asp?sym=ONXX
Zacks Quote ~ http://www.zacks.com/stock/quote/ONXX
Zacks Estimates ~ http://www.zacks.com/research/report.php?type=estimates&t=ONXX
Zacks Company Reports ~ http://www.zacks.com/research/report.php?type=report&t=ONXX
Knobias ~ http://knobias.10kwizard.com/files.php?sym=ONXX
StockScores ~ http://www.stockscores.com/quickreport.asp?ticker=ONXX
Trade-Ideas ~ http://www.trade-ideas.com/StockInfo/ONXX/HOT_TOPIC.html
Morningstar ~ http://performance.morningstar.com/stock/performance-return.action?region=USA&t=ONXX&culture=en-US
Morningstar Shareholders ~ http://investors.morningstar.com/ownership/shareholders-overview.html?t=ONXX®ion=USA&culture=en-us
Morningstar Transcripts~ http://www.morningstar.com/earnings/NoTranscript.aspx?t=ONXX®ion=USA
Morningstar Key Ratios ~ http://financials.morningstar.com/ratios/r.html?t=ONXX®ion=USA&culture=en-US
Morningstar Executive Compensation ~ http://insiders.morningstar.com/trading/executive-compensation.action?t=ONXX®ion=USA&culture=en-us
Morningstar Valuation ~ http://financials.morningstar.com/valuation/price-ratio.html?t=ONXX®ion=USA&culture=en-us
CCBN (Thompson Reuters) ~ http://ccbn.aol.com/company.asp?client=aol&ticker=ONXX
TradingMarkets ~ http://pr.tradingmarkets.com/?lid=leftPRbox&sym=ONXX
OTCBB ~ http://www.otcbb.com/asp/SiteSearch.asp?Criteria=ONXX&searcharea=e&image1.x=0&image1.y=0
Insidercow ~ http://www.insidercow.com/history/company.jsp?company=ONXX&B1=Search%21
Forbes News ~ http://search.forbes.com/search/find?tab=searchtabgeneraldark&MT=ONXX
Forbes Press Releases ~ http://search.forbes.com/search/find?&start=1&tab=searchtabgeneraldark&MT=ONXX&pub=businesswire,prnewswire&searchResults=pressRelease&tag=pr&premium=on
Forbes Web ~ http://search.forbes.com/search/web?MT=UNGS&start=1&max=10&searchResults=web&tag=web&sort=null
YouTube Symbol Search ~ http://www.youtube.com/results?search_query=ONXX
Buy-Ins ~ http://www.buyins.net/tools/symbol_stats.php?sym=ONXX
Quotemedia ~ http://www.quotemedia.com/results.php?qm_page=47556&qm_symbol=ONXX
Earnings Whispers ~ http://www.earningswhispers.com/stocks.asp?symbol=ONXX
Bloomberg Snapshot ~ http://investing.businessweek.com/research/stocks/snapshot/snapshot.asp?ticker=ONXX
Bloomberg People ~ http://investing.businessweek.com/research/stocks/people/people.asp?ticker=ONXX
Financial Times ~ http://markets.ft.com/Research/Markets/Tearsheets/Summary?s=ONXX
Investorpoint ~ http://www.investorpoint.com/ enter "ONXX" and click search.
Hotstocked ~ http://www.hotstocked.com/ enter "ONXX" and click search.
Raging Bull ~ http://ragingbull.quote.com/mboard/boards.cgi?board=ONXX
Hoovers ~ http://www.hoovers.com/search/company-search-results/100003765-1.html?type=company&term=ONXX
DD Machine ~ http://www.ddmachine.com/default.asp?m=stocktool_frame.asp?symbol=ONXX
SEC Form 4 ~ http://www.secform4.com/insider/showhistory.php?cik=ONXX
OTCBB Pulse ~ http://www.otcbbpulse.com/cgi-bin/pulsequote.cgi?symbol=ONXX
Failures To Deliver ~ http://failurestodeliver.com/default2.aspx enter "ONXX" and click search.
http://www.coordinatedlegal.com/SecretaryOfState.html
http://regsho.finra.org/regsho-Index.html
http://www.shortsqueeze.com/?symbol=ONXX&submit=Short+Quote%99
DTCC (PENSON/TDA) Check - (otc and pinks) - Note ~ I did not check for this chart blast. However, I try and help you to do so with the following links.
IHUB DTCC BOARD SEARCH #1 http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18682&srchyr=2011&SearchStr=ONXX
IHUB DTCC BOARD SEARCH #2: http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=14482&srchyr=2011&SearchStr=ONXX
Check those searches for recent ONXX mentions. If ONXX is showing up on older posts and not on new posts found in link below, The DTCC issues may have been addressed and fixed. Always call the broker if your security turns up on any DTCC/PENSON list.
http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18682&srchyr=2011&SearchStr=Complete+list
For a complete list see the pinned threads at the top here ---> http://tinyurl.com/TWO-OLD-FARTS
MACDlinks
hptaxis,
Looks like a lot of people are doing what the article suggests. As a long-time ONXX long, it is gratifying to see the stock price rise so much.
Onyx Pharma: An Underdog Worth Buying
http://www.thestreet.com/story/11460155/1/onyx-pharma-an-underdog-worth-buying.html
ONXX didn't miss, but rather beat expectations.
~ Wednesday! $ONXX ~ Earnings posted, pending or coming soon! In Charts and Links Below!
~ $ONXX ~ Earnings expected on Wednesday *
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=ONXX&p=D&b=3&g=0&id=p88783918276&a=237480049
http://stockcharts.com/h-sc/ui?s=ONXX&p=W&b=3&g=0&id=p54550695994
~ Google Finance: http://www.google.com/finance?q=ONXX
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=ONXX#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=ONXX+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=ONXX
Finviz: http://finviz.com/quote.ashx?t=ONXX
~ BusyStock: http://busystock.com/i.php?s=ONXX&v=2
<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=ONXX >>>>>>
http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916
*If the earnings date is in error please ignore error. I do my best.
Onyx Pharmaceuticals' CFO say company attractive target, Bloomberg reports
Theflyonthewall.comTheflyonthewall.com –
Matt Fust, the CFO of Onyx Pharmaceuticals (ONXX), which developed the kidney cancer drug Nexavar, said the company is an attractive target for acquirers because it may receive regulatory approvals for several new treatments during the next year, reports Bloomberg.
2:40AM Onyx Pharma Phase 3 Trial of investigational compound Regorafenib in metastatic colorectal cancer meets primary endpoint of improving overall survival (ONXX) : Co announces results from a Bayer HealthCare Pharmaceuticals (BAYRY) Phase 3 trial evaluating the investigational compound regorafenib for the treatment of patients with metastatic colorectal cancer whose disease has progressed after approved standard therapies. The trial met its primary endpoint of statistically significant improvement in overall survival. Onyx recently entered into an agreement with Bayer under which Bayer will pay Onyx a royalty on any future global net sales of regorafenib in oncology. Bayer will continue discussions with health authorities worldwide, including the EMA and FDA regarding next steps in filing for approval of regorafenib in the treatment of mCRC.
4:35PM Onyx Pharma misses by $0.26, misses on revs (ONXX) 30.37 -1.17 : Reports Q2 (Jun) loss of $0.43 per share, excluding non-recurring items, $0.26 worse than the Capital IQ Consensus Estimate of ($0.17); revenues fell 1.2% year/year to $68 mln vs the $74.6 mln consensus.
From a post by saw_bucks on the yahoo board.
<Onyx Pharma's Appeal Increases After Insights On Bayer DealFont size: A | A | A3:21 PM ET 11/4/10 | Dow Jones
By Jennifer Cummings
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Biopharmaceutical company Onyx Pharmaceuticals Inc. (ONXX) may start looking a lot more attractive to potential suitors next month.
The new allure comes after Onyx late Wednesday eased fears that an acquisition of the company would trigger much lower payments from its partnership with Germany-based Bayer AG (BAYRY) on the liver and kidney cancer drug Nexavar.
Shares of Onyx were recently up 5.6% to $28.19 on three times the average daily volume. The gains came even after the company reported mixed third-quarter results and lowered its 2010 global net sales guidance for Nexavar.
The momentum was sparked by new insights Onyx provided in a regulatory filing Wednesday about a clause in its partnership with Bayer.
Under the terms of the pact, their 50-50 profit-sharing agreement on the drug would end if Onyx were taken over, and Bayer would instead pay royalties to the newly formed company.
This so-called "change of control" clause has been an overhang on Onyx's shares because it was expected to trigger much lower payments to the company, likely detracting potential suitors.
But on Wednesday Onxx revealed new details about this clause, saying that as of Dec. 20 -- the fifth anniversary of the approval of Nexavar in kidney cancer -- the structure of the agreement with Bayer adjusts, and after that date, the value of the royalty payments will be "substantially equivalent" to the current 50-50 profit sharing agreement.
Onyx declined to comment on its potential as a takeover candidate and said it isn't actively pursuing a sale.
"If we receive an offer, the Onyx board of directors will evaluate the opportunity and what is best for shareholders, but we remain focused on building a standalone leading biopharmaceutical company," spokeswoman Lori Melancon told Dow Jones Newswires.
However, analysts said the new insights increase the appeal of the company.
"In our view, this significantly opens the playing field next year to potential acquirers looking for rights to a marketed cancer drug," Canaccord Adams said in a note Thursday.
Stifel Nicolaus & Co. analyst Stephen Willey said that while he thinks this will make a "non-Bayer acquisition of Onyx a bit more friendly," he noted that ongoing litigation between Onyx and Bayer could still put off potential acquirers.
Nexavar is Onyx's only approved product, and the company is working with Bayer on expanding the drug into other treatment areas, including late-stage lung cancer. Onyx also has a multiple myeloma drug, carfilzomib, in clinical trials and plans to file for U.S. approval of the drug in 2011.
-By Jennifer Cummings, Dow Jones Newswires; 212-416-2474; jennifer.cummings@dowjones.com>
Onyx Pharma enters Japanese drug development deal
Onyx Pharma gets Japanese drug development deal with potential value of more than $300 million
http://finance.yahoo.com/news/Onyx-Pharma-enters-Japanese-apf-2513117131.html?x=0&.v=2
9:03AM Onyx Pharma initiates a Phase 3 Carfilzomib combination trial in Relapsed Multiple Myeloma (ONXX) 20.79 : Co announces that it has begun enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid) and low dose dexamethasone in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment and received Scientific Advice from the European Medicines Agency on the design and planned analysis of the ASPIRE trial.
Company: Onyx Pharmaceuticals(ONXX)
Drug/indication: Carfilzomib for multiple myeloma
Estimated timing: Third quarter
Recent stock performance: Down 28% and near its 52-week low.
Onyx acquired the next-generation proteasome inhibitor carfilzomib when the company bought the privately held drug developer Proteolix in October 2009. This "pivotal" phase IIb study enrolled 269 patients with multiple myeloma that continued to grow despite two or three prior therapies. If carfilzomib can shrink tumors in a significant portion of these patients, Onyx intends to seek accelerated approval with the FDA.
http://www.thestreet.com/story/10805407/9/10-firms-expecting-clinical-trial-results.html
2:37AM Onyx Pharma: Ph. 3 trial of Nexavar in first-line advanced non-small cell lung cancer does not meet primary endpoint of overall survival (ONXX) 22.83 : Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announce that the final analysis of the Phase 3 NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar (sorafenib) tablets in patients with advanced non-squamous non-small cell lung cancer showed that the study did not meet its primary endpoint of improving overall survival in the first-line setting. NExUS evaluated Nexavar versus placebo in combination with two chemotherapeutic agents, gemcitabine and cisplatin. A positive secondary endpoint of progression-free survival was observed in the trial. The safety and tolerability of the treatment triplet was as expected and did not show any new or unexpected toxicities. Data from this study are expected to be presented at an upcoming scientific meeting. Co will host a teleconference and webcast on Monday, June 14, 2010, at 9:00 AM EST to provide an update on Nexavar tablets.
4:09PM Onyx Pharma will provide $20 mln in funding in partnership with S*BIO for JAK2 (JAKK) inhibitors (ONXX) 28.36 -0.87 :
Pfizer, Onyx drug offers hope against brain cancer
Tue Mar 30, 2010 1:00pm EDTStocks
Pfizer Inc.
* PD-0332991 shows "remarkable ability" in preclinical test
* Drug already in clinical trials for other cancer types
LONDON, March 30 (Reuters) - A drug being developed by Pfizer (PFE.N) and Onyx (ONXX.O) and already in clinical trials against a range of cancers has shown in laboratory tests "a remarkable ability" to halt growth of a deadly type of brain tumour, U.S. scientists said on Tuesday.
Researchers from Georgetown Lombardi Comprehensive Cancer Center and the University of California said the experimental drug, called PD-0332991, may become a new treatment option for glioblastoma, the commonest and deadliest form of brain cancer.
Clinical trials to test the drug in patients with recurrent brain cancer are under development, they said in a study published in the journal Cancer Research.
"We don't know how well this agent will perform in patients with glioblastoma but in the mice we studied we saw very impressive, durable effect," said David James, a professor of neurological surgery at UCSF, who worked on the study.
"What is especially encouraging about this agent is that we found it can easily pass through the blood-brain barrier and access glioblastoma, and that there is already a simple test available for screening glioblastoma patients in advance to see whether or not they should be responsive to this therapy."
Data from a recently-published study by The Cancer Genome Atlas Research Network, suggests about 90 percent of glioblastoma patients would be suitable candidates for the drug, he said.
PD-0332991, which Pfizer is developing under licence from Onyx, is being tested in human trials for other cancers such as multiple myeloma and mantle cell lymphoma. It is a pill designed to shut down activity of molecules called cyclin-dependent kinases 4 and 6 (cdk4 and cdk6) that drive cell division.
"In normal cells these kinases are kept under exquisite control by a gene known as p16," said Todd Waldman of Lombardi, who worked on the study with James.
"But in glioblastoma and other cancers, p16 is frequently deleted, and these two kinases are uncontrollably activated, which drives the cell to divide and form cancer."
But the drug does not work if the cancer is missing a protein known as retinoblastoma (Rb). A test for Rb is already being used to screen patients for use of PD-0332991 in the ongoing clinical trials.
In their study James's team implanted three different kinds of human glioblastoma directly into the brains of mice and then treated them with PD-0332991. They found the drug was able to get to the tumours and halt the cancer's growth as long as the mice stayed on the drug.
Because PD-0332991 itself does not kill cancer cells -- just halts their growth -- the researchers then combined the drug with radiation and found the combination worked better than PD-0332991 alone. They also successfully tested the drug in mice in which glioblastoma had come back after treatment with temozolomide, a chemotherapy used in many cancer patients. (Reporting by Kate Kelland; Editing by Greg Mahlich)
http://www.reuters.com/article/idCNLDE62T0GG20100330?rpc=44
Onyx Reports Higher Revenues
By Zacks Equity Research , On Wednesday February 24, 2010, 8:28 am
Onyx Pharmaceuticals (NasdaqGS: ONXX - News) has reported a fourth quarter loss of 9 cents per share, much better than a loss of 53 cents reported in the year-ago period. However, after adjusting non recurring items and treating stock-based compensation as a regular expense, the company reported earnings per share (EPS) of 4 cents compared to 7 cents in the fourth quarter of 2008. The Zacks Consensus Estimate for the reported quarter was 22 cents.
For the full year 2009, Onyx’s EPS (after adjustments) came in at 56 cents compared to 63 cents in 2008.
For the full year and fourth quarter of 2009, Onyx reported revenue from its Nexavar (sorafenib) collaboration agreement of $250.4 million (up 29%) and $67.3 million (up 35.6%), respectively. The increase in revenue is primarily due to an increase in Nexavar sales and royalty revenue partially offset by a rise in the drug’s commercial expenses.
Nexavar is currently approved and marketed for the treatment of liver cancer and advanced kidney cancer in the US, the European Union as well as other territories worldwide. The drug, manufactured by Bayer (Other OTC: BAYRY.PK - News), is being studied for several other indications as well – breast cancer, ovarian cancer, thyroid cancer and in combination therapy with chemotherapy agents.
Onyx and Bayer are splitting the development cost for Nexavar and share profits equally in all territories excluding Japan. Bayer pays royalty to Onyx on sales in Japan.
R&D expenses increased 3.8% in 2009 due to developmental programs of Nexavar for additional indications including thyroid, colorectal and adjuvant liver cancer and costs related to the further development of another candidate, ONX 0801.
In Sep 2009, Onyx began enrolling patients in a phase I study of ONX 0801 as a potential treatment for advanced solid tumors. This triggered a milestone payment of $7 million to BTG International Limited, which had licensed the drug to Onyx. Moreover, R&D expenses increased due to the development of carfilzomib following the acquisition of Proteolix in Oct 2009.
SG&A expenses increased 24.8% for the full year primarily due to an increase in cost associated with a rise in headcount and acquisition-related costs.
At the end of 2009, cash, cash equivalents, and marketable securities were $587.3 million, up from $458 million at the end of December 2008. The 84% increase in cash balance was primarily due to net proceeds from debt and equity financing in August 2009 and cash generated from operations, partially offset by cash paid for the Proteolix acquisition. We have a “Neutral rating on the stock.
8:04AM Onyx Pharma announces agreement with the FDA on a special protocol assessment for planned phase 3 carfilzomib combination trial in relapsed multiple myeloma (ONXX) 28.62 : Co announces it reached an agreement with the FDA on a Special Protocol Assessment for the Phase 3 international randomized trial. This pivotal trial, which is expected to begin in the first half of 2010, will enroll patients with relapsed multiple myeloma following treatment with one to three prior regimens. It is designed to evaluate the efficacy of carfilzomib in combination with lenalidomide and low dose dexamethasone, versus lenalidomide and low dose dexamethasone alone. "The SPA enables us to initiate this carfilzomib Phase 3 combination trial in the first half of this year with increased clarity on the full approval pathway, in the Phase 2b data reported at the American Society of Hematology meeting last December, carfilzomib showed promising response rates and good tolerability with this three-drug combination in patients with relapsed or refractory myeloma."
Onyx Pharmaceuticals Appoints Ted W. Love, M.D., as Head of Research & Development
Michael Kauffman, M.D., Ph.D., Named Chief Medical Officer
Press Release Source: Onyx Pharmaceuticals, Inc. On Monday February 1, 2010, 11:15 am
EMERYVILLE, Calif., Feb. 1 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that it has appointed Ted W. Love, M.D., Executive Vice President and Head of Research and Development. In addition, Michael Kauffman, M.D., Ph.D., who has served as Interim Chief Medical Officer since November 2009, has been appointed Chief Medical Officer reporting to Dr. Love.
In his new role, Dr. Love will report to the Chief Executive Officer and will be responsible for managing the research and development organization, including preclinical and clinical programs, regulatory affairs, quality assurance and control, and safety. Dr. Kauffman, in addition to partnering with Dr. Love across the company's portfolio, will continue to play a lead role in the clinical development of Onyx's pipeline of next-generation proteasome inhibitors, including carfilzomib, which is currently in a Phase 2b trial for relapsed, refractory multiple myeloma.
"Ted is a strategic thinker with broad leadership and management experience and a track record of developing some of the most successful cancer therapies, making him the ideal person to lead our research and development program of innovative oncology candidates," said N. Anthony Coles, M.D., President and Chief Executive Officer of Onyx. "Together, Ted and Michael bring highly complementary experience that spans solid tumor and hematologic cancers, and multiple drug classes and molecular pathways. These appointments empower Onyx with world class R&D leadership as we deliver on our vision to transform the lives of cancer patients and their families with innovative new medicines."
"Onyx has an established track record of success and a strong pipeline that could offer tremendous advances for patients and oncologists," said Dr. Love. "In addition to late-stage opportunities with Nexavar and carfilzomib, Onyx has acquired rights to a number of exciting earlier stage compounds that target some of the most innovative pathways in drug development. I look forward to partnering with Michael and the rest of the team to advance these novel molecules."
Most recently, Dr. Love was President, Chief Executive Officer, and Chairman of the Board of Directors of the biotechnology company Nuvelo, Inc. He grew Nuvelo into a late-stage development company focused on acute cardiovascular disease, cancer, and other debilitating medical conditions. Before joining Nuvelo in 2001, he served as Senior Vice President of Development at Theravance, Inc. Previously, Dr. Love spent six years at Genentech, Inc. in a number of senior management positions in Medical Affairs and Product Development. As Vice President of Product Development and Regulatory Affairs at Genentech, Dr. Love oversaw all drugs in development including Herceptin, Rituxan, and TNKase. He also served as chairman of Genentech's Product Development Committee.
Dr. Love earned his bachelor's degree in molecular biology from Haverford College and his medical degree at Yale Medical School. He completed his residency and fellowship training in internal medicine and cardiology at Massachusetts General Hospital and Harvard Medical School. Following residency training, Dr. Love joined the faculty of Massachusetts General in the department of cardiology. He currently serves on the board of directors of Affymax, Inc., Santarus, Inc., ARCA biopharma, Inc., and on the California Institute for Regenerative Medicine (CIRM) Independent Citizens' Oversight Committee.
Dr. Kauffman joined Onyx in November 2009 as Interim Chief Medical Officer. Most recently, Dr. Kauffman was Chief Medical Officer at Proteolix, Inc. where he was responsible for the clinical advancement of carfilzomib as well as their other pipeline candidates. Previously, Dr. Kauffman was President and Chief Executive Officer of EPIX Pharmaceuticals, Inc. (previously Predix Pharmaceuticals, Inc.) from 2002 to 2008. From 1997 to 2002, he held a number of senior medical and program leadership positions at Millennium Pharmaceuticals, Inc., where he played a key role in the development of the proteasome inhibitor VELCADE®. Earlier in his career, he served as Medical Director at Biogen Corporation (now Biogen Idec). Dr. Kauffman earned his undergraduate degree in biochemistry from Amherst College and his M.D. and Ph.D. in molecular biology and biochemistry from Johns Hopkins. He trained in Internal Medicine and Rheumatology at Beth Israel Deaconess Hospital and the Massachusetts General Hospital.
8:04AM Onyx Pharma: Carfilzomib demonstrates encouraging response rates in patients with relapsed and/or refractory multiple myeloma in an ongoing Phase 2 Study (ONXX) 29.77 : The co announces results from an ongoing Phase 2 study, known as the 004 study, of the company's lead proteasome inhibitor, carfilzomib. Results demonstrated promising overall response rates when carfilzomib was administered as a single agent in patients with relapsed and/or refractory multiple myeloma. These data were presented at the 51st annual meeting of the American Society of Hematology (ASH) in New Orleans... Overall, treatment with carfilzomib was well tolerated and no unexpected side effects occurred. The most common grade 3 treatment-related adverse events occurred in less than 5% of the patients and included fatigue, pneumonia, neutropenia, lymphopenia and anemia. Peripheral neuropathy of any grade was rare and there were no grade 4 adverse events observed.
Onyx Pharma ONXX Soleil started with a Buy rating & $35 price target
Onyx Pharma will pay up to $851M for Proteolix
Onyx will acquire Proteolix and its blood cancer drug candidate in deal worth up to $851M
On 8:02 am EDT, Monday October 12, 2009
Buzz up! 0 Print.Companies:Onyx Pharmaceuticals Inc.
NEW YORK (AP) -- Onyx Pharmaceuticals Inc. said Monday it will buy cancer drug developer Proteolix Inc. in a deal that could be worth as much as $851 million.
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Symbol Price Change
ONXX 26.90 0.00
{"s" : "onxx","k" : "c10,l10,p20,t10","o" : "","j" : ""} Onyx will pay $276 million upfront for the privately held South San Francisco company, and in the process it gains Proteolix's cancer drug candidate carfilzomib, which is being tested as a treatment for multiple myeloma, non-Hodgkin lymphoma, and solid tumors. Its drugs are designed to trigger cancer cell death with minimal damage to the rest of the patient's body.
Onyx, of South San Francisco, will pay another $40 million next year if carfilzomib reaches a development milestone, and will pay another $535 million if carfilzomib is approved in the U.S. and Europe. That includes a $170 million payment if the Food and Drug Administration decides to conduct a fast review of the drug.
The deal is expected to close in the fourth quarter, Onyx said.
Proteolix is conducting mid-stage clinical trials of carfilzomib as a standalone treatment for multiple myeloma, which is a cancer of the blood, and as a treatment for solid tumors. It is also running early-stage tests of carfilzomib as part of a combination therapy in addition to the lymphoma study.
The company is also testing an orally-dosed cancer drug, and is doing research on immunoselective compounds.
In premarket trading on Monday, Onyx shares rose 43 cents to $27.33.
(This version CORRECTS spelling of Onyx.)
Onyx Pharmaceuticals to Acquire Proteolix, Inc.
Acquisition Provides Next-Generation Product Candidate for Multiple Myeloma with Potential Accelerated Approval Pathway
Press Release
Source: Onyx Pharmaceuticals, Inc.
On 6:58 am EDT, Monday October 12, 2009
Buzz up! 0 Print.Companies:Onyx Pharmaceuticals Inc.
EMERYVILLE, Calif., Oct. 12 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that it has signed a definitive agreement to acquire Proteolix, Inc., a privately held biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of hematological malignancies and solid tumors. Proteolix's lead compound, carfilzomib, is a proteasome inhibitor currently in multiple clinical trials, including an advanced Phase 2b clinical trial for patients with relapsed and refractory multiple myeloma.
Related Quotes
Symbol Price Change
ONXX 26.90 0.00
{"s" : "onxx","k" : "c10,l10,p20,t10","o" : "","j" : ""} "Carfilzomib is a next generation product candidate with a proven and well-validated mechanism of action, strong efficacy signals, demonstrated tolerability and a potential accelerated approval pathway," said N. Anthony Coles, M.D., president and chief executive officer of Onyx. "This acquisition leverages Onyx's proven expertise in developing and commercializing Nexavar® and provides strategic expansion into the $16 billion hematological malignancies market. The transaction structure reflects our approach to growing our business in a disciplined fashion, including earnout payments contingent on specific approval-based events. In addition, our development plan is designed to maintain our ability to continue to grow operating cash flow in 2010 and beyond."
Under the terms of the transaction, Onyx will make a $276 million cash payment upon closing of the transaction. Additional payments include $40 million payable in 2010 based on the achievement of a development milestone and up to $535 million contingent upon the achievement of certain regulatory approvals for carfilzomib in the U.S. and Europe. Of the potential $535 million, a payment of $170 million is based upon the achievement of accelerated U.S. Food and Drug Administration approval. The transaction is expected to close in the fourth quarter of 2009, subject to the receipt of clearance under the Hart-Scott-Rodino Act and customary closing conditions.
"There is a tremendous need for new agents in multiple myeloma that can extend and improve the lives of patients and be used in combination with existing therapies. Current therapies are limited by serious side effects, particularly neurotoxicity, as well as limited duration of response and resistance," said Todd Yancey, vice president clinical development at Onyx. "We look forward to the presentation of important new data on carfilzomib at the American Society of Hematology meeting in December and the release of topline data from the Phase 2b trial in the second half of 2010."
Proteolix is developing several therapeutics that inhibit the cellular proteasome, a validated and well-characterized approach to treating certain hematological malignancies. Carfilzomib is a next generation proteasome inhibitor, selectively targeting the threonine protease with prolonged target suppression and improved anti-tumor activity in proof of concept trials. To date, carfilzomib has demonstrated strong response rates in multiple studies with an encouraging safety profile, including low rates of observed neurotoxicity, a known side effect of currently approved proteasome inhibitors. An ongoing 250-patient Phase 2b trial in patients with relapsed and refractory multiple myeloma is expected to complete enrollment in 2009 with data anticipated in the second half of 2010 to support a potential new drug application (NDA) filing by year-end 2010. A Phase 3 trial evaluating the combination of carfilzomib in combination with Revlimid and dexamethasone as a potential treatment option for patients with relapsed and refractory multiple myeloma is expected to begin in 2010. In addition, carfilzomib is being evaluated in a Phase 2 trial in relapsed patients with multiple myeloma. Carfilzomib is also being evaluated in a Phase 1b/2 study for solid tumor cancers. Proteolix is developing two molecules in addition to carfilzomib: an oral proteasome inhibitor and a selective inhibitor of the immunoproteasome.
Management Conference Call Today
Onyx will host a teleconference and webcast today to provide a general business overview and discuss the acquisition. The event will begin at 8:00am ET. The live webcast will be available at:
http://www.onyx-pharm.com/view.cfm/32/Event-Calendar
or by dialing 847-413-3362 847-413-3362 and using the passcode 25577870. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 630-652-3044 and using the passcode 25577870 later in the day. The replay will be available through November 12, 2009.
Briefing with External Clinical Experts
Following the teleconference, Onyx will host a webcast presentation at 11:00am ET with clinical experts in multiple myeloma who will review and discuss the disease landscape and the clinical development of carfilzomib.
The live webcast will be available at: http://www.onyx-pharm.com/view.cfm/32/Event-Calendar
A replay of the webcast will be available on the Onyx website through November 12, 2009.
About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with MM and approximately 20,000 new cases are diagnosed annually (i). Worldwide, more than 180,000 people are living with MM and approximately 86,000 new cases are diagnosed annually (ii).
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar®, a small molecule drug. Nexavar is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. For more information about Onyx, visit the company's website at www.onyx-pharm.com.
Nexavar® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals.
About Proteolix
Founded in December 2003, Proteolix, Inc. is a privately-held biopharmaceutical company, headquartered in South San Francisco, dedicated to discovering, developing and commercializing novel therapeutics that target protein degradation pathways for cancer and autoimmune diseases. Proteolix's lead product, carfilzomib, is the first in a new class of highly specific proteasome inhibitors, and is currently in multiple Phase 2 clinical studies to evaluate its safety and efficacy in multiple myeloma and other malignancies. Proteolix is also developing a pipeline of novel proteasome inhibitors, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor.
Forward Looking Statements
This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the consummation and anticipated benefits of the proposed acquisition of Proteolix and the timing, progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of carfilzomib. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks related to the ability of each company to meet the conditions necessary to close this transaction, the risk that Proteolix's operations will not be integrated successfully into Onyx's, the risk that Onyx may not realize the anticipated benefits of the acquisition and risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2008, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
(i)National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
(ii)International Agency for Research on Cancer , GLOBOCAN 2002 database
Results Reported for Exploratory Phase 2 Study of Nexavar in Combination With Chemotherapeutic Agent Paclitaxel for Treatment of Advanced Breast Cancer
Preliminary Results Require Further Analysis and Interpretation
Press Release
Source: Onyx Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals Inc.
On Wednesday September 30, 2009, 2:00 am EDT
Companies:Onyx Pharmaceuticals Inc.
WAYNE, N.J. and EMERYVILLE, Calif., Sept. 30 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced results from a randomized, placebo-controlled Phase 2 trial sponsored by Northwestern University. The study, which evaluated Nexavar® (sorafenib) tablets in combination with the chemotherapeutic agent, paclitaxel, in patients with locally advanced or metastatic HER-2 negative breast cancer, demonstrated a positive trend towards improvement of progression-free survival in the treatment group (p-value=0.09). The safety and tolerability profile of the combination was consistent with the previous experience with each agent and no new toxicities were observed.
A complete data analysis from this study is expected to be presented at an upcoming scientific meeting. Patients are continuing to be followed for a secondary endpoint of overall survival.
The trial was led by principle investigator William Gradishar, M.D., professor of medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "These encouraging data warrant further investigation to determine the potential of the Nexavar and paclitaxel treatment combination in patients with advanced breast cancer, an often underserved patient population," said Dr. Gradishar.
"The preliminary results in this study demonstrate a clinical signal in favor of this treatment combination. These data require further analysis and interpretation before we determine the appropriate path forward," said Todd Yancey, M.D., vice president of clinical development at Onyx. "This trial is the second of four from our comprehensive clinical program in breast cancer, which is intended to explore Nexavar's utility in a number of disease settings."
Bayer and Onyx recently reported statistically significant results in a randomized Phase 2 trial demonstrating that Nexavar in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression free survival by 74% in patients with locally advanced or metastatic HER-2 negative breast cancer. Treatment with Nexavar plus capecitabine was tolerable and resulted in no new side effects. Common grade 3 or 4 treatment-related adverse events included hand-foot skin reaction, diarrhea, dyspnea, neutropenia and mucositis.
Breast Cancer Trial Design
The randomized, double-blind, placebo-controlled Phase 2 study evaluated Nexavar in combination with the chemotherapeutic agent, paclitaxel, in 237 patients. These patients had locally recurrent or metastatic HER-2 negative breast cancer and had not received prior chemotherapy in this setting. The study included an assessment of the primary endpoint of progression-free survival. Secondary endpoints included overall survival, time to progression, and safety. Patients were randomized to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to paclitaxel, given at 90 mg/m2 weekly for three weeks followed by one week of rest.
Phase 2 study (ONXX) 33.96 : Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals (ONXX) announce the full results from their first collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trial showing that Nexavar tablets in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer. The data were presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress in Berlin. Jose Baselga, M.D., chairman and professor of medicine at Vall d'Hebron Institute of Oncology in Barcelona, scientific chairman of SOLTI and the principal investigator of this study, reported that patients receiving Nexavar plus capecitabine had a 74% improvement in the time they lived without their disease progressing compared to those who received the chemotherapy alone. The difference in median progression-free survival of Nexavar plus capecitabine versus capecitabine plus placebo was statistically significant, 6.4 months vs. 4.1 months.
Strong Showing for Onyx, Amgen at European Cancer Meeting: BioBuzz
By Adam Feuerstein 09/21/09 - 07:35 AM EDT Leave a Comment
Stock quotes in this article: ONXX , AMGN
EMERYVILLE, Calif. (TheStreet) -- Detailed data released Sunday from the phase IIb study of Onyx Pharmaceuticals'(ONXX Quote) cancer drug Nexavar in metastatic breast cancer patients looks really strong.
More from Adam Feuerstein Bulls, Bears Fight Over BioCryst: BioBuzzBiotech Stock Mailbag: Cyclacel PharmaArena Drug Aids Weight Loss But Not By MuchPsst... These Drug Firms Are Getting Bought: BioBuzzBioCryst Warns Peramivir Sales May Not Bring Profits: BioBuzzNew Medicare Rules for Dialysis Affect Biotech: BioBuzzBullish Case for Vanda Loses SteamDueling Views of Arena Pharma: BioBuzzBioCryst Still Waiting for Flu Drug Deals: BioBuzzTakeout Rumors Lift Dendreon, Bio Stocks: BioBuzz Market Activity ONYX Pharmaceuticals Inc| ONXX DOWNRecall that in July, Onyx announced that Nexavar extended progression-free survival (PFS) in this study. Well, the actual PFS benefit for Nexavar is 2.3 months, according to the late-breaker abstract for the study released Sunday to attendees at the European Society for Medical Oncology (ESMO) meeting in Berlin. This study enrolled a mixture of first-line and second-line metastatic breast cancer patients. The median PFS for Nexavar plus Xeloxa was 6.4 months compared to a PFS of 4.1 months for Xeloda alone. Xeloda is an oral cancer drug marketed by Roche.
Investors should view favorably any PFS benefit above two months in favor of Nexavar. This is the first study to demonstrate that an oral, targeted cancer drug could significantly improve time to tumor growth.
By comparison, the combination of Roche's Avastin and Xeloda improved PFS by 2.9 months compared to Xeloda alone in the previously presented Ribbon-1 study. This study enrolled only first-line metastatic breast cancer patients.
More details from the Nexavar study will be presented on Wednesday, including a breakdown of results between first-line and second-line patients. Nexavar, which Onyx co-markets with Bayer is already approved for the treatment of kidney cancer and liver cancer. The companies are moving ahead on other breast cancer studies in light of these new data.
Onyx shares closed Friday at $34.27
Amgen's Denosumab Cancer Data Positive
Cancer data from clinical trials of Amgen's(AMGN Quote) experimental bone drug denosumab is also trickling out of the ESMO meeting in Berlin, and so far, the results look positive for the drug.
http://www.thestreet.com/_yahoo/story/10600936/1/strong-showing-for-onyx-amgen-at-european-cancer-meeting-biobuzz.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
Drug stocks slip; Onyx slides on offerings
Aug 5, 2009, 10:59 a.m. EST
BOSTON (MarketWatch) -- Drug stocks slipped in early action Wednesday as shares of Onyx Pharmaceuticals slid on news that it plans to hold two public offerings.
Onyx said late Tuesday that it plans to offer 4 million common shares and $200 million in convertible senior notes due in 2016. The offerings are subject to market conditions.
Also late Tuesday, Onyx reported higher second-quarter earnings of 16 cents a share, compared with 8 cents in the 2008 period.
Revenue rose to $60 million, up from $45 million, due primarily to increased sales of its oncology drug Nexavar, which is co-marketed with Bayer AG.
Early Wednesday, analysts at Caris reportedly cut their rating on Onyx to above average from buy.
Shares of Inovio Biomedical /quotes/comstock/14*!ino/quotes/nls/ino (INO 2.66, +0.51, +23.73%) shot up 20% to $2.58.
Late Tuesday, Inovio reported positive results from a study for its experimental DNA-based vaccine in the treatment of prostate cancer.
Onyx Pharmaceuticals Inc. Q2 2009 Earnings Call Transcript
http://seekingalpha.com/article/153790-onyx-pharmaceuticals-inc-q2-2009-earnings-call-transcript?source=yahoo
8:04AM Onyx Pharma: Nexavar in combination with chemotherapy shown to extend progression-free survival in patients with advanced breast cancer (ONXX) : Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals (ONXX) announce that their first cooperative group-sponsored randomized Phase 2 trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival. The study evaluated Nexavar tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Study findings demonstrated that the median progression-free survival was extended in patients treated with Nexavar and capecitabine compared to patients receiving capecitabine and placebo. These results were statistically significant. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting.
Has ONXX given any guidance as to when we should expect interim/final analysis for the Nexavar Phase III trial in melanoma? It appears to be fully enrolled according to clinicaltrials.gov??
Also, the gov't website says PFS is primary endpoint, but the corporate presentation slides say OS is the primary endpoint. Which is it?
Thanks for any help!
Bayer and Onyx Begin Enrollment in STORM Trial Studying Nexavar as Adjuvant Therapy for Patients With Liver Cancer
Thursday August 21, 8:00 am ET
WAYNE, N.J. and EMERYVILLE, Calif., Aug. 21 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced the companies have begun enrolling patients in the STORM Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma trial. The randomized, double-blind, placebo-controlled Phase 3 study is evaluating Nexavar® (sorafenib) tablets as adjuvant treatment, which is treatment following surgery or local radiation, for patients with hepatocellular carcinoma (HCC), or primary liver cancer.
"Nexavar is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations," said Dimitris Voliotis, MD, vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "Liver cancer is the third largest global cancer killer worldwide and there is a significant need for new therapies that can be used at all stages in the course of the disease to delay disease progression and prolong life."
In addition, the U.S. Food and Drug Administration (FDA) has completed a Special Protocol Assessment (SPA) for the STORM trial. An SPA is a written agreement on the design and size of a clinical trial intended to form the basis for a new drug application.
Phase 3 Trial Design
The international multicenter study is expected to enroll approximately 1,100 patients and will include patients who have received surgical resection or local ablation. The study will look at whether providing oral Nexavar in the adjuvant setting delays the time to recurrence and increases overall survival. The primary endpoint of the study is recurrence free survival. Secondary endpoints include overall survival, time to recurrence, patient-reported outcomes, plasma biomarkers, safety and tolerability.
The study is enrolling patients with all HCC histologies. Patients will be randomized to receive 400 mg of Nexavar twice daily or matching placebo for up to four years. The study will be conducted at more than 200 sites in North America, South America, Europe and the Asia-Pacific region, including Japan. For information about enrolling in the study, please visit http://www.clinicaltrials.gov.
Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year (more than 400,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in the United States) and the incidence is increasing. In 2002, approximately 600,000 people died of liver cancer including approximately 370,000 in China, South Korea and Japan, 57,000 in the European Union, and 13,000 in the United States.(1,2)
Currently there are no adjuvant treatments with proven benefit in HCC and half of the patients who have undergone surgical resection or local ablation will see their tumors return within three years and 70 percent will see their tumors return within five years.(3)
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is currently approved in more than 40 countries for liver cancer and in more than 70 countries for the treatment of patients with advanced kidney cancer. Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including metastatic melanoma, lung cancer, breast cancer and as an adjuvant therapy for kidney cancer.
Important Safety Considerations For Patients Taking Nexavar
Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported with Nexavar in patients with unresectable HCC were diarrhea, fatigue, abdominal pain, weight loss, anorexia, nausea and hand-foot skin reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
For information about Nexavar including U.S. Nexavar prescribing information, visit http://www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).
The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer
Wednesday July 23, 5:00 pm ET
- Nexavar is First Approved Systemic Therapy to Treat the Disease -
WAYNE, N.J. and EMERYVILLE, Calif., July 23 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that The New England Journal of Medicine published results of a Phase 3 trial demonstrating that Nexavar® (sorafenib) tablets decreased the absolute risk of death by 31 percent in patients with unresectable hepatocellular carcinoma (HCC), or liver cancer, versus patients who received placebo. This represents a 44 percent improvement in median overall survival for patients treated with Nexavar.
Based on the strength of these data, Nexavar was approved for HCC by the European Agency for the Evaluation of Medicinal Products (EMEA) and by the U.S. Food and Drug Administration (FDA) in October and November 2007, respectively.
"Despite advances in the management of many other cancers, liver cancer has remained a treatment challenge, due to a lack of systemic therapies to extend life and limited opportunity for surgical intervention," said Dr. Josep M. Llovet, co-principal investigator of the study and professor of research, Barcelona Clinic Liver Cancer (BCLC) Group, IDIBAPS, Liver Unit, Hospital Clinic Barcelona; director of research, HCC Program, associate professor of Medicine, Mount Sinai School of Medicine, New York. "This landmark study reflects a new systemic standard of care using Nexavar in the first-line management of liver cancer."
"The number of lives lost to liver cancer continues to increase globally, due to the prevalence of hepatitis B and C infections," said Jordi Bruix, co-principal investigator and director of the Barcelona Clinic Liver Cancer (BCLC) Group; senior consultant, Liver Unit, Hospital Clinic of Barcelona. "We are encouraged that there is a new treatment option available for liver cancer that has clearly demonstrated a survival benefit in this patient population."
The international Phase 3 double-blind, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial evaluated 602 liver cancer patients who had no prior systemic therapy. The primary endpoints of the study included overall survival and time to symptomatic progression in patients administered Nexavar versus those who received placebo. Secondary endpoints included time to progression, disease control rate and safety.
Results were first presented at the American Society of Clinical Oncology in June 2007.
Median overall survival was 10.7 months for patients who received Nexavar compared to 7.9 months for patients who received placebo (HR=0.69; p=0.0006). There was no difference in time to symptomatic progression between patient groups, based on a patient-reported assessment questionnaire.
Median time to tumor progression was 5.5 months with Nexavar versus 2.8 months with placebo (HR=0.58; p=<0.001). The most common drug-related grade 3/4 events in patients receiving Nexavar were diarrhea and hand-foot-skin reaction. No indication of imbalances was observed with regard to serious adverse events between the Nexavar and placebo-treated groups.
"Hepatocellular cancer is the second type of cancer where Nexavar has demonstrated a meaningful clinical benefit," said Dimitris Voliotis, MD, vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "We are pleased that Nexavar is now available to patients suffering from liver cancer in the U.S. and Europe and we continue to work with worldwide regulatory authorities to secure approvals in other regions."
Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year (more than 400,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in the United States) and the incidence is increasing. In 2002, approximately 600,000 people died of liver cancer including approximately 370,000 in China, South Korea and Japan, 57,000 in the European Union, and 13,000 in the United States. (1,2)
In addition, chronic hepatitis B (HBV) and C (HCV) viral infections are the leading causes of primary liver cancer worldwide. In the Asia-Pacific region, more than eight percent of the general population is infected with HBV and between two and four percent is infected with HCV. (3,4)
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.
Nexavar is currently approved in more than 40 countries for liver cancer and in more than 70 countries for the treatment of patients with advanced kidney cancer. Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including metastatic melanoma, lung cancer, breast cancer and as an adjuvant therapy for kidney cancer.
Important Safety Considerations For Patients Taking Nexavar
Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported with Nexavar in patients with unresectable HCC were diarrhea, fatigue, abdominal pain, weight loss, anorexia, nausea and hand-foot skin reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
For information about Nexavar including U.S. Nexavar prescribing information, visit http://www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).
Onyx Pharmaceuticals Inc. CFO Gregory Schafer will leave the company by mid-December.
Schafer, Onyx's top financial officer since April 2006, is the third executive to leave or announce his departure from the Emeryville cancer drug developer (NASDAQ: ONXX) in the past six months. He's also the first officer to leave since N. Anthony Coles was hired as president and CEO in February.
Hollings Renton retired as chairman and CEO of Onyx in March and Edward Kenney left his president and COO jobs at the end of last year.
The company said Monday that Schafer, 43, said June 17 that he would quit, but it did not say why Schafer was leaving the company. He will leave Dec. 15 or sooner, if Onyx hires a new CFO before then.
Just as when Renton and Kenney retired, Schafer's departure includes consulting work for Onyx. He will consult for up to six months after he leaves the company at a rate of $250 an hour.
Schafer also will receive a lump-sum payment equal to 12 months of his current base salary -- $300,000, according to Onyx filings with the Securities and Exchange Commission -- reimbursed COBRA medical insurance premiums for 12 months and reimbursement for up to six months of job-search assistance up to $15,000.
Before joining Onyx, Schafer spent a month as a consultant to the company. He also had been a senior financial consultant to several public biotech companies and was CFO of Cerus Corp.
Schafer's total compensation last year, including stock and option awards and other compensation, totaled $689,897, according to Onyx's proxy statement to shareholders.
New Nexavar Data Presented in Multiple Tumor Types at 44th American Society of Clinical Oncology Annual Meeting
Monday June 2, 8:05 am ET
WAYNE, N.J. and EMERYVILLE, Calif., June 2 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced the presentation of new clinical data from the early clinical trials in the development program for Nexavar® (sorafenib) tablets in multiple tumor types including lung, thyroid, gastric and ovarian cancers. Nexavar is currently approved in more than 40 countries for the treatment of patients with unresectable liver cancer and in more than 70 countries for the treatment of patients with advanced kidney cancer.
"Findings from these early phase studies are encouraging and will be integral in informing our development strategies for the ongoing Nexavar clinical program," said Henry Fuchs, MD, executive vice president and chief medical officer of Onyx Pharmaceuticals. "We are committed to maximizing the potential of Nexavar and look forward to its ongoing study with international study groups, government agencies and individual investigators in a wide range of cancers."
Highlights from Nexavar data presented include:
Lung Cancer
A Randomized, Discontinuation Phase 2 Study of Sorafenib vs. Placebo in Patients with Non-Small Cell Lung Cancer (NSCLC) Who Have Failed at Least Two Prior Chemotherapy Regimens
Preliminary findings from this randomized discontinuation Phase 2 study showed that treatment with Nexavar yielded encouraging results in heavily pre-treated patients with NSCLC. The study showed that patients who remained on Nexavar experienced a longer period of disease control and disease stabilization than patients who discontinued Nexavar after the initial run-in phase of treatment. In the study, the most common treatment-emergent adverse events included fatigue, hand/foot syndrome and skin rash.
The lead investigator for this study is Joan Schiller, MD, professor and chief of the hematology/oncology division at the University of Texas Southwestern and Andrea L. Simmons distinguished chair in cancer research, Dallas, TX. (abstract #8014).
Thyroid Cancer
A Phase 2 Study of Sorafenib in Metastatic Thyroid Carcinoma
Findings from this single-arm Phase 2 study showed that treatment with Nexavar resulted in meaningful anti-tumor activity in the majority of patients with encouraging overall clinical benefit (disease stabilization and partial responses) in patients with advanced thyroid cancer. In the study, Nexavar was well-tolerated; the most common treatment-related adverse events included fatigue, rash, diarrhea, palmer-plantar erythema, musculoskeletal pain and weight loss. Patients enrolled in this study had been diagnosed with metastatic, iodine-refractory, unresectable or locally-advanced thyroid cancer.
The lead investigator for this study is Marcia S. Brose, MD, PhD, assistant professor, director of cancer genetics laboratory, University of Pennsylvania Health System, Philadelphia, PA. (abstract #6026).
Gastrointestinal Stromal Tumors
Activity of Sorafenib in Patients with Imatinib and Sunitinib-Resistant Gastrointestinal Stromal Tumors (GIST): A Phase 2 Trial of the University of Chicago Phase 2 Consortium
Findings from this single-arm Phase 2 study suggest that Nexavar is active and well tolerated in patients with Gleevec or Gleevec and Sutent resistant GIST. The most common treatment-emergent adverse events included hand-foot syndrome, hypertension, rash and diarrhea.
The lead investigator for this study is Lauren Wiebe, MD, fellow, University of Chicago, Chicago, IL. (abstract #10502).
Gastric/GEJ
A Phase 2 Study: Combination of Sorafenib with Docetaxel and Cisplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (ECOG 5203)
Findings from this single-arm Phase 2 study provide encouraging data for the potential use of Nexavar in combination with docetaxel and cisplatin to treat patients with metastatic/advanced gastric/GEJ adenocarcinoma. The most common treatment-emergent adverse events included neutropenia, fatigue, anorexia, hand-foot reaction, nausea, diarrhea and dehydration.
The lead investigator for this study is Weijing Sun, MD, assistant professor of medicine, University of Pennsylvania, director of the Upper GI and Pancreatic-Biliary-Hepatic Cancer Group and the associate director of the GI Cancer Program. (abstract #4535).
Ovarian
Phase 2 Trial of Sorafenib in Persistent or Recurrent Epithelial Ovarian Cancer or Primary Peritoneal Cancer: A Gynecologic Oncology Group Study
Preliminary findings from this Phase 2 study suggest that Nexavar is active and tolerated in patients with recurrent epithelial ovarian cancer. The most common treatment-emergent adverse events were dermatologic and metabolic.
The lead investigator for this study is Daniela Matei, M.D., Ph.D., assistant professor, department of medicine, Walther Oncology Center, Indiana University, Bloomington, IN. (abstract #5537).
"We continue to be encouraged by Nexavar's potential activity as a single agent or in combination with other chemotherapeutic agents in these early stage clinical trials in tumor types with high unmet treatment needs," said Susan Kelley, MD, vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "The more data we compile from various studies in multiple tumor types, the better informed we are to determine the appropriate direction for further development of Nexavar in additional clinical cancer settings."
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including metastatic melanoma, lung cancer, breast cancer and as an adjuvant therapy for kidney cancer.
Important Safety Considerations For Patients Taking Nexavar
Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma and advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. In HCC patients, bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. In RCC patients, incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common adverse events .20% related to Nexavar for both HCC and RCC were fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia, diarrhea, nausea, and abdominal pain. Grade 3/4 adverse events in HCC and RCC patients, respectively, were 45% for Nexavar vs. 32% for placebo and 38% for Nexavar and 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
Nexavar Significantly Improves Overall Survival by 47 Percent in Asia-Pacific Liver Cancer Study
Friday May 16, 2:30 am ET
- Trial Results Confirm Efficacy for Population Most Affected by Disease -
WAYNE, N.J. and EMERYVILLE, Calif., May 16 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that Nexavar® (sorafenib) tablets significantly improved overall survival by 47.3 percent (HR=0.68; p-value=0.014) in patients in the Asia-Pacific region with advanced hepatocellular carcinoma (HCC), or primary liver cancer versus those receiving placebo. Nexavar also significantly improved time to progression in these patients by 74 percent (HR=0.57; P=0.001). These data were presented at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) and further confirm Nexavar's efficacy in liver cancer.
The international, Phase 3, randomized trial evaluated efficacy and safety of Nexavar versus placebo in 226 Asian patients with advanced HCC who had not received prior systemic therapy. The study was designed to compare overall survival, time to progression, time to symptomatic progression, response as defined by RECIST criteria and safety in patients receiving Nexavar versus placebo. Median overall survival was 6.5 months in patients treated with Nexavar versus 4.2 months for those taking placebo. The survival benefit was seen across multiple patient subsets analyzed, including age, extrahepatic spread and/or macroscopic vascular invasion.
"Liver cancer in the Asia-Pacific region continues to grow because of a high incidence of chronic hepatitis B viral infections, which now impact approximately 275 million people in the region," said Ann-Lii Cheng, MD, PhD, Department of Internal Medicine and Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan and principal investigator of the trial. "Nexavar demonstrated a clear survival benefit in Asia-Pacific patients and had comparable results to last year's SHARP trial, despite these patients in the Asia-Pacific trial having poorer health status and more metastases."
Additional results from the trial are as follows:
-- Median time to progression was 2.8 months in Nexavar-treated patients
versus 1.4 months for those taking placebo.
-- Median time to symptomatic progression was 3.5 months in patients
treated with Nexavar versus 3.4 months for those taking placebo.
-- Disease control rate (complete response + partial response + stable
disease >/= 12 weeks) was 35 percent in Nexavar-treated patients versus
16 percent for those taking placebo.
Data from the study indicate that Nexavar was safe and well-tolerated in patients from the Asia-Pacific region. Adverse events were low to moderate in severity and treatment was well tolerated. The most common serious adverse events observed in the study were hand-foot-skin reaction, diarrhea, alopecia, fatigue, and rash/desquamation.
"These data provide further evidence that Nexavar is efficacious in liver cancer across multiple geographical regions and independent of disease characteristics and etiologies of underlying liver disease," said Susan Kelley, MD, Vice President, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "Nexavar has quickly become the systemic standard of care for liver cancer, and is the only systemic therapy that has been shown to improve overall survival in Asian patients with liver cancer."
Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year (more than 400,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in the United States) and the incidence is increasing. In 2002, approximately 600,000 people died of liver cancer including approximately 370,000 in China, South Korea and Japan, 57,000 in the European Union, and 13,000 in the United States.(1,2)
In addition, chronic hepatitis B (HBV) and C (HCV) viral infections are the leading causes of primary liver cancer worldwide. In the Asia-Pacific region, more than eight percent of the general population is infected with HBV and between two and four percent is infected with HCV.(3,4)
Upgrading Onyx Pharma to Buy
Wednesday May 7, 11:56 am ET
By Grant Zeng, CFA
Onyx Pharmaceuticals, Inc. (NasdaqGM: ONXX - News)delivered strong financial performance of its primary drug, Nexavar, in first quarter 2008. This is mainly attributed to Nexavarâs penetration into the liver cancer market, while Nexavarâs share in the kidney cancer market has stabilized despite heavy competition from Pfizer, Inc. (NYSE: PFE - News) and Wyeth (NYSE: WYE - News).
We believe Nexavar sales will continue to grow over the next several years since the label has expanded to liver cancer. Nexavar has the potential to become a blockbuster for Onyx. Sales of the drug grew dramatically in first quarter 2008. Total Nexavar sales came in at $151.9 million, up 149% year-over-year and 21.5% sequentially. US sales increased to $51 million in first quarter 2008, up 97% year-over-year and up 18.8% sequentially. International sales reached $101 million, up 188% year-over-year and up 23.2% sequentially.
The EU and the US approved Nexavar for first-line treatment of liver cancer in the fourth quarter 2007. In Asia, South Korea has approved Nexavar for liver cancer and approval in China for liver cancer is expected in the second half 2008. Other international filing is underway.
We believe Nexavar sales will be further boosted during the rest of 2008 and beyond due to this new indication. Label expansion for Nexavar into other cancer indications such as breast cancer is underway. We also believe that sales of Nexavar will reach $1 billion in 2010.
The current share price is attractive, and we recommend investors buy its shares at these levels. We upgrade Onyx shares from Hold to Buy with a price target of $46. We arrive at our price target of $46 by using biotech industry average P/E of 38x, multiplied by our estimated 2010 EPS of $1.75 (excluding share-based expenses), discounted at 20% for two years.
Onyx Pharmaceuticals Reports 2008 First Quarter Results
Tuesday May 6, 4:00 pm ET
Nexavar Net Sales increase 149% over First Quarter 2007
EMERYVILLE, Calif., May 6 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today reported its financial results for the first quarter ended March 31, 2008. Onyx reported net income of $15.4 million, or $0.27 per diluted share, for the first quarter of 2008 compared to a net loss of $12.2 million, or $0.26 per diluted share, in the same period in 2007.
Nexavar net sales as reported by Bayer HealthCare Pharmaceuticals, Inc., or Bayer, were $151.9 million for the first quarter ended March 31, 2008, a 149% increase over the $60.9 million reported in the same period in 2007. Onyx with its collaborator, Bayer, is marketing and developing Nexavar® (sorafenib) tablets, an anticancer therapy currently approved for the treatment of liver cancer and advanced kidney cancer in the United States, European Union, and other territories internationally.
"We are pleased with Nexavar's strong performance in the first quarter of 2008, generating worldwide net sales of $151.9 million, which we attribute to the continued successful launch of Nexavar in liver cancer in both the United States and in the rest of the world," said Tony Coles, M.D., president and chief executive officer of Onyx. "While we continue the global launch of Nexavar in liver cancer, we are focusing commercial efforts on the further development of this new market to support the long-term growth of this important opportunity. At the same time, we are investing in a broad clinical program to realize the potential benefits of Nexavar in numerous other tumor types."
The net profit for the first quarter ended March 31, 2008, included employee stock-based compensation expense of $5.2 million, or $0.09 per diluted share. The net loss for the quarter ended March 31, 2007, included employee stock-based compensation expense of $3.0 million, or $0.06 per diluted share.
Net Revenue from Unconsolidated Joint Business
In the first quarter of 2008, Onyx reported net revenue from unconsolidated joint business of $37.7 million compared to $3.0 million for the first quarter of 2007. The net revenues from unconsolidated joint business were based on total Nexavar sales of $151.9 million in the first quarter of 2008. The increase in net revenue from unconsolidated joint business over prior year is due to the increase in Nexavar revenue recognized by Bayer offset by the increase in combined commercial and research and development expenses for Nexavar. The calculation of this line item is shown in the table following the Condensed Statement of Operations.
Operating Expenses
In the first quarter of 2008, Onyx recorded research and development expenses of $7.4 million, an increase of $1.9 million over the first quarter of 2007. The increase in expenses incurred in the first quarter of 2008 was primarily due to higher costs incurred for the breast cancer program. Research and development expenses included $0.6 million of employee stock-based compensation for the first quarter of 2008 and $0.5 million for the first quarter of 2007.
In the first quarter of 2008, selling, general and administrative expenses were $19.8 million, an increase of $6.7 million over the first quarter of 2007. The increase in selling, general and administrative expenses was primarily due to increases in stock-based compensation, other employee-related expenses and increased marketing expense to support Nexavar. Selling, general and administrative expenses included $4.6 million of employee stock-based compensation in the first quarter of 2008 compared to $2.5 million for the first quarter of 2007.
Cash, Cash Equivalents and Marketable Securities
As of March 31, 2008, the company had cash, cash equivalents, and short and long-term marketable securities of $456.6 million compared to $469.7 million at December 31, 2007. This decrease was primarily due to cash used in operations for the three months ended March 31, 2008.
Onyx Pharmaceuticals Executive VP sells 12,500 shares
Thursday April 17, 3:52 pm ET
Onyx Pharmaceuticals Executive Vice President Laura Brege sells 12,500 shares of stock
NEW YORK (AP) -- The executive vice president and chief business officer of biopharmaceutical company Onyx Pharmaceuticals Inc. exercised options for and then sold 12,500 shares of common stock, according to a Securities and Exchange Commission filing Wednesday.
In a Form 4 filed with the SEC, Laura Brege reported she exercised options for the shares Tuesday for $15.44 apiece and then sold all of them the same day for $33.22 apiece.
The stock sale was conducted under a prearranged 10b5-1 trading plan which allows a company insider to set up a program in advance for such transactions and proceed with them even if he or she comes into possession of material non-public information.
Insiders file Form 4s with the SEC to report transactions in their companies' shares. Open market purchases and sales must be reported within two business days of the transaction.
Onyx is based in Emeryville, Calif.
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