3SOF

Public 3SOF Boards => Stock Picking => Topic started by: fill_the_gap on July 20, 2005, 02:02:29 PM

Title: ONXX
Post by: fill_the_gap on July 20, 2005, 02:02:29 PM
http://finance.yahoo.com/q/bc?s=ONXX&t=1d
Title: Re: ONXX
Post by: ScottishTrader on November 23, 2006, 12:51:51 PM
Re-post of my ONXX analysis from the options thread:


Right I had a little look at ONXX, and for the most part your charting is pretty much right on.  I would say that the 3 yr weekly chart shows ONXX is in a clear descending channel, although I would point out that support in this channel is much more clearly defined than resistance.  We have no less than 5 tags of this descending support, and if you take that trendline and transpose it to the upper bounds (i.e. move it and connext the top end with the pattern high in March 04) you get a pretty clear channel.  However, the tops of several of the movs do not correspond to the top of the channel, so using it as a sell target may not get made.

In any case, I would say that this chart is looking pretty bearish.  Note that both the RSI and MACD histo are trending downward now, and the CCI on the weekly scale just broke down from above 100.  The last 2 times it did this is signalled a major downward move shortly after (green vertical lines).  SUpport (measured from this weekly chart) looks to come in at 17.80 and 17.66, and below that around 16.85.  Clear overhead resistance comes in around 18.80 and 19.20.  If ONXX were to close above 19.20 on the weekly scale, we could consider that a bullish breakout with a targte of next resistance around $21.  But my intuition is that we won't see that, and this is confirmed by looking at the 6 month daily chart.

When we look at the daily chart, as you correctly noticed, trading through september and october was supported by a clear ascending trendline (note: I have used a semi-log scale here again, mainly becasue the range is quite large, but also we get 4 (or possibly 5) perfect tags of that trendline in the semi-log scale).  It rallied all the way to gap resistance at 19.60 (or 19.75 if you go from the June 2 closing price to the November high).  This resistance looks to be significant for ONXX.  Note also how tboth the RSI and CCI made bearish divergences in their peaks during the later stages of this rally, again suggesting a weakening trend.  However, ofter reaching this high, it has since broken its ascending trendline, and is now beginning to trend lower - and we already have 3 tags of a steep descending trendline that may provide new resistance.  ONXX is sitting right on 17.90 support as of yesterday's close, below that it also has support at 17.66-68.  If these break, next support is around 16.90, and then what should be strong support at $16.  One other thing, CCI is now oversold and rebounding slightly towards -100, which may signal a potential rally from support, but unless this takes out 19.21, I would not call it a bullish move.  In fact, a rally back to 19.20 resistance and failure again at that level would put in a nice H&S top with a technical target of 15.57.
Title: Re: ONXX
Post by: basonista on January 05, 2007, 08:18:50 PM
ONXX is an interesting play here on a purely technical view.  As can be seen on the weekly chart (and as pointed out by ScottishTrader), this stock has been in a bearish slide since mid-2004 after capping a 1200% run from early 2003. :o  What is interesting about this stock is the very definite swings from valley to peak, averaging -49.6% to the downside and +54.25% to the upside.  Technical indicators are bottoming and improving with both STOs crossing up, MACD starting to flatten and RSI turning up just over 30 so it looks like it is ready to make it's next swing up.  A 50% rise from the last low is 15.57 but it's possible that ONXX will want to fill the gap at 17.15.

Even the daily chart is looking better with bullish crosses of both the slow STO and MACD and RSI moving above 30.
Title: Re: ONXX
Post by: basonista on January 10, 2007, 07:43:14 AM
Hanging in there...
Title: Re: ONXX
Post by: basonista on January 14, 2007, 08:25:12 AM
ONXX still doing well although the shortterm indicators on the daily chart shows that this rally may need to rest a little at this level.  Weekly chart is still getting warmed up with STOs crossing and RSI/MACD indicators continuing to strengthen.

This news came out this week although this was really a non-event since it is just a report on what was already released last week.

Bayer and Onyx Announce Pivotal Nexavar(R) Kidney Cancer Study Published in New England Journal of Medicine  (http://biz.yahoo.com/prnews/070110/nyw150.html?.v=78)
Title: Re: ONXX
Post by: basonista on February 12, 2007, 09:32:42 AM
And I was thinking of getting back into this last week... :'(

Bayer, Onyx to Stop Liver Cancer Trial (http://biz.yahoo.com/ap/070212/bayeronyx.html?.v=2)
Title: Re: ONXX
Post by: ScottishTrader on February 12, 2007, 01:03:11 PM
ONXX is still absolutely ripping today.  Heavy short position on this one is causing quite a squeeze.  It really has that feeling of "this could just keep on going" today, and as I write this it just hit $24.  The news is obviously  huge, and virtually guarantees approval.

I picked some up in the PM at 20.30, and then started sweating it as it started breaking down in early trading.  Luckily I held on (in fact picked up some Feb 20 calls too, which are doing EXTREMELY well), but this is a bit of a rollercoaster ride now.  Tricky to figure out support and resistance, but there is definietly soem resistance in the 23.70-90 area. I think if it manages to hold above $24, it has a good shot at reaching next resistance at 25.88.  Above that we're talking $27 and $29.  Support should be around $22.40, although it was encountering some resistance on the way up around 22.75
Title: Re: ONXX
Post by: ScottishTrader on February 14, 2007, 04:56:22 AM
I mentioned on David's 3SOF intraday trading thread yesterday a symmetrical traingle breakdown on the intraday chart.  I thought I would post its resolution here - ONXX tagged the sym triangle's parallel lower rail at 25.07, late in the afternoon and then rallied all the way back up to $26.  Looks like a bull flag to me now.  ONXX could see some continuation of it breaks the top rail of this flag today.  Target of the flag breakout would be (26.62 - 25.07 = 1.55 + 26.62 = ) 28.17.

There may be more in the tank yet on ONXX
Title: Re: ONXX
Post by: la-onda on February 14, 2007, 07:13:27 AM
fyi  8)
ONYX Pharmaceuticals "buy," target price raised

Wednesday, February 14, 2007 10:27:28 PM ET
Banc of America

NEW YORK, February 14 (newratings.com) - Analyst David Witzke of Banc of America Securities reiterates his "buy" rating on ONYX Pharmaceuticals Inc (ONXX.NAS), while raising his estimates for the company. The target price has been raised from $19 to $37.

In a research note published yesterday, the analyst mentions that the company's share price does not reflect the leverage to the company's EPS from the potential approval of Nexavar for the treatment of HCC (liver cancer). According to the analyst, there is substantial opportunity for ONYX Pharmaceuticals' Nexavar drug in the HCC indication in the US and European markets going forward. The EPS estimates for 2008, 2009 and 2010 have been raised from $0.30 to $1.51, from $0.79 to $3.02 and from $1.36 to $3.50, respectively, to reflect the potential revenue accretion from the HCC indication.
Title: Re: ONXX
Post by: la-onda on February 20, 2007, 10:53:01 AM
Onyx Pharma
Briefing.com - February 20, 2007 9:38 AM ET


Lehman Brothers reiterates Overweight. Target $25 to $41.
Lehman raises their tgt on ONXX to $41 from $25 while recent strength has appropriately reflected US impact of Nexavar HCC survival data they believe another leg of upside is justified based on larger ex-U.S. opportunities. Firm notes ONXX announced on Feb 12 positive interim survival data from its 600-patient SHARP study in advanced hepatocullar carcinoma. With a final analysis powered to demonstrate 40% overall survival improvement to 9.7 months, interim data is expected to support a benefit beyond 10 months. With roughly 16,000 advanced HCC patients in the U.S. and LEH U.S. sales ests of $240 mln firm believes that recent share price appreciation appropriately reflects an incremental NPV of $10/share for Nexavar in the U.S. Firm believes that further upside potential may exist to dosing duration from full phase III data, Asian HCC opportunity, pursuit of melanoma compendia listing and NSCLC phase III data.


updated chart:
Title: Re: ONXX
Post by: la-onda on April 10, 2007, 04:38:59 AM
chart looks interesting again...
Title: Re: ONXX
Post by: la-onda on April 26, 2007, 08:10:01 PM
fyi:
ONXX: Short Interest UP 1.9% to 6.9M in Apr 2007
Tuesday , April 24, 2007 16:20ET

According to new short interest data from NASDAQ, short interest for ONYX Pharmaceuticals Inc (NasdaqNM: ONXX) INCREASED 1.9% to 6,872,355 shares for the month ended mid-April, 2007.

SYMBOL         MARCH           APRIL          CHANGE       %CHANGE  DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
ONXX           6,746,800       6,872,355        +125,555        +1.86%           6

Based on ONXX's 20-day average daily share volume of 1,277,330, it would require approximately 6 day(s) of buying to cover this short interest.

something is cooking IMO
Title: Re: ONXX
Post by: ScottishTrader on May 12, 2007, 09:38:05 AM
ONXX made a big volume spike intrady on Friday, breaking previous highs at $30, then pulling back and finding further strength towards the end of the day.  It appears that this spike may have been related to an upgrade by Morgan Stanley, who set their price target to $37.

It also may be due to "chatter" that Pfizer is having trouble with its liver cancer drug Sutent, which would be a direct competitor to Nexavar.

In any case, it looks like ONXX is shaping up to break $30 next week.  The short term chart is shaping up nicely, and the 3yr weekly chart shows that a break of $30 would be important for the stock.  Whether there is anything else driving this is pure speculation, but a break of $30 (and yesterday's high of 31.30) should put $34 in play.  I've liked ONXX for a while as a biotech with solid prospects, and have jumped back in here (i've been in and out several times over the last few months).
Title: Re: ONXX
Post by: setravis on May 12, 2007, 05:56:47 PM
Event.......
Record Price Break Out !


52wk Range: 10.38 - 31.28
Volume: 6,048,221
Avg Vol (3m): 3,346,020

Technicals
Record Price High
Most Actives
Record Price Break Out
Percentage Gainer

Last Price Quote is:
7.41%above 13-day MA
15.98%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $1,434.87 
P/E Ratio: NA 
PEG Ratio: -0.88 
Next Earnings: 08/07/2007
Title: Re: ONXX
Post by: la-onda on June 05, 2007, 10:22:45 AM
fyi:
Onyx Pharmaceuticals upgraded to "outperform" - update

Monday, June 04, 2007 3:15:24 PM ET
Bear Stearns

NEW YORK, June 4 (newratings.com) – Analyst Akhtar Samad of Bear Stearns upgrades Onyx Pharmaceuticals Inc (ONXX.NAS) from "peer perform" to "outperform." The target price is set to $40.

In a research note published this morning, the analyst mentions that the company is unlikely to witness competition for Nexavar in liver cancer (HCC) in the near term, and the duration of the therapy is expected to be longer than was previously anticipated. The analyst expresses his optimism regarding Nexavar becoming the standard of care in HCC going forward. The worldwide sales estimates for Nexavar in HCC for 2007, 2008 and 2010 have been raised from $0 to $10 million, from $78 million to $134 million and from $332 million to $547 million, respectively.
Title: Re: ONXX
Post by: la-onda on June 27, 2007, 11:36:51 PM
ONXX update (now looking interesting again imo):

1)
Onyx Pharmaceuticals Inc prices public offering of common shares
Friday , June 22, 2007 06:39ET

Jun 22, 2007 (M2 EQUITYBITES via COMTEX) -- Onyx Pharmaceuticals Inc (Nasdaq: ONXX), a biopharmaceutical company, reported on 21 June that it has priced its public offering of 6,600,000 common shares at USD28.00 per share. The company expects to complete the sale of these shares on or about 26 June 2007. Additionally, the company has granted the underwriters a 30-day option to purchase 990,000 additional common shares to cover over-allotments, if any.

2)
ONXX: Short Interest UP 13.6% to 7.8M in Jun 2007
Wednesday, June 27, 2007 06:00ET

According to new short interest data from NASDAQ, short interest for ONYX Pharmaceuticals Inc (NasdaqNM: ONXX) INCREASED 13.6% to 7,820,497 shares for the month ended mid-June, 2007.

SYMBOL        MAY            JUNE          CHANGE       %CHANGE        DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
ONXX     6,886,548     7,820,497    +933,949       +13.56%           3

Based on ONXX's 20-day average daily share volume of 3,449,955, it would require approximately 3 day(s) of buying to cover this short interest.

3)
Bayer and Onyx Submit Supplemental New Drug Application for Nexavar to Treat Liver Cancer
Wednesday, June 27, 2007 07:00ET

WAYNE, N.J. and EMERYVILLE, Calif., June 27 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals Inc. (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a Supplemental New Drug Application (sNDA) for Nexavar(R) (sorafenib) tablets has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer. The companies also confirmed that they are planning a company- sponsored Phase 3 study of Nexavar in the adjuvant treatment of HCC following the complete removal of early stage liver cancer.

The sNDA submission is based on positive data from the international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar extended overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Currently, there are no FDA-approved drug therapies that significantly extend survival of patients with liver cancer.

"These results are particularly meaningful considering that death rates from liver cancer continue to increase," said Susan Kelley, M.D., vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "After more than 100 clinical studies of many agents over three decades, Nexavar is the first drug therapy to demonstrate a significant survival benefit for patients with HCC, and, if approved, may fulfill a serious unmet need with a manageable toxicity profile."

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary liver cancers in adults.(1,2) It is the fifth most common cancer in the world(3) and the third leading cause of cancer-related deaths globally.(4) Over 600,000 cases of HCC are diagnosed globally each year(4) (about 19,000 in the United States(5) and 32,000 in the European Union(6)) and in 2002 approximately 600,000 people (about 13,000 Americans and 57,000 Europeans) died of HCC.(7)

"This filing exemplifies our commitment to providing valuable therapeutic options for significant unmet needs in cancer treatment," said Hank Fuchs, M.D., executive vice president and chief medical officer of Onyx. "We believe that Nexavar will become the reference standard of care in HCC, and will help advance our development program, which includes clinical trials studying Nexavar alone and in combination with other therapies across many different cancer types, including melanoma, non-small cell lung and breast cancer."
Title: Re: ONXX pick of year...
Post by: fill_the_gap on August 03, 2007, 10:04:09 PM
Hi,

Took some time off and am happy to be back.  Miss many of you on the board!

Been following ONXX since my initial post.

Buying August calls and the actual stock into Tuesdays cc.

Betting heavy on ONXX to rise several dollars.
http://stockcharts.com/h-sc/ui?s=onxx

Only drug for liver cancer and Bayer will make it interesting.

Title: Re: ONXX
Post by: la-onda on August 04, 2007, 11:21:04 PM
Welcome back fill_the_gap  ::)  ;) 8)
Nice to have you back on board. What are your other holdings?
cheers
Oliver

ONXX update (not holding):
1)
Onyx Pharmaceuticals Schedules August 7 Earnings Call
Wednesday, August 01, 2007 07:39ET
(financialwire.net via COMTEX) -- August 1, 2007 (FinancialWire) Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) will webcast a teleconference with management to discuss second quarter 2007 financial results and provide a general business overview on August 7 at 5 p.m. ET. Financial results for the second quarter ended June 30 will be released earlier that day.
A live webcast of the presentation will be available at streamlogics.net. A replay of the presentation will be available on the Onyx website or by phone around one hour after the teleconference concludes. The replay will be available through September 6.
Emeryville, California-based Onyx Pharmaceuticals is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer.

2)
ONXX: Short Interest UP 12.1% to 8.8M in Jul 2007
Tuesday , July 24, 2007 16:20ET

According to new short interest data from NASDAQ, short interest for ONYX Pharmaceuticals Inc (NasdaqNM: ONXX) INCREASED 12.1% to 8,766,221 shares for the month ended mid-July, 2007.

SYMBOL         JUNE            JULY          CHANGE       %CHANGE         DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
ONXX           7,820,497       8,766,221        +945,724       +12.09%           8

Based on ONXX's 20-day average daily share volume of 1,127,870, it would require approximately 8 day(s) of buying to cover this short interest.

3)
Nice chart action:
Title: Re: ONXX
Post by: fill_the_gap on August 06, 2007, 11:57:40 AM
Thank you!  It is nice to be back.

MO and KFT look good to me right here.

Banking on a solid ONXX call tomorrow.  Usually do not hold into a call but this time may work, imo.

Good luck.
Title: Re: ONXX Great Q !
Post by: fill_the_gap on August 07, 2007, 08:29:59 AM
 ;D

Revenue from Nexavar, one of the company's newest products, jumped by 160 percent to 60 million euros. Recent studies showed that the product is the first drug to prolong survival in kidney cancer patients. Rivaroxaban, an anti-clotting drug, was shown to be safer and more effective than a competing treatment, pushing up the share price.

http://www.bloomberg.com/apps/news?pid=20601087&sid=aE.VVf_dz2_I&refer=home
Title: Re: ONXX
Post by: fill_the_gap on August 07, 2007, 10:34:40 AM
Call is after hours today.

Sold most as up 120% on options and do not want to get greedy.

Title: Re: ONXX
Post by: la-onda on August 30, 2007, 09:18:22 PM
BAY: Releases Results from Study; Nexavar Tablets Found Effective
Monday , August 27, 2007 08:38ET

Bayer HealthCare Pharmaceuticals (BAY) and Onyx Pharmaceuticals, Inc. (ONXX) announced that a planned review by an independent data monitoring committee (DMC) found that Nexavar(R) (sorafenib) tablets significantly improved overall survival, progression free survival, and time to progression in an Asia-Pacific regional Phase 3 trial of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer.

Based on the DMC's recommendation, the trial will be stopped to allow all patients to receive treatment with Nexavar. Data from this study will be submitted for presentation at an upcoming scientific meeting.

&

Pill may mean windfall for drugmaker: News of Onyx Pharmaceuticals' successful trial of liver cancer treatment sends company's stocks soaring
Tuesday , August 28, 2007 08:43ET

David Morrill

Aug 28, 2007 (Contra Costa Times - McClatchy-Tribune Information Services via COMTEX) -- The lone drug of Onyx Pharmaceuticals Inc. has the potential to become a major cash cow for the Emeryville-based company if it can penetrate a liver cancer market estimated by analysts to be worth about $3 billion.

On Monday, the company reported that a trial in Asia using Nexavar showed such favorable results in patients with late-stage liver cancer that Onyx chose to end the study. Shares of the company surged more than 10 percent on the news, up $3.42, to close at $37.04.

"What this news does is it provides investors some real visibility on a real large Asian opportunity that in some sense many may not have thought a whole lot about before," said Jim Birchenough, an analyst with Lehman Brothers in San Francisco.

News of this study mirrors a second study in February that was also halted because of favorable results. Specific results of the data will be presented at an upcoming scientific meeting, the company said.

Onyx and its partner, Bayer Pharmaceuticals Corp., will now seek approval from U.S. and European regulators to sell Nexavar for treating liver cancer. In December 2005, the drug was approved for treating kidney cancer.

Nexavar is seen as a drug with great potential. It is often compared to the blockbuster drug Avastin, manufactured by biotechnology giant Genentech. Both drugs target a tumor cell's ability to grow by cutting off its blood supply.

One potential advantage Nexavar has over Avastin is that it's taken orally, versus intravenously at a medical clinic.

"One way to look at it is that it targets the same properties as Avastin, as well as other things beyond," Birchenough said. "So ultimately. it could be as big, if not bigger than Avastin."

The liver cancer market is valued at about $3 billion annually, based on about 15,000 patients in the United States, 45,000 to 60,000 in Europe, 30,000 in Japan and 500,000 in Asian countries outside of Japan.

It's higher in the Asia-Pacific region because of a greater prevalence of hepatitis C infection, which causes the number of liver cancer incidence to rise.

Last year, the Food and Drug Administration gave Nexavar "fast track" status, which allows the approval process to be sped up.

This designation is given to drugs that treat serious or life-threatening diseases where there is an unmet medical need. Liver cancer is the fifth most common cancer in the world and is the most prevalent in developing countries.

chart:


Title: Re: ONXX
Post by: setravis on September 04, 2007, 10:04:39 PM
Quote from: setravis on May 12, 2007, 05:56:47 PM
Event.......
Record Price Break Out !


52wk Range: 10.38 - 31.28
Volume: 6,048,221
Avg Vol (3m): 3,346,020

Technicals
Record Price High
Most Actives
Record Price Break Out
Percentage Gainer

Last Price Quote is:
7.41%above 13-day MA
15.98%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $1,434.87 
P/E Ratio: NA 
PEG Ratio: -0.88 
Next Earnings: 08/07/2007


Onyx Pharmaceutical shares leaped and partner Bayer AG... BAY
said early Monday that they ended a Phase III clinical trial for their oncology drug Nexavar early because of better-than-expected results. The companies are testing Nexavar, which is already approved to treat kidney cancer, for the treatment of advanced hepatocellular carcinoma, the most common form of liver cancer.
As a result of the early termination, all the patients in the trial will now have access to the drug. The FDA is expected to decide on whether to approve Nexavar for liver cancer within six months.
Bayer investors appeared to be less enthused, pushing down shares about 2%

Cup with Handle (continuation).......

52wk Range: 10.38 - 42.63
Volume: 3,047,946
Avg Vol (3m): 2,189,230

Technicals
Record Price High

Last Price Quote is:
16.24%above 13-day MA
31.27%above 50-day MA
RS Rating: 97 

Fundamentals
Key Data:
Market Cap (M): $2,167.38 
P/E Ratio: NA 
PEG Ratio: -1.708 
Next Earnings: 11/06/2007
Last Analyst Rating: Outperform
Title: Re: ONXX
Post by: la-onda on February 03, 2008, 02:36:08 AM
setravis, whats your opinion about ONXX?
cheers
O.

ONXX update:

Big on Onyx's Nexavar

Onyx Pharmaceuticals (Nasdaq: ONXX) delivered strong financial performance of Nexavar in 3Q07 in spite of heavy competition in the kidney cancer market from Pfizer (NYSE: PFE) and Wyeth (NYSE: WYE). We are optimistic about the potential of oncology candidate Nexavar (sorafenib). We believe Nexavar sales will continue to grow over the next several years since the label has expanded to liver cancer. Label expansion into other cancer indications are under way. Nexavar has the potential to become a blockbuster for Onyx. Nexavar sales continued to grow in 3Q07 in spite of heavy competition from Pfizer's Sutent and Wyeth's new drug Torisel for kidney cancer indications. Total Nexavar sales came in at $104.6 million, up 130% from $45.4 million in 3Q06. US sales increased to $41 million in 3Q07 from $28.4 million in 3Q06, up 44.4%. International sales reached $63.6 million, up 274% from $17 million in 3Q06. EU and the US approved Nexavar for 1st line treatment of liver cancer in 4Q07. Other international filing is underway. We believe Nexavar sales will be further boosted in 2008 and beyond due to this new indication. We model sales of Nexavar will reach $1 billion in 2010. The stock's current price is attractive; therefore, we upgrade Onyx shares to Buy from Hold with a price target of $64 per share.

January 2008 presentation:


http://www.onyx-pharm.com/pdf/Corporate_Presentation.pdf


latest news:
FRANKFURT, Jan. 22, 2008 (Thomson Financial delivered by Newstex) -- Bayer AG (NYSE:BAY) said the risks of high-blood pressure associated with its Nexavar cancer drug that were highlighted in an article in UK science journal The Lancet Oncology are known and covered by the labelling. 'Currently approved product labelling for Nexavar states that hypertension may occur, usually at the beginning of the course of the therapy, and is managed with anti-hypertensive agents,' Bayer spokesman Oliver Renner said. An analysis of nine studies in which Nexavar was tested on a total of 4,599 patients suffering from kidney cancer and other solid tumours, published by The Lancet, concluded that the drug was 'associated with a significantly increased risk of all-grade hypertension' and that 'appropriate monitoring and treatment is strongly recommended.' 'This is a known risk and it is covered by the currently approved product labelling,' Bayer's Renner commented on the on the article.
http://money.cnn.com/news/newsfeeds/articles/newstex/AFX-0013-22419161.htm

&

Bayer/Onyx Pharmaceuticals: Nexavar approved for kidney cancer in Japan

Monday , January 28, 2008 11:39ET

Jan 28, 2008 (Datamonitor via COMTEX) -- Nexavar has been approved in Japan for use in metastatic renal cell carcinoma patients. This makes Nexavar the first oral targeted therapy to be approved in this major pharmaceutical market for this indication. This approval will significantly advance the outcomes of patients affected with renal cell carcinoma as well as further enhance Nexavar's success. Nexavar (sorafenib) is a multi-kinase inhibitor that targets angiogenesis and cell proliferation mediators such as Raf kinase, the platelet-derived growth factor receptor (PDGFR) family and the vascular endothelial growth factor receptors (VEGFR) 2 and 3. It was the first targeted therapy to be approved for metastatic renal cell carcinoma (RCC) in the US in December 2005 with subsequent EU approval in July 2006. Approval was based on results from a randomized Phase III trial of more than 900 metastatic RCC patients which showed that Nexavar slowed tumor progression by 24 weeks compared to 12 weeks in the placebo group. However, it remains to be seen if this tumor growth suppression translates into a survival benefit for these patients. Kidney cancer affects over 200,000 people annually worldwide with about a third of patients presenting with metastatic disease. Renal cell carcinoma is the most common form of kidney cancer and accounts for around 8,000 new cases per year in Japan alone. RCC has been associated with high levels of unmet need and traditional cytokine therapy produces very low response rates. This presented a strong demand for better alternatives in advanced patients. The approval of targeted therapies such as Nexavar, Pfizer's Sutent (sutinib) and Wyeth's Torisel (temsirolimus) for RCC in recent years has positively widened the treatment options available for these patients. Nexavar competes with Sutent and Torisel in the US (Sutent approved January 2006; Torisel approved May 2007) and EU (Sutent approved July 2006) metastatic RCC markets. However, with its most recent approval in Japan, Nexavar will be able to exclusively penetrate this market as it is the first oral targeted therapy to be approved here. Bayer and Onyx Pharmaceuticals co-develop Nexavar worldwide, except in Japan where it is developed and marketed by Bayer. Nexavar is also approved in both the US and EU for advanced hepatocellular carcinoma. In September 2007, a new drug application for Nexavar was filed for use in patients with hepatocellular carcinoma in Japan for which priority review status has been recently granted. Approval in this additional indication will no doubt further boost Nexavar's success in this major pharmaceutical market.

Chart: