Onyx Pharmaceuticals (ONXX) reported third quarter earnings of 28 cents per share, well above the Zacks Consensus Estimate of 22 cents as well as 21 cents reported in the year-ago period. The company, along with Bayer AG (BAYRY.PK), developed Nexavar (sorafenib) tablets, an anticancer therapy currently approved and marketed for the treatment of liver cancer and advanced kidney cancer in the US, European Union, Japan and some other countries. Onyx’s earnings come in the form of royalty and collaboration income on Nexavar sales.  For the quarter, Onyx reported revenues of $69.1 million compared to $50.8 million for the same period in 2008 primarily due to an increase in Nexavar sales and royalty revenue and a decline in the drug’s commercial expenses. While revenues increased 36%, a 43.6% rise in operating expenses brought down Onyx’s operating margin by 450 basis points to 14.5%. R&D and SG&A expenses increased ...

Recently, Onyx Pharmaceuticals (ONXX) announced that it will purchase privately held cancer drugmaker Proteolix for an upfront cash payment of $276 million. This transaction gives Onyx access to Proteolix's lead compound, carfilzomib, a mid-stage multiple myeloma drug. Apart from the upfront cash payment, Onyx, which currently sells the liver and kidney cancer drug Nexavar along with Bayer AG, is also liable to pay $40 million in 2010 if carfilzomib achieves a development milestone and up to $535 million depending on the achievement of certain regulatory approvals for carfilzomib in the U.S. and Europe.  That is inclusive of a payment of $170 million if the Food and Drug Administration (FDA) decides to conduct a fast review of the drug. The all-cash transaction is expected to close in the fourth quarter of this year. As a reminder, carfilzomib is currently undergoing a phase II b trial (n=250) in ...

After releasing promising data from a mid-stage trial of regorafenib in kidney cancer, the company came out with impressive data on Nexavar for the treatment of breast cancer. Nexavar, which bayer co-developed with Onyx Pharmaceuticals (ONXX), is currently approved for liver and kidney cancers.

Data from a phase II trial that is studying Nexavar for the additional indication of breast cancer was presented at the ongoing 15th European CanCer Organisation and 34th European Society for Medical Oncology Multidisciplinary Congress in Berlin.

The trial on 229 patients studied the effect of Nexavar along with Roche’s chemotherapy agent Xeloda (capecitabine) compared to chemotherapy alone. Patients in the trial had locally advanced or metastatic breast cancer and had not received more than one chemotherapy previously.

Patients receiving Nexavar along with chemotherapy witnessed a 74% improvement in overall survival without the disease progressing. Additionally, the median progression free survival for the combination

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In a positive development, Bayer (BAYRY.PK) released encouraging results from a phase II trial of regorafenib in patients with metastatic renal cell carcinoma (RCC), a type of kidney cancer. The phase II trial was carried out on 49 previously untreated patients whose tumors could not be removed surgically or had started spreading. The trial met its primary endpoint, which was to evaluate response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST). It was observed that 31% of patients experienced a confirmed partial response (PR) whereas 50% of patients experienced stable disease (SD). In addition, the data showed an estimated median progression-free survival of 8.3 months. The data were presented in an oral session at the joint 15th Congress of the European CanCer Organisation and 34th Congress of the European Society for Medical Oncology (ECCO 15 - 34th ESMO) at ...

We maintain our Buy rating on Onyx (ONXX) shares with price target of $45.

Onyx delivered strong financial performance in 1Q09 and we expect the company will continue to deliver very good financials for 2009. Nexavar sales continued to grow in 1Q08, which was mainly attributed to the market penetration in liver cancer while market share has stabilized in kidney cancer market in spite of heavy competition. Total Nexavar sales came in at $178.1 million, up 17% year over year. This increase was mainly driven by international sales which reached $130 million, up 29% year over year.

EU and the US approved Nexavar for 1st line treatment of liver cancer in 4Q07. In Asia, South Korea and China have approved Nexavar for liver cancer. Other international filing is underway. We believe Nexavar sales will be further boosted in 2009 and beyond due to this new indication.

Label expansion for

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OVERVIEW

The Biotech industry as a whole continues to underperform the market so far this year. As of May 26, 2009, Both the AMEX Biotech Index and the broader NASDAQ Biotech Index declined 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies), while the Dow Jones Biotech Index declined 3% (which includes 33 companies).

At the same time, both the NASDAQ Composite and S&P 500 have achieved positive returns. NASDAQ has made a gain of 11% as of 5/26/09 and the S&P 500 has gained 0.8%, while the Dow Jones Industrials reached a negative 3.5% return.

This constitutes a sharp contrast with last year when the Biotech industry as a whole achieved much better performance than the market. In 2008, all three biotech indices outperformed all three major market indices by a large margin. The three major indices declined as much as over 40% (34%, 41%

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OVERVIEWThe Biotech industry as a whole continues to underperform the market so far this year. As of May 26, 2009, Both the AMEX Biotech Index and the broader NASDAQ Biotech Index declined 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies), while the Dow Jones Biotech Index declined 3% (which includes 33 companies).At the same time, both the NASDAQ Composite and S&P 500 have achieved positive returns. NASDAQ has made a gain of 11% as of 5/26/09 and the S&P 500 has gained 0.8%, while the Dow Jones Industrials reached a negative 3.5% return.This constitutes a sharp contrast with last year when the Biotech industry as a whole achieved much better performance than the market. In 2008, all three biotech indices outperformed all three major market indices by a large margin. The three major indices declined ...

Nexavar sales continued to grow in 1Q09 despite turbulent economic conditions; financial position is strongOn May 6, 2009, Onyx Pharmaceuticals (ONXX) reported 1Q09 earnings. Despite the turbulent economic conditions, worldwide Nexavar sales still increased by 17% to $178.1 million in 1Q09, compared to $151.9 million in 1Q08. Much of the growth was driven by its ex-US sales increase, which reached $130 million, up 29% year over year. US Nexavar sales were $48 million, down 6% year over year.Both the US sales and ex-US sales fell short of our expectations. International sales continued to outgrow the US sales. We believe the trend will continue in the coming quarters.According to the management from the conference call, growth was mainly due to the label expansion into its liver cancer indication. In spite of heavy competition in the kidney cancer market, Nexavar's market share ...

Ardea Biosciences' balance sheet gets boosted by Bayer partnershipEarly this morning in a news release, Ardea Biosciences, Inc. (RDEA) announced that it has entered into a global agreement with Bayer HealthCare (BAYRY) to develop Ardea's small molecule mitogen-activated ERK kinase (MEK) inhibitors for the treatment of cancer or other indications. The current focus will be on cancers.Pursuant to the agreement, Ardea will grant Bayer a worldwide, exclusive license to develop and commercialize Ardea's MEK inhibitors for all indications. The agreement is valued at $407 million, not including royalties. This amount includes an upfront cash payment to Ardea of $35 million, as well as additional cash payments upon achievement of certain development, regulatory and sales-based milestones. Ardea is also eligible to receive low double-digit royalties on sales of products under the agreement.The lead compound in this program is RDEA119, which is currently ...

For Immediate Release

Chicago, IL - April 17, 2009 - Zacks.com announces the latest Industry Outlook. Today's outlook from Zacks Equity Research analyst Grant Zeng discusses the Biotech sector. Highlighted stocks include: Myriad Genetics (MYGN), Onyx Pharmaceuticals Inc. (ONXX) and AMAG Pharmaceuticals Inc. (AMAG) and 3SBio Inc. (SSRX).

Here is the latest on the Biotech sector:

We continue to have BUY ratings on Myriad Genetics (MYGN), Onyx Pharmaceuticals Inc. (ONXX) and AMAG Pharmaceuticals Inc. (AMAG). All three companies have strong balance sheets, which eliminate immediate financing needs.

MYGN is a biopharmaceutical company that focuses on the development of molecular diagnostic and therapeutic products. The company's molecular diagnostics business has been very strong and continued to grow impressively in the fiscal second quarter of 2009 ended December 31, 2008, and the outlook is bright even in the current economic environment. We

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