Ardea Biosciences Inc. (RDEA) reported third quarter net loss of $2.47 million, or 13 cents per share, which was significantly lower than the Zacks Consensus Estimate of 47 cents. The company reported a net loss of $14.2 million or 95 cents in the year-ago period. The lower loss was attributable to the higher revenues coupled with lower operating expenses recorded in the quarter.  Revenues came in at $9.17 million as against none in the year-ago quarter. The revenues resulted from the recognition of a portion of the upfront payment of $35 million under the global agreement, with Bayer HealthCare focused on the development of MEK inhibitors for the treatment of cancer.  Operating expenses for the quarter decreased 21.4% to $11.4 million primarily due to reduced research and clinical development expenditures. Research and development expenses decreased to $9 million from $11.5 million in the third quarter of ...

Regeneron Pharmaceuticals Inc. (REGN) reported a third-quarter net loss of $1.015 million, or 1 cent per share, which was much better than the Zacks Consensus Estimate of a loss of 23 cents. The company suffered a loss of $19.084 million or 24 cents in the year-ago quarter. The narrower loss reflected the increased contract research and development revenues from its collaborations with Sanofi-Aventis (SNY) and Bayer HealthCare, coupled with a milestone payment from Bayer. Total revenues for the quarter came in at $117.45 million from $65.58 million, up 79%. Total revenues consisted of contract research and development revenues, a 2009 research progress payment, technology licensing revenues apart from net product sales. Revenues from contract research and development increased 56% to $82.48 million from $52.88 million in the year-ago quarter. Contract research and development revenues relate primarily to Regeneron’s aflibercept and antibody collaborations with Sanofi-Aventis ...

Bayer (BAYRY) announced its third quarter results yesterday. Revenues of the group recorded a 7% decline to €7.39 billion from €7.94 billion. The company’s earnings per share from continued operations were €0.78, compared to €0.85 in year-ago period.

Bayer operates through three major segments: Healthcare, accounting for 53.24% of total revenues in the third quarter of 2009; CropScience (15.4%), and Material Science (27.5%) with the remaining 4% coming from other items. While Healthcare segment revenues improved marginally by 3.5%, both cropscience and Material Science fell 8.6% and 20%, respectively.

The Healthcare segment recorded revenues of €3.9 billion compared to €3.8 billion in the corresponding period last year. Both the divisions of Healthcare – pharmaceuticals and consumer health contributed to the growth of the Healthcare segment. Bayer’s primary market, Europe – accounting for 39% of its Healthcare revenues – declined 3%, compared to the year-ago period. The other markets of North America,

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Yesterday, GlaxoSmithKline (GSK) received some good news with the US Food and Drug Administration’s (FDA) approval of Votrient (pazopanib) for the treatment of patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. However, the FDA approval does not come as a surprise to us as earlier this month the FDA’s Oncologic Drugs Advisory Committee (ODAC) had voted unanimously in favor of the drug.  The favorable recommendation was based on encouraging results from a phase III trial of Votrient, in which the drug reduced the risk of tumor progression or death by 54% compared to placebo, regardless of prior treatment. The overall median progression-free survival (PFS) was 9.2 months with Votrient and 4.2 months with placebo.  For both treatment naïve patients and those who received cytokine-based treatment, the median PFS was better with Votrient – 11.1 months versus 2.8 months with placebo, and 7.4 ...

This morning, Genzyme Corp (GENZ) reported third quarter earnings of 19 cents per share, which was well below the Zacks Consensus Estimate of 31 cents and the year ago earnings of 93 cents. Moreover, revenues declined 9% to $1.06 billion. As expected, the temporary shutdown of the company’s Allston manufacturing facility earlier this year impacted overall financial results. Although the company has resumed production at this facility, the temporary shutdown led to a disruption in the supply of key products Cerezyme and Fabrazyme. Cerezyme’s performance was highly affected with sales dropping 69.7% to $93.6 million in the reported quarter. Fabrazyme sales came in at $115.2 million, down 8% from the prior-year quarter. Genzyme expects to resume supply of new lots of Cerezyme and Fabrazyme from late November and late December, respectively. The company believes it will be in a position to meet anticipated demand for both ...

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 ...

The therapeutic area of Atrial Fibrillation (AF) is buzzing with news. We are pleased with the development made by Bayer Schering Pharma, a division of Bayer Healthcare in this field. The company completed patient enrollment in the phase III study for Rivaroxaban (Xarelto). The study aims to assess the efficacy and safety of this drug against Bristol-Myers Squibb’s (BMY) warfarin, which is primarily used for the prevention of stroke in AF patients.

The study is expected to include about 14,269 patients spanning over 45 countries with results due by next year. Atrial fibrillation is the most common heart rhythm abnormality in the US. An estimated 3 million people in the US have atrial fibrillation, which affects about one in 10 people aged over 70.

Rivaroxaban, jointly developed with Johnson and Johnson (JNJ) is also being studied for the treatment of venous thromboembolism (VTE) and deep vein thrombosis (DVT) (apart from

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Emerging Market for Pharma

Tony Daltorio, The Investment U Research Team

The shape of the global market for pharmaceuticals is undergoing a rapid change.

As recently as 2006, more than half of the market growth was in the United States. This data comes from IMS Health, a consultancy that is a leading provider of pharmaceutical trends.

However, the necessity for the pharmaceutical industry to develop new markets is urgent. The latest forecasts from IMS Health suggests that global sales in the industry will grow by just 2.5 – 3.5 percent this year, the smallest expansion it has ever recorded. The United States – which still accounts for two-fifths of all revenues – will decline by 1-2 percent.

Many large pharma companies are now realizing that a lot of future growth is likely to occur outside of what used to be

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ZymoGenetics, Inc. (ZGEN) has filed a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA) requesting the agency to remove King Pharmaceuticals’ (KG) Thrombin-JMI from the market in the interest of patient safety. ZymoGenetics filed the CP based on reports of serious or fatal bleeding-related adverse events in surgical patients exposed to bovine (cattle-derived) thrombin. Thrombin-JMI is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible. The source material for Thrombin-JMI comes from bovine plasma and lung tissue. The treatment is a key product in King’s portfolio. For the twelve months ended December 31, 2008, Thrombin-JMI accounted for 16.3% of total revenues. As such, the removal of the product from the market would be a major blow for the company. Thrombin-JMI revenues have been under pressure lately due to the entry ...