Companies featured in this edition of the newsletter: ACTC, CUR, CVM, DKAM, ENZ, IMUC, MFGD, NXOI, OMCM, ONEZ, PSID, XSNX

Markets continued to carry momentum during the early stages of last week, as the absence of significant economic news led to a continuation of the upward trend characterizing the past few weeks, until an earnings miss from Dell on Thursday led to a selloff in the technology sector which caused the major indices to end the week mixed. All told, the Dow ended the week in positive territory, gaining 47 points to close at 10318, up 0.5% on the week and 17.6% on the year. The Nasdaq surrendered 1.0% to close at 2146, paring its YTD gains to 36.1%, while the S&P 500 and Russell 2000 lost 0.2% and 0.3% respectively, reducing their yearly gains to 20.8 and 17.1.

Things got off to a strong start on Monday, with the

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  Amgen (AMGN) reported third quarter earnings per share of $1.47, well above the Zacks Consensus Estimate of $1.26 and 21% above the year-ago earnings of $1.21. Cost cuts and a lower tax rate helped boost the top-line despite a 2% decline in total revenues, which came in at $3,812 million. Total product sales decreased 1% to $3,736 million. While sales in the U.S. were relatively unchanged at $2,918 million, international sales declined 4% to $818 million mainly due to the unfavorable impact of foreign exchange (Fx) fluctuation, which affected sales by approximately $76 million. Aranesp sales declined 19% to $685 million (U.S. - $333 million, down 27%; ex-U.S. - $352 million, down 9%), mainly due to a decline in demand reflecting the negative impact, primarily in the supportive cancer care setting, of additional product label changes which occurred in August 2008. Aranesp continued to lose share ...

In a major disappointment for Spectrum Pharmaceuticals (SPPI), the US Food and Drug Administration (FDA) last week refused to approve the company’s supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) in its current form. The company was seeking approval for the treatment of patients with advanced metastatic colorectal cancer. Following the news, the shares plummeted 18% on Friday.

Spectrum received a Complete Response Letter (CRL) from the FDA, in which the agency stated that the Fusilev data did not confirm the drug’s non-inferiority to leucovorin. Spectrum Pharmaceuticals plans to request a meeting with the agency to discuss the future course of action. The drug is currently approved by the FDA as a treatment option after high dose of methotrexate therapy in patients with osteosarcoma, a type of bone cancer.

Earlier in September, the company raised $50 million in a registered direct offering of shares and warrants priced at $7.55. We believe

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Recently, Genomic Health Inc. (GHDX) announced data which confirmed that manual micro dissection (dissection of tissue or cells under the microscope) of biopsy cavities is essential for the accurate assessment of recurrence risk in patients with early-stage breast cancer.  Genomic Health's Oncotype DX is the only commercially available breast cancer test that makes use of manual microdissection following review by a board certified surgical pathologist with expertise in breast cancer to predict a patient's benefit from chemotherapy and risk of disease recurrence.  The results from the study revealed that the inclusion of biopsy cavities in breast cancer specimens is associated with significant changes in the expression of individual genes. Consequently, it was found that biopsy cavities had high-risk Recurrence Scores.  Genomic also presented results which demonstrated ability of Oncotype DX breast cancer test to predict the likelihood of disease recurrence in Japanese women with estrogen ...

Yesterday, Bristol-Myers Squibb (BMY) released inconsistent results for its colon cancer drug Erbitux (cetuximab) from two late-stage studies. Among the two retrospective analyses of the pivotal phase III studies, CRYSTAL and COIN, one reported positive results while the other failed to meet its primary end point. Erbitux is sold by Merck KGaA, Eli Lilly (LLY) and Bristol-Myers Squibb.

CRYSTAL is a multi-national study conducted by Merck KGaA. Erbitux, when added to Folfiri (a chemotherapy regimen) increased median overall survival to 19.9 months in an intent-to-treat population of first-line metastatic colorectal cancer (mCRC) patients compared to 18.6 months in the recipients of Folfiri only.

Moreover, when studied in a subset of mCRC patients with normal or wild-type version of a gene called KRAS, the median overall survival increased to 23.5 months in patients who received Erbitux plus Folfiri as against 20 months for those who took Folfiri alone.

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Yesterday, Amgen (AMGN) presented data from a phase III trial of its Vectibix in combination with Folfiri (an irinotecan based chemotherapy) as a second-line treatment for metastatic colorectal cancer at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin.

In the trial, Vectibix significantly improved progression-free survival (PFS) in patients with tumors containing a specific gene known as KRAS. Tumor KRAS status was confirmed in 91% of the 1,186 patients enrolled in the trial, the highest number ever reported for a second-line trial.

The combination treatment of Vectibix and Folfiri achieved the co-primary endpoint by improving the median PFS by 2 months (5.9 months versus 3.9 months) compared to Folfiri alone. The combination also showed significant improvement (35% versus 10%) in tumor response rate in patients. However, even though the median overall survival was numerically better (14.5 months versus 12.5 months), it did not achieve

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Wednesday September 16, 2009

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PWRM, Power 3 Medical Products Inc, PWRM.OB

AMGN, Amgen Inc.

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Power3 Medical Products, Inc. Headlines Session at International Molecular Diagnostic Meeting in China

- Power3 Medical Products, Inc. a Leader in Neurodegenerative Disease and Cancer Diagnostic Biomarkers Announces its Chief Scientific Officer is Chair and Keynote Speaker of Session at the BTI Life Sciences 2nd Annual Congress and Expo of Molecular Diagnostics in Beijing, China in November 2009 -

Power3 Medical Products, Inc. (OTC BB: PWRM), is a leading bio-medical company engaged in the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the development

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On Friday, Sanofi-Aventis (SNY) and collaboration partner, Regeneron Pharmaceuticals (REGN) suffered a pipeline setback with the companies halting development of their late-stage pipeline candidate, aflibercept, for the treatment of pancreatic cancer.

Aflibercept, an anti-angiogenesis agent being developed for a variety of tumor types, was in a phase III study, which was evaluating the efficacy of the drug in combination with Eli Lilly’s (LLY) Gemzar (gemcitabine) versus placebo plus Gemzar for the first-line treatment of pancreatic cancer.

A planned interim efficacy analysis of the study, carried out by an independent data monitoring committee, showed that the addition of aflibercept to Gemzar would not lead to a statistically significant improvement in the primary endpoint of overall survival compared to the placebo plus Gemzar combination. The companies will conduct a detailed analysis of the efficacy and safety data, which will be presented at a future medical meeting.

The discontinuation of the study is

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Tuesday September 8, 2009

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GATX Corporation (NYSE:GMT) today announced that Rhonda S. Johnson, director of investor relations, will present at the Longbow Research Second Annual Industrial Products Conference in New York on Thursday, September 10, 2009. The presentation will include an overview of GATX’s operations.

Concurrent (Nasdaq: CCUR), a worldwide leader in video and

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Yesterday, Genomic Health, Inc. (GHDX) announced that a number of leading U.S. surgeons ask for Genomic Health's Oncotype DX breast cancer assay at the time of surgery or biopsy, in an effort to provide patients with prompt, critical information about treatment options available at their maiden visit to an oncologist. Oncotype DX, the growth engine of the company, was launched in 2004. It is the first and only multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In late May 2009, Genomic Health announced that more than 100,000 test results have been delivered in over 40 countries worldwide since the commercial launch of Oncotype DX. The assay analyzes the activity of 21 genes within a breast cancer patient's tumor to calculate an individualized result (Recurrence Score). Upon ...