Genzyme Corporation’s (GENZ) problems continue with the company recently announcing the discontinuation of the development of its kidney disease drug. Genzyme reported results on its advanced phosphate binder (APB) from a phase II/III study.  Although the candidate met its primary endpoint, results showed that it was not more effective than Renvela, a product that is marketed by Genzyme. Based on these results, the company has decided to discontinue further clinical development of the APB.  Genzyme was looking to develop a product with higher potency that would more effectively bind phosphate, while maintaining all the benefits of Renvela. Renvela is a follow-on product of the company’s kidney disease drug, Renagel. Sales of Renagel/Renvela totaled $677.7 million or 15% of total revenue in 2008.  Renagel and Renvela are phosphate binders for the treatment of hyperphosphatemia. The company was looking to gain approval for the APB before Renagel/Renvela ...

Genzyme Corporation’s (GENZ) Lumizyme failed to receive approval from the US Food and Drug Administration (FDA) for the treatment of Pompe disease. The FDA issued a complete response letter (CRL) stating that the agency will not grant approval unless the company addresses the manufacturing issues at its Allston Landing plant in Boston. Genzyme said that it believes that other elements like the Risk Evaluation and Mitigation Strategy (REMS), product label and post-marketing requirements, have been satisfactorily addressed. The FDA’s response on Lumizyme does not come as a surprise. The news regarding the delay in Lumizyme’s approval follows a recent announcement regarding the detection of contamination in vials of five drugs marketed by the company. The agency completed its inspection of the company’s plant last week and has provided Genzyme with a list related to the manufacturing deficiencies found at the plant. The company stated that ...

Osiris Therapeutics (OSIR) reported a net loss of 21 cents per share in the third quarter of 2009, well above the Zacks Consensus Estimate of a net income of 6 cents. However, net loss in the year ago period was higher at 63 cents, mainly due to lower revenues.  Revenues in the reported quarter increased to $10.6 million compared to $0.995 million for the same period of the prior year. Osiris generates revenues from collaborative agreements, research licenses, and government contracts.  Revenues in the reported quarter included the recognition of $10 million in revenue under the company’s agreement with Genzyme Corporation (GENZ) for the development and commercialization of Prochymal and Chondrogen.  Osiris earned $0.4 million from its collaborative agreement with the Juvenile Diabetes Research Foundation (JDRF) for the development of Prochymal for type I diabetes, $0.1 million from its contract with the Department of ...

The pharmaceutical industry has witnessed major changes in 2009. Performance has been affected by factors like sluggish prescription trends, intensifying generic competition and limited phase III catalysts. The next five years are expected to reflect a significant imbalance between new product introductions and patent losses. According to IMS Health (RX), this is the main reason why global pharmaceutical market growth will be restricted to the mid-single digits through 2013. Over the next five years, products that currently generate about $137 billion in sales are expected to face generic competition, including Lipitor, Plavix and Seretide. At the same time, new products are not expected to generate the same level of sales as the products losing patent protection have. With most of the big pharma companies already facing patent challenges for their blockbuster products or likely to face them going forward, the companies have been looking toward mergers ...

Genzyme Corporation has announced that they have received a complete response letter from the Food and Drug Administration about the company’s supplemental New Drug Application for Clolar in patients suffering from acute myeloid leukemia or untreated older patients with AML. In the response letter to Genzyme Corporation, FDA has clearly mentioned that they need to have a randomized and controlled clinical trial be conducted for label expansion of Clolar. Genzyme’s Clolar drug is currently approved for pediatric ALL patients who have relapsed or have refractory diseases. FDA has also granted six months of extended market exclusivity to Clolar under the Best Pharmaceuticals for Children Act.

In September, FDA Oncologic Drugs Advisory Committee voted for Clolar and had emphasized that it was necessary to establish the efficacy and safety of Clolar for

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Genzyme Corporation (GENZ) recently reported positive results from a randomized phase III study that was conducted with Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients.  The company reported that patients treated with Campath and Fludara (FluCAM) experienced a significant improvement in progression free survival (PFS), compared to patients receiving only Fludara. The study was designed to detect at least a 50% overall improvement in PFS in the FluCAM arm compared to the Fludara arm.  Although the company did not disclose full results, Genzyme announced that the trial’s independent data safety monitoring board, in a pre-planned interim analysis, determined that the study achieved its primary endpoint and recommended early closure of the trial.  We look forward to detailed results from the study in December at the American Society of Hematology. Impressive PFS results could help the combination ...

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Wednesday September 23, 2009

DrStockPick.com Stock Report!

GENZ, PWRM, STEM, CTIC, PFE

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GENZ, Genzyme Corporation

GENZ is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion.

GENZ provided an update on its progress to restore supplies of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) for patients worldwide and revised its 2009 revenue guidance for these products. GENZ is now approximately half-way through the anticipated shortage period

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Friday September 11, 2009

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How Cummins Inc. (NYSE:CMI) and its Chinese customers cooperate in developing and using clean power was highlighted this week during a visit from Indiana Gov. Mitch Daniels, who is leading an Indiana delegation on a six-day visit to China. The governor was joined by representatives from the Zhejiang provincial government, technical officer of Hangzhou Public Transit Group (HZPT) and Steve Chapman, Group Vice President of Cummins.

Genzyme Corporation (Nasdaq: GENZ) reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained

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Monday August 10, 2009

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Avigen, Inc. (Nasdaq:AVGN) a biopharmaceutical company, today reported financial results for its second quarter ended June 30, 2009. At June 30, 2009, Avigen had approximately $41.6 million in financial assets, including cash, cash equivalents and available-for-sale securities and restricted investments, compared with approximately $56.8 million at December 31, 2008 before repaying $7.0 million of outstanding bank borrowings in March 2009.

FICO (NYSE:FIC), the leading provider of analytics and decision management technology, announced today that it will change the ticker symbol of its shares on the New York Stock Exchange from “FIC” to “FICO,” effective at the start of trading on Tuesday, August 18, 2009. The

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Monday August 3, 2009

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CTI Industries Corporation (NASDAQ: CTIB), today announced that it will host a conference call and live webcast to discuss fiscal 2009 second quarter earnings and 2009 year-to-date financial results. The conference call and webcast will take place on Wednesday, August 12, 2009 at 10:00 a.m. Central Daylight Time (11:00 a.m. Eastern Daylight Time).

Hagens Berman Sobol Shapiro is investigating reports of possible securities law violations by Genzyme Corporation (Nasdaq:GENZ), a biotechnology company, following reports that the company may have delayed news concerning manufacturing problems and plant inspections by the Food and Drug Administration (FDA).

RiT Technologies (NASDAQ: RITT) today announced that its previously announced one-for-eight

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