NEWS & COMMENTS

PROHOST    FILTER

FDA Delays decision on Roche’s Anemia Drug

       The decision was a response to Roche’s submission of additional data to the FDA to support its Biologic License Application (BLA) for Mircera®, the firm’s anemia drug. According to Roche, the additional data are intended to provide as comprehensive an understanding of Mircera as is possible to assist the FDA in completing the review process. FDA has granted Roche three month extension to the review period.   

      "The newly available Mircera data that we have proactively submitted will help to give the FDA additional clarity in key areas that the FDA is monitoring with already available anti-anemia agents," said Eduard Holdener, Global Head Pharma Development. He added, "We want to ensure that our application to the FDA is as robust as possible in an evolving regulatory environment and we are confident that the additional data submitted will facilitate a positive review of Mircera."  

      Roche is seeking an indication for Mircera in the treatment of anemia associated with chronic kidney disease (CKD) including patients on dialysis and not on dialysis. The BLA submitted to the FDA is based on data from all six studies that comprise the Phase 3 clinical program. This included treating anemia in previously untreated patients and maintaining hemoglobin (Hb) after conversion from epoetin alfa/beta or darbepoetin alfa. The program consisted of two treatment/correction and four conversion/maintenance studies of both intravenous and subcutaneous Mircera extended administration intervals of up to once monthly.

OTHER IMPORTANT NEWS

Positive News

GENENTECH (DNA)

       Positive news is coming from Genentech (DNA). The first is about Herceptin in breast cancer and the second about avastin on the same.

With regard to Herceptin, Taxotere®-based Regimens with Herceptin® in women with early-stage HER2-positive breast cancer dsemonstrate the highest reduction in the risk of death to date and provide a treatment option without anthracyclines

READ MORE: www.gene.com/gene/news/press-releases/display.do?method=detail&id=10267.   

    With regard to Avastin, Xeloda® plus Avastin® combination may produce clinical benefit in patients with advanced breast cancer. An interim analysis of the XCALIBr (Xeloda in Combination with Avastin as First-Line Treatment for HER2-Negative Metastatic Breast Cancer) trial suggested that first-line therapy with oral Xeloda® (capecitabine) in combination with Avastin® (bevacizumab) may offer clinical benefit in metastatic breast cancer. patients who have no prior history of treatment. At the time of study analysis, 72% of enrolled patients experienced a clinical benefit (a measure of response rate and stable disease) with Xeloda plus Avastin. The combination regimen was well tolerated by patients, with the majority of adverse events being mild or moderate.

OSI (OSIP)

       OSI’s cancer pill received positive opinion from health authorities in Europe

for treatment of patients with pancreatic cancer.

       The European Committee for Medicinal Products recommended approval of once-daily Tarceva in combination with gemcitabine as first-line therapy for metastatic pancreatic cancer. a final decision is expected from the European Commission within 45 days.  Encysive Pharmaceuticals (ENCY):  Encysive Pharmaceuticals announced it has provided the information requested by the U.S. Food and Drug Administration (FDA) in its letter to the Company dated December 13, 2006 regarding the Company's New Drug Application (NDA) for Thelin™ (sitaxsentan sodium) 100 mg tablets. This submission is Encysive's response to the FDA's determination that the Company's November 2, 2006 submission was not complete. The FDA is currently evaluating Thelin(tm) as a potential new oral treatment for pulmonary arterial hypertension. The good news would be confirmed If the FDA agrees that today's submission, taken together with the November 2, 2006 submission, represents a complete response. The FDA then will establish a new Prescription Drug User Fee Act (PDUFA) action date.

ENCYSIVE PHARMACEUTICALS (ENCY)

       Encysive Pharmaceuticals announced it has provided the information requested by the U.S. Food and Drug Administration (FDA) in its letter to the Company dated December 13, 2006 regarding the Company's New Drug Application (NDA) for Thelin™ (sitaxsentan sodium) 100 mg tablets. This submission is Encysive's response to the FDA's determination that the Company's November 2, 2006 submission was not complete. The FDA is currently evaluating Thelin(tm) as a potential new oral treatment for pulmonary arterial hypertension.

The good news would be confirmed If the FDA agrees that today's submission, taken together with the November 2, 2006 submission, represents a complete response. The FDA then will establish a new Prescription Drug User Fee Act (PDUFA) action date.

A Possible Setback

BIOPURE (BPUR)

       The FDA Blood Products Advisory Committee voted to recommend against proceeding with the Navy's proposed Phase 3 study of Hemopure – the pre-hospital treatment for hemorrhaging shock resulting from traumatic injury. The committee recommended that a Phase 2 study be designed to provide safety and efficacy data in a smaller patient population. The recommendation is not binding. It is based  on the committee’s questioning whether data presented justified a Phase 3 trial under which many patients would not be able to give their informed consent due to the nature of their injuries.

Prohost is independent publication providing information on biotech companies. Prohost does not accept compensation from companies that are featured or profiled. It is strongly recommended that any purchase or sale decisions to any of the featured companies be discussed with a financial advisor or broker prior to completing any such purchase or sale decision. All statements or expressions are the opinion of Prohost and are not meant to be a solicitation or recommendation to buy, sell, or hold securities. Investing in embryonic companies, micro-cap and growth securities is highly speculative and carries a high degree of risk. It is possible that an investor can lose all of his/her investment in this type of companies that are profiled. The information that Prohost relies on is either through the profiled company, news services, research reports, interviews, or other outside sources that Prohost believes are reliable. Prohost makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure of the profiled companies and accepts no responsibilities for inaccuracies or misleading content in any material supplied by those clients. There can be no assurance that future events relating to the profiled company will occur as anticipated. The information contained herein is provided as an information service only. Past performance of featured companies does not guarantee the future success of any currently featured or profiled company. We encourage our readers to invest carefully and read the investor information provided by the Securities and Exchange Commission ("SEC") and/or the National Association of Securities Dealers ("NASD"). We also strongly recommend that you read the SEC advisory to investors concerning Internet Stock Fraud, which can be found at: http://www.sec.gov/consumer/cyberfr.htm