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2009 BioMedTracker Outlook Report - Insight Into the Developmental Drugs and Catalysts that Could Impact the Biotech Market in 2009


Description: In the 2009 Outlook Report, BioMedTracker examines various high-profile developmental drugs in numerous indications and highlights upcoming catalysts in 2009 which could impact the likelihood of approval and market impact of those drugs.

The report is broken down as follows:

I. Executive Summary

II. Oncology
Within hematology, we believe Arzerra (Genmab, GSK) data will set the stage for the drug to eventually challenge Rituxan in multiple indications. Additionally, the final data from the Provenge IMPACT trial will answer the long-lasting dispute over Provenge’s ability to extend survival in hormone-refractory prostate cancer. Lastly, Avastin will report data to expand its use in colorectal cancer and breast cancer and has the potential to be approved for use in two additional indications, glioblastoma multiforme (GBM) and renal cell cancer (RCC).

III. Diabetes & Obesity
The pre-insulin landscape could be changed by 2009 PDUFAs for Victoza, Onglyza, and alogliptin. The outcome of these PDUFAs could be impacted though by several safety issues, including the FDA’s new guidance on ruling out cardiovascular risk in diabetes drugs. GLP-1 drugs have come under scrutiny in recent months due to case reports of severe pancreatitis with Byetta, an issue likely to be raised at Victoza’s advisory committee meeting. While obesity is an ever increasing health epidemic, few effective therapy options are available for physicians, but we expect data from more efficacious drugs this year. The division evaluating obesity products is the same one evaluating diabetes drugs, so they may well expand the cardiovascular analysis required in diabetes to obesity, particularly for a novel drug like tesofensine with an impact on blood pressure and pulse.

IV. Hepatitis C (HCV)
Major changes to the HCV standard of care are in the process of unfolding as new compounds have shown promising results and are likely to be approved in the near future. We are expecting several Companies to release top-line and updated results on their compounds for HCV treatment at this meeting. This includes a number of protease inhibitor compounds that are going head-to-head against standard interferon based therapy regimens.

V. Developing Country Trials
We are also highlighting data expected from a number of pivotal trials with international research sites, particularly in India, eastern Europe, and Mexico. Several international trial incidents last year prompted the need to increase the number of good clinical practice (GCP) inspections at international sites. Problems at such sites could lead to issues with the validity of data and even suspension of trials.

VI. Other Drugs of Interest
We have summarized three additional drugs we feel will have compelling events in 2009, Denosumab, Bapineuzumab, and Pimavanserin.

VII. Other Noteworth Expected Events

VIII. 2009 Catalysts by Type


Contents: I. EXECUTIVE SUMMARY

II. ONCOLOGY
- HEMATOLOGY
- Rituxan for Chronic Lymphocytic Leukemia (CLL)
- Arzerra for CLL & NHL
- Clolar for Acute Myelogenous Leukemia (AML)
- BiovaxID for Non-Hodgkin’s Lymphoma
- PROSTATE CANCER
- Provenge
- Abiraterone
- Acapodene
- AVASTIN
- Breast Cancer
- Colorectal Cancer
- Glioblastoma Multiforme (GBM)
- Renal Cell Cancer (RCC)
- FRONT-LINE NON-SMALL CELL LUNG CANCER (NSCLC)
- Erbitux
- Tarceva

III. DIABETES & OBESITY
- DIABETES DRUGS UNDER FDA REVIEW
- ADDITIONAL DIABETES DRUGS OF INTEREST
- GLP-1 Agonists
- SGLT-2 Inhibitors
- Inhaled Insulin
- Fast-Acting Insulin
- OBESITY DRUGS
- Contrave
- Empatic
- Qnexa
- Lorcaserin
- Symlin and Metreleptin
- Davalintide
- Tesofensine

IV. HEPATITIS C (HCV)
- Telaprevir
- Boceprevir
- ITMN-191
- Viramidine
- Albuferon

V. DEVELOPING COUNTRY TRIALS

VI. OTHER DRUGS OF INTEREST
- Denosumab
- Bapineuzumab
- Pimavanserin

VII. OTHER NOTABLE EXPECTED EVENTS

VIII. 2009 CATALYSTS BY TYPE


Companies Mentioned - Biogen Idec - Genmab - GlaxoSmithKline - Dendreon - Roche - Medarex - Genzyme - Accentia - Cougar - GTx - PDL Biopharma - Merck KGaA - Bristol-Myers Squibb - OSI Pharmaceuticals - Novo Nordisk - Johnson & Johnson - AstraZeneca - Pharmaceutical Product Development - Takeda - Amylin - Eli Lilly - Alkermes - Sanofi-Aventis - MannKind - Halozyme - Orexigen - Vivus - Arena - Amgen - NeuroSearch - Vertex - Schering Plough - Intermune - Valeant - Human Genome Sciences - Novartis - Elan - Wyeth - Acadia - Daiichi.


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