Despite the FDA filing by Dendreon (NASDAQ: DNDN) during the past week, the underlying ImmunoTherapy / Vaccines Index is off to a slow start and down by about 10% since mid-October.
Click here to visit the News Room page for ImmunoCellular Therapeutics (OTC: IMUC.OB), which posted impressive updated Phase 1 survival data for its brain cancer vaccine (ICT-107) in late October and appears to be forming a new support level around the $1 per share level after consolidating gains of about 2X from late August levels following a spate of good news that also included a deal with Roche (OTC: RHHBY.PK) for a cancer monoclonal antibody.
Despite a loss of about 20% for CVS Caremark (NYSE: CVS) during the past week on a weak outlook for its pharmacy benefit management (PBM) business, the Health Benefit Providers Index has posted strong gains lately to surpass the S&P 500 Index over the past three months as investors are hopeful that gridlock will prevent legislation from passing for widespread healthcare reform and a public health insurance option.
The Regulatory Catalyst Index has been weak over the past three months and most recently GTx Inc. (NASDAQ: GTXI) suffered a major setback as the Agency failed to approve its bone drug.
Generic drug stocks have fared the best over the past three months among my healthcare indexes, outpacing the overall market by approximately 2X on a percentage gain basis. Big stock price gainers over the past year among U.S.-based components include Hi-Tech Pharmacal (NASDAQ: HITK) and Mylan (NYSE: MYL).
ImmunoTherapy / Vaccines Index
The actively managed HavRx ImmunoTherapy / Vaccines Index includes companies with market caps below $5 billion at the time of index inclusion which are developing or commercializing any type of immunotherapy, gene therapy, or vaccine product that is designed to stimulate the immune system for the eradication, combination treatment, or prevention of cancer. In addition, the index will track companies which are developing or commercializing any type of vaccine product or vaccine adjuvant for all types of infectious disease such as influenza (flu) and bio-defense applications.
Cosmetic / Restorative Medicine Index
The HavRx Cosmetic / Restorative Medicine Index is actively managed and tracks the performance of companies that derive over 50% of revenue from any of the following activities: (1) prescription skin care therapeutics; (2) medical devices, products, services, OR equipment for procedures which are intended to enhance appearance; (3) medical devices, products, services, OR equipment for use as joint replacements, tissue repair agents, tissue reconstruction agents, surgical adhesives, and cardiovascular procedures; and (4) regenerative medicine products, services, and/or an active clinical pipeline which seeks to restore or repair the functionality of lost or damaged organ, tissue, cellular, and genetic material.
Emerging Cancer Diagnostic / Therapeutic (Dx / Tx) Index
The actively managed HavRx Emerging Cancer Dx / Tx Index constituents reflect a cross-section of emerging cancer companies with market caps below $500 million at the time of index inclusion, encompassing the following categories: (1) diagnostics (molecular diagnostics and device-based diagnostics), (2) lab services (personalized medicine applications to guide and track the effectiveness of cancer treatments), (3) drug discovery (screening and modifying compounds to achieve anti-cancer effects during the early stages of preclinical and Phase 1 clinical studies), (4) immunotherapy (a.k.a. cancer vaccines which are designed to stimulate the immune system to eradicate cancer), and (5) commercial or late-stage (Phase 2-3) clinical development therapeutics, devices, or diagnostics intended for use by cancer patients.
Emerging Diagnostics Index
The HavRx Emerging Diagnostics Index is actively managed and tracks the performance of companies with market caps below $500 million at the time of inclusion. The index includes diabetes monitoring device makers, laboratory services, clinical diagnostics, diagnostic imaging, diagnostic equipment makers, and molecular diagnostics.
Global Generic Drug Index
The HavRx Global Generic Drug Index is actively managed and tracks the performance of companies which meet any of the following three requirements: (1) Derive either $500 million (USD) OR more than 50% of trailing 12-month revenues from the manufacture and sale of any type of generic (off-patent) prescription or over-the-counter (OTC) drug product intended for use by humans, including contract manufacturing services for drug products and biological agents; (2) Have one or more compound(s) in active clinical development OR have a pending ANDA with the FDA for a generic drug candidate; (3) Receive FDA approval for an ANDA within the past 12 months. The breakdown by region for the companies in this index includes U.S. (27%), India (27%), Europe (16%), China (18%), Japan (6%), and other (6%).
Global Health Information Technology (Health IT) Index
The HavRx Global Health IT Index is actively managed and tracks the performance of companies with market caps below $10 billion that derive over either $50 million or 50% of their trailing 12-month revenue from products and services for the following activities: (1) electronic transmission, storage, and processing of prescriptions; (2) secure e-mail transmission for healthcare facilities; (3) electronic transmission, storage, and processing of medical imaging and diagnostic information; (4) electronic storage and systems for administrative functions of healthcare facilities and medical records; (5) electronic transmission, storage, and systems for healthcare market data and clinical trial data; (6) electronic systems, devices, and services for remote, real-time monitoring of patient health parameters; (7) medical transcription services, products, and systems for conversion into electronic medical records.
Global Stem Cell Index
The HavRx Global Stem Cell Index is actively managed and tracks the performance of regenerative medicine companies that derive over 50% of revenue or have compound(s) in active pre-clinical or clinical development which are designed to restore, replace, repair, or enhance the functionality or appearance of tissue and organ systems, including all types of embryonic and adult stem cell therapeutics. In addition, all types of products and services for stem cell banking are included in this index.
Health Benefit Providers Index
The HavRx Health Benefit Providers Index is actively managed and tracks the performance of retail pharmacies, pharmacy benefit managers, managed care companies, health insurers, hospital pharmacy operators, workers compensation insurers, and specialty health benefit providers.
Preventative Medicine Index
The HavRx Preventative Medicine Index is actively managed and tracks the performance of companies with market caps over $100 million at the time of inclusion that derive over either 50% or $100 million in trailing 12-month revenue from any of the following activities: (1) human vaccines which are already on the market or in active clinical development; (2) diagnostics and lab services; (3) diabetes care; and (4) vitamins, health supplements, functional foods, and weight loss products or services.
Regulatory Catalyst Index
The actively managed HavRx Regulatory Catalyst Index tracks the performance of healthcare companies with pending new drug, biological agent, or medical device/diagnostic product decisions at the FDA.
Pet Care / Animal Farma Index
The HavRx Pet Care / Animal Farma Index is actively managed and tracks the performance of companies with market caps below $5 billion at the time of inclusion that are active in the following business segments: animal breeding, animal `pharming`, veterinary stem cells, veterinary services, pet retailers, animal feeds nutrition, and veterinary medicine diagnostics. Favorable growth trends for the pet and animal care industry include (1) pet spending in the U.S. is estimated at $43.4B in 2008, up from $32.4B in 2003; (2) about 63% of U.S. households have a pet, which equals over 71M homes; and (3) the worldwide market for animal healthcare, excluding bulk feed and nutrition products, is expected to reach just under $20B in 2008, experiencing growth of 26% from $15.6B in 2003.
Global Hospital Index
The HavRx Global Hospital Index is actively managed and tracks the performance of companies which derive over 50% of revenue from the following activities: hospitals, inpatient rehabilitation facilities, dialysis facilities, hospice providers, inpatient behavioral healthcare facilities, and ambulatory surgery centers. The revenue requirement for this index excludes the following activities: home healthcare, outpatient medical services, and senior living centers.
The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my 22 ProActive HavRx stock indexes. This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes.
Disclosure: Long IMUC.OB
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