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Mike Havrilla is an index developer, pharmacist, writer, and Co-Founder of BioMedReports.com with experience that includes online investing since August 1997 and writing for investors since April 2007 with a focus on the healthcare sector and small / micro-cap stocks. Mike holds Doctor of... More
- My company:
- ProActive HavRx BioFund
- My blog:
- BioMedReports.com FDA Calendar
- My book:
- ProActive HavRx Stock Indexes
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StockTalks
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ProActive HavRx Stock Indexes / tracked at Investars YOU / Top gainers: Air Transport, Generic Drugs, Tobacco / http://bit.ly/67bSnu/about 3 hours ago
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$EXAS $CLDX $TZA $DCTH / MarketGuru.com Virtual investing portfolio up 14.5% ytd at http://bit.ly/6hOaf3about 5 hours ago
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$SNGX / Soligenix BUY rating, Griffin Securities $1.40 12-mo target, trading at $0.24 today / http://bit.ly/5JcIK7about 12 hours ago
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Dr. Bone on ProActive HavRx Stock Indexes at Investars YOU Mike,I think later for your readers. Please let...
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on Mentor Capital Plans Early ’10 Launch of Cancer Vaccine Active Index Fund YOUR ON TO SOMETHING HERE ;)
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New Indexes to Track Healthcare Trends and More
Below are links and descriptions for 23 new stock indexes I have created, revised, and tracked over the past few years which are now featured at a new website called Investars YOU. The new site includes automated index tracking, allows investors to create custom stock portfolios based on their individual preferences, and now features free access to all of the component stocks in each of my indexes. Some of the top performing stocks from my healthcare indexes on a year-to-date basis are highlighted below.
Cosmetic & Restorative Medicine Index: Allergan (NYSE:AGN) (+38%)
The Cosmetic and Restorative Medicine Index passively 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. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
BioMedReports.com Select Index: Access Pharma (ACCP.OB) (+348%)
The BioMedReports.com Select Index is an actively managed model portfolio of 30-40 stocks that will maintain at least a 90% sector weighting in healthcare with a focus on emerging small and micro-cap bio-pharmaceutical companies with market caps below $1 billion. Mid and large-cap stocks with market caps over $1 billion will typically account for about one-third to one-half of the index components. The selections will be made based on my research, experience, and activities as Managing editor of the website to identify companies which appear as either undervalued or those which are likely to benefit from upcoming binary event catalysts in the form of FDA decisions or key clinical trial results.
Cancer Dx/Tx Micro-Cap Index: Aeterna Zentaris (NASDAQ:AEZS) (+422%)
The passively managed Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index constituents reflect a cross-section of emerging cancer companies with market caps below $250 million at the inception date of 4/12/09, including (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. Components will only be removed from the index due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company`s stock.
Emerging Diagnostics Index: EXACT Sciences (NASDAQ:EXAS) (+395%)
The Emerging Diagnostics Index is passively managed and tracks the performance of companies with market caps below $250 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. The index will only be updated to remove components which are no longer trading due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company's stock.
Global Airline Index:
The Global Airline Index passively tracks the performance of companies with market caps over $200 million at the inception date of 7/16/08 which derive over 50% of revenue from passenger airline services. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
Global Carbon Trading Index:
The passively managed Global Carbon Trading Index tracks the performance of companies which generate carbon credits through their business operations and/or are involved with the trading of carbon credits. Examples of these activities include the following: waste-to-energy, landfill or methane gas collection, financial exchanges for carbon credits, carbon credit investment firms, and renewable energy projects that result in the generation of carbon credits (e.g. hydro-power, farming, industrial). The index will only be updated to remove components which are no longer trading due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company`s stock.
Global Generic Drug Index: Hi-Tech Pharmacal (NASDAQ:HITK) (+174%)
The Global Generic Drug Index passively 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) As an alternative to the revenue requirement, companies may also qualify by receiving FDA approval for an abbreviated new drug application (ANDA) within the past 12 months. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
Global Health IT Index: Merge Healthcare (NASDAQ:MRGE) (+223%)
The Global Health Information Technology (Health IT) Index passively 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 Metal Mining Index:
The Global Metal Mining Index passively tracks the top-rated companies with market caps over $1 billion at the inception date of 7/22/08 that derive over 50% of revenue from the exploration, mining, extraction, processing, and sale of all types of precious metals, minerals, and industrial metals. The top rated companies are chosen based on their trailing 12-month stock price performance, market cap weighting, and net income weighting. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
Global Railroad Index:
The Global Railroad Index passively tracks the performance of companies that derive either more than 50% OR $100 million of trailing 12-month revenue from any of the following activities: (1) passenger or freight rail transport services; (2) railcar and locomotive leasing; (3) railcar and locomotive fleet management; (4) rail infrastructure, railcar, locomotive, and railcar/locomotive component parts manufacturing; (5) railcar, locomotive, and component parts repair or refurbishment. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
Global Stem Cell Index: BioTime (BTIM.OB) (+103%)
The Global Stem Cell Index is passively managed to track the performance of regenerative medicine companies (with stock prices of at least 15 cents at the time of inclusion) which 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. The index will only be updated to remove components which are no longer trading due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company's stock.
Global Telecom Services Dividend Index:
The Global Telecom Services Dividend Index passively tracks the performance of companies with market caps over $1 billion at the time of inclusion that meet the following requirements: (1) All such companies must derive at least 50% of their trailing 12-month revenue from any types of voice and data telecom services such as fixed line communications, wireless communications, and internet access provider services and (2) All such companies must have a trailing 12-month dividend yield of at least 1.5%. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
Global Tobacco Index:
The Global Tobacco Index tracks the performance of companies which derive over 50% of their revenue from the distribution or manufacturing of any type of tobacco product (e.g. cigarettes, cigars, chewing tobacco) or any related tobacco supplies (e.g. wrapping papers, tobacco leafs, filters). The index is passively managed with updates only as needed to reflect mergers, bankruptcies, and other corporate events which affect the component stocks.
Global Trucking & Logistics Index:
The Global Trucking & Logistics Index passively tracks the performance of companies with market caps over $100 million at the time of inclusion that derive at least 50% of trailing 12-month revenue from any of the following activities: logistics and management support services for all types of transportation companies; all types of land-based, roadway freight forwarding freight transportation services; mail package delivery, transportation, and logistics services; and logistics management support services for roadway transportation companies. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
Health Benefit Providers Index: WellCare Health Plans (NYSE:WCG) (+80%)
The Health Benefit Providers Index is passively managed to track the performance of retail pharmacies, pharmacy benefit managers, managed care companies, health insurers, hospital pharmacy operators, workers compensation insurers, and specialty health benefit providers. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in the de-listing of the Company`s stock.
Highly Defensive Index: Medco Health Solutions (NYSE:MHS) (+27%)
The Highly Defensive Index passively tracks the performance of 35 companies based in the Americas, Canada, and Europe with the largest market caps from the following industry groups: (A) Mass Merchant Discount Retailer (1); (B) Consumer Staples (11); (C) Telecom Services (3); (D) At-Home Services (2): Cable TV/Internet Provider (1), Internet Portal/Search Provider (1); (E) Electric Utilities - Domestic (U.S. based) (2); (F) Fast Food Restaurants (1); (G) Commodities (2): Gold Mining (1) Agri-Biotech (Seeds & Fertilizers) (1); (H) Healthcare (11); (I) Aerospace (Non-Commercial) & Defense (1); (J) Energy (1). Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
Nation Cap Leaders Index:
The Nation Cap Leaders Index passively tracks the performance of companies with market caps over $5 billion at the inception date of 8/11/08 which represent the market cap leaders from each nation, spanning developed, emerging, and frontier markets. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
NordiCaps Region Index:
The NordiCaps Region Index passively tracks the top-rated companies with market caps over $1 billion at the inception date of 7/21/08 that are based in the Nordic Region countries of Sweden, Denmark, Finland, Iceland, and Norway. The top rated companies are chosen based on their trailing 12-month stock price performance, market cap weighting, and revenue weighting. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
Preventive Medicine Index: Electro-Optical Sciences (NASDAQ:MELA) (+119%)
The Preventive Medicine Index passively 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. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks.
Regulatory Catalyst Index: Human Genome Sciences (NASDAQ:HGSI) (+606%)
The Regulatory Catalyst Index tracks the performance of healthcare companies with pending new drug, biological agent, or medical device product decisions at the FDA. The index is actively managed and derived from the BioMedReports.com FDA Calendar database.
Pet Care & Animal Farma Index: Central Garden & Pet (NASDAQ:CENT) (+111%)
The Pet Care & Animal Farma Index passively 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.
Emerging Bio-Pharma Index: Dendreon (NASDAQ:DNDN) (+435%)
The Emerging Bio-Pharma Index is passively managed and tracks the performance of top-rated companies with market caps between $100 million to $2.5 billion at the time of inclusion. The rating system reflects the following factors: (1) the number of innovative clinical pipeline marketed products, (2) the market cap weighting, (3) the historical stock price return, and (4) the revenue weighting.
Global Hospital Index: Tenet Healthcare (NYSE:THC) (+271%)
The Global Hospital Index passively 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.
Disclosure: Long ACCP.OB, EXAS
FDA Calendar Updates: Covidien, Dynavax, Nuvo Research
On 8/4/09, Covidien (NYSE:COV) and Nuvo Research (NRI.TO) (NRIFF.PK) announced that the FDA issued a new PDUFA action date for Pennsaid (diclofenac sodium) topical solution 1.5% of 11/4/09. During the review process, Nuvo provided the FDA with supplemental information, which the Agency determined to be a major amendment to the Pennsaid New Drug Application (NDA). As a result, the FDA has extended its action date by three months to provide time for a full review of the submission.
On 6/16/09, Nuvo announced a deal with COV which granted exclusive rights to market and sell Pennsaid, and its follow-on product, Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac through the skin directly to the site of pain. Nuvo receives an up-front, non-refundable payment of US$10M and is also eligible to receive a US$15M milestone payment on Pennsaid's approval by the FDA, which will increase to US$20M if certain labeling criteria are agreed to by the FDA.
In addition, Nuvo will receive royalties on net U.S. sales of Pennsaid and Pennsaid Plus and is also eligible to receive additional escalating sales milestone payments for the products totaling up to US$100M. COV assumes responsibility for all future development activities and expenses for Pennsaid Plus, including two Phase 3 clinical trials that are expected to begin in 2010.
On 8/4/09, Dynavax (NASDAQ:DVAX) announced that the Company met with the FDA to discuss plans to resume development of Heplisav, which is the Company's Phase 3 investigational hepatitis B vaccine. DVAX proposed the continued clinical development of Heplisav in populations that are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and other groups such as individuals infected with HIV or diagnosed with chronic liver disease. The FDA expressed a general agreement that these populations are appropriate for further clinical development, pending the review of the study protocols and additional supportive data.
DVAX plans to submit this information to the FDA in August 2009 with a goal of having the agency remove the clinical hold in September 2009. The Company is prepared to restart clinical trials in individuals with chronic kidney disease upon removal of the clinical hold. Phase 3 data from the PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of Heplisav over one month achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six months. Over 2,500 individuals have been vaccinated with Heplisav to date. Dynavax has worldwide commercial rights to Heplisav, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
Disclosure: No positions
FDA Calendar Updates: Acorda, Amgen, DOR BioPharma
On 7/1/09, Acorda Therapeutics (NASDAQ:ACOR) announced an exclusive deal with Biogen Idec (NASDAQ:BIIB) to develop and commercialize Fampridine-SR in markets outside the U.S. while Acorda will continue to develop and commercialize Fampridine-SR in the U.S. Acorda will receive an upfront payment of $110 million and additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones along with tiered, double-digit royalty payments on ex-US sales. The FDA is currently reviewing a New Drug Application (NDA) for Fampridine-SR with a Priority Review (six-month) designation and a PDUFA action date during mid-4Q09 for a possible FDA decision.
On 4/23/09, ACOR announced the resubmission of its NDA for Fampridine-SR to the FDA as a new therapy being developed to improve walking ability in people with multiple sclerosis (MS) in response to a Refuse to File letter for the NDA on 3/30/09. On 5/6/09, the FDA accepted the NDA with a priority review designation and PDUFA decision date of 10/22/09 as there are currently no FDA approved treatments to improve the walking ability of people with MS. On 8/4/09, ACOR announced that a Peripheral and Central Nervous System Drugs FDA Advisory Committee meeting will be held to review Fampridine-SR, with the date to be announced. ACOR also provided an update of adverse events (AE) for its three key MS studies with the only new AE being MS relapse (at 5.3% for the Fampridine-SR treated group vs. 3.8% for placebo). The imbalance for this AE was due to worsening of MS symptoms occurring after discontinuation of the drug.
On 8/4/09, DOR BioPharma (DORB.OB) announced that the FDA granted Orphan Drug Designation to Oral BDP (beclomethasone 17,21-dipropionate or orBec) for the treatment of gastrointestinal symptoms associated with chronic Graft-versus-Host disease (cGVHD) in patients who have undergone allogeneic hematopoietic cell transplantation. orBec is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. orBec and oral BDP are currently in development by DOR for the treatment and prevention of GVHD, the prevention of acute radiation enteritis and the treatment of Crohn's disease. The upcoming confirmatory Phase 3 protocol will be a highly powered, double-blind, randomized, placebo-controlled, multi-center trial and will seek to enroll an estimated 166 patients with patient enrollment expected to begin during 2H09. The primary endpoint is the treatment failure rate at Study Day 80 (this endpoint was successfully measured as a secondary endpoint in the previous Phase 3).
On 6/9/09, DORB.OB announced that it received Protocol Assistance feedback from the European Medicines Agency (EMEA) on the design of this pivotal study. The EMEA agreed that should the new confirmatory Phase 3 study produce positive results, the data would be sufficient to support a marketing authorization approval in all 27 European Union (EU) member states, which is consistent with feedback previously received from FDA, which includes an agreement on the design of the upcoming Phase 3 study via the Special Protocol Assessment (SPA) procedure. The SPA procedure is an agreement with the FDA that the Phase 3 study design is acceptable to support a regulatory submission seeking new drug approval.
On 8/3/09, Amgen (NASDAQ:AMGN) announced positive top-line results from a pivotal Phase 3 head-to-head trial evaluating denosumab administered subcutaneously versus Zometa (zoledronic acid) administered as an intravenous (IV) infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma.
For the primary endpoint, patients treated with denosumab experienced a similar time to first skeletal-related event (SRE) (fracture, radiation to bone, surgery to bone, or spinal cord compression) compared with those receiving Zometa (hazard ratio 0.84, 95 percent CI: 0.71-0.98), which is statistically significant for non-inferiority (p<0.0007). Although numerically greater, the delay in the time to first SRE associated with denosumab treatment was not statistically superior compared to Zometa (adjusted p=0.06) (secondary endpoint). The time to first-and-subsequent SRE was also numerically greater but not statistically superior compared to Zometa (hazard ratio 0.90, 95 percent CI: 0.77-1.04) (secondary endpoint).
Overall, the incidence of adverse events and serious adverse events was consistent with what has previously been reported for these two agents. Rates of osteonecrosis of the jaw (ONJ) were balanced and infrequent in both treatment groups (10 patients receiving denosumab as compared with 11 patients receiving Zometa). Infectious adverse events were balanced between the two treatment arms, as was overall survival and the time to cancer progression.
AMGN has a pending BLA for denosumab with a PDUFA action date during mid-4Q09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen's experimental osteoporosis drug denosumab (proposed brand name Prolia) will be reviewed by an Advisory Panel at a meeting on 8/13/09. The FDA Advisory Panel will discuss the Company's proposed uses of (1) treating and preventing osteoporosis in post-menopausal women and (2) treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.
On 7/7/09, AMGN announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. On 7/27/09, AMGN and Glaxo (NYSE:GSK) announced a deal to share commercialization of denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand and Mexico. On 8/3/09, AMGN announced positive top-line results from a pivotal Phase 3 head-to-head trial (the second of three pivotal studies) evaluating denosumab administered subcutaneously versus Zometa administered as an IV infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma.
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