On 11/19/09, AstraZeneca (NYSE: AZN) announced the submission of a New Drug Application (NDA) to the FDA for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA. This submission is based on the results of a comprehensive program, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the Phase 3 head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin. Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. The mode of action involves inhibiting the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic (blood clot) events.

On 5/11/09, AZN announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus Plavix (clopidogrel), in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death. In PLATO, the overall safety profile for BRILINTA was in line with the safety data observed in the Phase 2 studies.

Echo Therapeutics (ECTE.OB) is a diabetes management company developing the needle-free Symphony Transdermal Continuous Glucose Monitoring (tCGM) System as a non-invasive, wireless, transdermal solution for monitoring blood sugar levels and the needle-free Prelude SkinPrep System for transdermal drug delivery applications.

On 11/19/09, the Company announced positive results in a pilot clinical study which included Prelude skin preparation and the placement of 10 Symphony tCGM biosensors on subjects with Type 1 or Type 2 Diabetes. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300STAT PLUS laboratory analyzer to establish the gold standard / reference in this study, resulting in 97% accuracy for the Symphony tCGM System that was derived from approximately 900 glucose measurements with no adverse events related to the Prelude skin prep / permeation process.

On 11/17/09, GeoVax (GOVX.OB) announced that the FDA has granted its request for a pre-IND meeting to discuss the proposed Investigational New Drug (IND) application for the Company’s therapeutic vaccine as a treatment for individuals already infected with HIV. The meeting will only take place if the Company is not satisfied or requires some clarification to the FDA's answers to the questions submitted in the pre-IND package.

Following the FDA response to the Pre-IND meeting questions, GeoVax will prepare and submit to the FDA an IND application for the therapeutic trial. A new IND with the FDA is required since this will be the first time the GeoVax vaccine will be used for a therapeutic application. The IND process is expected to take a number of months to complete and based on the Company's current progress, commencement of the trial is targeted for early 2010.

On 11/16/09, Cytori Therapeutics (NASDAQ: CYTX) completed enrollment in a 70-patient, international breast cancer reconstruction study, RESTORE 2. The study is evaluating the use of cell-enriched fat grafting to restore functional and cosmetic deformities in women who have undergone partial mastectomy for early breast cancer. Interim data on the first 32 patients who have reached the six-month follow-up will be presented as a poster at the San Antonio Breast Cancer Symposium on 12/12/0 at 7am (CT) by Mrs. Eva Weiler-Mithoff, MD, lead investigator at the Glasgow Royal Infirmary.

Cytori expects to present six-month data for 15-30 patients while final, 12-month data on all patients is expected in early 2011. The ClinicalTrials.gov identifier is NCT00616135 for the RESTORE-2 study, which is a European study designed to evaluate the transplantation of ADRC-enhanced autologous (patient-derived) fat tissue into and around breast deformities. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.

EXACT Sciences (NASDAQ: EXAS) is a molecular diagnostics company that is developing a next-generation (V3), stool DNA (sDNA) based screening test for colorectal cancer (CRC) which has demonstrated the ability to detect both early-stage cancer and pre-cancerous growths. The company's sDNA-based screening technology platform has also demonstrated the ability to detect related GI cancers and pre-cancers.

Only 24% of an estimated 90 million individuals in the U.S. are currently compliant with CRC screening recommendations, which results in an estimated 68 million people who are non-compliant. The early detection of CRC saves both lives and money by avoiding the high costs of dealing with late-stage disease through expensive anti-cancer drugs and/or palliative care. Late stage (III/IV) CRC accounts for 60% of diagnoses, but the five-year survival rates for Stage III CRC is 60% and just 11% for Stage IV disease. Compare those statistics to early stage disease, which includes a 90% five-year survival rate for Stage I CRC and 70% for Stage II.

Investors who are bullish on the generic drug industry may consider implementing a 130 / 30 global pharma investing strategy through equal-weight (5% each) short positions for the six brand drug companies outlined below with 30% of their assets while investing 130% of assets in long positions among generic drug makers. The list of brand drug companies with significant patent expiration exposure over the next 2-3 years includes Pfizer (NYSE: PFE), GlaxoSmithKline (NYSE: GSK), Takeda Pharma (OTC: TKPHY.PK), Sanofi-Aventis (SNY), AstraZeneca (AZN), and Merck (MRK).

The HavRx Global Generic Drug Index is actively managed and tracks the performance of companies which meet any of the following three requirements:

On 11/3/09, EXACT Sciences (NASDAQ: EXAS) reported its 3Q09 results and held a conference call to outline the Company’s progress and timeline for the development of a stool DNA based test kit for the early diagnosis and prevention of colorectal cancer (CRC). EXAS reported total revenue of $1.3 million (which primarily reflects non-cash recognition of Genzyme deal earlier this year), a net loss of $1 million, operating expenses of $2.3 million, and ended the quarter with cash / equivalents of $26.9 million.

Last week, EXAS made a SEC 8-K filing regarding its President / CEO, Kevin T. Conroy, who is considering a run for Governor of Wisconsin in 2010. Mr. Conroy stated on the call today that a succession plan is premature at this point, and he plans to make a decision in the very near future on whether to make the run for governor (this would be communicated in the form of another SEC 8-K filing) – indicating that he is only considering such a move because of confidence in the strong team that is already in place at EXAS.

Railroad stocks are steaming ahead today on news that Warren Buffett will buy Burlington Northern (NYSE: BNI) as a bet on the recovery of the domestic and global economy as part of Berkshire Hathaway's (NYSE: BRK.A) largest acquisition ever. Berkshire previously owned over 22% of BNI and will also conduct a 50 : 1 split of his Company's Class B shares (NYSE: BRK.B). Buffett is also bullish on the railroad industry as a green form of fuel / cost-effective means for the transportation of goods as compared to other forms of transport such as roadway trucking.

The ProActive Global Railroad Index (+4.3% today) is actively managed and 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. The rally today among railroad stocks is helping to stem some of the recent losses experienced over the past three months, as illustrated on the accompanying chart.

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.

On 10/29/09, MannKind (NASDAQ: MNKD) announced that results of two Phase 1 studies demonstrate that the novel, investigational cancer vaccines MKC1106-MT and MKC1106-PP are well-tolerated and show encouraging immune response rates and objective tumor response in advanced melanoma, prostate cancer and other solid malignancies, setting the stage for Phase 2 studies.

Below is a 10-stock BioMed Momentum Index that I have created along with related financial data from Google Finance as of 10/28/09, including the stock price, 52-week change, average daily trading volume, and market cap. I have screened for small and micro-cap stocks with market caps of approximately $500 million (M) or lower with stock price increases of at least 50% in the past year and average trading volume of at least 1M shares per day.

1.) Antigenics (AGEN) ($1.07) +60%, 2.5M shares / day, $95M

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)

As a follow up to my article on FDA Calendar stocks for October, ImmunoCellular Therapeutics (OTC: IMUC.OB) presented additional data at the Congress of Neurological Surgeons Annual Meeting in New Orleans which demonstrated that the Company's cancer stem cell therapeutic vaccine product candidate ICT-107 extends progression-free survival (PFS) by more than one year among patients with glioblastoma multiforme (GBM is the most common and aggressive form of brain cancer).

The new data presented is an update to preliminary data that was presented at ASCO 2009 in late May. It included a median PFS survival time (defined as the time between surgical tumor removal and tumor recurrence) in the 16 newly diagnosed patients enrolled in the trial of 19 months, which is over 12 months longer than the historical PFS of just 6.9 months. In addition, seven of the 16 patients continue to show no signs of tumor recurrence while three of the patients have gone more than two years without disease progression.

On 6/1/09, Antigenics (AGEN) announced results of an interim analysis from the Company’s ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage (vitespen) cancer vaccine compared with observation (n = 362; P = 0.036; hazard ratio [HR] = 0.54). The interim analysis from the patient registry, INSPIRE, reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study. Final results from INSPIRE are expected mid-2010.

On 10/19/09, Angiotech Pharma (ANPI) received notice from the FDA that Bio-Seal is a Class III medical device that requires Pre-Market Approval (PMA) for marketing clearance by the Agency. As a result, ANPI is reviewing its options with respect to this product candidate, including possibly appealing this FDA decision, and is discussing the possible preparation of a PMA submission with its partner, Biopsy Sciences, LLC. The Bio-Seal Lung Biopsy Tract Plug System is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydro-gel plug.

At the beginning of the month, Celldex Therapeutics (CLDX) announced the successful completion of its acquisition of CuraGen (formerly CRGN), which strengthens the balance sheet (approx. $85 million in cash / equivalents) while expanding the pipeline and increasing the expected news flow of clinical data catalysts for the combined entity over the near to intermediate term. At the end of 2Q09, Celldex reported cash / equivalents of $31.6 million, working capital of $20.7 million, and used $13.5 million in cash to fund operations in the first six months of the year.

Without the CuraGen merger, Celldex provided guidance at the time for adequate liquidity to fund operations for at least the next 12 months, which included an analysis of expected cash inflows from grants / collaborations, income interest, and pre-merger cash / equivalents. However, the balance sheet has been significantly strengthened with the closing of the CuraGen merger, which included a price tag of about $93.5 million after making adjustments for CuraGen’s $53.5 million in net cash.

NF Energy Saving Corp. (OTC: NFEC.OB) provides emission reduction and energy saving equipment / services for China’s rapidly growing cogeneration sector. The Company also manufactures wind power equipment and flow control systems for coal, hydro, and nuclear cogeneration facilities with an additional wind energy infrastructure manufacturing plant in the final stages of construction.

NF Energy is benefitting from a long-term growth trend in China to promote energy efficiency and renewable energy initiatives, in addition to strong growth in the power industry. Growth opportunities for the Company include expanding and diversifying their product, service and consulting offerings within the clean energy infrastructure space in China and other markets such as the recently announced deal in Russia.