Mike Havrilla's  Instablog

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.

Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) applies genetic engineering techniques to create innovative, targeted protein-based therapeutics which are focused on prostate conditions and cancer. The Company's clinical-stage pipeline is based on the PORxin and INxin technology platforms. Lead drugs in clinical development include PRX302 for the treatment of benign prostatic hyperplasia (BPH or enlarged prostate) and localized prostate cancer as well as PRX321 for primary brain cancer (glioblastoma multiforme / GBM and astrocytoma).

 

PRX302 Poster Presentation at SIU - Nov. 2009: Click on the preceding link for a PDF link to the Company’s poster presentation of detailed 12-month results from a Phase 2 open-label clinical trial that were presented at the 30th World Congress of the Societe Internationale d'Urologie (SIU) in early November. Below is a summary of the poster presentation at SIU 2009, which concluded that PRX302 is a novel and promising, first-in-class, disease modifying agent for the treatment of BPH based on Phase I/II clinical data that has been generated to date.

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: (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%). This index has been tracked at the Investars YOU website since 6/24/09 at a starting value of $1000 and currently includes a total of 73 stocks with a last closing price of $1305.48 for a gain of approximately 30.5% on an equal-weight basis for the entire period and gain of about 15.5% in the past three months.  Since there is a total of 73 stocks in the generic drug index; a semi-active ETF structure would be idea for selecting the top 30-40 rated companies on a monthly or quarterly basis through a quantitative, rules-based system.

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.