Top 10 Emerging Biotech Stocks

by: Mike Havrilla

Below are my top 10 emerging biotech stock rankings:

1) EXACT Sciences (NASDAQ:EXAS): On the verge of exponential increase in share price with likely inclusion in CRC screening guidelines in November, V2 technology trial results due before EOY07, and pending NCD app for Medicare reimbursement of PreGen-Plus

2) Javelin Pharma (JAV): Imminent approval for Dyloject in UK expected with planned 4Q07 launch plus 2 additional pipeline candidates with low clinical risk. Focus on pain management via unique delivery mechanisms for existing, approved drugs such as diclofenac (eg Dyloject) with estimated sales potential over $500 million for all 3 of Javelin's drug candidates.

3) Targeted Genetics (TGEN): Already up about 15% from my report date after CEO presented on Weds 10-Oct with expectation of confirmatory molecular testing results from the Univ. of Chicago due by "mid-October" so TGEN can apply to have clinical hold lifted by FDA on trials of its gene therapy candidate for inflammatory arthritis conditions. Look for stock to trade over $3 next week on test results and then higher after FDA releases hold & trial resumes by EOY07 (trial is still on track despite the clinical hold as long as confirmatory testing results next week match the prelim results which show no role of TGEN's gene therapy candidate in the trial death which caused clinical hold).

4) TorreyPines Therapeutics (TPTX): Lead pain & migraine drug tezampanel clinical trial results due during 4Q07 with high likelihood of success based on previous results. Tezampanel is a novel pain & migraine treatment that works differently than existing drugs such as billion dollar triptans, NSAIDs, etc. Stock is very thinly traded, but represents an excllent buy under $6 per share if you buy in small lots with limit orders.

5) GTC Biotherapeutics (GTCB): Recently received good news of fast-track FDA designation & permission for rolling BLA app for Atryn, which is laready approved in Europe & is produced by GTC's novel transgenic protein technology, which allows complex human proteins to be produced & purified in goats by inserting human DNA into the animals. GTC anticipates filing the initial sections with the FDA in 4Q07 and completing the rolling submission after all clinical data is gathered, analyzed, and available for the BLA, which is planned by end 1Q08. ATryn is GTC's recombinant form of human antithrombin, a protein with anticoagulant and anti-inflammatory properties. Finally, topline data for Atryn is due before EOY07.

6) ZymoGenetics (ZGEN): Has a new PDUFA date delayed until 17-Jan-08 for rThrombin to control bleeding during/after surgery. The FDA delayed the date due to previously submitted data related to an Italian manufacturing facility, which the agency decided constituted a major amendment to the original app & required more time to analyze. rThrombin has a high likelihood of approval & is superior to competition such as the recently approved human thrombin by Omrix as ZGEN's version is of non-animal orgin & a highly purified version made by recombinant technology. Also, note the heavy insider buying by Director Jon Leff of Warburg Pincus in September in the $11- $12 range, as well as other insiders.

7) Theravance (THRX): Likely approval for lead antibiotic drug candidate telavancin by next Friday, October 19th. Company has a full pipeline & strong partnership with Glaxo for development of asthma/allergy drugs & others.

8) Advanced Life Sciences (OTC:ADLS): Second clinical trial results due for lead antibiotic drug candidate cethromycin for community-acquired pneumonia (compared to Biaxin) due within the next month. Stock sold off after first Phase 3 results demonstrated non-inferiority (this was trial goal) to Biaxin, presentinmg a good buying opp below $2 per share. Cethromycin also holds promise for biodefense initiatives such as anthrax, as a trial showed it was more effective than gold standard Cipro. Next steps inlcude reporting Phase 3 CAP results, submitting NDA for cethro, and signing a partnership deal.

9) Neose Technologies (NTEC-OLD): Lead drug candidate for Neose is wholly-owned NE-180 (a GlycoPEG-erythropoietin) for use in the treatment of chemotherapy-induced anemia and anemia associated with chronic renal failure. Next in development is GlycoPEG-GCSF for decreased white blood cell counts resulting from chemotherapy. For a micro-cap biotech stock, Neose has an impressive institutional ownership exceeding 50% of all shares and other strong partnerships such as European drug giant Novo Nordisk in the area of therapeutic proteins for the bleeding disorder hemophilia. Other early stage research efforts for Neose focus on modified versions of human growth hormone and hepatitis C treatment interferon-alpha. With the company trading near all-time lows around $1.50 per share, it is worthy of a speculative buy rating in anticipation of positive clinical trial results by mid-2008.

10) InSite Vision (ISV): A longer term play on the Company's DuraSite topical drug delivery technology with one approved product called AzaSite, which is licensed to Inspire Pharma as an ocular antibiotic with a more convenient dosing regimen versus competing products. Market appears to be taking a wait & see approach with regard to AzaSite sales, but ISV has a full pipeline in development & additional catalysts in the form of international licensing opps for AzaSite as well as potential private equity interest by Warburg Pincus who has been very active in eye care investments, taking a 25% stake in Inspire Pharma & recently acquiring Bausch & Lomb (BOL).

Disclosure: Author has a long position in some of the above-mentioned securities