Below are three under the radar stocks from the healthcare sector that I have been following for the past 3-6 months which have upcoming catalysts in the form of expected strategic deals, clinical trial results, and other corporate developments. Click here to check out my <font> kaChing.com virtual investing portfolio </font> , strategy, long / short virtual stock picks, and statistics since I started using the site in mid-April.
<font> Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) </font> (click on preceding link for the Company’s ProActive News Room landing page) 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).
In early September 2009, Protox announced that it completed patient enrollment in a multi-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide.
TRIUMPH is the third BPH clinical trial of PRX302 conducted by Protox. In addition to being well-tolerated, the previous open-label Phase 2 study reported at the 2009 Annual Meeting of the American Urological Association, showed an 11 point improvement in the International Prostate Symptom Score at the optimal PRX302 dose used in the TRIUMPH study. The Company expects to report top-line results from the TRIUMPH study during late 2009 or early 2010.
PRX302 is the lead drug in the company's PORxin technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from BPH and prostate cancer. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.
<font> Pressure BioSciences (NASDAQ: PBIO) </font> (click on preceding link for the Company’s ProActive News Room landing page) is a life science research tools company that is commercializing and developing its innovative core technology platform known as pressure cycling technology (PCT). PCT uses cycles of hydrostatic (water-based) pressure between ambient and ultra-high levels (up to 45,000 PSI) at controlled temperatures to rapidly and repeatedly control interactions at the molecular level. The Company sells and installs pressure-generating instruments (Barocyclers), and its internally developed consumables product line includes PULSE (Pressure Used to Lyse Samples for Extraction) Tubes as well as application specific kits which include consumable products and reagents (ProteoSolve kits) which together make up the PCT Sample Preparation System.
In mid-November, PBIO announced 3Q09 results, which included a record number of Barocycler instrument installations (20 versus 17 in the year-ago period), revenue of $317,427 (+19% from the year-ago period), an operating loss of $754,180 (reduced 32% from the year-ago period), and cash burn for the quarter of approximately $597,000 (down 39% from the year-ago period). Last week, PBIO announced that it received over $1.1 million from an initial tranche of a $2.5 million private placement after closing 3Q09 with approximately $1.4 million in cash / equivalents and 2.2 million shares of common stock outstanding.
In addition, PBIO expects to announce a strategic marketing / distribution agreement with at least one large, multi-national life sciences company in late 2009 or early 2010, following a previously announced deal in mid-October with Protein Forest, Inc. that is designed to increase market share / sales, partner on new product development, and and achieve co-marketing synergies due to the common end-market shared by the companies that includes research labs utilizing mass spectrometry for biomarker analysis.
<font> Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) </font> (click on preceding link for the Company’s ProActive News Room landing page) is an emerging medical device manufacturer with business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices.
More than two billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000).
Key differentiating features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes include the following:
1.) a passive needle retraction system that is activated inside the body
2.) healthcare providers / shot administrators control the speed of needle retraction
3.) auto-disabling prevents re-use or tampering with used syringes.
The market opportunity for prefilled syringes includes 50 drugs (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including an estimated 3 billion prefilled syringes in use by 2012. Unilife has a distinct advantage with a disruptive technology since there are currently no prefilled syringes to deliver medications with fully-integrated safety features so pharmaceutical companies must add these features - which adds to production / shipping costs and increases the overall packaging size by up to 60%, resulting in both waste disposal and marketing issues.
Unilife is targeting initial annual commercial production of about 60 million units of the Unifill syringe with development expected to begin next month for installation in the Company's Central Pennsylvania manufacturing facility slated for 4Q10 in conjunction with industrialization partner Sanofi-Aventis (NYSE: SNY), which is a major customer for safety syringes to deliver injectable products such as the flu vaccine and blood thinner Lovenox. Earlier this month, Unilife announced the filing of an Information Memorandum with respect to its proposed relocation to the US and primary stock listing on the NASDAQ with a shareholder meeting / vote scheduled for 2010.
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The <font> BioMedReports.com FDA Calendar service </font> 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.
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