On a global scale, the International Diabetes Federation (IDF) estimates 285 million diabetics worldwide in 2010. I have outlined some investing opportunities in this article, with a focus on emerging small / micro-cap companies from across the world which are developing innovative therapeutics, diagnostics, and monitoring products to improve the treatment outcomes for the growing, global diabetes epidemic.

Epinex Diagnostics, Inc. (privately held) is dedicated to the development of innovative point-of-care technologies using rapid diagnostic tests. Epinex has developed a proprietary platform for rapid tests that apply existing immunoassay strips and biosensors to create unique quantitative diagnostic tests, focused on a significant initial market opportunity for a new type of diabetes monitoring test that measures glycated albumin (G1a), with an expected FDA 510(k) filing in early 2010 seeking marketing clearance as a Class 2 medical device for an expected review period of 90 days. My 13-page profile report and the most recent corporate profile for Epinex are available to view or download at the BioMedReports.com research downloads section or at the ProActive News Room landing page for Epinex.

Novo Nordisk (NYSE: NVO) is based in Denmark and represents the largest (market cap of US$39.5 billion), globally diversified play on diabetes care, deriving over 73% of total revenue (US$5.6 million / US$7.6 million) during the first nine months of 2009 from this business segment. During the first three quarters of 2009, NVO posed total and diabetes care segment sales growth of 15% (Danish kroner) and 11% (local currencies).

NVO expects to receive formal feedback from the FDA during 4Q09 for its pending Victoza (liraglutide is a once-daily human GLP-1 analogue) New Drug Application (NDA) seeking U.S. marketing approval for the treatment of type 2 diabetes in adults. In early July, the European Commission granted marketing authorization for liraglutide. Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high.

Another company awaiting a FDA decision for a new diabetes care product is MannKind Corp. (NASDAQ: MNKD), which submitted its NDA in mid-March that is seeking FDA approval of Afresa (insulin monomer human rDNA origin) Inhalation Powder and the AFRESA Inhaler for the treatment of adults with type 1 or type 2 diabetes. The FDA issued a standard, 10-month review for the NDA, with a decision expected in mid-January 2010. Afresa is an ultra rapid-acting form of insulin (achieving peak levels within 12-14 minutes to mimic the normal physiological release of insulin in healthy individuals) that is delivered through an inhaler rather than the typical route of injection by a syringe.

In early October, MNKD announced that it would not be able to sign a partnership deal for Afresa by year-end as it awaits the pending FDA decision, stating that the Company and potential partners will be better able to address appropriate deal terms and structure once the label for Afresa is clarified. In November 2007, Pfizer (NYSE: PFE) agreed to a settlement with Nektar Therapeutics (NASDAQ: NKTR) that included a one-time payment of $135 million to the latter after Exubera (the first FDA-approved inhaled insulin product) failed to generate meaningful sales despite a significant investment by Pfizer.

In early May, Amylin Pharma (NASDAQ: AMLN), Eli Lilly (NYSE: LLY), and Alkermes (NASDAQ: ALKS) announced that a NDA was filed seeking FDA approval of exenatide (Byetta LAR) as a once-weekly formulation for type 2 diabetes which is administered by subcutaneous injection, with a FDA decision expected in early 2010. Byetta is currently approved for use as a twice-daily injection for patients with Type 2 diabetes and is classified as an incretin that exhibits many of the same actions as GLP-1 (glucagon-like peptide-1) which act by stimulating insulin release when glucose levels become high.

Diabetes care companies in the Asia /Pacific region include Terumo Corp. (TYO: 4543) (OTC: TRUMY.PK) and Takeda Pharma (TYO: 4502) (OTC: TKPHY.PK). Terumo manufacturers medical devices / equipment such as insulin syringes while Takeda markets diabetes drug Actos with continued development of alogliptin as an experimental drug for Type 2 diabetes as both a single agent and in combination with Actos. In late June, Takeda received a Complete Response Letter (CRL) from the FDA for alogliptin, which is a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise that will require a cardiovascular safety study prior to possible FDA approval.

In September, Vivus Inc. (NASDAQ: VVUS) announced positive results from two final, Phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa (phentermine + topiramate) in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and Type 2 diabetes. Vivus expects to file a NDA before year-end and has an ongoing Phase 2 study evaluating Qnexa in Type 2 diabetics.

Access Pharma (OTC: ACCP.OB) has developed a nano-polymer drug delivery system for the oral administration of large molecules such as insulin, human growth hormone (hGH), and erythropoietin (EPO). This drug delivery technology involves coating a nano-particle with a B12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package, resulting in 1,000 to 1,000,000-fold increases in absorption through the gut of large molecule drugs typically administered by injection.

Licensing discussions are expected to formalize for the Company's basal (long-acting) oral insulin product following the mid-June announcement that two bio-pharmaceutical companies will conduct preclinical, animal studies before proceeding to more formal negotiations. The results of these preclinical studies will be made public, including one North American biotech company and one European biotech company. Access is providing the oral insulin while the two interested companies will conduct one animal study each (including a rat and dog model) with data expected before year-end.

Other investment opportunities related to diabetes care include (1) Unilife Medical Solutions (OTC: UNIFF.PK) (ASX: UNI.AX) (Unitract safety syringes, contract medical device manufacturing); (2) West Pharmaceutical Services (NYSE: WST) (syringe component manufacturer); (3) Retractable Technologies (AMEX: RVP) (VanishPoint safety syringes); (4) CPEX Pharma (NASDAQ: CPEX) (Nasulin is an experimental intranasal insulin product candidate); (5) Emisphere (OTC: EMIS.OB) (plans to change development focus to an oral formulation of a GLP-1 analog rather than continuing to pursue development of oral insulin).

The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market includes diversified, global healthcare giants and smaller niche players, including those outlined below.

Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Becton Dickinson (NYSE: BDX) (BD Diagnostics), Roche (OTC: RHHBY.PK) (Accu-Chek), Bayer (OTC: BAYRY.PK) (Ascenscia), Bio-Rad Labs (NYSE: BIO), Home Diagnostics (NASDAQ: HDIX), Insulet Corp. (NASDAQ: PODD), Echo Therapeutics (OTC: ECTE.OB), Trinity Biotech (NASDAQ: TRIB), and DexCom (NASDAQ: DXCM).

As I wrote last week, Echo Therapeutics announced positive results in a pilot clinical study for its needle-free Symphony Transdermal Continuous Glucose Monitoring (tCGM) System as a non-invasive, wireless, transdermal solution for monitoring blood sugar levels when used in conjunction with the needle-free Prelude SkinPrep System. The Prelude SkinPrep has been licensed to Ferndale Pharma in North America + UK for the enhanced delivery of its topical lidocaine skin-numbing agent (LMX4), with a FDA 510(k) submission expected during 1Q10 for potential marketing clearance while the Symphony tCGM will be evaluated in a pivotal trial that is expected to begin by late February 2010 with a FDA PMA submission expected to follow.

Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my 23 ProActive HavRx stock indexes. This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes.

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.

Disclosure: Long ACCP.OB, Epinex Diagnostics (privately held)

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.454 Life Sciences, a Roche Company (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY), announced today at the Association of Molecular Pathology Annual Meeting in Kissimmee, Florida a series of revolutionary developments which significantly expand the company’s high-throughput sequencing portfolio.Advanced Cell Technology, Inc. (OTCBB:ACTC) announced today that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD).Advanced Cell Technology, Inc. (OTCBB:ACTC) announced today that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD).Bioanalytical Systems, Inc. (NASDAQ:BASI) announced today that its application to transfer from the NASDAQ Stock Market to the NASDAQ Capital Market has been accepted. The transfer will occur on November 20, 2009.Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) presented data from its pipeline programs at the 2009 EORTC-NCI-AACR (European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research) annual meeting in Boston, Massachusetts.Geron Corporation (Nasdaq:GERN) today announced the presentation of interim data from its ongoing trial of imetelstat (GRN163L), a telomerase inhibitor drug, in patients with refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.NeoStem, Inc. (NYSE Amex: NBS), announced today that it has sent the following letter to its shareholders, discussing the Company's acquisition, on October 30, 2009, of China Biopharmaceuticals Holdings, Inc. (CHBP), an integrated bio-pharmaceutical company based in the People's Republic of China.Non-Invasive Monitoring Systems, Inc. [NIMS] (OTCBB:NIMU) announced that the Nogawa Patent Office in Japan issued Patent number 4391595 to NIMS on October 16, 2009. This patent, entitled “Reciprocating Movement Platform for Shifting Subject To and Fro In Headwards-Footwards Direction,” relates to the comprehensively researched technology underlying NIMS’ Exer-Rest acceleration therapeutic platform.OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that it will host a live webcast of its R&D Analyst Day on Thursday, December 3, 2009 at 12:30 p.m. Eastern Time.Perrigo Company (Nasdaq: PRGO; TASE) today announced that Perrigo Chairman and CEO Joseph C. Papa will present at the Sidoti Emerging Growth Conference on Friday, November 20, at 3:15 p.m. (EST) at the Grand Hyatt Hotel in New York City.Sensient Technologies Corporation (NYSE: SXT) announced today that it has entered into an agreement with a group of financial institutions for the issuance of $110 million in fixed-rate, senior notes.SeraCare Life Sciences, Inc. (NASDAQ: SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today reported operational and financial results for its fourth quarter and fiscal year ended September 30, 2009.Unilife Medical Solutions Limited ("Unilife" or "the Company") (ASX: UNI)(PINKSHEETS: UNIFF) today announced the appointment of Mikron Group ("Mikron") as its contracted supply partner for the development and supply of automated assembly systems to support the commercial production of the Unifill™ ready-to-fill syringe (Unifill™ syringe).

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.

The Prelude SkinPrep System removes the top level of dead skin (stratum corneum), which is painless and a similar process to exfoliation, resulting in the opportunity for enhanced delivery of reformulated, topical drugs that are already approved (e.g. lidocaine) and a needle-free means of measuring blood glucose levels in conjuction with the Symphony tCGM System by using an electrochemical sensor in combination with a short-range RF transmitter that is affixed to the skin area prepared with Prelude.

In mid-November, Echo Therapeutics announced a deal to raise about $3 million in capital that included the sale of 2.37 million shares of common stock @$1.25 per share and 2.2 million common stock warrants with an exercise price of $2 per share and a five-year term. The Company expects the additional capital will be sufficient to finance additional development activities and commercialization of its Prelude SkinPrep and Symphony tCGM Systems.

The Prelude SkinPrep has been licensed to Ferndale Pharma in North America + UK for the enhanced delivery of its topical lidocaine skin-numbing agent (LMX4), with a FDA 510(k) submission expected during 1Q10 for potential marketing clearance and royalty revenue starting in 2Q10. The deal with Ferndale included $750,000 upfront, another $750,000 upon FDA approval, double digit royalties on net product sales, and $12.5 million in milestone / guaranteed minimum royalties.

The Symphony tCGM has been licensed in South Korea to Handok Pharma and a pivotal trial is expected to begin by late February 2010 with a FDA PMA submission expected to follow. This deal included approximately $600,000 upfront, FDA approval / first South Korean sales milestone payments, royalties on net product sales, and Handok covers product development expenses in their local market.

The BioMedReports.com research download section includes the Company's most recent corporate presentation, which is available to view or download. 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.

The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market includes diversified, global healthcare giants and smaller niche players, including those outlined below.

Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Becton Dickinson (NYSE: BDX) (BD Diagnostics), Roche (OTC: RHHBY.PK) (Accu-Chek), Bayer (OTC: BAYRY.PK) (Ascenscia), Bio-Rad Labs (NYSE: BIO), Home Diagnostics (NASDAQ: HDIX), Insulet Corp. (NASDAQ: PODD), and DexCom (NASDAQ: DXCM).

Epinex Diagnostics Inc. (click on preceding link for the Company's News Room page) is a private company that is dedicated to the development of innovative point-of-care technologies using rapid diagnostic tests. Epinex has developed a proprietary platform for rapid tests that apply existing immunoassay strips and biosensors to create unique quantitative diagnostic tests. The Company is developing a test that measures glycated albumin (G1a) as a potential paradigm-shifting measurement of average blood sugar control over the past month, as compared to hemoglobin A1c which provides a measurement of average blood sugar levels over the past 2-3 months and is dependent on red blood cell levels whereas albumin is a more widespread protein that is found in the serum portion of the blood.

Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my 22 ProActive HavRx stock indexes. This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes.

Disclosure: No positions

ArQule, Inc. (Nasdaq: ARQL) presented data at the AACR-NCI-EORTC meeting in Boston demonstrating the capabilities of the Company’s proprietary drug discovery platform to generate a class of small molecules with significant therapeutic potential.Art's Way Manufacturing, Inc. (Nasdaq: ARTW), announces its wholly owned subsidiary, Art's Way Scientific, Inc. - Buildings For Science - will be providing 6 modular swine facilities for breeding, gestation, farrowing, nursery and finisher operations.BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a specialty pharmaceutical company developing products for female sexual health, including LibiGel® for th treatment of hypoactive sexual desire disorder (HSDD), applauds the efforts of Boehringer Ingelheim to develop a therapy to treat this unmet medical need. Cannabis Science Inc. (NASD OTCBB: CBIS) an emerging pharmaceutical cannabis company, is hailing the call by the American Medical Association's House of Delegates for “marijuana's status as a federal Schedule I controlled substance be reviewed with the goal of facilitating the conduct of clinical research and development of cannabinoid-based medicines."Cadus Corporation (OTC Bulletin Board: KDUS) announced financial results for the third quarter ended September 30, 2009.Derma Sciences, Inc. (OTC Bulletin Board: DSCI) a specialty medical device/pharmaceutical company focused on advanced wound care, announced it has filed an S-1 Registration Statement to offer 1,500,000 shares of its common stock. Enzon Pharmaceuticals, Inc. 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(Nasdaq: HGRD), the leading healthcare ratings company, announced Kerry Hicks, President and Chief Executive Officer of Health Grade, will be presenting at the Sidoti & Company, LLC New York II Emerging Growth Institutional Investor Forum at The Grand Hyatt Hotel in New York on Friday, November 20, 2009, at 8:30 a.m. Eastern time.Inovio Biomedical Corporation (NYSE AMEX: INO) reported financial results for the three and nine months ended September 30, 2009.Mead Johnson Nutrition Company (NYSE: MJN) announced it intends to file a Registration Statement on Form S-4 with the Securities and Exchange Commission (SEC), which includes details of a proposed exchange offer whereby Bristol-Myers Squibb Company (BMS) shareholders can exchange some, none or all of their shares of BMS common stock for shares of Mead Johnson common stock.Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on developing sustainable solutions for plastics, chemicals and energy, announced the complete on of its previously announced underwritten public offering of 3,450,000 shares of its common stock at a price of $9.00 per share for gross proceeds of approximately $31 million.  NovaDel Pharma Inc. (NYSE:NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, reported financial results for its third quarter and nine months ended September 30, 2009.Neogen Corporation (Nasdaq: NEOG) announced that its Board of Directors has approved a 3-for-2 stock split. OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced the Oncologic Drugs Advisory Committee (ODAC) will review the use of Tarceva® (erlotinib) as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy at its December 16, 2009 meeting.PPD, Inc. (Nasdaq: PPDI) announced it has entered an agreement with Janssen Pharmaceutica N.V. to develop and commercialize two Phase II-ready therapeutic compounds, one to treat diarrhea-predominant irritable bowel syndrome (IBS-d) and the other to treat complicated skin and skin structure and respiratory infections.Roche`s (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY) RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology, announced it has been selected for addition to the NASDAQ Biotechnology Index® (Nasdaq: NBI).Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, announced it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI) effective with the U.S. market open on Monday, November 23, 2009.ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced the R Series® defibrillators with new monitoring capability added as well as its new intravascular temperature management solutions are being exhibited in Booth #1417 at the American Heart Association Scientific Sessions 2009 November 15-17th at the Orange County Convention Center in Orlando.

Griffin Securities issued an updated research report today on ImmunoCellular Therapeutics (OTC: IMUC.OB), which includes a price objective of $3.25 per share. Below are some highlights from the report, which is available to view or download as a PDF at the BioMedReports.com research downloads section and at the ProActive News Room landing page for IMUC.

IMUC is an emerging cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells (CSCs), based on two distinct technology platforms - active (cancer vaccines) and passive (monoclonal antibodies or mAbs).

1.) The Phase I trial of ICT-107 yields tantalizing efficacy data against glioblastoma and with no safety issues.

2.) Roche (OTC: RHHBY.PK) licenses ICT-69 antibody therapy for multiple myeloma and ovarian cancer; more deals in the making.

3.) Therapies advance in the R&D pipeline, and the Company is preparing for new clinical trials.

4.) We reiterate our BUY recommendation and maintain our target price of $3.25 per share.

Early next year (1Q10 which ends 3/31/10), IMUC expects to make an IND filing with the FDA for permission to begin human clinical trials for a Phase 1 study of its off-the-shelf cancer stem cell vaccine candidate (ICT-121). IND Filings for ICT?121 are expected for Brain Tumors in US or Europe during 1Q10 while IND Filings for ICT?121 for Pancreatic Cancer are expected in the US or Europe during 3Q10.

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.

Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my 22 ProActive HavRx stock indexes. This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes.

Disclosure: Long IMUC.OB