The American Diabetes Association estimates that there are currently 23.6 million diabetics in the U.S. (7.8% of the total population, including 17.9 million diagnosed cases, 5.7 million undiagnosed, and 57 million pre-diabetics. Diabetes results in an estimated $174 billion in costs from diagnosed cases of diabetes in the U.S. (2007).[More...]

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)

Access Pharma (OTC: ACCP.OB) provided an update today on the status of the North American commercial launch for its FDA cleared treatment for oral mucositis, MuGard, which is expected to occur during 1Q10 in conjunction with the availability of initial product inventory by its liquid contract manufacturing partner, Accupac. In addition, Access signed an e-Marketing deal with iMedicor (OTC: VMCI.OB) in early October as a cost-efficient and highly targeted means of reaching over 200,000 oncologists in the U.S. market.   The e-Marketing deal and pending domestic MuGard launch is part of the Company’s strategy that includes simultaneous discussions for potential co-promotion agreements with oncology-related bio-pharmaceutical companies and the development of a sales team with experience in the supportive treatment of cancer patients. Access is also working with consultants to finalize third-party reimbursement for MuGard from insurance plans, Medicare, Medicaid, etc.   iMedicor’s ClearLobby is an application within the NaviNet healthcare communications portal that includes a network of more than 700,000 physicians. Doctors, healthcare providers, and support staff included in this network have the ability to access information on new medications and medical devices, in addition to medical / scientific journals, clinical trials, webinars, and continuing education programs. Sponsored products such as MuGard go beyond simply providing information, including the capability to order samples and make specific inquiries about the product at their convenience through 24 / 7 access.   The combination of liquid contract manufacturing (Accupac), e-Marketing (iMedicor) / dedicated oncology sales team, and the pending post-approval marketing data from Europe positions Access to launch MuGard in North America on its own in a highly targeted and cost-efficient manner without giving away a large chunk of sales as part of a licensing agreement. In addition, the pending capital raise is likely to be in the $10-15 million range (40-60% of the $25 million maximum in the recent SEC S-1 filing) to further strengthen the balance sheet, fund the MuGard launch, and ultimately improve the Company’s negotiating position for a potential MuGard co-promotion agreement(s).   European MuGard partner, SpePharm, is currently collecting information from approximately 1,500-2,000 patients as part of a comprehensive set of post-marketing / seeding studies being conducted in the UK, Germany, and Italy. SpePharm anticipates that data from these studies will be made on a rolling basis throughout late 2009 to early 2010 while the commercial launch of MuGard in France and other European countries will continue over the next 12-18 months. According to SpePharm, initial patient and clinician feedback has been very positive for MuGard, which validates interim data released from the UK study that demonstrated no cases of oral mucositis in 140 patients who received MuGard while undergoing treatment for head and neck cancer.   Access is also developing its own strategy for similar post-marketing studies in the U.S., if required, to support the use of MuGard as a preventative measure for oral mucositis arising from chemo / radiation therapy in addition to expanding the scope of use for all types of oral trauma such as canker sores, ulcers, and oral surgery complications.   Check out the ProActive News Room landing page for Access and iMedicor, which includes a compilation of digital media coverage links, report downloads, news feeds, and videos.   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 ACCP.OB

Access Pharma (OTC: ACCP.OB) provided an update today on the status of the North American commercial launch for its FDA cleared treatment for oral mucositis, MuGard, which is expected to occur during 1Q10 in conjunction with the availability of initial product inventory by its liquid contract manufacturing partner, Accupac. In addition, Access signed an e-Marketing deal with iMedicor (OTC: VMCI.OB) in early October as a cost-efficient and highly targeted means of reaching over 200,000 oncologists in the U.S. market.[More...]

On 8/3/09, Access Pharma (OTC:ACCP) (ACCP.OB) provided an update on its clinical development strategy for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumors in human clinical studies.  Access has commenced a new clinical study of ProLindac in France. The study will examine dose levels and regimens of ProLindac mono-therapy in cancer patients, provide additional data to support design of combination studies, and extend the safety database for the drug. Two ovarian cancer patients have been enrolled in the study to date, and the Company expects to enroll 6-12 patients this year before beginning to enroll patients in clinical trials evaluating ProLindac in combination with other chemotherapies (likely to involve ProLindac plus paclitaxel--Taxol and/or gemcitabine--Gemzar).

Access recently announced data from a recurrent ovarian cancer trial that showed that ProLindac was more active than currently available platinum drugs in that patient population, and that the drug was very well tolerated. ProLindac is a novel DACH platinum drug that has shown to be active in many solid tumors in human clinical studies. Platinum drugs are one of the most clinically and commercially successful class of chemotherapies and generated more than $3 billion in revenue globally in 2008.  Access believes that ProLindac, as a well-tolerated and active DACH platinum, represents a important improvement in the design and tolerability of platinum chemotherapies.

Later this month, an Access management and clinical development team is meeting with Access' partner, Aosaikang Medicinal Group (Ask-Pharm) and several key oncology opinion leaders to finalize plans for ProLindac development in China.  In addition, Access is meeting with its Korean partner, JCOM of Seoul, South Korea to finalize development plans in that territory.  Access believes that three ProLindac combination trials will start shortly upon regulatory approvals of protocols in both China and Korea.  Further, Access has reported receipt of additional milestone payments from its Far East partners in the ordinary course under their collaborative agreements.

"Our Chinese partner, Ask-Pharm, has made great progress on manufacturing scale-up of ProLindac and advancing the Regulatory process with the sFDA.  We are excited about finalizing protocols with Ask-Pharm and leading oncologists in China, and look forward to their continued progress," stated Jeffrey B. Davis, Access' President and CEO.  "Additionally, we are meeting this month with JCOM and key opinion leaders in Korea, and hope to get the combination trials started in Korea as soon as reasonably possible."

Access intends to design all clinical studies of ProLindac in accordance with FDA standards and intends to use the clinical data from all three planned clinical trials in the Far East to further development in North America and Europe.  Access has the right to all clinical data generated in the Far East under the agreements entered into with their Far East partners, and as previously announced, believes that these trials run by its ProLindac partners will save Access between $20-30 million in clinical development expenses.

Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories. The Company has previously announced that it has licensed ProLindac to Ask-Pharm for the Greater China Region and to JCOM, Ltd for South Korea. Under these agreements both of these partners will be conducting Phase 2 combination studies with ProLindac in specific tumor types at their expense based on these results.

ProLindac is a very promising, next-generation platinum anti-cancer compound which includes a proprietary nano-polymer drug delivery vehicle that allows for over 10X the dose of platinum to be delivered in a targeted manner to cancer cells with a much better safety profile compared to standard platinum-based drugs which cause significant and cumulative neurotoxicity. The unique nano-polymer delivery system selectively releases the platinum in a targeted manner to cancer cells because they reside at a low pH (acidic).

Pharmacology studies conducted outside of living, human tissue (ex-vivo) within comparable environments (e.g. acidic or low pH) to the tumors being treated by ProLindac have demonstrated that about half (50-60%) of the platinum is released over a period of 96 hours (four days) from a single administration. Thus, a single dose of ProLindac not only delivers over 10X the platinum dose in a targeted manner to cancer cells, but also mimics a four-day continuous infusion as the drug persists at the tumor site.

ProLindac is meant to be a safer, more effective replacement for Eloxatin (oxaliplatin), which posted estimated global sales of $2.5 billion in 2008 for Sanofi-Aventis (NYSE:SNY). In addition to having more side effects than ProLindac, Eloxatin is available on an off-patent basis in Europe. Access also employs Esteban Cvitkovic as their director of oncology R&D - who has over 30 years of experience in this area and played a key role at SNY in the development and approval of Eloxatin. Preliminary data from a Phase 2 clinical trial in patients with relapsed ovarian cancer demonstrated that over 12X the dose of ProLindac was delivered compared to Eloxatin and the final data from this trial is still pending.

Despite the much larger platinum dose delivered by ProLindac, the drug demonstrated an excellent safety profile in the trial among patients receiving nine or more cycles of therapy. Access previously announced positive safety and efficacy results from its Phase 2 mono-therapy clinical study of ProLindac in late-stage, heavily pretreated patients with ovarian cancer. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall.

Please visit the stock research section of BioMedReports.com to view or download my 15-page PDF stock profile report for Access Pharma, which includes an earnings model for MuGard through 2012 and other key milestones for the Company. The stock research section also includes an updated report for Access written by Griffin Securities with a buy rating and $11 price target in addition to the most recent corporate presentation for the Company.  Check out Access Pharma's Pro-Active News Room site for a compilation of links, videos, presentations, and social media sites for the Company.

Disclosure: Long ACCP.OB