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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)

AstraZeneca’s (AZN) third quarter earnings came in at $1.68 per American Depositary Shares (ADS), well above the Zacks Consensus Estimate of $1.36 and $1.32 reported in the year-ago period. Revenues increased 10% at constant exchange rates (CER) to $8.2 billion compared to the same period last year. The primary reasons for the increase in revenues were [...]

(AZN) AstraZeneca Beats Expectations and Raises

AstraZeneca’s (AZN) third quarter earnings came in at $1.68 per American Depositary Shares (ADS), well above the Zacks Consensus Estimate of $1.36 and $1.32 reported in the year-ago period. Revenues increased 10% at constant exchange rates (CER) to $8.2 billion compared to the same period last year.

The primary reasons for the increase in revenues were strong US sales of Toprol-XL benefiting from generic withdrawal, US sales of its H1N1 vaccine and robust growth in emerging markets.

AstraZeneca recorded strong sales across all geographies. Sales in North America, Emerging Markets and Established Markets increased (at CER) by 13%, 15% and 4%, respectively. The company expects double-digit revenue growth in Emerging Markets for the full year.

Among the product categories, apart from gastrointestinal and oncology, which recorded sales decline of 1% and 10% respectively, all other segments increased their revenues. AstraZeneca recorded more than 26% of its revenues during the quarter from cardiovascular drug sales.

This segment recorded the highest growth at 29%. Revenues for Respiratory and Inflammation, Neuroscience and Infection and others increased by 13%, 11% and 22%, respectively.

AstraZeneca’s gross margin improved to 84.9% from 81.3% in the year-ago period due to a reduction in cost of sales. Operating profit increased 29% to $3.6 billion due to improved gross margin and lower R&D expenditure, partially offset by higher SG&A expenses and less other income.

During the quarter, AstraZeneca received significant regulatory approval and entered into new licensing collaborations. These include:

·         Approval from the US Food and Drug Administration (FDA) for Onglyza (saxagliptin) to be used for the treatment of type 2 diabetes mellitus in adults. In addition, the drug received marketing authorization from the European Commission.
 
·         Approval from the US FDA for the H1N1 vaccine.
 
·         Collaboration agreement with Forest Laboratories (FRX) for the development and commercialization of ceftaroline in all major markets other than the U.S., Canada and Japan. The drug is in a late stage of development for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). While Forest expects to file a New Drug Application (NDA) in the US by the end of 2009, AstraZeneca expects to file a Marketing Authorization Application (MAA) in Europe by the end of 2010.
 
·         An exclusive worldwide license agreement with Nektar Therapeutics (NKTR) for two drug candidates; NKTR-118, a late stage investigational product for the treatment of opioid-induced constipation and NKTR-119, an early stage compound intended to deliver products for the treatment of pain without constipation as its side effect.
 
·         AstraZeneca submitted a MAA for Brilinta and expects to submit the NDA by the year end.
 
While all these were positive developments, AstraZeneca has had its share of failures too. The company had to withdraw the regulatory submissions for the use of Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from both the US and the EU. The submission was withdrawn due to lack of positive data.

Based on strong quarterly results, AstraZeneca provided guidance for the full year of 2009. The company expects its earnings per ADS in the range of $6.20-$6.40.
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Array BioPharma Inc. (Nasdaq:ARRY) will report financial results for the first quarter of fiscal 2010 on Monday, November 2, 2009, and will hold a conference call on Tuesday, November 3, 2009 at 9:00 a.m. eastern time to discuss these results.

Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at the 20th Annual Healthcare Conference in New York City at 3:55 p.m. ET on Wednesday, November 4, 2009.

Clinical Data, Inc. (NASDAQ:CLDA) announced it has raised gross proceeds of approximately $47.4 million through the public offering of 2,750,000 newly issued shares of its common stock at a price of $17.25 per share.

Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) announced it will release its 2009 third quarter financial results after the market closes on Thursday, November 5, 2009.

SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) announced a corporate restructuring will reduce its U.S.-based workforce by approximately 17%, primarily in research and development.

Safeguard Scientifics, Inc. (NYSE:SFE), a holding company builds value in growth-stage life sciences and technology companies, announced it led a $17.4 million Series B financing round for Quinnova Pharmaceuticals, Inc., with participation from existing investors Thomas, McNerney & Partners and H.I.G. BioVentures.

A.P. Pharma (Nasdaq:APPA), a specialty pharmaceutical company, announced on October 26, 2009, the Company received notice the Nasdaq Listing Qualifications Panel (Panel) has granted the Company’s request to transfer the listing of the Company’s common stock from The Nasdaq Global Market to The Nasdaq Capital Market, which will take effect with the opening of the market on Wednesday, October 28, 2009.

CardioNet, Inc. (NASDAQ:BEAT) announced the U.S. Patent and Trademark office has granted patent number 7,587,237 (“Biological Signal Management”) to CardioNet.

Neoprobe Corporation (OTC:NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced it would report its financial results for the third quarter of 2009 on Monday, November 2, 2009 after the close of the financial markets.

Alcon, Inc. (NYSE:ACL) reported global sales rose 5.9 percent to $1,614 million for the third quarter of 2009, or a 9.0 percent increase excluding the impact of foreign exchange fluctuations.

Antares Pharma, Inc. (NYSE:AIS) announced Dr. Paul K Wotton, Ph.D., President and Chief Executive Officer, will present at the 20th Annual Oppenheimer Healthcare Conference on Tuesday, November 3, 2009 at 4:30 pm ET (Eastern Time).

Nektar Therapeutics (Nasdaq:NKTR) announced it has completed enrollment ahead of schedule in its Phase 2 clinical study of NKTR-102 in platinum-resistant ovarian cancer.NKTR-102 is Nektar's investigational proprietary compound currently being evaluated in Phase 2 clinical development in ovarian, breast and colorectal cancers.

Arrayit Corporation (OTC:ARYC) announced the sale of a system to the Center of Excellence for Nucleic Acid-Based Technologies (CENAT) in Poznan, Poland.

Enzon Pharmaceuticals, Inc. (NASDAQ:ENZN) announced it will report its financial results for the quarter ended September 30, 2009, on Tuesday, November 3, 2009 at approximately 8:00 am Eastern Time (ET).

Advaxis, Inc., (OTC:ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, completed a second Company-run debt financing, as of October 26, 2009.

BioSphere Medical, Inc. (NASDAQ:BSMD) – the pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy –reported financial results for the three and nine months ended September 30, 2009.

Phase Forward Incorporated (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced it will be hosting an analyst session on Wednesday, November 4, 2009, in conjunction with the Phase Forward 8th Annual International Users Conference in Boston, MA.

SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced it will host a live webcast of its fourth quarter and fiscal year 2009 conference call on Wednesday, November 4, at 4:00 p.m. CT.

Genta Incorporated (OTC:GETA) announced the Company will host a conference call and live audio webcast to review top-line results of its Phase 3 trial of Genasense® in patients with advanced melanoma.

UnitedHealth Group (NYSE:UNH) announced the company has appointed both Christopher J. Walsh and Mitchell Zamoff to the position of executive vice president and general counsel, effective immediately.

CNS Response, Inc. (OTC:CNSO) announced that the company will present top-line results from its multi-site clinical trial next week at the U.S. Psychiatric and Mental Health Congress.

Bio Solutions Corp. (OTC:BISU) announced the introduction of their new website:  http://www.bio-solutionscorp.com".

by Marc Lichtenfeld, Healthcare Expert Wednesday, October 28, 2009: Issue #1125 When it comes to investing, how do you find the “Holy Grail?” Does it even exist? Over my 19 years of stock market experience, I’ve searched high and low for the answers. One of my first steps was to plow into technical analysis. I studied [...]

(NKTR) The F.I.R.S.T. System: Searching For the “Holy Grail” of Investing