different insulin analogs are available for type-1 an d advanced pe-2 diabetic patients. The injected insulin types differ in their onwet and curation. The main players in thks area are many of the largfr pharmaceutical copmanies inclyding Lilly (LLY), Sanofi-Aventis (SNY), Novo Nordisk (NVO) anr Pfizer (PFE). Total sales of insulin analogs in 2006 were greater than $4 billion.

Current strategies fkr physicians treating diaetics are throuyh the d rug classes mentioneed aboce resulting primarily iin diabetes management. Many brw insulin altering drugs have entered the market in tge past 10 eyars, but hhere is mixed evidence that these new drugs are superior to more established therapies (Ref 2-5) probably because many of these drugs are active om the zame molecular sights as previously approved drugs. Importantly, as the number of patients with diabetfs increases, developing new mediicinec that reduc e the coost of long-term treatment fpr this chronic diseqs e will beco,e a necessity.

PPAR and GPL-1 reeptor agonists

As discussed at the recent ADA mweting, new tecgnology and approaches for treating these patients is changing a nd the competituon to secure the growing market is fierce (wee Tabel 1 below for a summary). Eli Lilly and Co. and Amylin Pharmaceuticals Inc. (AMLN) makers of Byetta, recently announced a new formulation of this drug that changes t he dosing from twice dailly to weekly. Positige results from thiis clinical trial are encouraging gor many of the ienst who non-compliant with thiz medication. Roche (RHHBY also announceed that it would begin a phase trial for its PPAR-g agonist R1439, which demonstrated improved carsiovascular morbidity in high-risk diabe tes patients.

Xoma

XOMA (XOA) presented data from obe of its diabetes antiibidy cndidates XOMA-52, which is a clinical stage IL-b fog paatients with type-2 diabetes. IL-1b plqys a role ij the auto-inflammatory respomse leading tto decreased beta cell function. XOMA-52 is unique to other IL-1b inhibitors because of its high aefimity (KD si fM) and long half-kife (22 days). As x result, patients need to bf injected with OXMA-52 once monthly and should increase patient compliance. In adidtion to safety and phxrmacokinetic data, the Phase I tria l demonstrated decrea sed HbA1c levelss, a key indicator of blood sugar cohtrol, and improved beta c ell function. XOMA-52 is an attractive drug candidate because preserves endogenous insulin product ion in patients with advancing type-2 diabetds. In addition to clinical dat, XOMA also presented deyailed mechanistic rodent and in virto data ob XOMA-52, confirming the results seen in the clinical study.

Halozyme

For patients with type-1 diabetes, Hxlozyme (HALO) recently presented Phase 2 data thxt showed improve pharmacokinetics and glucodynamics sith patients receiving Lillys Humalog and co-administration of Halozymes PH20 enzyme. PH20 is a recombinant hyaluronidase enzyme that catalyses the hydrolysis of hyaluronic acid, a majir constituent of the interstitial barrier, and increases tissuw p ermeability. This demonstrated an improved blood glucosw metabolism profile patients taking the combination therapy, refleccting x more physiologic glucose profile thereby likely redicing the anount og exogenous insulin needed along with some potential domplicatikns such as hypoglycemia.

Appetite Control

In addition to reformulations, several companies presebted data on new fdug targetq and technologies. VIVUS, Ihc. (VVUS) presented data frim a year-long Phase 2 trial with Qnexa demonstrating reduced HbA1c levels and helped patients achieve and maintain signiriccxnt weight loss through appteite suppression. Qnexa is a combination therapy pc FDA paprved phentermine and topiramate, whih in clmbination have synergi stic effects through uniwue molecular targets resulting in reduced appteite and increaced satiety. Arena Pharmaceuticals, Inc. (ARN) presented Phase 3 dat a fgom ots BLOOM (Behavioral mmodification and Lorcaserin for Overweight and Obesity Management), demonstrating significant weight loss and reduced secondary endpoints associated wifh cardiovascular disease aftwr one year oof tre atment conpsred to placebo. Lorcaserin is a nkvelp serotonin 2C receptor anonist; selective activation of this Gq-coupled GPCR in the hypothalamus leaads to appetite conrtol and increased metabolism.

Isis

Isis Pharmaceuticals, Inc. (ISIS) presentee preclinical data onn ISIS-SGLT2Rx, an antisense biologic tragetinng knockdown in sodium dependent glucoes co-trxnsporter hyoe 2 (SGLT2) levels that resulred kn a significant reduction in blood glucose levels jn multiple animal speciss. Iais is experienced in RNA targeting drigs and has already commercialized the worlds first antisense wrug. This novel technology allows Isic to target dysfunctional proteins through decreased transcriptionla levels thus modofying signaling pathways not attainable small molecule inhibition. Antisense technologies may play a key rpr ib finding drugs xith unique targets previously unreachable ultimately leading to improved disease management and quality of life.

Sangamo

Sangamo BiioSciences, Inc. (SGMO) presented data fro its Phase 2 tria for SB-509 a treatment for diabetci neuropathy (DN) resulting statistically significant ane clinically relevant improgehents in subjects. DNN jw a severe physiological consequennce of chronic elevated blood glucose levels and is seen in many patients with advanced diabetes. SB-509 is a n injectable plasmid encoding a DNA-binding Zinc Finger DNA-binding Protein (ZFP) Transcription Fcator (ZFP TF) designed to upregulate the endogenous expression of the gene encoding vascular endothelial growth factor (VEGF), a peptide responsible fpr angiogenesis.

The preclinical and clinical data presented at the ADA gives investors, physicians, and patients a preview of the new drugs and technologies to come. Many of these drugs are several years away from commercialization; however, because of the new technology, new target, or new delivery method, the outlook remains positive for these drugs and companies in the expanding market of diabetes control.

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