Ceragenix Pilot Study Results for EpiCeram®

Ceragenix Pharmaceuticals (OTCBB: CGXP) announced positive results from its investigator-blinded pilot study comparing the safety and efficacy of EpiCeram® Skin Barrier Emulsion to that of Elidel® cream from Novartis (NYSE: NVS), a standard non-steroidal therapy in the treatment of mild-to-moderate pediatric atopic dermatitis (AD). Both EpiCeram® and Elidel® cream produced significant improvement in patients’ conditions after four weeks of treatment. There were no statistically significant differences between the groups treated with EpiCeram® compared to those treated with Elidel®.

Improvement in patient AD was a secondary endpoint of the study. Both treatments demonstrated a statistically significant reduction. Itching, a hallmark symptom of AD, was another secondary endpoint of the study. Both EpiCeram® and Elidel® cream produced significant relief from itching after 28 days of treatment, and there was no statistically significant difference between the two treatments in reduction of itching at this time point. The research was conducted by clinicians at the Oregon Health & Sciences University and the University of California School of Medicine, San Diego.

Atopic dermatitis is a chronic childhood skin condition that may affect patients for many years. Dermatology agents currently used to treat atopic dermatitis and other inflammatory skin disorders have limitations of use due to various safety concerns. The use of EpiCeram® does not raise any of the safety concerns associated with the use of topical steroids or topical immunosuppressants.

Ceragenix: $1.5M Milestone Payment from Dr. Reddy’s

Denver-based Ceragenix Pharmaceuticals (NASDAQ: CGXP.OB) a biopharmaceutical and medical device company focused on infectious disease and dermatology, announced that it received a $1.5M milestone payment pursuant to its exclusive distribution and supply agreement with Dr. Reddy’s Laboratories (NYSE: RDY), for the commercialization of EpiCeram®.

Ceragenix has two base technology platforms - Ceragenins™ for treatment of infectious disease and Barrier Repair for the treatment of dermatological disorders including atopic dermatitis, neonatal skin disorders and others. Ceragenin™ compounds are active against a broad range of gram positive and negative bacteria and has been used formulate Cerashield™ antimicrobial coatings for medical devices. The Company’s patented Barrier Repair technology is the platform for the development of two prescription topical creams - EpiCeram® and NeoCeram™. EpiCeram® has been cleared for marketing by the FDA and the Company has entered into an exclusive agreement with Dr. Reddy’s for marketing and sales in the US. Ceragenix anticipates that Dr. Reddy's will launch EpiCeram® during 2H08! That would be fantastic!

Colorado Public Company News:

By my calculations there are ten publicly traded CO-based life science companies. I will begin a regular update of this group. Another group of public companies are operating in or have other significant interests or relationships with entities in Colorado. This group includes Amgen (NASDAQ: AMGN), Gilead (NASDAQ: GILD), Merck (NYSE: MRK), Roche (VTX: ROG.VX) and Agilent (NYSE: A). I plan to do equivalent updates of this Colorado-Related Public Company group. Naturally if I am overlooking any companies that should be included in either category please bring them to my attention (via email).

Accelr8 (AMEX: AXK) ’06 REVENUE: ~ $213K APPROVED PRODUCT(S): None FOCUS: deliver bacterial identification and specific antibiotic susceptibility testing within 8 hours of specimen receipt. PIPELINE: development stage for the BACcel™-1.0 and the BACcelr8r™, based on its innovative surface coatings, assay processing, and detection technologies. Accelr8 also licenses certain of its proprietary technology for use in applications outside of its own products. NEWS: Announced accumulation of large data sets from prototype instruments and validating assays, next focus to ramp engineering to develop marketable product, Presented MRSA data at ASM meeting

Allos Therapeutics (NASDAQ: ALTH) '06 REVENUE: ~ ($32MM) APPROVED PRODUCT(S): None FOCUS: on the development of small molecule therapeutics for cancer PIPELINE: Pralatrexate (PDX) lead 2 Phase II for peripheral T-cell lymphoma and non-hodgkin’s lymphoma 3 Phase I for non-hodkin’s lymphoma (PDX plus gemcitabine), non-small cell lung cancer and T-cell lymphoma (PDX plu folic acid) NEWS: Presented at Bear Sterns conference yesterday, replay is (here), initiated enrollment for Phase I PDX plus folic acid study added to the Russel1 3000 broad market index.

Array BioPharma (NASDAQ: ARRY) – ’06 REVENUE: ~ $45MM APPROVED PRODUCT(S): None FOCUS: Cancer and inflammatory disease small molecule drugs. PIPELINE: 1 Phase II candidate ARRY886 MEK target, 6 Phase I candidates ErbB-2/EGFR, p38, KSP, MEK targets, 3 Pre-clinical candidates. NEWS: CEO Rob Conway presented at the TWP Healthcare conference last week. The webcast has not been posted yet, expect to find it (here), ARRY380 advances to Phase I trial

Aspen BioPharma (NASDAQ: APPY) ’06 REVENUE: ~ $1.2MM APPROVED PRODUCT(S): Manufactures and markets approximately 30 purified protein products primarily for use as controls by diagnostic test kit manufacturers and research facilities, to determine whether diagnostic test kits are functioning properly. FOCUS: Development of novel animal reproduction products for large worldwide markets. PIPELINE: Developing diagnostic products, such as AppyScore ELISA test and AppyScreen, for. It also provides three bovine reproduction products, SurBred, a blood test designed to determine pregnancy status in dairy cattle; StayBred, a luteinizing hormone analog for inducing ovulation in cows; and BoviPure FSH, a follicle stimulating hormone analog for ovulation and embryo transfer in dairy and beef cows. The company is developing two equine reproduction products, EquiPure LH, a luteinizing hormone analog for inducing ovulation in estrous mares; and EquiPure FSH, a follicle stimulating hormone analog for ovulation and embryo transfer in horses. NEWS: Presented at Roth Capital Partners conference, webcast available (here). Shares recently moved from trading on the OTC bulletin board under APNB.OB to the NASDAQ capital mrkts xchange under APPY.

Ceragenix Pharma (OTCBB: CGXP.OB) ’06 REVENUE: ~ ($4.7MM) APPROVED PRODUCT(S): EpiCeram® for treatment of atopic dermatitis (eczema) FOCUS: a biopharmaceutical company engaged in the discovery, development, and commercialization of a portfolio of small molecule cationic steroid antibiotic products in the fields of infectious disease and dermatology PIPELINE: preclinical candidates for neonatal barrier repair, cvc infections and burn dressing. Products are all based upon skin barrier repair and the ceragenin technologies NEWS: Recent recipient of the Frost & Sullivan's 2007 North American Technology Innovation Award for the field of Anti-Infective Coatings. Have not been able to consummate licensing deal for EpiCeram® by the forecasted dates previously released, commercialization is targeted for 2008. In vitro data indicate that CSA-13 may be effective to treat multi-drug resistant Pseudomonas aeuroginosa.

Encision (AMEX: ECI) ’06 REVENUE: ~ $11MM APPROVED PRODUCT(S): Sells a range of articulating instruments, such as scissors, graspers, and dissectors; fixed-tip electrodes; and suction-irrigation electrodes. In addition, Encision markets the Active Electrode Monitoring System monitor product line that is used in conjunction with the AEM Instruments. FOCUS: A medical device company offering a line of AEM Surgical Instruments, which prevents stray electrosurgical burns from insulation failure and capacitive coupling. PIPELINE: ? NEWS: Received warning letter from AMEX that ECI did not satisfy rule for continued listing. Reported a 3% decrease in quarter-over-quarter in net sales, ordering patterns of reorders for re-usable equipment was cited as a cause for the decrease. Will begin to manufacture its own disposable scissor inserts.

Heska (NASDAQ: HSKA) ’06 REVENUE: ~ $75MM APPROVED PRODUCT(S): Vet ABC-Diff Hematology System, ALLERCEPT® Allergy Testing and Treatment, CBC-Diff™ Veterinary System, E.R.D.-HealthScreen® Urine Tests, F.A. Granules, HemaTrue™ Veterinary System, i-STAT® Clinical Analyzers, Solo Step® Heartworm Tests, SPOTCHEM™ EZ Chemistry System, ThyroMed™ Chewable Tablets and Feline UltraNasal® Vaccines FOCUS: The company operates in two segments, Core Companion Animal Health, and Other Vaccines Pharmaceuticals and Products. The Core Companion Animal Health segment includes diagnostic and other instruments and supplies, as well as single use diagnostic and other tests, vaccines, and pharmaceuticals primarily for canine and feline use. PIPELINE: TBD NEWS: 3Q07 earnings call set for 7 November, call in info (here)

Pharmion (NASDAQ: PHRM) – ’06 REVENUE: ~ $239MM APPROVED PRODUCT(S): Vidaza® for myelodysplastic syndromes, Thalidomide® for multiple myeloma, erythema nodsum leprosum, Innohep® for deep vein thrombosis Refludan® heparin-induced thrombocytopenia FOCUS: Hematology and oncology PIPELINE: 4 Phase III candidates MDS, 1st and 2nd line MM, hormone refractory prostate caner, 5 Phase II candidates acute myelogenous, small cell lung cancer hematological malignancies, 4 Phase I candidates NEWS: Presentation from yesterday’s Bear Stearns conference will be posted (here), oral Azacitidine was granted fast-track status for myelosdysplastic syndromes, granted US Orphan Drug status for MGCD0103 for the treatment of hodgkin’s lymphoma

Replidyne (NASDAQ: RDYN) ’06 REVENUE: ~ $16MM APPROVED PRODUCT(S): None FOCUS: focused on discovering, developing, in-licensing, and commercializing anti-infective products. PIPELINE: 3 Phase III for bronchitis, sinusitis/pneumonia and acute otitis media, 2 Phase I for skin infections (impetigo and MRSA) and wound infections NEWS: Keep your eyes peeled for announcement of a new development partner for Faropenem.

Tapestry Pharma (NASDAQCM: TPPH) ’06 REVENUE: ~($17MM) APPROVED PRODUCT(S): None FOCUS: oncology, third-generation taxane prostate for pancreas and glioblastoma mutliforme PIPELINE: 1 Phase II candidate TPI287 for hormone refractory prostate cancer NEWS: Recently reported 2Q07 financial results, recently withdrew S-1 filing for proposed $40MM common stock offering based upon encouraging data presented at ASCO and is pursuing other financing opportunities.

Ceragenix - 510k Clearance of EpiCeram®

>Ceragenix Pharmaceuticals, Inc., (OTC BB: >CGXP.OB) a biopharmaceutical company focused on infectious disease and dermatology, announced it has received 510k clearance from the FDA for its EpiCeram® Skin Barrier Emulsion to improve dry skin conditions and to relieve and manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions. EpiCeram® is a topical, non-steroidal treatment that consists of a specific combination of lipids. The product will be available on a prescription-only basis. Ceragenix has licensed the lipid skin barrier technology from The Regents of the University of California on an exclusive basis for all prescription applications.

According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), more than 15 million people in the U.S. have symptoms of atopic dermatitis. Children are more commonly affected than adults, with 90 percent of acute dermatitis cases diagnosed by age five. Roughly 60 percent of infants affected continue to have one or more symptoms of atopic dermatitis into adulthood. NIAMS researchers project that U.S. health insurance companies spend more than $1 billion per year on atopic dermatitis.