CLSDF Public Companies

Colorado Public Company News:

noreply@blogger.com (Adam) — Wed, 12 Sep 2007 21:04:00 -0700

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.

ARRY-380 To Advance Into Human PI Trial

noreply@blogger.com (Adam) — Tue, 14 Aug 2007 14:20:00 -0700

Array BioPharma, Inc. (NASDAQ: ARRY) plans to initiate a Phase I trial this fall for ARRY-380, a selective, orally-active ErbB-2 inhibitor for metastatic breast cancer patients and perhaps those who are resistant to Genentech’s (NYSE: DNA) HER2 targeting blockbuster Herceptin.

Action At Allos

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:17:00 -0700

Lot’s of action transpiring at Allos Therapeutics (NASDAQ: ALTH) since Paul Berns has taken over the reigns. We should expect a $50.5M financing to close tomorrow courtesy of Merrill, where 9M shares of common are being floated at $6 less underwriting fees and expenses, much of which to be gobbled up by Baker Brothers Life Sciences Capital. The lion share of the use-of-proceeds will be allocated to advancing pralatrexate (PDX) clinical work. Recently an independent data monitor completed an interim safety analysis and indicated PDX should continue in its pivotal Phase II trail in patients with relapsed or refractory peripheral T-cell lymphoma. A second interim safety analysis should be expected following 35 enrollees who have completed at least one cycle of PDX treatment. Finally, William Ringo was appointed to the Allos board. Mr. Ringo, most recently served as President and CEO of Abgenix and guided the $2.7B acquisition by Amgen.

Allos + NASDAQ = Great News!

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:17:00 -0700

Allos Therapeutics, Inc. (NASDAQ: ALTH) having met all minimum requirements was added to the NASDAQ Biotechnology Index. Being added to an index typically yields an uptick in share price and corresponding market cap as all funds, ETF’s, separate accounts etc. that mirror an index must purchase the newly added position, in this particular case the iShares NASDAQ Biotechnology Index Fund (AMEX: IBB).

Taking a look at average daily volume of ALTH shares traded is ~275K however, today one may observe the buy spike of ~540K.

If you want to see a pretty one year chart take a look at this:

Pharmion: Bucks the Trend

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:16:00 -0700

After a fury of CO life science companies that have recently been acquired (e.g. Myogen/Gilead, RxKinetix/Endo and Sirna/Merck), Pharmion, Inc. (NASDAQ: PHRM) has reversed this local trend and gone out and purchased Cabrellis (privately held, San Diego, CA) for $55M with an additional $45M pending. Two additional payments of $12.5M are expected upon approval of amrubicin. Upon amrubicin's approval for a second indication in the US or EU an additional payment of $10 million will be made for each additional market.

Amrubicin (CALSED™) has been approved in Japan since 2002, for the treatment of SCLC and non-small cell lung cancer (NSCLC). Pharmion intends to initiate a Phase 3 registrational study in relapsed/refractory SCLC in the second half of 2007. Using data from these studies and supporting Japanese data, Pharmion expects to submit a NDA and a Marketing Authorization Application (MAA) in the EU for the treatment of relapsed/refractory SCLC during 2009.

The transaction adheres to the Pharmion model of late stage licensing and acquisitions; it may yield near term revenue (as early as 2010), complements the platform while expanding into solid tumor therapies and will also explore amrubicin in combination with their two epigenetic inhibitors.

Allos Therapeutics - Promising Data

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:15:00 -0700

Allos Therapeutics, Inc. (NASDAQ: ALTH) announced safety results from its Phase I/II trial of Pralatrexate (PDX) in patients with non-Hodgkin's lymphoma and Hodgkin's disease, and from its Phase II study of efaproxyn in patients with unresectable non-small cell lung cancer receiving sequential chemoradiotherapy (S-CRT).

Results of the PDX sudy indicate a higher incidence of stomatitis was observed in patients with elevations in pre-treatment homocysteine (Hcy) and methylmalonic acid (MMA). Little to no increase in stomatitis occurred in patients with Hcy and MMA less than 10 mM and 200 nM respectively. Patients with elevated Hcy and MMA who developed stomatitis with PDX did not develop advanced grade stomatitis after normalization of their Hcy and MMA with folic acid and vitamin B12 supplementation. Subsequent to this finding, all enrolled patients have received pre-treatment with vitamin B12 and folic acid, and normalization of Hcy and MMA levels has mitigated the incidence of stomatitis.

In July 2006, the FDA awarded orphan drug designation to PDX for the treatment of patients with T-cell lymphoma. PDX is a novel, small molecule chemotherapeutic agent that inhibits dihdrofolate reductase (DHRF), a folic acid dependent enzyme involved in the building of DNA and other processes. PDX was rationally designed for improved transport into tumor cells via the reduced folate carrier (RFC-1), and greater intracellular drug retention. These biochemical features, together with preclinical data in a variety of tumors, suggest that PDX has an enhanced potency and improved toxicity profile relative to methotrexate and other related DHFR inhibitors.

The efaproxyn study compared the safety and efficacy of efyaproxyn when administered with S-CRT in patients with unresectable NSCLC compared to data from a Phase III, Radiation Therapy Oncology Group (RTOG) study. Results of a 5-year survival analysis indicated that patients in the efaproxyn study exhibited superior survival to patients with similar characteristics in the RTOG study. Median survival of patients treated in the efaproxyn study was 20.6 months as compared to a median survival of 13.3 months for matched cases in the S-CRT arm of the RTOG study and 16.9 months in the concurrent chemoradiotherapy (C-CRT) arm of the RTOG study. The Kaplan-Meier estimates of 5-year survival rates for matched cases were 19% in the efaproxyn study and 10% in both the S-CRT and C-CRT arms of the RTOG study.

Efaproxyn is the first synthetic small molecule designed to sensitize hypoxic or oxygen-deprived areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, Allos believes that efaproxyn has the potential to enhance the efficacy of standard radiation therapy.

Black Eye For Macugen

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:15:00 -0700

At their quarterly conference call OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced a planned exit of their recent $650M Eyetech acquisition. OSI bought Eyetech primarily for the age related macular degeneration (AMD) drug Macugen. Macugen sales for the quarter rapidly and dramatically declined, reaching only $9M in sales relative to $87M for the previous two quarters. OSI seeks to maximize the value for Macugen and its research assets in the area via out-licensing, partnering or a sale of the business.

"We continue to believe that Macugen's product profile, our induction / maintenance strategy and promising data in the diabetic retinopathy area will ultimately result in a meaningful place for Macugen in treating retinal eye disease. However, it is evident that a key strategic goal behind our acquisition of Eyetech - that of generating positive cash-flow from the eye business in the 2006-2008 period - will not be realized."

Colin Goddard, Ph.D., Chief Executive Officer

The AMD market is crowded and is becoming ever more competitive. Visudyne, an AMD treatment from QLT, Inc. (NASDAQ: QLTI) and Novartis AG (NYSE: NVS), like OSI, has reported rapid sales erosion in 2006 of ~ $350M down from ~$380M. Genentech (NYSE: DNA) is on the AMD offensive with their off label sales of Avastin however, with planned royalties to Xoma (NASDAQ: XOMA), Lucentis appears to be accelerating as the choice for treatment. Lucentis is priced at $1,950 per dose and it is estimated that the average dosage will be five to seven treatments per year, yielding an annual cost of the treatment from $9,750 to $13,650. With as many as 15 million Americans affected by wet and dry forms of AMD Lucentis may easily achieve billion dollar sales and blockbuster status.

Array Biophamra: Phase I Data & IND

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:14:00 -0700

Two fantastic tidbits emerging out of Array Biopharma, Inc. (NASDAQ: ARRY) headquarters:

Array has filed an Investigational New Drug application for ARRY-797 with the FDA and is now able to proceed with human clinical studies. ARRY-797 is a potent, selective, orally active inhibitor of p38 MAP kinase and has demonstrated good tolerability and significant efficacy in preclinical models of human inflammatory diseases.

Array will be presenting data from a Phase 1 trial of AZD6244 (ARRY-142886), a novel MEK inhibitor, at the 18th Annual EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics to be held from November 7-10, 2006 in Prague, Czech Republic. AZD6244 has shown tumour suppressive activity in multiple pre-clinical models of human cancer including melanoma, pancreatic, colon, lung, and breast cancers.

Finally, Array will be reporting quarter end financial results today, 6 November, at market close. Listen to the conference call: (800) 310-6649

When It Rains It Pours...

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:13:00 -0700

And the Colorado M&A hits keep on coming…Merck & CO. (NYSE: MRK) announced the $1.1 billon acquisition of San Francisco headquartered Sirna Therapeutics, Inc. (NASDQ: RNAI).

Why does an acquisition story about an acquirer from New Jersey and an acquiree from San Francisco make it onto the virtual pages of Colorado Life Science Deal Flow you may ask? Well…

The story begins back in Boulder, CO, circa early-eighties, when then CU-Boulder biochemistry professor turned Nobel Prize winner (1989) and current Howard Hughes Medical Institute President, Thomas Cech, Ph.D. demonstrated how, using the Tetrahymena model organism, RNA could fold into complex shapes and catalyze biochemical reactions, a function previously thought to be restricted only to protein enzymes. This discovery led to the founding of Ribozyme Pharmaceuticals, Inc. (RPI) in 1992, where the catalytic properties of the “Ribozyme” would be designed as a therapeutic approach to target and cleave specific mRNA’s in specific diseases.

Tetrahymena - Where it all began
Courtesy of the Albert Einstein College of Medicine - Yeshiva University

As the fate of science, technology and innovation would have it the cellular mechanism RNA interference (RNAi) emerged as an extremely specific method for targeting mRNA’s and inhibiting gene expression. Thus RPI was in part reorganized as Sirna Therapeutics, Inc. in 2002 to focus pursuit upon the short interfering RNA (siRNA) technology and current CEO Howard Robin & Co. have subsequently continued to further build out a potent IP portfolio, become the first company to bring a chemically optimized siRNA into clinical trials, and have demonstrated stability, circulation, tissue targeting, cellular activity and immune response efficacy in their preclinical compounds. Shortly after the reorg the city of San Francisco presented an opportunity to then Boulder-based Sirna that could not be refused and if I am not mistaken all but the cGMP manufacturing facility packed up and headed West.

So on the heels of the Gilead-Myogen and Endo-RxKinetix, the Merck-Sirna deal perhaps catapults the 2006 bio deals to the level of historic and further validates the strength of the universities, IP, talent and investors in Colorado. But shhhh…I have reason to believe that this is just a taste of what is to come.

Replidyne: Silver Lining in FDA Letter

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:13:00 -0700

Following Replidyne’s (NASDAQ: RDYN) receipt of a non-approvable letter from the FDA for Faropenem® there are a numerous reasons why there is a sliver lining in this non-approvable letter cloud.

First, and of paramount importance, the FDA had no SAFETY or Chemistry Manufacturing and Control issues. Second, the IP which covers composition of matter and methods of manufacturing are in place through 2015 with up to three additional years of protection through certain extensions. Third, a strong management team is backed by cash on hand of $134M (includes IPO proceeds) with a burn of approximately $30M however, certain additional capital needs for the required superiority and microbiological studies may be absorbed through a previous agreement with their partner Forest Labs (NYSE: FRX).

In short, a Post Action conference with FDA will be held. The news out of that meeting will provide insight as to the structures of the requisite studies to address the lack of placebo controlled data; recall that the studies were designed as non-inferiority (Faropenem® vs. current approved treatment). I would expect perhaps some additional information on 26 October, their scheduled earnings release date.

RxKinetix: The Hits Keep Coming

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:12:00 -0700

Congratulations to Harry Ross and the entire RxKinetix team on the Endo Pharmaceuticals Holdings, Inc. (NASDAQ: ENDP) deal. The disclosed terms indicate Endo Pharma will pay a $20M up-front fee and will follow on with up to an additional $95M in clinical development and regulatory milestone payments.

Early indications are that RxKinteix, like Myogen, will remain in Colorado and continue to operate as a wholly owned subsidiary…more great news for Colorado bio.

RxKinetix's lead product is RK-0202, it is in clinical Phase II trials for the prevention of oral mucositis. Endo plans to conduct additional Phase II trials of RK- 0202 to continue to characterize the clinical profile of the product in head and neck cancer patients undergoing combination treatment of radiation and chemotherapy.

Importantly :-) CEO Harry Ross was also the first guest blogger to appear on Colorado Life Science Deal Flow, you can read his words of wisdom (here). Not only is Dr. Ross an accomplished physician, entrepreneur and investor he is also an incredibly accessible and caring individual.

Something To Pay Attention To?

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:11:00 -0700

Merrill Lynch believes a decision should be reached by the FDA regarding Replidyne’s (NASDAQ: RDYN)Faropenem® approval for acute bacterial sinusitis by or before 20 October. One may be inclined to pay close attention to next Tuesday or Wednesday’s FDA panel review of rival Oscient Pharmaceutical (NASDAQ: OSCI) for Factive® also for the treatment of acute bacterial sinusitis and already approved for pneumonia and bronchitis.

In question next week will be the FDA’s updated guidance for the use of placebo controlled trials for new antibiotics such as Faropenem® and Factive®. If the FDA suggests the necessity of placebo controlled trials for either of the candidates it may negatively impact approval and launch timing. However, Merrill Lynch does not believe that such a trial will be necessary for Faropenem® based upon its safety profile. Replidyne may likely move in some directly or inversely correlated manner to OSCI as soon as the news of the panels decision is released.

Both Merrill Lynch and Cowen & CO. are now covering Replidyne. I have not determined what if any IB relationships may exist between the entities but certainly plan to answer that question.

Move Over Macugen, Visudyne & Lucentis?

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:11:00 -0700

Sirna Therapeutics, Inc. (Nasdaq: RNAI), reported the final results from its completed Phase I trial for Sirna-027, a novel therapeutic for age-related macular degeneration (AMD). The Phase I study evaluated the safety, tolerability, and biological effect of single-ascending doses of Sirna-027 in patients with AMD. A total of 26 patients with active disease were enrolled to receive a single intravitreal injection of Sirna-027.

Single doses of Sirna-027 were safe and well tolerated, and all 26 patients (100%) showed visual acuity stabilization eight weeks after a single injection.

In addition, 19% of patients experienced clinically significant improvement in visual acuity. Three months after a single injection 92% of patients showed visual acuity stabilization, with 15% of patients experiencing clinically significant improvement in visual acuity. Importantly, a decrease in foveal thickness was observed in some patient groups, which is an indication of biological activity of Sirna-027 and chemically optimized siRNA's.

A Phase II trial is expected to initiate later this year.

Allos Therapeutics Receives Orphan Status

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:10:00 -0700

The FDA has granted Allos Therapeutics (NASDAQ: ALTH) next-generation chemotherapy drug pralatrexate, or PDX, for the treatment of T-cell lymphoma, with an orphan drug designation.

An orphan drug designation is assigned to a drug that targets the treatment of a disease with less than 200,000 sufferers in the U.S. The status provides seven years of marketing exclusivity for the treatment should it gain approval, along with tax breaks and possible development funding.

Feather in Colorado's Cap

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:09:00 -0700

Happy to see that Replidyne, Inc. (Nasdaq: RDYN) began trading this morning at 11:00am! Next stop...approval for Orapem™!

Array Biopharma Pads War Chest

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:08:00 -0700

BioMed Realty Trust, Inc. (NYSE: BMR) a real estate investment trust focused on the life science industry has entered into an agreement to acquire Array BioPharma's (Nasdaq: ARRY) approximately 150,000 square-foot, four-building campus in Boulder and 78,000 square-foot, two-building campus in Longmont.

The transactions are $45.0 million for the Boulder campus and $20.8 million for the Longmont campus for a total price tag of $65.8 million. Array will then fully lease back both of the properties under a new ten-year triple-net lease through 2016. The deal which is expected to close in 3Q06 will net Array approximately $32.0 million to cash which will be allocated towards aiding the advancement of the pipeline, this according to CEO Robert Conway.

Perhaps one may view this financing as a twist on the PIPE (private investment in public entity) and instead call it a pIPE (PUBLIC investment in public entity). Or maybe it is just called smart bio-business and this comment really illuminates my lack of sophistication. Regardless, any financing that nets tens of millions targeted for clinical development is simply…exciting. We are rooting hard for Array’s lead compounds targeting, MEK for oncology and inflammation, and targeting ErbB-2 for oncology to continue to demonstrate efficacy through their clinical trials.

Positive Phase II Data for Macugen®

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:07:00 -0700

There are many reasons why here in Colorado we keep a careful eye on Macugen, no pun intended…

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced interim Phase II study results showing that injections of Macugen® resulted in better visual acuity outcomes in patients with macular edema due to central retinal vein occlusion compared with those receiving a sham injection. Over 90 percent of patients maintained or improved vision at 30 weeks when treated with Macugen® injections compared to approximately 69 percent of those treated in the control arm. Patients treated with Macugen for 30 weeks had, on average, an improvement in visual acuity while the control group demonstrated a mean decrease in visual acuity from baseline to week 30. Vision gain was seen with a single injection of Macugen® within 6 weeks of treatment, versus a loss in the control group.

Array Initiates Phase I Clinical Trial

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:06:00 -0700

Array BioPharma, Inc. (Nasdaq: ARRY) initiated a Phase I clinical trial in the US for ARRY-438162, a novel MEK inhibitor for the treatment of inflammatory disease. The compound will be evaluated in dose escalation studies in normal, healthy volunteers.

MEK is a protein kinase that regulates both the biosynthesis of and response to a number of growth factors that drive uncontrolled inflammation associated with many human diseases. Array’s first MEK inhibitor, ARRY-142886, was licensed to AstraZeneca AB for cancer and is currently in clinical development. Array's new molecule, ARRY-438162, is a potent and selective inhibitor in enzyme and cellular systems. The Array thesis is that MEK inhibition will be useful in treating acute and chronic inflammatory diseases, including rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), and inflammatory bowel disease.

Ceragenix - 510k Clearance of EpiCeram®

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:06:00 -0700

>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.

Array BioPharma Selects 3rd Compound

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:05:00 -0700

Array BioPharma Inc. (Nasdaq: ARRY) and AstraZeneca AB selected a third compound for their small molecule MEK anti-cancer program, triggering a $1 million milestone payment from AstraZeneca to Array. The second compound was selected in January 2006, which also paid a $1 million milestone to Array. In December 2003, Array partnered the oncology portion of its MEK program, including its lead compound, ARRY-142886 (AZD6244), for co-development and commercialization with AstraZeneca. At that time, Array and AstraZeneca established a collaboration for research and development of additional clinical candidates.

MEK is a critical enzyme at the intersection of several biological pathways, which regulates cell proliferation and survival as part of the Ras/Raf/MEK/ERK pathway. Constitutive activation of the Ras/Raf/MEK/ERK pathway has been implicated in many cancers, including lung, pancreatic, colon, melanoma and thyroid caused by cancer-associated, mutational activation of bRAF and Ras proteins. MEK inhibition is an attractive anti-cancer strategy as it has the potential to block inappropriate signal transduction regardless of the upstream position of the oncogenic aberration.

Mayhem at Myogen?

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 21:04:00 -0700

So what the heck is going on at Myogen today?

The company announced that ambrisentan met its primary goal of helping people increase the amount of exercise they could do, and doing so without hurting their livers. Two great data points. Good news right? Share price zooms right? Well good news but not good enough as MYOG spent the day heading to a three month low on the day they also reported a big BUT…but the drug failed to significantly increase the time to clinical worsening observed in that study population.

Tapestry - $25.5M In Private Placement

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 20:56:00 -0700

It has been a Thursday morning full of great news...

Boulder based Tapestry Pharmaceuticals, Inc. (Nasdaq: TPPH ) announced today that it has closed on the sale of 12.75 million shares of its common stock at a price of $2.00 per share, for gross proceeds of $25.5 million, with nine institutional investors. Warrants for an additional 12.75 million shares were also issued with a strike price of $2.40 per share. The private placement was led by Special Situations Funds, Tang Capital Partners, LP, and Baker Brothers Investments and includes Biotechnology Value Fund, L.P., Fort Mason Partners, L.P., Heights Capital Management, Merlin BioMed Long Term Appreciation, LP, Versant Capital Management LLC, and Xmark Funds.

"The closing of this financing gives Tapestry the resources necessary to aggressively advance our lead oncology compound, TPI 287, into multiple Phase II clinical studies as well as to continue the development of an oral formulation of this drug candidate," commented Leonard Shaykin, Chairman and CEO of Tapestry Pharmaceuticals.

TPI 287, a proprietary third generation taxane, is Tapestry's lead clinical compound. This compound was designed to overcome multi-drug resistance in solid tumors that have become resistant to taxane therapy. TPI 287 is currently in two Phase I studies in the United States and overseas to determine the safety and pharmacokinetic profile of the compound. A number of Phase II studies are planned in several of the major tumor types and are projected to begin in this calendar year.Both in vitro and in vivo studies suggest that TPI 287 may be orally bioavailable. An oral form of the compound is currently in preclinical development.

Sirna Shaking It Up

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 20:55:00 -0700

Lot’s of news coming from Sirna Therapeutics Inc., this Monday morning. First RNAI announced today that the USPTO will issue U.S. Patent No. 7,022,828 on April 4, 2006. This is the first siRNA target patent issued in the United States and sets an important precedent for Sirna's entire target patent portfolio.

The patent covers any chemically modified siRNA targeting I Kappa B kinase-gamma (IKK-gamma). Importantly, the claims of the patent are not limited to a specific siRNA sequence but cover any siRNA sequence used against the gene. In addition, the claims of this patent are not limited to a specific type of chemical modification or structure but cover any chemical modification that can be made to the siRNA. The patent covers blunt-ended siRNAs as well as those with one or more nucleotide overhangs. IKK-gamma is an activator of the NF-kappaB pathway (NF-kb), an important mediator in a host of diseases, such as asthma, arthritis, cancer, chronic inflammation, neurodegenerative diseases and heart disease.

Secondly, GlaxoSmithKline said it will pay Sirna a $12 million upfront, and potentially more than $700 million in milestones, to enter into an exclusive multi-year alliance focused on discovery, development and commercialization of novel RNA interference therapies for respiratory diseases. The street responded quite well to these announcements in pre-market and are sustaining enthusiasm as the trading day continues.

Allos Therapeutics Names New CEO

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 20:54:00 -0700

Allos Therapeutics, Inc. announced today the appointment of Paul L. Berns as the Company's President, Chief Executive Officer and a member of the Board of Directors, effective immediately.

Mr. Berns brings close to 15 years of pharmaceutical industry experience to Allos. While leading Bone Care International, Inc. from June 2002 until its acquisition by Genzyme, Corp. in July 2005, revenues increased nearly 14-fold, the company became profitable and market capitalization increased from approximately $40 million to a sale value of $719 million. Prior to joining Bone Care International, Inc., Mr. Berns held senior management positions at Abbott Laboratories, BASF Pharmaceuticals, and Bristol-Myers Squibb Company.

More Good News for Myogen

noreply@blogger.com (Adam) — Wed, 11 Jul 2007 20:54:00 -0700

The FDA has granted Fast Track status for Myogen's ambrisentan, currently in Phase III clinical trials. This designation is aimed to expedite the review process.

The FDA designated ambrisentan as a Fast Track product for the following reasons:

1. Ambrisentan is intended to treat PAH, a life-threatening, progressive, and
incurable disease of the pulmonary vasculature.
2. The ambrisentan development program has been designed to address the unmet medical needs of patients with PAH, by demonstrating the following:

a. Ambrisentan has the potential for improved effects on exercise capacity, an efficacy measure that has been shown to correlate with and be prognostic of long-term survival.
b. Ambrisentan appears to delay the clinical worsening of PAH, a progressive and ultimately fatal disease.