ARRY-886 Widening the Phase II Funnel

Array BioPharma (NASDAQ: ARRY) and AstraZeneca (NYSE: AZN) recently announced plans for two additional randomized Phase II trials for ARRY-886, an oncology small molecule inhibitor targeting the Ras/Raf/MEK/ERK signaling pathway. The trials, scheduled to initiate in 2H08, will test ARRY-886 in combination with chemotherapeutic agents in melanoma and non small cell lung cancer patients.

Recall back in December 2003, Array entered into an out-licensing and collaboration agreement with AstraZeneca to develop the MEK program in the field of oncology. Under the agreement AstraZeneca acquired exclusive worldwide rights to the clinical development candidate ARRY-886, along with ARRY-704 and an additional second-generation compound for oncology indications developed during the collaboration. Array retains the rights to all non-oncology therapeutic indications for MEK compounds not selected by AstraZeneca for development. To date Array has earned $21.5 million in up-front and milestone payments. The agreement also provides for research funding, which is now complete, and potential additional development milestone payments of approximately $75 million and royalties on product sales. AstraZeneca is responsible for further clinical development and commercialization of ARRY-886 and ARRY-704 and for the third compound they licensed.


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Array BioPharma: Secures $80M Debt Facility

With over $116M in cash on the books as-of 31 March that did not keep management at Array BioPharma (NASDAQ: ARRY) from securing an additional $80M debt facility from Deerfield Management. Deerfield currently holds in excess of 4.7M shares of Array or nearly 10% of the company. This new debt round will be drawn down in two $40M tranches in June and December of 2008.

Needless to say how costly it is to commercialize a drug, depending on the source a common number used today is $800M and about ten years to reach the market. Now think about that cost for a single agent, small molecule, biologic etc. relative to the incredibly robust pipeline at Array where there are currently six compounds in the clinic for oncology and inflammation, and add to that the work ongoing in the discovery program…$116M simply may not provide enough dry-powder to get a single candidate to the finish line, but at this point financing events are rather often about achieving value-inflection based milestones, like demonstrating proof-of-concept, an IND filing or moving a compound into or advancing in the clinic, and not getting to market.

So how does management raise the requisite financings to achieve such milestones while protecting existing shareholders from dilutive effects? The answer is...debt, and CEO Robert Conway & Company are doing outstanding work not only stewarding the clinical and pre-clinical stage assets at Array but concurrently deploying a carefully architected fiduciary approach to the financing needs.

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ARRY-797: Analgesic Effect? Check!

Great news from Array Biopharma (NASDAQ: ARRY) re: Phase II results from the ARRY-797 asset, a small molecule p38-alpha inhibitor which modulates the production of TNF, IL-1 and IL-6 inflammatory mediators and the PGE2 pain mediator. The post-surgical molar extraction dental pain study achieved all of its total pain relief endpoints for analgesic efficacy. ARRY-797 proved statistically significant for total pain intensity, time to pain relief and total pain relief over 3, 6, 8, 12 and 24-hours post dose over placebo.

p38 is a kinase target that regulates the production TNF, IL-1, IL-6 and PGE2. TNF, IL-1 and IL-6 are all clinically validated cytokines for controlling inflammation in rheumatoid arthritis and are prevalent in many forms of inflammation. PGE2 is an important mediator of inflammatory pain and the target of NSAIDs. Many forms of acute and chronic pain have inflammatory origins, and pan-cytokine suppression may treat both the inflammation and the resulting pain. Array believes modulation of all three cytokines plus PGE2 may be more effective than inhibition of any one in isolation for controlling both the underlying inflammation and the resulting symptoms such as pain.

Additional Phase II inflammatory pain studies are queued up comparing dose rangess of ARRY-797 to placebo and to Pfizer’s (NYSE: PFE) Celebrex®. In addition is a planned Phase II study of ARRY-797 in ankylosing spondylitis, a chronic, painful, inflammatory disorder causing arthritis of the spine.

It would be fantastic to hear from some folks at Array in the comment section below specifically regarding what if any trial results may be released for the remainder of the year.

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Array Q’ly Report: Well Positioned!

Array Biopharma (NASDAQ: ARRY) is an incredibly well positioned tour de force biopharmaceutical company with a strong balance sheet, a vast portfolio of six wholly owned compounds, and a variety of pharma partnered development efforts with AstraZeneca (NYSE: AZN), Celgene (NASDAQ: CELG), InterMune (NASDAQ: ITMN) and Roche (Swiss: RO.SW). President and CEO Robert Conway and team have done a masterful job navigating the turbulent financing waters with a quarterly burn of approximately $20M per quarter with a current cash position of approximately $140M.

The conference call this morning kicked off bright and early at 7:00am. The next value inflection point shall come via the completion of a Phase II study of ARRY-797, a pan-cytokine inhibitor, in acute inflammatory pain, at some point in February. Here is a provided summary of recent accomplishments within the ARRY wholly owned assets for the quarter.

Proprietary Research Programs

• Completed enrollment of a Phase II trial with ARRY-797, a novel inhibitor of TNF, IL-1 and IL-6 as well as PGE2, to treat patients with post-operative dental pain.

• Completed a Phase Ib multiple ascending dose trial with the MEK inhibitor, ARRY-162, added to methotrexate in patients with stable rheumatoid arthritis.

• Initiated a Phase II trial with ARRY-162 added to methotrexate in 200 patients with active rheumatoid arthritis.

• Presented Phase I data on ARRY-543, an ErbB-2 and EGFR inhibitor, at the 2007 International Conference on Molecular Targets and Cancer Therapeutics and at the San Antonio Breast Cancer Symposium. ARRY-543 produced stable disease in refractory patients with advanced solid tumors and was well-tolerated.

• Began enrolling patients in a Phase I expansion trial at the maximum tolerated dose for ARRY-543; half of the patients will have trastuzumab-resistant ErbB2-positive metastatic breast cancer and half of the patients will have other ErbB-family-driven cancers.

• Completed patient enrollment in a Phase I dose escalation trial of ARRY-520, a small molecule kinesin spindle protein inhibitor, and started the expansion phase to further evaluate safety, tolerability and preliminary efficacy at the max tolerated dose.

• Completed the first site initiation for a Phase I clinical trial of ARRY-380, an oral, selective ErbB-2 inhibitor for cancer, and anticipate dosing patients this quarter.

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Array Biopharma: CLSDF Reader’s Take

A few weeks back I posted (here) about the news on Array BioPharma's (NASDAQ: ARRY) outcome for ARRY-886 and the response Wall Street was having as well as AstraZeneca (NYSE: AZN), Array’s development partner, and Schering Plough (NYSE: SGP) and their competitive oncology product, reactions . My argument was that matching standard of care as an outcome in this particular trial should not necessarily be considered a failure, semantics?

Well I love when CLSDF readers call me out, when necessary and especially when not. I encourage you to keep the emails (arubenstein [at] rnaventures [dot] com) and the comments (to be entered at the bottom of each post) coming!

I would like to extend my most gracious appreciation to Eric Austin, Ph.D., DABT, Senior Tox Consultant with Redmond, WA-based Veritox who had the following to say,

“I work in cancer drug development and being equivalent to standard of care is considered a failure in drug development unless you can demonstrate some sort of significant advantage (e.g. greatly improved side-effect profile). This has everything to do with reimbursement. Managed healthcare will not pay a premium (which is what is charged for novel compounds to recoup costs) unless there is a demonstrated advantage, and the FDA will not approve a drug unless there is a demonstrated advantage over standard of care."

Net Eric’s point was that if the architected endpoint was improved survival and not matching SOC then, well then there is your failure.

But I’ll continue to maintain my stance that though this trial failed that new potential studies perhaps in combination with another drug may work to move ARRY-886 forward of course with the caveat that going somewhat back to the drawing board is a slow and expensive process. We’ll have to wait and see to hear about managements intentions. A quarterly conference call date has not been set yet.

So what are your thoughts? Is ARRY a bargain south of $8.00?

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Array: Read Between the Lines!

Many are reeling from today’s near 28% plunge in Array’s (NASDAQ: ARRY) stock price based upon the news of a failed Phase II for ARRY-886…ummm, is the street calling it failure…people please, hold on there for a moment! What exactly happened in the Mek inhibitor molecule study of this first in class novel therapy used as first-line treatment for advanced melanoma? From my unsophisticated perspective what happened, as announced by AstraZeneca (NYSE: AZN), Array’s partner in development, was that ARRY-886 demonstrated the same efficacy of standard of care and that result is paralleling activity of Schering-Plough’s (NYSE: SGP) Temodar® (Temozolomide), a compound that sold $459M in 2004, $588M in 2005 and $703M in 2006 and thus the ARRY-886 compound appears to be showing great promise as a drug for oncology. I am not attempting to make lemonade from lemons here, from what I understand is that ARRY-886 is demonstrating the equivalent efficacy to a near billion dollar a year drug, so yes, the compound did not delay disease progression but did show equivalency. Is that data worthy of a 28% pull-back? Going forward the guess is that ARRY-886 may be aggressively examined in combination therapy studies. The take away from today’s jolt for me was that this is an irrational reaction to misinterpreted news. The silver lining is that an attractive entry point or opportunity to add to a position has been created…not that this is investment advice of any kind. I would be curious to hear what folks at Array, AstraZeneca and/or Schering make of this news. Please leave a comment below or contact me directly at arubenstein@rnaventures.com to maintain anonymity.

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An Array of Development and Discovery

Array Biopharma (NASDAQ: ARRY) is really hitting on all cylinders with eight-wholly owned development programs and a rich portfolio of discovery programs. Let’s take a closer look under the hood…shall we?

ARRY 162 – neared completion of a Phase I trial with of adding to methotrexate in patients with stable rheumatoid arthritis. Plans are to begin a Phase II trial in rheumatoid arthritis patients in early 2008. It is likely to be the first MEK inhibitor to enter Phase II studies for the treatment of inflammatory disease

ARRY 380 – an oral, selective ErbB-2 inhibitor for cancer, in a Phase 1 clinical trial.

ARRY 520 – a small molecule Kinesin Spindle Protein inhibitor, in a Phase I dose escalation clinical trial in cancer patients. Has caused marked tumor regression in preclinical models of human solid tumors and human leukemias.

ARRY 543 – an ErbB-2 and EGFR dual inhibitor; produced stable disease in refractory patients with advanced solid tumors in Phase I trial, was well-tolerated, systemic concentrations of increased with escalating doses at all dose levels tested. Plans are to initiate Phase Ib / II, which include: expansion of the Phase I trial in 30 to 40 additional patients at the maximum tolerated dose, half of the patients will have trastuzumab-resistant ErbB2-positive metastatic breast cancer and half of the patients will have other ErbB-family-driven cancers; A Phase Ib/II trial in combination with cetuximab in patients with metastatic colorectal cancer; A Phase Ib/II trial in combination with capecitabine in patients with metastatic breast cancer; and a Phase Ib/II trial in combination with trastuzumab as maintenance therapy for patients with metastatic breast cancer

ARRY 614 – a p38 / Tie2 inhibitor has completed regulated safety assessment testing and now is preparing an IND application with filing plans for1Q08.

ARRY 704 – a novel MEK inhibitor being developed by AstraZeneca, into a Phase 1 clinical trial in cancer patients.

ARRY 797 – a novel p38 inhibitor, in a Phase I multiple ascending dose clinical trial in healthy volunteers, which is nearing completion. Plans are to initiate a Phase II trial with to treat patients with post-operative dental pain.

ARRY 886 – a novel MEK inhibitor, in Phase II clinical development for the treatment of metastatic melanoma, colorectal, pancreatic and non-small cell lung cancers. These trials are being conducted by Array’s partner AstraZeneca.

Array recently announced a worldwide strategic collaboration with Celgene focused on the discovery, development and commercialization of novel therapeutics in cancer and inflammation, an option was granted to Celgene to license worldwide rights to drugs developed under the collaboration that are directed to two of the four mutually selected discovery targets. Array will be responsible for all discovery and clinical development through Phase I or Phase IIa. For the programs selected by Celgene, Celgene will be responsible for later-stage clinical development and commercialization, except for Array's co-promotion rights in the U.S. Under the agreement, Celgene made an upfront payment of $40M and Array is entitled to receive, for each drug licensed to Celgene, potential milestone payments of approximately $200 million, if certain discovery, development and regulatory milestones are achieved and $300 million if certain commercial milestones are achieved, as well as royalties on net sales. Array will retain all rights to the other programs

Wow…that was a mouthful and not necessarily new news however, it is nice to pull a comprehensive (and relatively) concise snapshot update together. Things are looking very promising over at Array…let’s hope everything remains on track!

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Celgene Makes Ya Go Hmmm…

Just what I think to be an interesting observation…that is how deep New Jersey-based Celgene (NASDAQ: CELG) has penetrated into the Colorado bio-scape. The connection appears to have initiated back in 2001 on a licensing deal with Pharmion (NASDAQ: PHRM) for Thalomid® (BTW…take a listen to Pharmion’s UBS Global Life Sciences Conference presentation from today here). Celgene then most recently struck an alliance deal with Array Biopharma (NASDAQ: ARRY) and yesterday confirmed participation in GlobeImmune’s Series C financing. More big pharma recognizing the value being created here in Colorado!

Array and Celgene Form Strong Alliance!

Array BioPharma, Inc. (NASDAQ: ARRY) and Celgene Corp. (NASDAQ: CELG) announced a worldwide strategic collaboration focused on the discovery, development and commercialization of novel therapeutics in cancer and inflammation. Celgene will make an upfront payment of $40MM to Array, in return Array will grant Celgene an option to select drugs developed under the collaboration that are directed to two of four mutually selected discovery targets. Array will be responsible for all discovery and clinical development through Phase I or Phase IIa. Celgene will then have the option to select drugs resulting from up to two of these four therapeutic programs and will receive exclusive worldwide rights to those drugs, except for Array's limited co-promotional rights in the U.S. Array is also entitled to receive, for each drug, potential milestone and royalty payments of as much as $300MM if certain commercial milestones are reached.

A great deal with a great partner. For those who pay attention to Mad Money Kramer is particularly bullish on the pair.

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.

ARRY-380 To Advance Into Human PI Trial

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.

The ARRY-380 candidate ErbB-2 inhibitor has shown efficacy and is well-tolerated in pre-clinical models of human cancer. ErbB-2 is a receptor kinase target that has been found to be over-expressed in breast and other cancers.

Data Data Data...

We can thank the Tufts Center for the Study of Drug Development for officially estimating the cost to bring a biotech product to market, that is $1.2B, with average preclinical costs of $615M and clinical costs of $626M, and requires just over eight years to bring to market. Note:

• Average out-of-pocket cost per approved biopharmaceutical for the preclinical period totaled $198M. When capitalized, this estimate is $615M per biopharmaceutical.

• Average out-of-pocket clinical period cost per approved biopharmaceutical was $361M. When capitalized, this estimate is $626M.

Also on the data front…Array Biopharma, Inc. (NASDAQ: ARRY) reported preliminary results of their MEK enzyme inhibitor (ARRY-142886) showing inhibition of MEK1/2 - an enzyme that plays an important role in the Ras/Raf/MEK/ERK cell signaling pathway, which regulates cell proliferation.

Results demonstrated 39 of 57 patients completed at least one cycle of treatment with ARRY-142886. After completion of the second cycle, 19 (49%) had stable disease, and nine of these patients (six melanoma, one each of breast cancer, non-small cell lung cancer and medullary thyroid cancer) remained stable for five or more months (range, 5-14+ months; median, 6 months). Two patients, one with thyroid cancer and the other with melanoma, continue to receive treatment with ARRY-142886 after one year. Sixteen of the 20 patients with melanoma completed at least one cycle of treatment. Twelve had stable disease after completion of cycle two, with stable disease persisting for at least five months in six patients (range, 5 - 13+ months; median, 6.5 months).

Encouraging results indeed as Phase II studies are initiated.

(Image courtesy of www.plala.or.jp)

Array Biopharma: Phase I Data & IND

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

Array Biopharma Pads War Chest

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.

Array Initiates Phase I Clinical Trial

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.

Array BioPharma Selects Third Compound

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.