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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