|Can Array BioPharma Attract Yet Another Partner?|
|By Patrick Crutcher|
|Tuesday, 05 October 2010 08:36|
Shares of Array BioPharma Inc.(NASDAQ:ARRY) traded up after announcing positive interim results of its novel, oral HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in patients with advanced cancer. As our premium subscribers were told yesterday, the results which presented at the 2010 ASCO Breast Cancer Symposium in National Harbor, Maryland may attract some attention to the company going forward. ARRY-380 is a potent, orally active small molecule drug that has been well-tolerated to date and selectively inhibits tumor growth in preclinical models of HER2-dependent tumors. HER2, also known as ErbB2, is a receptor tyrosine kinase that has been found to be over-expressed in breast cancer and other cancers such as gastric and ovarian. ARRY-380 has demonstrated significant dose-related tumor growth inhibition in preclinical models that was superior to Herceptin and Tykerb(lapatinib) and was additive for tumor growth inhibition in preclinical models when dosed in combination with the standard of care therapeutics such as Herceptin(trastuzumab) or Taxotere(docetaxel). Ideally, ARRY-380 would be competing with Herceptin, which is a blockbuster drug for Genentech.
The interim results concerned 17 HER2 positive metastatic breast cancer patients treated with ARRY-380 at doses greater than or equal to 200 mg BID. 29% of these patients had a partial response or stable disease for 6 months or longer. 13/17(76%) of patients had measurable disease as defined by the RECIST scale for tumors; of these patients, 7/17(54%) had regressions in target lesions. ARRY-380 has been well-tolerated; the predominant treatment-related adverse events have been Grade 1. Because ARRY-380 is selective for HER2 and does not inhibit EGFR, there was, as expected, a low incidence and severity of diarrhea, rash and fatigue. An expansion cohort in patients with HER2 positive metastatic breast cancer is ongoing to confirm safety and explore efficacy and pharmacodynamic markers.
What’s also important about these results? One could guess that a large pharma might be on prowl for this unpartnered program. At this point, ARRY’s pipeline is a bit young for most buyers to consider acquiring them. Once their pipeline has matured and it’s technology proven by clinical results, then there might be a possibility of being acquired.
ARRY has an impressive track record of landing partnerships with their pipeline candidates. Their largest collaborations include agreements with Novartis(NVS), Amgen(AMGN), AstraZeneca(AZN), Celgene(CELG), Eli Lilly(LLY), Genentech(via Roche-RHHBY), InterMune(ITMN) and VentiRx(Private). The deals with Amgen and Novartis totalling $145M in upfront payments, high royalties on sales of approved drugs, and an additional $422M/$666M if certain milestones are achieved.
They also have a potentially lucrative deal with Celgene for a discovery collaboration in cancer and inflammation. ARRY was paid $40M upfront to discover, develop, and commercialize therapeutics for those areas. For each drug that Celgene exercises their option for under this agreement, ARRY is entitled to receive potential milestones reaching $200M for clinical/regulatory milestones and and an additional $300M for certain commercial milestones, as well as royalties on net sales. ARRY will retain all rights to the other programs.