Clinical trial results can make or break the fortunes of a pharmaceutical, biotech or medical device company, particularly if it is a start-up or has no marketed products.
The company we are profiling today is Array BioPharma Inc. (ARRY), a biopharmaceutical company, which has a couple of potential value-creating events coming up during the second half of this year.
For readers who are new to Array, here's a brief overview of the company and what to expect in the coming months...
Array is focused on developing drugs for cancer and inflammatory diseases. The company has research partnerships with Novartis AG (NVS), Amgen Inc. (AMGN), AstraZeneca plc (AZN), Celgene Corp. (CELG), Eli Lilly (LLY), Roche Holding AG 's Genentech unit, InterMune Inc. (ITMN) and privately-held VentiRx.
The company's most advanced programs are currently in phase II clinical trials and they include, MEK162 (ARRY-162) for cancer, being developed by Array in partnership with Novartis and ARRY-520 for multiple myeloma, being developed internally by Array. Other clinical programs developed solely by Array are under phase I testing, and they are ARRY-380 for breast cancer and ARRY-614 for myelodysplastic syndrome or MDS. Last month, Array licensed ARRY-543, currently entering phase II development for solid tumors to Singapore-based ASLAN Pharmaceuticals Pte Ltd.
Array's advanced drug candidates under development exclusively by a partner include, Selumetinib (AZD6244), for cancer, being developed by AstraZeneca, Danoprevir (RG7227), for hepatitis C virus, being developed by Roche and LY2603618, for cancer, being developed by Eli Lilly - all of which are under phase II stage. Array's investigational drugs under phase I development exclusively by a partner include, AMG 151 (ARRY-403), for Type 2 diabetes, being developed by Amgen, GDC-0068, for cancer, being developed by Genentech , VTX-2337, for cancer, and VTX-1463, for allergy , both of which are being developed by VentiRx.
Now, let's take a look at the upcoming milestones...
The phase II results from trials evaluating Selumetinib (AZD6244) in combination with the gold standard DTIC for melanoma, and Selumetinib (AZD6244) in combination with Taxotere for non-small cell lung cancer are expected to be reported this year. The melanoma and non-small cell lung cancer trials of Selumetinib enrolled 91 patients and 80 patients, respectively. Enrollment in the two phase II trials was completed last year and data collection & analysis is on-going.
Selumetinib is a protein-kinase inhibitor and it blocks a protein called MEK (mitogen-activated extracellular signal-regulated kinase), needed by cancer cells to proliferate and survive. AstraZeneca acquired exclusive worldwide rights to Selumetinib from Array for oncology indications in 2003. AstraZeneca is also evaluating Selumetinib as a single agent for metastatic melanoma of the eye, and in combination with chemotherapy drug Irinotecan for advanced or metastatic colorectal cancer in phase II trials.
Array also expects to complete enrollment in a phase II single agent trial of ARRY-520 in multiple myeloma patients as well as in a phase 1b combo trial of ARRY-520 with bortezomib & dexamethasone. ARRY-520, which inhibits KSP (kinesin spindle protein), is 100 percent owned by the company. KSP inhibitors inhibit tumor growth by preventing mitotic spindle formation and cell division.
Another event of Array to keep an eye on this year is the release of phase 1 data on ARRY-614 in myelodysplastic syndrome patients. ARRY-614, which is also internally developed by Array, is known to block angiogenesis (formation of new blood vessels) to inhibit inflammation and to stop tumor growth. Myelodysplastic syndrome refers to a group of conditions that occur when the blood-forming cells in the bone marrow are damaged.
MEK162 (ARRY-162) for cancer is also a partnered clinical program under partnership with Novartis. Array granted Novartis exclusive worldwide right to develop and commercialize MEK162 last April. In March of this year, Novartis initiated a phase II trial of MEK162 in adult patients with advanced melanoma. Meanwhile, Array also anticipates reporting phase I dose escalation & biliary tract cancer expansion results of MEK162 this year.
A quick look at the company's balance sheet...
Array has no marketed products and derives revenue from licensing and collaboration agreements. Since its inception in 1998, the company has incurred significant losses.
As of March 31, 2011, the company had an accumulated deficit of $525.4 million and cash of $76 million. So far, the company has received a total of $507.1 million in research funding and in up-front and milestone payments from its collaboration partners. According to Array, under the existing collaboration agreements, it has the potential to earn over $2.8 billion in additional milestone payments and double-digit royalties if the objectives in the agreements are met.
In May of 2011, Array reduced the total principal under the credit facility with Deerfield Partners from $120 million to $90 million and extended the credit facility term from April 2014 to June 2015 and June 2016. Last month, the company slashed its workforce by approximately 20 percent, or 70 employees, to extend its financial resources and to focus on the development of its key clinical programs.
Array went public in November 2000 at a price of $7.50 per share. The stock, which has a 52-week price range of $2.05 to $3.60, closed Friday's trading at $2.12 on an above-average volume of 2.14 million shares.
Given the fact that Array has a diversified portfolio, multiple partnering opportunities and a couple of upcoming events, the stock is worth keeping an eye on.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.