Array Starts First Phase 3 Trial, Shifts to Late-Stage Development

Array Biopharma said Tuesday it has received a $5 million milestone payment from Novartis for beginning Phase 3 testing of a drug it hopes can treat ovarian cancer. The milestone is just part of a larger transition for the Boulder, CO-based biopharmaceutical company.

The event that triggered the payment was the beginning a multinational, randomized Phase 3 trial of a drug code-named MEK162 in patients with low-grade serous ovarian cancer (LGSOC.) The drug will be compared to standard chemotherapy treatments in 300 patients with recurrent or persistent LGSOC to see if it can increase progression-free or overall survival rates.

Array and Novartis, the Swiss pharmaceutical giant, struck a codevelopment and commercialization deal in 2010. Novartis has plans to initiate two other Phase 3 trials of MEK162 to treat two types of melanoma.

The trial in patients with ovarian cancer is the first Phase 3 trial Array has run. Array CEO Ron Squarer said the company is building its ability to conduct Phase 3 trials on its own.

“Anything that gives us experience in that regard is quite helpful. It’s all part of building up your capabilities,” Squarer told BioWorld Insight in May.

Array develops and commercializes small molecule drugs for cancer patients, and its focus has been on discovery and early development.

The company has several development and commercialization deals with global pharmaceutical companies, and recently completed a debt offering to finance future development and operations.

In addition to the deal with Novartis, Array has development and commercialization agreements with AstraZeneca, Amgen, Celgene, and Genentech. Array announced a partnership with Oncothyreon in May.

The $5 million payment comes on the heels of a $132.25 million debt offering the company completed June 10. According to Array’s SEC filings, its net proceeds from the offering were approximately $128 million. Array spent $92.6 million of that to pay off a debt it owed to Deerfield Capital. The remaining $35.4 million will be used for general corporate purposes.

Array raised the money by selling senior convertible notes at a 3 percent interest rate, and the debt can be converted to Array shares if certain provisions are met. The notes mature in 2020.

Under the partnership with Oncothyreon (NASDAQ: ONTY), a Seattle-based pharmaceutical company, Array will develop a new breast cancer drug candidate named ARRY-380. Oncothyreon will pay Array $10 million upfront in exchange for copromotion rights the U.S. and an equal share of the U.S. profits, plus a royalty stream outside the U.S. that amounts to a 50 percent share of the profits in those territories. Xconomy’s Luke Timmerman’s story has additional details on ARRY-380 and the terms of the deal.

Array also announced that AstraZeneca is expected to begin a Phase 3 trial of the non-small cell lung cancer drug selumetinib in October 2013. Three other drugs developed by Array drugs are also approaching Phase 3 or pivotal trial decisions that are expected by the end of 2013, according to the prospectus Array submitted to the SEC before the debt sale.

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