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Arrowhead Sees Partnership for Calando Subsidiary by Year End

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By Doug Macron

Arrowhead Research expects that its Calando Pharmaceuticals subsidiary will meet its longstanding goal of forging at least one industry partnership by the end of 2010, a company official said last week.

"Partnering strategies are a large part of our business [in order to] decrease costs and maximize our ability to bring products to market," Arrowhead CEO Christopher Anzalone said during a conference call held to discuss the company's fiscal third quarter. "Our primary partnering focus is on Calando … and it remains our goal to ink our first partnership by the end of the calendar year."

Calando has long been a key player in the RNAi drugs space and holds the distinction of being the first company to bring a formulated siRNA-based drug into human testing with the phase I cancer treatment CALAA-01 in mid-2008.

However, Arrowhead has experienced financial difficulties in recent years, and its failure to secure a partnership for Calando forced the parent company last year to eliminate virtually all of Calando's operations, with the ongoing development of CALAA-01 being conducted by contract research organizations (GSN 5/21/2009 and 11/5/2009).

Earlier this year, however, Arrowhead got a shot in the arm when Calando researchers published data in Nature from the phase I study demonstrating that CALAA-01 could knock down its intended target mRNA and protein inside a tumor through an RNA interference mechanism when delivered intravenously (GSN 3/25/2010).

In the trial, patients with solid tumors refractory to standard therapies were given 30-minute intravenous infusions with one of three doses of CALAA-01 on days 1, 3, 8, and 10 of a 21-day cycle.

Biopsies from melanoma patients enrolled in the study found the nanoparticles used to carry the drug's siRNA payload to be present inside the tumors, and that they accumulated in a dose-dependent manner. Additionally, "a reduction was found in both the specific messenger RNA and the protein levels when compared to pre-dosing tissue," according to the Nature paper.

Anzalone said a few months later that these data were expected to help Arrowhead finally secure a partnership for its subsidiary (GSN 5/20/2010). At the time, however, he did not offer any guidance on when a deal might be struck.

Last week, he said that the phase I trial of CALAA-01 is "progressing, and we are continuing to enroll patients," and that Calando's first partnership is expected to be consummated by the end of the year.

He added that the study is also expected to wrap up in 2010, although he didn't think "that a partnership is dependent upon finishing the phase I."

Fiscal Third Quarter

For the three-month period ended June 30, Arrowhead's net loss dropped to $400,000, or $0.01 per share, from a year-ago loss of $2.5 million, or $0.06 per share.

Revenues plummeted in the fiscal third quarter to $134,000 from $2.6 million, reflecting a one-time payment in the year-ago period associated with a license agreement signed by Calando and Cerulean Pharma for its non-RNAi assets (GSN 6/25/2009).

Arrowhead's total operating costs in the quarter fell to $2.3 million from $4.9 million a year earlier, in part due to cost-cutting measures that included the elimination of essentially all of Calando's staff.

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