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Keryx enrolling patents in phase 3 trial for colorectal cancer drug

BY Alaric DeArment

NEW YORK Drug maker Keryx Biopharmaceuticals has started registration for a late-stage clinical trial of a pill for colorectal cancer, Keryx announced Thursday.

The company hopes to have the phase 3 trial, for KRX-0401 (perifosine), finished in the second half of 2011. The trial will enroll about 430 patients with refractory, advanced colorectal cancer who will take either KRX-0401 and Genentech’s chemotherapy drug Xeloda (capecitabine) or placebo and Xeloda.

To enroll in the trial, dubbed X-PECT, patients must have failed to improve when taking therapies such as Sanofi-Aventis’ Eloxatin (oxaliplatin), Genentech’s Avastin (bevacizumab), Pfizer’s Camptosar (irinotecan), 5-fluorouracil, Eli Lilly’s and Bristol-Myers Squibb’s Erbitux (cetuximab) or Amgen’s Vectibix (panitumumab).

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Supervalu amends, extends revolving credit facility

BY Michael Johnsen

MINNEAPOLIS Supervalu on Monday announced the successful completion of its previously announced plan to amend and extend the revolving credit facility and a portion of its term facility under its secured credit agreement.

Pamela Knous, Supervalu CFO, stated, “Completing this amendment and reducing total debt in the past fiscal year by approximately $850 million, which exceeded our goal of $700 million, represent important milestones toward ensuring our future liquidity.”

The amended credit facility is comprised of the following extended tranches with updated pricing — $1.5 billion of revolving credit expiring April 5, 2015 and $500 million of term loan B maturing Oct. 5, 2015.

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Peter Ciano named Tris Pharma’s VP corporate development

BY Allison Cerra

MONMOUTH JUNCTION, N.J. A specialty pharmaceutical company that develops innovative drug delivery technologies has appointed a new VP corporate development.

Tris Pharma said Peter Ciano, who currently is a business development consultant for the company, now will lead and manage Tris’ lead all commercial efforts including business development, licensing, identifying growth opportunities and deal executions for its brand side of the business.

“As our technology gains wider acceptance for both Rx and OTC branded businesses, we are increasingly faced with the need for intelligent pursuit of the products and opportunities. Peter’s solid analytical approach coupled with his deep understanding of pharmaceutical marketer’s needs and health care provider’s requirement for reimbursement makes him uniquely qualified to guide and lead Tris in this position,” said Ketan Mehta, founder and CEO of Tris Pharma.

Prior to joining Tris, Ciano worked at Kos Pharmaceuticals (prior to its acquisition by Abbott) for nearly six years, including two years as its executive director of corporate development and business planning.

Most recently, Tris had announced FDA had approval two NDAs including first-ever 24-hour ER suspension. Tris has an active portfolio of more than 20 OTC and Rx products based on its proprietary technology.

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