Bay Area's Ardelyx Will Go It Alone on GI Drug As it Splits With AstraZeneca PLC

Published: Jun 04, 2015

Bay Area's Ardelyx Inc. Will Go It Alone on GI Drug As it Splits With AstraZeneca PLC
June 3, 2015
By Riley McDermid, Breaking News Sr. Editor

Fremont, Calif. based biotech Ardelyx Inc. will attempt to go it alone on its lead drug tenapanor, after a bruising Phase II trial lead it to terminate its agreement to develop the drug in tandem with much larger partner AstraZeneca PLC , the company said Wednesday.

Under the terms of the split, Ardelyx will buy back the GI tract sodium reducer for 1$5 million up front and $10 million in related research and development costs.

"Ardelyx's clinical programs hold great promise, and we are excited to continue to play an important role in the company's growth," said David Mott, head of the Healthcare Practice at NEA and chairman of Ardelyx, in a statement.

"Since our initial investment in 2008, Ardelyx is transforming into an emerging biotech company with a pipeline of proprietary and novel drug candidates that have a clear path to commercialization. The Company has an exceptional team that can advance its clinical programs and execute on its business strategy."

Tenapanor grabbed headlines earlier this year when it failed to meet its primary endpoint in a Phase IIb trial when tested on patients with Type 2 diabetes and chronic kidney disease. The drug was not significantly better than a placebo, a surprising outcome for a therapy that had only a month earlier been effective in dialysis patients.

That hasn’t phased Ardelyx, which said Wednesday it will continue to develop the drug, even in the face of some uncomfortable side effects like diarrhea.

"Given the extensive expertise of the Ardelyx team in developing and commercializing minimally-absorbed products including polymers in the cardio-renal field, we are uniquely positioned to develop an improved potassium binder to manage hyperkalemia in chronic kidney and heart disease patients," said Mike Raab, president and CEO of Ardelyx in a statement.

The company said it will now refocus its efforts on tenapanor and a new drug potassium treatment drug, RDX022, that heads into clinical trials this year. Ardelyx said it hopes to fast track RDX022 via the U.S. Food and Drug Administration’s 505b(2) program.

"Together with tenapanor and RDX013, our small molecule hyperkalemia program, RDX022 is an exciting program that augments a formidable pipeline of innovative products,” said Raab. “This is a pivotal point in the history of Ardelyx and an exciting time for our company as we focus our efforts towards building a commercially-driven, fully-integrated company with wholly-owned products to transform the treatment paradigm in the indications that they treat."

Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”

Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.

“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”

We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?

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