Friday, December 19, 2014

Yaupon Therapeutics switches CEOs as its prepares for FDA filing

Steve Tullman, one of the founders of Ception Therapeutics, was hired by Radnor's Yaupon, which is preparing to file a New Drug Application for its lead product.

Yaupon Therapeutics switches CEOs as its prepares for FDA filing

Sometimes, the life-sciences business in the Philadelphia area seems so small.

On Monday, Radnor-based Yaupon Therapeutics Inc. said it named Steve Tullman, the former chief executive of Malvern-based Ception Therapeutics Inc., as its chairman and CEO. He replaces Robert Alonso, who is no longer with the company.

Tullman was available because Ception had been acquired in April 2010 by Cephalon Inc., the Frazer biotechnology giant, for $250 million. Tullman and four others had founded the anti-inflammatory-drug developer in 2004, raising $110 million in venture capital over the years.

This would be a good time to say those investors were happy with their return on investment provided by Cephalon’s cash.

When you’re a seasoned pharmaceutical executive like Tullman, who had spent 14 years at SmithKline Beecham, and you achieve a successful “exit,” you tend to be in demand by venture-capital investors.

Tullman is also executive chairman of Malvern-based Vicept Therapeutics Inc., which has been working on a topical treatment for rosacea, a skin disorder, since its 2009 founding. Vicept raised $16 million from several venture firms, including Palo Alto, Calif.-based Vivo Ventures.

Vivo Ventures is also a major investor in Yaupon, which has been studying a topical treatment for cutaneous T-cell lymphoma (CTCL). And Vivo wanted Tullman to consider running the company.

Initially, he said he was not interested. Then, he did his own due diligence on what Yaupon was working on.

CTCL is characterized by lesions on the skin and is rare. The patient advocacy group Cutaneous Lymphoma Foundation estimates there are 30,000 people with CTCL in the United States, with about 3,500 people newly diagnosed annually.

Mechlorethamine, also called nitrogen mustard, has been used for decades as a treatment for lymphomas on the skin and is produced by compounding pharmacies, which actually prepare medications. In fact, Yaupon’s study was designed to determine if its formulation was “non-inferior” to pharmacy-compounded formulations.

Bringing standardization to a product with a small patient population is one reason the FDA had granted Yaupon’s mechlorethamine gel “fast-track” status as well as “orphan drug” status. While no guarantee of approval, such designations are aimed at encouraging drug developers to pursue treatments for rare conditions in exchange for priority review and longer market exclusivity for sales.

Last September, Yaupon announced that the topline results for a clinical study of its gel had met its primary and secondary endpoints. The study involved 260 patients at 13 cancer centers and was led by Dr. Stuart R. Lessin, of Fox Chase Cancer Center. Alonso, Yaupon’s CEO at that time, said the company hoped to file a New Drug Application with FDA approval later in the year.

Now the timetable is for the company to file its NDA in mid-2011. In an interview, Tullman said he didn’t want to be more specific until he and the management team he’s bringing into Yaupon had time to review its plan for getting regulatory approval of the mechlorethamine gel.

Yaupon currently has about a dozen employees, not including consultants. Tullman said he’s adding nine people, including some from his former Ception team.

Tullman said he considered himself lucky to get the chance to lead another venture. “I got a fantastic education” from SmithKline Beecham, he said. “I learned a tremendous amount from some very, very smart people.”

Building those contacts in both Big Pharma and Small Biotech is what has Tullman in demand as a “conductor” of sorts.

And it’s an example of how the global pharmaceutical business can seem like a very small place indeed.

Annual meetings

Here are the shareholder meetings by Philadelphia-area companies on the schedule for this week.

Tuesday: Cephalon Inc., Delphi Financial Group Inc.

Wednesday: BioClinica Inc., Comcast Corp., Liberty Property Trust, Quaint Oak Bancorp Inc., Quaker Chemical Corp., Radian Group Inc.

Thursday: Aqua America Inc., the Bancorp Inc., Eastern Insurance Holdings Inc., NutriSystem Inc.

Friday: Inovio Pharmaceuticals Inc.

Mike Armstrong Inquirer Columnist
About this blog
Mike Armstrong blogs about Philadelphia corporations and business-related topics. Contact him at 215-854-2980. Reach Mike at marmstrong@phillynews.com.

Mike Armstrong Inquirer Columnist
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