Biotech seeks stamp of approval

On July 24, GPC Biotech will go before the Oncologic Drugs Advisory Committee (ODAC) for a crucial review of its investigational prostate drug, satraplatin.

On July 24, GPC Biotech will go before the Oncologic Drugs Advisory Committee (ODAC) for a crucial review of its investigational prostate drug, satraplatin.

As companies in the sector become more involved in regulatory proceedings, they are discovering that a well-planned communications strategy can go a long way.

It's a big day for Laurie Doyle, GPC's director of IR and corporate communications, and her team, who have long been preparing for that day with the assistance of Russo Partners.

Satraplatin is a promising drug for patients with hormone-refractory prostate cancer (HRPC) whose chemotherapy has failed. The drug is unique within its platinum family of compounds in that it's given in capsule form so patients can take it at home.

Doyle's team has put into place a communications plan to help GPC march toward what it hopes will be an August approval by the Food and Drug Administration.

It is a long and sometimes grueling process to bring a new drug to market. The largest pharma companies go through it frequently, employing a team of seasoned experts and communications advisers to navigate the process. But in the past decade, as the biotech industry reaches a more mature phase in its growth, smaller companies, oftentimes bringing their first product to market, are excitedly going through the process.

And unlike the pharma giants, the survival of these small companies could literally depend on a decision from the FDA.

"It's important, particularly for any small biotech," says Doyle of the regulatory meetings. "Most biotechs don't have 10 products right behind this one ready to go."

Advanced preparation

Given that this is such a key time, GPC's communications plans have been organized well in advance.

"Obviously, it's important that you don't start preparing the week before an event," Doyle says. "It's important to have an ongoing proactive communications program. The last thing you want is for a key reporter to [first] hear about your company or product on the day of a major announcement."

David Schull, MD for Russo, emphasizes the critical nature of media relations. The communications team has set up a number of introductory meetings with journalists who cover FDA regulatory meetings for the wire services and may be unfamiliar with GPC.

"The key component is that when this moves to DC with a panel, we now have journalists who aren't familiar with the company writing about one of the most critical events in the company's drug development history," he notes. "It's our job to give them some background so that when the big day comes, there's a greater chance of them getting the facts right."

Doyle says preparing for ODAC meetings has become even more essential because more people watch the proceedings in real time.

"Several years ago, more people might have been waiting for you to issue your press release," she explains. "Today, a lot of people are watching it real time, so that increases the need for preparation."

Of course, the agency's job is internal as much as external. Agency executives have much experience with regulatory meetings, something of value in an industry only now coming to maturity.

"We have a wave of first-timers," Schull says of all the new companies going through the regulatory process. "There will be individuals who haven't gone through this, so our job as communicators is to teach [them] what's involved."

Doyle says her team has come up with many question-and-answer scenarios to go through. "You do your best to think of any issues that might come up," she says.

Planning out all possible scenarios worked well for Abraxis Bioscience when its breast cancer drug Abraxane came before the ODAC. Last September, the panel recommended that Abraxis and the FDA work together to find selected populations for a reasonably sized trial that would lead to approval as adjuvant treatment.

"That was [a] scenario we prepared for," says Christine Cassiano, Abraxis' corporate communications director. "You must be ready for every possible scenario. You have no time to react by the time there's a vote. Those stories are crossing the wires immediately."

Porter Novelli Life Sciences assisted Abraxis as it prepared to go before the ODAC. Holli Dickson, account supervisor, says the preparation meant the final press release was out the door within an hour of the panel's vote.

Consumer knowledge

Part of the challenge from a communications standpoint rests with the fact that, today, consumers are more immersed in potential treatments. Cassiano says the days of people not completely understanding the industry are over.

"Patients know all the trials are happening, they know what Phase 2 means, they know the language," she notes. "You can't just stay within your own world."

The increased attention means more eyes on events like ODAC panel meetings, but, says Cassiano, it's also a positive because expectations are more aligned with reality.

Whatever happens on July 24, Doyle is confident they'll be ready. For Schull, his belief is that GPC benefits from installing a thorough corporate communications program from the get-go - something crucial in being well and truly prepared for any regulatory meeting.

"It's not a case where GPC has to run to make something new happen," he says. "This is something GPC does on a regular basis."

Satraplatin

Journey toward approval

2002
September
GPC Biotech in-licenses satraplatin from Spectrum Pharmaceuticals

2003
September
Satraplatin Phase 3 SPARC (Satraplatin and Prednisone Against Refractory
Cancer) trial initiated

2005
December
Enrollment completed in SPARC trial in second-line hormone-refractory prostate cancer
December
Partnership announced for satraplatin with Pharmion Corp. for Europe (and Australia, New Zealand, and the Mideast)

2006
September
Positive top-line results from SPARC trial announced

2007
February
New Drug Application (NDA) filing for satraplatin completed
April
Food and Drug Administration notifies GPC Biotech that filing accepted for review and granted priority review status
April
PDUFA (Prescription Drug User Free Act) date for satraplatin (target date for FDA to act on filing)
July
Satraplatin NDA to be reviewed by FDA advisory panel

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