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Cephalon, Endo see regulatory issues that unite mid-cap firms

Seven mid-cap drug makers have been talking for months about how they can make sure their concerns about federal legislation get heard.

How many voices does an industry need?

When it comes to the pharmaceutical industry, apparently you can never have too many.

A couple of drug industry trade publications say that Frazer's Cephalon and Chadds Ford's Endo Pharmaceuticals have teamed with five other drug makers to form America's Specialty Medicines Companies.

The In Vivo blog cites a report in The Pink Sheet trade publication that the organization is still being formed, so it's not clear what its main priorities are. (I can't afford $1,900 a year to subscribe to The Pink Sheet. Those who can obviously can afford to belong to multiple trade associations. But it looks as if the item has been reprinted at

But the founding members indicated to the trade pub that they're not dissatisfied with the alphabet soup that is Washington's other advocacy organizations:

* PhRMA, the Pharmaceutical Research & Manufacturers Association, one of the most powerful trade associations in the nation. The Washington-based group represents dozens of pharmaceutical and biotechnology companies.

* GPhA - Generic drug makers have their own group called the Generic Pharmaceutical Association.

* And BIO, the Biotechnology Industry Organization, which has become the biggest trade association for biotech companies.

Besides the two Philadelphia-area drug companies, the ASMC would include Celgene, Cubist, Millennium, Purdue and Sepracor.

Sheryl Williams, Cephalon's vice president of public affairs, described the effort as an "informal working group" that had been talking for a few months trying to identify common ground. Legislation that might affect sales and marketing or changes at the Food and Drug Administration are some of the issues they've discussed.

What they do have in common is that each has at least one or two drugs that provide most of their revenue, Williams said. As a result, their situation can be more tenuous than a Big Pharma company that has dozens of products, including the blockbuster medicines that draw most of the public's attention.

She said the group sees its concerns as different from those of Big Pharma and traditional biotech even if it hasn't been able to articulate exactly what it will stand for. The companies just know that when it comes to legislation "it's not one size fits all," Williams said.

But one thing Cephalon does not want to see is the formation of a new trade association, she said. Because the lobbyists for these companies had been meeting and discussing issues, the group had to file paperwork with regulators disclosing that. She described the effort as "early in its development."

While it was founded as a biotechnology company, Cephalon isn't now. Provigil, which treats various sleep disorders, is its biggest-selling drug. Cephalon executives were key to Philadelphia's attracting the big BIO convention in 2005. But Cephalon became a full-fledged member of PhRMA in the last year. This is the first year Cephalon has not been a member of BIO, Williams said. (The company remains a member of Pennsylvania Bio, a statewide organization.)

Interestingly, Cephalon doesn't like, or use, the phrase "specialty pharmaceutical" company. But that's exactly how Endo describes itself. The company focuses on pain management drugs, and its top-selling drug is Lidoderm, a patch that contains lidocaine.

(Thanks to the FiercePharma newsletter for flagging this development.)