NEWS OF THE WEEK
GILEAD PLACES A HUGE BET PHARMACEUTICALS: Firm will spend $11 billion to nab a precommercial hepatitis C drug
G
O O
ILEAD SCIENCES is making a big wager on
the hepatitis C market, agreeing to pay roughly $11 billion for Pharmasset, a New Jersey-based firm with only 82 employees and no products on the market. What Pharmasset does have is PSI-7977, a uracil nucleotide analog that recently began Phase III clinical studies as a treatment for people O with the hepatitis C virus (HCV). If the compound is approved in 2014, NH as Gilead hopes, it will be part of the O N O first all-oral treatment for HCV. O N P O The acquisition, set to be comH pleted early in 2012, is the third big deO velopment in the HCV market this year. In HO F mid-May, the Food & Drug Administration approved a new HCV treatment from Merck & Co. Later that month, the agency okayed one from Vertex Pharmaceuticals. PSI-7977
REWRITING TOXIC SUBSTANCES LAW COURTESY OF SEN. CARDIN
CONGRESS: Senators ask industry
group to stop complaining and get specific about bill
S
ACC
Cardin
Dooley
ENATORS WANT the industry group American
Chemistry Council (ACC) to quit griping about legislation to reform the nation’s chemical control law and cough up details of what it wants in the bill. “Be straight with us,” said Sen. Benjamin L. Cardin (D-Md.) at a Nov. 17 hearing on S. 847, the proposed Safe Chemicals Act of 2011. The bill would modernize the 35-year-old Toxic Substances Control Act (TSCA). “If your objective is to defeat this legislation, I understand,” Cardin told Calvin M. Dooley, president and chief executive officer of ACC. Dooley was among witnesses at the hearing held by the Senate Environment & Public Works Subcommittee on Superfund, Toxics & Environmental Health. Without buy-in from ACC, the bill likely would not attract enough political support for Congress to pass it. At the hearing, some Democrats scolded ACC for WWW.CEN-ONLINE.ORG
8
The newly approved compounds still need to be taken with PEGylated interferon and ribavirin, the traditional standards of HCV care. Interferon is an injectable drug associated with fatigue, bone marrow suppression, and anemia. Ribavirin is a generic antiviral that must be taken twice daily as five or six pills. PSI7977 would be administered only with ribavirin. On a conference call, Gilead President John F. Milligan told stock analysts that the firm’s long-term goal is a single-pill HCV treatment. Gilead, which currently specializes in HIV drug combinations, plans to combine PSI-7977 with one or more of its own HCV molecules, seven of which are in earlier stages of clinical development. The firm is aiming at an HCV drug market that the investment firm Leerink Swann estimates will reach $4.1 billion in 2017 and $6.5 billion at its peak in 2020. The market is considered underserved today because many patients are reluctant to begin the current onerous treatment regimen. During the call, many analysts congratulated Milligan and other Gilead executives for the logic of their deal. But Joshua Schimmer, a Leerink Swann analyst, was less enthusiastic. “While we understand the strategic rationale, the price tag is lofty for a precommercial asset,” he told clients in a research brief. He noted that Gilead’s earlier commitment to smaller deals and a stock repurchase “seems to have gone out the window.”—MICHAEL MCCOY
criticizing parts of the bill without offering specific alternatives. ACC, which offered broad principles for TSCA reform two years ago, has said S. 847 has a number of fundamental flaws. “If you don’t like it, be more specific,” said Sen. Frank R. Lautenberg (D-N.J.), chairman of the subcommittee and sponsor of S. 847. Sen. Sheldon Whitehouse (D-R.I.) requested that Dooley provide a rewrite of S. 847—including detailed alternatives to the parts of the bill ACC finds unworkable—by the end of 2011. Dooley responded that ACC has met with Democratic staff members on the subcommittee to present the association’s views, which are not reflected in S. 847. He said ACC and others concerned with the legislation, including environmental and health activists and state regulators, “have fundamental disagreement” on what TSCA reform should include. Dooley said it would take “a significant period of time to resolve these complex issues.” “We’ve got to get this moving,” Cardin stated. “We need your help.” Lautenberg said he will call a vote on the bill in coming weeks or months. The hearing followed a series of private meetings that Lautenberg and Sen. James M. Inhofe of Oklahoma, the top Republican on the Environment & Public Works Committee, have jointly held with industry, activists, and states on how to reform TSCA.—CHERYL HOGUE
NOV E M BE R 2 8, 20 1 1
