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MERCK'S GILMARTIN RESIGNS AS CEO, REPLACED BY INSIDER CLARK

Merck & Co. Inc. revealed Thursday that Raymond Gilmartin, chairman, president, chief executive officer and a director of the company, resigned. Merck's board of directors elected Richard Clark, currently president of Merck's manufacturing division, to replace Gilmartin as the new president and CEO. Clark will serve as a member of the board.

"As CEO, my priorities are clear--meeting the needs of patients and building shareholder value," said Clark, who previously served as chairman and CEO of Medco Health Solutions Inc.

Merck's corporate regulations required Gilmartin to retire by age 65, which would have been in March of 2006.

Although Gilmartin's retirement is premature, Lawrence Bossidy, chairman of Merck's newly created executive committee, said in a media conference call that "in no way" did the board push Gilmartin out. Bossidy and Gilmartin said the directors decided to make the transition as soon as they found a replacement, according to a report in The Wall Street Journal.

The Journal added that Gilmartin thought "getting out of the way" would be best once a new CEO was appointed.

Merck's board has not yet named a new chairman. The company's new executive committee, which Merck anticipates keeping in place for a year or two, will "provide support and continuity as [Clark] assumes his new duties," Merck said. Gilmartin will serve as special advisor to the executive committee until his retirement in March.

After Merck's withdrawal of Vioxx (rofecoxib) last fall, rumors began to circulate that Merck might choose a new CEO from the outside, The Journal reported.

"The more we looked, the more convinced we became that the ideal candidate would be familiar and experienced with the industry and Merck," said Bossidy, chairman of Merck's compensation and benefits committee, which named Gilmartin's successor. "We have found that candidate in Dick Clark."

Analysts seem to have mixed feelings regarding the decision.

"I think highly of Clark," Deutsche Bank's Barbara Ryan told Reuters, "but he's basically a consolation prize because Wall Street wanted new blood, and he's a Merck insider."

Separately, Reuters reported that Merck's vice president for regulatory development, Dennis Erb, told the House Government Reform Committee that the company has not yet decided if it will attempt to bring Vioxx back to the market.

"We are in preliminary discussions with (the) FDA on what information they would like to see," he said. Merck shares closed at $34.75, down $0.18, or 0.5 percent, in moderate trading on the New York Stock Exchange.

GSK'S REQUIP APPROVED FOR TREATMENT OF RESTLESS LEGS SYNDROME

GlaxoSmithKline Plc received approval from the Food and Drug Administration for Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe primary restless legs syndrome (RLS) in adults. Requip is the first treatment to be approved for the chronic neurological condition, the company said.

The drug is a second-generation dopamine agonist that stimulates dopamine receptors in the brain to relieve the symptoms of RLS, which include "creeping-crawling, tingling, pulling or tightening" sensations in the legs that can disrupt sleep and daily activities, GSK said. Dopamine affects the nerve cells that control body movement.

The approval was supported by data from four clinical trials. In a recent U.S. clinical trial of the drug, patients treated with Requip reported significantly improved symptoms of moderate to severe primary RLS from baseline to week 12.

"Requip targets what doctors believe may be an underlying cause of the disorder, which is dysfunction of a system involving the brain chemical dopamine," said Dr. William Ondo, associate professor of neurology at Baylor College of Medicine, adding that approval of Requip "should help to validate this under-recognized and misunderstood condition."

FDA PANEL VOTES AGAINST ACCELERATED APPROVAL FOR J&J'S ZARNESTRA FOR THE TREATMENT OF AML

The Food and Drug Administration's Oncologic Drugs Advisory Committee voted against recommending accelerated approval of Johnson & Johnson's Zarnestra (tipifarnib), a drug aimed at treating newly diagnosed, poor-risk acute myeloid leukemia (AML) in patients aged 65 years or older, Dow Jones Newswires reported.

The panel voted 7-4 against accelerated approval, according to the report, because the drug appeared to help only a small number of patients.

Investigators of the study used to support the drug's proposed indication found a "complete response rate of 15 percent," according to advisory panel briefing documents posted on the FDA's Web site. A complete response means cancer was no longer detectable in the patient.

The FDA, however, found only an 11.1 percent complete response rate based on an assessment of the study results by independent reviewers; the reviewers were selected by the trial's sponsor. J&J considered 120 of the trial patients to be complete responders, but FDA briefing documents state that only 115 were confirmed as complete responders.

"I do think this drug does something to some people," said Silvana Martino, chief of the breast cancer section at the Cancer Institute Medical Group in Santa Monica, Calif., and chair of the advisory committee to the FDA. "But 85 percent to 90 percent of the time this ain't going to work," Martino, who voted against approval, told Dow Jones.

The Dow Jones report said some panel members expressed concern that if Zarnestra were to receive accelerated approval, it could remain on the market even if it later proves to be ineffective.

The report added that some members of the panel thought patients who responded to Zarnestra might have been good candidates for chemotherapy, which according to the FDA, offers complete response rates of approximately 30 percent to 50 percent.

Kate Purcell, senior director of J&J's global pharmaceutical communications, told Dow Jones the company was "obviously disappointed in the vote," but J&J plans to continue its discussions with the FDA and will proceed with a Phase III trial of Zarnestra. Results from the trial should be available in 2007.

The FDA typically follows the advice of its expert panels but is not required to do so.

CANGENE'S VACCINIA IMMUNE GLOBULIN APPROVED FOR TREATING, PREVENTING ADVERSE REACTIONS TO SMALLPOX VACCINE

Canadian biotechnology company Cangene Corp. received approval from the Food and Drug Administration for its Vaccinia immune globulin (VIG), which is to be used in the treatment and prevention of severe adverse reactions associated with the smallpox vaccine.

VIG is a highly purified specialty antibody made from human plasma, also known as a hyperimmune. The drug was developed under a contract with the Centers for Disease Control and Prevention as part of the U.S. government's smallpox vaccination program.

"An FDA approval is always a significant milestone, and this is the first of our biodefense products to receive licensure," said Dr. John Langstaff, Cangene's chief executive officer. "We committed to taking VIG through to licensure when we undertook the CDC contract," he added, "and this approval should also strengthen our international marketing efforts for this drug."

ALPHARMA'S KADIAN 200 MG DEEMED APPROVABLE BY FDA FOR TREATING CHRONIC PAIN

Alpharma Inc. said the 200 mg dosage of Kadian (morphine sulfate sustained-release), a treatment for chronic pain, was deemed approvable by the Food and Drug Administration.

Currently, Kadian is approved in 20 mg, 30 mg, 50 mg, 60 mg and 100 mg dosages. The company plans to launch the 200 mg capsules upon receiving final FDA approval.

"Kadian already has a significant advantage over competitive products as a result of the dosing flexibility it offers physicians and their patients and is the only brand in its category that can be dosed either once or twice daily," said Ronald Warner, Ph.D, president of the company's branded products division.

Last July, Alpharma entered into a three-year agreement with MGI Pharma Inc. to promote Kadian to oncology health care professionals as a treatment for moderate to severe cancer-related pain.

GLOBAL RETAIL PHARMACY DRUG SALES RISE 6 PERCENT IN 12-MONTH PERIOD ENDED FEBRUARY 2005, ACCORDING TO IMS HEALTH

Drug sales through retail pharmacies in 13 key global markets rose 6 percent at a constant exchange rate to $351.61 billion from March 2004 to February 2005, the IMS Drug Monitor reported.

For the 12 months ended February 2004, retail pharmacy drug sales totaled $321.26 billion.

U.S. and Canadian sales grew 8 percent to $186.9 billion during the 12 months ending with February 2005, led by $43.14 billion in sales of central nervous system drugs. Another key therapeutic growth area for this region was cardiovascular drugs, for which sales increased 12 percent to $34.86 billion. In the United States, total sales reached $176.61 billion, representing an 8 percent increase from the prior year.

Sales growth in the top five European markets, the top three Latin American markets and Japan was 5 percent, 13 percent and 2 percent, respectively.

Overall, cardiovascular drug sales reached $68.92 billion, while drugs in the central nervous system therapeutic category showed sales of $65.44 billion. Drug sales in the parasitology category demonstrated the largest growth at 13 percent.

Pfizer Inc.'s cholesterol-lowering drug, Lipitor (atorvastatin calcium), continued to be the highest seller, showing a 14.3 percent growth and valued at more than $10.75 billion. Bristol-Myers Squibb Co. and sanofi-aventis Group's thrombosis drug, Plavix (clopidogrel bisulfate), sales again showed the most growth at 29 percent.

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CEPHALON INC.

Cephalon Inc. said data from a double-blind, placebo-controlled, variable-dose Phase III trial of its cancer pain treatment, OraVescent fentanyl, showed the drug to be significantly effective in controlling breakthrough cancer pain in 123 patients already receiving constant pain-controlling medication. OraVescent fentanyl is a tablet that uses an enhanced absorption transmucosal drug delivery technology. "We are on track to complete the long-term safety portion of the OraVescent fentanyl program by mid-year and submit a New Drug Application to the U.S. Food and Drug Administration in the third quarter," said Dr. Paul Blake, an executive vice president at Cephalon.

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CELLEGY PHARMACEUTICALS INC.

Cellegy Pharmaceuticals Inc. received notification from the Food and Drug Administration that the agency is reviewing its recently amended New Drug Application for Cellegesic (nitroglycerin) 0.4% ointment as a potential treatment for pain associated with chronic anal fissures. The FDA's target date for completing the review is June 15. Cellegy first submitted a New Drug Application for Cellegesic in June of 2004 and received a not approvable letter in December. The company submitted new data analyses to the FDA in April, which according to Cellegy, have been accepted as a "complete, Class 1" response to the not approvable letter.

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CYTRX CORP.

CytRx Corp.'s lead small molecule drug candidate, arimoclomol, was granted orphan drug status from the Food and Drug Administration for the treatment of amyotrophic lateral sclerosis, or Lou Gehrig's disease. CytRx plans to file an Investigational New Drug application for arimoclomol this month and expects to begin a Phase II clinical trial for the drug this quarter.

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MCKESSON CORP.

McKesson Corp. reported net income of $259 million, or $0.85 per diluted share, for the fiscal 2005 fourth quarter ended March 31. In the same period last year, the company's net income was $214.2 million, or $0.73 per diluted share. Revenue for the quarter increased 15 percent, from $17.94 billion in last year's fourth quarter to $20.61 billion this year. McKesson attributed the increase in its results to a strong performance by its pharmaceutical solutions division.