PHARMACY

Savient announces executive appointments

BY Allison Cerra

EAST BRUNSWICK, N.J. — Savient Pharmaceuticals announced changes to its management team as it gears up for the commercial launch of its chronic gout treatment.

The drug maker appointed Louis Ferrari as its SVP corporate development, Christine Mikail as SVP and Stephen Davies as chief information officer and group VP.

Savient said the new additions to its executive team will strengthen the company as it globally launches Krystexxa (pegloticase), which received regulatory approval from the Food and Drug Administration last September as a chronic gout treatment for adult patients refractory to conventional therapy.

Louis Ferrari, a pharmaceutical industry veteran, joins Savient from Centocor Ortho Biotech, where he served as VP oncology and nephrology, sales and marketing, responsible for sales of Procrit and Doxil. At Savient, he will be responsible for all commercial activities in North America.

Christine Mikail, who served as VP, general counsel and secretary for ImClone Systems, will be responsible for all of Savient’s business development activities and strategic planning, including the initiative to launch Krystexxa globally.

Stephen Davies served as VP information technology at ImClone Systems before joining Savient, where he was responsible for developing an IT approach to enable international expansion and improved infrastructure security. In his role at Savient, Davies will be responsible for building all global information systems support for the Krystexxa launch.

All three executives will report to Savient CEO John Johnson, who recently joined the company from Eli Lilly, where he was president of its oncology unit.

"We are pleased to welcome Louis, Christine and Stephen to Savient," Johnson said. "This is an exciting time for Savient, and these are three key additions that will help make for a successful commercial launch of Krystexxa. Today’s appointments will augment our already strong team of talented executives and employees, all of whom are committed to bringing this life-changing therapy to adult patients suffering from chronic gout refractory to conventional therapy. I look forward to working closely with Louis, Christine and Stephen and the entire Savient team as we embark on this next phase in Savient’s history."

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PHARMACY

APhA encourages consumers to consult pharmacists about heart health

BY Alaric DeArment

WASHINGTON — February is American Heart Month, and a professional group representing the country’s pharmacists is using that as an opportunity to encourage the public to learn how to prevent heart disease from the most easily accessible members of the healthcare system.

The American Pharmacists Association said people should talk to their pharmacists about available screening and consultative services that could prevent and detect health problems usually associated with heart disease. Heart disease is the leading cause of death in the United States, and is a major cause of disability, with an estimated 785,000 having first-time heart attacks, and 470,000 having recurrent attacks in 2010, according to the American Heart Association.

Services that pharmacists often offer include blood-pressure screenings; cholesterol screenings; basal metabolism index screenings; blood-glucose testing; tobacco-cessation counseling; and counseling on diet, exercise and healthy living, the APhA noted.

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Report: Exclusivity period for biotech drugs may be reduced to seven years

BY Alaric DeArment

WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.

The administration originally supported a seven-year exclusivity period while the biosimilars provision still was under debate in Congress, though the final version of the healthcare bill that President Obama signed into law allowed for 12 years. The 12-year period was favored by branded drug and biotech companies, while the generic drug industry wanted an exclusivity period of five years, as pharmaceutical drugs have.

The data exclusivity period is the amount of time the Food and Drug Administration must wait after approving the branded version of a drug before it can accept an application for a generic or biosimilar version.

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