PHARMACY

Perrigo sees impressive sales, expects more in the near future

BY Allison Cerra

ALLEGAN, Mich. It seems that Perrigo Corp. is becoming a force to be reckoned with. By March, the company expects to market and distribute omeprazole, the generic form of Prilosec OTC, in the U.S. Dexcel Pharma Technologies in Israel, the company said, will manufacture the drug.

Although a patent litigation had occurred between the Dexcel and Prilosec’s maker AstraZeneca, Perrigo announced Thursday that the suit was settled. The generic drug first must win approval from the Food and Drug Administration. Prilosec sales are reportedly in the $750 million range.

Meanwhile, the company posted record-breaking sales and profits for its first quarter ended Sept. 29 and boosted its forecast for the balance of its fiscal year. Sales were up 12 percent from a year ago, to $382.7 million. Profits more than doubled, to $34.1 million compared with $16.9 million for the same period last year.

The company’s success caused it to increase its earnings-per-share forecast to $1.12 to $1.22 for 2008, up 26 to 37 percent over last year.

The move clears the way for a product that could bring $150 million to $200 million in sales next year.

“This is the largest opportunity in the 120-year history of Perrigo,” said chief executive officer Joseph Papa. “Perrigo will commercialize this product exclusively and save consumers up to $150 million per year.”

Perrigo, however, is already seeing green elsewhere.

The company has been gaining customers from its competitor, Leiner Health Products. Sales to former Leiner customers totaled $20 million. The expectation for the year is up to $100 million in sales.

“We’ve worked very hard to go out and rescue their customers,” Papa said.

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AVI gets fast-track status from FDA for DMD drug candidate

BY Adam Kraemer

WASHINGTON The Food and Drug Administration has granted fast-track status to drug developer AVI Biopharma’s product candidate for Duchenne muscular dystrophy, a fatal genetic disorder in children, the Associated Press reported.

Duchenne muscular dystrophy is an incurable muscle-wasting disease, caused by a mutation in a person’s dystrophin gene. The result is membrane leakage and fiber damage, leading to degeneration and death of the muscle fiber. About one in 3,500 boys is born with it, and roughly 15,000 to 20,000 children have DMD in the U.S., according to AVI.

The status means a company can submit data to the FDA as it becomes available and receive agency feedback, rather than having to wait and turn it in all at once. AVI plans to initiate a clinical trial with its drug candidate by mid-2008 to evaluate the safety and effectiveness of the drug in DMD patients who can still walk on their own.

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FDA investigation suggests online drug sales driven by lax prescription rules

BY Allison Cerra

WASHINGTON A yearlong Food and Drug Administration investigation has found that consumers may be purchasing drugs online to avoid the need for a prescription from their physician.

Although several drugs are mailed to the United States from foreign countries more often than not, the FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.

The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Among the remaining products were dietary supplements, foreign products with “incomprehensible labeling”, and some were medications not available in the United States.

The FDA stressed the risk of purchasing drugs online, as they may be a front for an illegal operation. Unregulated Internet drug sellers, they said, might have products which might not contain the correct ingredients and could contain toxic substances.

“The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription,” said Randall Lutter, FDA’s deputy commissioner for policy. “In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice.”

Meanwhile, more than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. Approved generic versions of nearly half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.

These data are based on surveys conducted from September 2006 to August 2007 in international mail facilities and courier facilities across the country. At each city, all parcels suspected by customs and border patrol of containing pharmaceuticals were stopped for a period of 24 hours. The FDA then recorded data on the contents of these packages, before handling them in accordance with its usual procedures.

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