PHARMACY

Actavis sales jump 57% in Q3

BY Alaric DeArment

DUBLIN — Actavis had sales of $2.01 billion in third quarter 2013, a 57% increase over the same period last year, the drug maker said Tuesday.

Profits for the quarter were $65.5 million, down from $76.7 million in third quarter 2012. The quarter’s results exclude figures from Ireland-based Warner Chilcott, which Actavis acquired at the beginning of the month.

For the company’s generics business, highlights of the quarter include the launch of generic versions of Endo Pharmaceuticals’ painkiller Opana ER (oxymorphone); Endo’s painkiller patch Lidoderm (lidocaine); and the Food and Drug Administration’s approval of a generic version of GlaxoSmithKline’s epilepsy and bipolar disorder treatment Lamictal ODT (lamotrigine).

"Double-digit revenue and earnings growth marked another exceptional quarter for Actavis Inc. as we continue to accelerate our transformation into a global specialty pharmaceutical leader," Actavis chairman and CEO Paul Bisaro said. "Strong global growth in our Actavis Pharma segment was driven by our ability to capitalize on product opportunities from our industry-leading R&D pipeline."

The company’s Actavis Specialty Brands segment, which makes drugs for indications like contraception and bladder problems, also experienced strong sales, Bisaro said.

 

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PHARMACY

Ranbaxy global sales rise in Q3

BY Alaric DeArment

GURGAON, India — Ranbaxy Labs had global sales of $447.6 million in third quarter 2013, compared with $434.6 million in third quarter 2012, the Indian drug maker said Tuesday.

Sales from generics were $208.4 million, while branded and OTC drugs had sales of $239.3 million North American sales were $143.24 million including $128.6 million in the United States, lower than in Q3 2012 due to a large contribution last year from new generic drugs.

"The company continues to grow in its focus branded markets in Asia, East Europe, CIS and Africa," Ranbaxy CEO and managing director Arun Sawhney said. CIS refers to the Commonwealth of Independent States, comprising countries in the former Soviet Union. "In India, however, the announcement of the pricing policy caused some uncertainty in the market, during which our sales in the home market faced some disruptions."

 

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BIO calls for different names for biosimilars, branded biotech drugs

BY Alaric DeArment

NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

Like their pharmaceutical counterparts, branded biotech drugs carry both a brand name and a generic chemical name, such as the autoimmune drug Enbrel, made by Amgen and Pfizer, known generically as etanercept. By law, generic pharmaceutical drugs are chemically identical to branded drugs and use the same generic names, and the companies wishing to make follow-on biologics, or biosimilars, want the same policy for their products.

But biotech companies say that because biosimilars are made from different cell lines from branded biologics, they are only similar rather than identical, and thus their generic names should be different, such as carrying a prefix.

Last week, six senators submitted a letter to Food and Drug Administration commissioner Margaret Hamburg expressing concerns over biosimilar naming, and the Biotechnology Industry Organization, a trade group representing biotech companies — which stand to lose billions in sales when biosimilars begin hitting the market and competing with their products — has said it "strongly opposes" using the same generic names for biosimilars and branded biologics, saying it will lead to confusion.

"Use of the same nonproprietary name suggests something that is not true for biosimilars — that they are the same as the innovator drugs they reference," a recent statement from BIO read. "When ultimately approved by the FDA, biosimilars will be similar to, but not the same as, their respective reference products."

By contrast, generic drug companies and their supporters say biosimilars and branded biologics have used the same generic names in Europe during the six years they have been available there, without any problems.

 

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