PHARMACY

Barr second-quarter earnings show impressive jump from year-ago

BY Adam Kraemer

WOODCLIFF LAKE, N.J. Barr Pharmaceuticals posted impressive second-quarter earnings, with generic sales increasing to $487 million, compared with $222 million during the second quarter of last year.

In addition, during the first half of 2007, generic sales increased to $961 million, compared with $423 million during the same period last year. The sales jump was primarily driven by the company’s acquisition of Pliva, as the Croatian drugmaker allowed Barr to sell products outside the U.S., a practice in which it had not previously engaged. Pliva’s generic sales in Europe and elsewhere were $191 million during the second quarter.

U.S. sales numbers increased from $222 million during the second quarter of 2006 to $296 million during the second quarter of this year. The increase was also related to sales of Pliva products, as well as strong generic Actiq (fentanyl citrate) sales, the company said.

In addition, generic oral contraceptives saw $116 million in sales during the second quarter, compared with $107 million during the year-ago period.

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PHARMACY

Esprit pays milestone to Indevus, acquires marketing rights for Sanctura XR

BY Adam Kraemer

EAST BRUNSWICK, N.J. Esprit Pharma announced this week that it has exercised its option to acquire the marketing rights of the recently approved Sancutra XR (trospium chloride extended release capsules).

Esprit paid its development and co-promotion partner, Indevus Pharmaceuticals, the milestone owed it Tuesday, following approval by the Food and Drug Administration. With the payment, Esprit secured rights to market Sancutra XR in the United States and its territories. Indevus announced on Monday, Aug. 6, that Sancutra XR had been approved by the FDA.

Sancutra XR is indicated for the once-daily treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Sancutra XR, the once-daily formulation of Sanctura, is a unique quaternary ammonium compound in a class of anticholinergic compounds known as muscarinic receptor antagonists. OAB is estimated to affect approximately 33 million Americans and represents a significant clinical problem with potential medical, hygienic, and social consequences. When untreated, this condition can lead to disability, dependence, and isolation from the community. It is most prevalent among the elderly and strikes women twice as frequently as men.

“The approval of Sancutra XR sets a new benchmark in the treatment of overactive bladder, further strengthens our flagship brand, and reinforces our commitment to patients who suffer from overactive bladder and the clinicians who treat them.,” stated John Spitznagel, chairman and chief executive officer of Esprit Pharma. “We are extremely excited about bringing this best in class compound to market in the near future.”

Esprit is responsible for the marketing and sales of Sancutra XR and Indevus is a sales co-promotion partner for the product through 2008.

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GSK, Takeda agree to add stronger warnings of heart failure to diabetes drug packaging

BY Adam Kraemer

WASHINGTON Manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, the Food and Drug Administration reported. The information will be included in the form of a “boxed” warning—FDA’s strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.

The FDA determined, following a postmarketing study of the drugs’ adverse effect, that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin) and Duetact (pioglitazone and glimepride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. The FDA had asked the drug’s manufacturers, GlaxoSmithKline and Takeda Pharmaceutical, to address these concerns.

“Under the FDA’s postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information,” said Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “This new boxed warning addresses FDA’s concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure.”

The FDA’s review found cases of significant weight gain and edema—warning signs of heart failure. In some reports, continuation of therapy has even been associated with death.

The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.

The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.

The review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA’s Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks).

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