PHARMACY

Amgen to reduce expenditures by $1.9 billion and cut staff by 12-14 percent

BY Adam Kraemer

THOUSAND OAKS, Calif. Amgen today announced initiatives that will reduce company staff by 12-14 percent and deliver other operational efficiencies while ensuring continued investment at industry-leading levels in research and development, the company reported.

These initiatives will be substantially completed by 2008 and yield pre-tax savings from prior plan of between $1.0 billion—$1.3 billion in 2008. Cumulative pre-tax restructuring charges associated with these changes are expected to be $600 million—$700 million in 2007 and 2008, which includes $289 million for asset impairment and related costs reported in the second quarter. The company also announced that adjusted earnings per share guidance for 2007 has been changed from $4.28 to a range of $4.13—$4.23, excluding restructuring charges, due to lower Aranesp revenues.

Amgen pointed to the lower revenues from Aranesp and Epogen— due to Food and Drug Administration changes in approved labeling—as a reason for the changes. “At Amgen we have always been committed to investing in the future while squarely facing the challenges of today,” said Kevin Sharer, Amgen’s chairman and chief executive officer. “Recent changes in coverage rules and adjustments to Amgen’s FDA approved labels for Epogen and Aranesp have and will adversely affect Amgen’s revenue. The initiatives announced today respond to that new reality by taking account of reduced revenues and appropriately lowering costs across the company. We will continue to strongly support our research efforts directed at development of new medicines for grievously ill patients. These changes will also position Amgen for success in 2008 and beyond.”

Plans announced by the company to improve its cost structure include:

  • Reducing headcount by 12-14 percent, or approximately 2,200-2,600 staff
  • Reducing planned capital expenditures by approximately $1.9 billion during the period 2007-2008, with a resulting improvement in cash flow
  • Closing certain production operations and rationalizing other facilities to achieve improved efficiencies
  • Making choices about the highest priorities in research and development and operations that build the framework for future growth.

Amgen stated that it plans to minimize the impact of the targeted reduction in force on our people through the use of attrition, hiring freezes and a voluntary transition program. Amgen staff adversely affected by these initiatives will receive career counseling assistance in securing new employment, the company said.

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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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