Medical device giant Boston Scientific (BSX) said it would eliminate as many as 1,300 jobs or 10 percent of its workforce as part of a series of restructuring initiatives and management changes it says will drive profitable growth for the company. As part of these changes, the Natick, Massachusetts-based company says it will eliminate its international headquarters. The presidents of Japan, Europe (including a consolidated Shared Services team) and the newly formed Emerging Markets Group will report directly to the CEO. Among other changes the company said the Cardiovascular Group and Cardiac Rhythm Management Group (formerly Guidant) will be combined into one. The company says it plans to further rationalize and refocus its business portfolio through both select divestitures and acquisitions in direct support of new strategic priorities. As a result of the restructuring, Boston Scientific expects to take pre-tax charges of approximately $180 million to $200 million. Gross expenses are expected to be reduced by a range of $200 million to $250 million from the 2009 base during the next two years, representing a reduction of 5.5 to 7 percent.
Strativa Pharmaceuticals said that the U.S. Food and Drug Administration notified the company it could not yet act on its application to begin marketing Zuplenz (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy and surgery. The company said that because of an agency-wide restriction on foreign travel in India, the FDA has been unable to perform an inspection of the clinical and analytical sites for a bioequivalence study, and therefore, cannot approve the application at this time. The FDA told the company it would schedule and perform an inspection of the sites as soon as possible.
OxiGene (OXGN) said it will eliminate 20 employees or about half its workforce as part of a restructuring designed to focus resources on the company's highest-value clinical assets and reduce its cash burn. The company will continue to advance its mid-stage trial of Zybrestat in non-small cell lung cancer. It expects to present results at the American Society of Clinical Oncology or ASCO meeting in June 2010. OxiGene also plans to stop further enrollment in the phase 2/3 clinical trial in anaplastic thyroid cancer, but will continue to treat and follow all patients who are currently enrolled. A survival analysis is anticipated in early 2011. The company said this will allow it to gain insight into the experimental drug’s antitumor activity earlier than previously expected while reducing spending. The mid-stage trial of Zybrestat in polypoidal choroidal vasculopathy, a form of macular degeneration, will continue with an interim analysis expected in the first half of 2010.
Cadence Pharmaceuticals (CADX) said that the U.S. Food and Drug Administration said it would not approve its application to begin marketing the company’s intravenous form of acetaminophen because of deficiencies the agency identified during a visit to the third party manufacturer producing the drug. The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval. Cadence said the third party manufacturer intends to respond promptly to the observations, and Cadence plans to request a meeting with the FDA to ensure that the deficiencies have been adequately addressed to meet the requirements for approval of its application.
The Medicines Company (MDCO) in a filing with the U. S. Securities and Exchange Commission said it is eliminating 43 employees or about 26 percent of its workforce. The cuts are being made in what the company characterized as field-based functions and said it would better align the company’s costs and structure for the future. The company expects to record a one-time charge of approximately $3.5 million associated with the employee severance arrangements, which will be recognized in the first quarter of 2010. The company expects to realize estimated annualized cost savings from the workforce reduction in the range of $8 million to $9 million starting in the first quarter of 2010.