GE Healthcare, a unit of General Electric Co., has acquired Wave Biotech LLC, a supplier of disposable manufacturing technologies for the biopharmaceutical industry. The acquisition of Wave Biotech LLC, including its subsidiary Wave Europe Pvt. Ltd., expands GE Healthcare's products and services for the manufacture of biopharmaceuticals such as antibodies and vaccines. Financial terms were not disclosed.

Wave Biotech develops and manufactures bioreactors designed to replace traditional and more expensive stainless steel tanks and piping. Wave Biotech's single use bioreactors are also increasingly being used to enable the manufacture of patient-specific cell and gene therapy products.

Ann O'Hara, general manager of GE Healthcare's BioProcess business, said, "Wave Biotech is an excellent company with a strong track record of innovation and a product range that is highly complementary with our existing BioProcess business. The combination of GE Healthcare and Wave Biotech will allow us to expand into new applications and to create a broad offering of added value tools and services for biopharmaceutical manufacture."

"We are very excited to be part of GE Healthcare, who already offer a broad range of technologies and services to the biopharmaceutical manufacturing industry," said Dr. Vijay Singh, president and founder of Wave Biotech. "Our customers will benefit greatly from the global presence and the R&D resources that GE Healthcare brings to the table. The integration of single-use cell culture with GE Healthcare's existing filtration and downstream operations will provide a host of new disposable solutions to this growing industry."

Patheon plans to restructure its network of six pharmaceutical manufacturing facilities in southern ON, Canada as part of its strategy to focus on developing and manufacturing prescription pharmaceutical products and to improve profitability.

The company plans to divest its Niagara-Burlington Operations business, which is focused on the manufacturing of over-the-counter (OTC) products, with facilities in Fort Erie and Burlington Gateway and the commercial operations at Burlington Century. The sale will include the assets, including equipment, facilities and land. Third-party contracts will be assigned to the purchaser, subject to client approval. It is anticipated that the purchaser will assume responsibility for the commercial manufacturing staff at all three locations. The company plans keep its leased Burlington Century facility where its central quality control lab is based.

To improve capacity and profitability of the remaining Canadian sites, Patheon plans to transfer all commercial production and development services at its York Mills site in Toronto to its site in Whitby, Ontario, and some production to its Mississauga and Cincinnati sites. Following completion of this process, expected to take approximately two years, the company plans to close its York Mills facility and sell the land and building at this location.

"This initiative represents a significant step forward in our strategy to improve the profitability of our business," said Riccardo Trecroce, chief executive officer, Patheon. "Our objective is to focus our resources and capital on the development and manufacture of prescription pharmaceutical products which represent higher-margin revenues, while also improving capacity utilization and operational effectiveness at our sites."

Johnson & Johnson

1Q Revenues: $15 billion (+16%)

1Q Earnings: $2.6 billion (-22%)

Comments: Worldwide Pharmaceutical sales were $6.2 billion in the quarter, up 11%. Sales growth reflects the strong performance of Topamax, Levaquin, and antipsychotic franchise, which includes Risperdal, Risperdal Consta and Invega. Earnings in the quarter reflect an in-process R&D charge of $807 million associated with the acquisition of Conor Medsystems, Inc.

Merck has submitted a sBLA for Gardasil to the FDA to update the labeling to include efficacy data showing protection against additional cervical cancer causing HPV types responsible for more than 10% of cervical cancers, vaginal and vulvar, and data on immune memory.

Gardasil is approved for use in girls and women ages 9 to 26 for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18.

Under the Prescription Drug User Fee Act (PDUFA), for standard supplemental BLAs filed in 2007, the FDA's goal is to review and act on 90% of BLAs within 10 months of receipt.

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