A Medical Device Daily

Sorin Group (Milan, Italy), a leader in cardiac surgery solutions, has received clearance from the FDA to manufacture mechanical heart valves that are marketesd by its CarboMedics (Austin, Texas) unit in the company's manufacturing facility in Vercelli, Italy, in the Saluggia region.

The inspection performed by FDA representatives on the Sorin Group's Heart Valves Business represented what it termed “a fundamental step in the industrial integration and consolidation process of the group.”

While the production of mechanical cardiac valves has been consolidated in one manufacturing facility in Saluggia, the company's facility in Austin will continue to serve as the assembly location of finished products for the North American market.

Sorin said this production shift would enable it to benefit from economies of scale and exploit the technological know-how developed through the work carried out in Saluggia over several decades. “Since 1977, hundreds of thousands of mechanical valves have been manufactured at Saluggia, and have been implanted in more than 70 countries without any structural malfunction,” the company said.

Franco Vallana, president of the Cardiac Surgery Business Unit, said the benefits that this integration effort is expected to produce include greater operational flexibility in managing brands and product lines, enabling the company to respond to any shifts in market demand; economies of scale and reduction of manufacturing costs; and greater integration between the manufacturing and R&D organizations.

Drago Cerchiari, Sorin's CEO, said, “This production relocation will result in a strategic reinforcement of the overall cardiac valves area, which will benefit from the world's greatest concentration of medical technology resources and product-specific know-how.”

Sorin Group has about 4,800 employees working at facilities in more than 80 countries throughout the world.

Orthopedic biomaterials sector seen growing

In a new report, Frost & Sullivan (F&S; London) has cited changing demographics and lifestyle habits as trends that are driving demand for orthopedic biomaterials across Europe.

The global consulting company said a rapidly aging population, together with improved longevity, are having a direct impact on the number of musculoskeletal diseases, while at the same time, changing lifestyle habits such as smoking and poor nutrition are increasing the incidence of typically age-related diseases such as osteopororis and osteoarthritis among the younger population.

Frost & Sullivan says that the European orthopedic biomaterials market earned $240 million in 2005 and estimates that it will reach $609 million by 2012.

“The use of biomaterials has shown considerable clinical advantages and has been found to be particularly useful in a range of orthopedic applications, including synthetic bone grafts, degradable fixation and bone fillers,” said F&S Research Analyst Eleni Grammenou. “Orthopedic biomaterials also have been found particularly useful in craniomaxillofacial applications.”

She noted, however, that the anticipated increase for orthopedic braces and supports would be challenged by cost-containment strategies being implemented by European governments. These reforms are not only affecting reimbursement levels, but also are transforming the market dynamics and competitive landscape for such biomaterials, Grammenou wrote.

“Across Europe, hospitals are being continuously faced with cost-containment issues that are, in turn, affecting purchasing trends in the orthopedic braces and supports market,” she said. “In many cases, hospitals are considering re-use [of] braces and support devices in an attempt to curb expenditures — a trend that will curb revenues for the industry.”

To sustain market growth and leadership within this industry, manufacturers will need to invest heavily in research and development. The nature of the industry also will lead to a number of acquisitions, continuing the consolidation of the market.

Grammenou said smaller companies will find it “ever harder to ensure their competitive survival.”

UK operation closed by Nektar

Nektar Therapeutics (San Carlos, California) said it has closed the Nektar UK (Bradford, UK) site as part of its ongoing strategy to realign business operations.

The company had reported its intent to dispose of the UK operation and its supercritical fluid technology during a 1Q06 financial results conference call on May 10.

“As Nektar transitions from being a technology development company to a commercial entity focused on achieving profitability, it is important that we channel our resources into those businesses that will drive future growth,” said Robert Chess, chairman and acting president/CEO. “To this end, disposing of our supercritical fluid processing technology represents a significant first step in aligning our spending with those activities that will drive our revenue in the near term.”

Among those activities, he cited developing proprietary products based on the company's drug-delivery technology; Exubera inhalable insulin, the product of a developmental collaboration between Pfizer (New York) and Nektar, along with other diabetes lifecycle management products; and high-value partner programs.

Nektar UK, which had about 35 employees, was closed as of June 30, save for a small staff that will remain for a short transition period.

“We still believe that supercritical fluid processing is a promising technology to manufacture powdered drugs,” said Chess. “However, we do not believe this technology would enable products Nektar could develop itself and consequently it is not a fit for our strategy.”

He said the company would continue to seek a buyer for the intellectual property and other assets involved with supercritical fluid technology, which uses a particle engineering process that yields consistent powder particles in terms of size, shape and morphology that can be incorporated into a number of dosage forms, including tablets, capsules and inhalation systems.

Nektar said the technology may serve as a platform technology for a diverse range of applications, including such uses as taste masking and selection of stable solid-state forms that can affect both the rate and extent of absorption of certain drugs.