A Medical Device Daily

The European Commission has approved Exubera inhaled human insulin for the treatment of adults with Type 1 and Type 2 diabetes. Pfizer (New York) said Exubera, which is the first non-injectable, inhalable form of insulin to be approved since the discovery of insulin in the 1920s, represents a “major advance“ in diabetes treatment.

Exubera is a fast-acting, dry powder formulation of insulin that is inhaled into the lungs via the mouth before meals using a hand-held device that does not require batteries or electricity. The device, which weighs four ounces and is about the size of a carrying case for a pair of eyeglasses, was developed and is manufactured by drug-delivery company Nektar Therapeutics (San Carlos, California).

The drug was developed by Sanofi-Aventis (Le Plessis Robinson, France), while Pfizer took the lead in financing its development. Pfizer recently reached an agreement to acquire Sanofi-Aventis' worldwide rights to Exubera.

In the European Union, Exubera has been approved for the treatment of adults with Type 2 diabetes not adequately controlled with oral antidiabetic agents and requiring insulin therapy, and also is indicated for the treatment of adult patients with Type 1 diabetes for whom the potential benefits of adding inhaled insulin to long- or intermediate-acting injectable insulin outweigh potential safety concerns.

According to the World Health Organization (WHO; Geneva, Switzerland), diabetes affects about 48 million people in Europe alone. The direct healthcare costs associated with diabetes are estimated to be around $286 billion worldwide.

The drug and inhaler system received a recommendation for approval by an FDA advisory panel last September (Medical Device Daily, Sept. 12, 2005), and approval by the agency is anticipated in the near future.

Since its discovery more than 80 years ago, insulin has been the “gold standard“ treatment for the disease, typically in daily or more frequent injections.

Hank McKinnell, Pfizer chairman and CEO, said, “Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease.“

He said the drug is the result of “one of the most rigorous and innovative diabetes development programs ever,“ adding that Pfizer's investment now stands at more than $1 billion. The company has invested in two new manufacturing facilities – the world's largest insulin plant in Frankfurt, Germany, and a high-tech facility in Terre Haute, Indiana – so that the product can reach patients as quickly as possible, McKinnell said.

Exubera's efficacy and safety profile was studied in more than 2,500 adults with Type 1 and Type 2 diabetes for an average duration of 20 months and was shown to be as effective as injectable insulin in achieving glycemic control.

Chantal Mathieu, professor of endocrinology at the University of Leuven in Belgium, said the European approval of the drug “is really good news for physicians and patients.“ She said being able to give insulin without needles “is truly a clinical and scientific milestone“ that will help physicians deal with patients' reluctance to take injections.

Varian to equip new UK oncology center

Varian Medical Systems (Palo Alto, California) said it has been selected to equip a new oncology center scheduled to open in southern England in 2008. As part of an initial $13 million order booked in its fiscal first quarter, Varian will equip the new unit at Oxford Churchill Hospital with six Clinac linear accelerators and a full suite of Varian information management and treatment planning software.

All of the accelerators will allow clinicians to carry out intensity-modulated radiation therapy (IMRT) to enable higher-precision treatments, while two of the machines also will also come equipped with Varian's robotic On-Board Imager device for image-guided radiation therapy (IGRT).

Oxford Churchill Hospital will be among the first centers in the UK to offer IGRT treatments for patients in addition to IMRT.

In addition to the initial installation of six linear accelerators, a full suite of Eclipse treatment planning workstations and Varian information management software, Oxford Churchill also will receive an Acuity imaging system with cone-beam computed tomography capability.

Walter Frei, head of Varian's Oncology Systems business in Europe, said the radiotherapy private financing initiative (PFI) contract is part of a relationship in which Varian has teamed with an Italian firm, Impregilo SpA, to provide such radiotherapy services. “We are delighted to be working closely with Impregilo on a long-term partnership that will bring enormous benefits to cancer sufferers in the UK,“ he added.

Varian has been selected as equipment supplier in several other PFI contracts – including at the Norfolk and Norwich Hospital and the Plymouth Oncology Center – but the company said the Oxford Churchill project is one of the largest of its kind. “This will be a magnificent facility that will help to establish a new standard of cancer care in the UK and we are proud that Varian technology and products will be part of this effort,“ Frei said.

Vickie Holcroft, project director for Oxford Churchill, said, “Varian was chosen to equip the new radiotherapy department because it is one of the technology leaders in this area and it has an excellent reputation for reliability.“

IGRT, which provides the ability to track organ motion and deliver treatments with higher precision, is offered routinely at only a handful of UK hospitals to date. Varian's On-Board Imager device is a digital imaging accessory mounted on the medical linear accelerator, which delivers the radiation treatments.

Varian's IMRT technology is a treatment that allows conforming of the treatment beam to the shape of the tumor, thus improving accuracy while minimizing damage to surrounding healthy tissue.

As part of the PFI arrangement, Varian will be responsible for equipment maintenance and replacements during the lifetime of the agreement. “It's a comprehensive long-term solution for the Trust,“ said Michael Sandhu, Varian's European director of public-private partnerships. “In a time of rapid technological change, these contracts protect against obsolescence so that clinics can continue to offer state-of-the-art medical care.“

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