Acusphere (Watertown, Massachusetts) said last month that it has entered into a collaboration, license and supply agreement with Nycomed (Roskilde, Denmark) for the European development and marketing rights to Acusphere's lead product candidate, AI-700, an ultrasound contrast agent currently in Phase III clinical trials for assessing myocardial perfusion in the diagnosis of coronary heart disease. As part of the agreement, Nycomed will provide $70 million in license fees, research and development funding, and milestone payments, including $12 million in payments over the first two years. These payments include $4 million in up-front license fees and $8 million in R&D funding payable in eight equal quarterly installments.
An additional $58 million in milestone payments are related to regulatory approvals and achievement of certain sales goals. In addition, Acusphere will be paid to manufacture the product for Nycomed and will receive royalties on Nycomed's sales of AI-700. Nycomed will be responsible for sales, marketing and the regulatory submissions required for marketing throughout its sales territory, which includes the member states of the European Union, as well as Russia/CIS and Turkey.
"Nycomed is an excellent partner to develop and market AI-700 throughout Europe," said Sherri Oberg, president and chief executive officer of Acusphere. "[It] brings a long, successful heritage in building close relations with healthcare professionals throughout the European hospital-specialist sector. Nycomed has sales forces in 19 European countries and its strategy to focus its marketing and sales activities almost exclusively in Europe is highly compatible with our commercial strategy in the U.S, where we plan to build our own marketing and sales capability for AI-700."
Hakan Bjorklund, Nycomed chief executive officer, said, "We are enthusiastic about the potential market opportunity for AI-700 in Europe and are impressed with the clinical results to date. AI-700 is an excellent match with our cardiovascular product focus." He noted that with "the successful in-licensing of Angiox (bivalirudin), a thrombin-specific anticoagulant for percutaneous coronary intervention, which is scheduled for pan-European launch later this year, we are already in the process of developing and training a hospital specialist sales force that will call on our customer base of cardiologists in Europe." He cited AI-700's "great potential to improve the diagnosis and management of coronary heart disease," and said Nycomed is "looking forward to supporting the MAA filing in the first half of 2006, consistent with Acusphere's planned filing date [in the U.S.]."
The companies said ultrasound is the only frequently used imaging technique without a commercially significant imaging agent. AI-700 is designed to work with ultrasound in the assessment of myocardial perfusion, a sensitive marker of coronary heart disease. In 2002, an estimated 9.5 million procedures were performed in the U.S. and 1.5 million to 2 million procedures in Europe to screen patients with suspected coronary heart disease, primarily using nuclear imaging. AI-700-enhanced ultrasound is being developed as a cost-effective and convenient alternative to nuclear imaging.
Sorin Group launches InPeria trial
Sorin Group (Milan, Italy), Europe's largest cardiovascular device group, reported that the first patient in the InPeria International randomized study has been enrolled. The goal of the Inperia study is to compare the clinical benefit of the Inperia Carbostent vs. patients treated with percutaneous transluminal angioplasty. Produced by Sorin, the InPeria Carbostent is the only stent available today that has been approved for endovascular procedures in below-the-knee arteries, Sorin said.
The initial procedure was performed last month by Denis Rossato, MD, at Molinette Hospital (Turin). The study will include more than 120 patients and is the first such trial in Europe, according to Sorin. It will be conducted in six different hospitals located in Madrid and Tenerife Spain; Wien in Austria; Leipzig in Germany; and Turin and Brescia in Italy.
"InPeria is a milestone in the peripheral vascular development strategy of the Sorin Group; we can match the highly performing Carbostent technology developed by Sorin and the growing opportunity in vascular disease," said Drago Cerchiari, chief executive officer.
The development of the InPeria peripheral stent was challenging, given the flow conditions and the small size of the target vessels, Sorin said. It was made possible by technology pioneered in its stent production and the use of Carbofilm, an ultra-thin film (a few tenths of a micron). The film is made of carbon atoms that impart to the coated surfaces of prostheses the bio- and hemocompatibility properties of pyrolitic carbon. These properties were confirmed by a program of in vivo tests involving vascular prostheses and peritoneal, bladder, bone and dental implants. Sorin said that Pyrolitic carbon, which has been used with success to coat coronary stents, "eliminates the risk of thrombosis, while reducing restenosis and tissue inflammation."
Greg Cash, president of vascular therapy and new businesses for the Sorin Group, said, "InPeria is targeted at patients affected by many problems and the first results are quite encouraging." He said that use of the InPeria stent in the treatment of infrapopliteal occlusions produced better results than traditional treatment methods in improving the conditions of the lower limbs.
The Sorin Group, a leading developer of medical technologies for cardiac surgery, offers therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney disease. Its companies include Dideco, CarboMedics, COBE Cardiovascular, St ckert, Mitroflow, ELA Medical, Sorin, Sorin Biomedica, Bellco and Soludia.
Eucomed argues on electric hazard rule
In its response to the public consultation on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS), submitted last month, the European Medical Technology Industry Association (Eucomed; Brussels) has issued a statement arguing that medical technology should continue to be exempted from the scope of the RoHS Directive. Eucomed stressed that the priority should be to ensure that medical devices and equipment are reliable and safe, both for patients and healthcare professionals. The introduction of new medical technology excluding all the hazardous substances identified by the European Commission in RoHS, the association said, would "at the very least, require five years."
Maurice Wagner, director general of Eucomed, said, "We fully support the aims and objectives of this directive and are keen that medical technology is seen to be environmentally friendly. But our absolute priority must remain to guarantee the quality and safety of patient care." Eucomed said, "Because of their importance in terms of public health and patient and user safety, medical devices and equipment should be allowed sufficient time for reliable data to become available from which informed assessments can be made, before switching to new materials or manufacturing processes."
Agreement on coated-stent antibodies
BioInvent International AB (Lund, Sweden) entered into an agreement with Orbus Medical Technologies (Fort Lauderdale, Florida) to supply cGMP-quality antibodies that will be incorporated into coated stents undergoing clinical evaluation. The device, which is expected to undergo commercialization in 2005, is designed to prevent thrombosis and to reduce the occurrence of restenosis following stenting procedures. Orbus plans to enter into a supply agreement with BioInvent for commercial-grade antibodies once successful process development and product approval are completed.