Confirming rumors swirling concerning the potential purchase of all or part of Igen International (Gaithersburg, Maryland) by Roche Diagnostics (Mannheim, Germany), Igen released a brief statement July 22 saying that it is in discussions concerning "a potential transaction" with the diagnostics giant, a division of F. Hoffman-LaRoche (Basel, Switzerland). With that brief statement, Igen provided the obligatory wording that there "can be no assurance that a transaction will be reached," and said also that it would not comment further on these talks "until an agreement is reached or discussions are terminated."
The confirmation of talks came roughly two weeks after Igen announced that it was terminating a licensing agreement with Roche Diagnostics concerning Roche's use of Igen's Origen technology. That announcement came swiftly on the heels of a ruling by the Fourth U.S. Circuit Court of Appeals in Richmond, Virginia, affirming Igen's right to effect that termination.
The reported talks between the two companies may spell an entirely new chapter in the relationship between the firms, a relationship that began as a prestigious partnership for Igen in its developmental stages, but then deteriorated into accusations by Igen of unfair business dealings by the diagnostics Goliath and have resulted in more than five years of suits, countersuits and heavy legal fees for both firms the latter easily absorbed by Roche but adding to Igen's loss statements.
Though it is still possible that Roche could continue the battle on the legal front and Igen has filed patent infringement suits against Roche in the U.S. and Germany to ensure that Roche ceases further sales of Origen products both companies appeared to be more interested in some form of reconciliation than continued combat. When Igen announced the license termination, Samuel Wohlstadter, chief executive officer, in a conference call referred to "a new playing field" for the two firms and the possibility of a relationship that could be developed on Igen's terms and to its greater benefit. Likewise, Roche hinted at new possibilities in a statement it released on July 10, saying that the company wished to continue its relationship with Igen and felt it was in "the interest of both parties to continue the collaboration started 12 years ago."
Both companies were gainers and losers in the recent appeals court decision. Besides ruling that Igen could terminate the licensing relationship with Roche Diagnostics, the court also said that Igen could retain the rights to certain improvements developed by Roche under the license agreement, including Roche's Elecsys diagnostic product line. Igen said that in essence, the decision now allows it "to secure maximum value from our technology in all diagnostic markets, including hospitals, blood banks and clinical reference laboratories" and seek other partners for the technology.
But Roche also won a good bit with the recent court decision. While the appeals court left intact Igen's right to $18 million in compensatory damages for unpaid royalties and other withheld fees, it reversed the portion of the original judgment that held Roche liable for unfair competition, vacated a $400 million punitive damage award against Roche and also reversed an $86.8 million award for compensatory damages.
Sensor/pump duo points to artificial pancreas
A new combination of insulin pump produced by Medtronic MiniMed (Northridge, California) and glucose monitor co-developed with Becton Dickinson (BD; Franklin Lakes, New Jersey) is being tabbed as a large leap forward in diabetes management, but its primary importance may be really much larger the foreshadowing of a true artificial pancreas. Last month, the companies announced FDA approval of the MiniMed Paradigm 512 Insulin Pump together with the Paradigm Link Blood Glucose Monitor a blood glucose sensor system combining the efforts of MiniMed and BD the two devices linked by a wireless technology.
Receiving immediate national rollout, the system was described by the FDA as the first device for diabetics "which integrates a glucose meter and an insulin pump with a dose calculator into one device." The agency added: "The new device could be the first step in the development of a fully automated glucose monitoring and insulin delivery system." A large key to the system is its wireless connectivity via radio frequency technology which enables the monitor portion of the device to communicate with the insulin pump and aid in controlling dosages of insulin to the wearer's body.
"What's valuable here is that [the devices] talk to each other for the very first time in this industry," said Rachel Scherer, spokesperson for Medtronic MiniMed. The patient must still use a fingerstick to capture a drop of blood and place it on a test strip to calibrate the meter, Scherer told The BBI Newsletter, but after that the system offers "two really cool things." The first, she notes, is the use of radio frequency signals sent from the meter to the pump to communicate sensor readings. The second is the ability of the pump to evaluate this information for more precise control of insulin delivery, via a technology called the Bolus Wizard calculator that measures and evaluates and incorporates a variety of preset factors.
"The pump is so smart, it uses a calculator [the Bolus Wizard] to determine insulin dosing it remembers how much insulin is in a patient's body for six to eight hours so it is not going to allow you to stack up that insulin," Scherer says. "It knows how much is still in the body and takes that into consideration before recommending a dosage to you." The user has the option of accepting the recommended dosage or overriding it if circumstances require more or less insulin. Both devices are worn externally, with the pump delivering insulin in the traditional way, via cannula into the body.
Because of the communication between the devices and the pump's advanced dosing capabilities, the companies are calling the combination of technologies the first "intelligent" insulin pump and glucose monitoring system. In essence, Scherer says that the "whole value [of the intelligent system] is simplification, ease of use and helping people control their blood sugar better." Based on this simplicity and developments which will be added to it, she says that the Paradigm pump/sensor combination "is going to take us to the future," that future being a true artificial pancreas, considered the Holy Grail of diabetes control. "We're going to continue to develop on this platform, make it more and more sophisticated, with more and more devices so that eventually you'll get to integrating [that produces] continuous monitoring," Scherer says. "The next step is integrating real-time reading values on the pump and the next step after that is to close the loop for an artificial pancreas."
Oncura promises 'major presence' in urology
Oncura, a new company resulting from the merger of business units of two other firms, aims to have what it terms "a major global presence in the treatment of prostate cancer." James McGlone, former president of Galil Medical (Yokneam, Israel), whose U.S.-based urology business represents part of the makeup of the new firm, has been named president and chief executive officer of Oncura, which will be headquartered in suburban Philadelphia, Pennsylvania. The major portion of Oncura came from Amersham's (Princeton, New Jersey/London) brachytherapy business, with the resulting firm "combining the market leadership of Amersham in brachytherapy with the rapidly growing area of cryotherapy," according to a company statement. Oncura will operate as an independent business of Amersham, with Galil holding a minority position of 25%. Its board will consist of three representatives from Amersham and two from Galil. John Jeans, formerly president of Amersham's Therapy business, will serve as Oncura's chairman.
McGlone told BBI that the company's initial emphasis would be on minimally invasive treatments for prostate cancer, but that its vision is the entire continuum of care for this disease, from early diagnosis to follow-on therapy. "We'll see what on that continuum makes sense for us to develop a product and include it in our portfolio," he said. "The ending point is to provide prostate cancer specialists a company they can turn to for the whole disease management pathway." Beyond that, he added, the company will build "on our base of complementary products . . . to develop strong franchise in the management of urological diseases," including the treatment of kidney cancer.
Most of its market opportunity is in the U.S., he said, where there is an 80% rate of diagnosing prostate cancers at a treatable stage. But McGlone projected faster growth in the European market, where the rate of early, treatable diagnosis is just 40%.
CardioGenesis dispute panel cancelled
CardioGenesis (Foothill Ranch, California), a developer of transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR) technologies, said last month that its scheduled Aug. 20 meeting with the FDA Medical Device Dispute Resolution Panel (MDDRP) has been cancelled, based upon a decision by CardioGenesis and the FDA that the agency will review additional data to be submitted by the company in support of its premarket approval supplement for the PMR system.
Michael Quinn, chairman and chief executive officer of CardioGenesis, said that the company and the FDA "have agreed to work interactively to attempt to settle the scientific dispute in connection with the company's pending PMA supplement for its PMR system without the need for a MDDRP hearing." He said the decision to defer the dispute resolution hearing is based on discussions with FDA management from the Center for Devices and Radiological Health and Office of Device Evaluation (ODE).
CardioGenesis said that it would soon submit additional information to the ODE, "which has committed to a rapid, interactive review with the company." Quinn said he is optimistic "that the additional information can resolve the dispute without the need for a hearing" and added that the company is "encouraged by the commitment of the FDA to work interactively with us on their review of the additional information, which we are hopeful will be adequate to address the concerns of the FDA and support an approval decision." Quinn said, "Their firm commitment to a rapid review and consideration of the additional information were the key factors in our decision to defer a hearing before the MDDRP."