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TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 6 OF 10NektarContinued from Page 1ties, Joyce Strand, director of corporate communicationsfor Nektar, told Medical Device Daily in September (MDD,Sept. 12, 2005).In approving the drug, the FDA followed the advice ofthe Endocrinologic and Metabolic Drugs Advisory Committee,which last September voted to recommend its approval.Strand at the time described the Nektar inhaler deviceas “like a thin soda pop can that extends like a telescope.The extended part is a clear chamber so you can seewhether you’ve take a dose or not in a simple manner.”Pulling a handle on the device, she said, “compressesthe air, forces the air through the powder and makes it intoa fine powder.”Nektar said in a statement following the announcementof the FDA approval that it would “receive royalties onall marketed products, as well as revenue for the manufactureof the powders and the inhalation devices.” It did notproject what these amounts will be.Pfizer is responsible for marketing, manufacturing andthe clinical development of Exubera. Nektar provides supportin the manufacturing process for Exubera insulin andmanufactures the inhalers.In its announcement of the approval, the FDA describedExubera as a “potential alternative for many of the morethan 5 million Americans who take insulin injections.”“Until today, patients with diabetes who need insulin tomanage their disease had only one way to treat their condition,”said Steven Galson, director of the FDA’s Center forDrug Evaluation and Research. “It is our hope that the availabilityof inhaled insulin will offer patients more op-tions tobetter control their blood sugars.”Larry Deeb, MD, president-elect, science and medicine,of the American Diabetes Association (ADA; Alexandria,Virginia), said patients have to remember that Exuberais “just insulin.”“It really is just insulin, and I think that’s an importantstatement to make, and so in a sense it can be expected todo no more and no less than insulin does,” Deeb told MDD.“The question really to me will be, are there people whowon’t take injections who might take inhaled insulin andthat might be appropriate.”Deeb said there clearly are certain groups of those withdiabetes who will be most likely to benefit from inhaledinsulin potentially: primarily those patients who do not currentlytake injections and those who intermittently takeinsulin and would be willing to take inhaled insulin andwant to switch. However, he doesn’t expect those withType 1 diabetes who are on strict diets and regimens ofinsulin injections to switch. “You can’t get that kind of vigor[for these patients] with inhaled insulin,” he said.The FDA said that the safety and efficacy of Exuberahave been studied in about 2,500 adult patients with Type1 and Type 2 diabetes. “In clinical studies Exubera reachedpeak insulin concentration more quickly than some insulin,called regular insulin, administered by an injection,” theagency said.Peak insulin levels were achieved at 49 minutes withExubera inhaled insulin compared to 105 minutes with regularinsulin, respectively.However, Exubera prescriptions will be accompaniedby a medication guide that the agency urges patients toadhere to for instructions on who is and who is not recommendedto take Exubera.The FDA specifically said that Exubera is “not to beused if you smoke or if you recently quit smoking,” withinthe past six months. Exubera is also not recommended inpatients with asthma, bronchitis or emphysema. Baselinetests for lung function are recommended to be repeatedevery six to 12 months thereafter, the FDA said.“Like any insulin product, low blood sugar is a sideeffect of Exubera and patients should carefully monitortheir blood sugars regularly,” the FDA said. “Other sideeffects associated with Exubera therapy seen in clinical trialsincluded cough, shortness of breath, sore throat and drymouth.”The agency also said it would continue to performlong-term studies on the insulin device “to confirm the continuedsafety of Exubera after it is marketed and to examinemore thoroughly the issue of the efficacy and safety ofExubera in patients with underlying lung disease.”The FDA approval followed an announcement the previousday that the European Union had approved Exuberafor the treatment of adults with Type 2 diabetes older than18 not adequately controlled with oral antidiabetic agentsand requiring insulin therapy (MDD, Jan. 27, 2006). Exuberaalso was approved in Europe for the treatment of adultswith Type 1 diabetes mellitus, in addition to long or intermediateacting injectable insulin, for whom the potentialbenefits of adding inhaled insulin outweigh the potentialsafety concerns.Originally, Exubera was developed jointly by Pfizer andSanofi-Aventis (Le Plessis Robinson, France). But Pfizerreached an agreement with Sanofi-Aventis earlier thismonth to obtain the worldwide rights to the inhaled insulinproduct. ■Applied Imaging retains Aquilo PartnersApplied Imaging (San Jose, California) reported thatthe company has retained investment bank Aquilo Partners(San Francisco) to assist management in exploring strategicalternatives to maximize shareholder value.The company said it believes that now is an “opportunetime” to launch such an initiative, given the resolution in2005 of outstanding legacy corporate issues, enhancementof the financial and operating performance of its corebusinesses, and further development of its CTC Inc. subsidiary.■To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.
TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 7 OF 10EuropeContinued from Page 1Columbia (also Vancouver).Boston Scientific is the exclusive licensee of the patentfor cardiovascular medicine, which encompasses, amongother things, claims describing a stent that uses a compositionof paclitaxel and a polymeric coating as a drug carrier.Biosensors said the judge in the case ruled that itsAxxion DES does not infringe the European patent.Yoh-Chie Lu, chairman and CEO of Biosensors, said,“The decision of the Dutch court enables us to continue tosell the Axxion DES and to pursue our business model.” Hesaid the introduction and rollout of Axxion in Europe “hasbeen an important step for Biosensors as it has allowed usto build our sales and marketing infrastructure, initiatemarket share and develop the necessary systems for theeventual launch of our flagship BioMatrix DES.”Biosensors’ European subsidiary, Occam International(Eindhoven, the Netherlands), received European marketingapproval for the Axxion stent last summer (Medical DeviceDaily, July 13, 2005). The Axxion DES is a polymer-free systemthat incorporates Biosensors’ Calix stent delivery systemand the drug paclitaxel, which is directly coated on thestent over a layer of glycocalix, a substrate designed toimprove biocompatibility of the metal stent surface after thedrug is released.The technology is licensed exclusively by Occam froma privately held company in Germany that is a manufacturerof ultra-thin coatings that according to Biosensors,“set unsurpassed standards of efficiency, hemocompatibilityand biocompatibility.”Lu noted that the legal action only involved the Axxionproduct and does not relate to the company’s BioMatrixDES, which is expected to receive CE-mark approval in thefirst half of 2006. He said the BioMatrix “features a fullybiodegradable polymer and our own proprietary drug, andwe plan for it to drive our growth in the coming years.”The BioMatrix DES system incorporates the company’sproprietary anti-restenotic drug, Biolimus A9, bioresorbablepolymer, S-Stent and stent delivery catheter, all ofwhich have been developed in-house.Askion to produce device for EOSElectro-Optical Sciences (EOS; Irvington, New York),a company focused on designing and developing a noninvasive,point-of-care instrument to assist in the earlydiagnosis of melanoma, said it has entered into an agreementwith Askion (Gera, Germany) for the production ofEOS’s MelaFind hand-held imaging device.The agreement calls for Aakion to produce MelaFindimaging devices for EOS to be used in the company’s pivotaltrial, which is expected to be conducted at more than20 clinical study sites in the U.S. The purpose of the pivotaltrial is to establish the safety and efficacy of MelaFind in theimaging of suspicious skin lesions.Financial terms of the agreement were not disclosed.“This agreement is an important milestone for EOS andis a significant step in our pre-commercialization process,”said Joseph Gulfo, president and CEO of EOS. “2006 will bean exciting year for EOS as we conduct our clinical trialsand anticipate PMA approval and commercialization ofMelaFind in 2007.”Gerald Wagner, PhD, acting chief operating officer andmember of EOS’s board of directors, said, “I have had first-handdealings with Askion management and personnel for 15 yearssince my days at Bayer Diagnostics and Agfa. Askion has a solidreputation for top-quality production and manufacturing.”EOS started as a part of Agfa-Gevaert AG in 1991,mostly with employees from the former Carl Zeiss Jena.The MelaFind product features a hand-held imagingdevice that emits multiple wavelengths of light to captureimages of suspicious pigmented skin lesions and extractdata. The data are then analyzed against EOS’s database ofmelanomas and benign lesions in order to provide informationto the physician and produce a recommendation ofwhether the lesion should be biopsied.AMRI agrees to buy Hungarian firmAlbany Molecular Research (AMRI; Albany, New York)said it has signed a stock purchase agreement to acquireprivately held drug discovery service company ComGenex(Budapest, Hungary).Founded in 1992, ComGenex provides contract chemistryservices to the pharmaceutical and biotechnologyindustries, and possesses what AMRI termed “unique technologiesfor the rational design of chemical libraries forlead generation.”Specifically, the company integrates parallel synthesiswith computational chemistry to create unique small moleculeswith drug-like characteristics. It also has developednovel applications in the areas of chemical genomics andtarget identification.In 2005, ComGenex generated about $8.5 million in contractrevenue. The company and its subsidiaries currently have119 employees, including 88 scientific and technical staff.Thomas D’Ambra, PhD, chairman, president and CEO ofAMRI, said, “The acquisition of ComGenex further expandsAMRI’s global chemistry services platform. This combinationcreates an immediate presence in Europe in a EU memberstate with a significantly lower cost structure thanWestern European countries, while maintaining access to acomparable talent pool not only in Hungary, but all ofEurope and neighboring regions.”D’Ambra said, “Along with [our] offerings in the U.S.,Singapore and India, this move represents another step inthe diversification and globalization of AMRI’s brand amongtechnologies, geographic access and a range of differentcost structures.”Subject to customary closing conditions, the transactionis expected to be completed by the end of 1Q06. ■To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.
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