14.09.2006 07:25:00
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Nektar Reports that Pfizer Announced New Analyses Showing that Exubera Is Effective in Diabetes Patients Who Have Respiratory Infections or Who are Exposed to Passive Cigarette Smoke
-- Analysis of Five Clinical Trials Showed That People with Either Type 1 or Type 2 Diabetes Who Used Exubera Gained Less Weight Than Those Using Injectable Insulin
-- Exubera Has the Potential to Encourage Twice as Many People with Uncontrolled Type 2 Diabetes to Try Insulin
Nektar Therapeutics (Nasdaq:NKTR) reported today that Pfizerannounced that new Exubera(R) (insulin human (rDNA origin)) InhalationPowder data were being presented today at the 42nd EuropeanAssociation for the Study of Diabetes. Pfizer announced that adultpatients with diabetes who took Exubera were able to safely maintaingood blood sugar control even if they developed a respiratoryinfection or were exposed to passive (second-hand) cigarette smoke.Retrospective analyses of 14 Exubera Phase II and III clinical studiesshowed Exubera was well tolerated and efficacious, even duringrespiratory illness in adults with type 1 or type 2 diabetes. Anothernew study found that while passive smoke exposure could result indecreased absorption, Exubera could be used by adult patients who wereexposed to a smoky environment.
In addition, Pfizer announced that an analysis of a previouslyreported study showed that Exubera has the potential to encouragetwice as many people with uncontrolled type 2 diabetes to try insulin(44 percent choosing insulin with Exubera availability versus 17percent choosing insulin without Exubera availability). This held trueeven in countries where insulin pens are commonly used to administerinsulin.
Finally, Pfizer announced that an analysis of five clinical trialsshowed that people with either type 1 or type 2 diabetes who usedExubera gained less weight than those using injectable insulin. Type 2patients gained less than half with Exubera (0.7 kg vs. 1.6 kg), whilethe difference was even greater for type 1 patients (0.2 kg withExubera vs. 1.1 kg with injected insulin).
"Today's clinical information is important for the healthcareprofessionals who treat diabetes," said John Patton, PhD, co-founderand chief scientific officer, Nektar.
Exubera is marketed by Pfizer and is a product of a developmentalcollaboration between Pfizer and Nektar. Under the agreement betweenthe two companies, Nektar will receive royalties on Exubera as well asrevenue for the manufacture of the powder and the Exubera Inhalers.
About Exubera
Exubera is the first inhaled form of insulin and the first insulinoption in the European Union, U.S., Brazil and Mexico in more than 80years that does not need to be administered by injection. Exubera iscurrently available in the U.S., United Kingdom, Ireland, and Germany.
It is a fast-acting powdered insulin that is inhaled through themouth prior to eating, using the handheld Exubera Inhaler. The uniqueExubera Inhaler produces a visible standing cloud of insulin powder,which is designed to pass rapidly into the bloodstream to regulate thebody's blood sugar levels.
In the European Union, Exubera is approved for the treatment ofadult patients with type 2 diabetes who require insulin therapy andare not adequately controlled with diabetes pills. In patients withtype 1 diabetes, Exubera should be used in combination with long orintermediate acting insulin, for whom the potential benefits of addinginhaled insulin outweigh the potential safety concerns.
In the U.S., Exubera is approved for the treatment of adults withtype 1 or type 2 diabetes for the control of high blood sugar levels.In patients with type 2 diabetes, Exubera can be used alone or incombination with diabetes pills or longer-acting insulin. In patientswith type 1 diabetes, Exubera should be used in combination with alonger-acting insulin.
Important Safety Information about Exubera
Patients should not take Exubera if they have poorly controlled orunstable lung disease, or if they smoke or have stopped smoking lessthan six months prior to starting Exubera treatment. If a patientstarts smoking or resumes smoking, he or she must stop using Exuberaand see a health care provider about a different treatment.
In clinical trials, mean treatment group differences betweenExubera and comparators showed that Exubera was associated with small,non-progressive declines in lung function relative to comparatortreatments.
Before starting treatment with Exubera, a healthcare professionalwill carry out a simple test to check lung function. This will help tofind out if Exubera is the right treatment for individual patients.Once a patient starts treatment, it is recommended that a healthcareprovider check lung function again at six months and yearlythereafter.
Like all medicines, Exubera can cause side effects. As with allforms of insulin, a possible side effect of Exubera is low blood sugarlevels.
Some patients have reported a mild cough while taking Exubera,which tended to occur within seconds to minutes after Exuberainhalation. Coughing occurred less frequently as patients continued touse Exubera.
About Nektar Advanced Pulmonary Delivery
Nektar Advanced Pulmonary Technology uses innovative molecularformulations and novel delivery devices designed for ease-of-use toimprove or enable administration of medicines to and through the lungsfor both lung diseases and systemic conditions. Exubera is the mostadvanced product using Nektar Advanced Pulmonary Technology. Thecompany has two proprietary inhaled anti-infective products currentlyin clinical development and four additional pulmonary products in theclinic with various partners.
About Nektar
Nektar Therapeutics is a biopharmaceutical company that developsand enables differentiated therapeutics with its industry-leading drugdelivery technologies, expertise and manufacturing capabilities.Nektar technology and know-how have enabled nine approved products forpartners, which include the world's leading pharmaceutical andbiotechnology companies. Nektar also develops its own products byapplying its drug delivery technologies and expertise to existingmedicines to enhance performance, such as improving efficacy, safetyand compliance.
Nektar has not independently verified and does not assumeresponsibility for the studies presented by third parties at the EASDCongress and referenced in this press release. This press releasecontains forward looking statements regarding Exubera. Thesestatements involve uncertainties and other risks, including but notlimited to (i) the commercial success of the ongoing Exubera productlaunch, including physician and patient preference, education andexperiences with Exubera, (ii) Nektar's ability to manufacture andsupply sufficient quantities of Exubera powder and Exubera Inhalers tomeet market demand, and (iii) the discovery of any new or more severeside effects or negative efficacy findings for Exubera, and (iv) anyExubera-related product liability claims. Other important risks anduncertainties are detailed in the company's reports and other filingswith the SEC, including its most recent Annual Report on Form 10-K,Quarterly Report on Form 10-Q, and Current Reports on Form 8-K. Actualresults could differ materially from the forward-looking statementscontained in this press release. Nektar undertakes no obligation toupdate forward-looking statements, whether as a result of newinformation, future events or otherwise.
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