12.09.2006 17:00:00
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Exubera Hailed as Innovation in Prestigious European and American Awards
-- WSJ/Professor Pedro Nueno: "The drug could encourage diabetes sufferers to get treatment earlier and more often. This has such a tremendous advantage for a huge number of people world-wide. It is a real breakthrough."
-- PharmaBarometer: "Despite only being launched into the German market in May 2006, it has been immediately endorsed by diabetologists as the most innovative product of the year."
Nektar Therapeutics (Nasdaq:NKTR) announced today that Exubera,the world's first inhalable, non-injectable insulin has garnered twoprestigious awards for innovation within months of its launch. In theUnited States, The Wall Street Journal recognized Exubera first in thebiotechnology and medical category as a technological breakthroughwith the bronze award overall. In Germany, Exubera was "immediatelyendorsed by diabetes experts as being the most innovative diabetesmedicine of 2006," according to PharmaBarometer.
"As the creator of the core technologies for Exubera, we at Nektarappreciate the recognition of Exubera for its innovation to bring abetter therapy option to diabetes patients," said Dr. John Patton,co-founder and chief scientific officer, Nektar.
Exubera is the first insulin, and first ever biotechnology-basedmedicine to treat a systemic disorder, that can be administeredwithout an injection. It is the only inhaled insulin to be approvedfor use in clinical practice in the European Union, U.S., Brazil andMexico, and it is pending approval in several other countries. Exuberawas co-developed by Pfizer and Nektar. Its development took over 15years and involved experts from diverse scientific disciplinesincluding biological, chemical, mechanical, manufacturing, fluidengineering, physics and even aeronautical engineers. In addition tothese awards, Exubera has also been recognized as an innovativetherapy by the 2005 Yearbook of Endocrinology, Popular Science ("Bestof What's New" award) and Prevention magazine ("Eight MedicalBreakthroughs").
About The Wall Street Journal 'Technology Innovation Award'
The Wall Street Journal received more than 600 entries for thisyear's Technology Innovation Awards. Exubera has been selected as theoverall bronze award winner for all technological categories by anindependent panel of judges. The award celebrates a technologicalbreakthrough in the field of biotechnology and medicine and Exuberawas selected as the winner in this category. Judges looked forinnovativeness, clarity of explanation and whether the innovation wascovered by patents or had achieved some kind of track record. Winnerswere featured in The Journal Report, appearing in The Wall StreetJournal's three global editions on September 11, 2006.
About the PharmaBarometer Award
German diabetologists have declared Exubera to be the mostinnovative diabetes medicine of 2006. This is the conclusion of PharmaTrend, a representative poll conducted for the trade magazine'PharmaBarometer. Every year, Pharma Trend surveys 1,500 healthcareprofessionals from ten medical disciplines. Honoring the bestpharmaceutical company, as well as the most innovative product in eachdiscipline, both awards have become the industry's 'Oscar' in Germany.The Pharma Trend 2006 market research surveyed a representative sampleof 100 diabetologists who were asked to name the medicine which, intheir opinion, was the most innovative of the year. Exubera receivedits 'Most Innovative Product 2006' award at a ceremony with 120leading healthcare industry representatives on September 12th inMunich, Germany.
About Exubera
Exubera is a rapid-acting powdered insulin that is inhaled throughthe mouth prior to eating, using the handheld Exubera(R) Inhaler.Exubera is currently available in the U.S., United Kingdom, Irelandand Germany. The unique Exubera(R) Inhaler produces a standing cloudof insulin powder, which is designed to pass rapidly into thebloodstream to regulate the body's blood sugar levels. In the U.S.,Exubera is approved for the treatment of adults with type 1 or type 2diabetes for the control of high blood sugar levels. In patients withtype 2 diabetes, Exubera can be used alone or in combination withdiabetes pills or longer-acting insulin. In patients with type 1diabetes, Exubera should be used in combination with a longer-actinginsulin.
In the European Union, Exubera is indicated for the treatment ofadult patients with type 2 diabetes mellitus not adequately controlledwith oral anti-diabetic agents and requiring insulin therapy. Exuberais also indicated for the treatment of adult patients with type 1diabetes mellitus, in addition to long or intermediate acting insulin,for whom the potential benefits of adding inhaled insulin outweigh thepotential safety concerns.
Exubera is marketed by Pfizer and is a product of a developmentalcollaboration between Pfizer and Nektar Therapeutics. Under theagreement between Nektar and Pfizer, Nektar will receive royalties onExubera as well as revenue for the manufacture of the powder and theinhalation devices.
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,nonprogressive 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 health careprovider 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 occur within seconds to minutes after Exubera inhalation.Coughing occurred less frequently as patients continued to useExubera.
About Nektar Advanced Pulmonary Delivery
Nektar Advanced Pulmonary Technology uses innovative molecularformulations and novel delivery devices to improve or enableadministration of medicines to and through the lungs for both lungdiseases and systemic conditions. Exubera is the most advanced productusing Nektar Advanced Pulmonary Technology. The company has twoproprietary inhaled anti-infective products currently in clinicaldevelopment and four additional pulmonary products in the clinic withvarious 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 statements and statistics of the third partyorganizations contained 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, (ii) Nektar's ability to manufacture and supply sufficientquantities of Exubera powder and Exubera Inhalers to meet marketdemand, and (iii) the discovery of any new or more severe side effectsor negative efficacy findings for Exubera or any product liabilityclaims related thereto. Other important risks and uncertainties aredetailed in the company's reports and other filings with the SEC,including its most recent Annual Report on Form 10-K, Quarterly Reporton Form 10-Q, and Current Reports on Form 8-K. Actual results coulddiffer materially from the forward-looking statements contained inthis press release. Nektar undertakes no obligation to updateforward-looking statements, whether as a result of new information,future events or otherwise.
For more information about Exubera, please visit www.Exubera.com.Exubera is a registered trademark of Pfizer Inc.
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