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The new delivery device, approved by the U.S. Food and Drug Administration(FDA) in June, is being shipped to pharmacies and is available for patientswhen they fill their prescriptions in the coming weeks.
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Lilly incorporated feedback from patients and healthcare professionalsdirectly into the design of the new FORTEO Delivery Device. Most notably,compared to the current FORTEO Pen, the new design includes a larger and widerbody; fewer steps to complete an injection with no priming necessary; andcolor-coded parts to enhance patient training and communication.
Design matters: patients respond to the new delivery device
To assess the experience of subjects using the new delivery device, Lillyconducted a well-controlled clinical trial over an eight-week period. Of the106 "non-experienced users" (subjects with limited or no experience using theprevious FORTEO Pen) who tested the new delivery device and completed aquestionnaire at the end of the trial, responses indicated the following:
-- Ninety-eight percent (98%) agreed that this delivery device was easy tolearn how to use.(1)
-- Ninety-eight percent (98%) agreed that it was easy to administer FORTEOwith the new delivery device.(1)
-- Ninety-one percent (91%) agreed they would be less reluctant to takeinjections using the new delivery device.(1)
"Lilly is committed to improving the lives of patients through thedevelopment of effective treatment delivery mechanisms," says VladimirKopernicky, medical director, U.S. Osteoporosis and Urology, for Eli Lilly andCompany. "We hope that this simpler design will help patients adhere to theirFORTEO treatment plan so they can receive the full benefits of theirmedication."
FORTEO is indicated for the treatment of osteoporosis in postmenopausalwomen who are at high risk for fracture and to increase bone mass in men withprimary or hypogonadal osteoporosis who are at high risk for fracture. FORTEO,marketed as FORSTEO in the European Union (EU), is the first osteoporosistherapy approved by the U.S. Food and Drug Administration (FDA) and theEuropean Medicines Agency (EMEA) that actually rebuilds bone.(2,3,4) Sincereceiving FDA approval in November 2002, more than 2.6 million prescriptionsfor FORTEO have been filled in the United States.(5)
Information about FORTEO
As part of drug testing, teriparatide, the active ingredient in FORTEO,was given to rats for a significant part of their lifetime. In these studies,teriparatide caused some rats to develop osteosarcoma, a bone cancer.Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma occursin about four out of every million older adults each year. It is not known ifhumans treated with FORTEO also have a higher chance of getting osteosarcoma.
FORTEO should be prescribed only to patients for whom the potentialbenefits are considered to outweigh the potential risk. The drug should not beprescribed for patients at increased baseline risk for osteosarcoma, includingpatients with Pagets disease of bone or unexplained elevations of alkalinephosphatase, children or growing adults, or those who have had prior externalbeam or implant radiation therapy involving the skeleton. Additionally,patients with bone metastases or a history of skeletal malignancies, and thosewith metabolic bone diseases other than osteoporosis, should not receiveFORTEO. Patients with high levels of calcium in their blood should not receiveFORTEO due to the possibility of increasing their blood levels of calcium.
Most side effects of FORTEO are mild. Side effects may include nausea,dizziness, leg cramps and joint aches. Injection site reactions includeredness, swelling, pain, itching, a few drops of blood and bruising.
FORTEO is supplied in a disposable delivery device that can be used for upto 28 days to give once-daily self-administered injections. FORTEO isavailable in a 20-mcg dose and is approved to be taken for a period of up to24 months. A Medication Guide explaining the details of the drug to thepatient also accompanies the product. FORTEO also has a "boxed warning" in itspackage insert about the osteosarcoma findings in rats during preclinicaltesting. For full prescribing information, please visit http://www.FORTEO.com.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growingportfolio of first-in-class and best-in-class pharmaceutical products byapplying the latest research from its own worldwide laboratories and fromcollaborations with eminent scientific organizations. Headquartered inIndianapolis, Ind., Lilly provides answers -- through medicines andinformation -- for some of the world's most urgent medical needs. Additionalinformation about Lilly is available at www.lilly.com.
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Forward Looking Statement
This press release contains forward-looking statements about the safetyand efficacy of FORTEO and reflects Lilly's current beliefs. However, as withany pharmaceutical product, there are substantial risks and uncertainties inthe process of development and commercialization. There is no guarantee thatFORTEO will continue to be commercially successful. For further discussion ofthese and other risks and uncertainties, see Lilly's filings with the UnitedStates Securities and Exchange Commission. Lilly undertakes no duty to updateforward-looking statements.
(1) Data on file, Lilly Research Laboratories (FOR20081009A).
(2) FORTEO Prescribing Information
(3) Osteoporosis Int. 2002;13:267-277.
(4) National Osteoporosis Foundation. Medications to prevent and treatosteoporosis. Available at: http://www.nof.org/patientinfo/medications.htm.Accessed October 10, 2008.
(5) Data on file, Lilly Research Laboratories (FOR20080317A).
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
