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`Isotretinoin Makers Reach Agreement with Celgene on S.T.E.P.S.
`(R) Risk Management Patents
`Covance Inc. Selected to Handle Complex Program Development
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`and Implementation Effort
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` NUTLEY, N.J., Nov. 23 /PRNewswire‐FirstCall/ ‐‐ The four manufacturers of
` isotretinoin have reached an agreement with Celgene Corporation to license
` patents directed to certain pharmaceutical delivery and restrictive
` distribution programs, including S.T.E.P.S. (System for Thalomid Education and
` Prescribing Safety).
` Isotretinoin is sold by Barr Pharmaceuticals (NYSE: BRL) as Claravis,
` Mylan/Bertek, a wholly owned subsidiary of Mylan Laboratories Inc.,
` (NYSE: MYL) on behalf of Genpharm as Amnesteem, Ranbaxy as Sotret and Roche
` (OTC: RHHBY) as Accutane. The drug, which is prescribed for the treatment of
` severe recalcitrant nodular acne that is not responsive to other treatments,
` is known to cause birth defects. Isotretinoin has a highly restrictive risk
` management program that is now undergoing an enhancement process to minimize
` pregnancy exposures to isotretinoin by incorporating a patient registry, among
` other elements.
` An isotretinoin pregnancy prevention program has been in place since 1988,
` and has included a prescriber registry since 2002.
` The four manufacturers of isotretinoin have entered into an agreement
` whereby they will pay Celgene an up‐front payment and continuing royalties in
` consideration for a license under the Celgene patents.
` Most important to note, since the U.S. Food and Drug Administration (FDA)
` Advisory Committee meeting in February, and while the Celgene patents were
` being evaluated, the companies continued to move forward with planning and
` initial development of the new system. Covance Inc., one of the largest and
` most comprehensive drug development services companies in the world, was
` selected to design, build, implement and run the program.
` The manufacturers of this drug will require adherence to the enhanced
` pregnancy risk management program developed after extensive discussions
` between the FDA and the companies pursuant to the Advisory Committee meeting.
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`http://www.printthis.clickability.com/pt/cpt?expire=&title=Isotretinoin+Makers+Reach+Agreement+with+Celgene+on+S.T.E.P.S.%28R%29+Risk+Managem… 1/2
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`CELGENE EXHIBIT 2017
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01096
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`Isotretinoin Makers Reach Agreement with Celgene on S.T.E.P.S.(R) Risk Management Patents re> NUTLEY, N.J., Nov. 23 /PRNewswireFirstCall/
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` It is being implemented as a means to further reduce the number of pregnancies
` in patients taking isotretinoin. Such pregnancies have continued to occur
` despite strong verbal and visual warnings on the packaging, in patient
` education materials, and in a patient agreement, and despite the requirements
` that female patients use two forms of birth control and undergo monthly
` pregnancy tests.
` Currently, the isotretinoin manufacturers' programs require registration
` of prescribers as part of their pregnancy risk management system. The
` enhanced pregnancy risk management program will now include patient and
` pharmacy registration. In addition, instead of home or in‐office pregnancy
` testing, the new system developed by the manufacturers will require test
` results from certified laboratories be recorded in the system and the
` prescriber and pharmacist must verify negative pregnancy results each month
` before writing the prescription and dispensing the drug. Finally, the enhanced
` system will require patients to interact with the system on a regular basis
` about their pregnancy prevention practices.
` Isotretinoin, available in the U.S. from Roche since 1982, has been used
` by more than 13 million patients worldwide for the treatment of severe
` recalcitrant nodular acne that has not responded to other treatments. Generic
` formulations, approved by FDA in late 2002 and 2003, are marketed by Barr,
` Mylan/Bertek for Genpharm, and Ranbaxy.
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`SOURCE Barr Pharmaceuticals; Mylan Laboratories Inc.; Genpharm Inc.; Ranbaxy
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