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Auxilium Pharmaceuticals, Inc. and CPEX Pharmaceuticals, Inc. File Lawsuit Against Upsher-Smith Laboratories, Inc. for Infringement of Testim(R) Patent
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MALVERN, PA and EXETER, NH -- (Marketwire) -- 12/04/08 -- Auxilium Pharmaceuticals, Inc.(NASDAQ: AUXL) and CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) announcedtoday that they have filed a lawsuit against Upsher-Smith Laboratories,Inc. (Upsher-Smith) for infringement of CPEX's U.S. Patent No. 7,320,968("the '968 Patent"), which covers Testim®, 1% testosterone gel. Thelawsuit was filed in the United States District Court for the District ofDelaware.
The Companies filed this lawsuit under the Hatch-Waxman Act in response tothe notice from Upsher-Smith of its filing of an Abbreviated New DrugApplication (ANDA) with the U.S. Food and Drug Administration (FDA)containing a Paragraph IV certification under 21 U.S.C. Section 355(j) fortestosterone gel. The Paragraph IV certification notice states thatUpsher-Smith does not believe that the testosterone gel product for whichit is seeking approval infringes the '968 Patent and that it would seek tomarket its generic product before the expiration of the '968 Patent. The'968 Patent is listed in Approved Drug Products with TherapeuticEquivalence Evaluations (commonly known as the Orange Book), published bythe U.S. FDA, and will expire in January 2025. Auxilium and CPEX arecommitted to protecting their intellectual property rights.
Under the Hatch-Waxman Act, final FDA approval of Upsher-Smith's proposedgeneric product will be stayed until the earlier of 30 months or resolutionof the patent infringement lawsuit. Should Upsher-Smith receive atentative approval of its generic version of Testim from the FDA, it cannotlawfully launch its generic version of Testim in the U.S. before theearlier of the expiration of the currently pending 30-month stay or adistrict court decision in its favor. Upsher-Smith will also not be able tolawfully launch a generic version of Testim in the U.S. without thenecessary final approval from the FDA.
About Testim
Testim is a novel, topical gel formulation that normalizes low levels oftestosterone in men with hypogonadism, a condition that occurs when a man'sbody does not produce adequate amounts of testosterone. Testim wasdeveloped by Auxilium using a proprietary technology licensed from CPEX andwas launched in the U.S. in the first quarter of 2003. Auxilium receivedits first European regulatory approval for Testim in the UK in 2003 andcurrently has regulatory approval in 15 countries in Europe.
About Hypogonadism
A 2006 study that was published in The International Journal of ClinicalPractice showed 39% of men over 45 years of age have low testosterone(total testosterone levels below 300 ng / dL). Hypogonadism is defined asreduced or absent secretion of testosterone which can lead to symptoms suchas loss or decline of libido, decrease in energy, reduced muscle mass, anincrease in abdominal fat, decreased sexual function, anemia, fatigue,depression, irritability, poor concentration, and reduced bone density thatmay result in an increased risk of osteoporosi. Auxilium research estimatesthat approximately 10% of men with hypogonadism currently receivetestosterone replacement therapy and that this low diagnosis rate stemsprimarily from low patient and physician awareness of the symptoms,treatment options and monitoring requirements.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical companywith a focus on developing and marketing to urologists, endocrinologists,orthopedists and select primary care physicians. Auxilium marketsTestim® 1%, a topical testosterone gel, for the treatment of hypogonadismthrough its approximately 190-person sales and marketing team. Auxiliumhas five projects in clinical development. XIAFLEX(TM) (clostridialcollagenase for injection), formerly referred to as AA4500, is in phaseIII of development for the treatment of Dupuytren's contracture and is inphase II of development for the treatment of Peyronie's disease and FrozenShoulder syndrome (Adhesive Capsulitis). Auxilium's transmucosal filmproduct candidate for the treatment of overactive bladder (AA4010) is inphase I of development. The Company is currently seeking a partner tofurther develop this product candidate. Auxilium also has one pain product(fentanyl) using its transmucosal film delivery system in phase I ofdevelopment. Auxilium has rights to seven additional pain products andproducts for hormone replacement and urologic disease using itstransmucosal film delivery system. Auxilium also has options to allindications using XIAFLEX for non-topical formulations. For additionalinformation, visit http://www.auxilium.com.
About CPEX Pharmaceuticals
CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) is an emerging specialtypharmaceutical company focused on the development, licensing andcommercialization of pharmaceutical products utilizing CPEX's validateddrug delivery platform technology. CPEX has U.S. and international patentsand other proprietary rights to technologies that facilitate the absorptionof drugs. CPEX has licensed applications of its proprietary CPE-215®drug delivery technology to Auxilium Pharmaceuticals, Inc., which launchedTestim®, a topical testosterone gel, in 2003. CPEX also is developing anintranasal insulin product candidate, Nasulin(TM), which is in Phase IIclinical trials. CPEX maintains its headquarters in Exeter, NH. For moreinformation about CPEX, please visit www.cpexpharm.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF1995
Auxilium
This press release contains "forward-looking statements" within the meaningof the provisions of The Private Securities Litigation Reform Act of 1995,including without limitation, statements regarding: the number of men withhypogonadism currently receiving testosterone replacement therapy, reasonsfor the low diagnosis rate of hypogonadism; Auxilium's commitment toprotecting its intellectual property rights; and all others statementscontaining projections, statements of future performance or expectations,or statements of plans or objectives for future operations (includingstatements of assumption underlying or relating to any of the foregoing).Forward-looking statements are subject to a number of risks anduncertainties that could cause actual results to differ materially fromfuture results expressed or implied by such statements. Factors that maycause such differences include, but are not limited to, risks associatedwith the following: the interpretation of market research, intellectualproperty litigation, the unpredictability of patent protection, competitionfrom other products, and other risks and uncertainties detailed under "RiskFactors" in Auxilium's Annual Report on Form 10-K for the fiscal year endedDecember 31, 2007 and in Auxilium's Quarterly Report on Form 10-Q for theperiod ended September 30, 2008 which are on file with the Securities andExchange Commission. Given these risks and uncertainties, any or all of theforward-looking statements contained in this press release may prove to beincorrect. Therefore, you should not rely on any such factors orforward-looking statements. Forward-looking statements contained in thispress release speak only as of the date of this document, and Auxiliumundertakes no obligation to update or revise such statements.
Auxilium disclaims responsibility for statements above in "About CPEXPharmaceuticals," which were provided by CPEX for inclusion in this pressrelease.
CPEX
This press release contains forward-looking statements, including, withoutlimitation, statements regarding the legal and regulatory options availableto defend U.S. Patent No. 7,320,968 and Testim and CPEX's intentionsregarding such options. These forward-looking statements are subject to anumber of risks and uncertainties that could cause actual results to differmaterially from future results expressed or implied by such statements.Factors that may cause such differences include, but are not limited to,risks associated with the following: intellectual property litigation, theunpredictability of patent protection, competition from other products, andother uncertainties detailed under "Risk Factors" in CPEX's RegistrationStatement on Form 10 dated June 17, 2008 in connection with thedistribution of CPEX's common stock to stockholders of BentleyPharmaceuticals, Inc. CPEX cautions investors not to place undue relianceon the forward-looking statements contained in this release. Thesestatements speak only as of the date of this document, and CPEX undertakesno obligation to update or revise the statements, except as may be requiredby law.
CPEX disclaims responsibility for statements above in "About Auxilium,"which were provided by Auxilium for inclusion in this release.
For More Information, Contact:James E. FickenscherChief Financial OfficerAuxilium Pharmaceuticals, Inc.+1-484-321-5900Email ContactorWilliam Q. Sargent Jr.Vice-President, Investor Relations and Corporate CommunicationsAuxilium Pharmaceuticals, Inc.+1-484-321-5900Email ContactorBob HebertChief Financial OfficerCPEX Pharmaceuticals, Inc.+1-603-658-6100Email ContactorLaura OkpalaThe Trout Group+1-617-583-1306Email Contact
Under the Hatch-Waxman Act, final FDA approval of Upsher-Smith's proposedgeneric product will be stayed until the earlier of 30 months or resolutionof the patent infringement lawsuit. Should Upsher-Smith receive atentative approval of its generic version of Testim from the FDA, it cannotlawfully launch its generic version of Testim in the U.S. before theearlier of the expiration of the currently pending 30-month stay or adistrict court decision in its favor. Upsher-Smith will also not be able tolawfully launch a generic version of Testim in the U.S. without thenecessary final approval from the FDA.
About Testim
Testim is a novel, topical gel formulation that normalizes low levels oftestosterone in men with hypogonadism, a condition that occurs when a man'sbody does not produce adequate amounts of testosterone. Testim wasdeveloped by Auxilium using a proprietary technology licensed from CPEX andwas launched in the U.S. in the first quarter of 2003. Auxilium receivedits first European regulatory approval for Testim in the UK in 2003 andcurrently has regulatory approval in 15 countries in Europe.
About Hypogonadism
A 2006 study that was published in The International Journal of ClinicalPractice showed 39% of men over 45 years of age have low testosterone(total testosterone levels below 300 ng / dL). Hypogonadism is defined asreduced or absent secretion of testosterone which can lead to symptoms suchas loss or decline of libido, decrease in energy, reduced muscle mass, anincrease in abdominal fat, decreased sexual function, anemia, fatigue,depression, irritability, poor concentration, and reduced bone density thatmay result in an increased risk of osteoporosi. Auxilium research estimatesthat approximately 10% of men with hypogonadism currently receivetestosterone replacement therapy and that this low diagnosis rate stemsprimarily from low patient and physician awareness of the symptoms,treatment options and monitoring requirements.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical companywith a focus on developing and marketing to urologists, endocrinologists,orthopedists and select primary care physicians. Auxilium marketsTestim® 1%, a topical testosterone gel, for the treatment of hypogonadismthrough its approximately 190-person sales and marketing team. Auxiliumhas five projects in clinical development. XIAFLEX(TM) (clostridialcollagenase for injection), formerly referred to as AA4500, is in phaseIII of development for the treatment of Dupuytren's contracture and is inphase II of development for the treatment of Peyronie's disease and FrozenShoulder syndrome (Adhesive Capsulitis). Auxilium's transmucosal filmproduct candidate for the treatment of overactive bladder (AA4010) is inphase I of development. The Company is currently seeking a partner tofurther develop this product candidate. Auxilium also has one pain product(fentanyl) using its transmucosal film delivery system in phase I ofdevelopment. Auxilium has rights to seven additional pain products andproducts for hormone replacement and urologic disease using itstransmucosal film delivery system. Auxilium also has options to allindications using XIAFLEX for non-topical formulations. For additionalinformation, visit http://www.auxilium.com.
About CPEX Pharmaceuticals
CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) is an emerging specialtypharmaceutical company focused on the development, licensing andcommercialization of pharmaceutical products utilizing CPEX's validateddrug delivery platform technology. CPEX has U.S. and international patentsand other proprietary rights to technologies that facilitate the absorptionof drugs. CPEX has licensed applications of its proprietary CPE-215®drug delivery technology to Auxilium Pharmaceuticals, Inc., which launchedTestim®, a topical testosterone gel, in 2003. CPEX also is developing anintranasal insulin product candidate, Nasulin(TM), which is in Phase IIclinical trials. CPEX maintains its headquarters in Exeter, NH. For moreinformation about CPEX, please visit www.cpexpharm.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF1995
Auxilium
This press release contains "forward-looking statements" within the meaningof the provisions of The Private Securities Litigation Reform Act of 1995,including without limitation, statements regarding: the number of men withhypogonadism currently receiving testosterone replacement therapy, reasonsfor the low diagnosis rate of hypogonadism; Auxilium's commitment toprotecting its intellectual property rights; and all others statementscontaining projections, statements of future performance or expectations,or statements of plans or objectives for future operations (includingstatements of assumption underlying or relating to any of the foregoing).Forward-looking statements are subject to a number of risks anduncertainties that could cause actual results to differ materially fromfuture results expressed or implied by such statements. Factors that maycause such differences include, but are not limited to, risks associatedwith the following: the interpretation of market research, intellectualproperty litigation, the unpredictability of patent protection, competitionfrom other products, and other risks and uncertainties detailed under "RiskFactors" in Auxilium's Annual Report on Form 10-K for the fiscal year endedDecember 31, 2007 and in Auxilium's Quarterly Report on Form 10-Q for theperiod ended September 30, 2008 which are on file with the Securities andExchange Commission. Given these risks and uncertainties, any or all of theforward-looking statements contained in this press release may prove to beincorrect. Therefore, you should not rely on any such factors orforward-looking statements. Forward-looking statements contained in thispress release speak only as of the date of this document, and Auxiliumundertakes no obligation to update or revise such statements.
Auxilium disclaims responsibility for statements above in "About CPEXPharmaceuticals," which were provided by CPEX for inclusion in this pressrelease.
CPEX
This press release contains forward-looking statements, including, withoutlimitation, statements regarding the legal and regulatory options availableto defend U.S. Patent No. 7,320,968 and Testim and CPEX's intentionsregarding such options. These forward-looking statements are subject to anumber of risks and uncertainties that could cause actual results to differmaterially from future results expressed or implied by such statements.Factors that may cause such differences include, but are not limited to,risks associated with the following: intellectual property litigation, theunpredictability of patent protection, competition from other products, andother uncertainties detailed under "Risk Factors" in CPEX's RegistrationStatement on Form 10 dated June 17, 2008 in connection with thedistribution of CPEX's common stock to stockholders of BentleyPharmaceuticals, Inc. CPEX cautions investors not to place undue relianceon the forward-looking statements contained in this release. Thesestatements speak only as of the date of this document, and CPEX undertakesno obligation to update or revise the statements, except as may be requiredby law.
CPEX disclaims responsibility for statements above in "About Auxilium,"which were provided by Auxilium for inclusion in this release.
For More Information, Contact:James E. FickenscherChief Financial OfficerAuxilium Pharmaceuticals, Inc.+1-484-321-5900Email ContactorWilliam Q. Sargent Jr.Vice-President, Investor Relations and Corporate CommunicationsAuxilium Pharmaceuticals, Inc.+1-484-321-5900Email ContactorBob HebertChief Financial OfficerCPEX Pharmaceuticals, Inc.+1-603-658-6100Email ContactorLaura OkpalaThe Trout Group+1-617-583-1306Email Contact
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