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Patent Portfolio Sale: Fosphenytoin and Propofol

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  • 1. CYDEX PHARMACEUTICALS INC. PATENT PORTFOLIO SALE OPPORTUNITY: CAPTISOL-ENABLED™ FOSPHENYTOIN AND PROPOFOL PRODUCT OPPORTUNITIES Table of ContentsI. Executive Summary Snapshot ....................................................................I-1II. Overview ..................................................................................................II-1III. Intellectual Property ................................................................................III-1IV. Market Data ........................................................................................... IV-1V. Deal Summary ......................................................................................... V-1 DISCLAIMERTHE INFORMATION THAT HAS BEEN PROVIDED IS BELIEVED TO BE COMPLETE TO THE EXTENTPROVIDED AND DESCRIBED, BUT NEITHER ICAP OCEAN TOMO NOR CYDEX PHARMACEUTICALSINC. MAKE ANY WARRANTY THAT IT IS COMPLETE FOR ALL PURPOSES OR ANY SPECIFICPURPOSE, INDUSTRY, OR BUSINESS. EACH PARTY CONSIDERING THE PORTFOLIO IS CAUTIONEDTO MAKE ITS OWN ANALYSIS REGARDING THE UTILITY AND COVERAGE OF THE PORTFOLIO,AND TO SEEK INDEPENDENT ASSISTANCE IN DOING SO.
  • 2. I. Executive Summary SnapshotThe advanced drug formulation technology of CyDex’s, Captisol®, is based on a modified cyclodextrinmolecule that enables creation of new products by significantly improving the solubility, stability,bioavailablity, safety and dosing of active pharmaceutical ingredients (APIs). Captisol® is one of a seriesof anionically charged sulfobutyl ether β-cyclodextrins (SBE-CDs) that were originally synthesized andpatented by scientists from the University of Kansas Higuchi Biosciences Center for Drug DeliveryResearch.Five Captisol-enabled products currently are approved for market by CyDex licensees, and numerousformulations using Captisol technology in various therapeutic areas and dosage forms are currentlyadvancing in the pipelines of other CyDex partners.On behalf of Cydex, ICAP Ocean Tomo is offering for sale a portfolio of patents and patent applicationscovering two important close-to-market, 505(b)(2), Captisol-enabled product opportunities: • Captisol-enabled™ Fosphenytoin (CE-FOS). Fosphenyltoin is an approved injectable drug for epilepsy (US tradename Cerebyx). However, this drug is formulated at high pH, and must be stored refrigerated. CE-FOS, which includes a small amount of Captisol, offers the advantages of converting from refrigerated storage at high pH to room temperature storage at a more bio- compatible pH. Product stability of CE-FOS at room temperature is 24 months. CE-FOS has already demonstrated to be bioequivalent to the marketed Cerebyx product. The product is nearly market-ready with an open IND, and requiring filing of the Final Report to gain marketing approval. • Captisol-enabled™ Propofol. Propofol (US tradename Diprivan) is an injectable general anesthetic which is only slightly soluble in water, and is formulated in a white, oil-water emulsion. CE-Propofol represents an improved formulation with enhanced stability, reliability, and effectiveness versus propofol, while reducing the potential for pain and allergic response. In terms of development, a stable formulation of CE-Propofol has been identified, and a clinical study has been completed. Marketing approval would require clinical BABE (bioabsorption bioequivalence) studies, manufacturing batch approval and FDA filing.This portfolio should be of interest to any pharmaceutical manufacturer, distributor, branded genericcompany or specialty pharma company looking to enhance their product offering, including thosecompanies focused on injectable product opportunities. I-1
  • 3. Deal SummaryInterested parties should contact ICAP Ocean Tomo for additional information on this portfolio.Contact InformationPlease direct all inquiries regarding this portfolio to:Cameron Gray, Ph.D, J.D. Thomas Reilly, Ph.D, MBASenior Vice President Senior Vice PresidentICAP Ocean Tomo ICAP Ocean TomoTelephone: (312) 327-8175 Telephone: (302) 528-9009Email: Cameron.Gray@us.icap.com Email: Thomas.Reilly@us.icap.com I-2
  • 4. II. OverviewCE-FosphenytoinFosphenytoin (Cerebyx) is approved in the United States for parenteral administration in the short term(five days or fewer) treatment of epilepsy. Fosphenytoin is a prodrug of phenytoin, and was createdaddress dosing issues with phenytoin including, required storage at high pH, induction of pain oninjection, poor solubility, and inability for intramuscular delivery. However to limit the conversion ofFosphenytoin to phenytoin during storage, the prodrug must be kept under refrigeration at 2°C to 8°C,and should not be stored at room temperature for more than 48 hours.CE- FOS is an advanced formulation of Fosphenytoin which offers the significant advantages of lower pHstability (7.0 to 8.5 for CE-FOS vs. 8.6 to 9.0 for Fosphenytoin 1) and storage at room temperature. TheCE-FOS product is bioequivalent to the marketed Cerebyx product. In this formulation, Captisol isadded not to solubilize the Fosphenytoin, but to solubilize any insoluble phenytoin that may form duringthe product shelf-life. 2 CE-FOS has been proven to have two year stability at 25°C/60%RH, and may bestored in either bags or syringes.CE-PropofolPropofol (2, 6-diisopropylphenol or 2, 6-bis (1-methylethyl)-phenol)) is an injectable, potent, short-acting, non-barbiturate sedative-hypnotic agent for use in the induction and maintenance of anesthesiaor sedation. Intravenous injection of a therapeutic dose of propofol rapidly induces anesthesia usuallywithin 40 seconds from the start of injection. The formulation of this portfolio consists of: propofol; asulfoalkyl ether cyclodextrin (SAE-CD); and an aqueous liquid carrier. This formulation has the followingadvantages over existing propofol formulations: • Unlike existing formulations, this formulation is pharmaceutically stable and does not degrade on exposure to light, oxidation or the presence of divalent or trivalent cations. • The formulation also reduces pain on injection as compared to the known emulsion type propofol formulations. • It minimizes the allergic response and microbial contamination typically associated with propofol parenteral formulations.1 http://www.medscape.com/druginfo/monograph?cid=med&drugid=13896&drugname=Fosphenytoin+Inj&monotype=monograph2 Narisawa S. and Stella V. J., Increased Shelf-Life of Fosphenytoin Solubilizaton of a Degradant, Phenytoin, throughComplexation with (SBE)7m-β-CD. J. Pharm. Sci. 87, (8),926-930 II-1
  • 5. • It reduces lipid loading due to the lack of oil in the current parenteral formulation. • The formulation can be sterile filtered unlike emulsion-type formulations of sedative hypnotics. • It can be lyophilized 3 or otherwise dried to yield a solid formulation.Technology PlatformFollowing is a pictorial representation of the technology platform used by both CE-FOS and CE-Propofol.3 Lyophilization is a way of drying something that minimizes damage to its internal structure II-2
  • 6. III. Intellectual PropertyThe patent portfolio contains two (2) issued US patents and fifteen (15) related foreign counterparts. Serial Priority Patent Expiration Title Country Filing Date Issue Date Number Date Number Date Cyclodextrin Enabled Drugs FosphenytoinPolar Drugs or ProdrugCompositions with Extended *United 09/096,747 6/12/1998 6/13/1997 6133248 10/17/2000 6/12/2018Shelf-life Storage and a Method Statesof Making Thereof AustraliaPolar Drugs or ProdrugCompositions with Extended Phillips 80591/98 6/12/1998 6/13/1997 750207 10/24/2002 6/12/2018Shelf-life Storage and a Method Ormonde &of Making Thereof FitzpatrickPolar Drugs or Prodrug AustriaCompositions with Extended 98928901 6/12/1998 6/13/1997 E253941 11/12/2003 6/12/2018Shelf-life Storage and a Method Sonn &of Making Thereof Partner BelgiumPolar Drugs or ProdrugCompositions with Extended Gevers & 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Vanderof Making Thereof Haeghen EuropeanPolar Drugs or Prodrug UnionCompositions with Extended Plougmann, 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Vingtoft &of Making Thereof PartnersPolar Drugs or Prodrug FranceCompositions with Extended Cabinet 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Regimbeauof Making Thereof GermanyPolar Drugs or Prodrug VonCompositions with Extended 69819721.6- Kreisler 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method 08 Seltingof Making Thereof WernerPolar Drugs or Prodrug ItalyCompositions with Extended Jacobacci & 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Partnersof Making Thereof III-1
  • 7. Serial Priority Patent Expiration Title Country Filing Date Issue Date Number Date Number DatePolar Drugs or Prodrug JapanCompositions with Extended Inoue & 502895/10 6/12/1998 6/13/1997Shelf-life Storage and a Method Associatesof Making Thereof NetherlandsPolar Drugs or Prodrug NederlandsCompositions with Extended ch 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Octrooibureof Making Thereof au PortugalPolar Drugs or Prodrug A.G.Compositions with Extended DaCunha 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Ferreira,of Making Thereof Lda.Polar Drugs or Prodrug SpainCompositions with Extended Duran- 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Corretjerof Making ThereofPolar Drugs or Prodrug SwedenCompositions with Extended Strom & 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Gulliksonof Making Thereof ABPolar Drugs or Prodrug SwitzerlandCompositions with Extended Micheli & 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Cie Saof Making ThereofPolar Drugs or Prodrug UnitedCompositions with Extended Kingdom 98928901 6/12/1998 6/13/1997 986403 11/12/2003 6/12/2018Shelf-life Storage and a Method Carpmaelsof Making Thereof & Ransford Serial Priority Patent Expiration Title Country Filing Date Issue Date Number Date Number Date PropofolFormulations Containing *UnitedPropofol And A Sulfoalkyl Ether 10/102,066 3/19/2002 3/20/2001 7,034,013 4/25/2006 3/19/2022 StatesCyclodextrin CanadaFormulations Containing GoudreauPropofol And Sulfoalkyl Ether 2,441,744 3/19/2002 3/20/2001 3/19/2022 GageCyclodextrin Dubuc III-2
  • 8. IV. Market Data • There are approximately 152,000 cases of status epilepticus each year in the U.S., resulting in annual patient cost of $3.8 to $7.0 billion. • In 2006, total US sales of Cerebyx were $71 million, and the market had growth of 16 percent per year since 1998. Since then, generics have entered the market – Cerebyx annual sales are now under $10 million. • The total Propofol market size is projected to increase to $2.46 B by the year 2012. 4 • More generally the total anasthesia market size is projected to increase to $6.16 B by year 2012. 54http://imshealth.com/imshealth/Global/Content/Static%20File/AMJ2006.pdf5http%3A%2F%2Frahuloliver.com%2Fresources%2FMGMT573_Project_Presentation_LEP.ppt&rct=j&q=propofol+market+size&ei=_gzrS9PQMor58AaQve3BBA&usg=AFQjCNHJEL6WCDY6GQ78vy34DXyUFNloaw IV-1
  • 9. • The U.S. drug delivery system industry is $80.2 billion and demand is expected to grow 10 percent annually through 2012. 6 One of the most challenging problems for the pharmaceutical industry in development of new drugs is poor solubility of lead compounds. In many cases, poor water-solubility can delay and even prevent the commercialization of promising new drugs. The use of Captisol to create a more soluble compound will be valuable to pharmaceutical companies as they look to commercialize new technologies.6 “Drug Delivery Systems to 2012 - Market Research, Market Share, Market Size, Sales, Demand Forecast, MarketLeaders, Company Profiles, Industry Trends,” Fredonia Group Study, March 2008. IV-2
  • 10. V. Deal SummaryInterested parties should contact either Cameron Gray or Thomas Reilly:Cameron Gray, Ph.D, J.D. Thomas Reilly, Ph.D, MBASenior Vice President Senior Vice PresidentICAP Ocean Tomo ICAP Ocean TomoTelephone: (312) 327-8175 Telephone: (302) 528-9009Email: Cameron.Gray@us.icap.com Email: Thomas.Reilly@us.icap.comAppendix V-1