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Alizyme PLC - COLAL-PRED Licensing

Thu Nov 29, 2007 2:01am EST

Actively seeking other parties for territorial deals in Europe and Rest

of the WorldUnder the terms of the agreement, Prometheus is granted an exclusive licence todevelop and market COLAL-PRED(R) for gastrointestinal diseases and otherapplications in North America, comprising the United States, Canada and Mexico

(the "Territory"). Alizyme will immediately receive $2.5 million, followed byadditional payments of up to $15.0 million on the achievement of futuredevelopment milestones up to registration of the product in the US. Prometheuswill be primarily responsible for clinical development costs for the licensedTerritory. Prometheus will also bear commercialisation costs in the Territoryand pay royalty rates to Alizyme which increase with higher annual net saleslevels of COLAL-PRED(R).Prometheus will initiate the clinical development of COLAL-PRED(R) in the USwith a Phase II study for ulcerative colitis commencing in H1 2008. Subject tothe successful completion of clinical trials, Prometheus anticipates that itwill file a new drug application ("NDA") with the FDA in 2011. Prometheus hasalready shown outstanding commitment to the partnership and to the developmentof COLAL-PRED(R) in the US ahead of entering into the licence agreementannounced today through extensive involvement in preparation for Alizyme'sregulatory discussions with the FDA in relation to the US development program.Alizyme is currently developing COLAL-PRED(R) for the treatment of ulcerativecolitis in Europe and recently announced that recruitment into the current EUPhase III registration clinical trial in up to 750 patients with activemoderate-to-severe ulcerative colitis remained on target for completion in 2007.Subject to the recruitment being completed this year, headline results areexpected to be reported in Q2 2008. Successful results from this EU Phase IIItrial would allow a Marketing Authorisation Application (MAA) to be submittedfor the EU in H2 2008.The ulcerative colitis market is currently dominated by anti-inflammatorysteroids and 5-ASA products, which have safety and/or efficacy issues.COLAL-PRED(R) has a unique competitive profile based on Alizyme's proprietarydrug delivery technology, COLAL(R), which clinical trials to date have shown toprovide effective treatment of ulcerative colitis with an anti-inflammatorysteroid without the usual debilitating side effects typically associated withsuch steroids.Currently around 2 million people in major territories suffer from ulcerativecolitis, of which an estimated 700,000 are in the US. Current projections ofsales of COLAL-PRED(R) in the major territories are in excess of $250m pa.Ferghana Partners Group (New York, Boston, London and Australia), a specialistinvestment bank in the life sciences field, acted as exclusive financial andtransaction advisor to Alizyme in this corporate partnering transaction.Commenting on today's announcement, Tim McCarthy, Alizyme's Chief ExecutiveOfficer said:"We are delighted to partner with Prometheus in North America for thedevelopment and commercialisation of COLAL-PRED(R). As a leader in the provisionof therapeutics and complementary diagnostics to gastrointestinal specialiststhroughout the United States, we believe Prometheus is uniquely positioned tomaximise the commercial potential of COLAL-PRED(R). This partnership withPrometheus marks an important step in the commercialisation of COLAL-PRED(R) inNorth America in parallel with our own development and commercialisation plansin Europe and the Rest of the World (ROW)."Separate discussions are ongoing with other parties for territorial deals inEurope and ROW for COLAL-PRED(R). In addition we remain focused on deliveringfurther commercialisation deals across the remainder of the product portfolio."Commenting on today's announcement, Joseph M. Limber, Chief Executive Officer ofPrometheus said:"We are excited to have entered into this partnership with Alizyme. COLAL-PRED

(R) adds a therapeutically and commercially attractive development stage productto our portfolio of proprietary, marketed pharmaceutical products, thusstrengthening our gastrointestinal franchise for the future. COLAL-PRED(R) canprovide a complementary therapeutic to our IBD Serology 7 diagnostic test, whichhelps physicians diagnose ulcerative colitis and Crohn's disease."For further information, please contact:Tim McCarthy, Chief Executive OfficerDavid Campbell, Finance DirectorALIZYME plc +44 (0) 1223 896000Lisa Baderoon/Rebecca Skye DietrichBUCHANAN COMMUNICATIONS +44 (0) 20 7466 5000Lee M. SternThe Trout Group LLC +1 (646) 378 2922Further information on Alizyme can be found on the Company's website:www.alizyme.comEditor's NoteAlizyme plcAlizyme is a speciality biopharmaceutical development company, focused on thetherapeutic areas of metabolic disorders, gastrointestinal disorders and cancersupportive care. In addition to COLAL-PRED(R) it is developing cetilistat forthe treatment and management of obesity and related diseases, such as Type IIdiabetes, renzapride for the treatment of irritable bowel syndrome ("IBS"), andATL-104 for mucositis, a side effect of cancer therapy.Prometheus Laboratories Inc.Prometheus is a privately owned US specialty pharmaceutical company committed todeveloping new ways to help physicians individualize patient care. Prometheusfocuses on the treatment, diagnosis and detection of gastrointestinal,autoimmune and inflammatory diseases and disorders. Prometheus' strategyincludes the marketing and delivery of pharmaceutical products complemented byits proprietary, high-value diagnostic testing services. By integratingtherapeutics and diagnostic services, Prometheus addresses the continuum ofpatient care, thereby providing physicians with a comprehensive solution totreat chronic diseases. Prometheus' corporate offices are located in San Diego,California.Additional information about Prometheus can be found at www.prometheuslabs.com.COLAL-PRED(R)COLAL-PRED(R) is a proprietary gastrointestinal product developed by Alizyme forthe treatment of ulcerative colitis ("UC"). UC is an inflammatory disease of thecolon, which causes symptoms such as abdominal pain, bleeding, cramping, fatigueand diarrhoea. These conditions are characterised by episodes of acute flare ofthe inflammation, followed by periods of remission. In severe cases, surgery maybe required to remove the diseased tissue.COLAL-PRED(R) is the combination of Alizyme's proprietary colonic drug deliverysystem, COLAL(R), and prednisolone metasulfobenzoate sodium ("PMSBS"), anapproved steroid in Europe. COLAL-PRED(R) has a starch coating that is onlybroken down in the gut by bacteria occurring in the colon. This leads to topicaldelivery of PMSBS to the colon rather than systemic delivery. It has been shownin a Phase II clinical trial to provide levels of efficacy comparable to thatreported for prednisolone, but without the side effects of steroids.COLAL(R)COLAL(R) is a drug delivery technology which enables drugs to be taken orallyand then be specifically released when the preparation reaches the colon.Achieving colonic release with conventional oral dosage forms has proveddifficult because of the variation between individuals in transit times andconditions within the gastrointestinal tract. COLAL(R) overcomes this difficultyby covering small pellets containing the drug with a coating of ethylcelluloseand a specific form of amylose (derived from starch). This coating prevents drugrelease in the stomach and small intestine. When the pellets reach the colon theamylose in the coating is broken down by bacterial enzymes and the drug isreleased.The identification of compounds for successful research, their progress throughdevelopment and the obtaining of regulatory approvals or authorisations beforemarketing, manufacture and/or distribution of products is not certain or aformality.

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