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Lifecycle Pharma A/S Annual Report

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Lifecycle Pharma A/S Annual Report 2008 LIFECYCLE PHARMA A/S ANNUAL REPORT IMPROVING TREATMENTS IMPROVING LIVES About LifeCycle Pharma A/S (LCP) Based in Hørsholm, Denmark, with an office in New York, LCP is an emerging specialty pharmaceutical company. Clinical development is the core of LCP’s effort to develop a product portfolio which includes products for immunosuppression, specifically organ transplantation, and products to combat certain cardiovascular diseases. As a fully integrated company, LCP adapts new technologies on a fast commercial timetable. LCP’s unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability – at low-scale up costs – not only for a broad spectrum of drugs already on the market but also for new chemical entities. LCP has a cholesterol-lowering product, Fenoglide™, currently on the US market and a diversified near- and medium-term pipeline with six clinical development programs with four product candidates and a number of product candidates in pre-clinical development. LCP is listed on the Nasdaq OMX Nordic Exchange Copenhagen under the trading symbol (OMX: LCP). For further information, please visit www.lcpharma.com w Business Summary Product Pipeline Shareholders 2008 Highlights Contents Geographical Split LifeCycle Pharma (LCP) currently has two key areas of Product Indication Preclinial Phase 1 Phase 2 Phase 3 Market therapeutic focus: Jan. 02 LifeCycle Pharma initiates Phase 2 clinical trial of LCP- 2008 Highlights .........................................3 Interna�onal TacroTM for the treatment of autoimmune hepatitis Immunosuppression Projects DK Shareholders To Our Shareholders ................................4 Immunosuppressive Treatment for Shareholders 30% LCP-TacroTM Kidney Transplant Feb. 21 LifeCycle Pharma has its first product FenoglideTM in Organ Transplantation: 70% Immunosuppressive Treatment .................6 TM the US launched through its partner Sciele (a Shionogi LCP-Tacro is the Company’s lead product candidate LCP-TacroTM Liver Transplant Three Keys to After-Care Success ........... 12 for immunosuppression in kidney and liver transplan- Company) LCP-TacroTM Autoimmune Hepatitis tation. Currently in Phase 3 clinical trials. Cholesterol-lowering Treatment............ 14 LCP-3301 Immunosuppression Mar. 03 LifeCycle Pharma announces positive top-line results of Phase 2 clinical trial of LCP-TacroTM for the preven- Cholesterol Lowering Treatments Major Shareholders MeltDose® – A Proven Technology (dyslipidemia and hypertension): tion of organ rejection after kidney transplantation to Enhance Drug Performance .............. 20 Retail LCP’s first commercialized product, LCP-FenoChol, Cholesterol Lowering Projects 10% LFI A/S Apr. 17 Life Cycle Pharma announces successful conclusion of Financial Review .................................... 24 has received FDA approval for sale in the US under Fenoglide ™ High Triglycerides 28% the brand name Fenoglide™ for the treatment of dys- a rights issue with gross proceeds of DKK 407.8 mil- Financial Highlights (DKK) ...................... 26 LCP-AtorFen Dyslipidemia lipidemia as an adjunct to dietary changes in adult lion Financial Highlights (EUR) ...................... 27 patients. Launched in February 2008, Fenoglide™ is LCP-Feno High Triglycerides Ins�tu�ons 35% May 07 LifeCycle Pharma announces positive data from LCP- marketed by Sciele Pharma, Inc., a partner. LCP in- Risk Management .................................. 28 tends to rely on partnering for marketing and sales of Novo AtorFen Phase 2 clinical program 21% Preclinical Projects Corporate Governance .......................... 30 products for cardiovascular indications. Alta May 28 LifeCycle Pharma announces successful completion of 6% Shareholder Information ....................... 32 Currently, LCP has one of its products on the market; Internal Projects Undisclosed pilot studies of LCP-Feno Over 50% of LifeCycle Pharma’s shares are owned six clinical development programs with four product by 3 Major Shareholders: Stock Exchange Releases 2008 .............. 33 External Partner Undisclosed projects • LFI A/S (Lundbeck Foundation) Jul. 08 LifeCycle Pharma announces positive top-line results candidates; and a number of product candidates in • Novo A/S TM Board of Directors ................................. 34 pre-clinical development. • Alta Partners from Phase 2 clinical study of LCP-Tacro once daily in stable liver transplant patients Executive Management ......................... 35 MeltDose® – A New Revolution In Drug Delivery TM Our proprietary MeltDose® technology platform en- Aug. 21 LifeCycle Pharma sells Fenoglide royalty stream to Executive Management´s and ables the creation of new, potentially best-in-class Cowen Healthcare Royalty Partners for up to USD 105 Board and Director´s Statement versions of drugs currently on the market. Shareholder million, including an upfront payment of USD 29 mil- on the Annual Report ............................ 36 Company History lion. Information Independent Auditor’s Report............... 37 MeltDose® has been validated in clinical studies. Its Official Listing: Oct. 17 LifeCycle Pharma appoints Dr. Jim New as President success to date has led LCP to form several partner- 2002 Established as a spin-off from H. Lundbeck A/S EU patent for the MeltDose® technology. New Financial Statements ............................. 38 Nasdaq OMX Nordic Exchange and Chief Executive Officer ships with leading international pharmaceutical com- and based on MeltDose® technology. Drug Application (NDA) for Fenoglide™. Listed Copenhagen panies. on Nasdaq OMX Nordic Exchange Copenhagen Dec. 29 LifeCycle Pharma progresses LCP-TacroTM into clinical raising more than DKK 500 million. 2004 Initiated clinical studies of tacrolimus and feno- Trading Admission: Phase 3 MeltDose® provides efficacious new versions of a fibrate. 13 November, 2006 wide spectrum of existing compounds more quickly, 2007 Established affiliate in New York. Agreement Trading Symbol: OMX:LCP more economically, and with a higher success rate 2006 Commercialized agreement for LCP-Feno with with Sciele Pharma, Inc. to market Fenoglide™ than traditional drug-making methods. Sandoz (US) and Mylan (EU). in North America and Mexico. US patent for LCP ID Code (ISIN): DK0060048148 Melt Dose® technology. FDA approved Feno- We believe MeltDose® has broad application across a glide™. Nominal Share Capital: wide range of compounds and therapeutic areas with DKK 56,287,507 established commercial potential. LifecyCLE PHARMA / annual report 2008 / TO OUR Shareholders To Our Shareholders Milestones 2009 Dear Shareholder, Improving Treatments Our Future Together LCP-TacroTM Kidney: In 2008, we took solid, proactive steps to position LifeCycle LifeCycle Pharma is dedicated to broadening the horizons of We are very proud of, and grateful for, the support of our share- Results from Phase 2 in de novo kidney patients in H1 Pharma for long-term success and sustainable growth in specialty medicine. Clinical development is the core of our holders and commitment by our employees during 2008. Initiation of Phase 3 in de novo kidney patients in H2 a business environment characterized by turbulence and effort to develop a differentiated product portfolio with a LCP-TacroTM Liver: changing structures. focus on two markets: immunosuppression and cholesterol- LifeCycle Pharma is an emerging specialty pharma company Results from Phase 2 in de novo liver patients in H1 lowering products. that is contemplating further investments in research and Results from Phase 2 extension study in stable liver patients Over the past year, LifeCycle Pharma achieved important development. In this respect we focus on bringing our lead in H2 milestones that strengthened our ability to capitalize on A truly revolutionary tool for this purpose is the MeltDose® product candidate, LCP-Tacro™ tablets, closer to the market LCP-TacroTM (Autoimmune Hepatitis): attractive business opportunities: technology, our patented technology for enhancing drug de- place, on further differentiating LCP-AtorFen from it’s com- Results from ongoing Phase 2 study in H2 livery. We invite you to take an insider’s look (page 20) at petitors as well as ensuring a well-balanced product port- • Despite the tough financial environment, we completed the MeltDose® platform, which enables the creation of new, folio, including a satisfactory early-stage pipeline. LCP-3301: a rights issue with gross proceeds of DKK 407.8 million, patent protected best-in-class versions of a broad spectrum Results from Phase 1 studies securing a strong cash position. of drugs currently on the market on a fast commercial time- Simultaneously, the responsibility rests on us to be flexible LCP-AtorFen: table. Moreover, MeltDose® provides unique solutions to and position ourselves in a changing world – both in terms Results from Phase 2 extension studies in H1. • We sold our future Fenoglide™ royalty stream in North new drugs developed in cases where low absorption and of governmental initiatives regarding healthcare systems as Preparation for Phase 3 studies and differentiation of product America to Cowen Healthcare Royalty Partners, L.P. for up poor bioavailability present barriers to patient convenience well as in relation to the business dynamics of the pharma- LCP-Feno: to USD 105 million (DKK approx. 551 million), including an and compliance. ceutical industry. Results from pivotal bioequivalence studies in H2 upfront payment of USD 29 million (DKK approx. 152 mil- lion). This transaction
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