M E D I V I R A N N U A L R E P O R T To develop pharmaceuticals is a bit like doing jigsaw puzzles.

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1 M E D I V I R A N N U A L R E P O R T To develop pharmaceuticals is a bit like doing jigsaw puzzles.

2 Contents Business highlights in Medivir in review Key facts about the company, its business concept and strategies... 2 Medivir s professionals a strategic strength... 3 CEO s letter Operations maintaining a brisk pace... 4 Lipsovir the past year Phase III program completed, a total of five studies conducted... 6 The Medivir share Share price performance in The art of managing risk and creating opportunities CFO Rein Piir reports on operational and financial risks Patents and patent filings...19 Hepatitis C the anticipation for new pharmaceuticals There is a pressing need for new pharmaceuticals...20 HCV research making advances Plenty of new pharmaceuticals in the pipeline, with major potential predicted for protease inhibitors...22 Medivir at the leading edge TMC has made the most progress of the second generation of HCV protease inhibitors...23 A market on the verge of robust growth Market forecast to double over the next five years...24 Operations Markets, product portfolio and priority indications...14 Project review A review of each project including its therapy area and competitive edges...16 Report of the directors Income statement Balance sheet Change in shareholders equity.. 34 Cash flow statement Accounting principles Notes Report of the auditors Six-year summary key figures Definitions The board and auditors Management glossary TO gain A QUICk OVERVIEW Medivir in review... 2 CEO s letter... 4 Operations Project description table... 16

3 4 Jan 18 Jan 5 Feb 7 Feb Medivir files an application to start clinical phase I studies with MIV-701 against osteoporosis, osteoarthritis and rheumatoid arthritis. Two sub-studies start in Lipsovir s phase III program, testing the preparation against cold sores in children and immuno-deficient patients. Associate Professor Börje Darpö appointed as Vice President of Medivir s Development function. Medivir s new share issue fully subscribed. 8 Feb Phase I studies start on Medivir s and Tibotec s project relating to the treatment of chronic hepatitis C virus (HCV) infection with protease inhibitor TMC Business highlights in Feb 6 Mar 19 Mar 3 May 6 Jul 21 Aug 30 Aug 4 Sep 6 Sep 10 Sep 13 Sep 20 Sep 1 Oct 8 Nov 21 Nov 22 Nov 10 Dec 14 Dec 21 Dec Medivir outlicenses antiviral compound MIV-160 to Guangdong Lantai Viewland Pharmaceutical Co. Ltd. Medivir starts clinical phase I studies on cathepsin K inhibitor MIV-701 against osteoporosis. Epiphany Biosciences, Medivir s licensing partner for shingles project MIV-606 (EPB-348), completes a new share issue. As a result, Medivir receives a milestone payment of usd 0.5 m and shares in the company. Medivir s partner presents preclinical data on its anti-hiv compound MIV-410 (PPI-801) at a symposium in the US. The Bristol-Myers Squibb Company returns MIV-170 against HIV. Medivir will not continue development of this project in-house. Medivir transfers the licensing rights on MIV-160 to a subsidiary of one of China s largest condom producers, Beijing Mefuvir Medicinal Technology Co. Ltd. Medivir receives shares from licensing partner Presidio s new share issue. Tibotec returns the licensing rights for MIV-210 against hepatitis B virus and Medivir signs a new deal with Hainan Noken Pharmaceutical Industry Ltd. of China. Stefan Mårtensson, hired as Vice President of Sales & Marketing, will be responsible for building and leading future sales and marketing resources. Mr. Mårtensson joins Medivir in October. Preclinical data on hepatitis C compound TMC presented at a symposium in Scotland. Phase III trial on cold sore pharmaceutical Lipsovir includes all patients in the pivotal study (pharmaceuticals adm.). Positive efficacy data for MIV-701 in preclinical test models against osteoporosis presented at a research meeting in the US. Data from a clinical phase Ia study demonstrates that hepatitis C inhibitor TMC is well tolerated and absorbed by the body in a manner that probably enables a single daily tablet dose. These results are presented at a liver disease conference in the US on 6 November. Epiphany Biosciences starts clinical phase IIb studies on valomaciclovir (MIV-606, EBP-348) licensed from Medivir on shingles patients. After the successful conclusion of a phase I study on hepatitis C protease inhibitor TMC with promising results, Medivir s licensing partner Tibotec decides to start a European phase IIa study involving 130 patients. The final patient in the pivotal study on the phase III program on Lipsovir starts therapy. Interim results from the phase I study on MIV-701 demonstrate the compound s efficacy on bone degradation in a clinically relevant manner proof of concept and are presented at a capital markets day. Epiphany Biosciences starts additional clinical phase II studies on valomaciclovir, now targeted against glandular fever (mononucleosis) caused by the Epstein-Barr virus (EBV). Medivir receives two milestone payments linked to the HCV collaboration with Tibotec. License revenues total eur 17 m, the largest Medivir has ever received. Medivir transfers the license for MIV-310 from Presidio to Chinese company Mefuvir, which previously also licensed MIV-160.

4 Medivir in review The group consists of Medivir AB (publ), the subsidiaries Medivir HIV Franchise AB, Medivir Personal AB and Medivir UK Ltd., whose operating activities were transferred to Medivir AB in Huddinge, Sweden in early Phase III studies on Medivir s Lipsovir project completed at yearend results will be published at the end of the first quarter Apart from Lipsovir, Medivir has four projects in phase II and two projects in phase I. Medivir has several collaborations with established pharmaceutical companies as well as smaller biotech enterprises. At year-end 2007, the group had 97 employees. Medivir has been quoted on the Stockholm Stock Exchange since Medivir s net sales in 2007 was sek m. Competitive edge The capacity to produce candidate drugs (CDs) cost-efficiently and repeatedly, based on selective inhibition of protease enzymes, which play a vital role in a number of disorders. A broad and well-balanced project portfolio with one project in clinical phase III, four projects in phase II and two projects in phase I, as well as a range of preclinical research programs. Objectives Medivir is endeavoring to attain sustainable profitability from: Revenues from current and future licensing agreements on its preclinical and clinical pharmaceutical development projects. Revenues from regional sales, primarily of specialist pharmaceuticals. These may be proprietary products either developed in-house, received as remuneration in licensing agreements or acquired, as well as the co-promotion of products belonging to other companies. Revenues from proprietary projects that Medivir brings to market registration. 2

5 Medivir s professionals a strategic strength The high level of qualifications and specialist know-how of its professionals is Medivir s strength and also a key criteria for a successful drug development process with many projects in different phases. Qualifications and experience Medivir s professionals have extensive, broadbased knowledge and experience of running projects right from early discovery phases, in preclinical research through extensive clinical development all the way to the registration process. The knowledge base represented by Medivir s employees is highly competitive; all employees are offered the opportunity of continuous skills enhancement. Some 51% of its scientists are PhDs, and three of them are Professors. These professionals have an average of 15 years professional experience in the pharma ceutical sector. Equality initiatives are a natural part of day-today business. The company also endeavors to help its employees reconcile their work and parenting, and ensure that women and men have the same opportunities for parental leave. The company has considerable ethnic diversity, which creates a positive, progressive dynamic, and creates opportunities to establish contacts with companies and organizations in other countries quickly. Working environment and safety philosophy Research environments have very stringent working environment standards, thus safety-consciousness is an important part of laboratory work. Working environment practices are an integrated part of day-to-day operations. A risk assessment is conducted before laboratory work, and predeter- mined routines govern work that involves increased risk. The company works continually on reducing its working environment risks. Medivir also conducts safety inspections, as well as ongoing monitoring of air-conditioning systems, safety ventilation and other technical equipment. Ergonomics are important, and the company is investing in more standing-desks as well as ergonomic seated office environments. Workplace lighting is also being reviewed. Medivir s working environment policy stipulates that the working environment should make a positive contribution to business development, create physical and psychological well-being and commitment, and enhance the quality of life and personal development of each employee. Overall environmental efforts are an integrated part of Medivir s operations, and the company prioritizes protecting its employees and the surrounding environment, as well as individuals outside the company. Medivir s employees are regularly informed and trained on environmental issues. The company has detailed written standard operating procedures (SOPs). Another objective of Medivir s environmental policy is to reduce its waste volumes and increase the recycling of waste generated by its operations. Keep-fit and health The company offers an hour s keep-fit each week, and provides its employees with subsidies for visits to masseurs, chiropractors or naprapaths, for example. The company also funds regular health-checks. Fresh fruit is offered every day, and all employees can eat lunch and take breaks in shared spaces. The company follows all aspects of the National Tax Board s recommendations on taxable benefits. EMPLOYEE DATA, 2007 Division between sexes Average no. of women: 43 Average no. of men: 54 Qualifications PhDs: 51% Graduates: 35% Other: 14% Sickness absence Total sickness absence: 1.3% Long-term sickness absence: 0.9% Other Average period of employment: 7 years Average age: 44 No. of nationalities: 12 Staff turnover: 13.4% 3

6 CEO s letter Three of our projects progressed to clinical trials in the year, and we were able to conclude one phase III program in-house. The positive financial effects of having focused the research operations to Sweden are starting to appear, and we concluded the year with the highest revenue volumes in Medivir s history. Simply put, our operations moved forward briskly in In the year, we took two projects to clinical studies, one of which, against hepatitis C, has already entered phase II. In the other, the cathepsin K program addressing bone disorders, the first CD MIV-701 has undergone phase I clinical trials with good results. The integration of our two research units, in the UK and Sweden, to a single facility in Huddinge, Sweden, also went very well. We were able to maintain our productivity and for a lower cost. Our phase III study on Lipsovir was a very exciting activity in the year. We now look forward to being able to unblind the code for the pivotal study and thereby access the results. This is expected to occur at the end of March It feels satisfying that we ve succeeded in running this program in-house. So far, Medivir s and Tibotec s collaboration on hepatitis C, and the compound TMC435350, has gone really well. During the year, we saw what an extremely effective and potent inhibitor it is, and have been able to take it into phase II studies rapidly. The phase Ia study Tibotec conducted demonstrates that this pharmaceutical is absorbed so effectively in the body that we can probably keep dosage to a single daily tablet. A low dose and few tablets are a big advantage for patients. may be sufficient. Further biomarker studies also demonstrated that this compound has the expected efficacy against bone degradation. Cathepsin K (MIV-701) can be used against osteoporosis, osteoarthritis and skeletal metastases. Owning a research project that addresses such widespread diseases is attractive, although Medivir s size, will make it difficult for us to take it further in-house. We now feel in a good position to start discussions with feasible partners. Medivir s ambition is to form a partnership with a large company that can utilize the phase I product, and develop other follow-ons. A project portfolio with breadth Medivir also brought one wholly owned program, MIV-701 (cathepsin K) into phase I studies. MIV-701 targets skeletal disorders, and here too, we ve been able to conclude that the compound is well absorbed by the body, so a single daily dose 4

7 Our collaboration partner Epiphany has also taken MIV-606 into phase II studies against shingles and glandular fever. Selling specialist pharmaceuticals A small portion of our cash reserves will be used to develop in-house sales and marketing resources. Our type of business operations necessitate us maintaining good margins, because scheduling our next source of revenue precisely, and its scale, is problematic. Going into 2008 with a secure financial position gives us room to maneuver for our future. For several years now, we have been careful to retain Nordic market rights when outlicensing projects. Our idea was that one day, we would have the possibility of selling pharmaceuticals with healthy margins on the Nordic market ourselves. This year, we hired a professional with broad experience of the pharmaceutical market, and we are currently examining our prospects of assisting large pharmaceutical companies in selling pharmaceuticals to a limited circle of physicians, namely specialists. By starting to sell specialist pharmaceuticals, we could build a platform for inhouse sales resources, which would then prepared, if and when our outlicensed projects become registered pharmaceuticals. Going into 2008 with a secure financial position gives us room to maneuver for our future. Costs cut finances strengthened Bringing all our research operations to Huddinge, Sweden, has made us more efficient. In the year, we started to see this pay off in the costs of our preclinical research activities. On the revenue side, 2007 was a new record for Medivir our net sales was sek m (126.0). The increase in net sales was some 98% year on year, mainly thanks to two contracted payments in December totaling eur 17 m from Tibotec on the anti-hiv compound TMC A portion of this turnover was a milestone payment for the project entering phase II studies. We also received eur 12 m in exchange for us declining our option to potentially receive rights to sales of one pharmaceutical on the Nordic market in the future. A review of our immediate future If the results from the studies on Lipsovir are favorable, this will open a wealth of new opportunities in 2008, including partnerships on marketing and extensive NDAs to the US and European authorities. We will be designating another CD in our broad cathepsin K research program, which addresses a range of chronic diseases. With our preclinical program and the phase I compound MIV-701 in our locker, we are now looking for broad partnerships with established companies worldwide. In late-2007, our collaboration partner Tibotec started phase IIa studies on TMC and we look forward to receiving the data in These results will be a valuable foundation for designing the phase IIb studies. We are also looking forward to the results from the phase II trials Epiphany started on shingles and glandular fever patients. Our ambition is to secure collaborations on specialist pharmaceuticals in 2008, get smallerscale sales resources in place and start to generate revenues. Moreover, we hope to be able to designate at least one new CD from our preclinical research portfolio in the year. Our cost level in 2008 will be significantly lower than 2007, mainly because of reducing costs for the Lipsovir program, and that our preclinical research has been concentrated on our Swedish facility. Lars Adlersson Chief Executive Officer Huddinge, Sweden, February

8 Lipsovir progress in the past year In 2007, Medivir took the final step in its phase III program for Lipsovir against cold sores caused by the herpes virus. This is the first time in the company s history that all research phases of a clinical pharmaceutical development program have been conducted in-house. Intensive work will now follow until the end of the first quarter 2008 when the code to all data can be unblinded and Lipsovir s efficacy can be evaluated. Lipsovir s phase III program complete In 2007, work on Medivir s phase III program for a new topical cold sore therapy entered its final phase. A total of five clinical studies were conducted. Most of the activities in the year can be summarized in just a few words: implementation, completion, documentation, logistics, analysis and preparations. It s unusual for a company of Medivir s type and size to conduct all the clinical development phases, including phase III, itself, comments Eva Arlander, it consumed a lot of resources and drained our energies, but it s fair to say we ve coped, and as Lipsovir s Project Manager, I m very pleased and proud of the way we did it. The pivotal study of the phase III program started in summer 2006, and as always when studies are to form the basis for a new drug application, was double-blind. This means that patients received their products in coded tubes, and that no one the patients, physicians or Medivir knows who received placebo and who received the active compound before the study is complete. Completion and documentation It takes just over three months after the last patient completes therapy before Medivir, with the help of CROs, receives and records all data. In this time, the final patients complete treatment and make repeat visits. All data and pharmaceuticals from the patients that have not started therapy must also be collected. The routine after each study is fairly similar. When we ve got all the data, it s entered in a database what therapy each patient received is still completely unknown at this time. All data must be verified, and any questions on the information go to the study clinics. Their responses are also entered into the database. When this is complete, quality control is conducted on the database, which is then locked, and then no data can be amended. When the database is completely locked, the study is unblinded so that every patient s therapy becomes known. It s not until then we know which tubes contained Lipsovir. Only then can we conduct the statistical analysis that tells us about the efficacy the pharmaceutical compound really has against cold sores, concludes Eva Arlander. 6 A total of five studies were conducted in phase III A study on young people was conducted in Sweden and Russia. This was completed ahead of schedule, with the final patients treated in the autumn. A study on immuno-deficient patients was completed in September, also ahead of schedule. The study was conducted in Russia and the Ukraine. The pivotal study, covering a total of 2,500 patients, was conducted in the US and Canada. Two different phototoxicity studies examined whether sunlight exposure after applying Lipsovir has any effect on the skin. These studies are complete. Logistics and preparations Given the results in the pivotal study are positive it s important to file an NDA (new drug application) for Lipsovir quickly in the US and Europe. During the year, Medivir had a series of contacts and meetings with pharmaceutical regulators and a number of discussions with feasible marketing partners. Preparations are also in hand for regulator inspection of the facility in Canada that will produce Lipsovir. These processes must be conducted in a tight timescale so the process proceeds to pharmaceutical registration without delay. For example, pharmaceutical regulators have differing examination periods, which our planning must factor in. We collaborate with a lot of consultants around the world. The closer we get to the results, the more important it gets to gather our strength. We need a lot of analysis and good coordination to integrate all the constituent parts of an NDA. It s a challenge but we re going to make it. Compilation of results underway The results from the clinical program are being compiled and processed in the first quarter The schedule for final reporting is determined by data compilation and evaluating results from the pivotal study. At present, all five studies are scheduled to be published late March/early April. E VA A R L A N D E R, PROJECT MANAGER OF LIPSOVIR S PHASE III PROGRAM AT MEDIVIR

9 The Medivir share B-Share General Index Biotech Index Number of shares traded, thousands (incl. adjustments) (C) SIX 2007 B-Share Number of shares traded, thousands (incl. adjustments) Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 0 (C) SIX. Medivir files an application to start clinical phase I studies with MIV-701 against osteoporosis, osteoarthritis and rheumatoid arthritis. 2. Two sub-studies start in Lipsovir s phase III program, testing the preparation against cold sores in children and immuno-deficient patients. 3. Phase I studies start on Medivir s and Tibotec s project relating to the treatment of chronic hepatitis C virus (HCV) infection with protease inhibitor TMC Financial Statemet. 5. Medivir starts clinical phase I studies on cathepsin K inhibitor MIV-701 against osteoporosis. 6. Q1 report. 7. The Bristol-Myers Squibb Company returns MIV-170 against HIV. Medivir will not continue development of this project in-house. 8. Q2 report. 9. Preclinical data on hepatitis C compound TMC presented at a symposium in Scotland. 0. Data from a clinical phase Ia study demonstrates that hepatitis C inhibitor TMC is well tolerated and absorbed by the body in a manner that probably enables a single daily tablet dose. These results are presented at a liver disease conference in the US on 6 November.. Q3 report. 2. Epiphany Biosciences starts clinical phase IIb studies on valomaciclovir (MIV-606, EBP-348) licensed from Medivir on shingles patients. 3. After the successful conclusion of a phase I study on hepatitis C protease inhibitor TMC with promising results, Medivir s licensing partner Tibotec decides to start a European phase IIa study involving 130 patients. 4. Medivir receives two milestone payments linked to the HCV collaboration with Tibotec. License revenues total eur 17 m, the largest Medivir has ever received. 7

10 T h e M e d i v i r s h a r e The Medivir share Medivir s class B share was floated on the Stockholm Stock Exchange on 14 November 1996; the high-vote class A share is not listed. Share structure Medivir has 20,843,547 shares divided between 660,000 class A and 20,183,547 class B shares. All shares confer equal rights to participation in Medivir s assets and profits. Class A shares have ten votes and class B shares one vote. The share capital is sek 104,217,735. Share structure, 28 December 2007 Share class No. of shares No. of votes % of capital % of votes Shares after full exercise of options A 10 votes 660,000 6,600, ,000 B 1 vote 20,183,547 20,183, ,285,847 Total 20,843,547 26,783, ,945,847 Share price performance and turnover in 2007 Medivir s share price rose 12.9%, from sek 44.3 to sek 50, in In the same period, the Stockholm Small Cap Index (OMXSSCPI) fell 15.3% and the biotechnology index fell 38.1%. At year-end 2007, Medivir s market capitalization was sek 1,042 m, based on the closing price for the year of sek ,840,160 Medivir shares were turned over on OMX Stockholm Exchange in 2007, equivalent to a turnover rate of 64% against 139% for OMX Stockholm Exchange as a whole. As of 29 February 2008, the share price was sek 53, equivalent to a market capitalization of sek 1,104 m. Beta value As of 31 December 2007, Medivir s class B share had a beta value of This value is based on historical closing prices on the last trading day of each of the preceding 24 months. The same measure is applied on the Stockholm All-share Index, and provides an indication of the extent to which a share price fluctuates against an index. If a share has the same price variation as the index, its beta value is 1.0; if it has been more volatile, its value is greater than 1.0, and vice versa. Dividend policy A proposal on dividends will not be raised until long-term profitability can be expected through new product launches on the market. Accordingly, no dividends are anticipated during the coming years. Warrants and stock options Medivir had three outstanding stock option plans at year-end (see table on page 9). At 1 January, there were 676,995 outstanding options, with 142,408 options converted to class B shares in the year, 44,587 options expiring and 480,000 options added through the new stock option plan designated At year-end there were 970,000 stock options, corresponding to 1,102,300 class B shares. The number of outstanding options could increase shareholders equity by sek 82.9 m, and upon full conversion, the total number of shares would be 21,945,847. As a result of the new issue completed at the beginning of 2007, the stock option plans launched in 2004 and 2006 have been restated, whereupon the stock options confer rights to the conversion of 1.27 shares per option and the exercise price has been restated, see the table on page 9. The plan This plan, encompassing 200,000 staff stock options at a subscription price of sek 46.40, matured on 31 December ,408 options were converted to class B shares in the year, while 44,587 options matured without any conversion occurring. Due to the new issue completed in 2007, this plan has been restated, whereupon one option conferred the right to 1.4 shares at the exercise price of sek The plan The Annual General Meeting on 22 April 2004 resolved to raise a subordinated debenture of sek 1,000 through the issuance of debt instruments with 210,000 detachable warrants. The debenture was subject to 5% interest and has been repaid. Of the 210,000 options, 156,000 were granted to staff, with the remainder held by Medivir Personal AB to cover social security costs. Medivir s hedge for its various staff stock option plans do not mean that Medivir is utilizing what is termed hedge accounting according to IAS 39. For a review of Medivir s hedge, please refer to the section on accounting policies under staff stock option plans on page 37, and the section rights to acquire shares on page 10. The stock options are only to be utilized to the extent that total profit upon conversion does not exceed an amount corresponding to the product of the number of stock options and 500% of the stock options exercise price. Subscription for class B shares is possible from 1 May June 2009 inclusive, at a price of sek 126. The subsidiary Medivir Personal AB controls these detachable warrants in order to fulfill undertakings relating to stock options issued within the framework of the stock 8

11 T h e M e d i v i r s h a r e option plan Each stock option is exercisable to acquire one share in Medivir AB through the agency of the subsidiary, against the payment of a redemption fee equivalent to at least 130% of the closing price of the Medivir class B share quoted on OMX Stockholm Exchange s Small Cap-list at the grant date (albeit subject to a minimum of sek 126) for each share. These stock options have been issued to staff of the Medivir group, free of charge. The theoretical market value according to the Black & Scholes equation was sek per option at the grant date, and sek 0.15 as of year-end 31 December Upon full conversion of the detachable warrants, Medivir s liquid assets and shareholders equity would increase by approximately sek 26.5 m, whereupon the company s share capital would increase by sek 1.33 m. The number of class B shares would increase by 266,700. As a result of the new issue completed in 2007, the plan has been restated, whereupon one option confers the right to conversion to 1.27 shares at an exercise price of sek The plan The Annual General Meeting of 21 April 2005 resolved to raise a subordinated debenture of sek 1,000 through the issuance of debt instruments with 280,000 detachable warrants. The debenture was subject to 5% interest and has been repaid. Of the 280,000 options, 183,600 were granted to staff, with the remainder held by Medivir Personal AB to cover social security costs. Subscription for class B shares is possible from 1 July 2005 to 31 December 2010, at a price of sek 87. The subsidiary Medivir Personal AB controls these detachable warrants in order to fulfill undertakings relating to stock options issued within the framework of the stock option plan Each stock option is exercisable to acquire one Medivir AB share through the agency of the subsidiary, against the payment of a redemption fee equivalent to at least 130% of the closing price of the Medivir class B share quoted on OMX Stockholm Exchange s Small Cap-list at the grant date (albeit subject to a minimum of sek 87.00). These stock options have been issued to staff of the Medivir group, free of charge. The theoretical market value according to the Black & Scholes equation was sek per option at the grant date, and sek 4.93 as of year-end 31 December Upon full conversion of the detachable warrants, Medivir s liquid assets and shareholders equity would increase by approximately sek 24.4 m, whereupon the company s share capital would increase by sek 1.78 m. The number of class B shares would increase by 355,600. As a result of the new issue completed in 2007, the plan has been restated whereupon one option confers the right to conversion to 1.27 shares at an exercise price of sek Outstanding option plans, 28 December 2007 Type Duration Number Rights to no. shares Exercise price sek Outstanding shares today and at conv. 20,843,547 Stock opt , , ,110,247 Stock opt , , ,465,847 Stock opt , , ,945,847 Total 970,000 1,102,300 Medivir s 15 largest shareholders, 28 December 2007* Descending order of vote Shareholder categories, 28 December 2007* Shareholder statistics as of 28 December 2007, by size of holding* Size of holdings No. of shareholders % of Votes % of Capital No. of shares % of capital No. of shareholders Swedish institutions Foreign institutions Swedish private individuals ,317 Foreign private individuals Totalt ,858 * Source: VPC Analys Class A shares Class B shares % of votes % of capital Bo Öberg 284, , Nils-Gunnar Johansson 284, , Staffan Rasjö 2 872, DNB Nor Bank AB 1,316, Christer Sahlberg 92,000 41, Länsförsäkringar 946, Handelsbanken 934, Awake Swedish Equity Fund 818, Nordea Bank Finland 796, Tredje AP-fonden 765, Skandia Liv 756, INTER 676, Unionen 563, Bear Sterns & Co 393, Reabourne Melin Life Science 358, Others 8,361, Total 660,000 20,183, * Source: VPC Analys, register of shareholders. The table may include composites from multiple entries in VPC s statistics. These composite entries are intended to indicate an institution or private individual s total holdings in Medivir. Such composite entries are not utilized in other tables relating to the Medivir share. % of votes ,293 58, ,671 1,080, ,590, ,267, ,524, ,660, Total 4,858 20,183, * Source: VPC Analys 9

12 T h e M e d i v i r s h a r e The plan The Annual General Meeting of 24 April 2007 resolved to raise a subordinated debenture of sek 1,000 through the issuance of debt instruments with 480,000 detachable warrants. The debenture was subject to 5% interest and has been repaid. Of the 480,000 options, 360,000 were granted to staff, with the remainder held by Medivir Personal AB to cover social security costs. Subscription for class B shares is possible from 18 June 2007 to 30 April 2012, at a price of sek The subsidiary Medivir Personal AB controls these detachable warrants in order to fulfill undertakings relating to stock options issued within the framework of the stock option plan Each stock option is exercisable to acquire 1.0 Medivir AB share through the agency of the subsidiary, against the payment of a redemption fee equivalent to at least 115% of the closing price of the Medivir class B share quoted on OMX Stockholm Exchange s Small Cap-list at the grant date (albeit subject to a minimum of sek 64.64) for each share. These stock options have been issued to staff of the Medivir group, free of charge. The theoretical market value according to the Black & Scholes equation was sek per option at the grant date, and sek 9.28 as of year-end 31 December Upon full conversion of the detachable warrants, Medivir s liquid assets and shareholders equity would increase by approximately sek 32.0 m, whereupon the company s share capital would increase by sek 2.4 m. The number of class B shares would increase by 480,000. Rights to acquire shares For the stock options issued in 2004, each holder possesses the right to exercise one third of the total number of granted stock options from a date one year after granting onwards, with another one third on the corresponding date in each of the ensuing two years, providing the stock option holder remains an employee of the Medivir group. The plan issued in 2005 is subject to the above terms, apart from the first one third not being exercisable until two years have passed, with a further one third in the subsequent two years. The plan issued in 2007 confers the right to acquire new shares at 30% of the whole number of granted options from the date occurring one year after granting onwards, another 30% on the second anniversary and 40% on the third anniversary. Upon exercise, a taxable benefit arises, and to cover future social security costs, the subsidiary controls a number of options for subscription for new Medivir AB stock (as a hedge). Share capital history Year Transaction Nominal amount, sek Change in share capital, sek Total share capital, sek Total no. of class A shares Total no. of class B shares Total no. of shares 1988/89 Incorporation 10 50,000 5,000 5,000 New share issue 1: , ,000 10,000 10,000 New share issue 3: , ,000 10,000 30,000 40, /92 Bonus issue 1: , ,000 20,000 60,000 80,000 New share issue 1: , ,000 22,500 67,500 90, /93 Bonus issue 4:1 10 3,600,000 4,500, , , , /95 Non-cash issue 1:7 10 2,250,000 6,750, , , , Bonus issue 3: ,250,000 27,000, ,000 2,250,000 2,700,000 Split 2:1 5 27,000, ,000 4,500,000 5,400,000 Reclassification to class B shares 5 27,000, ,000 4,660,000 5,400,000 New share issue 598:2700 at a subscription price of sek ,980,000 32,980, ,000 5,856,000 6,596, Reclassification to class B shares 5 32,980, ,000 5,936,000 6,596, Non-cash issue 5 295,110 33,275, ,000 5,995,022 6,655, Private placement 5 7,025,000 40,300, ,000 7,400,022 8,060, Non-cash issue 5 475,000 40,775, ,000 7,495,022 8,155, Options conversion, ,000 41,440, ,000 7,628,022 8,288, Options conversion, ,440, ,000 7,628,122 8,288, Private placement 5 1,507,390 42,948, ,000 7,929,600 8,589, New share issue 2:1 5 21,498,410 64,446, ,000 12,229,282 12,889, Options conversion, ,645 64,513, ,000 12,242,611 12,902, New share issue 5:3 5 38,707,830 51,610, ,000 19,984,177 20,644, Options conversion, ,850 52,607, ,000 20,183,547 20,843,547 10

13 T h e M e d i v i r s h a r e The hedge functions by those options assigned to the hedge held by Medivir Personal AB being converted to shares, which are sold on the market to generate a commensurate cash flow for the group to cover the payment of social security costs. However, the personnel costs arising in the Income Statement are not offset by a cost reduction (revenue), but rather the effect arises in cash flow terms exclusively. This is because the income from such share sales from a group perspective is considered as an issue from shareholders equity. More information under Accounting principles, Social security costs on stock options, on page 37. Cash consideration The Board resolved in November to introduce the possibility of cash consideration in respect of all staff share option schemes. This will facilitate the issuing of shares. Outstanding options Upon full subscription, the total number of outstanding detachable Warrants as of 31 December 2007, 970,000, confer rights to 1,102,300 new class B shares, corresponding to some 5.3% of the share capital and 4.1% of the vote upon full exercise. 142,408 (0) stock options were exercised in the year, converted to 199,370 (0) new class B shares. As of 1 January, the total number of outstanding detachable warrants was 676,995, and 970,000 at 31 December. The difference comprises the 480,000 newly issued options, 142,408 new subscriptions and 44,587 expired options relating to the plan. The Income Statement includes a provision of some sek 0.8 (0.2) m for accrued social security costs that would arise on the taxable benefit coincident with exercise of the stock options. The value of the outstanding options for the purposes of calculation of accruals is in accordance with URA 46, IFRS 2 and social security costs, which were initiated in Information on accounting principles is available in the Stock option plans section on page 37. Valuation of staff benefits via stock option plans Medivir utilizes the Black & Scholes model for calculating the theoretical value of the stock options its employees receive. This model is used both at the grant date and at each quarterly financial statement. Medivir utilizes this value, determined by the Black & Scholes model at the grant date, to account a personnel cost pursuant to IFRS 2, which is allocated over the accrual period. For a review of accounting pursuant to IFRS 2, please refer to Stock option plans in the Accounting principles section on page 38. The market value of the option is also calculated quarterly, and utilized to determine the provision for social security costs to be accounted pursuant to URA 46. Calculations consider share price, exercise price, the option term, expected volatility, risk-free interest and expected dividends. During the financial year, expected volatility of 30% has been applied in accordance with a valuation by Carnegie Investment Bank AB in the preceding year. Adoption of IFRS 2 and related effects Medivir accounts its stock option plans pursuant to IFRS 2. As applicable, this has also been applied retroactively to those plans within the time interval of the transference rules of IFRS 2. The recommendation implies that Medivir values the relevant plans (currently the three plans , and ) at market value at issuance, then allocates the value over the accrual period as a personnel cost. This remuneration to staff means that Medivir issues its own financial instruments (warrants possessed by the staff providing entitlements pursuant to the agreements in the plans). In consequence the costs for each period are reflected by the corresponding increase in other paid-up capital (premium fund in the parent company). The parent company Medivir AB has adopted IFRS 2 for its accounting of stock option plans from 1 January 2005 onwards. This has meant retroactive adoption of IFRS 2 for the same periods as the group. The adoption of IFRS 2 results in personnel costs of sek 2.1 (1.5) m in the group, and the capital reserve other paid-up capital increasing by the same amount. Shareholder agreement and pre-emption An agreement exists between holders of class A shares in Medivir, stipulating that the parties will behave in accordance with decisions reached on relevant issues by the parties prior to shareholders meetings. If, during their preparatory deliberation, the parties are unable to agree on a particular issue, the resulting decision is that opinion represented by the majority of class A share votes represented during the deliberation process. Furthermore, the agreement implies that if holders of class A shares wish to transfer their class A shares in the company to another holder of class A shares or a third party, the shares will be converted into class B shares. The same applies if a party acquires class A shares in the company in any other way. If a majority of the holders of class A shares so decide, the class A shares will have the facility for transfer to a new owner without conversion, at which point the new owner will become party to the current shareholders agreement for holders of class A shares. For class A shares, pre-emptive rights apply pursuant to the Articles of Association. 11

14 The art of managing risk and creating opportunities Medivir s existing and potential shareholders are aware that investing in a research and pharmaceutical company implies high risk. Generally, some 85% of all candidate drugs (CDs) are unsuccessful in the clinical development phases on the route to market registration. This fact demonstrates the complexity and risk levels inherent in pharmaceutical development. From an operational perspective We have two types of risk to address operational and financial. Medivir has worked strategically and on a goal-oriented basis for many years to lay the most stable foundation possible, but nevertheless, there are still always factors we cannot influence. Each development phase generates new results that can affect the company and our projects. Our strength is that rather than focusing our business on specific therapy areas, we ve opted to focus on a single approach to an array of disorders we develop protease inhibitors and we do so efficiently, with good results, comments Rein Piir, Medivir s Chief Financial Officer. Proteases are a type of enzyme involved in many diseases, and in the wrong circumstances, can create a lot of problems for the body. With Medivir s know-how and capacity in preclinical and clinical development, we can run several projects in different development phases simultaneously. This enables us to diversify and reduce operational risk we ve always got a pipeline of projects to top up from if one should fail. From a financial perspective Pharmaceutical development projects consume a lot of time and resources; the further a project is taken through clinical development, the more resources are needed. To achieve success, Medivir enters partnerships with pharmaceutical companies in various phases of the development process. At this point, Medivir considers its own needs and those of the project. Medivir has several partnerships with established pharmaceutical companies and smaller biotech enterprises. These collaborations strengthen us, and create stability and opportunities. Our partners assume responsibility for project funding, and Medivir receives revenue through milestone payments when projects progress towards the market. This revenue helps us fund other parts of our business. The key thing is to maintain a good mix of partnership structures, both in early research collaborations and on projects in later-phase clinical development. The financial paradigm shift occurs on the day our own compound becomes a pharmaceutical on the market, continues Rein Piir. Forward integration Medivir is consciously moving its position slowly but surely forward, from being a pure research enterprise into becoming a research-based pharmaceutical company with an in-house sales function. We took our first step when we decided to conduct a clinical phase III study on Lipsovir inhouse, which is the final phase before a compound can be approved as a pharmaceutical. This project was a good experience, and clearly demonstrated that we have the know-how and capacity to lead a phase III program, but it s also taken time, money and resources. Our objective is to enter partnerships after we ve seen the results from this program. A partnership agreement for a project with strong phase III results is a commercial marketing agreement rather than a research collaboration. In tandem with this process, Medivir has started work on seeking collaborations with established pharmaceutical companies to help them sell their products. This is how we hope to pave the way for our own smaller-scale, fast-moving Nordic sales function that can focus on selling pharmaceuticals to specialists and clinics. The revenues this generates will consolidate our cash reserves and reduce our financial risk. Risk management is an ongoing process that creates the best prospects for the company s projects. 12

15 Freedom of choice for investors Investors in research and pharmaceuticals companies have plenty of characteristics to study: therapy focus, platform focus, geographical exposure and the breadth and maturity of project portfolios to name but a few. The majority of Medivir s shareholders are in the Nordic region, and many probably see advantages in investing in a company from their own region, listed on a Nordic exchange. For example, many Nordic investors have exhibited acute interest in the potential of the Lipsovir project. However, our foreign investor share has increased. US investors especially joined Medivir as shareholders in Their primary interest is in the hepatitis C program Medivir is running in collaboration with Tibotec, which is now in phase IIa. Medivir has to explain how we work on our projects, and how these projects are doing compared to competitors. It s also important that we re unequivocal about what the company is doing to reduce the various risks associated with our operations, and highlighting the opportunities inherent in our projects, adds Rein Piir, we do this by regularly meeting potential and current shareholders. We re also committed to meeting Nordic and multinational investment banks that show an interest in our work. Awareness of Medivir outside the Nordic region has grown significantly over the past two years. Capital markets activities In 2007, Medivir participated in about 10 investor conferences, conducted over 50 investor presentations and held a capital markets day for institutional investors and investment banks. Medivir was actively monitored by eight Nordic investment banks and their analysts in Certain Medivir projects are also monitored actively by several international investment banks. R E I N P I I R CHIEF FINANCIAL OFFICER What s most important to Medivir in the coming years? In the short term, the forthcoming phase III results on Lipsovir are important, and clearly, we hope they fulfill our expectations. It is also important that the recently started process to seek collaborations with established pharma - ceuticals companies turns out well. Continued success with our hepatitis C project, TMC435350, is also highly significant to Medivir. In the long-term, it s essential that we continue to produce products that are very likely to achieve market launch. Obviously, we also hope that our licensees will continue to take projects forward at least as effectively as they did in

16 Operations Business orientation Medivir s current focus is on research and development projects involving proteases (a class of enzyme) and protease inhibitors. These are targeted at major therapy areas including hepatitis C, HIV, osteoporosis, osteoarthritis, bone metastases, chronic obstructive pulmonary disease (COPD) and hypertension. Medivir was formerly also active on compounds whose purpose was to block polymerases, another enzyme class. Apart from the projects reviewed on pages 16-17, early phase activities in the protease inhibitor segment are also conducted in collaboration with partners, or in networks with various universities. These early activities are intended to create a continuous flow of new ideas, thus ensuring the long-term supply of new projects for Medivir. Medivir s project portfolio is reviewed on page 18. Focus Taking pharmaceutical development from original idea to clinical studies requires focus and high efficiency. Thanks to its specialization on a single enzyme class, Medivir can take a relatively high number of parallel early projects into preclinical research, despite the company s limited size. Here, in these preclinical phases, Medivir enjoys its greatest competitive edge the ability to produce candidate drugs in a very time-efficient manner. For onward development after projects reach late preclinical or early clinical phases, the company s chosen strategy is to enter partnerships with other companies. Clinical development is far more resource intensive, both financially and in terms of know-how. The need for resources and know-how in various therapeutic areas means that often, it is more appropriate to allow established pharmaceutical companies to take projects onwards to market registration. Partnerships Medivir enters partnerships in various development phases. One example of an early-phase collaboration is the protease inhibitor TMC against hepatitis C, which was outlicensed in early preclinical research. This project is being conducted in collaboration with Tibotec, and after just three years after outlicensing, is already in phase IIa studies. The cathepsin K inhibitor MIV-701 against bone degradation diseases is an example of a project Medivir has opted to take onto early clinical development itself. In 2007, Medivir took the project into clinical development until phase Ib, where measurement of biomarkers for bone degradation demonstrated the desired good efficacy. Some unique opportunities to take projects towards market registration in-house may constitute exceptions to the principle of entering partnerships. Lipsovir against cold sores caused by labial herpes may be an example of a project where Medivir enters partnerships after phase III in the near future. Entering partnerships at the right time on each project is decisive to creating the greatest commercial returns over time. Selling pharmaceuticals step-by-step Medivir s ambition is to create a sales function, first and foremost for the Nordic market. A first step towards generating sales revenues will be to seek collaboration agreements with established pharmaceutical companies to sell specialist pharmaceuticals. More opportunities to generate sales volumes appear when future partnerships transform into rights to sales of selected products or smaller acquisitions. In its current partnerships, Medivir has retained the rights to sales and markets in the Nordic region, and in some cases, to other world regions (see also page 18). Looking further ahead, sales of these products will add sales revenues in Medivir s sales regions. However, the big revenue step-up occurs on the day one of the products Medivir has developed itself starts to generate royalty revenues via partners an active year In 2007, Medivir conducted seven clinical studies itself or alongside partners involving over 3,100 people, and started three clinical studies that are still proceeding. Lipsovir phase III program A total of five clinical studies concluded in the year; 2,450 patients were recruited to the pivotal study, 1,450 of which were treated with Lipsovir, acyclovir or placebo. Two supportive phase III studies were started and concluded in the year, involving 430 recruited and 240 treated patients. 80 patients were treated in two smaller-scale studies. The phase III program is now complete, and the results being compiled. These results are scheduled to be complete late March Assuming positive results, work on negotiating a partner or partners and structure for future sales of Lipsovir will be conducted in TMC hepatitis C project in collaboration with Tibotec Phase I studies began and were conducted in 2007 with very positive results. These results prove that TMC can be administered in low doses and once daily, a big competitive edge on other development programs in this segment. Based on the positive outcome of these studies, phase IIa studies started late in the year, which will involve 130 patients, 34 of whom have not responded to therapy with extant pharmaceuticals. 14

17 MIV-701 phase I study started and completed in 2007 In this phase I program, now completed, Medivir examined how an oral preparation of MIV-701 is absorbed and tolerated by the body. By studying what are termed biomarkers, Medivir also gained its first impression of the compound s efficacy against osteoporosis. The final part of the study involved a group of post-menopausal women (a group often affected by osteoporosis, which studied the effect of MIV-701 on biomarkers for osteoporosis. At a single daily dose of MIV-701 for 14 days, the effect on biomarkers proved that bone degradation reduced by approximately 50%. These results are consistent with Medivir s hopes and constitute proof of principle. Valomaciclovir (MIV-606) run by US company Epiphany Biosciences. Two clinical phase IIb studies were started in the late-autumn, the first against shingles, comparing MIV-606 against current market-leading pharmaceutical Valtrex. The second study is against glandular fever, a disease that currently has no effective pharmaceuticals. More potential CDs in preclinical research Resources for early preclinical research in the year were mainly assigned to conducting the cathepsin K protease projects (follow-ons to MIV-701), hepatitis C (follow-ons to TMC435350), HIV protease inhibitors in collaboration with Tibotec and the COPD project. Additionally, some early activities against hypertension (renin) and Alzheimer s disease (BACE) made advances. As more mature preclinical projects achieve successes in 2008, these early activities will be assigned additional resources and be taken to optimization. New partnerships for polymerase-based HIV/hepatitis B projects Three of the polymerase-based projects changed partners in the year: MIV-310, MIV-210 and MIV-160 all secured more suitable partners in the context of their prospects. Beijing Mefuvir Medicinal Technology Co. Ltd. of China will be responsible for and fund the clinical development and commercialization of MIV-310 and MIV-160 against HIV in Asia. Medivir has retained the market rights to these compounds outside Asia. Noken Pharmaceutical Industry Ltd. in China will be responsible for the funding and clinical development of the compound MIV-210 (in the hepatitis B segment). Medivir has retained market rights to the compound outside Asia. Project portfolio Medivir s project portfolio consists of 17 projects, seven of which are in clinical development, three in the regulated preclinical development phase and seven in the earlier preclinical phase. At present, nine of Medivir s projects are being conducted with partners, five of which are in the clinical development phase. 15

18 Project review Polymerase inhibition/hydrocortisone Protease inhibitor Polymerase inhibitor Medivir AB Lipsovir Therapy area Topical combination therapy for recurrent labial herpes. TMC435350, HCV protease inhibitor Therapy area Treatment of hepatitis C virus (HCV) infection. MIV-701, cathepsin K inhibitor Therapy area Bone degradation diseases including osteoporosis, osteoarthritis and skeletal metastases. Phase Phase III studies completed in 2007; results will be reported in March Phase Phase II studies initiated in November Phase Phase I studies completed (single and multi-dose and proof of concept). Competitive edge The first treatment with substantial efficacy against recurrent labial herpes expected to prevent occurrence of cold sores with early treatment onset. Competitive edge HCV NS3/4A protease inhibitor with excellent antiviral activity in the replicon cell-based assay. Phase I studies proved that the CD, TMC435350, is well tolerated and demonstrated very good oral bioavailability, enabling a single daily dose. Competitive edge Cathepsin K inhibitors markedly decrease degradation of bone without effecting bone formation, which is expected to lead to improved strength of the skeleton. Rapid onset and offset of inhibitory activity on bone resorption is a marked advantage over current commonly prescribed pharmaceuticals. Project data First treatment of recurrent labial herpes with potential to prevent lesion development. Low risk for adverse events. Genital herpes is a potential second indication. Project data Collaboration with Tibotec Pharmaceuticals Ltd. since late TMC is a highly potent HCV NS3/4A protease inhibitor. Phase I study (healthy volunteers Ia and patients Ib) conducted in TMC now being evaluated in a phase IIa study. Project data Phase I study provides proof of concept for MIV-701 and thus the cathepsin K program. Goal of entering a collaboration to develop MIV-701 for osteoporosis and other indications. Three main products in 2007 usd m* Valtrex GlaxoSmithKline 1,762 Zovirax GSK/Biovail 350 Famvir Novartis 272 Three main products in 2007 usd m* Pegasys Roche 1,290 Pegintron Schering-Plough 880 Rebetol Schering-Plough 280 Three main products in 2007 usd m* Fosamax Merck 3,042 Actonel Procter & Gamble Not available Evista Eli Lilly 1,075 Renin BACE Cathepsin S Therapy area High blood pressure, organ protection. Therapy area Protease inhibitor for treating Alzheimer s disease. Therapy area Autoimmune diseases e.g. rheumatoid arthritis, multiple sclerosis and chronic pain. Phase Heading towards preclinical optimization phase. Phase Heading towards preclinical optimization phase. Phase Heading towards preclinical optimization phase. Competitive edge Blood pressure reduction combined with a potential positive effect on end-organs, e.g. heart and kidneys. Competitive edge Potent and selective BACE inhibitors with promising pharmacokinetics have been identified. BACE inhibitors have the potential to become the primary therapy to block the development of Alzheimer s disease. Competitive edge Cathepsin S inhibitors have the potential for improved efficacy, fewer side-effects and better cost-effectiveness than current autoimmune therapies. 16

19 Cathepsin K inhibitor (follow-on) Therapy area Bone degradation diseases including osteoporosis, osteoarthritis and skeletal metastases. COPD Therapy area Chronic obstructive pulmonary disease (COPD). HIV-PI Therapy area HIV. Phase Designating clinical CD. Phase Preclinical optimization phase. Phase Preclinical optimization. Competitive edge Cathepsin K inhibitors markedly decrease degradation of bone without affecting bone formation, which is expected to lead to improved strength of the skeleton. Rapid onset and offset of inhibitory activity on bone resorption is a marked advantage over current commonly prescribed pharmaceuticals. Competitive edge Potent protease inhibitor with good selectivity. There is currently no satisfactory treatment against COPD. Competitive edge HIV protease inhibitors with highly potent antiviral effect against both wild-type and multiresistant virus has been identified. Very positive pharmacokinetics may enable single daily dose. Project data Highly potent and selective cathepsin K inhibitor. Long effect duration in preclinical models. Two patented new compound classes. Project data Highly effective and selective inhibitor compounds. High and significant efficacy in a preclinical test model of COPD. Good oral bioavailability. Project data Collaboration with Tibotec Pharmaceuticals Ltd since 30 June Several series of potent compounds against wild-type HIV and resistant virus. Three main products in 2007 usd m* Fosamax Merck 3,042 Actonel Procter & Gamble Not available Evista Eli Lilly 1,075 Three main products in 2007 usd m* Seretide/Advair GlaxoSmithKline 6,725 Symbicort AstraZeneca 1,462 Pulmicort AstraZeneca 1,407 Three main products in 2007 usd m* Truvada Gilead Sciences 1,477 Kaletra Abbot 1,250 Reyataz Bristol-Myers Squibb 1,045 HCV POL Therapy area Treatment of hepatitis C virus infection. *The sales figures are for Q Q Phase Preclinical optimization. Competitive edge HCV polymerase inhibitors. Clinical studies have shown that efficient inhibition of virus duplication can be obtained. 17

20 P r o j e c t r e v i e w Prioritized projects Project Indication(s) Partners/ Date of agreement Terms Medivir s markets Explorative phase tion dev. 1 Phase I Phase II Phase III Optimiza- Preclinical NDA Lipsovir (ME-609) Labial herpes In-house TMC (HCV-PI) Hepatitis C Tibotec / meur+royalties FTE funding Nordic region MIV-701 (Cath K) Osteoporosis, osteoarthritis, bone metastases In-house Cathepsin K Osteoporosis, osteoarthritis, bone metastases In-house HCV POL Hepatitis C Roche / 2003 / In-house Undisclosed Nordic region HIV PI HIV Tibotec / 2006 COPD PI COPD In-house (Hengrui) Renin Hypertension In-house 64 meur + royalties and FTE funding Nordic region World exc. China BACE Alzheimer s In-house Cathepsin S Rheumatoid arthritis, multiple sclerosis In-house Polymerase inhibitor projects Project Valomaciclovir (MIV-606) Alovudine (MIV-310) MIV-210 MIV-150 Indication(s) Shingles, herpes virus Partners/ Date of agreement Epiphany Biosciences / 2006 Terms 24.5 musd + royalties. Epiphany shares Medivir s markets Nordic region HIV Mefuvir/2007 Royalties World excl. Asia Hepatitis B, HIV HIV Hainan Noken/2007 Population Council / 2003 MIV-160 HIV Mefuvir/2007 MIV-410 HIV, CMV Presidio / musd + royalties Mefuvir shares and royalties musd + royalties. Presidio shares World excl. China, Taiwan and Macao Option on 50% of Western world World excl. China, Taiwan and Macao Nordic region and UK. Option on Europe Explorative phase tion dev. 1 Phase I Phase II Phase III Optimiza- Preclinical NDA MIV-170 HIV Polymerase inhibition/hydrocortisone Protease inhibitor Polymerase inhibitor 1) The regulated preclinical development phase. Preclinical research phases Explorative phase identifying active hit compounds. Lead identification identifying feasible compounds with drugable potential. Optimization phase this stage is focused on producing the optimal compound/ compound class possessing pharmaceutical potential. Towards the end of this phase, CDs (candidate drugs) are designated. IND-late preclinical development the final working phase before designated CDs enter clinical studies. This phase is authority regulated and includes extensive safety studies, pharmacokinetics, metabolism studies and is when the first kilogram-scale amounts of the active compound are produced. Applications for regulatory approval for clinical trials of designated CDs are also filed. Clinical development phases Phase I trials of the CD on healthy volunteers, usually involving 20 to 50 individuals. Phase I is divided into two parts. In phase Ia, a single dose of increasing strength, then repeat doses, are administered to healthy volunteers. Sometimes, phase Ib studies are conducted, on a small group of patients for a short period. Phase II the first trials on patients suffering from the target disorder. Studies usually encompass 100 to 500 patients, with efficacy and safety assessed. Phase II is also divided into two parts. Phase IIa is intended to demonstrate that the course of the disease can genuinely be influenced. Phase IIb demonstrates the efficacy of various doses on the course of the disease. Phase III comparative trials on a large sample of patients to measure efficacy in relation to other treatments, if any exist, as well as safety. NDA New Drug Application, which often requires Phase III trials as documentation. 18

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