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Company Presentation November 2010 Dr Julian Gilbert.

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Presentation on theme: "Company Presentation November 2010 Dr Julian Gilbert."— Presentation transcript:

1 Company Presentation November 2010 Dr Julian Gilbert

2 Introduction Acacia Pharma is a focused, cancer supportive care company –A significant, growing commercial opportunity with high unmet needs Experienced management team, track record of value creation Investment from Gilde Healthcare Partners & Management Generated a clinical pipeline with multiple, near term, value inflection points, using proprietary in-house R&D “engine” –High probability of success, based on established drugs –High value, unmet medical need Investment of £6.5 million from Gilde & Management –Cash through to December 2011 delivering Phase I & II for APD515 (xerostomia) Phase IIa PoC for APD421 & APD403 (PONV & CINV) Phase IIa PoC for APD209 (cancer cachexia)

3 Team Dr Julian Gilbert – CEO –Commercial Director & Co-founder, Arakis SK&F, BTG, Mundipharma, Chiroscience Dr Robert Gristwood – CSO –CSO & Co-founder, Arachnova Pfizer, SK&F, Almirall, Chiroscience Andrew Muncey – CFO –CEO, Amura Swiss Bank Corp, PwC, Lorantis Dr Gabriel Fox – CMO –Head, Global Oncology Marketing, Roche NeXstar, Gilead Dr Ian Walker – Head of Project Leadership –Head of Development, Arakis Reckitt & Colman, Ethical, Quadrant

4 Focus Acacia Pharma is a hospital focused pharmaceutical company Advantages of a hospital focus: –Target areas of high unmet medical need –Be competitive (many large pharma focused on primary care) –Develop products through to the marketplace –Retain product rights, thereby value, through own sales Acacia Pharma has a therapeutic focus in cancer supportive care –The management of symptoms of cancer and the side effects of treatment of cancer This therapeutic focus provides –Focused sales route via specialty hospital physician, the oncologist –A clear commercial opportunity with a coherent set of conditions

5 Healthier patients can tolerate higher doses of cancer therapy Improve the patients’ quality of life (QoL) Cancer supportive care – the opportunity

6 Cancer supportive care – the commercial opportunity Significant commercial successes within cancer supportive care –Erythropoietins for cancer related anaemia (eg Aranesp, $4.4bn*) –GCSFs for neutropenia (eg Neupogen, $1.4bn) –5HT 3 -antagonists for nausea & vomiting (eg Zofran, $1bn) –Bisphosphonates for metastatic bone disease (eg Zometa, $1.2bn) –CR opioids for cancer pain (eg Oxycontin, $3bn) –IR opioids for cancer breakthrough pain (eg Actiq, $284m) Despite this there appear to be –Limited product opportunities in development (PharmaProjects & Datamonitor 2007) –Few companies focused within the space Significant opportunity existed for Acacia to become a leading cancer supportive care company * 30-40% sales in CSC

7 Discovery & development Discovery & development based on established drugs –Higher probability of success, more rapid development, lower cost Commercially led process, driven by unmet needs of the oncologist Product differentiation (from marketed drug) and patent protection key –Significant internal experience Process has been used to nominate the four clinical development opportunities: –APD209 – cancer cachexia –APD421 & APD403 – nausea & vomiting (PONV & CINV) –APD515 – xerostomia in advanced cancer patients Condition Unmet need Required biology Drug/ delivery Patents

8 Cancer cachexia – market need Cancer cachexia is an area of enormous unmet need –Complex condition, multiple metabolic dysfunctions and cytokine abnormalities, present in 50% of cancer patients; strong association with poorer survival and reduced QoL Major unmet needs exists - no approved therapy or gold standard –Physicians seek Increased body weight, specifically muscle mass and function Increased appetite, normal function and fuel for increased mass Multiple mechanisms are required to get broad efficacy in this highly complex condition –Modulation of key cytokines –Anabolism, and preferably anti-catabolism Condition Unmet need Required biology

9 Cancer cachexia – APD209 Pharmacological target profile (PTP) – multifactorial pharmacology –Down-regulation of cytokines TNFα, IL-1, IL-6 and IFNγ Rectify abnormalities and stimulate appetite –Down-regulation of ubiquitin and caspase pathways Produce anabolism and anti-catabolism Acacia identified a product having the required pharmacological profile APD209 is an oral combo product, based on a known drug delivered currently by a “non-oral” route, for the new use cancer cachexia –New use and delivery provides both differentiation and IP –Sales estimated ~£300 million per annum Significant upside available in other muscle wasting conditions (eg frailty) Currently being investigated in a Phase IIa clinical study Required biology Drug/ delivery Patents

10 APD209 – preclinical data APD209 tested in Yoshida AH130 hepatoma model –Seven day model which rapidly produces cachexia –APD209 increased Appetite (food intake) Overall weight (body & carcass) Muscle mass (gastrocnemius – calf muscle)

11 Nausea & vomiting – market need Nausea & vomiting (NV) is a complex multi-pathway condition –Dopamine, neurokinin, serotonin, opioid, histamine involved Despite the products available on the market, a clear unmet needs still exists (MR and KOLs) –Improved efficacy, in particular Ability to reduce nausea Late stage CINV Effective against opiate induced sickness Safe D 2 antagonist for PONV Particular need for safe D 2 antagonism following the demise of droperidol, a particularly good anti-nauseant Condition Unmet need Required biology

12 Nausea & vomiting – APD421 & APD403 Pharmacological target profile (PTP) generated Identified a widely marketed, safe, oral drug, that meets the above –APD421/APD403 appears to be a “safe droperidol” APD421/APD403 is an IV formulation of this known drug for the new use of nausea & vomiting –IV route is route of choice for the anaesthetist and oncologist Ability to formulate drug in non-invasive presentations for use at home –New use and delivery route provides both differentiation and IP –APD421 sales estimated >£200 million pa in post-operative N&V (PONV) –Similar sales estimated for APD403 in chemotherapy-induced N&V (CINV) Clinical proof-of-concept to be initiated 1Q2011 Required biology Drug/ delivery Patents

13 APD421 – preclinical data (PONV) APD421 tested in gold standard ferret model –Morphine (a risk factor for PONV) used as emetogen –Significant anti-emetic effects seen in this challenging model

14 APD403 – preclinical data (CINV) APD403 tested in gold standard ferret model –Cisplatin (highly emetogenic chemotherapy) used as emetogen –Significant anti-emetic effects seen at very low doses

15 Xerostomia – market need Xerostomia is dry mouth due to change in composition or amount of secreted saliva – Discomfort, difficulty eating, dental caries and infection Up to 80% of advanced cancer patients suffer from the condition primarily associated with chemo & concomitants (MR and KOLs) –No registered treatment –Systemic salivary stimulants used off label High side effect and high tablet burden –Patient and physician seeks local treatment Local salivary stimulation required –Targeting the local salivary glands which are responsible for production of mucins and mouthfeel Condition Unmet need Required biology

16 Xerostomia – APD515 Pharmacological target profile (PTP) generated –Salivary stimulant with appropriate physical chemistry for local delivery Identified a marketed, oral drug, that meets the above criteria APD515 is an optimised buccal formulation of this known drug for the new use of xerostomia in advanced cancer –Buccal delivery meets physician and patient requirements –New use and delivery provides both differentiation and IP –Sales estimated >£120 million per annum in initial indication –Significant upside in hospital - early cancer, head & neck, Sjögren's, but also in the general geriatric primary care market Phase I to be initiated 4Q2010 with Phase II starting 2Q2011 Required biology Drug/ delivery Patents

17 APD515 – preclinical data APD515 tested in rabbit model (similar physiology to humans) –Up to five fold increase in salivary flow for duration of experiment (2hrs)

18 Milestones to the end of 2011 Product opportunityValue adding milestoneDate APD209 - cachexia Complete Phase II Pilot Initiate licensing plan Mar 2011 May 2011 APD421 & APD403 - nausea & vomiting Initiate Phase II PoC in cancer pts Complete Phase II PoC Jan 2011 Mar 2011 APD515 - xerostomia Initiate and complete Phase I PK Initiate Phase II dose ranging Complete Phase II dose ranging Dec 2010 Jun 2011 Oct 2011 APD421 - PONV Initiate Phase II dose ranging* Complete Phase II dose ranging Jun 2011 Dec 2011 * Subject to further funding

19 Exit opportunities Acacia Pharma provides investors with a number of exit opportunities –Trade sale based on cancer supportive portfolio at end of Phase II (2012) Valuations could be up to £150m at the end of Phase II (based on the sum of heavily discounted NPVs) –Divestment of specific products at the end of Phase II (PanGenetics model) Value linked to project’s NPV, we know there is an appetite for our projects –Other exit options exist Exit post Phase III - substantially improved valuation, but more time and more investment required IPO, not currently available, but our model supports this (late stage pipeline with opportunity to sell in-house) Key is to provide Board with options –Management experienced in deal doing –Significant number of companies are interested in the space –Portfolio lends itself to having different options available

20 Summary Focused cancer supportive care company with a leadership position in the area Lower risk development business model, that delivers product opportunities of high value in a cash efficient manner Experienced management team supported by appropriate external experts Supportive investor base Pipeline comprising four clinical stage developments –Rapid milestone achievement Commercially attractive products providing the opportunity to deliver significant return to stakeholders

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