EFTA00596368.pdf

Global Insulin Opportunity a generic solution to supply constraints ERivium At FUNDS lac EFTA00596368 Special Note Regarding Forward Looking Statements Preface This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements give our current expectations or forecasts of future events. Words such as "expect," "may," "anticipate," "intend," "would," "will," "plan," "believe," "estimate," "should," and similar expressions identify forward-looking statements. Forward-looking statements in this presentation include express or implied statements concerning our future revenues. acquisitions, expenditures, capital or other funding requirements, the adequacy of our current cash and working capital balances to fund our present and planned operations and financing needs. expansion of and demand for our product and services offerings, the growth of our business and operations as well as future economic and other conditions both generally and in our specific geographic and product and service markets. These statements are based on our estimates, projections. beliefs and assumptions and are not guarantees of future performance. We caution that these risk factors. among others. could cause our actual results to differ materially from those expressed in forward-looking statements made by or on behalf of us in this presentation. Our forward-looking statements relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward- looking statements, whether as a result of new information. future events or otherwise, even if experience or future changes make it clear that any projected results or events expressed or implied therein will not be realized. THIS PRESENTATION IS CONFIDENTIAL INFORMATION OF PRIVIUM FUNDS, LLC THE INFORMATION CONTAINED IN THIS PRESENTATION IS CONFIDENTIAL AND PROPRIETARY TO THE COMPANY. IT IS BEING PRESENTED TO PROSPECTIVE INVESTORS SOLELY FOR SUCH INVESTORS' CONFIDENTIAL USE, WITH THE EXPRESS UNDERSTANDING THAT, WITHOUT THE PRIOR PERMISSION IN WRITING FROM THE COMPANY, RECIPIENTS WILL NOT DISCLOSE OR DISCUSS THIS PRESENTATION OR THE INFORMATION CONTAINED HEREIN WITH ANY OTHER PERSON OTHER THAN PERSONS AUTHORIZED BY THE COMPANY AND FOR ANY PURPOSE OTHER THAN EVALUATING A POTENTIAL INVESTMENT IN THE COMPANY. 2 l m„c FUNDS EFTA00596369 Insulin Pricing Can be Undercut by up to 50% Strategic Overview By leveraging a unique manufacturing process, Privium will capitalize on pricing inequities and penetrate the global marketplace Strategic Overview • Become renowned for making available the purest form of insulin to the widest number of users in target countries worldwide, offering it through the most convenient distribution channels in the most cost effective manner, thereby playing a role in alleviating the suffering of diabetic users • Foment and nurture long term business partnerships with the leading medical providers in each target country to ensure speedy approval, effective and cost efficient distribution of our products to the widest user base 3 PRIVIUM -SW FUNDS EFTA00596370 Market Trends Trends Diabetes is an under served epidemic due to supply and cost constraints Over 1.5MM New Cases of Diagnosed Diabetes/Year in the U.S. Alone Estimated New Cases of US Diagnosed Diabetes by Age 1.000.000 Group 1 819.000 800.000 600.000 536,000 400.000 218.000 200.000 20-39 40-59 60+ 6MM individuals in the U.S. alone take insulin and 50MM people worldwide As there are 27MM people in the U.S. with diabetes and 250MM worldwide, oral insulin would expand current usage by several fold 1. Estimated number of new cases of diagnosed diabetes in people aged 20 years or older, by age group, United States, CDC 2007 pD IVIUM 4 NDS EFTA00596371 `Bio-Same' not Biosimilar Product: 1St True Generic Insulin Business Vision The likelihood of an AB-rating should mandate health insurers to convert to this product globally Sio-Same' not Biosimilar Insulin Therapy Category of Data Non-AB Route AB Route CMC Data Comparative analysis Rigorous comparative analysis Bioassay Data One comparative bioassay Two comparative assays Preclinical DATA May be waived (I) May be waived (') Rigorous comparative PK study to Rigorous comparative PK studies to PK/PD listed reference drug listed reference drug Immunogenicity Data Comparative data (2) Comparative data (2) Efficacy data required (3) Efficacy from Clinical trials (immunogenicity data can be obtained Not mandatory simultaneously) Additional Considerations for CMC Data for Filing (1) If the CMC data is found acceptable. (2) Fifty (50) patients are allowed for 6 months. Comparative data may would be either historical data or an active control obtained through a clinical efficacy trial. (3) A non-inferiority study is recommended. The demonstration of non-inferiority with respect to one indication (for the listed Ax) may be sufficient to obtain all of the indications described in the listed Rx's prescribing information (provided there is no active market exclusivity that precludes this). 5 PR IUM FuN IVDS EFTA00596372  Intellectual Property (IP) Scope BUS VOSS V'S Or. There is an opportunity to own the entire sphere of core insulin products. Initially, we will cannibalize the vast opportunities in the regular generic insulin market; an expansion into other forms will follow Scope of current core Generic Insulin IP The generic insulin scope has Lantus Other WIP activities been defined as: that will expand the IP scope • All insulin related products including glucagon • All products related to insulin. including oral and inhaled bulk suppliers Humalog Novalog • The production of insulin as a minor fraction of the cost • Advanced methodology such that no other generic player can come in for duration of IP (18 years) • Analytical tools and capabilities to support protein therapeutics in other areas Glucagon Manufacturing IP is the center of the patent estate and a full suite of patents have been filed and issued globally In each division, there is room for IP discovery to move into othecell formulations, such as oral insulin 6 aPRIvium a FUNDS LLc EFTA00596373 Next Steps Next Steps • U.S. regulatory authorities have approved IND for human clinical trials and regulatory approval abroad is ongoing for generic-rated product in the next several months • Current facilities have capacity for twice the current U.S. demand and country-specific agreements are being negotiated for regular injectable insulin • Production and facility infrastructrure costs are a fraction of the cost of current processes, thereby opening the potential for a first-in-class pill-form insulin, which is subject to negotiation with Privium • Other analogs of insulin are also being developed in conjunction to complement current therapeutic usage and also subject to in-licensing with Privium • Glucagon in both injectable and pill form are available for discussion separate from insulin and insulin derivative agreements • Contact Privium for partnering discussion related to Human Growth Hormone opportunities that are manufactured in the same U.S. facility 7 PR IUM FuN IVDS EFTA00596374