Case File
efta-efta00596368DOJ Data Set 9OtherGlobal Insulin Opportunity
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DOJ Data Set 9
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efta-efta00596368
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Global Insulin Opportunity
a generic solution to supply constraints
AtERivium
FUNDS lac
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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.
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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
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Market 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
1.000.000
800.000
600.000
400.000
200.000
Estimated New Cases of US Diagnosed Diabetes by Age
Group 1
218.000
20-39
819.000
40-59
536,000
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
Trends
1. Estimated number of new cases of diagnosed diabetes in people aged 20 years or older, by age group, United States, CDC 2007
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`Bio-Same' not Biosimilar Product: 1St True Generic
Insulin
The likelihood of an AB-rating should mandate health insurers to convert to this
product globally
Business Vision
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 (')
PK/PD
Rigorous comparative PK study to
listed reference drug
Rigorous comparative PK studies to
listed reference drug
Immunogenicity Data
Comparative data (2)
Comparative data (2)
Efficacy from Clinical trials
Efficacy data required (3)
(immunogenicity data can be obtained
simultaneously)
Not mandatory
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).
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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
The generic insulin scope has
been defined as:
• All insulin related products
including glucagon
• All products related to insulin.
including oral and inhaled bulk
suppliers
• 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
Generic Insulin
Lantus
Humalog Novalog
Glucagon
Manufacturing IP is the center of the patent estate and a full suite of patents
have been filed and issued globally
cell
In each division, there is room for IP discovery to move into othe
formulations, such as oral insulin
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Scope of current core
IP
Other WIP activities
that will expand the IP
scope
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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
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