Unigene Laboratories (UGNE) 8-K Regulation FD Disclosure

Unigene Laboratories Inc.

Corporate Overview 2010

Exhibit 99.1

SAFE HARBOR STATEMENT

Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This

presentation contains forward-looking statements as defined in Section 27A of the Securities Act

of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such

forward-looking statements are based upon Unigene Laboratories, Inc.’s management’s current

expectations, estimates, beliefs, assumptions, and projections about Unigene's business and

industry.

Words

such

as

“anticipates,”

“expects,”

“intends,”

“plans,”

“predicts,”

“believes,”

“seeks,”

“estimates,”

“may,”

“will,”

“should,”

“would,”

“potential,”

“continue,”

and variations of

these words (or negatives of these words) or similar expressions, are intended to identify

forward-looking statements. In addition, any statements that refer to expectations, projections,

or other characterizations of future events or circumstances, including any underlying

assumptions, are forward-looking statements. These forward-looking statements are not

guarantees of future performance and are subject to certain risks, uncertainties, and assumptions

that are difficult to predict. Therefore, our actual results could differ materially and adversely

from those expressed in any forward-looking statements as a result of various risk factors. These

risks and uncertainties include the risks associated with the effect of changing economic

conditions, trends in the products markets, variations in Unigene's cash flow, market acceptance

risks, technical development risks and other risk factors detailed in Unigene's Securities and

Exchange Commission filings.

3

Outline

China Joint Venture

Introduction to Unigene and its Objectives

Unigene Technology Overview

Osteoporosis Treatments

Site Directed Bone Growth (SDBG)

University of London Collaboration

Obesity

4

Introduction to Unigene and its Objectives

University of London Collaboration

Unigene Technology Overview

Osteoporosis Treatments

Site Directed Bone Growth

Obesity

China Joint Venture

5

Unigene History

1980

1990

2000

Current

1980 

Unigene

Founded

1987

Unigene

Public

Offering

1995

Completed

cGMP Manu-

facturing

Facility

2004

Chinese NDA

for Fortical

Nasal and

Injectable

2001

Switzerland

Marketing

Authorization

Forcaltonin®

Injection

2005

US NDA

Approval for

Fortical™

Nasal Spray

2004

IND for Oral

PTH

1999

IND for Oral

sCT

1999          

EU Centralized

Marketing

Authorization

Forcaltonin®

Injection

1984 

Unigene

begins peptide

manu-

facturing

business

1994 

Unigene oral

peptide

technology

developed

6

Peptide Technology

Platforms

Therapeutic Product

Programs

Unigene’s Parallel Pathways To Business

Success

Unigene Dual

Business Model

Secrapep™

r-DNA Peptide Manufacturing

Enteripep™

Solid Dosage Oral Peptide Delivery

Nasapep™

Nasal Peptide Delivery

Oral PTH analog

Oral Calcitonin

Osteoporosis

Osteoarthritis / Combination Rx (Tarsa)

Combination Products (QMUL)

Site Directed Bone Growth

Obesity

Annexin

1

Broad patent portfolio covering platform

technologies and therapeutic products

Licensing technology

platforms to multiple

pharma

partners

Portfolio of drug

candidates

–

Internally developed

–

Out-licensed to partners

Peptide API manufacturer

for pharma

partners

Industry acceptance of

Unigene

technologies as

validated peptide

delivery and

manufacturing platforms

Clinical development

partnerships

Commercialization

partnerships for

products

7

Unigene’s

Mission: To Be an Industry leader in

Peptide Therapeutics

Industry leader in

developing peptide based

therapeutics utilizing

Unigene’s

technologies

Year 1

Year 2

Year 3

Year 4

Year 5

Year 6

Year 10

Unigene’s

Business Objectives Timeline

Current

Intermediate term

Longer term

8

Multiple Strategic Partnerships Validates

Technologies and Programs

Oral PTH Manufacturing and Oral Delivery License

Licensing and Clinical Supply Agreement for Recombinant

Calcitonin

Manufacturing

Marketing and Distribution of Fortical

®

Nasal Spray in US

Joint Venture for Marketing and Distribution of Oral and

Nasal calcitonin, PTH and other Biotechnology Products in

China,  Contract Manufacturing of Peptide/Protein API’s

New company formed by three VC groups and Unigene,

acquires license to commercialize oral calcitonin

product

currently in Phase III clinical study

Novartis

GSK

Upsher-Smith

SPG

Tarsa

Therapeutics

Inc.

9

Introduction to Unigene

and its Objectives

Unigene

Technology Overview

Osteoporosis Treatments

SDBG

University of London Collaboration

Obesity

China Joint Venture

10

Unigene

Technology Platforms Enable Patient

Friendly Cost Effective Therapeutic Alternatives

Oral Peptide Products

PTH Analogs, Calcitonin, Obesity

Peptides , Glucose Regulatory

Peptides, etc.

Enteripep

®

Unigene’s

proprietary oral

peptide delivery technology

Secrapep

®

Unigene’s

proprietary

recombinant peptide

manufacturing process

11

Challenges for Oral Peptide Delivery

Oral Peptide Delivery with Enteripep

®

Unigene’s

Enteripep

®

Technology Offers An

Innovative Solution For Oral Peptide

Delivery

•

Low absorption through the GI tract

–

Molecules with molecular mass greater than 300 (more than 2-3 amino acids) have limited

bioavailability

–

Hydrophilic nature of peptides inhibits absorption

–

Mucosal layer of GI tract binds charged molecules such as peptides, inhibiting absorption

•

Degradation of peptide in the digestive tract

Enteric coating permits passage through the stomach into the small intestine

Organic acid inhibits proteases

Absorption

enhancer

facilitates

the

uptake

of

the

peptide

by

a

paracellular

transport

mechanism

Absolute

bioavailability ranging from 1% to greater than 20% of the bioavailability of IV infusion,

depending upon the peptide

12

Secrapep

®

Recombinant Peptide Manufacturing

Secrapep

®

Peptide Manufacturing Platform

Delivers High Yield and High Product Purity

At Low Cost

E. coli Expression of Glycine

Extended Peptide

CHO Expression of

-Amidating

Enzyme

In-vitro Amidation

of peptide

NH

2

Amidated

Therapeutically Active

Peptide

97.4

66.2

45.0

31.0

21.5

14.4

6.5

kDa

Product of

Interest is

Secreted Directly

into the Culture

Medium

In-vitro

Amidation

•

Required for

peptides that need

C-terminal amide for

activity

•

Can enhance

bioavailability for

non-amidated

peptides

SDS PAGE of

Crude Medium

Enriched Starting

Material

Extracellular yields of

400 to 1300 mg/L

Reduced purification

steps

13

Introduction to Unigene

and its Objectives

Unigene

Technology Overview

Osteoporosis Treatments

SDBG

University of London Collaboration

Obesity

China Joint Venture

Osteoporosis Overview

•

Epidemiology

•

Global Prevalence (2008): 200 million, 80% female

•

US

Prevalence/Incidence

(2008):

59

million

total,

10

million

per

year

•

A large portion of potential patients are undiagnosed or diagnosed well after the

initial development of osteoporosis

•

~2/3 of hip fractures are associated with osteoporosis

•

Market Size

•

Global osteoporosis market is estimated to be ~$11.1 billion by 2010

•

Compound annual growth rate from 2000-2010 of 7.1%

•

US osteoporosis market is estimated to be ~$7.1 billion by 2010

•

Compound annual growth rate from 2000-2010 of 8.4%

•

Direct cost for treating osteoporosis-related fractures is greater than $48 billion per

year in North America and Europe combined

14

Source: “Osteoporosis Therapeutics: A Global Strategic Business Report” Global Industry Analysts, Inc.

15

Current Treatments For Osteoporosis

Selective Estrogen

Receptor Modulators

(SERM)

Parathyroid

Hormone

Evista®

(Eli Lilly)

Forteo®

(Eli Lilly)

Products

Treatment Class

Calcitonin

Fortical

®

(Upsher

Smith)

Miacalcin

®

(Novartis)

Generics

Activation of specific

estrogen receptors inhibiting

bone destruction

Bone anabolic agent which

stimulates osteoblasts,

increasing bone formation

Mode of Action

Mitigates bone resorption

by

inhibition of osteoclasts

Bisphosphonates

Fosamax®

(Merck)

Boniva®

(Glaxo-Roche)

Actonel®

(WC, SA)

Reclast®/Aclasta®

(Novartis)

Controls bone breakdown

and mitigates bone resorption

through osteoclast

inhibition

16

Factors Desired For Ideal Osteoporosis

Therapy

Calcitonin

SERM

Bis-phosphonates

Injectable

PTH

Deliver high quality bone

growth

Manageable side effect

profiles

Easy administration

Meets Need

Partially Meets Need

Fails to Meet Need

17

Calcitonin

18

Fortical

®

Nasal Spray

•

Fortical

®

Calcitonin-Salmon (rDNA

origin)

Nasal Spray Received Marketing Approval by

the FDA on August 12, 2005

•

Fortical

®

Nasal Spray is Currently Marketed

by Upsher-Smith Laboratories

•

Fortical

sales for year ending Dec 31 2009

were $50.8 Million

•

Fortical

Rx share Dec 2009 was 43%

•

Unigene

Income

from

Fortical

sales

in

2009

was  $10.9 Million

19

Novartis/Unigene

Oral Calcitonin

Collaboration

•

Oral Calcitonin

for Osteoporosis and Osteoarthritis

–

Novartis’

Phase III study with oral calcitonin

for osteoporosis (4,500

patients, 3 years) initiated February 2007, recruiting completed

•

Estimated filing for regulatory review 2011*

–

Novartis’

Phase III study with oral calcitonin

for knee osteoarthritis

(2,000 patients, 2 years) initiated May 2007, recruiting completed

–

Novartis’

second Phase III study with oral calcitonin

for knee

osteoarthritis initiated October 2008, recruiting completed

•

Potentially the first disease-modifying drug for osteoarthritis

•

Estimated filing for regulatory review 2011*

Dec

10,

2009

–

After

reviewing

1

year

safety

and

efficacy

data,

an

independent

Data

Monitoring

Committee informed Novartis and its partner Nordic Bioscience about their unanimous

recommendation to proceed with the Osteoporosis Phase III Study 2303 and the Osteoarthritis

Phase III Study 2301. 

* www.novartis.com/research/pharmaceutical-product.shtml

20

Oral Calcitonin Licensing Deal With Tarsa

Therapeutics

–

Tarsa Therapeutics, a new pharmaceutical company focused on the development of the Enteripep®

oral sCT program

–

Exclusive

license

for

Enteripep®

Oral

sCT

granted

to

Tarsa

by

Unigene

–

Tarsa to assume all development and commercialization responsibilities

–

David Brand, former GSK executive with 30 years pharmaceutical experience, hired as Tarsa’s CEO

–

Held senior management positions at GSK in marketing, business development and international

operations Involved in the launch of many products, including Paxil, Kytril, Coreg, Hycamptin,

Requip and Avandia

–

Assembled a Team of Seasoned Biopharmaceutical Executives to Commercialize the Asset

–

$24 million in Series A financing from leading healthcare VC firms

–

Syndicate members are MVM Life Science Partners, Quaker BioVentures and Novo A/S

–

Unigene’s financial participation

–

26% ownership of Tarsa

–

Unigene received $9 million at close for reimbursement of expenses related to the clinical study

–

Milestone payments associated with sales benchmarks

–

Unigene will receive pass through royalties on sale of product

–

Unigene holds one Board seat and Unigene’s Vice President of Product Development serves as

Tarsa’s Chief Scientific Officer

21

Tarsa

Therapeutics Development of

Unigene’s Oral Calcitonin

•

Unigene licensed it’s oral calcitonin product to Tarsa

Therapeutics in October of 2009

•

Tarsa

is pursuing 505(b)(2) pathway

•

Tarsa

Therapeutics is managing A global phase III trial

called the “ORACAL”

study

–

Compares oral calcitonin to intranasal and placebo in a

double blind, non-inferiority study

–

Trial has completed enrollment and data will be available

in spring of 2011 (www.clinicaltrials.gov)

•

For more information see (www.tarsatherapeutics.com)

22

Oral PTH Analog

23

Limitations of Injectable

PTH = The Need For

Unigene’s

Oral PTH Analog

Unigene

Oral

PTH

Solution

Injectable

PTH Limitations

High Patient Cost

Difficult

Posology

Black Box Warning

Restrictive Product

Label

Unigene’s

Secrapep™

technology establishes an attractive

COGs

as well as commercial scalability that will satisfy the

needs of oral administration

Oral dosing will increase patient acceptance and compliance

Potential room temperature stability of tablets would increase

convenience to patient

Concerns of osteosarcoma

with PTH therapy have largely

dissipated following several years of market exposure of

Lilly’s Forteo.  Possibility of new oral product without black

box warning

The availability of a safe, cost effective oral anabolic therapy

could alter the standard of care to bring PTH to the status of a

first line therapy for patients with established osteoporosis

24

Market Opportunity for Unigene’s

Oral

PTH Analog

25

Conclusions from Phase I Study                 

UGL-OR0901 and Path Forward

•

The amount of drug measurable in circulating plasma was

significantly

higher

than

reported

for

Forteo

®

at

the

20

µg

marketed dose

•

The dose variability in this study was significantly reduced

compared to previous studies with oral formulations

•

There were no cardiac events or other serious adverse events

reported during the study

•

The

bone

anabolic

activity

of

the

oral

PTH

analog

will

be

confirmed in a Phase II clinical study in osteoporotic women

measuring lumbar spine BMD and plasma PINP as the primary

and secondary endpoints

Unigene eligible to receive up to $142 million from GSK

in additional milestones through marketing approval

26

Unigene IP Protection May Create Barriers

Against Competitive Entry For More Than A

Decade

Coverage Region

Patent Title

Latest Patent Expiry

* Based on pending patent applications

US/ROW

Recombinant expression

for PTH Analog

2025

US/ROW

Oral delivery of

PTH Analog

2028*

27

Forteo®

Revenue Forecast (US)

$0.0

$200.0

$400.0

$600.0

$800.0

$1,000.0

$1,200.0

$1,400.0

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

Year

Revenue

U.S. Osteoporosis Market June 26, 2008

Frost & Sullivan Market Engineering

The

Market

For

Forteo

®

Has

Shown

Consistent

Growth

A new entrant, that

addresses

Forteo

®

deficiencies should

sharply accelerate

PTH adoption and

revenue growth

28

Life Cycle of Osteoporosis Drugs

(U.S. Sales)

Note: Bubble Diameter Indicates Segment’s 2007 Revenue Size.

Infancy

Early Growth

Late Growth

Maturity

Segment Life Cycle Stage

Calcitonins

$286.1 million

Parathyroid Hormones

$494.1 million

SERMS

$706.1 million

Bisphosphonates

$3,366.0 million

PTH In Early Growth Stage

•

Market growth potential

•

Room for competitive

products

•

Cost advantages can grow

market.

29

PTH Competitive Landscape

•High cost to patient

•Requires daily injection

•Refrigerated storage

•Black Box Warning

Issues

Forteo®

-

Lilly

•Market Leader

•IP Protection

•Only Anabolic on the US Market

Products

•No US Presence

•Difficult to Manufacture

•Only available as injectable

Preos

®

-

NPS/Nycomed

•Approved & Marketed in Europe

•Seeking US Indication for Hypo-

parathyroidism

Follow On Products 505(b)(2)

ZT-034 -

Zelos™

•Initiated Ph 1 trial for Injectable-

10/09

•Initiated Ph 1 trial for Nasal-

01/10

ZP PTH -

Zosano

Pharma

•Transdermal micro needle patch

•Completed Ph 2 study-

increased hip and

spine BMD

RF Transdermal Patch-

Transpharma/Lilly

•Phase 2b 1 year Study Projected

completion July 2011

30

Osteoporosis Treatments

SDBG

University of London Collaboration

Obesity

Introduction to Unigene and its Objectives

Unigene Technology Overview

China Joint Venture

31

Obesity Market

–

Obesity is growing faster than any previous public health

issue. If current trends continue, 103 million American

adults will be considered obese by 2018.

–

The U.S. is expected to spend $344

billion on health care

costs attributable to obesity in 2018 if rates continue to

increase at their current levels. Obesity-related direct

expenditures are expected to account for more than 21

percent of the nation’s direct health care spending in

2018.

–

The U.S. anti-obesity prescription market is expected to

grow

from

$262.3

million

in

2005

to

$1,774.1

million

in

2012 representing a CAGR of 31.4 percent.

References:

The

Future

Costs

of

Obesity:

National

and

State

Estimates

of

the

Impact

of

Obesity

on

Direct

Health

Care

Expenses

A collaborative report from United Health

Foundation, the American Public Health Association and Partnership for Prevention

November 2009

U.S.

ANTI-OBESITY

PRESCRIPTION

MARKETS

October 2006

Publisher: Frost & Sullivan,

32

Unigene Commercial Opportunities

•

Unigene class of peptides are covered by strong composition

of matter IP

•

Amenable

to

both

Enteripep

®

and

Secrapep

®

platform

technologies

•

Oral delivery advantage versus injection for all peptide based

products currently in clinical development

•

Unigene peptides shown to decrease food intake by greater

than 50% over placebo in rats

•

Importance of obesity treatment as unmet medical need is

highlighted by Amylin Pharmaceuticals signed $1 billion deal

with Takeda ($70 million upfront) for injectable peptide

products for obesity

33

Current Status of Unigene Obesity Peptides

•

Original anorexigenic peptide (presented at the Keystone

2009 Symposium) was UGP 269

•

Several additional peptides, including UGP271, UGP276,

and UGP281 have now been synthesized and tested

•

To date, the peptide with the highest potency is UGP281

Oral delivery studies

in beagle dogs are

currently ongoing

12.0

12.1

12.2

12.3

12.4

12.5

12.6

12.7

12.8

12.9

13.0

Weight Change Following Oral Capsule Administration of

sCT

or UGP269 in Beagle Dogs

No capsule

Group 2

UGP269

Placebo

No capsule

Group 1

0

7

14

21

28

35

No capsule

No capsule

UGP269

Days

Group 1

sCT

34

IP Position on Unigene

Obesity Peptides

•

Unigene

has filed for composition of matter as well as use patents

for these peptides.

•

Unigene

also has broad patent coverage on oral delivery of

peptides,

and

on

recombinant

production

and

in

vitro

amidation.

Placebo

UGP281

Peptide A

Days

Placebo

UGP281

Ppetide

A

Effect on Food Consumption and Weight of Rats

UGP281 has greater efficacy than other peptides in

clinical development

-80

-60

-40

-20

0

20

-2

-6

-4

-2

0

2

4

0

2

4

6

8

10

12

14

16

35

Introduction to Unigene

and its Objectives

Unigene

Technology Overview

Osteoporosis Treatments

SDBG

University of London Collaboration

Obesity

China Joint Venture

36

SDBG: A Revolutionary Technology

Developed in Collaboration With Dr. Agnès Vignery of Yale University

–

SDBG technology promotes growth of bone to specific skeletal sites

–

Spine: as treatment and/or prevention of vertebral crush fractures associated

with osteoporosis

–

Hip:  Prevention of hip fracture in patients at high risk and potential treatment to

accelerate healing

–

Trauma Fractures: Potential therapy to accelerate fracture repair in non-

union

fractures

–

Novel therapy involving a minimally invasive surgical procedure followed by

drug therapy

–

Bone marrow in targeted bone is removed by irrigation.

–

Follow-up bone anabolic treatment with bone anabolic therapy for 6 months to 1

year promotes accelerated bone growth to irrigated section as well as overall

benefits to the skeleton

–

Bone cement can be employed where stabilization of bone is needed and

provides a scaffold for new bone growth

–

Strong IP position on combination therapy, surgical devices and cement

Two issued Unigene patents covering combination therapy

37

Projected Incidence Of Vertebral Crush Fracture

(VCF) Treatments, Hip Fractures and Traumatic

Non-union Fractures

0

100000

200000

300000

400000

500000

VCF Repair Procedures

Hip Fractures

Long Bone Non-union Fractures

Data collected and prepared from

numerous sources by Unigene

contracted market research firm

38

Bone Marrow Irrigation Promotes a Transient

Induction in Bone Formation:

Anabolic Treatment Augments the Response

Control

Treated

39

Bone Augmentation In Conjunction With

Biocompatible Cements*

•

Proprietary BioCompatible

Cement 

–

Cohesiveness

–

Hardness

–

Osteo-inductive and conductive

–

Proper flow characteristics

•

Combination Of Cement And Anabolic Resulted In             

Unexpected Increase In Cortical Bone Thickness

Increased

cortical bone

thickness

* Q. Zhang, J. Carlson, HZ. Ke, J. Li, M. Kim, K. Murphy,  N. Mehta , J. Gilligan, A Vignery.

Dramatic increase in cortical thickness induced by femoral marrow ablation followed by a three-

month treatment with PTH in rats.

JBMR Feb 2010,

40

Unigene Opportunities (Licensing Strategy)

•

License to large pharmaceutical company

–

Allows full development of technology

–

Requires company with presence in medical devices

and pharmaceutical products

•

License to surgical device specialty company

–

Greater number of potential partners

–

Unigene has option of holding marketing rights or

licensing separately the anabolic therapy

41

Introduction to Unigene and its Objectives

Unigene Technology Overview

Osteoporosis Treatments

SDBG

University of London Collaboration

Obesity

China Joint Venture

42

Annexin

1 Peptide

In Collaboration With Dr. Mauro Perretti

Of Queen Mary College University

of London

–

Annexin

1 (Anx-A1) is one variant of a large group of

proteins that bind cell membranes in a calcium-dependent

manner.

–

Some of the anti-inflammatory actions of glucocorticoids

have been shown to be due to the up-regulation of Anx-A1

and its receptor (FPRL-1)

–

Exogenous ANXA1 and N-terminus derived peptides inhibit

leukocyte recruitment in several experimental rodent models of

rheumatoid arthritis, stroke and myocardial infarct

–

N-terminal fragments of the Anx-A1 retain the anti-

inflammatory potency of the full-length molecule

–

Analogs of N-terminal fragments currently being developed

will provide new composition of matter IP

43

Annexin

1 Commercial Opportunities

–

Potential Indications:

–

Percutaneous

Coronary Angiography

–

Organ Transplantation

–

Reperfusion Injury

•

Stroke

•

Myocardial infarction

–

Chronic Inflammatory Conditions

–

Ophthalmic inflammation

–

Unigene will file for composition of matter IP

–

Peptides can be manufactured using Secrapep

®

technology

44

Combination Products With

Salmon Calcitonin

45

Calcitonin Plus Low Dose Glucocorticoid

Dramatically Reduces Inflammation

•

Calcitonin combination

reduces glucocorticoid dose

by 5 fold in rat inflammation

model

•

Reduces side effects of

chronic glucocorticoid

therapy

•

Enables chronic use of

glucocorticoid for

rheumatoid arthritis and

other inflammatory

conditions

Clinical Score (units)

0

10

20

11

13

16

20

24

26

Time post-CIA (days)

control

sCT (2 µg/kg/day)

sCT+Pred

(3 mg/kg/day)

sCT+Pred

(0.6 mg/kg/day)

Pred

(3 mg/kg/day)

Pred

(0.6 mg/kg/day)

46

Introduction to Unigene and its Objectives

Unigene Technology Overview

Osteoporosis Treatments

SDBG

Obesity / Satiety

Annexin

China Joint Venture

47

Unigene Biotechnology Co. (China)

–

Joint venture of Unigene and SPG of China

–

45% owned by Unigene Laboratories Inc.

–

Groundbreaking April 2008

–

Exterior construction completed

–

Goal to be operationally compliant with

FDA and ICH guidelines

–

Manufacturing

–

Bacterial fermentation (expansion suites)

–

Tablet manufacturing

–

Liquid fill suites

48

Unigene Biotechnology Co. (China)

•

China Represents One of the Fastest Growing Pharmaceutical

Markets in the World

•

CSPC is One of the Most profitable Pharmaceutical Companies in

China

•

Listed on the Hong Kong Stock Exchange

•

Principally Owned by Lenovo Holdings

•

Near Term Market Opportunity Under Chinese NDA for:

–

Oral and Nasal sCT products

–

PTH (Injectable and Nasal)

•

Developing Peptides for Diabetes

–

Exenatide  and Others

•

Opportunity for Small Molecule Generics

•

Contract Peptide API Manufacturing for Big Pharma