DRY EYE TREATMENT - MaxVal dry eye treatment. ... Overview of Dry Eye Treatment tears Artificial...

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SAMPLE REPORT Draft A report by MaxVal Group, Inc._Sourabh December 11, 2009 DRY EYE TREATMENT VERSION - II Market and IP Survey Report (Sample report)

Transcript of DRY EYE TREATMENT - MaxVal dry eye treatment. ... Overview of Dry Eye Treatment tears Artificial...

Page 1: DRY EYE TREATMENT - MaxVal dry eye treatment. ... Overview of Dry Eye Treatment tears Artificial Alcohol eye drops Punctal plugs Fatty acid tears/ Ointments Oral dosage forms .

SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh December 11, 2009

DRY EYE TREATMENT VERSION - II

Market and IP Survey Report (Sample report)

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh December 11, 2009

TABLE OF CONTENTS

OBJECTIVE .............................................................................................................................. 1

SUBJECT OF THE SEARCH ................................................................................................... 1

Categories of Therapeutic Products ....................................................................................... 2

SUMMARY ............................................................................................................................... 4

Key Players & Products ......................................................................................................... 5

IP Landscape ........................................................................................................................ 10

Eye Drops/Artificial Tears Category Has Maximum Patent Coverage ................................... 10

Upsurge in Filing Activity Since 2002 .................................................................................... 10

Six Major IPC Codes in IP Filings .......................................................................................... 13

Emerging Trends ...................................................................................................................... 14

SEARCH RESULTS ............................................................................................................... 15

Products and Manufacturers ................................................................................................ 16

Top Companies- Business, M&A, Partnerships and Collaborations ................................... 36

Representative IP assets and Product Availability of Top Assignees .................................. 41

Top Inventors and Representative IP Assets ....................................................................... 42

EMERGING TRENDS ............................................................................................................ 44

From IP Search .................................................................................................................... 44

From Recent Research Activities......................................................................................... 45

From Non-Patent Literature ................................................................................................. 46

APPENDIX .............................................................................................................................. 51

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A report by MaxVal Group, Inc._Sourabh 1 December 11, 2009

OBJECTIVE

The objective of this search was three fold;-

To identify companies having products on the market and under development that are related

to dry eye treatment.

To identify relevant patents and applications.

To identify filing trends of key assignees.

SUBJECT OF THE SEARCH

Dry eye syndrome, also called as Keratoconjuctivitis sicca or Xerophthalmia, is an eye disease caused

by decreased tear production by lacrimal glands or increased tear film evaporation. Typical symptoms

of the disease include dryness, burning and a sandy-gritty eye irritation. Aging and Vitamin A

deficiency are the most common causes for this disorder. The disease is diagnosed by tear break test

or Schirmer’s Test. The figure below presents an overview of treatments available for dry eye.

Overview of Dry Eye Treatment

Punctal plugs Alcohol eye drops Artificial

tears

Fatty acid

tears/

Ointments

Oral dosage

forms

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Categories of Therapeutic Products

There are 4 main categories of therapeutic products used for treatment of dry eye

A. Artificial Tears

Tear replacement by topical artificial tears and lubricants is currently the most widely used

therapy for dry eye. The goal of using tear substitutes is to increase humidity at ocular surface and

to improve lubrication. Major constituents of artificial tears are hydrogels. The hydrogels make

artificial tears more viscous so they stay on the eye for longer time. Hydrogels are actually

polymers that are endowed with the property of swelling up in water and retaining the moisture.

The following hydrogels have been used in artificial tears:

o Hydroxypropyl Methylcellulose (HPMC)

o CarboxyMethycellulose (CMS)

o Polyvinyl Alcohol (PVA) and

o Carbopol

B. Punctal Plugs

After Artificial tears, punctual occlusion with plugs (shown in picture below) is one of the

common forms of invasive treatment of chronic dry eye. The most typical usage of plugs is in the

lower two puncta but some patients have plugs in all four ducts (2 lower and 2 upper). Punctal

plugs are generally made of silicone.

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A report by MaxVal Group, Inc._Sourabh 3 December 11, 2009

C. Gels/Ointments

Ointments or gels (less thick than ointments) are most preferred alternatives to artificial tears for

moderate to chronic dry eyes. Anti- inflammatory properties and high consistency characteristics

of fatty acids are exploited in gel/ ointment based treatments for dry eye.

D. Oral Compositions

In recent years, oral dosage forms meant primarily for dry mouth disease and Sjögren‟s syndrome

have been found effective in dry eye treatment. Oral medicines currently available in the market

contain systemic cholinergic agonists such as Pilocarpine or Cevimeline which stimulate secretion

from lacrimal glands. Dietary polyunsaturated fatty acids are also being studied for treatment of

dry eyes.

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A report by MaxVal Group, Inc._Sourabh 4 December 11, 2009

SUMMARY

A comprehensive search was performed to identify companies with relevant products and patents1

related to treatment of dry eye syndrome or keratoconjuctivitis.

Figure 1: Dry Eye Treatment- Current Landscape

1 By patents ,we mean issued and published applications

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Key Players & Products

29 Companies & 49 Products

General search for companies with products for treatment of dry eye syndrome revealed a total of

twenty nine companies having forty nine2 products across four different categories in this

space.

Figure 2A: Companies & Products (with marketing status3)

# - Marketing status for a product not found. * - Marketing status for 4Punctal plugs not available.

2 In Version-I, 47 products have been listed and this version is updated with two more additional products

(Abbott and Senju Pharmaceuticals). 3 OTC - Over the counter drug & RX - Prescription drug.

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Figure 2B: Top 10 Companies Based on Number of Products

Of the top 10 players, only Allergan, Medennium and Advanced Vision Research have FDA

approved products; Allergan has 3 approved products out of the total 6 and the other 2companies

have one each.

It is to be noted that no company has products in all therapeutic categories. Only three companies-

Alcon Inc., Allergan and Novartis AG were found to have products in more than one category

viz. artificial tears/eye drops and ointments/gels.

All the above top 10 players were identified to have IP related to dry eye with Alcon leading the

landscape with 142 IP assets followed by Allergan (62) and Bausch and Lomb (40).

Ten companies, listed below, were found to have only products for dry eye treatment but no

corresponding IP assets.

Akorn Pharmaceuticals

Altacor Pharma

Aton Pharma

Corneal Science Corp

Focus Laboratories

FCI Ophthalmic

MGI Pharma

Optics Laboratories Inc

Prestige Brands

Science based health

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The overall product status for dry eye treatment is shown in Figure 2C. Of the 49 products on the

market, 37 are available for over-the-counter (OTC) use while 12 are available as prescription

(Rx) drugs. These numbers indicate the widespread usage of OTC medicines.

Figure 2C: Status of Products

Note: In the above figure, clinical trials that are either terminated or related to other aspects of age related eye disease are

excluded.

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Figure 3A: Overview of Companies with Products on the Market

Note: Size of circle is proportional to number of products on the market. Assignees not hyperlinked in this chart do not have websites. Companies with products under

clinical trials will be made available in Version 3.

*-Companies with FDA approved products.

ARTIFICIAL

TEARS/ EYE DROPS

32 PRODUCTS ON

THE MARKET

Alcon (4)

Allergan (4)*

Advanced Vision (1)*

Altacor Pharma (1)

Bausch& Lomb (4)

Farmigea (1)

Novartis (3)

Abbott (3)

Senju Pharma (2)

Similasan Corp (1)

Johnson& Johnson (1)

Akorn Pharma (1)

Cynacon (1)

Focus Labs (1)

Optics Labs (1)

Theralife (1)

Corneal Science Corp (1)

Prestige Brands (1)

OINTMENTS/

GELS

5 PRODUCTS ON THE

MARKET

Allergan (2)

Alcon (1)

Cynacon (1)

Novartis (1)

ORAL DOSAGE

FORMS

4 PRODUCTS ON THE

MARKET

MGI Pharma (1)

Daiichi Sankyo(1)

Biosyntrx (1)*

Science based Health (1)*

8 PRODUCTS ON

THE MARKET

Eagle Vision (1)

Oasis Medical (1)

Medennium (2)*

Aton Pharma (1)*

FCI Ophthalmics (1)*

Lacrimedics (1)*

Odyssey Medical (1)

PUNCTUM PLUGS

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Figure 3B: Overview of Products & Marketing Status

Note: FDA approved products are in bold orange

*- Marketing status for the products not available

Products and their marketing status

OTC • OPTIVE™ • REFRESH®

TheraTears NewMytear®

• MyTearMoisture A® • SYSTANE® • Blink® Tears • Tears Naturale® Free • GenTeal • Visine Tears® • Advanced Eye

Relief™ • Soothe® Lubricant

Eye Drops • Dropst ar® • Murine® Tears • Hypo Tears • Akwa Tears® • MiniDrops® • Refresh Endura • Soothe®XP • Clerz Plus Lens Drops • Aquify®

• COMPLETE® Blink-

N-Clean® • Blink Contacts® • ReNu® Rewetting

Drops • VIVA Eye Drops • Theralife Eye

RX • Clinitas Soothe • Dry Eye ReliefTM • Tears Again® • FreshKote® • Bion® Tears • Restasis®

RX • Form Fit™ • Lacrisert® • Parasol Punctal

Occluder System • Herrick Lacrimal

Plug

Others

*

• DuraPlug™ • Xsorb Plug® • Snug Plugs® • SmartPlugs™

OTC • REFRESH P.M • REFRESH

® LACRI-

LUBE®

• Tears Naturale® P.M • GenTeal Gel • Tears Again® Night &

Day™ Gel

OTC • BioTears • Hydro Eye®

RX

• Evoxac • Salagen

Artificial Tears/ Eye drops (32 Products)

Punctal Plugs (7 Products)

Ointments/ Gels (5 Products)

Oral Compositions (4 Products)

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A report by MaxVal Group, Inc._Sourabh 10 December 11, 2009

IP Landscape

Category of Eye Drops/Artificial Tears Has Maximum Patent Coverage

The technology classification

4 of patents and published applications related to dry eye treatment is

based on the following product categories:

Eye drops/artificial tears

Punctal plugs

Ointments/gels

Oral dosage forms

Figure 4 below shows that most number of patents and published applications fall under the eye

drops/artificial tears category (523), followed by oral dosage forms (235), ointments/gels (238)

and punctal plugs (163).

Figure 4: Patent Coverage for Different Formulations

523

163

238

235

Eye Drops

Punctal Plugs

Ointments

Oral forms

Upsurge in Filing Activity Since 2002

General filing trends for the last ten years (1998 to 2008), as shown in the Figure 5 below, clearly

indicate an upsurge in filing activity (based on published applications) in this space from year

2002 onwards.

4 Search strings used to identify IP assets under each category are mentioned in Appendix

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Figure 5: General Filing Trends5

Alcon is the Lead Assignee with Maximum Number of Patents and Published

Applications

Assignee-wise filing trends for the period 1999-2009, shown graphically in Figure 6 below,

reveals Alcon Inc. to be the leading assignee with 134 IP assets, followed by Allergan (62),

Parion Sciences (46) and others.

Figure 6: Top 10 assignees based on IP6

5 As of Aug 05,2009

6 SS used: ((((("dry eye" or keratoconjuctivitis) and (treat* or cur* or medicin* or plug)) <in> CLAIMS))) in US

issued, US publications, EP and PCT publications as of August 05, 2009.

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Figure 7 shows the graphical presentation of the patent applications related to treatment for dry eye

filed by top assignees over a period of ten years (1998-2008).

Figure 7: Filing Trends of Top 10

Assignees

Note: 2009 data is as of Aug only.

As evident from Figure 7, Alcon Inc has shown consistent filings in this space with applications

filed every year from 1998 except 2006.

Parion Sciences and Merck Co. have no products on the market or in the pipeline but they have

shown patent activity from 1999 and 2002 respectively.

Allergan, Bausch & Lomb, Johnson & Co and Novagali are emerging companies in dry eye

treatment space from 2004.

Senju Pharma shows consistent filings from 2002 except in the year 2003 & 2008.

Vertex has filings from 2003 except in the years 2004 & 2006.

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A report by MaxVal Group, Inc._Sourabh 13 December 11, 2009

Six Major IPC Codes in IP Filings

Based on our analysis, the major IPC codes in this field are found to be A61K, A61P, CO7D,

C07C, C07K, and A61F.

Figure 8 also indicates that maximum number of patents and applications that are filed under

A61K (63%) broadly translates into medical compositions followed by A61P (18%) and C07D

(8%) which define therapeutic chemical compounds and heterocyclic compounds respectively.

Figure 8: Concentration of IPC Codes

Table 1 below shows the IPC classifications filed by various assignees having products in the

market or under development. It is evident from this table that most of the companies currently

developing treatments for dry eye have filed patent applications under IPC code A61K followed

by A61F.

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Table 1: Classification of Products Under IPCs

IPC

Code Definition

Companies7 with product on

market

Companies with product

under development/ Clinical

trials

A61K

Preparations for

medical, dental, or

toilet purposes

Alcon, Allergan, Bausch and

Lomb, Novartis, Senju

Pharmaceuticals, Johnson and

Johnson, Advanced Vision

Research, Abbott, Similasan

Corp

Parion Sciences, Novagali

Pharma, Resolvyx Pharma,

Lux Biosciences, Macusight

Inc, Vertex Pharma

A61F

Prostheses; devices

providing patency,

treatment or protection

of eyes or ears;

Alcon, Allergan, Bausch and

Lomb, Johnson and Johnson

Parion Sciences, QLT Plug

delivery systems, Insite Vision

A61P

Therapeutic activity of

chemical compounds or

medical compositions

Alcon, Allergan Vertex Pharma

C07D Heterocyclic

compounds Alcon, Allergan

Parion Sciences, Vertex

Pharma

C07C Acyclic or carbocyclic

compounds Alcon, Novartis Ista Pharma

C07K Peptides Bausch and Lomb, Novartis,

Johnson and Johnson -

Emerging Trends

Analysis of recently filed patent applications (2006 onwards) revealed following four

relatively new therapeutic areas for treatment of dry eye syndrome:

Monoclonal antibodies based treatment

Eyewear with moisture pads

Application of thermal energy to meibomian glands

Use of platelet rich plasma/ cell extract

Recent research activities and non-patent literature (2006 onwards) indicate novel methods of

treating dry eye syndrome including novel drugs/compounds (e.g., tear film lipids, compounds

for proliferation of goblet cells), bioabsorbable plugs, and testosterone based gel, topical

apolipoprotein, use of latent heat, etc.

7 Unassigned assets have not been considered

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A report by MaxVal Group, Inc._Sourabh 15 December 11, 2009

SEARCH RESULTS

Figure 1 shows the current landscape on dry eye treatment.

Figure 2A gives an overview of all the product categories available for treatment of dry eye

along with the number of companies and products under each category while Figure 2B

shows the top 10 companies based on number of products available in the market.

Figure 2C shows the market and development status of all the products for dry eye treatment.

Classification of products under IPCs is given in Table 1.

An overall tabular representation of the companies and their products across various

categories for treatment of dry eye syndrome are depicted in Table 2A-D.

Figure 3A gives a pictorial summary of all the companies involved in dry eye treatment along

with their product status and Figure 3B gives the list of products across various categories viz.

OTC and RX.

Technological classification of relevant IP assets among various categories is shown

graphically in Figure 4.

A glance at the business activities, mergers/ collaborations and revenues of the top 10

assignees is given in Table 3.

Top 10 assignees and Inventors along with their representative IPs and product availability

are presented in Table 4A and Table 4B respectively.

Figure 5 shows the general IP filing trends in US for the period 1999-2009 and Figure 6 gives

an overview of the distribution of IP assets (Publications and granted) among top assignees in

this field.

Filing trends of the key assignees during 1998-2008 are shown in Figure 7.

Figure 8 gives an overall concentration of the IPC codes.

Recent activities of Universities/Institutes in dry eye treatment space have been listed in Table

5.

Emerging, relatively new therapeutic treatments for dry eyes were identified and are

represented pictorially in Figure 9.

Table 6 lists the recent non- patent references discussing novel, emerging treatments for dry

eye syndrome.

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Products and Manufacturers

Table 2A: Companies Manufacturing Artificial Tears/Eye Drops

Carboxyl Methylcellulose (CMC) Artificial Tears

Note: Products are categorized based on the active ingredient gleaned from Eye digest

8.

FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name

Marketing

Status

Exemplary IP9

No of

IP

Assets10

Product Description and Application11

(Carboxyl Methylcellulose Artificial Tears)

Allergan

OPTIVE™

FDA approved

OTC US6350442

US6984628

US5981607

US5707614

US20070299004

62

OPTIVE™ Lubricant Eye Drops is an over-the-counter artificial

tear that lubricates and hydrates eyes to provide relief from dry

eye symptoms.

REFRESH®

FDA approved

OTC

REFRESH TEARS® Lubricant Eye Drops moisturizes and relieves

dry, irritated eyes with a preservative free formula to provide

soothing effect on eyes.

8 Published by University of Illinois Eye & Ear Infirmary

9 Relevant patents and published applications identified in this search, that are related to a product category, were randomly picked and listed in this column

10 US, Europe( issued and applications) and PCT

11 Information obtained from company‟s website

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Company Name Product Name

Marketing

Status

Exemplary IP9

No of

IP

Assets10

Product Description and Application11

(Carboxyl Methylcellulose Artificial Tears)

Advanced Vision

Research, Inc.

TheraTears

FDA approved

OTC

US6432934

US20040076695

US20080020064

7

TheraTears Lubricant Eye Drops help put back the lost water,

lowering the high salt concentration, so as to wet and rehydrate

dry eyes. TheraTears provides a lubricating form of

carboxymethylcellulose that gives relief from the dryness, stinging

and burning, and sandy-gritty irritation of dry eye.

Senju

Pharmaceuticals

NewMytear®

OTC

OTC

US5185372

US7459441

US7485654

US5830913

WO2009105534

19 Lacrimal Type. Reduce and prevent dryness.

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Company Name Product Name

Marketing

Status

Exemplary IP9

No of

IP

Assets10

Product Description and Application11

(Carboxyl Methylcellulose Artificial Tears)

MyTearMoisture

Polyethylene Glycol Artificial Tears

Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name12

Marketing

Status

Representative

IP

No of IP

Assets13

Product Description and Application

(Polyethylene Glycol Artificial Tears)

Alcon laboratories

SYSTANE®

OTC

US5403598

US4039662

US4966773

EP1348427

US20090156693

134

SYSTANE® Lubricant Eye Drops reduces both the signs and

symptoms of dry eye. Provides immediate moisture and protection

to the eyes.

12

FDA approval link is provided wherever applicable. 13

US, Europe( issued and applications) and PCT

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Company Name Product Name12

Marketing

Status

Representative

IP

No of IP

Assets13

Product Description and Application

(Polyethylene Glycol Artificial Tears)

Abbott Medical

Optics

Blink® Tears

OTC

US20080273171

US20090201465

WO2007130960

EP1581211

9

Blink® Tears Lubricating Eye Drops formula replenishes tear

film at each time blink. It contains a GENTLE OCUPURE™

preservative that disappears in eyes.

Hydroxypropyl Methylcellulose (HPMC) Artificial Tears

Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name14

Marketing

Status

Representative

IP

No of

IP

Assets15

Product Description and Application

(Hydroxypropyl Methylcellulose Artificial Tears)

Alcon laboratories

Bion® Tears

RX

US5460834

US6320062

US6696453

US7060728

WO2009064983

134

Bion® Tears temporarily relieves the burning and irritation

associated with dry eye. Bion® Tears helps restore the eye to its

natural environment, Bion® Tears contains zinc and bicarbonate,

two essential components of natural tears.

Tears Naturale® OTC Tears Naturale® Forte withTrisorb

® technology contains 3

ingredients to lock in moisture to bring relief to dry eyes. Provides

14

FDA approval link is provided wherever applicable. 15

US, Europe( issued and applications) and P�

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Company Name Product Name14

Marketing

Status

Representative

IP

No of

IP

Assets15

Product Description and Application

(Hydroxypropyl Methylcellulose Artificial Tears)

Forte

better "wettability" and slow evaporation of the tear film.

Novartis

Opthalmics AG

(merger of Ciba

Geigy and Sandoz)

GenTeal

OTC

US5597559

WO05089715

WO03017990

16

GenTeal ® PF is a hypotonic and preservative-free solution,

formulated to be a soothing lubricant. A disappearing preservative

that turns into pure water and oxygen upon contact with eye,

thereby minimizing the irritation.

Johnson &

Johnson

Healthcare

Products

Visine Tears®

OTC

US7381707

US6367929

US3991759

US20080153909

11 Visine Tears® moisturizes and soothes eyes and protects against

further irritation. Its "Natural Tears Formula" contains 10 important

ingredients found in natural tears.

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Glycerin Artificial Tears

Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name

Marketing

Status

Representative

IP

No of

IP

Assets16

Product Description and Application

(Glycerin Artificial Tears)

Altacor Pharma

Clinitas Soothe

RX - -

Clinitas contains 0.4% sodium hyaluronate producing high

concentration of HA that ensures prolonged relief from dry,

gritty eyes caused by contact lens wear or other factors.

Bausch & Lomb

Advanced Eye

Relief™

OTC US5800807

US6348508

US6277365

US6180093

WO2009018060

40

Advanced Eye Relief Dry Eye Environmental Lubricant Eye

Drops provide instant moisture for dry and irritated eyes. Dry

Eye Environmental Lubricant Eye Drops contain 1% glycerin.

Glycerin has high water-binding properties that restore moisture to

the eyes.

Soothe® Lubricant

Eye Drops OTC

Bausch & Lomb Soothe® Lubricant Eye Drops Long Lasting

formula are clinically proven to soothe dry and irritated eyes.

This revolutionary advance in dry eye therapy provides soothing

comfort and long lasting lubrication, keeping eyes feeling fresh

throughout the day.

16

US, Europe( issued and applications) and PCT

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Company Name Product Name

Marketing

Status

Representative

IP

No of

IP

Assets16

Product Description and Application

(Glycerin Artificial Tears)

Farmigea SpA

Dropstar®

OTC

US7321000

US6056950

WO03011249

EP1408929

9 Dropstar® contains sodium hyaluronate. It acts as a lubricant and

humectants of the eye with lachrymal insufficiency.

Similasan

Corporation

Dry Eye ReliefTM

RX US5336508 4

Similasan Dry Eye Relief eye drops for dry, red eyes stimulate

the eye's natural ability to fight dryness and clear redness due to

smog, stress, age, contact lens wear, etc. The active ingredients in

Similasan Dry Eye Relief eye drops work effectively with no

known side effects and no known drug interactions.

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 23 December 11, 2009

Polyvinyl Alcohol (PVA) Artificial Tears

Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name17

Marketing

Status

Representative

IP

No of IP

Assets18

Product Description and Application

(Polyvinyl alcohol Artificial Tears)

Prestige Brands,

Inc

Murine® Tears

OTC - -

Murine® Tears Lubricant Eye Drops is a natural tears formula

designed to soothe and lubricate dry, irritated eyes. This product

contains six ingredients found in natural tears. It temporarily

relieves burning and irritation due to dryness of the eye and also

protects against further irritation.

Novartis

Opthalmics AG

Hypo Tears

OTC

US5597559

US7615562

US6310099

WO2008074853

16

Hypo tears for dry eye contain 1% Polyvinyl Alcohol, 1% PEG

400. Hypotonic Benzalkonium Chloride (0.01%) as preservative.

Hypo tears are also available as Preservative Free single-use vials.

Akorn

Pharmaceuticals

Inc.

Akwa Tears®

OTC - -

Akwa Tears is a solution containing polyvinyl alcohol is

formulated to moisturize the eyes. This ocular lubricant is used to

relieve burning, irritation, and discomfort of the eyes due to

dryness.

CYNACON / Tears Again® RX US4904698 2 Tears Again® drops offer a thicker consistency and spreads out

evenly across the tear film upon instillation. Tears Again® drops

17

FDA approval link is provided wherever applicable. 18

US, Europe( issued and applications) and PCT

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 24 December 11, 2009

Company Name Product Name17

Marketing

Status

Representative

IP

No of IP

Assets18

Product Description and Application

(Polyvinyl alcohol Artificial Tears)

OCuSOFT Inc.

minimize frequent instillations.

Focus

Laboratories

FreshKote®

RX - -

FreshKote® treats All 3 Layers of the Tear Film and provides relief

by adding a lacrophilic aqueous solution which interacts properly

both with the lipid and mucin layer and a mucomimetic polymer

blend designed to achieve complete wetting.

Optics Laboratory,

Inc.

MiniDrops®

OTC - -

MiniDrops Eye Therapy, is a preservative free lubricating eye

drops for relief from dry eyes. It is also useful against minor

allergies and computer vision syndrome.

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 25 December 11, 2009

Oil Containing Eye Drops

Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name19

Marketing

Status

Representative

IP

No of

IP

Assets20

Product Description and Application

(Oil containing Eye Drops)

Allergan

Refresh Endura

OTC

US5474979

US5981607

US20080268051

US20080112922

62

Refresh Endura is an artificial tear that contains a castor oil

emulsion. It has uniform pale milky color. On the tear film castor

oil spreads rapidly to fortify lipid layer. This reduces evaporative

fluid loss. Carbomer 1342 is the hydrogel is an important

constituent. Polysorbate and glycerin are the other lubricants used.

Bausch & Lomb

(Acquired the

formulation from

Alimera Sciences)

Soothe®XP

Emollient

(Lubricant)

OTC

US5895645

US6610318

US20050182039

40

Bausch & Lomb Soothe® XP Emollient (Lubricant) Eye Drops

provides moisture and it contains Restoryl®, a lipid restorative

which provides a barrier to tear loss for relief up to 8 hours.

TheraLife TheraLife® Eye 6

Revitalizes and strengthens the eye's tear secretion functions.

19

FDA approval link is provided wherever applicable. 20

US, Europe( issued and applications) and PCT

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A report by MaxVal Group, Inc._Sourabh 26 December 11, 2009

Company Name Product Name19

Marketing

Status

Representative

IP

No of

IP

Assets20

Product Description and Application

(Oil containing Eye Drops)

OTC

US6383524

US6537581

WO2001091765

Contains Lutein and Zeaxanthin natural anti oxidant ingredients.

Eye Drops for Rewetting Contact lens

Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name21

Marketing

Status

Representative

IP

No of

IP

Assets22

Product Description and Application

(Eye Drops for Rewetting Contact Lens)

Alcon laboratories

Clerz Plus Lens

Drops

OTC

US4525346

US4039662

US5075104

WO2008036855

134

Clerz Plus retains moisture and fights protein buildup. Clerz Plus

contains two ingredients i.e. Tetronic 1304 and RLM- 100 that

work together to enhance lens-wearing comfort. Clerz Plus works

with any lens care regimen.

21

FDA approval link is provided wherever applicable. 22

US, Europe( issued and applications) and PCT

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 27 December 11, 2009

Company Name Product Name21

Marketing

Status

Representative

IP

No of

IP

Assets22

Product Description and Application

(Eye Drops for Rewetting Contact Lens)

Allergan

Restasis®

(FDA Approved)

RX

US5981607

US6872705

US6024954

US5252318

US20030068250

62

RESTASIS® ophthalmic emulsion contains small concentration of

cyclosporine. It helps to increase the eyes' natural ability to

produce tears which may be suppressed by inflammation due to

chronic dry eye.

Novartis-

CIBAVISION(Cib

aVision is eye care

unit of Novartis)

Aquify®

OTC

US6827966

US6827966

US7329415

WO200589715

16

Blink-activated Aquify® Drops mimic the behavior of natural

tears. Its ingredient sodium hyaluronate slowly releases water

molecules, so the moisture lasts. Helps relieve lens-related

dryness and increases lubrication.

Abbott Medical

Optics

COMPLETE®

Blink-N-Clean®

Lens Drops

OTC

US20090247640

WO2007130960

WO2004062660

9

COMPLETE® Blink-N-Clean® Lens Drops Helps prevent

annoying protein film buildup. Removes particulate material that

can cause irritation and discomfort. Promotes lens cleanliness

during wear, lubricates and rewets contact lenses

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 28 December 11, 2009

Company Name Product Name21

Marketing

Status

Representative

IP

No of

IP

Assets22

Product Description and Application

(Eye Drops for Rewetting Contact Lens)

Blink Contacts®

OTC

Blink Contacts® Lubricating Eye Drops offers lubrication for

contact lens wearers, with improved tear-break-up-time and

increases tear film stability. It also provides protection for patients

with RGP and soft contact lenses.

Bausch & Lomb

ReNu® Rewetting

Drops

OTC

US6180093

US7067479

US5895645

US20080314767

40

ReNu® Rewetting Drops rewet lenses and help prevent film

deposit build-up. Promotes rewetting, frequent replacement,

disposable or extended wear lenses, especially after awakening.

Also help remove particulate matter.

Corneal Science

Corporation

VIVA Eye Drops

OTC - -

VIVA contains an iron chelator that scavenges for free iron in the

tears, as well as seven antioxidants, that are crucial for avoiding

free radical damage secondary to the inflammatory process. Free

radicals are released into the tears from any surgery performed on

the cornea, contact lens use, in the presence of free iron (low

Lactoferrin levels) and during any type of inflammatory process

involving the cornea and the conjunctival tissue.

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 29 December 11, 2009

Table 2B: Companies Manufacturing Punctal Plugs

Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name23

Marketing

Status

Representative

IP

No of

IP

Assets24

Product Description and Application

(Punctal Plugs)

Aton Pharma

LACRISERT®

FDA Approved

RX - -

LACRISERT® is a small insert that is placed into the pocket of

lower eyelid. Once inserted, LACRISERT® gently begins to

dissolve within minutes. Optimal improvement is observed in 6-9

weeks.

Eagle Vision, Inc. Duraplug® NA

US5283063

US6344047

US5334137

WO2004034518

17

Duraplug® is meant for post lasik induced dry eye, seasonal dry

eye and for retention of ocular medication.

FCI Ophthalmic

Snug Plugs™

(FDA Approved,

K061398)

NA - -

Snug Plugs™ are designed to provide effective punctal occlusion

for the treatment of dry eye. Snug Plugs™ are made of medical

grade silicone and are preloaded in a stretched position, returning

to their natural shape when released in the punctum.

23

FDA approval link is provided wherever applicable. 24

US, Europe( issued and applications) and PCT

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 30 December 11, 2009

Company Name Product Name23

Marketing

Status

Representative

IP

No of

IP

Assets24

Product Description and Application

(Punctal Plugs)

Lacrimedics, Inc.

Herrick Lacrimal

Plug™

(FDA Approved,

K896175)

RX

US5171270

1

Opaque Herrick Lacrimal Plugs may be used in the treatment of

dry Eye symptoms: dryness, redness, itching, burning,

intermittent tearing or foreign body sensation. Herrick Lacrimal

Plugs are medical grade silicone, are provided sterile, and

premounted on an insertion tool.

Medennium Inc.

SmartPLUG™

(FDA Approved,

K022043)

RX

US6234175

US20060074370

EP1305061 9

SmartPLUG from Medennium is used to occlude the "punctum"

or tear duct, and conserve the eye's natural tears. SmartPLUG

is designed to fit a range of punctum sizes. Made of a flexible

thermosensitive acrylic material, SmartPLUG adjusts to the exact

shape and size of the punctum.

Xsorb™ Plug

NA

The Xsorb™ Plug provides immediate dry eye relief and

improves patient comfort. Xsorb™

temporary punctum plugs last up to three months.

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A report by MaxVal Group, Inc._Sourabh 31 December 11, 2009

Company Name Product Name23

Marketing

Status

Representative

IP

No of

IP

Assets24

Product Description and Application

(Punctal Plugs)

Oasis Medical Inc. Form Fit™

RX US5766243 2

The Form Fit™ plug is made of a hydrogel material that

expands into a soft, pliable, gelatinous material when it contacts

tear film. Once inserted into the punctum, Form Fit™ hydrates

over a 10 minute period.

Odyssey Medical

Parasol® Punctal

Occluder System

(FDA Approved,

K972523)

RX US5830171

US6527780 3

Parasol Punctal Occluder System consists of a hollow nose

structure to ease insertion and offers distinct advantages to dry

eye patients.

Table 2C: Companies Manufacturing Ointments & Gels

Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name25

Marketing

Status

Representative

IP

No of

IP

Assets26

Product Description and Application

(Ointments & Gels)

Allergan

REFRESH P.M.®

OTC

US5808083

US6254860

US7045121

US20050271748

62

REFRESH P.M. ®

Lubricant Eye Ointment provides strong,

soothing nighttime relief for more intense dry, irritated eyes.

REFRESH P.M. ®

is a preservative-free lubricant eye ointment that

is ideal for use at bedtime.

25

FDA approval link is provided wherever applicable. 26

US, Europe( issued and applications) and PCT

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 32 December 11, 2009

Company Name Product Name25

Marketing

Status

Representative

IP

No of

IP

Assets26

Product Description and Application

(Ointments & Gels)

REFRESH®

LACRI-LUBE®

OTC

REFRESH® LACRI-LUBE

® Lubricant Eye Ointment provides

strong, soothing nighttime relief for more intense dry, irritated

eyes and is ideal for use at bedtime.

Alcon laboratories

Tears Naturale®

P.M.

OTC

US5075104

US4966773

US5403841

US4525346

WO2008052031

134

Tears Naturale® P.M. is a lubricant that prevents further irritation

and relieves dryness of the eye. It forms a smooth, protective film

that provides protection and comfort to the eyes.

Novartis

Opthalmics AG

GenTeal Gel

OTC

US6291523

US6670379

US7615562

US20080312212

11

The GenTeal PM Ointment formulation contains the high

concentration of moisture for use at night time. GenTeal provides

advanced hydration for dry eye relief.

CYNACON /

OCuSOFT Inc.

Tears Again®

Night & Day™ Gel OTC US4904698 2

Tears Again® Gel offer a thicker consistency than most drops yet

spread out evenly across the tear film upon instillation. Tears

Again® Gel minimizes frequent instillations providing greater

economy. Tears Again® Night & Day™ Gel is recommended for

moderate to severe conditions of dry eye.

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 33 December 11, 2009

Company Name Product Name25

Marketing

Status

Representative

IP

No of

IP

Assets26

Product Description and Application

(Ointments & Gels)

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 34 December 11, 2009

Table 2D: Companies Manufacturing Oral Compositions

Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).

Company Name Product Name27

Marketing

Status

Representative

IP

No of IP

Assets

Product Description and Application

(Oral Compositions)

Biosyntrx Inc

BioTears

OTC

US7029712

2

BioTears are oral gel caps which reduce tear film

inflammatory markers IL-1 and 6. It targets tear-specific

inflammatory processes. Addresses the tear film structure

necessary for optimal visual clarity.

Daiichi Sankyo

Evoxac

(FDA Approved)

RX US6287596 3

The active ingredient of Evoxac is cevimeline. It stimulates

secretion from Lacrimal gland. It has been approved by FDA

for treatment of dry mouth, Sjoergen‟s syndrome and dry eyes

as well.

MGI Pharma

(BIPI

Manufacturing for

MGI pharm.)

Salagen

(FDA Approved) RX - -

The active ingredient of Salagen is pilocarpine. It stimulates

specific receptors in Lacrimal gland and cause increased

secretion of tears.

27

FDA approval link is provided wherever applicable.

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A report by MaxVal Group, Inc._Sourabh 35 December 11, 2009

Company Name Product Name27

Marketing

Status

Representative

IP

No of IP

Assets

Product Description and Application

(Oral Compositions)

Science Based

Health

Hydro Eye®

OTC - -

Hydro Eyes contain Omega-3 EPA and DHA. It is

recommended for dry eye treatment for discomfort due to

age, tear deficiency, lasik surgery or other reasons.

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 36 December 11, 2009

Top Companies- Business, M&A, Partnerships and Collaborations

Table 3

Company Revenue/Sales Partnerships/Collaborations (since 2005)

Alcon

(a subsidiary

of Nestle, S.A.,)

M&A28

Alcon to acquire

Swiss biotech firm,

ESBATech AG (Sep.

2009)

Novartis may opt out

of Alcon deal (June

2009)

Business Focus:

Eye Care

(3 main business

divisions- surgical,

pharmaceutical and

consumer vision care)

$1.04 billion (as

of 06/2009)

Jul. 2009

Alcon commences Phase 2 clinical trial of NovaBay‟s

NVC-422 for viral conjunctivitis

Alcon and Astrazeneca to collaborate on Eye Drug

Development

Oct. 2008

Alcon expands licensing agreement with GSK for global

ophthalmic rights to Cilomist

Jul. 2006

Eli Lily and Alcon sign marketing collaboration for

potentially the first oral medication for diabetic

retinopathy

Origenis and Alcon- research partnership

Apr. 2006

Alcon and Amgen sign collaboration agreement to

develop and commercialize innovative therapies in

Ophthalmology

Jan. 2006

Kalypsys, Inc announces small molecule research

collaboration with Alcon

Oct. 2005

Dharmacon and Alcon enters RNAi collaboration

Jan. 2005

Jerini AG announces research collaboration with Alcon

Allergan

M&A

Allergan completes

merger agreement

with Inamed Corp.

(Dec. 2005)

Business Focus:

Allergan is a global

pharmaceutical

Allergan

estimates $500

million and

$510 million for

the year 2009

on its product -

Restasis

Sep. 2009

Pieris AG enters into Anticalin collaboration with

Allergan, Inc

Sep. 2006

Syntaxin (a biopharmaceutical company) expands its

strategic alliance with Allergan for novel therapeutic

compounds

Oct. 2005

Sirna Therapeutics and Allergan enter into strategic

Ophthalmic Alliance (Sirna out-licensed Phase I AMD

28

Only recent (post 2007) M&A activities are reported

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 37 December 11, 2009

Company Revenue/Sales Partnerships/Collaborations (since 2005)

company focused on

ophthalmics,

neurology,

dermatology and

urologics.

drug sirna-027 to Allergan)

Parion Biosciences

Business Focus:

Development-stage

Pharmaceutical

company focused in

treatment of defective

mucosal surfaces

(e.g., COPD, Cystic

Fibrosis and

Bronchiectesis)

Not found

Dec. 2008

Parion receives NIH biodefense grant ($850,000) to study

novel methods for mitigating radiation-induced lung

injury

Parion announces initiation of Phase I clinical trial to

evaluate safety and tolerability of GS9411; receives

$5million milestone payment from Gilead sciences

Oct. 28, 2008

Kainos Medicines, Inc to fund up to $25 million to

advance P-552 used in the treatment of dry mouth

treatment

Bausch & Lomb

Business Focus:

Eye care

M&A

B&L acquires

commercial assets of

Italian Ophthalmic

pharmaceuticals

company Tubilux

(Oct. 2009)

B&L completes

acquisition of

Eyeonics, Inc

(Feb. 2008)

Warburg Pincus

completes acquisition

of B&L (Oct. 2007)

Bausch &

Lomb projects

2007 sales of

approximately

$2.5 billion29

Sep. 2009

Bosch & Lomb subsidiaries and CROMA will co-

promote Bromfenac ophthalmic solution in Europe

April 2009

Bausch & Lomb and Pfizer Inc. will copromote

ophthalmic drugs in the United States

Apr. 2008

B&L and Galapagos NV (a drug discovery company) sign

agreement to collaborate on ophthalmic disease research

Jan. 2008

R&D collaboration with Crystalgenomics to study

potential new treatments for inflammatory ophthalmic

diseases

Jan. 2007

Alliance with Acufocus, Inc for presbyopic correction

technology

Sep. 2006

B&L licenses SEGRA compound from Schering AG for

ophthalmic use

Vertex Pharma

Business Focus:

Cash balance -

$754 million as

of June 2009.

9 drugs in

Nov. 2009

Bend Research enters collaboration with Vertex

Pharmaceuticals

29

2009 income/sales is not available

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 38 December 11, 2009

Company Revenue/Sales Partnerships/Collaborations (since 2005)

Biopharmaceutical

company focused on

drug development for

Cystic fibrosis,

inflammatory diseases

and cancer.

M&A

Vertex

Pharmaceuticals

closes on acquisition

of Virochem Pharma

(Mar. 2009)

pipeline.

Jun. 2006

Janssen Pharmaceutica announces collaboration with

Vertex to develop and commercialize VX-950 for

treatment of Hepatitis C

Mar. 2006

Vertex and Cystic Foundation Therapeutics enter

collaboration to develop oral drug candidate VX-770 for

CF

Caprion Pharmaceuticals announces new biomarker

discovery collaboration with Vertex

Dec. 2005

GSK, Vertex collaborate to develop VX-409 for the

treatment of pain

Johnson & Johnson

(includes Vistakon, a

division of J&J Vision

care)

Business Focus:

Healthcare company.

(3 main business

divisions- medical

devices ,

pharmaceutical and

consumer health care)

M&A

J&J completes

acquisition of Cougar

Biotechnology (a

oncology company)

(July 2009)

J&J buying cosmetic-

product and implant

maker, Mentor Corp.

for $1.07 billion (Dec.

2008)

Israels‟s Omrix gets

$15.1billion for

Q3 (as of Oct

2009)

Sep. 2009

J&J and Crucell N.V. announce strategic collaboration,

J&J acquires 18% stake (collaboration focusing on

monoclonal antibodies and vaccines for prevention of

influenza and other infectious and non-infectious

diseases)

Jul. 2009

Collaboration between Gilead Sciences and Tibotec unit

of J&J to develop a new single-pill HIV treatment

Oct. 2008

WuXi Pharma Tech expands J&J collaboration in the

integrated research services

Sep. 2007

Isis and J&J ink diabetes drug deal

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 39 December 11, 2009

Company Revenue/Sales Partnerships/Collaborations (since 2005)

acquired by J&J (Nov.

2008)

Inspire Pharma

Business Focus:

Biopharmaceutical

company focused on

development and

commercialization of

prescription products

for ophthalmic and

pulmonary diseases.

Inspire reports a

revenue of

$25.2 million

for the third

quarter of 2009

Oct. 2008

Inspire Pharma announces issuance of patent for

Elestat®

Nov. 2004

Inspire Pharma licenses novel glaucoma technology from

Wisconsin Alumni Research Foundation; addition of new

ophthalmic program enhances pipeline

Dec. 2003

Allergan and Inspire enter into collaboration to co-

promote Elestat (FDA approved in Oct. 2003; used to

prevent itching associated with allergic conjunctivitis) in

U.S.

Senju Pharma

Business Focus:

Japan based

Pharmaceutical

company with

marketing

collaborations

worldwide. Focused

on OTC medicines

and animal science.

Total sales

¥21.1 billion

($2.4 million)

(for year ending

2008)

Jul. 2009

Senju obtains marketing rights to Gatifloxacin ophthalmic

solution in China from Kyorin Pharmaceutical Co. Ltd.

Aug. 2006

ISTA pharmaceuticals acquired exclusive North

American rights to investigational ophthalmic therapy

(Senju‟s Bepotastine) for allergic conjunctivitis

Jun. 2006

ISTA pharma acquires rights to two glaucoma drug

candidates from Senju Pharma

Nov. 2005

Novartis signed a global and commercialization

agreement with Senju for Y39983, drug designed to

topically treat glaucoma

June 2004

Allergan and Senju sign joint marketing agreement.

Merck

Business Focus:

Merck is a

pharmaceutical giant

with over $60 billions

in revenue. Four

ophthalmic products

in market.

Total sales $6.0

billion for Q3,

2009.

Apr. 2009

Merck & Co., Inc. and Santen Sign Licensing Agreement

In Ophthalmology

Jan. 2008

Merck & Co has expanded its licensing agreement with

SurModics

May 2006

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SAMPLE REPORT Draft

A report by MaxVal Group, Inc._Sourabh 40 December 11, 2009

Company Revenue/Sales Partnerships/Collaborations (since 2005)

M&A

Merck Acquire

Schering-Plough

(Mar. 2009)

Merck acquires

Serono for €10.4bn

(Sep. 2006)

Harvard Medical signs agreement with Merck to develop

potential therapy for macular degeneration

Novagali Pharma

Business Focus:

Novagali is a France

based developmental

stage ophthalmic drug

company.

Not found

Oct. 2008

Novagali gets 15M-euro in new funding round.

Apr. 2007

Topigen Pharmaceuticals Inc. and Novagali Pharma Enter

Into Strategic Collaboration for Allergic Ocular Diseases

and Allergic Rhinitis

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Representative IP assets and Product Availability of Top Assignees

Table 4A

Assignee Representative IP No. of IP Assets30

Product

Availability

Alcon Inc

US4966773

EP1348427

US20090156693

134

Allergan

US5981607

US5707614

US20070299004

62

Parion Sciences

US6903105

US7388013

US2008096896

46 X

Bausch& Lomb Inc.

US5591426

US6277365

WO2009089401

40

Vertex Pharma US7553855

WO2009076593A1

37 X

Johnson& Johnson

US6367929

US7037517

US7381707

22

Inspire Pharma US6277855

US7528119

21 X

Senju Pharma

US5185372

US7459441

US2007093513A1

19

30

US, Europe( issued and applications) and PCT

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Assignee Representative IP No. of IP Assets30

Product

Availability

Merck& Co. US7053085

US7238710 16 X

Novagali Pharma

US6656460

US2009124565A1

US2009170944A1

13 X

Top Inventors and Representative IP Assets

Table 4B: Top 10 Inventors31

Top Inventors Associated

Assignee

No. of IP

Assets Representative IP

Johnson,

Michael R Parion Sciences 54 US6903105: Sodium channel blockers

Klimko, Peter,

G. Alcon Inc 31

US6331644: 3-heteroatom substituted and two

carbon homologs of 15-HETE and methods of

use

Ruah; Sara S.

Hadida

Vertex

Pharmaceuticals 28

WO05035514: Modulators Of ATP-Binding

Cassette Transporters

Yanni, John.M. Alcon Inc. 26

US5696166: Phenyl or heteroaryl and

tetrahydronaphthyl substituted diene compound

having retinoid like biological activity

Yerxa,

Benjamin, R. Inspire Pharma 25

US6277855: Method of treating dry eye disease

with nicotinic acetylcholine receptor agonists

Dalton, James T. GTX Inc. 23 US2003225040: Selective androgen receptor

modulators and methods of use thereof

31

SS used: ((((("dry eye" or keratoconjuctivitis) and (treat* or cur* or medicin* or plug)) <in> CLAIMS))) in

US issued, US publications, EP and PCT publications

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Top Inventors Associated

Assignee

No. of IP

Assets Representative IP

Gamache Daniel

Alcon Inc. 23

EP1393277: Use of NF-kappa-b inhibitors to

treat dry eye disorders

Chandraratna ,

Roshantha A.

Allergan 21

US5183827: Acetylenes disubstituted with a

heteroaromatic group and a 2-substituted

chromanyl, thiochromanyl or 1,2,3,4-

tetrahydroquinolinyl group having retinoid-like

activity

Ueno, Ryuji R-Tech Ueno Ltd. 20 US6403598: Ophthalmic composition

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EMERGING TRENDS

From IP Search

Four relatively new therapeutic areas (based on recent filings and scientific literatures) for

treatment of dry eye syndrome were identified and assignees employing them with their IP assets

are presented in Figure 9 below.

Figure 9: Emerging Technologies

Representative patent applications disclosing new technologies include,

Application of monoclonal antibodies targeting receptors in lacrimal gland is disclosed in

patent application US2008292637 assigned to Canfite Biopharma.

Use and efficacy of silicone gel moisture pads prevent evaporation of tears thereby

improving dry eye condition is disclosed in patent application US2006157064 assigned to

Suzanne Davison et al.

NEW TECHNOLOGIES

D R Y E Y E

Monoclonal antibodies based treatment US2008292637 (Assignee: Can Fite Biopharma)

Eyewear with moisture pads US2006157064 (Assignee: Suzanne Davison et al.)

Application of thermal energy US20080109052 (Assignee: Grenon Stephen M)

Using platelet rich blood plasma/cell extracts WO2008023026 (Assignee: Turzi Antoine)

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One patent application US20080109052 assigned to Grenon Stephen discloses

delivering of thermal energy to meibomian gland for comforting dry eyes.

One PCT application WO2008023026 assigned to Turzi Antoine discuss the role of

platelet rich plasma and cell extracts for treatment of dry eyes.

From Recent Research Activities

Six research institutes/ universities were identified (since 2008) to be involved in research focused

on dry eye treatment. These institutes along with their research areas are listed in Table 5.

Two institutions- Institute for Eye Research and University of Illinois are

independently investigating novel drugs for dry eyes based on tear film lipids and

immunologic-mediating chemicals respectively.

Southern California College of Optometry is studying meibomian gland dysfunction to

develop novel formulations for dry eye. The Institute recently licensed Testosterone based

gel for dry eyes to Argentis Pharma.

University of Florida has developed new bioabsorbable punctal plugs and is seeking

companies interested in commercializing the product.

University of Virginia is developing novel contact lens for delivering lacritin (a protein

regulating tear formation) to dry eyes.

Schepens Eye Research Institute has patented novel compounds for proliferation of

Goblet cells and is working on developing eye drops/ contact lenses based on these

compounds. The institute is currently looking for companies to license this technology.

Table 5: Recent Research Activities (since 2008) of Universities/Institutes

Note: Hyperlinks are linked with the respective web source pages.

Universities/Institutes Recent Activities32

Institute for Eye

Research

Institute for Eye Research in collaboration with the University of Wollongong

and University of New South Wales has opened an Australian Research Council

(ARC) linkage grant that will support a collaborative project investigating tear

film lipids. This investigation will lead to development of new treatments for dry

eye and novel technologies that provide greater comfort for contact lens wearers.

Southern California

College of Optometry

Currently center for vision research at SCCO engaged in several dry eye studies

include, development of a video meibography method of assessing oil gland

(called “meibomian” gland) dysfunction, residence time of novel formulations in

dry eye, etc.

32

Information listed in this table are as described in the web source pages

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Universities/Institutes Recent Activities32

University of Florida

University of Florida has created an efficient punctal plug that can deliver dry

eye medication at a continuous rate for an extended period of time. Currently

they are seeking companies interested in commercializing such an improved

punctal plugs that deliver medication to dry eye patients with greater efficiency

and effectiveness.

University of Illinois

Medical Center

UIC Eye Center is trying to find the best methods of treatment for dry eyes by

testing different types of artificial tears as well as chemicals that may stimulate

tear secretion. They are also testing immunologic-mediating drugs that may

decrease the dry eye complications in some diseases and also are developing new

medical and surgical treatments to manage the dry eye conditions.

University of Virginia

University of Virginia is currently working on developing novel contact lens

technologies for delivering lacritin – a novel drug to regulate the dry eye

condition which autostimulates „basal tearing. Lacritin is itself a component of

tears, and is 1 of only 7 tear proteins selectively downregulated in dry eye tears.

Schepens Eye

Research Institute

The institute has cultured and characterized goblet cells and invented novel

compounds for proliferation of goblet cells. The compounds of the invention

could be administered as drops or added to contact lenses to improve dry eye

condition. Schepens Eye Research Institute has patented the technology under

US patents 7052690 and 7316927 and is currently available for licensing.

From Non-Patent Literature

Table 6: Non-Patent References on Dry Eye Treatment (since 2005)

Note: Non-patent references listed in this table are related to novel technologies in dry eye treatment. Texts

related to subject matter are highlighted in bold italics.

S. No. Bibliographic Details (Journals, White Papers, Conferences)

1

Topical Apolipoprotein A-1 May Have a Beneficial Effect on the Corneal Epithelium in a

Mouse Model of Dry Eye: A Pilot Study

Nyunt Aung Kyaw, Ishida Yusuke, and Shimada Shoichi

Publication: Eye & Contact Lens: Science & Clinical Practice; Vol. 34, Issue 5

Publication Date: Sep 2008

Technology: Dry eye syndrome treatment using ApoA-1 with d-pantethine.

Abstract

Dry-eye syndrome affects millions of individuals and it is essential to develop effective

therapeutic agents for the treatment of this complex condition. The goal of this study was to

evaluate the effect of apolipoprotein A (ApoA)-1 and its synergistic action with d-

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S. No. Bibliographic Details (Journals, White Papers, Conferences)

pantethine (DP) on corneal epithelial disorders in dry-eye mouse model. Methods.

Aqueous tear production of C57BL/6J Jms Slc male mice aged 10 to 12 weeks were

inhibited by subcutaneous scopolamine injection and mice were placed in a continuous

airflow blower to create desiccating environmental stress. During desiccation, 1 eye of each

mouse was treated with ApoA-1 (0.01%, 0.04%, or 0.1%) or ApoA-1 (0.04%) + DP (0.05%,

0.1%, or 0.2%) and the other control eye was instilled with phosphate-buffered saline 4

times daily for 5 days. Phenol red thread test, corneal fluorescein staining (score, 0-4), and

measurement of corneal epithelial thickness measurements were performed. Results.

Significant reductions of staining scores and higher corneal epithelial thickness values were

observed in both ApoA-1- and ApoA-1 + DP-treated groups compared with untreated dry-

eye mouse and phosphate-buffered saline-treated group. Conclusions. These results suggest

that ApoA-1 and DP may be potential therapeutic agents for ocular surface epithelial

disorders in patients with dry eye.

2

Symptomatic Dry Eye Treatment with Autologous Platelet-Rich Plasma

Jorge L. Alio, José R. Colecha, Silvia Pastor and Alberto Artola

Universidad Miguel Hernandez, Spain

Publication: Ophthalmic Research; Vol. 39, Issue 3

Publication Date: Nov 2007

Technology: Autologous platelet-rich plasma in dry eye treatment.

Abstract

Background: Autologous platelet-rich plasma (PRP) has been proven to be very effective on

tissue regeneration and wound healing. Here we investigate the potential use of PRP in the

treatment of symptomatic dry eye. Methods: Eighteen consecutive patients with

symptomatic dry eye were treated with topical PRP and followed up for 1 month.

Disappearance of subjective symptoms, increase in best corrected visual acuity, tear

meniscus, tear breakup time, decrease in inflammation, fluorescein staining and

improvement in impression cytology were measured. Results: Symptoms improved

significantly in 89% of the patients, 28% improved at least 1 line of best corrected visual

acuity. A significant improvement on lachrymal meniscus and conjunctival hyperemia and a

decrease or disappearance of corneal fluorescein staining was observed. Impression cytology

revealed a significant increase in conjunctival goblet cells. Conclusion: Treatment of

patients suffering from significant dry eye symptoms with autologous RPR proved to be

very effective, improving both patient symptoms and major clinical signs.

3

Use of silicone hydrogel material for daily wear

Michel Guillon, Cécile Maissa

Optometric Technology Group Research & Consultancy, UK

Publication: Contact Lens and Anterior Eye; Vol. 30, Issue 1

Publication Date: Mar 2007

Technology: galyfilcon A and alphafilcon in contact lens to improve eye wettability.

Abstract

Silicone hydrogel contact lenses were initially developed to optimize oxygen transmissibility

for extended wear use. The concerns with such contact lenses have been their higher

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S. No. Bibliographic Details (Journals, White Papers, Conferences)

elastomeric and hydrophobic characteristics associated with the incorporation of silicone

type monomers. The use of silicone hydrogel has most recently been suggested for daily

wear to eliminate all hypoxic related problems. The primary aim of the investigation was to

test in vivo wetting performance and subjective acceptance of the first silicone hydrogel

contact lens developed for daily wear, ACUVUE® ADVANCE™ with HYDRACLEAR™

(galyfilcon A), compared to a conventional hydrogel contact lens for the same application

SofLens®66 (alphafilcon A).

The investigation was a randomized, subject masked bilateral cross over investigation testing

of the two contact lens materials over their approved replacement periods (galyfilcon A 2

weeks and alphafilcon A 2 weeks (USA) and 4 weeks (Europe)). In all cases ReNu

Multiplus® lens care system was used.

The investigation carried out on 24 contact lens wearers showed that: (i) in vivo wettability

was superior for galyfilcon A which had a thicker lipid layer (thin layer incidence: galyfilcon

A 54%; alphafilcon A 70–86%, p < 0.05), a thicker aqueous layer (thick layer incidence:

galyfilcon A 88%; alphafilcon A 35–64%, p < 0.05) and a more stable tear film (galyfilcon

A 7.8 s; alphafilcon A 2 weeks 5.6 s, p = 0.022; 4 weeks 7.4 s, p = 0.276); (ii) for the

intended replacement period, comfort was better with galyfilcon A (2 weeks) compared to

alphafilcon A (4 weeks) at insertion (p = 0.001) and, throughout the day (daytime and

evening p = 0.008).

Contact lenses made from galyfilcon A and replaced two weekly achieved better in vivo

wettability than contact lenses made from alphafilcon A and replaced either two or four

weekly; the better wettability was associated with an overall better comfort for galyfilcon

A.

4

Mechanisms of autoantibody production and the relationship between autoantibodies and the

clinical manifestations in Sjögren‟s syndrome

Hideki Nakamura, Atsushi Kawakami and Katsumi Eguchi

Nagasaki University, Japan

Publication: Translational Research; Vol. 148, Issue 6

Publication Date: Dec 2006

Technology: Auto antibodies in Sjögren‟s syndrome.

Abstract

The major target organs of Sjögren’s syndrome (SS) are lacrimal glands and salivary

glands where prominent lymphocytic infiltration occurs, which may induce varying levels of

autoantibody production. Multiple factors, including environmental stress, viral infection,

hormonal imbalance, and apoptosis, are thought to be involved in the pathogenesis of SS.

Production of anti-SS-A/Ro and anti-SS-B/La antibodies is thought to be regulated by the

presentation of autoantigens in context with an aberrant expression pattern of human

leukocyte antigen (HLA) in situ. Molecular mimicry with some viral sequences is also

hypothesized. The apoptosis-resistance phenotype of B cells in labial salivary glands (LSGs)

of SS is important in autoantibody production. CD40/CD40L (CD40 ligand) and Bcl-2

family proteins, in tandem with B cell-activating factor (BAFF), are supposed to protect

infiltrating lymphocytes from apoptosis. Anti-muscarinic3 receptor antibody plays an

important role in cholinergic hyperresponsiveness in SS. Fragmentation of autoantigens such

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S. No. Bibliographic Details (Journals, White Papers, Conferences)

as SS-B/La or alfa-fodrin during the process of apoptosis causes the redistribution of these

autoantigens, leading to the production of autoantibodies in SS. In this review, the role of

autoantibodies found in SS, corresponding to clinical aspects of each antibody as well as

the mechanisms of production is discussed.

5

Tear film lipid layer thickness and ocular comfort after meibomian therapy via latent heat

with a novel device in normal subjects

M. Mitra, G J Menon, A Casini, S Hamada, D Adams and J Fuller

Royal Eye Infirmary, UK

Publication: Eye; Vol. 19

Publication Date: Aug 2005

Technology: Meibomian therapy using latent heat with a novel device

Abstract

This study measures changes in tear film lipid layer thickness (LLT) and ocular comfort

in normal subjects after 10 min use of a novel device, which delivers meibomian therapy

with latent heat. The device is designed to promote the release of meibomian sebum into the

tear film by delivering latent heat to the eyelids, thus thickening the lipid layer. Normal lid

movements are maintained, facilitating resurfacing of the tear film.

Method

A prospective, controlled, observer masked, single intervention trial in which 24 normal

subjects were randomised into three groups. Group I underwent 10 min treatment with the

activated device, Group II used the inactivated device for the same duration of time, and

Group III had no intervention. The LLT of each subject was measured with a Keeler

Tearscope® prior and subsequent to the 10-min period. Subjective alteration in ocular

comfort was also assessed.

Results

Seven of eight subjects (87.5%) in Group I exhibited an increase in LLT. The mean LLT in

this group showed a statistically significant increase (left eyes 1.0 levels, P<0.001, right eyes

0.9 levels, P<0.003) compared to Groups II and III. Six of eight subjects (75%) using the

activated device experienced subjective improvement in ocular comfort.

Conclusion

Meibomian therapy with this device increases LLT in normal individuals. This implies a

more stable tear film, reflected in subjective improvement in ocular comfort.

6

Autologous serum in the treatment of dry eye syndrome. Technological aspects

Herrero-Vanrell R1 and Molina-Martínez

Complutense University.

Publication: Arch Soc Esp Oftalmol, vol 83, Page - 521-524

Publication Year: 2008

Technology: Autologous serum in dry eye treatment.

Description:

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S. No. Bibliographic Details (Journals, White Papers, Conferences)

This journal discuss about Autologous serum in the treatment of dry eye syndrome The

advantages in its use as a treatment for severe dry eye syndrome are based on the fact that

said fluid includes a number of factors which are associated to beneficial effects, particularly

those related to the growth and maintenance of epithelial cells.

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APPENDIX

List of Companies/Universities not discussed33

in this report:

S. No Company

1 Aciex, Inc.

2 Advanced Ocular Systems Limited

3 Agennix Incorporated

4 Altana Pharma Ag

5 Alza Corporation

6 Amedis Pharmaceuticals Limited

7 Amr Technology, Inc.

8 Anthrogenesis Corporation

9 Applied Research Systems Ars Holding

N.V.

10 Archemix Corp.

11 Ardea Biosciences

12 Avicena Group, Inc.

13 Azad Pharma Ag

14 Barnes-Hind Pharmaceuticals, Inc.

15 Bristol-Myers Squibb Company

16 Chakshu Research, Inc.

17 Clarity Corporation

18 Deo Corporation

19 Clear Solutions Biotech, Inc.

20 Combinatorx, Incorporated

21 Compugen Ltd

22 Control Delivery Sys Inc

23 Cytos Pharmaceuticals Llc

24 Dong-A Pharm. Co., Ltd

25 Eco Eye Inc

26 Fuso Pharmaceutical Industries Ltd

27 Galderma Research & Development

33

The list includes companies identified during IP search but not discussed in the report due to minimal number

of patents and published applications, non- availability of product/ product development information.

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S. No Company

29 Genentech, Inc.

30 Gpi Nil Holdings, Inc.

31 Kissei Pharmaceutical Co., Ltd.

32 Laboratoire Medidom S.A.

33 Liposome Technology, Inc.

34 Md Bioalpha Co., Ltd.

35 Yissum Research Development Company

36 Targegen, Inc.

37 Supernus Pharmaceuticals, Inc.

38 Sosei R & D Ltd

39 Sinclair Pharmaceuticals Limited

40 Sigma-Tau Industrie Farmaceutiche Riunite

S.P.A.

41 Melbj Holdings, Llc

42 Menicon Co., Ltd.

43 Milcin Therapeutics Llc

44 Milestone Pharmaceuticals Inc.

45 Molichem Medicines, Inc.

46 Nascent Pharmaceuticals, Inc.

47 Nihon Tenganyaku Kenkyusho Co., Ltd.

48 Nitromed, Inc

49 Novavax

50 Ocular Research Of Boston Inc.

52 Ono Pharmaceutical Co. Lted

53 Ophthalmic Research Associates, Inc.

54 Osmotica Corp.

55 Paratek Pharmaceuticals, Inc.

56 Pericor Science, Inc.

57 Plexxikon, Inc.

58 Predix Pharmaceuticals Ltd.

59 Quark Pharmaceuticals, Inc.

60 Regenerx Biopharmaceuticals, Inc.

61 Revalesio Corporation

62 Rohto Pharmaceutical Co., Ltd.

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S. No University/ Institution

1 The University Of Tennessee Research

Corporation

2 The University Of North Carolina At Chapel

Hill

3 The Johns Hopkins School Of Medicine

4 The Hong Kong Polytechnic University

5 University Of Utah Research Foundation

6 University Of Miami

7 University Of Edinburgh

8 Tufts University

9 Board Of Regents Of The University Of

Nebraska

Search Strategy:

The search was performed in

World Wide Web to identify the relevant manufacturers, products and IP holders in the field

of dry eye treatment.

Delphion to identify key players and their relevant IP assets using optimized search string (see

below highlighted in yellow) that resulted in 1200 hits for US (Issued, Applications), Europe

(Issued, Applications) and PCT applications.

Search Strings

S. No. Search String No. of

Hits

1 (((((("dry eye" or keratoconjuctivitis) and (treat* or cur* or medicin* or plug))))) 4855

2 ((((((dry and eye) or keratoconjuctivitis) and (treat* or cure or medicine)) <in>

(AB,TI,CLAIMS)))) 2081

3 ((((("dry eye" or keratoconjuctivitis) and (treat* or cure or medicine)) <in> (TI, AB,

CLAIMS)))) 1508

4 ((((("dry eye" or keratoconjuctivitis) and (treat* or cur* or medicin* or plug)) <in>

CLAIMS))) 1200

5 ((("dry eye" or keratoconjuctivitis) and (treat*)) <in> CLAIMS) 1181

For Technology Classification

1 (("dry eye" or keratoconjuctivitis) and ((punctal or punctum or plug) <IN> CLAIMS)) 163

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S. No. Search String No. of

Hits

2 (("dry eye" or keratoconjuctivitis) and (("eye drops" or "artificial tears" or "ophthalmic

solution" or "ophthalmic composition") <IN> CLAIMS)) 523

3 ((("dry eye" or keratoconjuctivitis)) AND (((ointment or gel)) <in> CLAIMS) AND NOT

(("artificial tears" or "eye drops"))) 235

4 ((("dry eye" or keratoconjuctivitis)) AND ((("oral composition" or tablet or capsule or oral

)) <in> CLAIMS) AND NOT (("artificial tears" or "eye drops" or plug))) 238

Databases searched: US (granted and applications), Europe (granted and applications), PCT

Keywords: dry eye, keratoconjunctivitis, xerophthalmia, treatment, tears, plugs, medicine, punctal,

punctum, sjogren‟s syndrome, ointment, gels, ophthalmic, artificial tears, eye drops

DISCLAIMER

The information provided in this document and its attachment(s) has been obtained from sources deemed reliable. MaxVal-

IP does not guarantee the accuracy, completeness or adequacy of such information and expressly disclaims any liability or

responsibility for the accuracy, errors, omissions or inadequacies in the enclosed information or for interpretations thereof.

Any decisions or actions by any party based in any way whatsoever on the contents of the attachment(s) shall be the sole

responsibility of that party.