Endo Pharmaceuticals Solutions (IDEV) 8-K Acquisition of Valera Pharmaceuticals

Acquisition of Valera Pharmaceuticals

December 12, 2006

Exhibit 99.1

Safe Harbor Statement

This presentation contains “forward-looking statements”

as defined in the Private Securities Litigation

Reform Act of 1995. These statements are based on current expectations of future events. Such statements

include, but are not limited to, the timing of completion of the

transaction and potential purchase accounting

charges. These statements are just predictions and are subject to risks and uncertainties that could cause

the actual events or results to differ materially. These risks and uncertainties include receipt of regulatory

and stockholder approval, integration of the two companies post-closing, market acceptance for the

transaction and approved products, management of rapid growth, risks of regulatory review and clinical

trials, intellectual property risks, and the need to acquire additional products. The reader is referred to the

documents that Indevus and Valera file from time to time with the Securities and Exchange Commission. 

Indevus and Valera do not undertake any obligation to publicly release the results of any revisions that may

be made to any forward-looking statements to reflect the occurrence of anticipated or unanticipated events

or circumstances after the date of such statements.

Indevus 2006 –

A Year of Milestone Achievement

•

Acquired U.S. rights to DELATESTRYL

®

•

Completed enrollment of NEBIDO

®

Phase III PK study

•

Announced positive results of pagoclone stuttering trial

•

Announced positive results of SANCTURA XR™

Phase III studies

•

Completed $35.0 million secondary offering

•

Filed NDA for SANCTURA XR™

•

Out-licensed aminocandin to sanofi-aventis

spinout, Novexel

•

Announced acquisition of Valera Pharmaceuticals

Strategic Rationale

Acquisition creates an emerging leader in urology and men’s health

•

Perfect fit with the Indevus corporate strategy of building a world

class urology and men’s health franchise

•

Upon closing, the combined Company will have 3 marketed products

(one from Valera) and anticipates 5 product launches within 2 years

(2 in 2007 / 3 in 2008), including 3 from Valera

•

Fully leverages Indevus’

national sales force

•

Expected to be accretive within 2 years and significantly increase

EPS upon achievement of profitability

Indevus + Valera –

Product Pipeline

Building a Focused Portfolio of Products

CORE THERAPEUTIC AREAS

CORE THERAPEUTIC AREAS

Phase I     Phase II     Phase III        NDA

Market

Overactive bladder

SANCTURA XR

™

PRO 2000

Prevention of HIV

& other STDs

DELATESTRYL

®

Hypogonadism

NEBIDO

®

Hypogonadism

VANTAS

®

Prostate Cancer

SUPPRELIN

®

-LA

Central Precocious

Puberty

Overactive bladder

SANCTURA

®

VALSTAR

®

Bladder Cancer

Ureteral

Stent

Kidney Stones and

Other

Octreotide

Implant

Acromegaly

Indevus products in dark blue

Valera products in light blue

Indevus + Valera –

Product Pipeline

Partnered & Partnerable

Products

OTHER THERAPEUTIC AREAS

OTHER THERAPEUTIC AREAS

Preclinical   Phase I       Phase II      Phase III      Market

Pagoclone

Naltrexone

Implant

Drug Addiction

Hydron

Implant Tech

Stuttering

Serious fungal

infections

Aminocandin

PMDD

Sarafem

Other Uses

IP 751

Anti-inflammatory

Disorders

Indevus products in dark blue

Valera products in light blue

Licensed to Eli Lilly/Galen

Licensed to Novexel

Transaction Overview

•

Stock for Stock purchase of Valera Pharmaceuticals (VLRX)

•

$7.75 per share of Valera common stock with 10% collar

Maximum exchange ratio: 1.1766

Minimum exchange ratio:  0.9626

•

Deal Value ~ $120 Million + contingent payments

•

Contingent Payments in Indevus stock:

$1.00/share upon approval of SUPPRELIN

®

-LA and sufficient launch

quantities

$1.00/share upon approval of ureteral

stent

$1.50/share upon approval of octreotide

implant

•

Transaction expected to close on or about April 30, 2007

•

Conditions to closing:

Indevus and Valera shareholder approval

HSR clearance

Other customary conditions of merger agreement

Indevus Product Portfolio

SANCTURA XR™

-

Overactive Bladder

Current Profile of SANCTURA

®

Only quaternary ammonium on the market

Low CNS side-effects

No clinically relevant metabolic drug-drug interactions

Excreted largely unchanged in the urine

Rapid onset of action

PLUS

Once-a-day dosing

Lower anti-cholinergic side effects

NDA

Submitted

–

October

2006

Two large Phase III trials with high-degree of efficacy

Landmark tolerability profile with 10.7% dry mouth rate

Target

product

launch

–

2H

2007

U.S. OAB market in 2006: $1.5B (est.)

Indevus Product Portfolio

Co-Promotion Financial Terms with Esprit Pharma

Up Front and Approval Milestone

$150M

Phase III Initiation Milestone

$  10M

NDA Submission

$  10M

Future Milestones:

Approval

$35M

Commercialization (2013)

$20M

$125M+

20%

$  75 -

$125M

17.5%

$    0 -

$  75M

15%

Royalty Rates

Guaranteed Minimum Royalties

$10.5M

7/1/07-6/30/08

$  7.9M

7/1/06-6/30/07

$  5.6M

7/1/05-6/30/06

Esprit responsible for 100% of A&P expenses

Sales Force Subsidy:  $8.8MM per year

Co-promotion term:     December 2008

Indevus Product Portfolio

NEBIDO

®

-

Hypogonadism

•

Novel, long-acting preparation of testosterone undecanoate

•

First and ONLY

3-month injection 

•

Approved in over 80 countries

•

Phase

III

pharmacokinetic

study

complete

–

Q2

2007

•

Anticipated

NDA

submission

–

Summer

2007

•

Highly differentiable from existing therapies

•

U.S. market for testosterone replacement: $500M (est.)

Indevus Product Portfolio

Pagoclone -

Persistent Stuttering

•

Over 3 million patients in the U.S. with persistent stuttering

•

Novel, selective GABA-A receptor agonist

•

Complete toxicology, pharmacology and manufacturing packages for

NDA with more than 1,000 patients studied in previous anxiety trials

•

Successful

Phase

II

trial

completed

–

May

2006

•

Phase

III

to

include

adult

and

pediatric

studies

–

Initiate

1H

2007

Fixed-dose response trials

6-month duration

Quantitative and qualitative primary and secondary endpoints

•

Worldwide rights to compound

Indevus Product Portfolio

PRO 2000 -

Prevention of Sexual Transmission of HIV

•

Topical vaginal microbicide blocks pathogen entry into

susceptible cells

•

Active against a wide range of HIV isolates, chlamydia, herpes

and gonorrhea

•

Significant interest in female-controlled option

•

>$100M in designated funding by NIH and MRC

NIH Phase II/III trial –

3,200 women (on-going)

MRC Phase III trial –

10,000 women (on-going)

•

Large market opportunity

Traditional pharmaceutical pricing in U.S./Europe

Commodity pricing in developing world

Valera Product Portfolio

VANTAS

®

(histrelin

implant) -

Advanced Prostate Cancer

•

U.S. launch -

November 2004

•

Soft,

flexible

implant

utilizing

Hydron

Implant

Technology

•

12-month implant to deliver histrelin

(most

potent LHRH agonist) for the treatment of

advanced prostate cancer

Limits need for multiple physician visits

•

Rapid sustained testosterone suppression

slows tumor growth

•

Total U.S. market for advanced prostate cancer

treatment > $600M

VANTAS

®

revenues as of 9/30/06

•

3 months: $  2.9M

•

9 months: $14.6M

Valera Product Portfolio

VANTAS

®

Co-Promotion Financial Terms with Indevus

•

Separate

agreement

to

co-promote

VANTAS

®

•

Indevus sales force to initiate co-promotion activities

in January 2007

Indevus ~ 85 reps

Valera ~ 25 reps

•

2-year term

•

Royalty rates:

13.5% of VANTAS

®

sales up to a baseline level

30.0% of VANTAS

®

sales on units exceeding baseline

35.0% of VANTAS

®

sales to Rx-driven specialty

pharmacy accounts

Valera Product Portfolio

SUPPRELIN

®

-LA -

Central Precocious Puberty

•

12-month specifically formulated implant to deliver

histrelin

for the treatment of central precocious

puberty (CPP)

•

Provides consistent, reliable suppression for a 12-

month period

•

FDA Granted Orphan Drug Status in November

2005

•

Active agent previously approved for CPP

•

NDA submitted in June 2006

•

May 3, 2007 PDUFA date

Controlled diffusion

through implant wall

Valera Product Portfolio

SUPPRELIN

®

-LA -

Central Precocious Puberty

•

CPP is the early onset of puberty in young children

•

Incidence: 1 in every 5,000 –

10,000 children

More common in female children

Patient age: typically under 9 years; as young as 4 years or less

Duration of therapy: 3 to 5 years or longer

•

U.S. prevalence: ~20,000 children

Treatment normally performed by pediatric endocrinologist

Hormonal suppression using LHRH agonist

•

Market dominated by single company

Approved leuprolide

depot suspension

Intramuscular injection

Administered to afflicted child every 3 to 4 weeks

Current price for Lupron

Depot-PED: $12,000 -

$15,000/yr

Valera Product Portfolio

SUPPRELIN

®

-LA -

Market Opportunity

Sample Responses From Surveyed Ped

Endos

•

Implant

conceptually

attractive

-

easier

on

families;

less

traumatic

for

kids

•

Steady 1-year hormonal suppression off-sets possible emotional “ups & downs”

associated with monthly injections

•

Expect improved compliance over multiple years of therapy; especially valuable for

younger patients who need up to 7 years of therapy

13 -

17 injections per year for 3 to 5 years

SUPPRELIN

®

-LA

Offer parents

a choice

This

Or

Valera Product Portfolio

VALSTAR

®

(valrubicin) -

Bladder Cancer

•

Anthracycline

derivative of Doxorubicin solution for

bladder instillation

•

Current approved usage

29,000 BCG refractory patients per year (AUA est.)

•

15,000 –

not candidates for bladder removal

•

Valstar

®

is the only

approved product for these patients

•

FDA approved 1998

•

Product currently on FDA Drug Shortages List

•

Reformulation complete

Submission of supplemental NDA -

1H 2007

Valera Product Portfolio

Octreotide

Implant -

Acromegaly

•

6 month octreotide

(somatostatin

analog) implant to treat

acromegaly

•

Acromegaly: a chronic hormonal disorder

Excessive growth hormone & abnormal physical features

Higher incidence of diabetes & cardiovascular disease

•

Current

therapy:

Sandostatin

®

Daily or Monthly injections

2005 Worldwide Sales –

$900 million

•

U.S. sales for acromegaly

–

$200 million

Valera Product Portfolio

Octreotide

Implant -

Acromegaly

•

Approximately 1,000 new acromegaly

patients per year

Treated by endocrinologists

•

Completed

Phase

I/II

study

demonstrating

significant

suppression

of

growth hormone and IGF-1 levels for 6 months

•

Commencing Phase II pharmacokinetic study in 30 patients in early

2007

•

Phase III trial to begin 2H 2007

Primary endpoint -

suppression of growth hormone and IGF-1 levels at

1 month

Studies designed to follow patients for 7 months

Valera Product Portfolio

Biodegradable Ureteral

Stent

•

Presently, conventional non-biodegradable stents

are inserted into the

ureter

to allow urine to drain when the flow of urine may be obstructed

Approximately

1.2

million

procedures

per

year

for

the

removal

of

kidney

stones

in U.S.

Estimated 800,000 ureteral

stents

used per year

•

Vast majority of kidney stone removals are done by urologists

•

Currently available ureteral

stents

require physician intervention for

removal from the body

•

Biodegradable stent

offers multiple potential advantages:

Patient comfort

Single procedure –

no need for retrieval

Lack of encrustation

Considered highly desirable by urology consultants

•

Device application (510k) may be submitted by end of 2007

Financial Highlights

Combined

Company

–

pro

forma

$70.4 million in LTM revenues

$95.0 million in Cash (9/30/06)

Acquisition expected to be accretive within 2 years

Identified synergies of approximately $5.0 million per year

Valera

14.9 million shares outstanding

$19.9 million in LTM revenues

$11.0 million in LTM Net Loss

$18.9 million in Cash (9/30/06)

No Debt

Integration Plan

•

Expected Closing –

on or around April 30, 2007

Subject to Indevus and Valera shareholder approval

HSR clearance

Other customary conditions of merger agreement

•

Indevus President/COO & Indevus EVP/Chief Business Officer to lead

integration planning

•

Cross-functional integration teams at both companies established

•

Valera VP of Operations & Valera VP of R&D expected to join Indevus

senior management team

•

Retention of Cranbury, NJ facility

cGMP

compliant manufacturing facility

•

Currently

manufacture

VANTAS

®

•

Expect

to

manufacture

SUPPRELIN

®

-LA

Significant addition to Indevus capabilities

Desirable pharma

location

2007 Milestones

Begin VANTAS

®

co-promotion

Pagoclone Phase III initiation

SUPPRELIN

®

-LA approval and launch

VALSTAR

®

supplemental NDA submission

NEBIDO

®

NDA submission

SANCTURA XR™

approval and launch

Octreotide

Implant Phase III initiation

Biodegradable Ureteral

Stent

510k submission

Additional Information and Where to Find It

In connection with the merger between Indevus and Valera, Indevus intends to file with the SEC a registration

statement on Form S-4, containing a joint proxy statement/prospectus and other relevant materials.  The final

joint proxy statement/prospectus will be mailed to the stockholders of Indevus and Valera.  INVESTORS AND

SECURITY HOLDERS OF INDEVUS AND VALERA ARE URGED TO READ THE JOINT PROXY

STATEMENT/PROSPECTUS AND THE OTHER RELEVANT MATERIALS WHEN THEY BECOME

AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT INDEVUS, VALERA

AND THE MERGER.  The registration statement and joint proxy statement/prospectus and other relevant

materials (when they become available), and any other documents filed by Indevus or Valera with the SEC,

may be obtained free of charge at the SEC’s web site at www.sec.gov. In addition, investors and security

holders may obtain free copies of the documents (when they are available) filed with the SEC by Indevus by

directing a request to: Indevus Pharmaceuticals, Inc. 33 Hayden Avenue Lexington, MA 02421-7966, Attn:

Investor Relations.  Investors and security holders may obtain free copies of the documents filed with the SEC

by Valera by contacting Valera Pharmaceuticals, Inc., 7 Clarke Drive, Cranbury, NJ 08512 Attn: Investor

Relations.

Participants in the Merger Solicitation

Indevus, Valera and their respective executive officers and directors may be deemed to be participants in the

solicitation of proxies from the stockholders of Indevus and Valera in favor of the merger. Information about the

executive officers and directors of Indevus and their ownership of Indevus common stock is set forth in

Indevus' Annual Report on Form 10-K for the year ended September 30, 2006, which was filed with the SEC

on December 7, 2006 and the proxy statement for Indevus' 2006 Annual Meeting of Stockholders, which was

filed with the SEC on January 30, 2006.  Information regarding Valera’s directors and executive officers and

their ownership of Valera common stock is set forth in Valera’s Annual Report on Form 10-K for the year ended

December 31, 2005, which was filed with the SEC on March 20, 2006.  Investors and security holders may

obtain more detailed information regarding the direct and indirect interests of Indevus, Valera and their

respective executive officers and directors in the merger by reading the joint proxy statement/prospectus

regarding the merger

when it becomes available.