Forest Laboratories (FRX) 8-K Entry into a Material Definitive Agreement

Forest to Acquire Furiex

for $1.1 Billion

4/28/2014

©

2013 Forest Laboratories Inc.

Exhibit 99.3

Safe Harbor

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2013 Forest Laboratories Inc.

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This presentation contains forward-looking statements within the meaning of the Private

Securities Litigation Reform Act of 1995. These statements involve a number of

risks and uncertainties, including that the transactions may not be timely completed,

if at all, that prior to completion of the transactions, Furiex’s business may

experience significant disruptions due to transaction-related uncertainty or other

factors, the timing and the benefits of the business combination transaction, the

ability to obtain regulatory approvals of the transaction on the proposed terms and

schedule, the requirement that Furiex’s security holders approve the transaction, the

risk that the businesses will not be integrated successfully, the difficulty of predicting

FDA approvals, the acceptance and demand for new pharmaceutical products, the

impact of competitive products and pricing, the timing of Actavis plc’s acquisition of

Forest, the timely development and launch of new products, and the risk factors

listed from time to time in Forest Laboratories’ Annual Report on Form 10-K,

Quarterly Reports on Form 10-Q and any subsequent SEC filings and Furiex’s

Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and any subsequent

SEC filings. 

Safe Harbor -

continued

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2013 Forest Laboratories Inc.

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Neither Forest nor Furiex assumes any obligation to update forward-looking statements

contained in this release to reflect new information or future events or developments.  

Each of Forest and Furiex intends such forward-looking statements to be covered by the

Safe Harbor provisions for forward-looking statements contained in the Private Securities

Litigation Reform Act of 1995, and is including this statement for purposes of complying

with these Safe Harbor provisions.  Forward-looking statements, which are based on

certain assumptions and describe future plans, strategies and expectations of each of

Forest and Furiex, may be identified by use of the words “believe,” “expect,” “intend,”

“anticipate,” “project,” or similar expressions.  Investors should not rely on forward-looking

statements because they are subject to a variety of risks, uncertainties and other factors

that could cause actual results to differ materially from such forward-looking statements.  

All forward-looking statements in this document are qualified in their entirety by this

cautionary statement.

Additional Information and Where to Find It

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2013 Forest Laboratories Inc.

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This communication does not constitute an offer to sell or the solicitation of an offer to buy

any securities or a solicitation of any vote or approval, nor shall there be any sale of

securities in any jurisdiction in which such offer, solicitation or sale would be unlawful

prior to registration or qualification under the securities laws of any such jurisdiction. In

connection with the proposed acquisition of Furiex by Forest, Furiex will file a proxy

statement with the SEC (the “Furiex Proxy”). Additionally, Furiex will file other relevant

materials with the SEC in connection of the proposed acquisition. The Furiex Proxy

and other materials that Furiex plans to file with the SEC will contain important

information about Furiex, Forest, the proposed merger and related matters.  The

Furiex Proxy will be delivered to the security holders of Furiex. In connection with the

proposed merger between Actavis, plc (“Actavis”) and Forest, Actavis has filed with the

SEC a registration statement on Form S-4 that includes a preliminary joint proxy

statement of Actavis and Forest that also constitutes a preliminary prospectus of

Actavis (the “Forest/Actavis Proxy and Prospectus”).

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2013 Forest Laboratories Inc.

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The registration statement is not yet effective. The definitive Forest/Actavis Proxy and

Prospectus will be delivered to security holders of Actavis and Forest. INVESTORS

AND SECURITY HOLDERS ARE URGED TO READ THE FURIEX PROXY, THE

FOREST/ACTAVIS PROXY AND PROSPECTUS AND OTHER RELEVANT

DOCUMENTS FILED WITH THE SEC THAT HAVE BEEN OR WILL BE FILED WITH

THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME

AVAILABLE, AS THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE

PROPOSED ACQUISITION AND THE PARTIES THERETO THAT SECURITY

HOLDERS SHOULD CONSIDER BEFORE MAKING A DECISION ABOUT THE

MERGER.  Security holders of Furiex may obtain free copies of the Furiex Proxy and

other documents filed with the SEC by Forest or Furiex, without charge, from the SEC's

website (http://www.sec.gov). In addition, investors and security holders of Furiex may

obtain free copies of the documents Furiex files with the SEC by directing a written

request to Furiex Pharmaceuticals, Inc., 3900 Paramount Parkway, Suite 150,

Morrisville, NC 27560, Attention: Investor Relations.  Copies of Furiex’s filings with the

SEC may also be obtained at the “Investors” section of Furiex’s internet website at

www.furiex.com. Investors and security holders of Actavis and Forest may obtain free

copies of the Forest/Actavis Proxy and other documents filed with the SEC by Actavis

and Forest, without charge, from the SEC's website (http://www.sec.gov). In addition,

copies of the documents filed with the SEC by Actavis may be obtained free of charge

on Actavis’ internet website at www.actavis.com or by contacting Actavis’ Investor

Relations Department at (862) 261-7488. Copies of the documents filed with the SEC

by Forest may be obtained free of charge on Forest’s internet website at www.frx.com

or by contacting Forest’s Investor Relations Department at (212) 224-6713.

Participants in the Solicitation

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2013 Forest Laboratories Inc.

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Forest, Furiex and their directors and certain of their executive officers may be considered

participants in the solicitation of proxies from the security holders of Furiex in

connection with the proposed transaction between Forest and Furiex. Information about

those directors and executive officers of Furiex, including their ownership of Furiex

securities, is set forth in the proxy statement for Furiex’s 2014 Annual Meeting of

Stockholders, which was filed with the SEC on April 11, 2014, as supplemented by

other Furiex filings with the SEC. Information about the directors and executive officers

of Forest is set forth in its proxy statement for its 2013 annual meeting of stockholders,

which was filed with the SEC on July 8, 2013 and certain of its Current Reports on

Form 8-K. Investors and security holders may obtain additional information regarding

the direct and indirect interests of Furiex, Forest and their directors and executive

officers in the proposed transaction by reading the applicable proxy statement and

other public filings referred to above.  Additional information regarding the participants

in the proxy solicitation and a description of their direct and indirect interests, by

security holdings or otherwise, will be contained in the Furiex Proxy and other relevant

materials to be filed with the SEC when they become available.

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2013 Forest Laboratories Inc.

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Actavis, Forest, their respective directors and certain of their executive officers and

employees may be considered participants in the solicitation of proxies in connection

with the proposed transaction between Actavis and Forest. Information regarding the

persons who may, under the rules of the SEC, be deemed participants in the solicitation

of the Actavis and Forest shareholders in connection with the proposed merger will be

set forth in Forest/Actavis Proxy and Prospectus when it is filed with the SEC.

Information about the directors and executive officers of Forest is set forth in its proxy

statement for its 2013 annual meeting of stockholders, which was filed with the SEC on

July 8, 2013 and certain of its Current Reports on Form 8-K. Information about the

directors and executive officers of Actavis is set forth in Actavis’ proxy statement for its

2014 annual meeting of shareholders, which was filed with the SEC on March 28, 2014.

Additional information regarding the participants in the proxy solicitations and a

description of their direct and indirect interests, by security holdings or otherwise, are

contained in the preliminary Forest/Actavis Proxy and Prospectus and will be contained

in the definitive Forest/Actavis Proxy and Prospectus and other relevant materials to be

filed with the SEC when they become available.

Furiex Acquisition Rationale

•

Builds a leading GI company within Forest

–

Natural extension following Aptalis acquisition in

January

–

Highly complementary to our anchor GI product

Linzess

•

Brings a near-term filing opportunity into

Forest's R&D

•

Expands Forest product offering geographically

•

Gives Forest another enduring growth driver

with a long patent life

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Forest Goal is to Build an Exceptional

Company

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BUSINESS

development

DRUG

development

ENGINE

Marketed Drugs

NDA

EXECUTION

EXCEPTIONAL

COMPANY

commercial

AN

–

Positive topline Phase 3 data released Feb 2014

–

On track to be filed by end of Q3 2014

Mechanism potentially addresses both diarrhea and abdominal pain

without severe constipating effects and opioid receptor desensitization

–

Low potential for drug-drug interactions with commonly used medicines

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Eluxadoline for IBS-D

mu

opioid receptor

activation reduces pain,

gastric propulsion

delta opioid receptor

inhibition restores G-protein

signaling; removes mu agonist-

related desensitization

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Designed to work locally in the gut with low systemic absorption and

bioavailability, minimizing side effects and toxicity

Eluxadoline is a novel mixed mu(µ) opioid receptor agonist/delta(

) opioid

receptor antagonist in development for IBS-D

Two simultaneous studies, one with 52-week and one with 30-week

treatment periods, with study centers in the U.S., Canada and U.K.

Primary

endpoints:

composite

response

at

12

weeks

(FDA

guidance)

and

26 weeks (EMA guidance), as defined¹:

–

Daily pain score improved by

30% vs. baseline average, and

–

Bristol stool score <5

Eluxadoline Phase 3 Study Design

1. Responder must have daily composite response criteria met on at least 50% of days during the analysis period

11

Eluxadoline 75mg BID (n = 375)

Eluxadoline 100mg BID (n =

375)

Placebo BID (n = 375)

N = 1,125 x 2

Screening

(IBS-D)

FDA

Endpoint

EMA

Endpoint

Week 0

Week 26

Week 12

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Statistically significant improvements in responder rates through 12

weeks (FDA endpoint) across both Study 3001 and Study 3002

–

Rapid onset of action, efficacy both in males and females

Significant Efficacy in Two Phase 3

Studies –

FDA

P < 0.025 statistically significant

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p < 0.001

p < 0.001

p = 0.014

p = 0.004

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Study 3001

Study 3002

Placebo

Eluxadoline 75mg

Eluxadoline 100mg

17.1%

16.2%

23.9%

28.9%

25.1%

29.6%

Statistically significant improvements in responder rates through 26

weeks (EMA endpoint) across both Study 3001 and Study 3002

–

Rapid onset of action with sustained efficacy through 6 months

Significant Efficacy in Two Phase 3

Studies –

EMA

P < 0.025 statistically significant

p = 0.001

p < 0.001

p = 0.11

p < 0.001

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19.0%

20.2%

23.4%

30.4%

29.3%

32.7%

Study 3001

Study 3002

Placebo

Eluxadoline 75mg

Eluxadoline 100mg

Statistically significant improvements vs. placebo in pre-specified pooled

Phase 3 ITT analysis of pain responder rates at 12 weeks¹

–

Analysis conducted per FDA request and is consistent with 2012 FDA guidance

Pooled Phase 3 Pain Responder

Analysis –

FDA

1.

These analyses assessed worst abdominal pain (without regard to stool consistency). Patient must meet pain score change

criteria on at least 50% of days to be responder.

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p = 0.047

p = 0.011

p = 0.078

p = 0.003

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P <0.05  statistically significant

Furiex Transaction Overview

•

Acquisition of all outstanding shares of Furiex for ~$1.1 B

$95 per share

•

Transaction also includes  Contingent Value Right (CVR) of up to

$30 per Furiex share (~$360 million in aggregate)

$10 per share if eluxadoline is designated schedule IV drug

$20 per share if eluxadoline is designated schedule V drug

$30 per share if eluxadoline is NOT designated a scheduled drug

•

Upon completion of the Furiex acquisition, Forest expects to divest

Furiex's royalties on alogliptin and Priligy to Royalty Pharma

$415 million

$315 million after tax

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Commercial Perspective

•

Overall GI market valued at $38

billion

•

IBS-d Affects ~ 28 million in US

and Europe

•

High degree of Physician overlap

in IBS-d and IBS-C

•

New combined GI sales force in

place

•

No significant increase in field

promotions required

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