UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549


 

SCHEDULE TO

 

(RULE 14d-100)

 

TENDER OFFER STATEMENT

 

UNDER SECTION 14(D)(1) OR SECTION 13(E)(1) OF THE SECURITIES EXCHANGE ACT OF 1934


 

MGI PHARMA, INC.

(Name of Subject Company (Issuer))

 


 

JAGUAR ACQUISITION CORP.

a wholly owned subsidiary of

 

EISAI CORPORATION OF NORTH AMERICA

a wholly owned subsidiary of

 

EISAI CO., LTD.

(Name of Filing Persons (Offeror))

 

Common Stock, Par Value $0.01 per share,

and associated preferred stock purchase rights

(Title of Class of Securities)

 

552880-10-6

(CUSIP Number of Class of Securities)

 

Douglas Snyder, Esq.

Jaguar Acquisition Corp.

100 Tice Boulevard

Woodcliff Lake, NJ 07677

(201) 746-02305

 

(Name, address and telephone number of person authorized

to receive notices and communications on behalf of filing persons)

 

with copies to:

 

George J. Sampas, Esq.

Sullivan & Cromwell LLP

125 Broad Street

New York, NY 10004

(212) 558-4945

 

CALCULATION OF FILING FEE

 

Transaction Valuation

 

Amount of Filing Fee

Not Applicable*

 

Not Applicable*

 

*                                          A filing fee is not required in connection with this filing as it relates solely to preliminary communications made before the commencement of a tender offer.

 

o                                     Check the box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify the filing with which the offsetting fee was previously paid.

 

Identify the previous filing by registration statement number or the Form or Schedule and the date of its filing.

 

Amount Previously Paid:

 

N/A

 

Form or Registration No.:

 

N/A

 

Filing Party:

 

N/A

 

Date Filed:

 

N/A

 

 

x                                   Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.

 

Check the appropriate boxes below to designate any transactions to which the statement relates:

x                                   third-party tender offer subject to Rule 14d-1.

o                                     issuer tender offer subject to Rule 13e-4.

o                                     going-private transaction subject to Rule 13e-3.

o                                     amendment to Schedule 13D under Rule 13d-2.

Check the following box if the filing is a final amendment reporting the results of the tender offer: o

 

 


 



THE FOLLOWING MATERIAL WAS MADE AVAILABLE ON EISAI CO., LTD.’S WEBISTE ON DECEMBER 12, 2007.

 

Important Additional information Will be Filed with the Securities and Exchange Commission (“SEC”)

 

The tender offer by Jaguar Acquisition Corp., an indirect wholly-owned subsidiary of Eisai Co., Ltd., for all issued and outstanding shares of MGI PHARMA, Inc.’s common stock has not yet commenced, and this filing is neither an offer to purchase nor a solicitation of an offer to sell shares of MGI PHARMA, Inc.’s common stock.  INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE TENDER OFFER WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.  The tender offer statement will be filed by Jaguar Acquisition Corp. with the SEC, and the solicitation/recommendation statement will be filed by MGI PHARMA, Inc. with the SEC.  Investors and security holders may obtain a free copy of these statements (when available) and other documents filed by Jaguar Acquisition Corp. or MGI PHARMA, Inc. with the SEC at the website maintained by the SEC at www.sec.gov.  The tender offer statement and related materials, solicitation/recommendation statement, and such other documents may be obtained for free by directing such requests to Georgeson, Inc., the information agent for the tender offer, at 1-212-440-9800 for banks and brokers or 1-888-605-7543 for all others.

 

Reference Data

 

1. MGI PHARMA’s Operating Results

 

(In US$ millions)

 

Year Ended December 31

 

Revenues

 

R&D Expenses

 

Gain (loss) on Operations

 

Net gain (loss)

2004

 

195.7

 

62.6

 

(84.7)

 

(85.7)

2005

 

279.4

 

70.9

 

(134.8)

 

(132.4)

2006

 

342.8

 

100.1

 

(31.2)

 

(40.2)

2007 3Q

 

288.8

 

56.9

 

14.5

 

13.7

 

2. MGI PHARMA’s Core Products Profile

 

(1)  Aloxi ® (injection)

 

Generic name:

 

palonosetron hydrochloride

 

 

 

 

 

 

 

MOA & characteristics:

 

Serotonin subtype 3(5-HT3) receptor antagonist

 

 

 

 

 

 

 

Indication:

 

Chemotherapy-induced nausea and vomiting (CINV)

 

 

 

 

 

 

 

Features:

 

Only 5HT 3 receptor antagonist approved for prevention of both acute and delayed chemotherapy-induced nausea and vomiting

 

 

 

 

 

 

 

US Launch:

 

2003

 

 

 

 

 

 

 

Sales for 2006:

 

US$251 million

 

 

 

 

 

 

 

New indication:

 

Post-operative nausea and vomiting (PONV): U.S. NDA filed

 

 

 

 

 

 

 

New formulation:

 

Oral formulation: U.S. NDA submitted

 

 

 

 

 

 

(2)  Dacogen ® (injection)

 

 

 

 

 

 

 

Generic name:

 

decitabine

 

 

 

 

 

 

 

MOA & characteristics:

 

Anti-cancer activities through inhibition of DNA methylation

 

 

 

 

 

 

Indication:

 

Myelodysplastic syndrome (MDS)

 

 

 

 

 

 

Features:

 

Broad indication in patients with MDS: all subtypes, de novo and secondary MDS, previously treated and untreated

 

 

 

 

 

 

US Launch:

 

2006

 

 

 

 

 

 

Sales for 2006:

 

US$36 million

 

 

 

 

 

 

New indication:

 

Acute myeloid leukemia (AML): Phase III

 

 

 

1



 

(3) Gliadel ® Wafer

 

 

 

 

 

Generic name:

 

polifeprosan 20 with carmustine implant

 

 

 

MOA & characteristics

 

Localized delivery of carmustine, DNA/RNA alkylating agent

 

 

 

Indication:

 

Newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation

 

 

 

 

 

Recurrent glioblastoma patients as an adjunct to surgery

 

 

 

Features:

 

Only FDA approved implant treatment for brain cancer

 

 

 

US Launch:

 

1996

 

 

 

Sales for 2006:

 

US$36 million

 

3. MGI PHARMA’s Pipeline

 

(1) Submitted

 

Aloxi®

[Additional indication] Post-operative nausea and vomiting (PONV)

 

 

 

[New formulation] Oral formulation (Chemotherapy-induced nausea and vomiting (CINV)

 

 

Aquavan

Minimal to moderate sedation of patients undergoing brief diagnostic or surgical procedures

 

Clinical Development

 

Saforis

 

Oral mucositis

 

Phase III

 

 

 

 

 

Dacogen ®

 

[Additional indication] Acute myeloid leukemia (AML)

 

Phase  III

 

 

 

 

 

Amolimogene
(therapeutic
DNA vaccine)

 

Cervical dysplasia

 

Phase II / III

 

 

 

 

 

AKR-501

 

Idiopathic thrombocytopenic purpura (ITP)

 

Phase II

 

 

 

 

 

Irofulven

 

Hormone refractory prostate cancer

 

Phase II

 

 

 

 

 

ZYC300
(therapeutic
DNA vaccine)

 

Solid tumors

 

Phase I / II

 

 

 

2



 

 

4. Eisai’s Oncology Portfolio Overview

 

(1) Products

 

ONTAK®
(denileukin diftitox)

 

Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma, whose malignant cells express the CD25 component of the Interleukin-2 receptor

 

 

 

Targretin®
(bexarotene) capsules

 

Treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy

 

 

 

Targretin®
(bexarotene) gel 1%v

 

Treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy

 

 

 

Panretin®
(alitretinoin) gel 0.1%

 

Treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma

 

 

 

FRAGMIN ®
(dalteparin sodium injection)

 

Extended treatment of symptomatic venous thromboembolism (VTE) (proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) to reduce the recurrence of VTE in patients with cancer

 

(2) Pipeline

 

 

Mode of Action

 

Target Indication and Phase

 

Status

E7389

 

Microtubule growth suppressor

 

Breast cancer (3 rd line treatment)

 

U nder preparation for submission under Subpart H

 

 

 

 

Breast cancer (2 nd  & 3 rd line treatment)

 

Phase III

 

 

 

 

Prostate cancer, Sarcoma

 

Phase II

 

 

 

 

NSCLC (combination therapy)

 

Phase I

 

 

 

 

 

 

 

MORAb-003

 

Monoclonal antibody

 

Ovarian cancer

 

Phase II

 

 

3



 

E7820

 

Alpha 2 integrin expression inhibitor

 

Cancer

 

Phase I / II

 

 

 

 

 

 

 

E7070

 

Cell cycle GI phase targeting agent

 

Small cell lung c ancer , pancreatic c ancer (combination therapy)

 

Phase I

E7080

 

VEGF receptor tyrosin kinase inhibitor

 

Cancer

 

Phase I

 

 

 

 

 

 

 

E7974

 

Hemiasterlin type tubuin polymerization inhibitor

 

Cancer

 

Phase I

 

 

 

 

 

 

 

MORAb-009

 

Monoclonal antibody

 

Pancreatic cancer

 

Phase1

 

 

 

 

 

 

 

E7107

 

Splicing factor modulator

 

Cancer

 

Phase1

 

 

 

 

 

 

 

E6201

 

Multi-kinase inhibitor

 

Cancer

 

Preparing
for Phase1

 

 

4


 


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