-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NJ2k+tqeV9TBINRFCe7aJoXfTGc0ZvkkStI4OD9R/NjuTmC1UArHIwxK1odLcD9L eIVXpSw+IG5rFOlgs9TkoA== 0001104659-03-022451.txt : 20031009 0001104659-03-022451.hdr.sgml : 20031009 20031009120820 ACCESSION NUMBER: 0001104659-03-022451 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20031008 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031009 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SAVIENT PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000722104 STANDARD INDUSTRIAL CLASSIFICATION: MEDICINAL CHEMICALS & BOTANICAL PRODUCTS [2833] IRS NUMBER: 133033811 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15313 FILM NUMBER: 03934534 BUSINESS ADDRESS: STREET 1: ONE TOWER CENTER CITY: EAST BRUNSWICK STATE: NJ ZIP: 08816 BUSINESS PHONE: 7324189300 MAIL ADDRESS: STREET 1: ONE TOWER CENTER CITY: EAST BRUNSWICK STATE: NJ ZIP: 08816 FORMER COMPANY: FORMER CONFORMED NAME: BIO TECHNOLOGY GENERAL CORP DATE OF NAME CHANGE: 19920703 8-K 1 a03-3931_18k.htm 8-K

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 8-K

 

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

 

 

Date of Report (Date of earliest event reported): October 8, 2003

 

Savient Pharmaceuticals, Inc.

(Exact name of issuer as specified in its charter)

 

 



Delaware

 

0-15313

 

13-3033811

(State or Other Jurisdiction of
Incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

 

 

 

 

One Tower Center, 14th Floor
East Brunswick, New Jersey

 

 

08816

 

 

(Address ofPrincipal Executive Offices)

 

 

(Zip Code)

 

 

 

Registrant’s telephone number, including area code: (732) 418-9300

 

 

None.

(Former Name or Former Address, if Changed Since Last Report.)

 

 



 

ITEM 5.

OTHER EVENTS AND REGULATION FD DISCLOSURE.

 

 

Savient Pharmaceuticals, Inc. (the "Company") reacquired commercial rights to the Company's sodium hyaluronate product for treatment of pain associated with osteoarthritis of the knee from DePuy Orthopaedics, Inc. ("Depuy").  Under Staff Accounting Bulletein No. 101 (“SAB 101”), contract fee revenues of $5 million paid by DePuy Orthopaedics to the Company for distribution rights to the osteoarthritis product were being recognized over the estimated term of the license agreement.  However, as a result of the reacquisition, in the third quarter of 2003, the Company will recognize non-cash contract fee revenue of $3.4 million, representing the unamortized balance of milestone fees that had previously been deferred in accordance with SAB No. 101.

 

 

ITEM 7.

FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.

 

 

 

(c)

Exhibits.

 

 

 

99.1

Press release issued by Savient Pharmaceuticals, Inc. on October 8, 2003.

 

 

 

 

 

 

2



 

SIGNATURES

 

 

                Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

SAVIENT PHARMACEUTICALS, INC.

 

(Registrant)

 

 

 

By:

/s/ Whiteny K. Stearns, Jr.

 

 

Whitney K. Stearns, Jr.

 

 

Senior Vice President—Chief Financial Officer and Treasurer

 

 

 

 

  Dated: October 9, 2003

 

3


EX-99.1 3 a03-3931_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Investor Relations

 

Company Contact

Don Weinberger
 
Leah Berkovits

Wolfe Axelrod Weinberger Assoc.

 

Savient Pharmaceuticals, Inc.

212-370-4500

 

732-418-9300

 

 

FOR IMMEDIATE RELEASE

 

SAVIENT PHARMACEUTICALS, INC. ANNOUNCES FDA ISSUANCE OF APPROVABLE LETTER FOR OSTEOARTHRITIS PRODUCT

 

– REACQUIRES PRODUCT RIGHTS FROM DEPUY ORTHOPAEDICS –

 

 

East Brunswick, New Jersey, October 8, 2003 — Savient Pharmaceuticals, Inc.  (Savient), (NASDAQ:SVNT) announced today that the U.S. Food and Drug Administration has issued an approvable letter with respect to the Company’s sodium hyaluronate product for the treatment of pain associated with osteoarthritis of the knee.  In the letter, the FDA states that FDA approval of the Pre-Market Approval Application for the product is subject to satisfactory audit of Savient’s new manufacturing facility in Israel and the finalization of product labeling.

 

Simultaneously, Savient announced that it reacquired commercial rights to the product on September 25, 2003, which had previously been exclusively licensed by DePuy Orthopaedics Inc., a Johnson & Johnson Company, for all countries worldwide except Japan and Israel, and which was marketed in Europe by DePuy under the trade name Arthrease™.

 

Arthrease, a treatment of three weekly injections of sodium hyaluronate into the knee joint for the relief of pain due to osteoarthritis, is approved and marketed in Europe and Israel.  It is a high molecular weight formulation of sodium hyaluronate developed and manufactured by Savient’s wholly owned subsidiary, Bio-Technology General (Israel) Ltd., utilizing a patented fermentation method.  The product’s molecular weight and viscoelastic properties are similar to healthy synovial fluid of the knee.

 



 

According to IMS Research, the U.S. market for viscosupplementation products for the treatment of knee pain due to osteoarthritis has been growing at an annual rate of more than 15% for the past five years.  It now exceeds $280 million and is anticipated to continue to grow at this pace.

 

“We are very pleased with both of these developments,” stated Sim Fass, Chairman and Chief Executive Officer of Savient.  “We are working closely with the FDA to facilitate their site inspection and resolve all outstanding issues at the earliest opportunity.  As we proceed on this track, we are also working to put in place a marketing plan for the United States and Europe, now that we have reacquired the rights to our product.  With the viscosupplementation market expected to continue to grow, we believe we have a new and exciting business opportunity.”

 

The product will continue to be marketed in Israel under the trade name Arthrease.  In Europe and in the United States, it will be marketed under a different as yet undisclosed name.

 

About Savient Pharmaceuticals, Inc.

Savient Pharmaceuticals, Inc. (formerly Bio-Technology General Corp.) is a specialty pharmaceuticals company with expertise in developing, manufacturing, and marketing human health care products for niche and wider markets.  Products marketed by Savient’s sales force in the United States are Oxandrin® (oxandrolone, USP) and Delatestryl® (testosterone enanthate).  The Company’s subsidiary, Rosemont Pharmaceuticals Limited, develops, manufactures, and markets through its own sales force oral liquid formulations of prescription products for the UK pharmaceutical market.  The Company’s Israeli subsidiary, Bio-Technology General (Israel) Ltd., manufactures and markets in Israel Bio-Tropin™ (recombinant human growth hormone), BioLon™ (sodium hyaluronate), Bio-Hep-Bâ (hepatitis B vaccine), and Arthreaseä (sodium hyaluronate for osteoarthritis).  Products marketed by Savient’s licensees are Mircetteâ

 



 

(oral contraceptive), and BioLon™ in the United States, and Bio-Tropin™, BioLon™, Bio-Hep-Bâ, Silkis® (vitamin D derivative), and recombinant human insulin, in international markets.  Savient’s news releases and other information are available on the Company’s website at www.savientpharma.com.

 

Arthrease is a trademark of DePuy Orthopaedics, Inc., except in Israel, where it is owned by Bio-Technology General (Israel) Ltd., Savient’s wholly owned subsidiary; Mircette is a registered trademark of Organon, Inc.; Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.; Silkis is a registered trademark of Galderma S.A.

 

#####

Statements in this news release concerning the Company’s business outlook or future economic performance, anticipated profitability, revenues, expenses or other financial items; and statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements” as that term is defined under the Federal Securities Laws.  Forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those stated in such statements.  Such risks, uncertainties and factors include, but are not limited to, changes and delays in product development plans and schedules, changes and delays in product approval and introduction, customer acceptance of new products, development, introduction, or consumer acceptance of competing products, changes in pricing or other actions by competitors, patents owned by the Company and its competitors, changes in healthcare reimbursement, risk of operations in Israel, risk of product or other litigation liability, governmental regulation, dependence on  third parties to manufacture products and commercialize products, and  general economic conditions, as well as other risks detailed in the Company’s filings with the Securities and Exchange Commission.

 


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