0001193125-13-275595.txt : 20130628 0001193125-13-275595.hdr.sgml : 20130628 20130628060739 ACCESSION NUMBER: 0001193125-13-275595 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20130624 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Submission of Matters to a Vote of Security Holders ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130628 DATE AS OF CHANGE: 20130628 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SCICLONE PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000880771 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943116852 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19825 FILM NUMBER: 13938861 BUSINESS ADDRESS: STREET 1: 950 TOWER LANE STREET 2: SUITE 900 CITY: FOSTER CITY STATE: CA ZIP: 94404-2125 BUSINESS PHONE: 650-358-3456 MAIL ADDRESS: STREET 1: 950 TOWER LANE STREET 2: SUITE 900 CITY: FOSTER CITY STATE: CA ZIP: 94404-2125 8-K 1 d560913d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

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: June 24, 2013

(Date of earliest event reported)

 

 

SciClone Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware
  0-19825
  94-3116852
(State or other jurisdiction
of incorporation)
 

(Commission

File Number)

  (IRS Employer
Identification Number)

950 Tower Lane, Suite 900

Foster City, CA

  94404
(Address of principal executive offices)   (Zip Code)

(650) 358-3456

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 1.01 Entry into a Material Definitive Agreement.

On June 25, 2013, SciClone Pharmaceuticals, Inc. (the “Company”) (through its subsidiary SciClone Pharmaceuticals International China Holding Ltd.) entered into a Framework Agreement (the “Agreement”) with Taiwan Liposome Company (“TLC”) granting the Company an exclusive license and the exclusive rights in the People’s Republic of China, Hong Kong and Macau to promote, market, distribute and sell ProFlow® for the treatment of peripheral artery disease (PAD) and other indications. The Agreement provides for the principal terms of the arrangement between the parties, and under the Agreement, the parties have agreed to negotiate a supplemental license and supply agreement in furtherance of the matters set forth in the Agreement.

Under the terms of the Agreement, TLC will be responsible for the continued development, including potential clinical trials and regulatory activities, as well as the manufacturing and supply of ProFlow and the Company will be responsible for all aspects of commercialization, including the pre-and post-launch activities. Financial terms of the agreement include clinical, regulatory and sales milestone payments up to an aggregate of $39.5 million. The Company issued a press release on June 25, 2013 regarding the ProFlow® collaboration. A copy of the press release is attached as Exhibit 99.1 hereto.

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

(b) On June 24, 2013, Stephanie Wong, Vice President, Finance and Controller of the Company informed the Company that she is resigning effective August 2, 2013.

 

Item 5.07 Submission of Matters to a Vote of Security Holders.

At the 2013 Annual Meeting of Stockholders of the Company held on June 27, 2013 (the “Annual Meeting”), the matters on which the stockholders voted, in person or by proxy were:

 

(i) to elect five nominees as directors to serve until the next Annual Meeting and until their successors have been elected and qualified;

 

(ii) to approve, on an advisory basis, the compensation of the Company’s named executive officers as disclosed in the Company’s Proxy Statement;

 

(iii) to ratify the selection of PricewaterhouseCoopers LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2013.

The five nominees were elected, the compensation of named executive officers was approved and the appointment of the independent registered public accounting firm was ratified. The results of the voting were as follows:

Election of Directors:

 

Director

   Votes For      Votes
Withheld
     Broker
Non-Votes
 

Jon S. Saxe

     22,895,489         4,498,354         11,895,594   

Friedhelm Blobel, Ph.D.

     26,103,357         1,290,486         11,895,594   

Richard J. Hawkins

     22,935,266         4,458,577         11,895,594   

Gregg A. Lapointe

     22,883,658         4,510,185         11,895,594   

Simon Li

     26,517,191         876,652         11,895,594   

Approval of the Executive Compensation:

 

Votes For

 

Votes Against

 

Abstentions

 

Broker Non-Votes

23,798,133   1,670,690   1,925,020   11,895,594

Ratification of Appointment of Independent Registered Public Accounting Firm:

 

Votes For

 

Votes Against

 

Abstentions

    
38,052,989   1,028,051   208,397  

 

Item 9.01. Financial Statements and Exhibits

(d) Exhibits.

 

Exhibit No.

  

Description

99.1    Press Release dated June 25, 2013 regarding the Taiwan Liposome collaboration.


SIGNATURE

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.

 

Dated: June 28, 2013     SCICLONE PHARMACEUTICALS, INC.
    By:  

/s/ Friedhelm Blobel, Ph.D

      Friedhelm Blobel, Ph.D
      President and Chief Executive Officer


Exhibit Index

 

Exhibit No.

  

Description

99.1    Press Release dated June 25, 2013 regarding the Taiwan Liposome collaboration.
EX-99.1 2 d560913dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

 

Corporate Contacts  

Jane Green

  Paggy Liou

SciClone Investors/Media

  Taiwan Liposome Company/Media

650.358.1447

  886 (2) 2655.7377 ext.105

jgreen@sciclone.com

  paggy@tlcbio.com

SCICLONE AND TAIWAN LIPOSOME COMPANY ENTER INTO A LICENSING AGREEMENT FOR PROFLOW®, A NOVEL TREATMENT FOR PERIPHERAL ARTERIAL DISEASE FOR THE CHINA MARKET

Foster City, Calif. and Taipei City, Taiwan – June 25, 2013 – SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that the Company has entered into an agreement with Taiwan Liposome Company (TLC) granting SciClone a license and the exclusive rights in China, Hong Kong and Macau to promote, market, distribute and sell ProFlow® for the treatment of peripheral arterial disease (PAD) and other indications.

ProFlow is a novel lipid emulsion-based formulation of prostaglandin E1 (PGE1), a vasodilator and platelet inhibitor. TLC’s proprietary lipid-based delivery systems (LDDS) are designed to modify and broaden the use of existing drugs and enhance their therapeutic index. ProFlow has demonstrated to have twice the shelf life as currently marketed lipid emulsion formulations of PGE1. A patent providing broad protection for ProFlow has been granted in China, Japan and Taiwan. TLC has also applied for worldwide composition of matter patents.

Peripheral arterial disease is a serious cardiovascular condition in which blood flow to the limbs (usually the legs) is restricted due to arterial plaque build-up. PAD can cause severe pain and restricted mobility, and potentially life-threatening blood clots. PAD represents a large and growing market opportunity in China. The current market leading drug generates annual revenue of more than $200 million.

Commented Friedhelm Blobel, Ph.D., SciClone’s Chief Executive Officer: “We are excited to add ProFlow to our product portfolio, as the cardiovascular market represents a large and growing commercial opportunity for which SciClone is well-positioned. We can leverage our considerable sales and marketing expertise for this product. We believe that ProFlow has significant therapeutic and commercial advantages that differentiate it from other branded and generic competitors in the expanding PAD segment. We look forward to working with our partner TLC to bring this important medical advance to patients in need.”

“China is becoming an increasingly prominent market, and we are very pleased to be working with a NASDAQ company that has a strong presence in China, such as SciClone,” said Dr. Keelung Hong, Chairman and Chief Executive Officer of TLC. “SciClone was


ranked number 39 in Fortune’s 2012 Fastest-Growing Companies, which makes it an ideal partner for such a rapidly growing market like China, and also a perfect strategic fit for TLC, since we share the same enthusiasm and sense of urgency for bringing important new therapeutics to patients.”

Under the terms of the agreement, TLC will be responsible for the continued development, including potential clinical trials and regulatory activities, as well as the manufacturing and supply of ProFlow, and SciClone will be responsible for all aspects of commercialization, including pre- and post-launch activities. ProFlow has been submitted to the China Food and Drug Administration (CFDA) for approval, and it is expected that some additional clinical testing may be required prior to approval. Financial terms of the agreement include clinical, regulatory and sales milestone payments up to an aggregate of $39.5 million. The agreement provides for the principal terms of the arrangement between SciClone and TLC, and the companies have agreed to negotiate a supplemental license and supply agreement.

About Taiwan Liposome Company

Incorporated in 1997, Taiwan Liposome Company is a biopharmaceutical company engaging in research, development and commercialization of proprietary drug delivery system for improving the treatment of cancer, ophthalmic conditions, and infectious diseases. TLC was founded and led by renowned scientist Dr. Keelung Hong, who has over 30 years of research and development experience in liposomes with over 100 publications. Led by Dr. Hong, TLC has a team of scientists, management, manufacturing experts and advisors working together to build the company into an organization recognized for its excellence in drug delivery and rapid advancement of products. TLC currently operates its headquarter in Taipei (Taiwan), and subsidiary offices in South San Francisco (US) and Leiden (The Netherlands). For more information, visit http://www.tlcbio.com.

About SciClone

SciClone Pharmaceuticals is a US-based, China-focused specialty pharmaceutical company with a product portfolio of therapies for oncology, infectious diseases, cardiovascular, urological, respiratory, and central nervous system disorders. SciClone’s ZADAXIN® (thymalfasin) is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV) and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. Besides ZADAXIN, SciClone markets about 14 mostly partnered products in China, including Depakine®, the most widely prescribed broad-spectrum anti-convulsant in China; Tritace®, an ACE inhibitor for the treatment of hypertension; Stilnox®, a leading hypnotic for the short-term treatment of insomnia (marketed as Ambien® in the US); and Aggrastat®, a recently-launched interventional cardiology product. SciClone is also pursuing the registration of several other therapeutic products in China. SciClone is headquartered in Foster City, California. For additional information, please visit www.sciclone.com.


Forward-Looking Statements

This press release contains forward-looking statements. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” “unaudited,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties relating to: the clinical trial process, including the regulatory approval and the process of initiating trials at, and enrolling patients at, clinical sites, to the extent required; the effect of changes in its practices and policies related to the Company’s compliance programs. Please also refer to other risks and uncertainties described in SciClone’s filings with the SEC. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.

Ambien, Depakine, Stilnox and Tritace are registered trademarks of Sanofi and/or its affiliates.

Aggrastat is a registered trademark of Medicure International Inc. in the United States, and Iroko Cardio LLC or Merck & Co., Inc. in numerous other countries.

SciClone, SciClone Pharmaceuticals, the SciClone Pharmaceuticals design, the SciClone logo and ZADAXIN are registered trademarks of SciClone Pharmaceuticals, Inc. in the United States and numerous other countries.

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