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 (Date of earliest event Reported): May 17, 2018  

BEIGENE, LTD.
(Exact Name of Registrant as Specified in Charter)

Cayman Islands 001-37686 98-1209416
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number)

 

c/o Mourant Ozannes Corporate Services (Cayman) Limited
94 Solaris Avenue, Camana Bay
Grand Cayman KY1-1108
Cayman Islands
(Address of Principal Executive Offices) (Zip Code)

+1 (345) 949 4123
(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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [   ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [   ]

 
 

Item 8.01. Other Events.

On May 17, 2018, BeiGene, Ltd. (the “Company”) issued a press release announcing t hat the first patient was enrolled in a Phase 3 clinical trial in China of pamiparib (BGB-290), an investigational PARP inhibitor, in patients with platinum-sensitive recurrent ovarian cancer. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits .

Exhibit No.   Description
99.1   Press Release issued on May 17, 2018



EXHIBIT INDEX

 

Exhibit No.   Description
99.1   Press Release issued on May 17, 2018


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.

  BEIGENE, LTD.
     
   
Date: May 18, 2018 By:  /s/ Scott A. Samuels        
    Scott A. Samuels
    Senior Vice President, General Counsel
   

EXHIBIT 99.1

BeiGene Initiates Phase 3 Trial of Pamiparib as Maintenance Therapy in Chinese Patients with Ovarian Cancer

BEIJING, China and CAMBRIDGE, Mass., May 17, 2018 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the first patient was enrolled in a Phase 3 clinical trial in China of pamiparib (BGB-290), an investigational PARP inhibitor, in patients with platinum-sensitive recurrent ovarian cancer.

“We are pleased to announce the initiation of this Phase 3 trial of pamiparib in China as a potential maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer. This trial is designed to provide important confirmatory clinical data that could enable registration in the maintenance setting, as well support our planned initial regulatory submission for the treatment of patients with advanced ovarian cancer who carry a germline BRCA1/2 mutation,” commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology of BeiGene.

“In China there are currently no approved PARP inhibitors, despite the multiple approvals of PARP inhibitors in other regions of the world and in a variety of settings. Our development program in ovarian cancer is designed to address the limited treatment options that currently exist for these patients in China,” commented Lai Wang, Ph.D., Senior Vice President and Head of China Development of BeiGene.

The Phase 3 randomized, double-blind, placebo-controlled, multi-center trial is designed to evaluate the efficacy of maintenance therapy with pamiparib versus a placebo in patients with recurrent ovarian cancer who achieved a complete response or partial response after platinum-based chemotherapy, as measured by progression-free survival (PFS) determined by independent review. Secondary objectives include PFS per RECIST version 1.1 determined by investigator, overall survival, objective response rate, duration of response, time to response, safety, and tolerability. Approximately 215 patients are planned to be enrolled in this trial at 15-20 cancer centers in China.

“As we look to improve the current 30 to 40 percent five-year survival rate for patients with advanced ovarian cancer, I look forward to evaluating pamiparib as a potential new maintenance therapy. We are excited to build upon the knowledge base we have of pamiparib from its Phase 1 and 2 studies as well as from other PARP inhibitors in ovarian cancer,” said Professor Ding Ma, M.D.,  Director of Obstetrics and Gynecology, Tongji Medical College of Huazhong University of Science and Technology; and Principal Investigator of the trial.

For more information about the trial, patients and physicians should email clinicaltrials@beigene.com.

About Ovarian Cancer in China

In China, over 50,000 women are diagnosed with ovarian cancer and more than 22,000 die from the disease each year 1 . More than 70 percent of patients are diagnosed with advanced disease 2 . The standard therapy for ovarian cancer consists of surgery followed by postoperative platinum-based chemotherapy. An estimated 85 percent of patients with epithelial ovarian cancer who achieve a full remission following first-line therapy will develop recurrent disease 3 .

About Pamiparib

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP–DNA complex trapping in preclinical models. Pamiparib is being evaluated in pivotal clinical trials in China. It is currently in global clinical development as a monotherapy, and in combination with other agents, including BeiGene’s investigational anti-PD1 antibody, tislelizumab (BGB-A317), for a variety of solid tumor malignancies.

About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 1,100 employees in China, the United States, and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene markets ABRAXANE ® (nanoparticle albumin–bound paclitaxel), REVLIMID ® (lenalidomide), and VIDAZA ® (azaciditine) in China under a license from Celgene Corporation. 4

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s advancement of, and anticipated clinical development and regulatory milestones and plans related to pamiparib.  Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve r commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission.  All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.  

Investor Contact                             Media Contact

Lucy Li, Ph.D.                                   Liza Heapes
+1 781-801-1800                              +1 857-302-5663
ir@beigene.com                               media@beigene.com



1 Chen et al., CA Cancer J Clin, 2016.

2 Fleming et al.,  J. Epithelial ovarian cancer, 2009.

3 Corrado et al., Expert Rev Anticancer Ther, 2017.

4 ABRAXANE ® , REVLIMID ® , and VIDAZA ® are registered trademarks of Celgene Corporation.