0001193125-16-426608.txt : 20160111 0001193125-16-426608.hdr.sgml : 20160111 20160111165233 ACCESSION NUMBER: 0001193125-16-426608 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20160106 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160111 DATE AS OF CHANGE: 20160111 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Novocure Ltd CENTRAL INDEX KEY: 0001645113 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37565 FILM NUMBER: 161336863 BUSINESS ADDRESS: STREET 1: LE MASURIER HOUSE, LA RUE LE MASURIER CITY: ST. HELIER STATE: Y9 ZIP: JE2 4YE BUSINESS PHONE: 44 (0)15 3475 6700 MAIL ADDRESS: STREET 1: LE MASURIER HOUSE, LA RUE LE MASURIER CITY: ST. HELIER STATE: Y9 ZIP: JE2 4YE 8-K 1 d113225d8k.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 (Date of earliest event reported): January 6, 2016

 

 

NovoCure Limited

(Exact name of registrant as specified in its charter)

 

 

 

Jersey (Channel Islands)   001-37565   Not Applicable

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

Le Masurier House

La Rue Le Masurier

St. Helier, Jersey

   JE2 4YE
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: +44 (0)15 3475 6700

N/A

(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 (see General Instruction A.2. to Form 8-K):

 

¨ 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 7.01 Regulation FD Disclosure

The press releases of NovoCure Limited, dated January 6, 2016, January 7, 2016, and January 11, 2016, are furnished herewith as Exhibits 99.1, 99.2 and 99.3, respectively.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit
No.

   

Description

99.1    Press Release of NovoCure Limited, dated January 6, 2016
99.2    Press Release of NovoCure Limited, dated January 7, 2016
99.3    Press Release of NovoCure Limited, dated January 11, 2016

The information in Item 7.01 (including any exhibits furnished under Item 9.01 relating thereto) in this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (as amended, the “Exchange Act”) or otherwise subject to the liabilities of that Section, and shall not be or be deemed to be incorporated by reference in any NovoCure Limited filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

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.

NovoCure Limited

(Registrant)

Date: January 11, 2016

 

By:  

/s/ Wilco Groenhuysen

  Name:   Wilco Groenhuysen
  Title:   Chief Financial Officer

Index to Exhibits

 

Exhibit
No.

   

Description

99.1    Press Release of NovoCure Limited, dated January 6, 2016
99.2    Press Release of NovoCure Limited, dated January 7, 2016
99.3    Press Release of NovoCure Limited, dated January 11, 2016
 EX-99.1 2 d113225dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Novocure Files Premarket Approval Supplement Application With FDA for Second Generation Optune System

Second generation Tumor Treating Fields delivery system is more than 50 percent lighter and 50 percent smaller than first generation Optune

St. Helier, Jersey – Jan. 6, 2016 – Novocure (NASDAQ: NVCR) filed a premarket approval (PMA) supplement application for its new, second generation Optune system with the U.S. Food and Drug Administration on Dec. 22, 2015. FDA approval of the PMA supplement is required before Novocure can make the improved Optune system available to glioblastoma patients in the U.S.

Optune is a portable, noninvasive device that delivers Tumor Treating Fields (TTFields) therapy to patients with newly diagnosed and recurrent glioblastoma. Novocure designed the second generation Optune system to improve the convenience and manageability of TTFields therapy for patients. The new model features a TTFields generator that is half the size and half the weight of the current system. The second generation Optune system, including its battery, weighs 2.7 pounds (1.3 kilograms) compared to the current version that weighs 6 pounds (3 kilograms). The improvements of the second generation Optune system were achieved using novel digital signal generation technology.

“We’re making significant advancements in the technology used to deliver TTFields therapy,” said Mike Ambrogi, Novocure’s Chief Operating Officer. “The big improvement with the second generation device is the reduction in size and weight achieved by digital signal generation technology. From a patient-convenience view, we believe it is a significant step forward.”

Novocure started offering the second generation Optune device to patients in Germany in October 2015 and has since made it available to all new patients throughout Europe. Novocure is in the process of upgrading European patients who previously started TTFields therapy on the first generation Optune.

“Many of our European patients are pleased with the new ergonomic, lightweight Optune system, which they incorporate into their daily routines with more ease,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We will continue to improve all aspects of our Tumor Treating Fields delivery systems to enhance the quality of life of our patients.”

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.

Approved Indications

In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance

temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than four weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.

In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.

Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union.

About Novocure

Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s US operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Quarterly Report on Form 10-Q filed on October 27, 2015 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

###

Media and Investor Contact:

Ashley Cordova, Novocure

acordova@novocure.com

212 767 7558

EX-99.2 3 d113225dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

LOGO

Novocure Submits PMA Partial Amendment Application to Japanese Pharmaceuticals and Medical Devices Agency for Treatment of Newly Diagnosed Glioblastoma Patients

St. Helier, Jersey – Jan. 7, 2016 – Novocure announced today that it submitted a premarket approval (PMA) partial amendment application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Optune, a Tumor Treating Fields (TTFields) therapy delivery device, in patients with newly diagnosed glioblastoma. The Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of Optune in patients with recurrent glioblastoma in March 2015.

Optune was approved for the treatment of newly diagnosed glioblastoma by the U.S. FDA on Oct. 5, 2015, based on the successful results of the EF-14 phase 3 trial.

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.

Approved Indications

In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than four weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.

In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.

Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the U.S. or by email at supportEMEA@novocure.com in the European Union.

About Novocure

Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s U.S. operations are based in Portsmouth, NH, New York, NY, and Malvern, PA.

Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Quarterly Report on Form 10-Q filed on October 27, 2015 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

###

Media and Investor Contact:

Ashley Cordova, Novocure

acordova@novocure.com

212 767 7558

EX-99.3 4 d113225dex993.htm EX-99.3 EX-99.3

Exhibit 99.3

Novocure Announces Preliminary 2015 Operating Statistics

555 prescriptions were received in the fourth quarter of 2015, an increase of 108% versus the prior year quarter

603 active patients at December 31, 2015, an increase of 168% versus December 31, 2014

St. Helier, Jersey – Novocure (NASDAQ: NVCR), a commercial stage oncology company pioneering a novel therapy for solid tumors, will provide a business update as well as its preliminary operating statistics for the fourth quarter and full year 2015 at the 34th Annual J.P. Morgan Healthcare Conference. The fourth quarter of 2015 was marked by substantial growth versus the prior quarter driven primarily by the FDA approval for Optune in newly diagnosed glioblastoma on October 5, 2015. This growth was largely achieved prior to the peer-reviewed publication of the successful EF-14 newly diagnosed glioblastoma phase 3 clinical trial in the Journal of the American Medical Association (JAMA) on December 15, 2015.

“The fourth quarter of 2015 was an outstanding quarter for Novocure and the momentum from 2015 positions us for another year of strong growth in 2016,” said Asaf Danziger, Novocure’s Chief Executive Officer. “The FDA approval of Optune for newly diagnosed glioblastoma was a key catalyst of our commercial business and we enter 2016 focused on communicating our superior outcomes in glioblastoma as we work to transform the standard of care for this disease.

Fourth Quarter and Full Year 2015 Operating Statistics

 

  •   555 prescriptions were received in the quarter, an increase of 108% versus the prior year quarter. 499 of the prescriptions were received in the U.S. and 56 were received outside of the U.S., primarily in Europe.

 

  •   1,774 prescriptions were received in the year, an increase of 151% versus the prior year. 1,607 of the prescriptions were received in the U.S. and 167 were received outside of the U.S., primarily in Europe.

 

  •   There were 603 active patients on Optune therapy on December 31, 2015, an increase of 168% versus December 31, 2014. 529 of the active patients were in the U.S. and 74 of the active patients were outside of the U.S., primarily in Europe.

 

  •   U.S. sales force expanded to 31 full-time employees as of December 31, 2015.

 

  •   244 U.S. cancer centers certified to prescribe Optune as of December 31, 2015.

About Tumor Treating Fields (TTFields)

Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.

Approved Indications

In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.

In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.

In Japan, Optune (the NovoTTF-100A System) is approved for the treatment of adult patients with recurrent supra-tentorial glioblastoma after all possible surgical and radiation therapy options have been exhausted.

Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union.

About Novocure

Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s US operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Quarterly Report on Form 10-Q filed on October 27, 2015 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

Media and Investor Contact:

Ashley Cordova, Novocure

acordova@novocure.com

212 767 7558

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