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): March 14, 2016
Celladon Corporation
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36183 |
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33-0971591 |
(State or other jurisdiction
of incorporation) |
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(Commission
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(IRS Employer
Identification No.) |
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12707 High Bluff Drive, Suite 200
San Diego, CA |
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92130 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (858) 350-4355
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events.
As previously announced, on November 18, 2015, Celladon Corporation (Celladon), Celladon Merger Sub, Inc.
(Merger Sub) and Eiger BioPharmaceuticals, Inc. (Eiger) entered into an Agreement and Plan of Merger and Reorganization (Merger Agreement), pursuant to which, among other things, subject to
the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Eiger, with Eiger becoming a wholly-owned subsidiary of Celladon and the surviving corporation of the merger.
Attached hereto and incorporated herein by reference as Exhibit 99.1 is a press release issued by Eiger on March 14, 2016 entitled
Eiger Announces Completion of Enrollment of Phase 2 LOWR HDV 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus 4) Study at Hannover Medical School.
Additional Information about the Merger and Where to Find It
In connection with the proposed merger, Celladon has filed a registration statement on Form S-4 with the Securities and Exchange Commission
(the SEC) including a proxy statement/prospectus/information statement. The registration statement was declared effective by the SEC on February 12, 2016. The proxy statement/prospectus/information statement and any
other relevant documents filed by Celladon with the SEC may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Celladon by
directing a written request to: Celladon Corporation, 12707 High Bluff Dr. #200, San Diego, CA 92130, Attention: Investor Relations. Investors and security holders are urged to read the proxy statement/prospectus/information statement and the
other relevant materials before making any voting or investment decision with respect to the proposed merger.
This communication shall
not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful
prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of
the Securities Act of 1933, as amended.
Participants in the Solicitation
Celladon and its directors and executive officers and Eiger and its directors and executive officers may be deemed to be participants in the
solicitation of proxies from the stockholders of Celladon in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger is included in the proxy
statement/prospectus/information statement referred to above. Additional information regarding the directors and executive officers of Celladon is also included in Celladons Annual Report on Form 10-K for the year ended December 31, 2014
and the proxy statement for Celladons 2015 Annual Meeting of Stockholders. These documents are available free of charge at the SEC web site at www.sec.gov and from Investor Relations at Celladon at the address described above.
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Item 9.01 Financial Statements and Exhibits.
Reference is made to the Exhibit Index included with this Current Report on Form 8-K.
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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.
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Celladon Corporation |
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Dated: March 14, 2016 |
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By: |
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/s/ Andrew C. Jackson |
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Andrew C. Jackson |
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Chief Financial Officer |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press release issued by Eiger BioPharmaceuticals, Inc. on March 14, 2016 entitled Eiger Announces Completion of Enrollment of Phase 2 LOWR HDV 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus 4) Study
at Hannover Medical School. |
Exhibit 99.1
Eiger Announces Completion of Enrollment of Phase 2 LOWR HDV 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus 4) Study at Hannover
Medical School
PALO ALTO, Calif., March 14, 2016 /PRNewswire/ Eiger BioPharmaceuticals, Inc. today announced the
completion of enrollment of LOWR HDV 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus 4) at Hannover Medical School in Hannover, Germany. LOWR HDV 4 is an open-label study designed to evaluate the efficacy and tolerability
of lonafarnib combined with ritonavir twice daily with the option of dose escalation at the discretion of the investigator. Fifteen people with chronic hepatitis delta will receive study drugs for 24 weeks. Enrollment was completed in less than 4
months.
We are very pleased to conduct our first study with lonafarnib combined with ritonavir in HDV infected patients, said Heiner
Wedemeyer, MD, Research Group Leader in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School. Many drugs are dose escalated or titrated to allow patients to acclimate to therapy and optimize treatment.
The LOWR HDV - 4 protocol design enables us to investigate the efficacy and tolerability of lonafarnib in combination with ritonavir in HDV infected patients with an option to dose escalate or titrate at pre-specified times during the 24 week dosing
period.
Hepatitis delta causes the most aggressive form of human viral hepatitis, with fast progression to cirrhosis and other
life-threatening complications, said Eduardo Martins, MD, DPhil, Senior Vice President of Liver and Infectious Diseases Drug Development at Eiger BioPharmaceuticals. LOWR HDV 4 is designed to help elucidate the antiviral potential
of lonafarnib in combination with ritonavir in a longer duration study with the optionality of dose escalation, and we eagerly await results.
About Sarasar® (lonafarnib)
Lonafarnib is a well-characterized, late-stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a
process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the virus life cycle at the stage of
assembly. Since prenylation is carried out by a host enzyme, this compound may present a higher barrier to development of viral resistance mutations to therapy. Lonafarnib has been dosed in over 60 HDV-infected
patients across international academic centers and is in Phase 2 development for HDV. Lonafarnib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA), and Fast Track Designation by U.S. FDA. Lonafarnib is not approved for any indication, and is licensed from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada).
About Hepatitis Delta Virus (HDV)
Hepatitis Delta (or
Hepatitis D) is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV). Hepatitis D leads to more
severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis D is a disease with a significant impact on global health, which may affect up to approximately 15-20 million
people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 4.3% to 5.7%% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with
chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia
and Pakistan.
About Eiger
Eiger is a clinical-stage
biopharmaceutical company committed to bringing to market novel products for the treatment of Orphan diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which
the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
Safe Harbor Statements
In connection with the proposed merger of Celladon Corporation (NASDAQ: CLDN) and Eiger, Celladon has filed a registration statement on Form S-4 (File
No. 333-208521) with the Securities and Exchange Commission, or the SEC, including a proxy statement/prospectus/information statement. The registration statement was declared effective by the SEC on February 12, 2016. The proxy
statement/prospectus/information statement and any other relevant documents filed by Celladon with the SEC may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and
security holders may obtain free copies of the documents filed with the SEC by Celladon by directing a written request to: Celladon Corporation, 12707 High Bluff Dr. #200, San Diego, CA
92130, Attention: Investor Relations. Investors and security holders are urged to read the proxy statement/prospectus/information statement and the other relevant materials before making any voting or investment decision with respect to
the proposed merger.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer
to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No
offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Celladon and its directors and executive officers and Eiger and its directors and executive officers may be deemed to be participants in the solicitation
of proxies from the stockholders of Celladon in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger is included in the
proxy statement/prospectus/information statement referred to above. Additional information regarding the directors and executive officers of Celladon is also included in Celladon Annual Report on Form 10-K for the year ended
December 31, 2014 and the proxy statement for Celladons 2015 Annual Meeting of Stockholders. These documents are available free of charge at the SEC web site at www.sec.gov and from Investor Relations at Celladon at the address
described above.
Note Regarding Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the structure, timing and completion of Eigers proposed merger with Celladon and the development
and potential benefits of Eigers product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These
forward-looking statements are based upon Celladons and Eigers current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ
materially from those
anticipated in such forward-looking statements as a result of various factors, include the risks described in the Risk Factors section of the proxy
statement/prospectus/information statement referred to above. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eiger undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the date on which they were made.
SOURCE Eiger Bio, Inc.
Investors: Jim Shaffer, Eiger Bio, Inc., 919-345-4256, jshaffer@eigerbio.com
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