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
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
File Number) |
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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 January 6, 2016 entitled
Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 LOWR HDV 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus 4) Study at Hannover Medical School in Hannover, Germany.
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, or
the SEC, including a proxy statement/prospectus/information statement, but the registration statement has not yet become effective. 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 (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: January 6, 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 January 6, 2016 entitled Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 LOWR HDV 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus
4) Study at Hannover Medical School in Hannover, Germany. |
Exhibit 99.1
Eiger BioPharmaceuticals Announces First Patient Dosed in Phase 2 LOWR HDV 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus 4) Study at
Hannover Medical School in Hannover, Germany
PALO ALTO, Calif., January 6, 2016 /PRNewswire/ Eiger BioPharmaceuticals, Inc.
today announced the initiation of enrollment and first patient dosed in LOWR HDV 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus 4) at the Hannover Medical School in Hannover, Germany.
LOWR HDV 4 is an open label, dose titration study designed to evaluate the efficacy and tolerability of lonafarnib combined with ritonavir for a total of 24 weeks in fifteen patients with chronic hepatitis delta.
We are very pleased to participate in our first Phase 2 study involving lonafarnib in hepatitis delta-infected patients, said Heiner Wedemeyer,
MD, Principal Investigator, Research Group Leader in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School and founding member of the Hepatitis Delta International Network (HDIN). We are committed to
advancing research and to identifying effective therapeutic options for patients infected with HDV, the most aggressive form of chronic viral hepatitis.
Dr. Wedemeyer is a long-time advisor to Eiger BioPharmaceuticals and we are proud to involve Hannover Medical School in our development of lonafarnib
for HDV, 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 potential benefits of dose titration as
well as the antiviral potential of lonafarnib in combination with ritonavir in a longer duration study.
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. Lonafarnib has been
dosed in over 50 HDV-infected patients across international academic centers and is in Phase 2 development for HDV. Lonafarnib has been granted Orphan Drug Designation by the US FDA and European
Medicines Agency (EMA), and Fast Track Designation by US 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 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in
approximately 5-6% 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
Additional Information
about the Proposed Merger between Celladon Corporation and Eiger BioPharmaceuticals, Inc. and Where to Find It
In connection with the proposed
merger between Celladon Corporation and Eiger BioPharmaceuticals, Inc., Celladon has filed a registration statement on Form S-4 with the Securities and Exchange Commission, or the SEC, including a proxy statement/prospectus/information statement,
but the registration statement has not yet become effective. 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 (www.sec.gov) and from Investor Relations at Celladon at the address described above.
SOURCE Eiger Bio, Inc.
Investors: Jim Shaffer, Eiger Bio, Inc., 919-345-4256, jshaffer@eigerbio.com
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