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): November 30, 2015
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)) |
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 November 30, 2015 entitled Eiger BioPharmaceuticals Granted Orphan Drug Status for Ubenimex in Pulmonary Arterial Hypertension.
Additional Information about the Merger and Where to Find It
In connection with the proposed merger, Celladon and Eiger intend to file relevant materials with the Securities and Exchange
Commission, or the SEC, including a registration statement on Form S-4 that will contain a prospectus and a proxy statement/information statement. Investors and security holders of Celladon and Eiger are urged to read these materials when they
become available because they will contain important information about Celladon, Eiger and the proposed merger. The proxy statement/information statement, prospectus and other relevant materials (when they become available), and any other 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/information statement, prospectus and the other relevant materials when they
become available 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.
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: December 1, 2015 |
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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
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Description |
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99.1 |
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Press release issued by Eiger BioPharmaceuticals, Inc. on November 30, 2015 entitled Eiger BioPharmaceuticals Granted Orphan Drug Status for Ubenimex in Pulmonary Arterial Hypertension. |
Exhibit 99.1
Eiger BioPharmaceuticals Granted Orphan Drug Status for Ubenimex in Pulmonary
Arterial Hypertension
PALO
ALTO, Calif., November 30, 2015 /PRNewswire/ Eiger BioPharmaceuticals, Inc. today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug status to ubenimex for the treatment of pulmonary
arterial hypertension (PAH).
The FDA Office of Orphan Products Development (OOPD) evaluates scientific and clinical data
submissions from sponsors to identify and designate drug candidates that could potentially treat rare diseases to help advance the evaluation and development of such products, said Joanne Quan, MD, Chief Medical Officer at Eiger. We
are pleased with the OOPDs designation of orphan drug status for ubenimex in PAH.
About Ubenimex
Ubenimex is a well-characterized, oral, small-molecule, dual-inhibitor of aminopeptidase and leukotriene A4 hydrolase (LTA4H), the enzyme responsible for catalyzing the committed step in the formation of the pro-inflammatory mediator, LTB4. Ubenimex is approved in Japan as an adjunct to chemotherapy agents to extend survival and to maintain remission after treatment for acute non-lymphocytic
leukemia in adults. Ubenimex has been used for over 25 years in Japan and remains commercially available through Nippon Kayaku under the brand name, Bestatin. Ubenimex is not approved for any indication in the US or Europe.
About PAH
Pulmonary Arterial
Hypertension (PAH) is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. PAH begins when tiny arteries in the lungs, called pulmonary arterioles, become narrowed, blocked or destroyed. This
makes it harder for blood to flow through the lungs, and raises pressure within the lungs arteries. As the pressure builds, the hearts lower right chamber (right ventricle) must work harder to pump blood through the lungs, eventually
causing the heart muscle to weaken and eventually fail. PAH is a progressive, life-threatening illness and meets criteria for Orphan Designation in the US, EU, and Japan.
About Orphan Drug Status
Under the
Orphan Drug Act, the FDA may grant orphan drug designation to drug candidates intended to treat a rare disease or condition that generally affects fewer than 200,000 individuals in the United States. Orphan drug designation qualifies
the sponsor of the drug candidate for various development incentives, which may include tax credits for qualified clinical testing, an exemption from fees under the Prescription Drug User Fee Act (PDUFA), and a seven-year marketing exclusivity
period following approval. Orphan Drug status applies specifically to the active moiety and the indication for which it is granted, and is not applicable to other indications for that moiety.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market products for the treatment of Orphan diseases. The
Company has built a diverse, clinical-stage portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology is clear and 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 previously disclosed proposed merger between Celladon Corporation and Eiger BioPharmaceuticals, Inc., Celladon and Eiger intend to file relevant materials with the Securities and Exchange Commission, or the SEC, including a
registration statement on Form S-4 that will contain a prospectus and a joint proxy statement. Investors and security holders of Celladon and Eiger are urged to read these materials when they become
available because they will contain important information about Celladon, Eiger and the proposed merger. Investors and security holders are urged to read the joint proxy statement, prospectus and the other relevant materials when they become
available 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.
SOURCE Eiger Bio, Inc.
Investors: Jim Shaffer, Eiger Bio, Inc., 919-345-4256, jshaffer@eigerbio.com
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