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)
August 4, 2014
AKEBIA THERAPEUTICS, INC.
(Exact name of registrant as specified in charter)
| Delaware | 001-36352 | 20-8756903 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
245 First Street, Suite 1100, Cambridge, Massachusetts 02142
(Address of Principal Executive Offices, including Zip Code)
(617) 871-2098
(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)) |
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On August 5, 2014, Akebia Therapeutics, Inc. (the “Company”) and Robert Shalwitz, M.D., Chief Medical Officer of the Company, agreed upon terms relating to Dr. Shalwitz’s resignation from the Company, which will be effective as of December 31, 2014. Under the terms of Dr. Shalwitz’s separation agreement, from August 5, 2014 to December 31, 2014 he will be employed by the Company as Executive Vice President and will no longer serve in the position of Chief Medical Officer. Beginning January 1, 2015, he will receive severance in the amount of one year’s salary, or $410,000, payable bi-weekly and will be eligible to receive a taxable reimbursement for up to twelve months of COBRA continuation coverage. The Company has also entered into a two-year consulting agreement with Dr. Shalwitz, commencing on January 1, 2015 and ending on December 31, 2016, under which he will provide consulting services to the Company in exchange for continued vesting of his outstanding restricted stock and stock options during the term of the consulting agreement and, under certain circumstances set forth in the consulting agreement, an extended exercise period for any vested stock options at the end of the consulting period. In addition, all of Dr. Shalwitz’s unvested restricted stock and stock options will immediately vest upon the termination of the consulting agreement on December 31, 2016 or, if earlier, upon a change of control of the Company or the termination of the consulting agreement due to his death or by the Company without cause. For consulting services provided in excess of 30 hours per month in the first year of the consulting agreement and 10 hours per month in the second year of the consulting agreement, the Company will compensate Dr. Shalwitz on an hourly basis. All severance and consulting benefits are contingent on Dr. Shalwitz’s continued compliance with the non-disparagement, confidentiality, non-compete and non-solicitation clauses in the agreements, as well as all other terms.
Item 7.01 Regulation FD Disclosure.
The information contained in this Item shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing.
On August 6, 2014, the Company issued a press release announcing the appointment by the Board of Bradley Maroni, M.D., as the Senior Vice President and Chief Medical Officer of the Company as of August 18, 2014. A copy of the press release is attached to this report as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press Release of Akebia Therapeutics, Inc. dated August 6, 2014 | |
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.
| AKEBIA THERAPEUTICS, INC. | ||
| By: | /s/ JOHN P. BUTLER | |
| John P. Butler | ||
| President and Chief Executive Officer | ||
Date: August 6, 2014
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press Release of Akebia Therapeutics, Inc. dated August 6, 2014 | |
Exhibit 99.1
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Akebia Therapeutics, Inc. 245 First Street, Suite 1100 Cambridge, MA 02142 T: +1 617.871.2098 F: +1 617.871.2099 www.akebia.com |
Akebia Therapeutics Announces Expansion of Management Team
Key additions will help drive strategic growth and advance lead clinical programs
Cambridge, Mass. – August 6, 2014 – Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on harnessing the potential of hypoxia-inducible factor (HIF) biology to develop and commercialize novel therapeutics to treat kidney disease, today announced the expansion of its senior management team with three key additions: Brad Maroni, M.D., as Senior Vice President and Chief Medical Officer, Mark De Rosch, Ph.D., as Vice President of Regulatory Affairs and Tamara Dillon as Vice President of Human Resources.
The new additions to Akebia bring individuals with deep and relevant experience to support the company through its next critical stages, including completion of its Phase 2b study for AKB-6548, initiation and execution of a global Phase 3 program, expanded interactions with regulatory authorities and the early stage development of additional novel products in the company’s pipeline.
“Collectively, Brad, Mark and Tamara bring a tremendous breadth and depth of experience to Akebia that will help strengthen our ability to accomplish our goal of delivering innovative products to patients in need,” said John P. Butler, President and Chief Executive Officer of Akebia. “We are confident they will make an immediate and important contribution to Akebia as we advance our lead programs, engage in critical regulatory discussions and continue to scale the organization in anticipation of the global Phase 3 clinical development of AKB-6548.”
Robert Shalwitz, M.D., co-founder of Akebia and current Chief Medical Officer, will take on the role of Executive Vice President and work closely alongside Dr. Maroni and Dr. De Rosch through the end of this year, at which time he will transition to a multi-year assignment as senior scientific advisor to the company. In this capacity, Dr. Shalwitz will continue to lend his expertise to the clinical and regulatory advancement of AKB-6548, and will also focus on leveraging Akebia’s HIF platform and knowledge in a variety of promising future applications.
“Our management team expansion and the evolution of Bob’s role will provide Akebia with near-term continuity, while also enabling Bob to focus sufficient attention on the large number of intriguing therapeutic opportunities beyond our initial indication,” said Mr. Butler. “Bob’s expertise and guidance will be a critical asset as we approach the next phase of the AKB-6548 clinical development program. In the long term, his scientific and strategic insights will be invaluable in guiding the direction of our important early-stage pipeline candidates.”
Brad Maroni, M.D., most recently served as Vice President, Medical Research at Biogen Idec. Prior to that role, Dr. Maroni served as Chief Medical Officer of Stromedix, Inc. until the company was acquired by Biogen Idec in 2012. His previous experience also includes serving as Executive Vice President and Chief Medical Officer at RenaMed Biologics, as well as multiple roles at Amgen Inc., including Vice President, Clinical Development and Anemia/Nephrology Therapeutic Area Head. At Amgen, Dr. Maroni led the cross-functional
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Akebia Therapeutics, Inc. 245 First Street, Suite 1100 Cambridge, MA 02142 T: +1 617.871.2098 F: +1 617.871.2099 www.akebia.com |
team responsible for the registration program and global regulatory approval of Aranesp®, a novel long-acting recombinant erythropoietic protein, indicated for the treatment of anemia in chronic kidney disease. During his tenure, Amgen also received approval for Sensipar®, a first-in-class small molecule for the treatment of bone disease in dialysis patients. Dr. Maroni trained as a nephrologist at Brigham and Women’s Hospital in Boston, Massachusetts, after which he spent 10 years in academia at Emory University.
Mark De Rosch, Ph.D., brings to Akebia over two decades of experience guiding global regulatory strategies for clinical, nonclinical and chemistry, manufacturing and controls (CMC) in multiple therapeutic areas including renal, hemophilia, autoimmune, pulmonary and oncology/hematology, among others. Most recently, Dr. De Rosch served as Vice President, Regulatory Drugs/Biologics & Head, U.S. Operations for Voisin Consulting Life Sciences, where he served as the organization’s lead U.S. Food & Drug Administration (FDA) regulatory expert. Previously, Dr. De Rosch served as Vice President, Head of Global Regulatory Affairs for Inspiration Biopharmaceuticals, Inc., leading the development and implementation of global regulatory strategies for the hemophilia-focused company. He also served in multiple key roles at Vertex Pharmaceuticals, Inc., including Senior Director, Global Clinical Regulatory Strategy, where he led the regulatory strategy and submissions process for Kalydeco® in cystic fibrosis leading to approvals in the U.S. and E.U.
Tamara Dillon joins Akebia from Novartis Institutes for BioMedical Research, where she served as Head of Human Resources, Global Discovery Chemistry, responsible for all aspects of human resources across five sites and four countries. Previously, she held several key roles at Genzyme, a Sanofi Company, including Senior Director Human Resources, Global Research and Development. In this global leadership role, Ms. Dillon oversaw expansive human resources management and coordinated closely with the senior management team to ensure that overall business strategies were translated into effective human resources programs.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on harnessing the potential of hypoxia-inducible factor (HIF) biology to develop and commercialize novel, proprietary therapeutics to treat kidney disease. Akebia’s lead clinical program, AKB-6548, is a once-daily, oral therapy currently in Phase 2b clinical development for the treatment of anemia related to chronic kidney disease, a serious medical condition that leads to increased morbidity and mortality if left untreated. For more information on Akebia, please visit www.akebia.com.
Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements include those about Akebia’s strategy, future plans and prospects, including statements regarding the potential indications and benefits of AKB-6548 and the development plan for AKB-6548 and additional product candidates. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of
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Akebia Therapeutics, Inc. 245 First Street, Suite 1100 Cambridge, MA 02142 T: +1 617.871.2098 F: +1 617.871.2099 www.akebia.com |
the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of AKB-6548 or any other product candidate; the ability of Akebia to successfully complete pre-clinical development of additional product candidates; the content and timing of decisions by the FDA and other regulatory authorities; the funding required to develop Akebia’s product candidates and operate the company, and the actual expenses associated therewith; the content of decisions made by the FDA and other regulatory authorities; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; and Akebia’s ability to obtain, maintain and enforce patent and other intellectual property protection for AKB-6548 or any other product candidates. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
Contact:
Investors:
Argot Partners, LLC
David Pitts, +1-212-600-1902
david@argotpartners.com
Susan Kim, +1-212-203-4433
susan@argotpartners.com
Media:
Feinstein Kean Healthcare
Liz Falcone, +1-617-761-6727
liz.falcone@fkhealth.com
Source: Akebia Therapeutics, Inc.
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