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): December 20, 2013
Biota Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
001-35285 |
59-1212264 |
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(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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2500 Northwinds Parkway, Suite 100 Alpharetta, GA |
30009 | |
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(Address of principal executive offices) |
(Zip Code) | |
Registrant’s telephone number, including area code: (678) 762-3240
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 (see General Instruction A.2. below):
☐ 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 8.01 Other Events
On December 20, 2013, Biota Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that Daiichi Sankyo Company, Limited has been granted regulatory approval in Japan to manufacture and market Inavir® Dry Powder Inhaler 20mg (generic name laninamivir octanoate) for the prevention of influenza A and B. A copy of the Company’s press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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99.1 |
Press release dated December 20, 2013. | |
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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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Biota Pharmaceuticals, Inc. | ||
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Date: December 23, 2013 |
/s/ Russell H Plumb | |
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Name: |
Russell H Plumb | |
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Title: |
Chief Executive Officer and President | |
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(Duly Authorized Officer) | ||
EXHIBIT INDEX
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Exhibit Number |
Description | |
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99.1 |
Press release dated December 20, 2013. |
Exhibit 99.1
PRESS RELEASE
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www.biotapharma.com |
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FOR IMMEDIATE RELEASE
BIOTA REPORTS THAT LANINAMIVIR OCTANOATE IS APPROVED
FOR THE PREVENTION OF INFLUENZA IN JAPAN
ATLANTA, GA – December 20, 2013 — Biota Pharmaceuticals, Inc. (NASDAQ: BOTA, “Biota” or the “Company”) today reported that Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) has been granted regulatory approval in Japan to manufacture and market Inavir® Dry Powder Inhaler 20mg (generic name laninamivir octanoate) for the prevention of influenza A and B. Inavir® was successfully developed and launched by Daiichi Sankyo in Japan for treatment of influenza A and B viruses in October, 2010. Biota is developing laninamivir octanoate outside of Japan for the treatment of influenza, and is currently conducting a large, multi-national Phase 2 trial of laninamivir octanoate in adults infected with influenza. In 2003, the Company and Daiichi Sankyo entered into a collaboration and license agreement to develop long-acting neuraminidase inhibitors, including laninamivir octanoate, and in March 2009, the parties entered into a commercialization agreement, pursuant to which Daiichi Sankyo obtained exclusive marketing rights to laninamivir octanoate in Japan.
About Biota
Biota Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery and development of products to prevent and treat serious and potentially life-threatening infectious diseases. The Company currently has two Phase 2 clinical-stage product candidates in development: laninamivir octanoate (LANI), a long-acting neuraminidase inhibitor that the Company is developing for the treatment of influenza A and B infections under an IND in the United States through a contract with the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA) that is designed to provide up to $231 million in financial support to complete its clinical development; and vapendavir, a potent, oral broad spectrum capsid inhibitor of enteroviruses, including human rhinovirus (HRV). In addition to these clinical-stage programs, the Company has a preclinical program focused on developing treatments for respiratory syncytial virus (RSV). For additional information about the Company, please visit www.biotapharma.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve known and unknown risks and uncertainties. All statements, other than historical facts are forward looking statements. Various important factors could cause actual results, performance, events or achievements to materially differ from those expressed or implied by the forward-looking statements, including cautionary statements contained elsewhere in this press release and in the Company’s Annual Report on Form 10-K for the year ended June 30, 2013, as filed with the U.S. Securities and Exchange Commission, or SEC, on September 27, 2013 and in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, as filed with the SEC on November 12, 2013.
There may be events in the future that the Company is unable to predict, or over which it has no control, and the Company’s business, financial condition, results of operations and prospects may change in the future. The Company may not update these forward-looking statements more frequently than quarterly unless it has an obligation under U.S. Federal securities laws to do so.
Biota is a registered trademark of Biota Holdings Limited and Inavir® is a registered trademark of Daiichi Sankyo Company, Limited.
Contacts:
Russell H. Plumb
Chief Executive Officer
(678) 221-3351
r.plumb@biotapharma.com
Lee M. Stern
The Trout Group
(646) 378-2922
lstern@troutgroup.com