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bota20131205_8k.htm

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 5, 2013

 

Biota Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-35285

59-1212264

(State or other jurisdiction

of incorporation)

(Commission 

File Number)

(IRS Employer

Identification No.)

   

2500 Northwinds Parkway, Suite 100

Alpharetta, GA

30009

(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 5, 2013, Biota Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has initiated dosing in the Phase 2 clinical trial of laninamivir octanoate in the northern hemisphere for the treatment of influenza in adults. 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

 

99.1

Press release dated December 5, 2013.

   
   

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.

 

Biota Pharmaceuticals, Inc.

   

Date: December 5, 2013

/s/ Russell H Plumb

 

Name:

Russell H Plumb

 

Title:

Chief Executive Officer and President

   

(Duly Authorized Officer)

 

EXHIBIT INDEX

Exhibit

Number

  

Description

99.1

  

Press release dated December 5, 2013.

 

 

ex99-1.htm

Exhibit 99.1

 

PRESS RELEASE

 

 

www.biotapharma.com

FOR IMMEDIATE RELEASE

 

 

BIOTA INITIATES DOSING IN PHASE 2 IGLOO TRIAL OF LANI

IN THE NORTHERN HEMISPHERE 

 

 

ATLANTA, GA – December 5, 2013 — Biota Pharmaceuticals, Inc. (NASDAQ: BOTA, the “Company”) today announced that it has commenced dosing patients in the Northern Hemisphere portion of its ongoing Phase 2, randomized, double blind, placebo controlled, parallel arm clinical trial of laninamivir octanoate (LANI). The trial, referred to as “IGLOO”, compares the safety and efficacy of 40 mg and 80 mg of LANI with placebo, all delivered by a TwinCaps® inhaler in adults with presumed influenza A or B infection. The trial was initiated in the Southern Hemisphere in June and is now continuing in multiple countries in the Northern Hemisphere. The Company’s goal is to complete enrollment in the IGLOO trial by the end of the influenza season in the Northern Hemisphere and have top-line data available in mid-2014. IGLOO is being conducted in connection with the Company’s contract with the U.S. Office of Biomedical Advanced Research and Development Authority (“BARDA”). Further details regarding the design of IGLOO are available at www.clinicaltrials.gov.

 

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: 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 U.S. and through a contract with 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, including statements regarding the anticipated time in which the Company expects to complete enrollment and have top-line data from the ongoing Phase 2 IGLOO trial, 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: the Company, BARDA, the FDA or a similar regulatory body in another country, a data safety monitoring board, or an institutional review board, delaying, limiting, suspending or terminating the clinical development of LANI at any time for a lack of safety, tolerability, anti-viral activity, commercial viability, regulatory or manufacturing issues, or any other reason whatsoever; BARDA terminating or significantly amending the Company’s existing contract to develop LANI; a prolonged shutdown of the U.S. government or other actions by the U.S. government that could delay or suspend the development of LANI; the Company’s ability to comply with extensive government regulations in various countries and regions in which it expects to conduct its clinical trials; the Company’s ability to secure, manage and retain qualified third-party clinical research, preclinical research, data management and contract manufacturing organizations which it relies on to assist in the design, development and implementation of the clinical development of LANI; the Company’s ability to recruit and manage multi-national clinical trials; the severity and seasonality of influenza in regions where the Company is conducting its clinical trials of LANI; and other 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 quarters 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 TwinCaps® is a registered trademark of Hovione FarmaCiencia SA.

 

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

 

Biota Pharmaceuticals, Inc.  ♦  2500 Northwinds Parkway, Suite 100  ♦  Alpharetta, GA 30009  ♦  Tel: (678) 221-3343