SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
May 14, 2014
Date of Report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction||(Commission File Number)||(IRS Employer Identification No.)|
|2505 Meridian Parkway, Suite 340 Durham, NC||27713|
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code: (919) 806-1074
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:
|¨||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 1.02 Termination of a Material Definitive Agreement.
On May 14, 2014, we received notice from Merck Sharp & Dohme Corp. (“Merck”) of its intention to terminate the Collaboration and Exclusive License Agreement by and between us and Merck, dated July 23, 2012 (the “License Agreement”). The termination of the License Agreement will be effective 90 days after the date we received the notice.
Pursuant to the License Agreement, we granted Merck an exclusive worldwide license to develop and commercialize CMX157, our novel lipid acyclic nucleoside phosphonate, for HIV and other indications, and Merck was responsible for all development and marketing activities for CMX157 on a worldwide basis. Upon the effectiveness of the termination of the License Agreement, we will reacquire all worldwide rights to CMX157.
Merck made the decision to terminate the License Agreement following a routine pipeline portfolio assessment, in connection with which Merck made the decision to no longer pursue development of CMX157.
We filed a press release announcing the termination of the License Agreement on May 16, 2014, a copy of which is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
|99.1||Press release of Chimerix, Inc. dated May 16, 2014.|
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.
|Dated: May 16, 2014|
|By:||/s/ Timothy W. Trost|
|Timothy W. Trost|
|Senior Vice President, Chief Financial Officer and|
INDEX TO EXHIBITS
|99.1||Press release of Chimerix, Inc. dated May 16, 2014.|
Chimerix Regains Worldwide Rights to CMX157
DURHAM, NC – May 16, 2014 – Chimerix, Inc. (Nasdaq: CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that it has regained the worldwide rights to CMX157, Chimerix's novel lipid acyclic nucleoside phosphonate, from Merck, known as MSD outside the United States and Canada. Following a routine pipeline portfolio assessment, Merck made the decision to no longer pursue development of CMX157.
The compound is currently being evaluated for future development opportunities; however, Chimerix has no present plans for allocation of current or future resources to the development of CMX157.
"Our focus remains on the aggressive development of brincidofovir for the prevention of CMV and the treatment of adenovirus infections in patients with compromised immune systems," said M. Michelle Berrey, MD, MPH, President, CEO, and CMO of Chimerix.
CMX157 is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent tenofovir diphosphate. CMX157 is active against HBV and more than 200-fold more potent in vitro versus tenofovir against all major HIV subtypes resistant to current therapies, which may allow activity against tenofovir-resistant viruses (e.g., K65R). CMX157's novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects. CMX157 has completed a Phase 1 clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability and drug distribution profile.
Chimerix is a biopharmaceutical company dedicated to developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix's proprietary technology has given rise to two clinical-stage nucleotide analog lipid-conjugates, brincidofovir and CMX157, both of which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. Chimerix is currently enrolling SUPPRESS, a Phase 3 study of brincidofovir for the prevention of CMV, and the pilot portion of a Phase 3 study of brincidofovir treatment for adenovirus infection. Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. For further information, please visit Chimerix's website, www.chimerix.com.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Chimerix's filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q, its most recently filed Current Reports on Form 8-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
# # #
Joseph T. Schepers
Executive Director, Investor Relations and Corporate Communications
|2505 Meridian Parkway, #340||Tel: (919) 806-1074|
|Durham, NC 27713||Fax: (919) 806-1146|