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
December 13, 2013
Date of Report (Date of earliest event reported)
| Chimerix, Inc. |
| (Exact name of registrant as specified in its charter) |
| Delaware | 001-35867 | 33-0903395 | ||
| (State or other jurisdiction | (Commission File Number) | (IRS Employer Identification No.) | ||
| of incorporation) |
| 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 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
(c) On December 13, 2013, Chimerix, Inc. (the “Company”) hired Linda M. Richardson as the Company’s Chief Commercial Officer. The commencement of Ms. Richardson’s employment with the Company is expected to be on or about January 8, 2014. A copy of the press release announcing the hiring of Ms. Richardson is attached hereto as Exhibit 99.1.
Prior to joining the Company, from December 2011, Ms. Richardson, age 50, served as Vice-President, Head of Global lixisenatide franchise at Sanofi S.A., a global pharmaceutical company. From September 2008 to November 2011, Ms. Richardson served as Vice-President, U.S. Marketing at Sanofi S.A. where she held various marketing leadership responsibilities with eplivanserin, Auvi-Q and Multaq. From October 2006 to June 2008, Ms. Richardson served as Vice President, Marketing at Reliant Pharmaceuticals, Inc. Ms. Richardson earned a B.A. in English from the University of Pennsylvania.
In connection with her hiring as the Company’s Chief Commercial Officer, Ms. Richardson entered into an offer letter (the “Offer Letter”) detailing the terms of her employment. Pursuant to the Offer Letter, Ms. Richardson will be entitled to receive a base salary of $340,000 per year, and an initial stock option to purchase up to 120,000 shares of the Company’s common stock, 25% of which will vest on the first anniversary of Ms. Richardson’s start date, and the remainder of which will vest in equal monthly installments thereafter over three years. Ms. Richardson will also be entitled to receive a one-time signing bonus of $50,000, plus $75,000 to cover expenses in connection with her relocation to North Carolina. In addition to a base salary, Ms. Richardson is entitled to a discretionary annual performance-based cash bonus, with a target bonus equal to 35% of her base salary. Ms. Richardson is also entitled to receive health care coverage under the Company’s medical, vision and dental plans, and can participate in the Company’s 2013 Employee Stock Purchase Plan and 401(k) Plan.
As an executive officer of the Company, Ms. Richardson is entitled to receive the severance and change of control benefits described under the heading “Other Named Executive Officers” in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 11, 2013.
A copy of the Offer Letter is attached hereto as Exhibit 99.2.
| Item 8.01 | Other Events. |
On December 17, 2013, the Company announced in the press release attached hereto as Exhibit 99.3 and incorporated herein by reference, that it has been selected for addition to the NASDAQ Biotechnology Index, which will become effective upon market open on December 23, 2013.
The information in this Item 8.01 and the attached Exhibit 99.3 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 8.01 and the attached Exhibit 99.3 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit No. | Description | |
| 99.1 | Press Release of Chimerix, Inc. dated December 18, 2013. | |
| 99.2 | Employment Offer Letter to Linda M. Richardson dated December 12, 2013. | |
| 99.3 | Press Release of Chimerix, Inc. dated December 17, 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.
| Chimerix, Inc. | |||
| Dated: December 18, 2013 | |||
| By: | /s/ Timothy W. Trost | ||
| Timothy W. Trost | |||
| Senior Vice President, Chief Financial Officer and Corporate Secretary | |||
INDEX TO EXHIBITS
| Exhibit No. | Description | |
| 99.1 | Press Release of Chimerix, Inc. dated December 18, 2013. | |
| 99.2 | Employment Offer Letter to Linda M. Richardson dated December 12, 2013. | |
| 99.3 | Press Release of Chimerix, Inc. dated December 17, 2013. |
Chimerix Appoints Linda M. Richardson as Chief Commercial Officer
Durham, NC, December 18, 2013 — Chimerix, Inc. (NASDAQ: CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the appointment of Linda M. Richardson as Chief Commercial Officer. Ms. Richardson brings more than 25 years of pharmaceutical sales and marketing experience to Chimerix and will be responsible for establishing the company’s commercial infrastructure and building its capabilities for the potential launch of lead compound brincidofovir. Brincidofovir is currently in a Phase 3 clinical study, SUPPRESS, for the prevention of cytomegalovirus (CMV) in hematopoietic cell transplant recipients (HCT).
"Linda’s successful pharmaceutical product pre-launch and launch expertise and proven track record in developing new therapeutic areas makes her ideally suited to lead our commercial team,” said Kenneth I. Moch, Chimerix President and CEO. “Her broad experience will be extremely valuable in building our commercial platform for the potential launch of brincidofovir, which addresses a high unmet medical need in preventing life-threatening infections caused by CMV in HCT recipients.”
“I am truly excited about joining the Chimerix leadership team at this important point in the organization’s growth, with the Phase 3 development program for brincidofovir underway. It is especially rewarding to work on commercial plans that could potentially change the standard of care for HCT recipients,” said Ms. Richardson.
Ms. Richardson was previously with Sanofi, where she most recently served as Vice President and Head of the Global lixisenatide franchise, leading the commercial worldwide launch of Lyxumia, a new injectable drug for Type 2 diabetes. While at Sanofi, she also led the pre-launch strategy development for several other products, and reinvigorated Multaq performance in the U.S. Prior to joining Sanofi, Ms. Richardson was Vice President of Marketing at Reliant Pharmaceuticals, where she directed the marketing and market research functions for the cardiovascular portfolio. She was instrumental in building and implementing the successful launch of the first prescription omega-3 product, which helped lead to the company’s acquisition by GlaxoSmithKline. Ms. Richardson held various positions of increasing responsibility at GlaxoSmithKline in the sales, market research, and marketing functions. Ms. Richardson served on the Board of Directors of Healthy Women, a non-profit organization dedicated to promoting health and wellness among women. In 2008, she was nominated by her peers as one of the “100 Most Inspiring Leaders” in the Life Sciences field and labeled as a “Market Maker” in PharmaVoice magazine, and in 2011 she was given the “Rising Star” award by the Healthcare Businesswomen’s Association. She earned her BA in English at the University of Pennsylvania.
About Brincidofovir (CMX001)
Chimerix's lead product candidate, brincidofovir (CMX001), is an oral nucleotide analog that has shown broad-spectrum antiviral activity against all five families of dsDNA viruses that affect humans, including CMV, AdV, BK virus (BKV) and herpes simplex viruses. Brincidofovir has a favorable safety and tolerability profile, with no evidence of kidney or bone marrow toxicity in nearly 900 patients dosed with brincidofovir to date. Chimerix believes that brincidofovir has the potential to be the first broad-spectrum antiviral for the prevention and treatment of clinically significant infections and diseases caused by dsDNA viruses.
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
Following positive Phase 2 results, in the third quarter of 2013 Chimerix initiated the Phase 3 SUPPRESS trial which will support Chimerix's initial regulatory submission for prevention of CMV infection in adult HCT recipients. Chimerix recently presented results from its Phase 2 trial in AdV, an often-fatal infection with no approved treatment. A brincidofovir dose of 100 mg twice weekly demonstrated a potent antiviral effect on levels of AdV in the blood, and a numeric decrease in overall mortality. Chimerix continues to work with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir as a medical countermeasure against smallpox.
About the Phase 3 SUPPRESS Trial
SUPPRESS is designed to demonstrate the efficacy and safety of brincidofovir for the prevention of CMV infection versus a placebo control, as no therapy is currently approved for the prevention of CMV in HCT recipients. The primary endpoint for SUPPRESS is the rate of clinically significant CMV infection through the first 24 weeks post-transplant. The trial is powered to detect a relative 50% decrease in clinically significant CMV infection in subjects receiving brincidofovir versus those receiving placebo. Secondary endpoints in the SUPPRESS trial include clinical and virologic evidence of dsDNA viral infections, including AdV, BKV and other herpes viruses such as HHV-6 and varicella zoster virus that contribute to morbidity and mortality in the first year following HCT.
SUPPRESS is anticipated to enroll approximately 450 HCT recipients who are at increased risk of CMV infection, with approximately 300 subjects receiving 100 mg twice weekly brincidofovir and 150 receiving placebo (2-to-1 ratio). Approximately 40 transplant centers will participate in SUPPRESS. Dosing of study drug will begin shortly after subjects receive their transplant, and will not require evidence of stem cell "engraftment" (evidence of production of blood cells by the new transplant), a safety precaution incorporated in the Phase 2 trial of brincidofovir and other recent trials of investigational antivirals for CMV prevention. Enrolled subjects will continue on brincidofovir or placebo through Week 14 post-transplant, the period of highest risk for viral reactivation. Subjects will continue to be monitored for evidence of CMV and other dsDNA viral infections through Week 24 post-transplant.
Data from SUPPRESS are anticipated in mid-2015 and, if positive, may support Accelerated Approval of brincidofovir for the prevention of CMV infection.
About Cytomegalovirus (CMV) and Double-Stranded DNA (dsDNA) Viruses
CMV is a member of the herpes virus family and is the most common infectious pathogen in transplant recipients. A majority of adults in the US have been exposed to CMV, generally in childhood, with lifelong viral latency established following resolution. In healthy individuals with a functioning immune system, CMV remains dormant throughout life. A functioning immune system protects an infected individual against future exposure to CMV but does not clear the virus from their body. In immunocompromised individuals with weakened immune systems, such as transplant recipients, CMV often reactivates during the post-transplant period when the immune system is rebuilding itself. No therapies are approved for the prevention of CMV in HCT recipients. Currently available systemic anti-CMV agents can be effective against CMV; however, their use is limited by significant toxicities, including bone marrow suppression and renal impairment, and these therapies are only approved for certain solid organ transplant patient populations. CMV infection is known to correlate with progression to CMV disease and death. CMV itself is immunosuppressive and reactivation of the virus can predispose a patient to other opportunistic viral infections in addition to fungal and bacterial infections.
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
About Chimerix
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 (CMX001) and CMX157, which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. Chimerix’s lead product candidate, brincidofovir, is an oral nucleotide analog that has shown broad-spectrum activity against all five families of double-stranded DNA (dsDNA) viruses that affect humans, including cytomegalovirus (CMV), adenovirus, BK virus and herpes simplex viruses. In the third quarter of 2013, Chimerix initiated the Phase 3 SUPPRESS trial of brincidofovir for the prevention of CMV infection in adult hematopoietic cell transplant (HCT) recipients, also known as bone marrow transplants. Brincidofovir has received Fast Track designation by the FDA, and the Phase 3 data, if positive, may support Accelerated Approval of brincidofovir for the prevention of CMV infection in adult HCT recipients. Chimerix continues to work with the Biomedical Advanced Research and Development Authority (BARDA) to development brincidofovir as a medical countermeasure against smallpox. Chimerix’s second product candidate, CMX157, an oral nucleotide analog for treatment of HIV infection, was licensed to Merck in July 2012. For further information, please visit Chimerix’s website, www.chimerix.com.
Forward-Looking Statements
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 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.
# # #
CHIMERIX CONTACT:
Joseph T. Schepers
Executive Director, Investor Relations and Corporate Communications
jschepers@chimerix.com
919-287-4125
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
December 12, 2013
Ms. Linda M. Richardson
4248 Rexford Drive
Bethlehem, PA 18020
Dear Linda:
Chimerix is pleased to extend an offer of employment to you for the position of Chief Commercial Officer, reporting to Kenneth Moch, President and CEO. We hope that you will accept this offer and look forward to having a mutually successful relationship with you. Your anticipated hire date is January 8, 2014.
The following are the terms of this offer:
| Base Salary: | Your per pay period base salary will be $14,166.66 (annualized, $340,000.00). Currently, paychecks are issued semi-monthly for a total of 24 pay periods per year. |
| Stock Options: | You will be granted an option to purchase 120,000 shares of Chimerix common stock. All stock option grants are subject to the vesting schedule and terms and conditions outlined in the Chimerix 2013 Equity Incentive Plan (the “Plan”). You will be issued a grant notice, option agreement and details of the Plan. Such shares shall vest over a period of four years so long as you continue to provide services to the Company, with 25% vesting one year from the vesting commencement date and the balance vesting at the rate of 1/36 per month over the remaining three years. The exercise price of the options to be granted will be equal to the closing per share price of Chimerix common stock (as determined by NASDAQ) on your official start date of employment. |
| Additional vesting scenarios are discussed below under the heading “Severance Plan.” | |
| Target Bonus: | As part of the Chimerix senior management team in 2014 you will be eligible for an annual bonus of up to 35% of your base salary. Such bonus is paid in 2015 and is based upon your achievement of the goals and objectives agreed to in the performance dialog process with your manager and the formula determined by the Board of Directors for 2014. |
| Benefits: | As an employee of Chimerix you will be eligible for comprehensive health, vision and dental insurance benefits for yourself and your eligible dependents for the plan year 12/01/2013-11/20/2014. This coverage is effective on the first day of employment and currently Chimerix pays the entire monthly premium for this coverage. You will also be eligible for Company-paid term life insurance, short term and long-term disability insurance, effective on your hire date. |
| Additional benefits for which you will be eligible include: accrued vacation equal to Twenty (20) days per year and twelve (12) paid holidays per calendar year. You will also be eligible to participate in the Chimerix Employee Stock Purchase Plan, effective on the 1st pay period in March 2014 and the Chimerix 401(k) Plan, effective on the first day of the month following your date of hire (February 1, 2014). Full details of group benefits will be provided once you are on board. | |
| Severance Plan: | Upon joining you are eligible to participate in the Company’s severance plan for executive officers. Under this plan, you would receive 12 months of salary and benefits continuation in the event of a termination by the Company that is not in connection with a change of control. In addition, such a termination would result in 12 months’ forward acceleration of any unvested portion of your option grant. |
| In the event of a termination in connection with a change of control, in addition to 12 months of salary continuation, eligible executives receive a payment equal to their current target bonus. Your option grant is subject to a standard “double trigger” vesting acceleration provision that applies in the event of a change in control occurring after the first three months of your employment. Specifically, if your employment is terminated without cause or you resign for good reason within 13 months after a change of control of Chimerix (and the change in control happens after 90 days of your start date), the vesting of your stock option will be accelerated in full. | |
| In all cases, receipt of the severance benefit assumes a “not for cause” termination and is contingent upon the execution of an approved release and non-compete agreement. | |
| Signing Bonus: | Within 30 days of joining Chimerix you will be eligible for a signing bonus of $50,000. In the event your employment terminates within twelve months of joining the Company (other than in connection with a change of control), this bonus amount will be subtracted from the termination payment described in the Section immediately above. |
| Relocation Allowance: | We will provide a gross lump sum payment of $75,000 to assist you in your relocation to North Carolina. We also offer three months of temporary living assistance while you explore the area for your permanent housing location. |
Chimerix is an at-will employer and as such your employment must be entered into voluntarily and for no specified period. As a result, you are free to resign or the company may terminate your employment at any time, for any reason, with or without cause. No one other than the CEO has the authority to alter this employment relationship, either verbally or in writing.
As with all new employees, you will be asked to provide to the Company documentary evidence of your eligibility for employment in the United States when you join the Company. Such documentation must be provided to us within three business days of your date of hire, or our employment relationship with you may be terminated.
Please understand it is the policy of the Company not to solicit or accept proprietary information and/or trade secrets of other companies. If you have or have had access to trade secrets or other confidential, proprietary information developed by your former employer; the use of such information in performing your duties at Chimerix is prohibited. This may include, but is not limited to, confidential or proprietary information in the form of documents, magnetic media, software, customer lists, formulae and business plans or strategies. You will be required to execute a standard Proprietary Information and Inventions Agreement with Chimerix, a copy of which is attached as Exhibit A.
If you accept this offer, the terms described in this letter, together with the Proprietary Information and Inventions Agreement, shall be the terms of your employment, provided, however, that your duties are performed in accordance with all standards and policies adopted by the company. Your duties may change from time to time, depending upon the needs of the company and your skills. This letter supersedes any prior agreements, representations or promises of any kind, express or implied, concerning your employment and it constitutes the full and complete agreement between you and the Company.
We are very excited about the prospect of your joining our team. We are confident that you have much to contribute to the success of Chimerix. The strength of our technology, the quality and experience of our personnel and your presence will facilitate this success.
This offer expires five business days after your receipt of this letter and is contingent on you passing our pre-employment background check. If the terms described herein are acceptable to you, please acknowledge your acceptance by signing below and returning the original to us in the envelope provided. You may also forward your acceptance via secured fax to 919-313-6781. Please keep a copy for your records.
Linda, all of us at Chimerix look forward to your joining our Team!
With warm regards,
CHIMERIX, Inc.
Kenneth I. Moch
President and CEO
Enclosures
Accepted:
| /s/ Linda M. Richardson | December 13, 2013 | |
| Linda M. Richardson | Date |
Chimerix Added to NASDAQ Biotechnology Index (NBI)
DURHAM, NC, December 17, 2013 – Chimerix, Inc. (NASDAQ: CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (Nasdaq:^NBI). The annual re-ranking of the NASDAQ Biotechnology Index will become effective upon market open on December 23, 2013.
The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The NASDAQ Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is re-ranked annually. The NASDAQ Biotechnology Index is the basis for the iShares NASDAQ Biotechnology Index(SM) Fund (Nasdaq:IBB), which seeks investment results that correspond generally to the price and yield performance, before fees and expenses, of the NASDAQ Biotechnology Index. In addition, options based on the iShares NASDAQ Biotechnology Index Fund trade on various exchanges.
About Brincidofovir (CMX001)
Chimerix's lead product candidate, brincidofovir (CMX001), is an oral nucleotide analog that has shown broad-spectrum antiviral activity against all five families of dsDNA viruses that affect humans, including cytomegalovirus (CMV), adenovirus (AdV), BK virus (BKV) and herpes simplex viruses. Brincidofovir has a favorable safety and tolerability profile, with no evidence of kidney or bone marrow toxicity in nearly 900 patients dosed with brincidofovir to date. Chimerix believes that brincidofovir has the potential to be the first broad-spectrum antiviral for the prevention and treatment of clinically significant infections and diseases caused by dsDNA viruses.
Following positive Phase 2 results, in the third quarter of 2013 Chimerix initiated the Phase 3 SUPPRESS trial which will support Chimerix's initial regulatory submission for prevention of CMV infection in adult hematopoietic cell transplant (HCT) recipients. Chimerix recently presented results from its Phase 2 trial in AdV, an often-fatal infection with no approved treatment. A brincidofovir dose of 100 mg twice weekly demonstrated a potent antiviral effect on levels of AdV in the blood, and a numeric decrease in overall mortality. Chimerix continues to work with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir as a medical countermeasure against smallpox.
About the Phase 3 SUPPRESS Trial
SUPPRESS is designed to demonstrate the efficacy and safety of brincidofovir for the prevention of CMV infection versus a placebo control, as no therapy is currently approved for the prevention of CMV in HCT recipients. The primary endpoint for SUPPRESS is the rate of clinically significant CMV infection through the first 24 weeks post-transplant. The trial is powered to detect a relative 50% decrease in clinically significant CMV infection in subjects receiving brincidofovir versus those receiving placebo. Secondary endpoints in the SUPPRESS trial include clinical and virologic evidence of dsDNA viral infections, including AdV, BKV and other herpes viruses such as HHV-6 and varicella zoster virus that contribute to morbidity and mortality in the first year following HCT.
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
SUPPRESS is anticipated to enroll approximately 450 HCT recipients who are at increased risk of CMV infection, with approximately 300 subjects receiving 100 mg twice weekly brincidofovir and 150 receiving placebo (2-to-1 ratio). Approximately 40 transplant centers will participate in SUPPRESS. Dosing of study drug will begin shortly after subjects receive their transplant, and will not require evidence of stem cell "engraftment" (evidence of production of blood cells by the new transplant), a safety precaution incorporated in the Phase 2 trial of brincidofovir and other recent trials of investigational antivirals for CMV prevention. Enrolled subjects will continue on brincidofovir or placebo through Week 14 post-transplant, the period of highest risk for viral reactivation. Subjects will continue to be monitored for evidence of CMV and other dsDNA viral infections through Week 24 post-transplant.
Data from SUPPRESS are anticipated in mid-2015 and, if positive, may support Accelerated Approval of brincidofovir for the prevention of CMV infection.
About Cytomegalovirus (CMV) and Double-Stranded DNA (dsDNA) Viruses
CMV is a member of the herpes virus family and is the most common infectious pathogen in transplant recipients. A majority of adults in the US have been exposed to CMV, generally in childhood, with lifelong viral latency established following resolution. In healthy individuals with a functioning immune system, CMV remains dormant throughout life. A functioning immune system protects an infected individual against future exposure to CMV but does not clear the virus from their body. In immunocompromised individuals with weakened immune systems, such as transplant recipients, CMV often reactivates during the post-transplant period when the immune system is rebuilding itself. No therapies are approved for the prevention of CMV in HCT recipients. Currently available systemic anti-CMV agents can be effective against CMV; however, their use is limited by significant toxicities, including bone marrow suppression and renal impairment, and these therapies are only approved for certain solid organ transplant patient populations. CMV infection is known to correlate with progression to CMV disease and death. CMV itself is immunosuppressive and reactivation of the virus can predispose a patient to other opportunistic viral infections in addition to fungal and bacterial infections.
About Chimerix
Chimerix is a biopharmaceutical company dedicated to developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix's proprietary lipid technology has given rise to two clinical-stage nucleotide analog lipid-conjugates, brincidofovir (CMX001) and CMX157, which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. Chimerix's lead product candidate, brincidofovir (CMX001), is an oral nucleotide analog that has shown broad-spectrum antiviral activity against all five families of dsDNA viruses that affect humans, including CMV, AdV, BKV and herpes simplex viruses. In the third quarter of 2013, Chimerix initiated the Phase 3 SUPPRESS trial of brincidofovir for the prevention of CMV infection in adult hematopoietic cell transplant (HCT) recipients, also known as bone marrow transplants. Brincidofovir has received Fast Track designation by the FDA, and the Phase 3 data, if positive, may support Accelerated Approval of brincidofovir for the prevention of CMV infection in adult HCT recipients. Chimerix continues to work with the Biomedical Advanced Research and Development Authority (BARDA) to development brincidofovir as a medical countermeasure against smallpox. Chimerix's second product candidate, CMX157, an oral nucleotide analog for the treatment of HIV infection, was licensed to Merck in July 2012.
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |
Forward-Looking Statements
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. Such statements include, but are not limited to, statements regarding Chimerix’s anticipated inclusion in the NASDAQ Biotechnology Index, and there is no guarantee that Chimerix will continue to be included in the index in the future. Additional risks include the success of the SUPPRESS trial, the demonstrated efficacy of brincidofovir in the SUPPRESS trial, Chimerix’s financial position, and regulatory developments in the United States and foreign countries. Other risks and uncertainties affecting Chimerix 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 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.
# # #
CHIMERIX CONTACT:
Joseph T. Schepers
Executive Director, Investor Relations and Corporate Communications
jschepers@chimerix.com
919-287-4125
| CHIMERIX, INC. | |
| 2505 Meridian Parkway, #340 | Tel: (919) 806-1074 |
| Durham, NC 27713 | Fax: (919) 806-1146 |