Chimerix Initiates Phase 3 SUPPRESS Trial of Brincidofovir (CMX001) for Prevention of CMV in HCT Recipients

Chimerix Initiates Phase 3 SUPPRESS Trial of Brincidofovir (CMX001) for Prevention of CMV in HCT Recipients

 
DURHAM, N.C., Sept. 9, 2013 (GLOBE NEWSWIRE) — Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced initiation of dosing in the Phase 3 SUPPRESS trial (ClinicalTrials.gov ID: NCT01769170). SUPPRESS is evaluating brincidofovir (CMX001) for the prevention of cytomegalovirus (CMV) infection, the most significant infectious disease in hematopoietic cell transplant (HCT) recipients. Brincidofovir is an investigational oral nucleotide analog lipid-conjugate that has demonstrated activity against all pathogenic double-stranded DNA (dsDNA) viruses, including herpesviruses, adenoviruses, and polyomaviruses.

Chimerix Announces Top Line Data From CMX001 Phase 2 Adenovirus Study and Late-Breaker Presentation at ICAAC

 
-Encouraging results from the first proof-of-concept study for adenovirus infection support continued clinical development of CMX001 as a first-in-class broad-spectrum antiviral for prevention of double-stranded DNA viral infections

-Data accepted for oral late-breaker presentation at the ICAAC Annual Meeting on September 10th

DURHAM, N.C., Aug. 14, 2013 (GLOBE NEWSWIRE) — Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced top line data from the exploratory Phase 2 study of CMX001 as preemptive therapy for adenovirus (AdV) infection, the first interventional trial in AdV infection. In this trial in allogeneic hematopoietic cell transplant (HCT) recipients, the 100 mg dose given twice weekly (BIW) demonstrated decreased levels of AdV viremia and showed a potential benefit in reducing both progression to AdV disease and all-cause mortality, compared to subjects who received placebo or CMX001 given once weekly (QW). Planned intent-to-treat analyses as well as exploratory analyses in specific patient groups were consistent in trends favoring the CMX001 BIW regimen over placebo, although statistical significance was not established in this exploratory study.

Chimerix CEO: Public market is critical to financing biotech R&D

 
July 15, 2013
Chimerix (Nasdaq: CMRX) CEO Ken Moch is speaking out about the role of the public market in financing research and development.

Moch, whose company hit the public market earlier this year, recently spoke at a hearing held by the House Financial Services’ Subcommittee on Capital Markets and Government Sponsored Enterprises.

Chimerix stock pops 34% after IPO at $14 per share

 

DURHAM, N.C., April 12, 2013 — Chimerix’s debut as a public company produced a whopping climb in stock price.

The Durham company went public at $14 per share, raising $102 million for the antivirals company.

But Chimerix’s public debut proved to be even stronger and the stock marched upward throughout the day topping the $18 per share mark in afternoon trading. Chimerix (Nasdaq: CMRX) closed its first day of trading at $18.79 per share, up 34 percent from its offering price.

The closing price was the high for the day. Some 4.5 million shares were traded.

Chimerix sold 7.3 million shares, which is some 20 percent more than the 6.1 million shares that the company had originally planned to sell. Morgan Stanley and Cowen and Company are joint book-running managers for the offering. William Blair and Lazard Capital Markets are co-managers.

Chimerix can raise even more money. Underwriters have 30 days to purchase up to an additional 1 million shares of common stock to cover over-allotments, if any. The offering is expected to close on April 16.

Chimerix Announces Pricing of Initial Public Offering

RESEARCH TRIANGLE PARK, Apr 11, 2013 (GLOBE NEWSWIRE via COMTEX) — Chimerix, Inc. CMRX 0.00%  , a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today the pricing of its initial public offering of 7,320,000 shares of its common stock at a price to the public of $14.00 per share. The shares of Chimerix’s common stock are scheduled to begin trading on the NASDAQ Global Market under the symbol “CMRX” on April 11, 2013. All of the shares of common stock are being offered by Chimerix. In addition, Chimerix has granted the underwriters a 30-day option to purchase up to an additional 1,098,000 shares of common stock to cover over-allotments, if any. The offering is expected to close on April 16, 2013, subject to customary closing conditions.

Morgan Stanley and Cowen and Company are acting as joint book-running managers for the offering. William Blair and Lazard Capital Markets are acting as co-managers.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on April 10, 2013. The offering will be made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained from: Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2 Floor, New York, NY 10014, or by calling toll free 1-866-718-1649 or emailing at prospectus@morganstanley.com; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by calling (631) 274-2806, or faxing (631) 254-7140.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Planning IPO, Chimerix says its antiviral makes FDA fast track

RESEARCH TRIANGLE PARK, N.C., March 12, 2013 — Chimerix, the antiviral drug company that last week filed for an initial public offering of stock, is now on a faster regulatory path for its lead drug candidate.

The Food and Drug Administration’s “fast track” designation for CMX001 gives the Research Triangle Park company’s compound priority review. That faster review is reserved for new drugs addressing serious or life threatening conditions that have few if any alternative treatments. CMX001 is a compound that Chimerix is developing to prevent cytomegalovirus (CMV) infection, an infection that can severely sicken patients with already compromised immune systems. The antiviral works by blocking replication of double-stranded DNA (dsDNA) viruses.

Chimerix has completed phase II clinical trials studying CMX001 as a way of preventing CMV in patients undergoing hematopoietic stem cell transplant procedures. The company expects to start a phase III study later this year in patients undergoing these transplants.

Planning IPO, Chimerix says its antiviral makes FDA fast track

RESEARCH TRIANGLE PARK, N.C. — Chimerix, the antiviral drug company that last week filed for an initial public offering of stock, is now on a faster regulatory path for its lead drug candidate.

The Food and Drug Administration’s “fast track” designation for CMX001 gives the Research Triangle Park company’s compound priority review. That faster review is reserved for new drugs addressing serious or life threatening conditions that have few if any alternative treatments. CMX001 is a compound that Chimerix is developing to prevent cytomegalovirus (CMV) infection, an infection that can severely sicken patients with already compromised immune systems. The antiviral works by blocking replication of double-stranded DNA (dsDNA) viruses.

Chimerix has completed phase II clinical trials studying CMX001 as a way of preventing CMV in patients undergoing hematopoietic stem cell transplant procedures. The company expects to start a phase III study later this year in patients undergoing these transplants.

Ernest Mario named Chairman of Chimerix

 

February 20, 2013

Chimerix, a Durham, N.C.-based biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has appointed Ernest Mario, Ph.D., as chairman of its board of directors.

During the course of his career, Mario has served as the CEO, chairman and a director of several pharmaceutical companies. From 1989 to 1993, he served as chief executive of Glaxo Holdings, then the second-largest drug company in the world. Mario led drug delivery technology company ALZA from 1993 until its acquisition by Johnson & Johnson in 2001. He served as chairman and CEO of Reliant Pharmaceuticals from 2003 until its acquisition by GlaxoSmithKline in 2007. He also previously served as the chairman of multinational CRO Pharmaceutical Product Development (PPD) from 1993 to 2011.

Mario currently serves as chairman and CEO of Capnia, a privately held pharmaceutical company, as well as chairman of the American Foundation for Pharmaceutical Education.

Chimerix Press Release – Chimerix Appoints Michelle Berrey Chief Medical Officer

RESEARCH TRIANGLE PARK, NC, November 12, 2012 — Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced today that Michelle Berrey, MD, MPH, has joined the company as Chief Medical Officer.

“We are delighted to have Michelle join our leadership team. Dr. Berrey is a seasoned drug developer who has established a strong track record in antivirals, in particular with nucleotide analogs. She joins Chimerix at an important time for the company as our lead compound, CMX001, advances into Phase 3 clinical testing,” said Kenneth I. Moch, Chimerix President and Chief Executive Officer. “Her extensive background in antiviral drug development will be invaluable to our already strong team.”

Prior to joining Chimerix, Dr. Berrey was Chief Medical Officer at Pharmasset, Inc. (NASDAQ: VRUS), a company that focused on the development of nucleotide analogs for the treatment of hepatitis C, from 1997 until its acquisition by Gilead Sciences, Inc. (NASDAQ: GILD) in January 2012. Dr. Berrey’s experience includes the design, early development, medical governance, clinical strategy and product life cycle management of antiviral products.

Click here to read the full press release.

Chimerix Appoints Michelle Berrey Chief Medical Officer

RESEARCH TRIANGLE PARK, NC, November 12, 2012 — Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced today that Michelle Berrey, MD, MPH, has joined the company as Chief Medical Officer.

“We are delighted to have Michelle join our leadership team. Dr. Berrey is a seasoned drug developer who has established a strong track record in antivirals, in particular with nucleotide analogs. She joins Chimerix at an important time for the company as our lead compound, CMX001, advances into Phase 3 clinical testing,” said Kenneth I. Moch, Chimerix President and Chief Executive Officer. “Her extensive background in antiviral drug development will be invaluable to our already strong team.”