Ultragenyx Press Release: Ultragenyx Appoints Eric Yuen, MD as Chief Medical Officer and Senior Vice President

Ultragenyx Press Release: Ultragenyx Appoints Eric Yuen, MD as Chief Medical Officer and Senior Vice President

NOVATO, CA –May 1, 2013 - Ultragenyx Pharmaceutical Inc., a biotechnology company focused on the development of treatments for rare and ultra-rare genetic disorders, today announced it has appointed Eric Yuen, MD as its Chief Medical Officer and Senior Vice President.  In this new role, Dr. Yuen will provide leadership and direction to Clinical Operations, Clinical Affairs, Clinical Sciences, Data Management/Biometrics, and Drug Safety.  He will report to Dr. Emil Kakkis, CEO, and will serve on the Senior Management Team.

Dr. Yuen brings over 19 years of clinical development experience in academia and industry.   In 2004, Dr. Yuen joined Johnson & Johnson as Senior Director and Neurology Franchise Medical Leader.   During his tenure at J&J, he also held several executive positions including Vice President, Therapeutic Area Head, CNS in 2006 and Vice President, Scientific Licensing from 2008 to 2009.  Dr. Yuen joins Ultragenyx from Janssen Alzheimer Immunotherapy R&D, LLC, a J&J affiliate, where he was the Head of Clinical Development since 2009.  Prior to J&J, Dr. Yuen also served as Director of Clinical Research, Department of Clinical Neuroscience at the Merck Research Laboratories. 

“As a board-certified neurologist, Dr. Yuen’s addition to the management team at Ultragenyx will provide critical support in advancing our clinical programs,” said Dr. Kakkis.  “His clinical vision and proven leadership, as well as his extensive medical and research experience, will strengthen our clinical development efforts and support the progress of our product pipeline.”

Dr. Yuen commented, “I am excited about being a part of a dedicated team focused on developing novel treatments for rare disease patients who have no approved treatments and applying my experiences in clinical development and neuromuscular diseases to help solve the devastating medical problems of these metabolic genetic diseases.” 

Dr. Yuen received his undergraduate training at Stanford University and his M.D. from the University of Chicago, Pritzker School of Medicine.  He completed his residency in Neurology and post-doctoral fellowships at the University of California, San Francisco.  Before joining industry in 2000, Dr. Yuen was a faculty member at the University of Washington, serving as a clinical investigator, studying treatments for ALS, neuropathy and multiple sclerosis. 

About Ultragenyx

Ultragenyx is a privately held, development-stage biotechnology company committed to bringing to market life-transforming therapeutics for patients with rare and ultra-rare metabolic genetic diseases.  The company focuses on diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no effective treatments. 

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics.  Ultragenyx’ strategy is predicated upon time and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency. 

For more information on Ultragenyx, please visit the company’s website at www.ultragenyx.com.

TyRx Press Release - TYRX® Announces First EverImplantation of AIGISRx® R Fully Resorbable Antibacterial Envelope

Monmouth Junction, NJ. (April 15, 2013): TYRX, Inc., the leader in the commercialization of implantable medical devices intended to help reduce surgical site infections, announced today that the first implantation of its new AIGISRx R Fully Resorbable Antibacterial Envelope has taken place at the Quebec Heart and Lung Institute in Quebec City, Canada by Dr. François Philippon. TYRX announced on January 31, 2013 that it had received a license from Health Canada to market its AIGISRx R Fully Resorbable technology.

The AIGISRx R Antibacterial Envelope is specifically designed to stabilize Electronic Implantable Devices (EIDs), such as pacemakers and defibrillators, while also releasing antimicrobial agents to help provide protection from microbial colonization of the device during surgical implantation.

“Surgical site infections are on the rise and have profound consequences to the patient with regard to having to spend extra time in the hospital, having to undergo additional surgical procedures, and having significant increases in morbidity and mortality. They are also very expensive to treat,” stated Dr. Philippon, cardiac electrophysiologist at the Quebec Heart and Lung Institute. “I found implantation of the fully resorbable envelope to be very straightforward and believe that the combination of stabilization and locally delivered antibiotics provided by the product will be of great potential benefit to our patients.”

“We are very excited to have the world’s first AIGISRx R Antibacterial Envelope implanted at the Quebec Heart and Lung Institute,” commented Robert White, TYRX President and Chief Executive Officer. “The AIGISRx R includes all of the advantages of the original AIGISRx, such as stability and infection reduction, but now with the added benefit of full resorption in approximately 9 weeks.”

The AIGISRx R Envelope is intended to hold the EIDs, such as pacemakers and implantable cardioverter defibrillators (ICDs), securely in place in order to provide a stable environment when implanted in the body. Additionally, the AIGISRx R contains the antimicrobial agents rifampin and minocycline, which are released over a minimum of 7 days in order to help provide protection from microbial colonization of the device during surgical implantation.

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 stock pops 34% after IPO at $14 per share

DURHAM, N.C. — 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.

At the $14 per share offering price, Chimerix estimated that it would see net proceeds of $93 million from the $102.5 million raised. The company plans to spend $45 million on phase III clinical trials of lead program; CMX001 is being studied as a way to prevent infection in patients who are undergoing stem cell transplants. The remaining proceeds will be spent on working capital.

The phase III trials on CMX001 are expected to start this year. The company has already completed phase II studies of CMX001. The Food and Drug Administration has put CMX001 on a “fast track,” a designation reserved for new drugs that address serious diseases that have few, if any, treatments.

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.

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.

UltraGenyx Press Release - Ultragenyx Initiates Novel Disease Monitoring Program for Hereditary Inclusion Body Myopathy

First patient enrolled in integrated program designed to improve knowledge of rare disease

NOVATO, CA –April 8, 2013 -Ultragenyx Pharmaceutical Inc. today announced the launch of a unique Disease Monitoring Program (DMP) for Hereditary Inclusion Body Myopathy (HIBM), also known as GNE Myopathy. The goal of the HIBM-DMP is to improve the body of knowledge about this rare disease and its typical course. This novel program is being conducted in partnership with the University of Newcastle's TREATNMD organization, a global neuromuscular physician network in Newcastle, England.The main objectives of the HIBM-DMP are to expand knowledge of the clinical presentation, progression and variation of HIBM patients; identify and qualify biomarkers and other efficacy measures; inform the design and interpretation of clinical studies of investigational products for HIBM and eventually to optimize patient management. 

The HIBM-DMP is designed to assist the HIBM communities in several ways, including:

- integration of an online registry capturing patient-reported information, a fully monitored physician-driven natural history study, and potentially any post-approval patient follow-up into a single cohesive program.

- knowledge-sharing gained from the program about HIBM with investigators, physicians and patients in a manner compliant with patient data protection regulations.