Companies Archives - Page 31 of 59

Nanotechnology firm Liquidia plans new ophthalmology company

MORRISVILLE, N.C. — Nanotechnology company Liquidia Technologies plans to form a new ophthalmology company with an experimental glaucoma treatment expected to start clinical trials in 2014.

Morrisville-based Liquidia said today that the new company would be able to advance Liquidia’s efforts to create products in ophthalmology and other therapeutic areas while also maximizing the return for the company’s investors. WRAL Tech Wire reported in February that Liquidia was considering spinning out one or more companies this year.

Liquidia offered few other details in today’s announcement, other than to say it would have more information later in the second quarter. In a statement, CEO Neal Fowler said that the structure for creating and financing the new company will be considered for other assets and therapeutic areas.

Liquidia’s proprietary “PRINT” technology enables a nanoparticle manufacturer to control the size and shape of the nanoparticles. Changing the size and shape of a nanoparticle can improve drug delivery and reduce side effects. Vaccines were Liquidia’s first target, a pursuit that GlaxoSmithKline liked enough to strike a licensing deal that gave GSK exclusive rights to develop new vaccines with the technology.

Liquidia said in today’s announcement that it independent from the new ophthalmology business, Liquidia will continue to focus on vaccine and pulmonary product development, including the work that has already begun under the GSK partnership.

Liquidia’s technology is a platform technology that has medical as well as consumer product applications. Fowler has acknowledged a partnership with Proctor & Gamble (NYSE: PG). In February, Fowler said that Liquidia’s PRINT technology can be used to make nanoparticles that improve how a product is delivered to the skin. At the time, he said an ophthalmology company could be spun out first, followed by a consumer product with P&G.

Liquidia Technologies - 05/02/2013

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.

Ultragenyx Pharmaceutical - 05/01/2013

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.

TYRX - 04/15/2013

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 / Uncategorized - 04/12/2013

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 / Uncategorized - 04/11/2013

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.

Ultragenyx Pharmaceutical - 04/08/2013

Ultragenyx Initiates Novel Disease Monitoring Program for Hereditary Inclusion Body Myopathy

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

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.

Ultragenyx Pharmaceutical - 04/08/2013

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.

Chimerix - 03/12/2013

Man with a plan: Emil Kakkis aims to lure big-market drugs toward rare diseases

February 26, 2013

Emil Kakkis is making another run at rare diseases.

The president and CEO of Ultragenyx Pharmaceutical Inc. and former chief medical officer at BioMarin Pharmaceutical Inc. is laying out a new strategy Tuesday to get more drugs into children with rare diseases. Under the banner of the EveryLife Foundation for Rare Diseases, which Kakkis founded and has largely bankrolled, he is proposing that companies with already-approved, big-market drugs be rewarded with a two-month extension of that drug’s patent life if it wins a new Food and Drug Administration-approved label in an orphan disease.

Ultragenyx Pharmaceutical - 02/26/2013

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 - 02/20/2013