press release - Page 25 - Pappas Capital

Pappas Ventures Promotes Scott Weiner to Partner

RESEARCH TRIANGLE PARK, N.C., Jan. 8, 2014 /PRNewswire/ -- Pappas Ventures, a life science venture capital firm, announced today that Scott Weiner, who joined the firm in 2006, has been promoted to Partner.

"We are pleased to recognize Scott's many contributions to the development and success of our firm," said Art Pappas, Managing Partner at Pappas Ventures. "His knowledge of the life sciences industry and broad transaction experience is valued immensely both by my Pappas colleagues and by our many portfolio companies."

Among the many Pappas Ventures portfolio companies with which Mr. Weiner has been involved, he played a key role in the firm's successful investments in TESARO, Achillion Pharmaceuticals and Athersys. He currently serves as a director for Gentis and Milestone Pharmaceuticals, and as an observer for IlluminOss Medical, Liquidia Technologies and Thrasos Therapeutics.

Uncategorized - 01/08/2014

Medtronic Announces Acquisition of TYRX, INC., Developer of Solutions for Surgical Site Infections

MINNEAPOLIS - Jan. 06, 2014 - Medtronic, Inc. (NYSE: MDT) today announced that it has acquired TYRX, Inc., a privately held, New Jersey-based developer of implantable combination antibiotic drug and implanted medical devices. TYRX's product offerings include the recently FDA cleared AIGISRx® R Fully Resorbable Antibacterial Envelope, designed to reduce surgical site infections associated with Cardiac Implantable Electronic Devices (CIEDs), and the AIGISRx® N Antibacterial Envelope, for use with spinal cord neuromostimulators. The all cash transaction includes an initial payment of $160 million plus potential earn out and performance based milestone payments. Medtronic expects the net impact from this transaction to be neutral to fiscal year 2014 earnings and for this transaction to be consistent with the company's disciplined focus on long-term returns.

TYRX - 01/06/2014

Ultragenyx Announces Results from Phase 2 Study of Sialic Acid Extended-Release Treatment in Hereditary Inclusion Body Myopathy

Upper extremity muscle strength composite shows statistically significant difference between the 6 gram and 3 gram dose groups

Novato, CA — December 20, 2013 — Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced topline results from a 48-week Phase 2 clinical study of sialic acid extended-release (SA-ER, UX001) tablets in 46 patients with hereditary inclusion body myopathy (HIBM), a progressive muscle-wasting disease. SA-ER is designed to replace the deficient sialic acid substrate in patients with HIBM. Patients were initially randomized to either receive placebo, 3 grams or 6 grams of SA-ER per day. After 24 weeks, placebo patients crossed over to either 3 grams or 6 grams total daily dose, on a blinded basis, for an additional 24 weeks. The final analysis compared change at week 48 from baseline for the combined groups at 6 grams versus 3 grams of SA-ER.

Ultragenyx Pharmaceutical - 12/20/2013

Ultragenyx Investigational New Drug Application for Triheptanoin for the Treatment of Glucose Transporter Type-1 Deficiency Syndrome is in Effect

Phase 2 Clinical Study Expected to Begin in the First Half of 2014
NOVATO, CA – December 17, 2013 – Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, announced today that its Investigational New Drug (IND) application
filing for triheptanoin (UX007) for the treatment of glucose transporter type-1 deficiency syndrome (Glut1 DS) is in effect. The IND allows the company to proceed with its clinical development program for triheptanoin in Glut1 DS in the United States. The company plans to initiate a Phase 2 trial studying triheptanoin in Glut1 DS in the first half of 2014.

Ultragenyx Pharmaceutical - 12/17/2013

Pappas Ventures Names Franz B. Humer as Venture Partner and Senior Advisor

RESEARCH TRIANGLE PARK, N.C., Dec. 10, 2013 /PRNewswire/ -- Pappas Ventures, a life science venture capital firm, announced today the appointment of Franz B. Humer as a Venture Partner and Senior Advisor with the firm. Dr. Humer is currently the Chairman of Roche Holding Ltd, a position he will retire from in March 2014.

Dr. Humer brings a wealth of leadership experience from the pharmaceutical and life science industry, including a transformative 15-year tenure as Chairman and/or Chief Executive Officer of Roche. He previously served as Chief Operating Officer and Head of Pharmaceuticals for F. Hoffmann-La Roche Ltd.

Uncategorized - 12/10/2013

FDA Clears TYRX Antibacterial Envelope for Use with Spinal Cord Neuromodulators

Monmouth Junction, NJ. (December 4, 2013): TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance for expanded indications in marketing the AIGISRx® N Antibacterial Envelope for use with spinal cord neuromodulators. This comes after the recent FDA clearance of the AIGISRx N for use with vagus nerve stimulators. This expanded clearance extends TYRX’s leadership in the commercialization of implantable medical devices designed to help reduce Surgical Site Infections (SSIs) associated with implantable devices in the fields of neurosurgery and cardiology.

TYRX - 12/04/2013

Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases

Company receives first positive opinion in the European Union for Primary Sclerosing Cholangitis

SAN DIEGO – November 18, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced that it has received positive opinions for four Orphan Drug Designations by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for LUM001. The company’s lead drug candidate, LUM001, received the first positive opinion granted by the EMA for primary sclerosing cholangitis (PSC). In addition, the company received positive opinions for LUM001 in three other rare cholestatic liver diseases including Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and primary biliary cirrhosis (PBC). This follows the Orphan Drug Designation in September by the U.S. Food & Drug Administration (FDA) Office of Orphan Product Development for LUM001 in the same indications.

Lumena Pharmaceuticals - 11/18/2013

Envisia Therapeutics Debuts with $25 Million Series A Financing

Transformative New Ophthalmology Company Licenses Technology from Liquidia

RESEARCH TRIANGLE PARK, NC– November 12, 2013 – Envisia Therapeutics, a new biotechnology company formed by Liquidia Technologies, today announced the Company’s debut, which is being backed by $25 million in Series A financing. Envisia will focus on addressing unmet medical needs in various areas of ophthalmology. Envisia’s lead product, ENV515, is an extended-release formulation of a prostaglandin analogue. ENV515 has the potential to offer glaucoma patients an innovative product that can provide a sustained reduction in intraocular pressure (IOP) over many months after single administration.

Envisia Therapeutics - 11/12/2013

Inhibition of ASBT Improves Liver Function in an Animal Model of Cholestatic Liver Disease

Data Presented Today at Annual Meeting of the American Association for the Study of Liver Diseases in Washington DC Provides Additional Preclinical Validation for LUM001 Currently Being Evaluated in Phase II Studies in Multiple Cholestatic Liver Disease Populations

SAN DIEGO – November 5, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for cholestatic liver diseases, today announced that inhibition of the apical sodium-dependent bile acid transporter (ASBT) improves liver function in animal models of cholestasis. The data will be presented at 11:15 a.m. EST today in an oral presentation titled “SC-435, an Oral Inhibitor of ASBT, Improves Liver Function in a Rat Partial Bile Duct Ligation Model of Cholestasis,” at the 64th Annual Meeting of the American Association for the Study of Liver Diseases in Washington DC.

Lumena Pharmaceuticals - 11/05/2013

Lumena Pharmaceuticals Initiates the CLARITY Phase II Study of LUM001 in Patients with Primary Biliary Cirrhosis

Novel therapeutic approach to be evaluated for its ability to reduce elevated bile acid levels and associated severe itching

SAN DIEGO – October 29, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced the dosing of the first patient in the CLARITY Phase II study of its drug candidate LUM001 in patients with primary biliary cirrhosis (PBC). LUM001 is being developed as a possible therapy for a number of cholestatic liver diseases including, PBC, Alagille syndrome, progressive familial intrahepatic cholestasis and primary sclerosing cholangitis, that result in impaired bile acid flow and retention of bile acids in the liver, leading to progressive liver damage and, ultimately, liver failure. In the CLARITY Phase II study, LUM001 is being evaluated for its ability to alleviate the symptom of severe itching associated with PBC.

Lumena Pharmaceuticals - 10/29/2013