UIP & Fervent

UIP will be working with Fervent Pharmaceuticals to develop its treatment for hot flashes and other vasomotor symptoms.  UIP involvement will be focused on formulation development aspects of the Fervent program, and UIP will manufacture development-scale clinical batches for its upcoming Phase II trial.  Fervent CEO George Royster is excited about the partnership: “UIP offers Fervent the perfect blend of drug development expertise and experience. They’ve been practicing cGMP-compliant formulation development and product manufacturing for 40 years. I’ve been extremely impressed by their capabilities and their facility, which is the only one of its kind offering the range and scope of services needed by commercial clients like us.”  For more information go to:

http://ferventpharma.com/university-of-iowa-pharmaceuticals-added-to-growing-list-of-fervent-strategic-partners/

http://ferventpharma.com/

UIP TO PARTICIPATE IN NIIMBL VIA NIPTE

U.S. Secretary of Commerce Penny Pritzker announced on December 16, 2016 an award of $70 million to the new National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), the eleventh institute in the Manufacturing USA network.  This is the first institute with a focus area proposed by industry and the first funded by the U.S. Department of Commerce (DOC).  UIP is part of NIIMBL through the UI College of Pharmacy via NIPTE (National Institute for Pharmaceutical Technology and Education).  NIIMBL will help to advance U.S. leadership in the biopharmaceutical industry, foster economic development, improve medical treatments and ensure a qualified workforce by collaborating with educational institutions to develop new training programs matched to specific biopharma skill needs.

UI BREAKS GROUND ON NEW PHARMACY BUILDING

On September 29, 2016 UI officially broke ground on a new $96.3 million pharmacy building that will feature cutting-edge research laboratories, innovative technology, and collaborative learning spaces.  The lower level of this new building will be home to UIP’s new sterile products manufacturing area.  This new sterile manufacturing area will be approximately 16,000 square feet and include two complete isolator lines, each with its own lyophilizer.  This will increase UIP’s batch size capacity approximately 5-fold to 20,000 vials/batch.  UIP will continue to retain its ability to make small, IND enabling batches for clinical supplies with this facility.

INTERCEPT PHARMACEUTICALS RECEIVES FDA APPROVAL FOR OCALIVA®

Intercept Pharmaceuticals, Inc. received FDA approval for the orphan drug Ocaliva on May 27, 2016 – one of only 22 NMEs (New Molecular Entities) to receive approval by the FDA!  It is indicated for the treatment of Primary Biliary Cholangitis in patients with an inadequate response to UDCA or as monotherapy – PBC is a disease for which there has not been a significant new treatment in nearly 20 years.  Intercept is a long-standing client of UIP’s.  UIP’s analytical laboratory is a laboratory of record in their NDA for this drug product.

UIP HOSTS FDA INSPECTION

An FDA Inspector conducted a general cGMP and preapproval inspection of UIP in November 2015 (both the manufacturing and laboratory site were inspected). This preapproval portion of the inspection was for two different products; a generic sterile injectable solution manufactured by UIP and an oral, immediate release tablet product containing an NCE on which UIP performs finished product and stability testing. This latter product was originally formulated by UIP. The latter product is intended for the treatment of liver disease and is on an accelerated approval track. The inspector completed the inspection and did not leave a Form 483 at either site. This inspection brings to 4 the number of successful preapproval inspections UIP has hosted since 2009. This is a significant accomplishment for UIP.