Print
Health Care

Diabetes Drug PPD Helped Develop Approved In Japan

By Alison Lee Satake, posted Apr 27, 2010

A new type 2 diabetes drug developed by Japan’s largest pharmaceutical company in partnership PPD has been approved by Japan’s Ministry of Health, Labour and Welfare. The approval of a new drug application for NESINA (alogliptin) came on April 16.

Under PPD’s agreement with Takeda, the Wilmington-based company is entitled to a $7.5 million milestone payment from Takeda since the drug received regulatory approval.

“This approval is an important milestone and confirms our strategy of partnering with pharmaceutical companies such as Takeda to bring new therapies to market,” said Fred Eshelman, executive chairman of PPD in a press release.

PPD expects to complete the spin-off of its compound partnering division, which partnered with Takeda to develop this drug. The spin-off will be complete by mid-2010 and Furiex Pharmaceuticals, Inc. will operate as an independent, publicly traded company based out of Morrisville.

In October 2008, the U.S. Food and Drug Administration (FDA) announced it would not complete its review of Takeda's new drug application (NDA) for alogliptin by the Prescription Drug User Fee Act (PDUFA) date because of insufficient FDA resources. The FDA subsequently set a new PDUFA date in second quarter 2009, according to an email from a PPD spokesperson. In addition to the U.S. regulatory review, Takeda submitted an NDA for alogliptin to Japan's Ministry of Health, Labour and Welfare in September 2008, triggering a milestone payment to PPD.

If approved, alogliptin will be one of a new class of drugs for the treatment of type 2 diabetes. PPD's collaboration with Takeda to develop alogliptin demonstrates the effectiveness of PPD's compound partnering program in accelerating the drug development process. PPD took the compound from lead optimization to NDA submission in a total of 49 months, trouncing traditional development timelines. If approved and marketed, PPD will be entitled to receive milestone payments and royalties on drug sales, according to the email.

Ico insights

INSIGHTS

SPONSORS' CONTENT
Mikestonestreetcropped 862150530

Going Virtual for Your HOA’s Annual Meeting? Read This First

Mike Stonestreet - CAMS (Community Association Management Services)
Jasonpathfinder3

Your Retirement Portfolio: Simplicity Is Your Friend

Jason Wheeler - Pathfinder Wealth Consulting
Atromitos micheallegady headshot

What it takes: Lessons from an Entrepreneur

Michealle Gady - Atromitos

Trending News

Development Proposal Plants Commercial Space On Farm Land

Cece Nunn - Dec 3, 2021

New Stores, Eateries Aim To Boost Mall

Cece Nunn - Dec 3, 2021

Plantation Village Marks $57M Phase Of Expansion Project

Cece Nunn - Dec 3, 2021

With Listening Sessions Complete, New Hanover Endowment Looks Ahead

Johanna F. Still - Dec 2, 2021

NCino Reports Higher Revenues, Higher Costs For Q3

Jenny Callison - Dec 2, 2021

In The Current Issue

Seniors Find Health, Friends In Fitness

If there’s one word to describe the members of Sandy Sneakers, an exercise group for seniors, it’s “vivacious.” They have the energy of a 30...


Employers Monitor Vaccine Rules

With judicial review underway on the Biden administration’s vaccination mandate for businesses with 100 or more employees, leading employers...


Chain Reaction: Coping With A Disrupted Supply Chain

The worldwide supply chain disruption is a perfect storm, said Drew Rosen, professor of supply chain management at the University of North C...

Book On Business

The 2021 WilmingtonBiz: Book on Business is an annual publication showcasing the Wilmington region as a center of business.

Order Your Copy Today!


Galleries

Videos

Trying to Grow a Business?
2020 Health Care Heroes
2020 WilmingtonBiz 100