Health and Healthcare

What Shire Is Planning With Its Newest FDA Submission

Chris Lange

Published: December 27, 2017 1:10 pm

Last Updated: January 12, 2020 5:05 am

Although Shire PLC (NASDAQ: SHPG) is not seeing much of a bump in its share price, the firm is creating a lot of value with its most recent submission to the U.S. Food and Drug Administration (FDA). According to the firm, it entered its first submission to the FDA for the company`s new plasma manufacturing facility in Covington, Georgia.

Overall, this facility is expected to add roughly 30% capacity to the company’s internal network once fully operational, and the commercial production is expected to begin in 2018.

The first submission is for the transfer of Gammagard Liquid [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI). The company expects to make a second submission to the FDA in 2018 for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

Matt Walker, head of Technical Operations for Shire, commented:

We are pleased to have filed the Georgia site and look forward to working with the FDA to seek approval for manufacturing in 2018. The additional capacity from this site is a key element to support the growth in our Immunology franchise.

Shire has proven that it has growth potential as it has experienced significant growth in immunology, including a 21% increase in September year-to-date product sales in 2017. While this growth is significant, shares have been on a slower track, down about 8% year to date. However, over the past month the stock is up closer to 6%.

With a consensus analyst price target of $215.14, most analysts are implying upside of about 38% from the current price level.

Shares of Shire were last seen at $156.28, in a 52-week trading range of $137.17 to $192.15.