Shire said today it is pursuing FDA approval for a new plasma manufacturing facility within its Covington, GA, campus that is expected to boost the site’s production capacity by approximately 30%.

“The additional capacity from this site is a key element to support the growth in our immunology franchise,” Matt Walker, Shire’s head of technical operations, said in a statement.

Immunology is one of Shire’s seven therapeutic areas, generating $1.516 billion of Shire’s $11.4 billion in 2016 revenues. During the third quarter of 2017, Shire reported 32% growth in its Immunology franchise—the company’s fastest-growing franchise—to $802 million, second in sales to hematology at $916 million, helping account for a 7% overall increase in product sales to $3.534 billion.

For the first nine months of 2017, Shire saw its global immunology revenues rise to $2.2 billion, a 21% increase in year-to-date product sales on a pro forma basis. Among key growth drivers cited along with growing demand by Shire in an investor presentation of third-quarter results were greater market penetration due to a growing diagnosis rate and rising standard of care; refocusing of hospital contracts on the broader portfolio, geographic expansion, strong plasma collection and fractionation capabilities; and the absence of sales erosion typical of other drugs as patents expire.

Shire expanded into immunology in 2016 when it completed its $32 billion acquisition of Baxalta. That company was spun out of Baxter International, which first announced plans for the Covington campus in 2012, with plans back then to base 1500 jobs there.

The plasma manufacturing facility would grow as part of an expansion of the Covington site that the company said will boost employment beyond the approximately 900 full-time staffers and contract employees now based there.


Ramping Up Hiring

Shire said the Covington site plans to ramp up hiring in 2018 to fill positions (the company statement did not say exactly how many) in manufacturing, quality, engineering, maintenance, utilities, warehouse, and a variety of support and facility roles.

The biotech giant disclosed that it has filed its first of two planned submissions to the FDA, which would allow the transfer of Gammagard Liquid® [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI) in adults and children 2 years old and older.

Gammagard Liquid was one of three “key” immunology products cited by Shire in the presentation, along with Adynovate® [Antihemophilic Factor (Recombinant), PEGylated], a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency); and HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], which is indicated for PI in adults.

Shire said combined sales of HyQvia and CuvitruTM [Immune Globulin Subcutaneous (Human)] 20% Solution, another treatment indicated for P) in adults and children 2 years old and older, grew by 75% year-over-year during Q3.

The second submission, Shire said, would be filed in 2018 and would seek approval for its albumin therapy, primarily used as plasma-volume replacement therapy in immune disorders, trauma, and other critical conditions.

In addition to the facility expansion, Shire said it also expects to continue expanding its plasma collection network in Georgia and throughout the U.S. through a subsidiary, BioLife Plasma Services. BioLife collects the human plasma that will be processed into the drugs manufactured at the Covington, GA facility.

In addition to immunology, Shire’s therapeutic areas include genetic diseases, hematology, internal medicine, neuroscience, oncology, and ophthalmology.







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