GSK today announced $139 million of new investment in its biopharmaceutical manufacturing site in Rockville, MD to support growing demand for BENLYSTA® (belimumab) for adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

The Rockville site is also expected to house production of a new subcutaneous form of belimumab which is currently under review with the FDA.

The $139 million investment will be used to provide additional internal capacity to increase bulk drug substance production by close to 50% at the Rockville site, to respond to increased demand.

"Benlysta is the first medicine specifically developed and approved for SLE in over 50 years. We are so pleased that on the first day of Lupus Awareness Month we are able to announce this expansion in Rockville, increasing our ability to provide this important medicine to patients," said Sheri Mullen, VP Immunology & Rare Diseases, GSK.

Benlysta continues to be a growing product for GSK. Since 2014, the product has grown at least 18% per year in the US on a constant exchange rate basis. In 2016, the company reported $377million in BENLYSTA sales in the US.

GSK announced regulatory filings for a subcutaneous (self-injectable) formulation of belimumab, currently available as an intravenous formulation, in Europe and the US in 2016 and is expecting to hear from regulatory bodies in the second half of 2017. The subcutaneous formulation of belimumab is currently not approved for use anywhere in the world.

The Rockville biopharmaceutical manufacturing site consists of two FDA-licensed facilities for large and small scale manufacturing, which employ more than 400 highly-skilled scientists, engineers and manufacturing and quality professionals among other specialists.

Today's announcement is the latest investment in the US that GSK has made following:

• $50 million to continue to develop its Global Vaccines R&D Headquarters in Rockville, MD, opened in December 2016.
• $245 million to transform its Upper Providence, PA site into one of two major R&D hubs for GSK globally, which was announced in December 2014.

About Lupus and Systemic Lupus Erythematosus

Lupus is an incurable, chronic, autoimmune disease that can affect any part of the body (skin, joints, and/or organs inside the body). Approximately five million people worldwide have a form of lupus. Approximately, 170,000-200,000 Americans live with systemic lupus erythematosus (SLE), one of the most common and serious forms.

About BENLYSTA ® (belimumab)

BENLYSTA is the first medicine specifically developed and approved for SLE in over 50 years. It is a human monoclonal antibody that selectively targets B-lymphocyte stimulator (BLyS), an important factor in the survival of B cells.

BENLYSTA is indicated in the US for the treatment of adult patients with active, autoantibody-positive, SLE who are receiving standard therapy

Limitations of Use

The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.

BENLYSTA is available as 120 mg in a 5-mL single-use vial and 400 mg in a 20-mL single-use vial for injection in the US, for intravenous use only.

BENLYSTA is licensed in the European Union as an add-on therapy in adult patients with active autoantibody-positive SLE, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy.

For the EU Summary of Product Characteristics for Benlysta, please visit www.ema.europa.eu

IMPORTANT SAFETY INFORMATION for BENLYSTA® (belimumab)

Please consult the full US Prescribing Information for all the labelled safety information for BENLYSTA (belimumab) for injection, for intravenous use only.

CONTRAINDICATION

BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab.

WARNINGS AND PRECAUTIONS

MORTALITY

There were more deaths reported with BENLYSTA than with placebo during the controlled period of the clinical trials. Out of 2133 patients in 3 clinical trials, a total of 14 deaths occurred in the following groups: 3/675 in placebo, 5/673 in BENLYSTA 1 mg/kg, 0/111 in BENLYSTA 4 mg/kg, and 6/674 in BENLYSTA 10 mg/kg. No single cause of death predominated. Etiologies included infection, cardiovascular disease, and suicide.

SERIOUS INFECTIONS

Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. Caution should be exercised when considering use in patients with a history of chronic infections. Patients receiving therapy for a chronic infection should not receive BENLYSTA. Consider interrupting therapy with BENLYSTA in patients who develop a new infection while receiving BENLYSTA. The most frequent serious infections included pneumonia, urinary tract infection, cellulitis, and bronchitis.

Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. Patients presenting with new-onset or deteriorating neurological signs and symptoms should be evaluated for PML by an appropriate specialist. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.

MALIGNANCY

The impact of treatment with BENLYSTA on the development of malignancies is not known. The mechanism of action of BENLYSTA could increase the risk of malignancies.

HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) AND INFUSION REACTIONS

Acute hypersensitivity reactions, including anaphylaxis and death, have been reported with BENLYSTA. These events generally occurred within hours of the infusion; however, they may occur later. Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema, have been reported and typically occurred up to a week following the most recent infusion. Hypersensitivity, including serious reactions, has occurred in patients who have previously tolerated infusions of BENLYSTA. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. Some patients received premedication; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of these reactions.

Healthcare providers should be aware of the risk of hypersensitivity reactions, which may present as infusion reactions, and monitor patients closely. Manifestations of hypersensitivity included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea. In the event of a serious hypersensitivity reaction, discontinue BENLYSTA immediately and administer appropriate medical therapy. Infusion-associated adverse events were also reported. Serious infusion reactions included bradycardia, myalgia, headache, rash, urticaria, and hypotension. In the event of an infusion reaction, the infusion rate may be slowed or interrupted.

Patients should be informed of the signs and symptoms of an acute hypersensitivity reaction and be instructed to seek immediate medical care should a reaction occur.

DEPRESSION

In clinical trials, psychiatric events (primarily depression, insomnia, and anxiety) were reported more frequently with BENLYSTA than with placebo. Serious psychiatric events, serious depression, and two suicides were also reported. It is unknown if treatment with BENLYSTA is associated with increased risk for these events. Patients should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes.

IMMUNIZATION

Live vaccines should not be given for 30 days before or concurrently with BENLYSTA. BENLYSTA may interfere with the response to immunizations.

USE WITH BIOLOGIC THERAPIES OR IV CYCLOPHOSPHAMIDE

BENLYSTA has not been studied in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide. Therefore, use of BENLYSTA is not recommended in combination with these therapies.

ADVERSE REACTIONS

The most common serious adverse reactions were serious infections (6.0% and 5.2% in patients receiving BENLYSTA and placebo, respectively), some of which were fatal. Adverse reactions, regardless of causality, occurring in at least 3% of patients with SLE who received BENLYSTA 10 mg/kg and placebo respectively and, at an incidence at least 1% greater than that observed with placebo in the 3 controlled studies were: nausea 15% and 12%; diarrhea 12% and 9%; pyrexia 10% and 8%; nasopharyngitis 9% and 7%; bronchitis 9% and 5%; insomnia 7% and 5%; pain in extremity 6% and 4%; depression 5% and 4%; migraine 5% and 4%; pharyngitis 5% and 3%; cystitis 4% and 3%; leukopenia 4% and 2%; viral gastroenteritis 3% and 1%.

Other Important Information for BENLYSTA

USE IN SPECIFIC POPULATIONS

Pregnancy: There are insufficient data on use of BENLYSTA in pregnant women to determine whether there is drug-associated risk for major birth defects or miscarriage. Following an assessment of benefit versus risk, if prevention is warranted, women of childbearing potential should use effective contraception during treatment and for at least 4 months after the final treatment.

Lactation: There is no information available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BENLYSTA and any potential adverse effects on the breastfed child from BENLYSTA or from the underlying maternal condition.

Effect in black/African American patients: In exploratory analyses of 2 Phase III trials, response rates were lower for black patients (N=148) in the groups receiving BENLYSTA relative to black patients in the placebo group. In the Phase II trial, black patients (N=106) in the groups receiving BENLYSTA did not appear to have a different response than the rest of the study population. Although no definitive conclusions can be drawn from these analyses, caution should be used when considering BENLYSTA for black/African American patients.

About GSK

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