Intended audience: global
Shire Files Submission for U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia
- FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions
- Shire received its first FDA approval for the Georgia facility, to manufacture GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, in June 2018
- This state-of the art facility supports continued growth of Shire’s immunoglobulin and bio-therapeutics portfolio and further strengthens our ability to deliver complex therapies for patients
Dublin, Ireland – October 25, 2018 – Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that it has filed its second submission to the United States Food and Drug Administration (FDA) for its new plasma manufacturing facility near Covington, Georgia.
This second submission is for the manufacturing of FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution, a treatment primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions. The Georgia facility received its first FDA approval, to manufacture GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution.
“We are very pleased to file this second submission for our state-of-the-art manufacturing facility in Georgia, after the facility received FDA approval earlier this year,” said Matt Walker, Head of Technical Operations for Shire. “Expanding our capacity for manufacturing FLEXBUMIN will allow us to better meet the increasing global demand for plasma protein therapies and further supports our growing immunoglobulin and bio-therapeutics portfolio by enabling us to deliver these important treatments to our patients.”
Shire's Immunology franchise has seen strong demand, with product sales increasing +13% in the second quarter of 2018 versus the prior year.
The Georgia site currently employs approximately 900 full-time colleagues and contract employees. Since the beginning of 2018, Shire has ramped up hiring to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and various support and facility roles.
Shire also plans to continue expanding its plasma collection network in Georgia and throughout the United States through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma used in the manufacturing process for immunology products at the Georgia facility.
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GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution
GAMMAGARD LIQUID is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years.
Important US Safety Information
WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.
- For patients at risk of thrombosis, administer GAMMAGARD LIQUID at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
- History of anaphylactic or severe systemic hypersensitivity reactions to human IG
- IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG. Anaphylaxis has been reported with intravenous (IV) use of GAMMAGARD LIQUID.
Warnings and Precautions
Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.
Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with IV use of IG products, especially those containing sucrose. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and use the minimum infusion rate practicable for IV administration. If renal function deteriorates, consider discontinuation.
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. It is critical to distinguish true hyponatremia from a pseudohyponatremia because certain treatments may lead to volume depletion, a further increase in serum viscosity, and a predisposition to thromboembolic events.
Thrombosis: May occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Aseptic Meningitis Syndrome: Has been reported with use of IG and may occur more frequently in females. Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae.
Hemolysis: GAMMAGARD LIQUID contains blood group antibodies, which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.
Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.
Transmittable Infectious Agents: Because GAMMAGARD LIQUID is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with GAMMAGARD LIQUID.
Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.
IV administration for PI: The serious adverse reaction seen during IV clinical studies was aseptic meningitis. The most common adverse reactions observed in ≥5% of subjects were headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur.
Subcutaneous administration for PI: The most common adverse reactions observed in ≥5% of subjects were infusion site (local) event (rash, erythema, edema, hemorrhage, and irritation), headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity.
Passive transfer of antibodies may transiently interfere with immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).
Please click for Full Prescribing Information, including Boxed Warning regarding Thrombosis, Renal Dysfunction and Acute Renal Failure.
FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution
What is FLEXBUMIN?
FLEXBUMIN 25% is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). Albumin is not indicated as an intravenous nutrient
Important US Safety Information
- History of hypersensitivity reaction to albumin preparations or to any of the excipients (N-acetyltryptophan and sodium caprylate). Reactions have included anaphylactic shock, anaphylactic reaction, or hypersensitivity/allergic reactions
- Severe anemia or cardiac failure with normal or increased intravascular volume.
Warnings and Precautions
Hypersensitivity Reactions: have been observed (including anaphylactic reactions). If hypersensitivity reaction is suspected, discontinue administration immediately and implement appropriate standard medical treatment.
Hypervolemia/Hemodilution: Under conditions where hypervolemia and/or hemodilution may occur, adjust the dose and rate of infusion to the patient’s volume status. When administering large volumes, monitor hemodynamic parameters. Ensure adequate substitution of other blood constituents and monitor electrolyte balance. Discontinue administration at the first clinical signs of cardiovascular overload.
Hemodynamics: Closely monitor hemodynamic parameters after administration for evidence of cardiac or respiratory failure, renal failure or increasing intracranial pressure
Blood Pressure: Monitor blood pressure in trauma patients and postoperative surgery patients in order to detect re-bleeding secondary to clot disruption.
Hemolysis: Do not dilute with Sterile Water for Injection, as there is potential risk of fatal hemolysis and acute renal failure in recipients.
Transmission of Infectious Agents: Because FLEXBUMIN 25% is made from human plasma it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No cases of transmission of viral diseases, Creutzfeldt-Jakob disease (CJD) or variant Creutzfeldt-Jakob disease (vCJD) have ever been identified.
The most serious adverse reactions are hypersensitivity reaction (including anaphylactic reaction) and pulmonary edema.
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.
Please click for Full Prescribing Information.
For further information please contact:
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NOTES TO EDITORS
Shire is the global biotechnology leader serving patients with rare diseases and specialized conditions. We seek to push boundaries through discovering and delivering new possibilities for patient communities who often have few or no other champions. Relentlessly on the edge of what’s next, we are serial innovators with a diverse pipeline offering fresh thinking and new hope. Serving patients and partnering with healthcare communities in over 100 countries, we strive to be part of the entire patient journey to enable earlier diagnosis, raise standards of care, accelerate access to treatment, and support patients. Our diverse portfolio of therapeutic areas includes Immunology, Haematology, Genetic Diseases, Neuroscience, Internal Medicine, and Ophthalmics.
Championing patients is our call to action - it brings the opportunity - and responsibility - to change people’s lives.
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, projected revenues, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
* Shire’s products may not be a commercial success;
* increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s future revenues, financial condition and results of operations;
* Shire depends on third parties to supply certain inputs and services critical to its operations including certain inputs, services and ingredients critical to its manufacturing processes. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
* the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
* the nature of producing plasma-based therapies may prevent Shire from timely responding to market forces and effectively managing its production capacity;
* Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
* the actions of certain customers could affect Shire’s ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
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* Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
* Shire’s patented products are subject to significant competition from generics;
* adverse outcomes in legal matters, tax audits and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
* Shire may fail to obtain, maintain, enforce or defend the intellectual property rights required to conduct its business;
* Shire faces intense competition for highly qualified personnel from other companies and organizations;
* failure to successfully execute or attain strategic objectives from Shire’s acquisitions and growth strategy may adversely affect Shire’s financial condition and results of operations;
* Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
* a slowdown of global economic growth, or economic instability of countries in which Shire does business, could have negative consequences for Shire’s business and increase the risk of non-payment by Shire’s customers;
* changes in foreign currency exchange rates and interest rates could have a material adverse effect on Shire’s operating results and liquidity;
* Shire is subject to evolving and complex tax laws, which may result in additional liabilities that may adversely affect Shire’s financial condition or results of operations;
* if a marketed product fails to work effectively or causes adverse side effects, this could result in damage to Shire’s reputation, the withdrawal of the product and legal action against Shire;
* Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
* Shire faces risks relating to the expected exit of the United Kingdom from the European Union;
* Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs and may decrease its business flexibility;
* the potential uncertainty among our employees, customers, suppliers, and other business partners resulting from the announcement by Takeda Pharmaceutical Company Limited on May 8, 2018 of a recommended offer for Shire under the UK Takeover Code; and
a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.