• February 18, 2020

As Global Coronavirus Concerns Grow, Octaplas™ Provides Enhanced Safety Option - Odessa American: Business

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As Global Coronavirus Concerns Grow, Octaplas™ Provides Enhanced Safety Option

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Posted: Thursday, February 6, 2020 8:01 am | Updated: 8:31 am, Thu Feb 6, 2020.

HOBOKEN, N.J.--(BUSINESS WIRE)--Feb 6, 2020--

With global health concerns regarding the 2019 Novel Coronavirus (2019-nCoV) continuing to rise, hospital administrators and healthcare professionals are evaluating their options for providing patients with blood products that have an added level of safety.

Octaplas™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, provides that peace of mind the healthcare community is looking for,” said Octapharma USA President Flemming Nielsen. “With untreated, non-virus inactivated fresh frozen plasma (FFP), it is only possible to test for viruses that are known and those for which tests are available. Octaplas™ offers an additional layer of protection in the manufacturing process, beginning with plasma pooling and cell filtration. These steps are followed by S/D treatment, which is a proactive safety step designed to inactivate enveloped viruses, including unknown emerging viruses.”

The U.S. Food and Drug Administration (FDA) classifies Octaplas™ as a biologic, requiring every product batch of Octaplas™ to be assessed for quality and consistency before release for sale.” 1 - 4

Octapharma utilizes a multi-step manufacturing and purification process for all plasma derivatives, including the gold standard – S/D treatment – as well as nanofiltration and terminal dry heat treatment with temperatures at 100°C or pasteurization at 60°C. Based on current data, 5 a transmission of Severe Acute Respiratory Syndrome (SARS) or 2019-nCoV is very unlikely.

The Centers for Disease Control and Prevention (CDC) recently confirmed the first U.S. person-to-person transmission of the new virus. The World Health Organization (WHO) has officially declared the novel coronavirus – a virus not reported in humans previously – a public health emergency of international concern.

Coronaviruses are a large group of viruses that are common in many species of animals, according to the CDC. Rarely, animal coronaviruses can infect people and then spread among humans such as with Middle East Respiratory Syndrome (MERS) and SARS and now 2019-nCoV. The outbreak started in Wuhan, China less than a month ago with the confirmed cases globally quickly rising into the thousands and increasing daily. The CDC is tracking the confirmed cases in the U.S. and internationally at cdc.gov.

“Coronaviruses spread person-to-person may produce concerns about the safety of blood transfusions and products derived from human plasma,” said Arthur Bracey, M.D., Chief of Clinical Pathology at Baylor St. Luke’s Medical Center in Houston, TX. “It is unlikely for the virus to be transmitted through virus inactivated plasma or fractionated plasma-derived products, such as intravenous immunoglobulin (IVIG) or von Willebrand factor (VWF) and coagulation factor VIII (FVIII) because of existing viral inactivation and removal methods. The added safety measures to prevent virus transmissions through blood products eliminate almost all of the need to worry in this constantly evolving biosphere.” 5

About Octaplas™

Octaplas™ is a solvent/detergent (S/D) treated, pooled human plasma indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or who are undergoing cardiac surgery or liver transplantation; and plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).

WARNINGS AND PRECAUTIONS

Transfusion reactions can occur with ABO blood group mismatches; high infusion rates can induce hypervolemia with consequent pulmonary edema or heart failure; excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha 2-antiplasmin; thrombosis can occur due to low levels of Protein S; citrate toxicity can occur with volumes exceeding one milliliter of Octaplas™ per kg per minute; Octaplas™ is made from human blood and may carry the risk of transmitting infectious agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease and Creutzfeldt-Jakob disease agent.

Please see full prescribing information at www.octaplasus.com.

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs approximately 8,314 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Hoboken, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com.

REFERENCES

1. Data on file, Octapharma USA, 2019.

2. Octaplas™, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion. Complete Prescribing Information. Hoboken, NJ: Octapharma USA; 2015.

3. Bertolini J, Gross N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Hoboken, NJ; John Wiley & Sons; 2013: chap 25.

4. Hellstern P, Solheim BG. The use of solvent/detergent treatment in pathogen reduction of plasma. Transfus Med Hemother. 2011; 38:65-70.

5. Statement from the Plasma Protein Therapeutics Association (PPTA), 2019 Novel Coronavirus (2019-nCoV) and Plasma Protein Therapies, January 29, 2020.

OPLAS-0128-PPR

Octapharma USA, Inc.• 121 River Street, Suite 1201• Hoboken, NJ 07030 • 201-604-1130 • www.octapharmausa.com

View source version on businesswire.com:https://www.businesswire.com/news/home/20200206005250/en/

CONTACT: Anita Callari

Yankee Public Relations

anita@yankeepr.com

908-425-4878

KEYWORD: UNITED STATES NORTH AMERICA NEW JERSEY

INDUSTRY KEYWORD: INFECTIOUS DISEASES BIOTECHNOLOGY HEALTH

SOURCE: Octapharma USA

Copyright Business Wire 2020.

PUB: 02/06/2020 09:00 AM/DISC: 02/06/2020 09:00 AM

http://www.businesswire.com/news/home/20200206005250/en

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