ViroPharma Announces Completion of Enrollment in Phase 2 Study E...
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`CSL EXHIBIT 1063
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`ViroPharma Announces Completion of Enrollment in Phase 2 Study E...
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`http:Ntvwwpmewswire.com/news-releasesm’viropharma—announces—co...
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`Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product
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`that has been approved by FDA for routine prophylaxis against angioedema attacks in adolescent and
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`adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe
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`to treat patients with C1 inhibitor deficiency. Cinryze is not currently approved in the European Union or
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`any of its member states.
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`The most common adverse reactions observed have been upper respiratory infection, sinusitis, rash
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`and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials.
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`Severe hypersensitivity reactions may occur. Thrombotic events have occurred in patients receiving
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`high dose off-label C1 inhibitor therapy well above the approved treatment dosage regimen. Monitor
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`patients with known risk factors for thrombotic events. With any blood or plasma derived product, there
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`may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The
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`risk has been reduced by screening plasma donors for prior exposure to certain virus infections and by
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`manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.
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`Cinryze is for intravenous use only. A dose of 1000 Units of Cinryze can be administered every 3 or 4
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`days for routine prophylaxis against angioedema attacks in HAE patients. Cinryze is administered at an
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`injection rate of 1 mL per minute.
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`About Hereditary Angioedema (HAE)
`<
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`>
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`HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1
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`inhibitor, a human plasma protein. This condition is the result of a defect in the gene controlling the
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`synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and
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`fibrinolytic systems, that when left unregulated, can initiate or perpetuate an attack by consuming the
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`already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency
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`experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of
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`inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. Patients with HAE
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`experience approximately 20 to 100 days of incapacitation per year. There are estimated to be at least
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`6,000 people with HAE in the United States.
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`For more information on HAE, visit the US. HAE Association's website at: http://www.haea.org/.
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`About ViroPharma Incorporated
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`ViroPharma Incorporated is an international biopharmaceutical company committed to developing and
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`ViroPharma Announces Completion of Enrollment in Phase 2 Study E...
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`http:llwwwpmewswire.com/news-releasesr’viropharma—announces—co...
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`commercializing innovative products for physician specialists to enable the support of patients with
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`serious diseases for which there is an unmet medical need, and providing rewarding careers to
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`employees. ViroPharma commercializes Cinryze” (C1 esterase inhibitor [human]) for routine prophylaxis
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`against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE).
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`ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-
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`associated pseudomembranous colitis caused by Clostridium diffici/e and enterocolitis caused by
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`Staphylococcus aureus, including methicillin-resistant strains (for prescribing information on
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`ViroPharma‘s commercial products, please download the package inserts at
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`http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development
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`activities in diseases including C1 esterase inhibitor deficiency and C. diffici/e.
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`ViroPharma routinely posts information, including press releases, which may be important to investors
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`in the investor relations and media sections of our company's web site, http://www.viropharma.com/.
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`The company encourages investors to consult these sections for more information on ViroPharma and
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`our business.
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`Forward Looking Statements
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`Certain statements in this press release contain forward-looking statements that involve a number of
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`risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of
`<future events, including the therapeutic indication and use, safety, efficacy, tolerability and potential of
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`>
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`Cinryze and our focus, goals, strategy, research and development programs, and ability to develop
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`pharmaceutical products, commercialize pharmaceutical products, and execute on our plans including
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`clinical development activities with Cinryze related to subcutaneous administration. There can be no
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`assurance that that our phase 2 clinical program with Cinryze utilizing subcutaneous administration will
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`yield positive results or support further development of Cinryze for subcutaneous administration. The
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`FDA or EMA may view the data regarding subcutaneous administration of Cinryze as insufficient or
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`inconclusive, request additional data, require additional clinical studies, delay any decision past the
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`time frames anticipated by us, limit any approved indications, or deny the approval of Cinryze for
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`subcutaneous administration. These factors, and other factors, including, but not limited to those
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`described in our annual report on Form 10-K for the year ended December 31, 2009 filed with the
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`Securities and Exchange Commission, could cause future results to differ materially from the
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`expectations expressed in this press release. The fonNard-looking statements contained in this press
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`release are made as of the date hereof and may become outdated over time. ViroPharma does not
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`assume any responsibility for updating any fonNard-looking statements. These forward looking
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`statements should not be relied upon as representing our assessments as of any date subsequent to
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`the date of this press release.
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`ViroPharma Announces Completion of Enrollment in Phase 2 Study E...
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`http://www.prnewswire.com/news-releases/viropharma-announces-co...
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