Press Release
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`EX-99.1 2 d389870dex991.htm PRESS RELEASE
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`Exhibit 99.1
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`ViroPharma Provides Update on Phase 2 Clinical Evaluation of Subcutaneous Cinryze (C1 esterase inhibitor [human]) with
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`Recombinant Human Hyaluronidase (rHuPH20)
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`Exton, PA, August 1, 2012 — ViroPharma Incorporated (NASDAQ: VPHM) today announced that ViroPharma and Halozyme Therapeutics
`were notified by the Center for Biologics Evaluation and Research (CBER) division of the U.S. Food and Drug Administration that FDA is
`evaluating potential safety concerns with Halozyme’s recombinant human hyaluronidase enzyme (rHuPH20). Although FDA did not
`disclose the specific concerns due to their confidentiality requirements, Halozyme informed ViroPharma that FDA is evaluating the potential
`risk of long term effect of anti-rHuPH20 non-neutralizing antibodies associated with the use of Halozyme’s recombinant human
`hyaluronidase enzyme (rHuPH20) that were detected in a separate development program not involving Cinryze.
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`In the interim, FDA indicated that studies of the combination of Cinryze (C1 esterase inhibitor [human]) and rHuPH20 were being placed
`®
`on temporary clinical hold. ViroPharma’s partner Halozyme informed ViroPharma that Halozyme must provide results from additional pre-
`clinical studies to CBER before clinical investigations in combination with rHuPH20 on temporary hold can resume. FDA stated that the
`issues are not specific to Cinryze and that ViroPharma could continue to evaluate subcutaneous administration of Cinryze without rHuPH20.
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`In light of this FDA action, ViroPharma is preparing to commence a Phase 2 study that will evaluate the safety and efficacy of two different
`doses of the subcutaneous administration of Cinryze as a stand alone therapy. The company received FDA clearance in 2011 of its
`Investigational New Drug (IND) application and the related Phase 2 clinical protocol to study subcutaneous administration of Cinryze
`without rHuPH20.
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`Further, ViroPharma is in the process of notifying European regulatory authorities of CBER’s action and will defer enrollment at European
`sites in the Phase 2 study combining Cinryze and rHuPH20 until there is clarity from FDA on its potential safety concerns.
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`“We remain committed to creating therapeutic options for patients suffering from HAE, and will continue to leverage our flexibility to move
`our Phase 2 subcutaneous program forward,” stated Vincent Milano, ViroPharma’s president and chief executive officer.
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`Cinryze is approved in the United States as intravenous (IV) administration for routine prophylaxis against angioedema attacks in adolescent
`and adult patients with hereditary angioedema (HAE), and in Europe for routine prevention, pre-procedure prevention and acute treatment of
`angioedema attacks in adolescent and adult patients with HAE.
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`https://www.sec.gov/Archives/edgar/data/946840/000119312512328821/d389870dex991.htm
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`5/25/2017
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`CSL EXHIBIT 1070
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`Press Release
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`l A
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`bout Cinryzee (C1 esterase inhibitor [human])
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`Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C 1 esterase inhibitor product. In the U.S., Cinryze is approved by
`the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. In the E.U., the product is approved
`by the EMA for the treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema
`(HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema
`(HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with
`repeated acute treatment. Cinryze is for intravenous use only.
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`Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze, and in patients
`receiving off-label high dose C1 inhibitor therapy. Monitor patients with known risk factors for thrombotic events. With any blood or plasma
`derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The risk has been
`reduced by screening donors for prior exposure to certain virus infections and by manufactming steps to reduce the risk of viral transmission
`including pasteurization and nanofiltration.
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`The most connnon adverse reactions in clinical trials associated with Cinryze were rash, headache, nausea, erythema, phlebitis and local
`reactions at the injection site. Adverse events of sinusitis and upper respiratory infection also were observed in clinical trials. No drug-related
`serious adverse events (SAEs) were reported in clinical trials.
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`Please visit hm://www.viropharma.com/Eoducts/cimzeaspx for the full U.S. Prescribing Information; the prescribing information for
`other countries can be found at www.viropharma.com.
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`About Hereditary Angioedema (HAE)
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`HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, 3 human plasma protein. This
`condition is the result of a defect in the gene controlling the synthesis of Cl inhibitor. C1 inhibitor maintains the natural regulation of the
`contact. complement, and fibrinolytic systems. that when left unregulated, can initiate or perpetuate an attack by consuming the already low
`levels of endogenous Cl inhibitor in HAE patients. Patients with C 1 inhibitor deficiency experience recurrent, unpredictable, debilitating,
`and potentially life threatening attacks of inflammation affecting the larynx. abdomen, face, extremities and urogenital tract. Patients with
`HAE experience approximately 20 to 100 days of incapacitation per year. There are estimated to be at least 6,500 people with HAE in the
`United States and at least 10,000 people in the European Union.
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`For more information on HAE, visit the HAEi’s (International Patient Organization for C l Inhibitor Deficiencies) website at www.haei.org
`and the U.S. HAE Association’s website at: 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 commercializing novel solutions for
`physician specialists to address unmet medical needs of patients living with diseases that have few if any clinical therapeutic options,
`including Cl esterase inhibitor deficiency, treatment of seizures in children and adolescents. adrenal insufficiency (AI). and C. dzflicile
`infection (CDI). Our goal is to provide rewarding careers to employees, to create new standards of care in the way serious diseases are
`treated, and to build international partnerships with the patients, advocates, and health care professionals we serve. ViroPharma’s commercial
`products address diseases including hereditary angioedema (HAE), seizures in children and adolescents, and CD1; for full U.S. prescribing
`information on our products, please download the package inserts at hm://www.viropharma.com/Products.aspx: the prescribing information
`for other countries can be found at wwwxjmharmaxom.
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`Press Release
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`ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media
`sections of our company’s web site, www.viropharma.com. The company encourages investors to consult these sections for more
`information on ViroPharma and our business.
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`Virolerma Forward Looking Statements
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`Certain statements in this press release contain forward-looking statements that involve a number ofrisks 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 Cinryze and our focus, goals. strategy, research and development programs, and ability to develop
`pharmaceutical products, commercialize pharmaceutical products, and execute on our plans including clinical development activities with
`Cinryze related to subcutaneous administration in combination with rHuPH20 or alternatively as a stand alone product candidate. There can
`be no assurance that Halozyme will be able to perform the additional pre-clinical studies requested by CBER before clinical investigations of
`products in combination with rHuPH20 can resume in a timeframe that we expect, or that the results of such preclinical studies will be
`acceptable to the FDA or EMA to allow us to continue our planned Phase 2 study of subcutaneous administration of Cinryze in combination
`with rHuPH20, or that we will be able to conduct any additional clinical studies of the subcutaneous administration of Cinryze in
`combination with rHuPH20. We may also experience delays in commencing a Phase 2 study of the subcutaneous administration of Cinryze
`as a stand alone therapy. Additionally, any future studies with Cinryze utilizing subcutaneous administration in combination with rHuPH20
`or as a stand alone therapy may not yield positive results or support further development of Cinryze for subcutaneous administration in
`combination with rHuPH20 or as a stand alone therapy. The FDA or EMA may view the data regarding subcutaneous administration of
`Cinryze in combination with rHuPH20 or as a stand alone therapy as insufficient or inconclusive. request additional data, require additional
`clinical studies, delay any decision past the time frames anticipated by us, limit any approved indications, or deny the approval of Cinryze for
`subcutaneous administration in combination with rHuPH20 or as a stand alone therapy. These factors, and other factors, including, but not
`limited to those described in our annual report on Form 10-K for the year ended December 31, 2011 and Form 10-Q for the quarter ended
`March 31, 2012 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations
`expressed in this press release. The forward-looking statements contained in this press release are made as of the date hereof and may
`become outdated over time. ViroPhamla does not assume any responsibility for updating any forward-looking statements. These forward
`looking statements should not be relied upon as representing our assessments as of any date subsequent to the date of this press release.
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`ViroPharma Media Contacts:
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`Kristina M. Broadbelt
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`Associate Director, PR & Advocacy
`(610) 321 - 2358
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`Shaman M. Sanders
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`Manager, PR & Advocacy
`(215) 495 — 9433
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`ViroPharma Investor Contact:
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`Robert A. Doody
`Assistant Director, Investor Relations
`610-321-6290
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`-ENDS-
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