Halozyme Therapeutics - ViroPharma and Halozyme Therapeutics Announce Initiat...
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`NEWS RELEASES DETAILS
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`ViroPharma and Halozyme Therapeutics Announce
`Initiation of Phase 2b Dose Ranging Combination
`Study for Subcutaneous Administration of Cinryze®
`(C1 esterase inhibitor [human]) With Hyaluronidase
`(rHuPH20)
`
`12/19/2012
`
`EXTON, Pa., Dec. 19, 2012 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq:
`VPHM) and Halozyme Therapeutics (Nasdaq: HALO) announced today  that
`ViroPharma has initiated its Phase 2b double blind, multicenter, dose ranging
`study to evaluate the safety and efficacy of subcutaneous (SC) administration of
`Cinryze® (C1 esterase inhibitor [human)] in combination with Halozyme's
`Enhanze™ technology, a proprietary drug delivery platform using Halozyme's
`recombinant human hyaluronidase enzyme (rHuPH20), in adolescents and adults
`with hereditary angioedema (HAE) for prevention of HAE attacks. Cinryze is
`currently approved for intravenous (IV) administration.
`
`"Routine prevention of attacks of hereditary angioedema is an important
`therapeutic option for many patients," commented Prof. Dr. med. Marcus Maurer,
`Department of Dermatology, Venerology and Allergy, Charite – University
`Medicine Berlin, Germany and principal investigator of the study in Germany.
`"While the current IV formulation of Cinryze is an important option for patients
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`http://www.halozyme.com/investors/news-releases/news-release-details/2012/ViroPha...
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`19.02.2016
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`CSL EXHIBIT 1027
`CSL v. Shire
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`seeking to prevent their attacks, a subcutaneous formulation could represent a
`more convenient alternative for many."
`
`This double blind, cross-over, dose ranging study will be conducted in
`approximately 40 adolescent and adult subjects in the U.S. and Europe. Qualified
`subjects will be randomized into one of two 8-week treatment sequences of either
`1000 U Cinryze with 24,000 U rHuPH20 or 2000 U Cinryze with 48,000 U rHuPH20
`as a twice weekly SC injection. Each subject will participate for approximately 6
`months. The primary efficacy endpoint is the normalized number of angioedema
`attacks recorded during each treatment period. In addition, several secondary
`endpoints will be assessed, including attack severity, quality of life parameters
`using a novel angioedema tool, and number of angioedema attacks requiring
`acute treatment. Additional information about this Phase 2 subcutaneous Cinryze
`clinical trial can be found at clinicaltrials.gov.
`
`"Our goal is to optimize the delivery and convenience of self administration of
`Cinryze, and we believe that the combination with rHuPH20 offers us the best
`opportunity to achieve that goal," commented Jennifer Schranz, MD, ViroPharma's
`vice president, clinical research. "The initiation of this important phase 2 study is
`an essential step toward continually enhancing the Cinryze experience for all
`patients who seek greater control over their disease through routine prevention."
`
`About Cinryze® (C1 esterase inhibitor [human])
`
`Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1
`esterase inhibitor product.  In the U.S. andCanada, Cinryze is approved for routine
`prophylaxis (prevention) 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.
`
`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 manufacturing steps to reduce the risk of viral transmission
`including pasteurization and nanofiltration. 
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`The most common 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.
`
`Please visit http://www.viropharma.com/products/cinryze.aspx for the full U.S.
`Prescribing Information; the prescribing information for other countries can be
`found at www.viropharma.com. 
`
`About Enhanze™ Technology
`
`Enhanze is Halozyme's proprietary drug delivery platform based on the Company's
`patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 acts by
`removing traditional limitations on the volume of drugs that can be delivered
`subcutaneously (just under the skin). By using Enhanze, some drugs that are
`administered intravenously may instead be delivered subcutaneously. Enhanze
`may also benefit subcutaneous drugs by reducing the need for multiple injections.
`This improved delivery may improve patient convenience and reduce overall costs
`to the healthcare system.
`
`About Hereditary Angioedema (HAE)
`
`HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a
`deficiency of C1 inhibitor, a human plasma protein. This condition is the result of a
`defect in the gene controlling the synthesis of C1 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 C1 inhibitor in HAE patients. Patients with C1
`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.
`
`For more information on HAE, visit the HAEi's (International Patient Organization
`for C1 Inhibitor Deficiencies) website atwww.haei.org and the U.S. HAE
`Association's website at: www.haea.org.
`
`About ViroPharma Incorporated
`
`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
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`have few if any clinical therapeutic options, including C1 esterase inhibitor
`deficiency, pediatric epilepsy and C. difficile 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) and
`CDI; for prescribing information on our products, please download the package
`inserts athttp://www.viropharma.com/Products.aspx.
`
`ViroPharma routinely posts information, including press releases, which may be
`important to investors in the investor relations and media sections of our
`company's website, http://www.viropharma.com/. The company encourages
`investors to consult these sections for more information on ViroPharma and our
`business
`
`About Halozyme
`
`Halozyme Therapeutics is a biopharmaceutical company dedicated to developing
`and commercializing innovative products that advance patient care. With a
`diversified portfolio of enzymes that target the extracellular matrix, the Company's
`research focuses primarily on a family of human enzymes, known as
`hyaluronidases, that increase the absorption and dispersion of biologics.
`Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and
`dermatology that have significant unmet medical need. The Company markets
`HYLENEX® recombinant (hyaluronidase human injection) and has partnerships
`with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San
`Diego, CA. For more information on how we are innovating, please visit our
`corporate website atwww.halozyme.com
`
`Forward Looking Statements
`
`Certain statements in this press release contain forward-looking statements that
`involve a number of risks and uncertainties. Forward-looking statements provide
`our current expectations or forecasts of future events, including the therapeutic
`indication and use, safety, efficacy, tolerability, convenience of subcutaneous
`administration, 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. There can be no assurance that that our clinical program with
`Cinryze utilizing subcutaneous administration in combination with rHuPH20 will
`yield positive results, be viewed by patients as more convenient than IV
`administration, or support further development of Cinryze for subcutaneous
`administration in combination with rHuPH20. The FDA or EMA may view the data
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`regarding subcutaneous administration of Cinryze in combination with rHuPH20 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. 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, 2010 and 10-Q filings for the quarters ended March
`31, 2012, June 30, 2012, and September 30, 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. ViroPharma 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.
`
`SOURCE ViroPharma Incorporated; Halozyme Therapeutics
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