Click here to close now.

SYS-CON MEDIA Authors: Liz McMillan, Elizabeth White, Dana Gardner, Pat Romanski, tru welu

News Feed Item

Crealta Pharmaceuticals LLC Announces Completion of the Acquisition of Substantially All of the Assets of Savient Pharmaceuticals, Inc.

Acquisition is highlighted by KRYSTEXXA® (pegloticase), the only product approved for the treatment of refractory chronic gout

GLENDALE, Wis., Jan. 10, 2014 /PRNewswire/ -- Crealta Pharmaceuticals LLC ("Crealta"), a new specialty pharmaceutical company, announced today the completion of the acquisition of substantially all of the assets of Savient Pharmaceuticals, Inc. ("Savient"). Crealta previously announced the winning of an auction for these assets, the signing of a definitive acquisition agreement with Savient, and the subsequent approval of the transaction by the U.S. Bankruptcy Court for the District of Delaware.

The key asset acquired by Crealta is KRYSTEXXA (pegloticase), a novel biologic product that was approved by the FDA in 2010. KRYSTEXXA is a PEGylated uric acid specific enzyme, or uricase, that has been shown to statistically significantly reduce uric acid levels for many patients with refractory chronic gout.

"We are tremendously excited to have completed the transaction, and more importantly, to ensure the continued availability of this critical product," commented Ed Fiorentino, Chairman and CEO of Crealta. "Crealta is committed to providing outstanding support and service to healthcare professionals and the patients that they serve with refractory chronic gout."

Crealta was established in August 2013 in partnership with GTCR, one of the nation's leading private equity firms.

KRYSTEXXA IMPORTANT SAFETY INFORMATION

The following information is provided in both the U.S. and European prescribing information.

KRYSTEXXA is not indicated for the treatment of asymptomatic hyperuricemia. KRYSTEXXA is indicated for adults who have tried or cannot take oral gout medications and still have high uric acid levels and signs and symptoms of gout. Patients who have a genetic condition known as G6PD deficiency should not use KRYSTEXXA.

Discontinue oral urate-lowering therapies before instituting KRYSTEXXA and do not institute oral urate-lowering therapy while the patient is on KRYSTEXXA therapy.

Warnings and Precautions:

  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be pre-medicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
  • Infusion reactions which occurred in some patients treated with KRYSTEXXA. The risk of an infusion reaction is higher in patients who have lost therapeutic response. Because the risk of infusion reactions is higher in patients who lose therapeutic response to KRYSTEXXA, monitor serum uric acid before each infusion and discontinue treatment if levels rise above 6mg/dL, particularly when two consecutive levels above 6 mg/dL are observed.
  • An increase in gout flares was seen in some patients treated with KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion. 

Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully. 

In addition, the European Summary of Product Characteristics (SmPC) includes two other special warnings and precautions for use.

  • If hemolysis and/or methemoglobinemia occur in patients receiving KRYSTEXXA, treatment should be immediately and permanently discontinued and appropriate measures initiated.
  • Patients over 100 kg body weight may have higher titers of anti-pegloticase antibodies and infusion-related reactions showed a tendency to occur in a greater proportion of patients in this weight group.

The most commonly reported serious adverse reactions were anaphylaxis, infusion reactions and gout flares. The SmPC includes the following very common adverse reactions: gout flares, infusion reactions, nausea, dermatitis, urticaria, pruritus, skin irritation and dry skin. In the U.S. prescribing information, the most common adverse reactions (5% or greater) reported were gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

Please see full prescribing information for KRYSTEXXA.

About Refractory Chronic Gout (RCG)
Symptoms of gout are caused by the body's response to the presence of high uric acid (urate) levels which can lead to the formation of urate crystals in the joints and surrounding tissue, which form when uric acid levels in the blood are elevated (a condition called hyperuricemia). The longer hyperuricemia persists, the higher the risk of developing gout. Symptoms of gout may include painful flares, pain or swelling in the joints (known as "gouty arthritis") or deposits of urate crystals under the skin, called "tophi." Although most cases of gout can be controlled with conventional urate-lowering therapy, uric acid levels may remain high and symptoms persist despite treatment efforts, even at maximum medically appropriate doses of conventional therapies.

RCG is a chronic disease that, if left untreated, can lead to chronic pain, tophi-induced joint destruction and disfigurement, and significant mobility restrictions for patients. RCG has been granted orphan drug status by the FDA due to the relatively small patient population afflicted with this debilitating condition.

About Crealta
Crealta is a specialty pharmaceutical company focused on innovative therapeutics designed to improve patient outcomes. The company was formed to acquire, develop, and market specialty pharmaceutical products with a focus on select physician specialties. For more information about Crealta, please visit www.crealtapharma.com, call 1-781-639-1910, or email [email protected].

About GTCR
Founded in 1980, GTCR is a leading private equity firm focused on investing in growth companies in the Financial Services & Technology, Healthcare and Information Services & Technology industries. The Chicago-based firm pioneered The Leaders Strategy™ – finding and partnering with management leaders in core domains to identify, acquire and build market-leading companies through transformational acquisitions and organic growth. Since its inception, GTCR has invested more than $10 billion in over 200 companies. For more information, please visit www.gtcr.com.

SOURCE Crealta Pharmaceuticals LLC

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. 8th International Big Data Expo, co-located with 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. As advanced data storage, access and analytics technologies aimed at handling high-volume and/or fast moving data all move center stage, aided by the cloud computing bo...
Every day we read jaw-dropping stats on the explosion of data. We allocate significant resources to harness and better understand it. We build businesses around it. But we’ve only just begun. For big payoffs in Big Data, CIOs are turning to cognitive computing. Cognitive computing’s ability to securely extract insights, understand natural language, and get smarter each time it’s used is the next, logical step for Big Data.
There's no doubt that the Internet of Things is driving the next wave of innovation. Google has spent billions over the past few months vacuuming up companies that specialize in smart appliances and machine learning. Already, Philips light bulbs, Audi automobiles, and Samsung washers and dryers can communicate with and be controlled from mobile devices. To take advantage of the opportunities the Internet of Things brings to your business, you'll want to start preparing now.
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
In a world of ever-accelerating business cycles and fast-changing client expectations, the cloud increasingly serves as a growth engine and a path to new business models. Dynamic clouds enable businesses to continuously reinvent themselves, adapting their business processes, their service and software delivery and their operations to achieve speed-to-market and quick response to customer feedback. As the cloud evolves, the industry has multiple competing cloud technologies, offering on-premises ...
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
Over the years, a variety of methodologies have emerged in order to overcome the challenges related to project constraints. The successful use of each methodology seems highly context-dependent. However, communication seems to be the common denominator of the many challenges that project management methodologies intend to resolve. In this respect, Information and Communication Technologies (ICTs) can be viewed as powerful tools for managing projects. Few research papers have focused on the way...
As the world moves from DevOps to NoOps, application deployment to the cloud ought to become a lot simpler. However, applications have been architected with a much tighter coupling than it needs to be which makes deployment in different environments and migration between them harder. The microservices architecture, which is the basis of many new age distributed systems such as OpenStack, Netflix and so on is at the heart of CloudFoundry – a complete developer-oriented Platform as a Service (PaaS...
In high-production environments where release cycles are measured in hours or minutes — not days or weeks — there's little room for mistakes and no room for confusion. Everyone has to understand what's happening, in real time, and have the means to do whatever is necessary to keep applications up and running optimally. DevOps is a high-stakes world, but done well, it delivers the agility and performance to significantly impact business competitiveness.
The OpenStack cloud operating system includes Trove, a database abstraction layer. Rather than applications connecting directly to a specific type of database, they connect to Trove, which in turn connects to one or more specific databases. One target database is Postgres Plus Cloud Database, which includes its own RESTful API. Trove was originally developed around MySQL, whose interfaces are significantly less complicated than those of the Postgres cloud database. In his session at 16th Cloud...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading in...
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at @ThingsExpo, Robin Raymond, Chief Architect...