|By PR Newswire||
|January 8, 2013 06:38 PM EST||
MARKHAM, Ontario, January 8, 2013 /PRNewswire/ --
Acquisition Includes Replidea[TM]and Alpharen[TM], Both in Phase 3 Clinical Trials with Kidney Disease Patients
Cytochroma today announced that it has entered into a definitive agreement with OPKO Health, Inc. (NYSE:OPK) under which Cytochroma, a privately held pharmaceutical company with operations in Markham, ON and Bannockburn, IL, will be acquired by OPKO. Through this transaction, OPKO will acquire worldwide rights to Cytochroma's two lead product candidates: Replidea[TM] (coded CTAP101 Capsules), a vitamin D prohormone to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency; and, Alpharen[TM](Fermagate Tablets), a non-absorbed phosphate binder to treat hyperphosphatemia in dialysis patients. Both products are in phase 3 development in the United States. Cytochroma's officers will join the OPKO management team, and all other Cytochroma employees will be retained by OPKO.
Replidea™ has been shown in a phase 2b clinical trial to effectively and safely treat SHPT and the underlying vitamin D insufficiency in pre-dialysis patients. Vitamin D insufficiency arises in CKD due to the abnormal upregulation of CYP24, an enzyme which destroys vitamin D and its metabolites. Studies in CKD patients have demonstrated that currently available over-the-counter and prescription vitamin D products cannot reliably raise blood vitamin D prohormone levels or effectively treat SHPT.
"OPKO intends to market Replidea™ along with OPKO's proprietary point-of-care vitamin D diagnostic test currently in development," stated Phillip Frost, MD, OPKO's CEO and Chairman. "We envision these remarkable products as part of the foundation for a new and markedly improved standard of care for chronic kidney disease patients."
"We are pleased that OPKO and Cytochroma have joined forces to improve the care of kidney patients," commented Alan J. Lewis, PhD, Cytochroma's Chairman. "The combined companies are well positioned to become a major new global player in the chronic kidney disease space."
Alpharen™ has been shown safe and effective in treating hyperphosphatemia (elevated serum phosphorus) in the phase 2 and 3 clinical trials undertaken to date in dialysis patients. Hyperphosphatemia exacerbates SHPT and promotes bone disease, soft tissue mineralization and progression of kidney disease. Approximately 90% of dialysis patients in the United States require regular treatment. Cytochroma acquired global rights to Alpharen[TM] from INEOS Healthcare in 2010.
About Chronic Kidney Disease
CKD is a condition characterized by a progressive decline in kidney function. The kidney is normally responsible for excreting waste and excess water from the body, and for regulating various hormones. CKD is classified in five different stages - mild (stage 1) to severe (stage 5) disease - as measured by the kidney's glomerular filtration rate. According to the National Kidney Foundation, CKD afflicts over 26 million people in the US, including more than eight million patients with moderate (stages 3 and 4) and severe (stage 5) forms of CKD. In stage 5 CKD, kidney function is minimal to absent and patients require regular dialysis or a kidney transplant for survival.
About Vitamin D Insufficiency
Vitamin D insufficiency is a condition in which the body has low vitamin D stores, characterized by inadequate blood levels of vitamin D prohormones, collectively known as 25-hydroxyvitamin D. An estimated 70-90% of CKD patients have vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases.
About Secondary Hyperparathyroidism (SHPT)
SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of parathyroid hormone (PTH). SHPT arises as a result of vitamin D insufficiency or impaired kidney function that prevents sufficient production of vitamin D hormones to properly regulate calcium and phosphorus metabolism, and PTH secretion. Prolonged elevation of blood PTH causes excessive calcium and phosphorus to be released from bone, leading to elevated serum calcium and phosphorus, softening of the bones (osteomalacia) and calcification of vascular and renal tissues. SHPT affects 40-60% of patients with moderate CKD and approximately 90% of patients with severe CKD.
Hyperphosphatemia, or elevated serum phosphorus, is common in dialysis patients and tightly linked to the progression of SHPT. The kidneys provide the primary route of excretion for excess phosphorus absorbed from ingested food. As kidney function worsens, serum phosphorus levels increase and directly stimulate PTH secretion. Stage 5 CKD patients must reduce their dietary phosphate intake and usually require regular treatment with phosphate binding agents to lower serum phosphorus to meet the recommendations of the National Kidney Foundation's Clinical Practice Guidelines that serum phosphorus levels should be maintained at <5.5 mg/dL.
Cytochroma is a clinical-stage specialty pharmaceutical company focused on developing and commercializing proprietary products to treat and prevent the clinical consequences of vitamin D insufficiency and SHPT associated with CKD. The Company, founded in 1996 by Martin J. Petkovich, PhD, Cytochroma's CSO and Glenville Jones, PhD, former Head of Biochemistry, Queen's University, Kingston, ON, specializes in developing new vitamin D therapies which are designed to safely and effectively treat patients with stage 3, 4 or 5 CKD. Cytochroma also has a portfolio CYP24 and phosphate-uptake inhibitors in early stages of development. Cytochroma's phase 3 clinical programs are being funded, in part, by committed financings of nearly $CDN 32 million of which the first two stages closed in 2012. The lead investors in the financings were Covington Fund II (Toronto), Business Development Bank of Canada (Montreal) and GrowthWorks (Toronto). Participating investors included the Bombardier Trust (Canada) Funds (Montreal), Caisse de dépôt et placement du Québec (Québec), Comerica Bank (Toronto), MaRS Investment Accelerator Fund (Toronto), Partners Group (Zug), Roseway Capital Sarl (Luxembourg) and VentureLink Innovation Fund (Toronto).
For further information:
Eric J. Messner, MBA
Chief Operating Officer
Tel: +1(847)236-7707 x238
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jun. 3, 2015 06:15 PM EDT Reads: 4,665
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jun. 3, 2015 06:00 PM EDT Reads: 4,314
IBM has acquired Blue Box Group, Inc., a managed private cloud provider built on OpenStack. Customers benefit from the ability to more easily deploy workloads across hybrid cloud environments. Financial details were not disclosed. Enterprises are seeking ways to embrace all types of cloud to address a wide range of workloads. Today's announcement reinforces IBM's commitment to deliver flexible cloud computing models that make it easier for customers to move to data and applications across cloud...
Jun. 3, 2015 06:00 PM EDT Reads: 667
ProfitBricks has an early preview of its new Docker hosting platform. The ProfitBricks Docker platform enables its customers to build fully-portable applications within the ProfitBricks cloud. Unlike other Docker platforms, ProfitBricks’ Docker provides developers and system administrators with a platform with dedicated resources that autoscales the Docker hosts. Early access customers will be able to utilize up to 2,500 CPU core hours as part of ProfitBricks’ early access Docker preview.
Jun. 3, 2015 06:00 PM EDT Reads: 644
The WebRTC Meetup, where WebRTC enthusiasts exchange ideas, is being held on Wednesday, June 10, from 7 pm – 9 pm at the 4th WebRTC Summit, June 9-11, 2015, at the Javits Center in New York City, NY. The WebRTC Meetup is being hosted by the New York WebRTC Developer Group. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 4th WebRTC Summit continues our tradition of delivering the late...
Jun. 3, 2015 06:00 PM EDT Reads: 699
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jun. 3, 2015 05:15 PM EDT Reads: 4,267
"Blue Box has been around for 10-11 years, and last year we launched Blue Box Cloud. We like the term 'Private Cloud as a Service' because we think that embodies what we are launching as a product - it's a managed hosted private cloud," explained Giles Frith, Vice President of Customer Operations at Blue Box, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jun. 3, 2015 05:00 PM EDT Reads: 4,594
It’s no news that microservices are one of the top trends, if not the top trend, in application architectures today. Take large monolithic applications which are brittle and difficult to change and break them into smaller manageable pieces to provide flexibility in deployment models, facilitating agile release and development to meet today’s rapidly shifting digital businesses. Unfortunately, with this change, application and infrastructure management is more complex due to size and technology c...
Jun. 3, 2015 05:00 PM EDT Reads: 422
We’re entering a new era of computing technology that many are calling the Internet of Things (IoT). Machine to machine, machine to infrastructure, machine to environment, the Internet of Everything, the Internet of Intelligent Things, intelligent systems – call it what you want, but it’s happening, and its potential is huge. IoT is comprised of smart machines interacting and communicating with other machines, objects, environments and infrastructures. As a result, huge volumes of data are bein...
Jun. 3, 2015 04:30 PM EDT Reads: 1,247
In his General Session at 16th Cloud Expo, David Shacochis, host of The Hybrid IT Files podcast and Vice President at CenturyLink, will investigate three key trends of the “gigabit economy" though the story of a Fortune 500 communications company in transformation. Narrating how multi-modal hybrid IT, service automation, and agile delivery all intersect, he will cover the role of storytelling and empathy in achieving strategic alignment between the enterprise and its information technology.
Jun. 3, 2015 04:19 PM EDT Reads: 402
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not ...
Jun. 3, 2015 04:00 PM EDT Reads: 1,102
SYS-CON Events announced today that the "First Containers & Microservices Conference" will take place June 9-11, 2015, at the Javits Center in New York City. The “Second Containers & Microservices Conference” will take place November 3-5, 2015, at Santa Clara Convention Center, Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
Jun. 3, 2015 04:00 PM EDT Reads: 2,231
"NuoDB is a transactionally consistent SQL database that does scale out, that does all the things you want in a cloud. If you want more transactional throughput, if you want higher availability if you want to run in multiple data centers this is a technology that can scale and still provide a single logical consistent database," explained Seth Proctor, CTO of NuoDB, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jun. 3, 2015 04:00 PM EDT Reads: 5,032
Thanks to widespread Internet adoption and more than 10 billion connected devices around the world, companies became more excited than ever about the Internet of Things in 2014. Add in the hype around Google Glass and the Nest Thermostat, and nearly every business, including those from traditionally low-tech industries, wanted in. But despite the buzz, some very real business questions emerged – mainly, not if a device can be connected, or even when, but why? Why does connecting to the cloud cre...
Jun. 3, 2015 04:00 PM EDT Reads: 1,155
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...
Jun. 3, 2015 03:45 PM EDT Reads: 1,766