Welcome!

News Feed Item

ONY Inc., A Pioneer In Neonatal Pharmaceutical Development, Has Entered Into A Co-Promotion Agreement With Recordati Rare Diseases For NeoProfen®

AMHERST, N.Y., Feb. 26, 2014 /PRNewswire/ -- ONY, Inc., a pioneer in neonatal pharmaceutical development, has reached an agreement with Recordati Rare Diseases to co-promote NeoProfen® (ibuprofen lysine) Injection.

(Logo:  http://photos.prnewswire.com/prnh/20140226/CL72787LOGO )

NeoProfen® is indicated to close a clinically significant Patent Ductus Arteriosis (PDA) in premature infants weighing between 500 and 1500 grams, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective.

ONY, is the manufacturer and marketer of Infasurf® (calfactant) a lung surfactant for the prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants.

"The co-promotion provides ONY a second product used exclusively in Neonatal Intensive Care Units, and continues the company's commitment to neonatology," said John Librie, CEO, ONY. "Recordati Rare Diseases is an excellent partner that shares the priorities of ONY and whose expertise is complementary to ONY's strengths."

"We have evaluated all of the scientific and medical evidence available for NeoProfen® and believe it is an excellent and important neonatology product for the treatment of Patent Ductus Arteriosus. We are proud to be able to represent NeoProfen® to those caring for premature babies with Patent Ductus Arteriosus," said Edmund A. Egan, M.D., ONY Chairman and Chief Medical Officer.

About ONY:

ONY Inc. is a small, privately held, biopharmaceuctical company focused on the research, development and commercialization of products for the hospital and acute care markets.

ONY was founded by Dr. Edmund Egan, Professor of Pediatrics, State University of New York at Buffalo. Dr. Egan is a pioneering neonatologist whose team conducted trials of one of just three FDA-approved drugs to treat lungs of premature babies at Buffalo Women & Children's Hospital.

ONY is located in the Baird Research Park in Amherst, N.Y.

About Recordati Rare Diseases:

Recordati Rare Diseases (RRD) Inc. began marketing products to treat rare diseases in 2013. RRD is a member of the Recordati Group, which consists of Recordati S.p.A. and Orphan Europe. The Recordati Group was established in 1926 and now has over 3,200 employees worldwide.

RRD's mission is to partner with patients, health care providers, advocacy and industry to make products available to treat rare and severe diseases.

RRD's product portfolio consists of:

-   Carbaglu® (carglumic acid)
-   NeoProfen® (ibuprofen lysine) Injection
-   Panhematin® (hemin for injection)

Other products distributed by RRD are Chemet® (succimer capsules), Cosmegen® (dactinomycin for injection), Desoxyn® CII (methamphetamine hydrochloride tablets, USP), Mustargen® (mechlorethamine HCl for injection), Peganone® (ethotoin tablets, USP), and Tranxene® CIV (clorazepate dipotassium).

About NeoProfen:

NeoProfen is indicated to close a clinically significant Patent Ductus Arteriosus (PDA) in premature infants weighing between 500 and 1500 grams, who are no more than 32 weeks gestational age when usual medical management is ineffective.  The clinical trial was conducted among infants with an asymptomatic PDA.  However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

NeoProfen is contraindicated in preterm infants with: proven or suspected infection that is untreated; congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta); who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; with thrombocytopenia; with coagulation defects; with or who are suspected of having necrotizing enterocolitis; with significant impairment of renal function.

There are no long-term evaluations of the infants treated with ibuprofen at durations greater than the 36 weeks post-conceptual age observation period. Ibuprofen's effects on neurodevelopmental outcome and growth as well as disease processes associated with prematurity (such as retinopathy of prematurity and chronic lung disease) have not been assessed.

NeoProfen may alter the usual signs of infection. The physician must be continually on the alert and should use the drug with extra care in the presence of controlled infection and in infants at risk of infection.

NeoProfen, like other non-steroidal anti-inflammatory agents, can inhibit platelet aggregation. Preterm infants should be observed for signs of bleeding. 

Ibuprofen has been shown to displace bilirubin from albumin binding-sites; therefore, it should be used with caution in patients with elevated total bilirubin.

NeoProfen should be administered carefully to avoid extravascular injection or leakage, as solution may be irritating to tissue.   

Most common adverse reactions (greater than or equal to 10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, and respiratory failure.

About Infasurf:

Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.

Prophylaxis

Prophylaxis therapy at birth with Infasurf is indicated for premature infants <29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth.

Treatment

Infasurf therapy is indicated for infants 72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.

Important Safety Information

Infasurf is intended for intratracheal use only. THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING INFASURF, OFTEN RAPIDLY IMPROVES OXYGENATION AND LUNG COMPLIANCE. Following administration of Infasurf, patients should be carefully monitored so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status.

Infasurf therapy is not a substitute for neonatal intensive care. Optimal care of premature infants at risk for RDS and new born infants with RDS who need endotracheal intubation requires an acute care unit organized, staffed, equipped, and experienced with intubation, ventilator management, and general care of these patients.

TRANSIENT EPISODES OF REFLUX OF INFASURF INTO THE ENDOTRACHEAL TUBE, CYANOSIS, BRADYCARDIA, OR AIRWAY OBSTRUCTION HAVE OCCURRED DURING THE DOSING PROCEDURES that required stopping Infasurf and taking appropriate measures to alleviate the condition. After the patient is stable, dosing can proceed with appropriate monitoring.

An increased proportion of patients with both intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) was observed in Infasurf-treated infants in the Infasurf- Exosurf Neonatal controlled trials. These observations were not associated with increased mortality.

The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65 percent), airway obstruction (39 percent), bradycardia (34 perfect), reflux of surfactant into the endotracheal tube (21 percent), requirement for manual ventilation (16 percent), and reintubation (3 percent). These events were generally transient and not associated with serious complications or death.

The incidence of common complications of prematurity and RDS in the four controlled Infasurf trials are presented in the attached table. Prophylaxis and treatment study results for each surfactant are combined.

Common Complications of Prematurity and RDS in Controlled Trials

INFASURF (n=1001), %

Exosurf Neonatal® (n=978), %

INFASURF (n=553), %

Survanta® (n=566), %

Apnea

61

61

76

76

Patent ductus arteriosus

47

48

45

48

Intracranial hemorrhage

29

31

36

36

Severe intracranial hemorrhagea

12

10

9

7

IVH and PVLb

7

3

5

5

Sepsis

20

22

28

27

Pulmonary air leaks

12

22

15

15

Pulmonary interstitial emphysema

7

17

10

10

Pulmonary hemorrhage

7

7

7

6

Necrotizing enterocolitis

5

5

17

18

a Grade III and IV by the method of Papile.
b Patients with both intraventricular hemorrhage and periventricular leukomalacia.

CONTACT:                              
John Librie
CEO, ONY, Inc.
(716) 636-9096
[email protected]

SOURCE ONY, Inc.

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
SYS-CON Events announced today TechTarget has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. TechTarget is the Web’s leading destination for serious technology buyers researching and making enterprise technology decisions. Its extensive global networ...
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
SYS-CON Events announced today Object Management Group® has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
As cloud and storage projections continue to rise, the number of organizations moving to the cloud is escalating and it is clear cloud storage is here to stay. However, is it secure? Data is the lifeblood for government entities, countries, cloud service providers and enterprises alike and losing or exposing that data can have disastrous results. There are new concepts for data storage on the horizon that will deliver secure solutions for storing and moving sensitive data around the world. ...
SYS-CON Events announced today that MangoApps will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. MangoApps provides modern company intranets and team collaboration software, allowing workers to stay connected and productive from anywhere in the world and from any device. For more information, please visit https://www.mangoapps.com/.
The essence of data analysis involves setting up data pipelines that consist of several operations that are chained together – starting from data collection, data quality checks, data integration, data analysis and data visualization (including the setting up of interaction paths in that visualization). In our opinion, the challenges stem from the technology diversity at each stage of the data pipeline as well as the lack of process around the analysis.
Many banks and financial institutions are experimenting with containers in development environments, but when will they move into production? Containers are seen as the key to achieving the ultimate in information technology flexibility and agility. Containers work on both public and private clouds, and make it easy to build and deploy applications. The challenge for regulated industries is the cost and complexity of container security compliance. VM security compliance is already challenging, ...
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
Designing IoT applications is complex, but deploying them in a scalable fashion is even more complex. A scalable, API first IaaS cloud is a good start, but in order to understand the various components specific to deploying IoT applications, one needs to understand the architecture of these applications and figure out how to scale these components independently. In his session at @ThingsExpo, Nara Rajagopalan is CEO of Accelerite, will discuss the fundamental architecture of IoT applications, ...
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, wh...
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 18th International CloudExpo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
In his session at 18th Cloud Expo, Bruce Swann, Senior Product Marketing Manager at Adobe, will discuss how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects). Bruce Swann has more than 15 years of experience working with digital marketing disciplines like web analytics, social med...
SYS-CON Events announced today that EastBanc Technologies will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. EastBanc Technologies has been working at the frontier of technology since 1999. Today, the firm provides full-lifecycle software development delivering flexible technology solutions that seamlessly integrate with existing systems – whether on premise or cloud. EastBanc Technologies partners with p...