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
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The Internet of Things 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, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...