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
The Internet giants are fully embracing AI. All the services they offer to their customers are aimed at drawing a map of the world with the data they get. The AIs from these companies are used to build disruptive approaches that cannot be used by established enterprises, which are threatened by these disruptions. However, most leaders underestimate the effect this will have on their businesses. In his session at 21st Cloud Expo, Rene Buest, Director Market Research & Technology Evangelism at Ara...
WebRTC is great technology to build your own communication tools. It will be even more exciting experience it with advanced devices, such as a 360 Camera, 360 microphone, and a depth sensor camera. In his session at @ThingsExpo, Masashi Ganeko, a manager at INFOCOM Corporation, will introduce two experimental projects from his team and what they learned from them. "Shotoku Tamago" uses the robot audition software HARK to track speakers in 360 video of a remote party. "Virtual Teleport" uses a mu...
Trying to improve density, lower costs and run applications faster than before? Today, enterprises looking for a secure cloud strategy are increasingly turning to container-based Platform as a Service solutions for on-premises hosted DevOps. In her session at 21st Cloud Expo, Alise Cashman Spence, Offering Manager, Power Systems Cloud Solutions at IBM, will discuss the driving factors behind these cloud trends and how IBM customers are realizing exceptional performance, security and control for ...
Internet of @ThingsExpo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 21st Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devic...
Mobile device usage has increased exponentially during the past several years, as consumers rely on handhelds for everything from news and weather to banking and purchases. What can we expect in the next few years? The way in which we interact with our devices will fundamentally change, as businesses leverage Artificial Intelligence. We already see this taking shape as businesses leverage AI for cost savings and customer responsiveness. This trend will continue, as AI is used for more sophistica...
"When we talk about cloud without compromise what we're talking about is that when people think about 'I need the flexibility of the cloud' - it's the ability to create applications and run them in a cloud environment that's far more flexible,” explained Matthew Finnie, CTO of Interoute, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"NetApp's vision is how we help organizations manage data - delivering the right data in the right place, in the right time, to the people who need it, and doing it agnostic to what the platform is," explained Josh Atwell, Developer Advocate for NetApp, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
SYS-CON Events announced today that SourceForge has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. SourceForge is the largest, most trusted destination for Open Source Software development, collaboration, discovery and download on the web serving over 32 million viewers, 150 million downloads and over 460,000 active development projects each and every month.
What You Need to Know You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technolog...
SYS-CON Events announced today that DXWorldExpo has been named “Global Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Digital Transformation is the key issue driving the global enterprise IT business. Digital Transformation is most prominent among Global 2000 enterprises and government institutions.
One of the biggest challenges with adopting a DevOps mentality is: new applications are easily adapted to cloud-native, microservice-based, or containerized architectures - they can be built for them - but old applications need complex refactoring. On the other hand, these new technologies can require relearning or adapting new, oftentimes more complex, methodologies and tools to be ready for production. In his general session at @DevOpsSummit at 20th Cloud Expo, Chris Brown, Solutions Marketi...
SYS-CON Events announced today that Nihon Micron will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Nihon Micron Co., Ltd. strives for technological innovation to establish high-density, high-precision processing technology for providing printed circuit board and metal mount RFID tags used for communication devices. For more inf...
SYS-CON Events announced today that Ryobi Systems will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Ryobi Systems Co., Ltd., as an information service company, specialized in business support for local governments and medical industry. We are challenging to achive the precision farming with AI. For more information, visit http:...
SYS-CON Events announced today that mruby Forum will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. mruby is the lightweight implementation of the Ruby language. We introduce mruby and the mruby IoT framework that enhances development productivity. For more information, visit http://forum.mruby.org/.
SYS-CON Events announced today that Mobile Create USA will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Mobile Create USA Inc. is an MVNO-based business model that uses portable communication devices and cellular-based infrastructure in the development, sales, operation and mobile communications systems incorporating GPS capabi...