SOURCE: Chiesi USA, Inc.

Chiesi USA, Inc.

February 20, 2015 11:06 ET

Chiesi USA Presents: Pioneering Innovative Research and Philanthropy in the Neonatal Community

Educational Seminar Held During NEO: The Conference for Neonatology

ORLANDO, FL--(Marketwired - February 20, 2015) - Chiesi USA, dedicated to assisting with the advancement of neonatal research, hosted a complimentary seminar to provide a glimpse of the latest developments from the company's innovative neonatology R&D hub as well as philanthropy efforts serving the neonatology community. The breakfast seminar was held on Thursday, Feb. 19 at the Hilton Bonnet Creek Waldorf Grand Ballroom in Orlando, Florida during NEO: The Conference for Neonatology.

The event focused on Chiesi USA's commitment to advancing the field of neonatology through its portfolio of pioneering treatments, education initiatives and partnerships with leading organizations that share a mission to provide the highest level of care to the youngest of patients. Highlights included a panel discussion with a question and answer session with Rangasamy Ramanathan, M.D., NICU medical director at LAC+USC Medical Center, Linda Storari, Head of Neonatal Drug Development for Chiesi Group, and Josh Franklin, Vice President of Strategy and Business Development with Chiesi USA.

Chiesi's industry-leading neonatology platform was established through the clinical success of CUROSURF® (poractant alfa), which is an FDA approved surfactant indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. Transient adverse effects seen with the administration of CUROSURF include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation.

"Chiesi is excited to have sponsored this informative session as part of our mission to enhance neonatal care," said Franklin. "This presented us a valuable opportunity to showcase Chiesi's upcoming developments, in the neonatal field, from developing a robust pipeline to discussing the clinical perspective on unmet needs and highlighting neonatal efforts around the globe." 

Premature birth is the leading killer of America's newborns. According to the March of Dimes, in the United States, one in nine babies is born prematurely.1 The most common risk preterm infants face is the development of RDS. Coupled with ongoing advances in treatment options for RDS, including antenatal corticosteroids and surfactant replacement therapy, the RDS mortality rate has decreased by nearly 30 percent since the 1960s.2 However, each year in the United States, approximately 50,000 premature infants born are at risk for RDS,3 which is commonly experienced by premature babies born before 32 weeks of gestation and most frequently in those born before 28 weeks.4

To learn more about Chiesi USA's support initiatives for the neonatal community, visit NEO Booth #412 in the exhibit hall.

INDICATION
CUROSURF® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS.

IMPORTANT SAFETY INFORMATION
CUROSURF® (poractant alfa) Intratracheal Suspension is intended for intratracheal use only. The administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes.

CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants.

Transient adverse effects seen with the administration of CUROSURF include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.

Pulmonary hemorrhage is a known complication of premature birth and very low birth-weight and has been reported with CUROSURF. The rates of common complications of prematurity observed in a multicenter single-dose study that enrolled infants 700-2000 g birth weight with RDS requiring mechanical ventilation and FiO2 ≥ 0.60 are as follows for CUROSURF 2.5 mL/kg (200 mg/kg) (n=78) and control (n=66; no surfactant) respectively: acquired pneumonia (17% vs. 21%), acquired septicemia (14% vs. 18%), bronchopulmonary dysplasia (18% vs. 22%), intracranial hemorrhage (51% vs. 64%), patent ductus arteriosus (60% vs. 48%), pneumothorax (21% vs. 36%), and pulmonary interstitial emphysema (21% vs. 38%).

Please see Full Prescribing Information available at www.curosurf.com.

About Chiesi USA
Chiesi USA, Inc., headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek opportunities to acquire companies, marketed or registration-stage products and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. Chiesi USA, Inc. is a wholly-owned subsidiary of Chiesi Farmaceutici S.p.A. For more information, visit www.chiesiusa.com.

  1. March of Dimes. (2015). Prematurity Campaign. Retrieved February 17, 2015, from http://www.marchofdimes.org/mission/prematurity-campaign.aspx.
  2. American Thoracic Society. (2014). Respiratory distress syndrome of the newborn. In Schraufnagel DE (Ed.), Breathing in America: Diseases, progress, and hope (pp. 197-205). New York, NY: The American Thoracic Society. 
  3. Whitsett JA et al. Acute respiratory disorders.(2005). In: MacDonald MG et al (Eds.), Avery's Neonatology: Pathophysiology and Management of the Newborn. (p. 554). Philadelphia, PA: Lippincott Williams & Wilkins.
  4. What is respiratory distress syndrome? (2012). Retrieved June 17, 2012, from http://www.nhlbi.nih.gov/health/health-topics/topics/rds/#

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