Galena Biopharma Inc. (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced the product launch for Zuplenz® (ondansetron) Oral Soluble Film in the United States.
Zuplenz is now available nationwide and is supplied in both 4 mg and 8 mg strengths. Zuplenz is clinically bioequivalent to ondansetron orally disintegrating tablets (ODT) with a safety profile equivalent to ondansetron. The novel, PharmFilm® oral soluble film technology utilized by Zuplenz provides for convenient delivery and several key patient benefits including:
- Rapidly dissolves in the mouth in about 10 seconds
- Eliminates the burden of swallowing pills during emesis and in cases of oral irritation
- Does not require water to administer
- Pleasant peppermint flavor with no gritty aftertaste
“Ondansetron is the gold-standard treatment option for patients suffering from nausea and vomiting due to chemotherapy, radiation treatments, and surgical procedures; and, we believe the unique and innovative product attributes of Zuplenz will be a valuable treatment option for patients and physicians to relieve these debilitating side-effects,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “With the launch of Zuplenz, we will leverage our existing commercial infrastructure including our outsourced Galena Patient Services (GPS) program to work directly with the patient, prescriber, insurance provider, and pharmacy to help guide the process of getting the patient their medication once prescribed by the physician.”
Zuplenz is approved in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved for moderately emetogenic CINV in pediatric patients four years and older.
The active pharmaceutical ingredient in Zuplenz, ondansetron, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. The National Comprehensive Cancer Network (NCCN) 2014 guidelines recommend the use of ondansetron in patients with highly and moderately emetogenic cancer chemotherapy-induced and radiotherapy-induced nausea and vomiting. Ondansetron belongs to a class of medications called serotonin 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting. According to data from both IMS and Wolters Kluwer, the branded 5-HT3 market exceeded $1 billion in the U.S. in 2014. The product was licensed from MonoSol Rx, LLC, the developer of the oral soluble film technology, PharmFilm®, and manufacturer of the product. (Original Source)
Shares of Galena Biopharma closed yesterday at $1.61. GALE has a 1-year high of $3.16 and a 1-year low of $1.28. The stock’s 50-day moving average is $1.77 and its 200-day moving average is $1.62.
On the ratings front, Galenahas been the subject of a number of recent research reports. In a report issued on June 15, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on GALE, with a price target of $8, which implies an upside of 396.9% from current levels. Separately, on May 27, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $7.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Jason Kolbert have a total average return of 5.7% and -4.8% respectively. Pantginis has a success rate of 47.1% and is ranked #520 out of 3718 analysts, while Kolbert has a success rate of 34.6% and is ranked #3646.
Overall, 4 research analysts have given a Buy rating to GALE. When considering if perhaps the stock is under or overvalued, the average price target is $7.00 which is 334.8% above where the stock closed yesterday.
Galena Biopharma Inc, is abiopharmaceutical company focused on developing and commercializing targeted oncology therapeutics that address medical needs across the full spectrum of cancer care.