Eton Pharmaceuticals Inc. (ETON:NASDAQ), which is focused on developing and commercializing injectable and pediatric oral liquid products, today announced that "it has acquired U.S. marketing rights to Alkindi® Sprinkle from Diurnal Group Plc (DNL:AIM)."
The company indicated that "Alkindi Sprinkle's New Drug Application is currently under review with the U.S Food and Drug Administration (FDA) for approval as a replacement therapy for pediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH) in patients from birth to less than 17 years of age and that the application has been assigned a Prescription Drug User Fee Act date of September 29, 2020."
The company's CEO Sean Brynjelsen commented, "Alkindi Sprinkle represents a transformational acquisition for Eton and a major step forward on our journey to become a leader in pediatric rare disease products. This product represents the largest market opportunity within our pipeline and adds a major near-term product launch...We are excited to be partnering with Diurnal to bring Alkindi Sprinkle to pediatric patients, and we plan to immediately begin launch activities to ensure its commercial success."
Martin Whitaker, CEO of Diurnal Group Plc, remarked, "We have been impressed by Eton's enthusiasm and vision for the product throughout the Alkindi Sprinkle partnering process...If approved, Alkindi Sprinkle will provide a major breakthrough in the U.S. as the only licensed treatment specifically designed for use in children with adrenal insufficiency, where there is a significant unmet patient need."
The company stated that its leadership position in pediatric rare diseases products makes Alkindi Sprinkle a strong strategic fit with its current pediatric portfolio. The firm advised that it believes this product represents a $100 million market opportunity. The company estimates that approximately 5,000 pediatric patients suffer from adrenal insufficiency in the U.S. and noted that "current FDA-approved treatment options do not offer physicians the ability to properly dose and titrate for many of these pediatric patients."
The company explained that Alkindi Sprinkle is a taste neutral sprinkle granule formulation of hydrocortisone and added that if approved it would be the first AI replacement therapy specifically designed and developed for children. The firm defined AI as a condition in which the adrenal glands do not produce adequate amounts of cortisol, which is often caused by Addison's Disease or CAH. The firm reported that the FDA has granted Alkindi Sprinkle Orphan Drug Designation and the drug was approved in Europe in 2018 under the trade name Alkindi and has been launched in several countries there.
The license agreement terms included an immediate cash payment by Eton to Diurnal in the amount of $3.5 million. In addition, Eton issued Diurnal 379,474 shares of its common stock, representing approximately $1.5 million based on Eton's average fifteen-day trailing stock price. The firm noted that "upon commercial launch of the product with Orphan Drug Exclusivity granted, Eton will pay Diurnal an additional cash milestone payment of $2.5 million."
The company reported that "in conjunction with the Alkindi Sprinkle transaction, it has executed agreements to raise $7.8 million from the sale of 2.6 million shares of common stock at $3.00 per share and that the equity financing was led by Opaleye Management." The company also stated that it amended its credit line to draw $2 million of debt financing with the option to draw an additional $3 million and that the proceeds will be used to support current and future licensing payments to Diurnal, as well as Alkindi Sprinkle-related commercial launch expenses.
Eton Pharmaceuticals is a specialty pharmaceutical company based in Deer Park, Ill., that focuses on acquiring, developing and commercializing high-value innovative products. The company mentioned that it is primarily focused on hospital injectable and pediatric oral liquid products. The company stated that its first commercial product Biorphen, which was launched in December 2019 is the only FDA approved ready-to-use formulation of phenylephrine injection. The firm indicated that it has eight other products in development including three that are currently under FDA review.
Diurnal Group is headquartered in the U.K. and is a specialty pharmaceutical company developing medicines for treatment of chronic endocrine conditions including CAH and AI.
Eton Pharmaceuticals began the day with a market capitalization of around $59.5 million with approximately 17.88 million shares outstanding. ETON shares opened 5% higher today at $3.51 (+$0.18, +5.41%) over yesterday's $3.33 closing price. The stock has traded today between $3.44 and $4.87 per share and at present is trading at $4.07 (+$0.74, +22.22%).[NLINSERT]
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