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Eton Pharmaceuticals Announces Commercial Availability of Biorphen (phenylephrine HCI) Injection ~ Biorphen is the First and Only Ready-to-Use FDA-Approved Injectable Formulation of Phenylephrine ~ ~ Biorphen is Now Avai

Key Takeaway: Pharmaceuticals Announces Commercial Availability of Biorphen (phenylephrine HCI) Injection Biorphen is the First and Only Ready-to-Use FDA-Approved Injectable Formulation of Phenylephrine ~ Biorphen is Now Available for Order Through Major Wholesalers ~ Biorphen is Eton Pharm

Full Press Release Details

Pharmaceuticals Announces Commercial Availability of Biorphen (phenylephrine HCI) Injection
Biorphen is the First and Only Ready-to-Use FDA-Approved Injectable Formulation of Phenylephrine ~
Biorphen is Now Available for Order Through Major Wholesalers ~
Biorphen is Eton Pharmaceuticals' First Commercially Available Product ~
PARK, Ill., Dec. 2, 2019 (GLOBE NEWSWIRE) - Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company
focused on developing and commercializing innovative drug products, today announced that Biorphen , the first and
only FDA-approved ready-to-use formulation of phenylephrine for the treatment of clinically important hypotension resulting primarily
from vasodilation in the setting of anesthesia, is now commercially available. Biorphen is available in a 5mL ampule containing
500mcg of phenylephrine. The product is now available for ordering through wholesalers McKesson, AmerisourceBergen, and Cardinal
Biorphen's approval, we have seen strong interest from both physicians and hospital pharmacy directors and we are excited
to begin supplying the product. The availability of Biorphen reduces the need for hospitals to rely on compounders to provide
unapproved compounded phenylephrine," said Sean Brynjelsen, President and Chief Executive Officer of Eton. "In addition,
Biorphen's three-year shelf life allows hospitals to more easily stock the product in operating rooms, emergency rooms,
and crash carts. We are well prepared for the commercial success of Biorphen with a strong and experienced sales team that is
fully trained and deployed promoting Biorphen to hospitals throughout the US."
teams at Eton and Sintetica have worked closely together to ensure that Biorphen is ready for launch and to assuredly supply the
United States healthcare system from day one with the first and only FDA-approved ready-to-use injectable formulation of phenylephrine,"
said Pasquale Mitidieri, Corporate Director of Sintetica's Global Division.
estimates the total addressable market for Biorphen is more than 20 million units annually. In tandem with its manufacturing partner
Sintetica, Eton expects to have the capacity to supply this market as necessary. Eton's sales force currently includes a
team of field representatives and inside sales representatives that will be initially targeting the institutions with the highest
phenylephrine usage.
ordering and product information visit www.Biorphen.com.
(phenylephrine HCI) Injection is the first and only FDA-approved ready-to-use formulation of phenylephrine for treating
clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Ready-to-use Biorphen can
be standardized and stocked in operating rooms, emergency departments and intensive care units, as well as in crash carts throughout
the hospital. With a three-year shelf life, Biorphen can be stocked throughout hospitals without frequent restocking.
injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting
primarily from vasodilation in the setting of anesthesia.
and Precautions: BIORPHEN can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate
underlying heart failure, and increase pulmonary arterial pressure. Can also cause excessive peripheral and visceral vasoconstriction
and ischemia to vital organs. Extravasation during intravenous administration may cause necrosis or sloughing of tissue. Can cause
severe bradycardia and decreased cardiac output, renal toxicity, augmented pressor effect in patients with autonomic dysfunction
and pressor effect with concomitant oxytocic drugs.
common adverse reactions during treatment: nausea, vomiting, and headache.
report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-888-450-0568 or FDA at 1-800-FDA-1088.
Agonistic Effects (increase in BIORPHEN blood pressure effect) can occur with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transporter inhibitors, ergot alkaloids.
Antagonistic Effects (decrease in BIORPHEN blood pressure effect) can occur with -adrenergic antagonists, phosphodiesterase Type 5 inhibitors, mixed - and -receptor antagonists, calcium channel blockers, benzodiazepines and ACE inhibitors, centrally acting sympatholytic agents
of BIORPHEN (phenylephrine hydrochloride) can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting,
hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including
ventricular extrasystoles and ventricular tachycardia.
Eton Pharmaceuticals, Inc.
Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative products utilizing
the FDA's 505(b)(2) regulatory pathway. Eton is primarily focused on liquid dosage forms including injectables, oral liquids
and ophthalmics. Eton has a diversified pipeline of high-value product candidates in various stages of development and therapeutic
areas, including multiple product candidates currently under review by the FDA.
contained in this press release regarding matters that are not historical facts are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability
of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited
to statements regarding Eton's business strategy, Eton's plans to develop and commercialize its product candidates,
the safety and efficacy of Eton's product candidates, Eton's plans and expected timing with respect to regulatory
filings and approvals, and the size and growth potential of the markets for Eton's product candidates. Because such statements
are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking
statements. Words such as "believes," "anticipates," "plans," "expects," "intends,"
"will," "goal," "potential" and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon Eton's current expectations and involve assumptions that may
never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated
with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics,
and in the endeavor of building a business around such drugs. These and other risks concerning Eton's development programs
and financial position are described in additional detail in Eton's filings with the Securities and Exchange Commission.
All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes
no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they
Last updated: Dec 2, 2019