Full Press Release Details
Pharmaceuticals and Xellia Pharmaceuticals Announce Biorphen (phenylephrine HCl) Co-Promotion Agreement
| - | Xellia's U.S.- Based Hospital Sales Force Will Immediately Begin Promoting Biorphen in Collaboration with Eton | |
| - | Agreement Significantly Expands Biorphen Commercial Footprint and Provides Access to Institutions that Prefer Ready-to-Use Injectable Formulations | |
| - | Biorphen, the Only FDA-approved Formulation of Ready-to-Use Phenylephrine Injection, was Launched in December 2019 |
PARK, Ill., Jan. 21, 2020 (GLOBE NEWSWIRE) - Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company
focused on developing and commercializing innovative drug products, announced it has entered into a co-promotion agreement with
Xellia Pharmaceuticals for the promotion of Biorphen (phenylephrine HCl), the first and only FDA approved ready-to-use
formulation of phenylephrine injection indicated for the treatment of clinically important hypotension resulting primarily from
vasodilation in the setting of anesthesia.
are excited to collaborate with Xellia on the promotion of Biorphen. Given our overlapping target markets, this agreement is a
compelling opportunity for Eton to increase Biorphen's commercial footprint and leverage Xellia's established relationships
with hospitals that have adopted ready-to-use injectable products," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "We
have been pleased with the customer reaction to Biorphen in our first few weeks since launch, and we look forward to working with
Xellia to continue driving adoption of Biorphen"
is a great opportunity for us to work with Eton to co-promote Biorphen; the collaboration fits well with our overall mission to
bring life-saving medicines that address unmet patients' needs. Eton has a similarly bold company culture and focus to Xellia,
which aligns with our ambition to bring more ready-to-use products to the US market where time is critical to the patient and
in alignment to industry guidelines" said Carl-Aake Carlsson, CEO of Xellia Pharmaceuticals.
hospital sales force will immediately begin promoting Biorphen in certain market segments in collaboration with Eton's existing
commercial team. The agreement significantly increases the number of sales representatives actively promoting Biorphen and provides
Eton with immediate access to accounts that have already adopted Xellia's Vanco Ready, a ready-to-use formulation of Vancomycin
injection. In addition, Xellia will be expanding its sales force to support the co-promotion. Eton will continue to promote Biorphen
to all market segments. Xellia will receive a commission on Biorphen sales realized from certain customer accounts.
(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. The market
for ready-to-use phenylephrine injection is estimated to be more than 20 million doses annually.
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.
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
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.
Xellia Pharmaceuticals
Pharmaceuticals ("Xellia") is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective
treatments against serious and often life-threatening bacterial and fungal infections.
over 100 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs,
comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia
is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience
and ease of use for healthcare professionals.
in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia
and North America and is investing significantly to expand its sales and manufacturing capabilities within the United States.
Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,700 people.
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
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are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking
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never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated
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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.
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no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they