Full Press Release Details
Pharmaceuticals Announces Co-Promotion Agreement with Tolmar Pharmaceuticals for ALKINDI SPRINKLE
Tolmar's 62-person sales force will co-promote ALKINDI SPRINKLE to pediatric endocrinologists -
PARK, Ill., Nov. 15, 2021 (GLOBE NEWSWIRE) - Eton Pharmaceuticals, Inc (Nasdaq: ETON) today announced that it has entered into
a multi-year agreement with Tolmar Pharmaceuticals, Inc. to co-promote ALKINDI SPRINKLE . Eton will leverage Tolmar's
62-person sales force and their existing relationships in the pediatric endocrinology specialty. Tolmar currently promotes FENSOLVI
(leuprolide acetate) for injectable suspension, indicated for pediatric patients 2 years of age and older with Central Precocious
clear that physicians see the need for ALKINDI SPRINKLE's accurate dosing when treating adrenal insufficiency, however, we have
found that changing the decades old prescribing habits of pediatric endocrinologists is often requiring multiple face-to-face interactions.
With this partnership, our reach will be increasing more than 10-fold and we will drastically increase the number of face-to-face interactions.
We believe this will translate to significantly faster adoption of ALKINDI SPRINKLE and accelerate the time to reach peak conversion,"
said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "We are confident Tolmar is the right partner for ALKINDI SPRINKLE. Their FENSOLVI
launch results speak for themselves and highlight their team's ability to drive treatment change in pediatric endocrinology,"
are excited to co-promote ALKINDI SPRINKLE," said Tolmar CEO Anil D'Souza. "This agreement will further enhance Tolmar's
commitment to the pediatric endocrinology space. It allows Tolmar to continue providing therapies with optimal delivery mechanisms that
improve patient and caregiver experience."
pediatric endocrinology sales force currently promotes the specialty drug FENSOLVI for CPP, a rare disease that impacts
roughly one in 5,000-10,000 children in the United States. FENSOLVI was launched in May 2020 and has already reached
more than 1,500 patients.
terms of the agreement, Tolmar's sales force will promote ALKINDI SPRINKLE to their pediatric endocrinology targets
alongside FENSOLVI . Tolmar will receive a royalty on net sales growth above ALKINDI SPRINKLE 's
current baseline sales. Eton's sales force will continue to promote the product and Eton will maintain responsibility for all non-sales
force related commercial activities.
companies expect Tolmar's sales force to start promoting ALKINDI SPRINKLE in December. In tandem with the co-promotion
launch, Eton plans to introduce an expanded digital marketing campaign targeted at raising awareness among patients and caregivers.
ALKINDI SPRINKLE (hydrocortisone) oral granules is FDA-approved as replacement therapy for Adrenocortical Insufficiency
(AI) in children under 17 years of age. ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for the
treatment of adrenocortical insufficiency specifically designed for use in children. The approval of ALKINDI SPRINKLE was supported by
six clinical studies, including the first and only interventional open-label Phase III study of oral hydrocortisone for Pediatric AI
in neonates to children under eight years of age. Prior to the approval of ALKINDI SPRINKLE, oral hydrocortisone was only FDA-approved
in tablet formulations of 5mg and stronger. Many pediatric patients require significantly lower doses and the flexibility of precise
titration. ALKINDI SPRINKLE is available in 0.5mg, 1mg, 2mg, and 5mg strengths, allowing clinicians greater flexibility to individualize
dosing based on each patient's needs in accordance with the instructions for dosage and administration. Common adverse reactions
for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes,
increased appetite, and weight gain.
Eton Pharmaceuticals
Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.
The company currently owns or receives royalties from six FDA-approved products, including ALKINDI SPRINKLE, carglumic
acid, Biorphen , Alaway Preservative Free, Rezipres , and Eprontia , and has four
additional products that have been submitted to the FDA.
Tolmar is a fully integrated pharmaceutical company focused on the innovative development, approval, manufacturing, and commercialization
of specialty pharmaceuticals. "Tolmar" refers to Tolmar Holding, Inc. and its wholly owned operating subsidiaries, Tolmar
Inc., Tolmar Therapeutics, Inc., and Tolmar Pharmaceuticals, Inc. Tolmar global headquarters, product development and manufacturing facilities
are based in northern Colorado, while Tolmar Pharmaceuticals' U.S. commercial business is based in Buffalo Grove, Illinois. For
more information about the company, please visit www.tolmar.com.
Forward-Looking Statements
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 were made.
Safety Information for ALKINDI SPRINKLE (hydrocortisone) Oral Granules
Crisis: Undertreatment or sudden discontinuation of therapy may lead to symptoms of adrenal insufficiency, adrenal crisis, and death.
Adrenal crisis may also be induced by stressor events, such as infections or surgery. Monitor patients closely when switching from other
forms of hydrocortisone to ALKINDI SPRINKLE. Increase the dose during periods of stress. Switch patients who are vomiting, severely ill,
or unable to take oral medications to parenteral corticosteroid formulations.
Excessive doses may increase the risks of new infections or exacerbation of latent infections with any pathogen, including viral, bacterial,
fungal, protozoan, or helminthic infections. Monitor patients for signs and symptoms of infections. Treat all infections seriously, and
initiate stress dosing of steroids early.
Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired
clinical response and monitor the patient's growth.
Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing's syndrome.
Monitor patients for signs and symptoms of Cushing's syndrome every 6 months; pediatric patients under one year of age may require
more frequent monitoring.
in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption, which may lead to inhibition of bone growth
and development of osteoporosis. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response.
Adverse Reactions: Use may be associated with severe psychiatric adverse reactions, such as euphoria, mania, psychosis with hallucinations
and delirium, or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after
either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances
during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop.
Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor
patients for blurred vision or other visual disturbances, and if they occur, refer them to an ophthalmologist.
Adverse Reactions: There is an increased risk of gastrointestinal perforation in patients with certain gastrointestinal disorders. Signs
of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Corticosteroids
should be used with caution if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis;
fresh intestinal anastomoses; and active or latent peptic ulcer.
Concurrent administration of corticosteroids with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal
adverse reactions. Monitor patients receiving corticosteroids and concomitant NSAIDs for gastrointestinal adverse reactions.
adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral
and mood changes, increased appetite, and weight gain.
SPRINKLE is a corticosteroid indicated for replacement therapy in pediatric patients with adrenocortical insufficiency.
see full Prescribing Information for more information.
Safety Information for FENSOLVI (leuprolide acetate) for injectable suspension
(leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years
of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls
under the age of 8 or in boys under the age of 9.
is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, in individuals who are allergic
to any of the ingredients in FENSOLVI, or in individuals who are pregnant. FENSOLVI may cause fetal harm when administered to a pregnant
the first few weeks of treatment, increases in gonadotropins and sex steroids above baseline may result in an increase in signs and symptoms