Canada and United Kingdom characterize two of the most important markets inside the ALK portfolio with plans to increase filings of neffy (epinephrine nasal spray) 2 mg in different key world areas
SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) — ARS Prescription drugs, Inc. (Nasdaq: SPRY), a biopharmaceutical firm devoted to empowering at-risk sufferers and caregivers to raised defend themselves from allergic reactions that might result in anaphylaxis, introduced at present that ARS Pharma has filed for approval of neffy® (epinephrine nasal spray) 2 mg in Canada and the UK (U.Ok.), the place it will likely be marketed as EURneffy®, on behalf of its licensing accomplice, ALK- Abelló A/S (ALK). neffy was not too long ago authorised within the U.S. for the therapy of Sort I Allergic Reactions, together with anaphylaxis, in adults and kids who weigh ≥30 kg (66 lbs.). In November 2024, ARS Pharma introduced a licensing settlement offering ALK with unique rights to commercialize neffy in Europe, Canada, United Kingdom and sure different geographies exterior of the U.S.
“Constructing upon the approval of neffy within the U.S. and Europe for the emergency therapy of extreme allergic reactions, we’re dedicated to serving to facilitate entry to this life-saving therapy worldwide,” says Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “With submission in Canada and the U.Ok., ARS Pharma now has approval or has filed for approval in jurisdictions comprising greater than 98 p.c of the present world marketplace for epinephrine. We look ahead to listening to from the regulatory companies following their assessment of the functions.”
Below the phrases of the licensing settlement, ARS Pharma obtained an upfront cost of $145 million and is eligible to obtain as much as a further $320 million in regulatory and gross sales milestones, in addition to tiered, double-digit royalties within the teenagers on internet gross sales in licensed geographies. ARS Pharma shall be accountable for manufacturing and supplying neffy to ALK.
ARS Pharma retains all U.S. rights for neffy and has present licensing partnerships in China, Japan, Australia and New Zealand with Pediatrix Therapeutics, Alfresa Pharma, and CSL Seqirus, respectively.
ARS Pharma can be evaluating its intranasal epinephrine expertise for the therapy of acute flares in sufferers with persistent urticaria, with plans to start a Part 2b medical trial in early 2025. The license settlement with ALK additionally offers them unique rights for any new indications within the licensed territories.
About neffy®
neffy is an intranasal epinephrine product for sufferers with Sort I allergic reactions resulting from insect stings or bites, meals, medicinal merchandise, different allergens, in addition to idiopathic or train induced anaphylaxis that might result in life-threatening anaphylaxis.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy 2 mg is indicated for emergency therapy of Sort I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers who weigh 30 kg or larger.
IMPORTANT SAFETY INFORMATION
It’s endorsed that sufferers are prescribed and have speedy entry to 2 neffy nasal sprays always. Within the absence of medical enchancment or if signs worsen after preliminary therapy, administer a second dose of neffy in the identical nostril with a brand new nasal spray beginning 5 minutes after the primary dose.
neffy is to be used within the nostril solely.
Advise sufferers when to hunt emergency medical help for shut monitoring of the anaphylactic episode and within the occasion additional therapy is required.
Absorption of neffy could also be affected by underlying structural or anatomical nasal situations.
Administer with warning to sufferers who’ve coronary heart illness; epinephrine could worsen angina pectoris or produce ventricular arrhythmias. Arrhythmias, together with deadly ventricular fibrillation, have been reported, significantly in sufferers with underlying cardiac illness or taking cardiac glycosides, diuretics, or anti-arrhythmics.
The presence of a sulfite in neffy mustn’t deter use.
neffy could alter nasal mucosa for as much as 2 weeks after administration and enhance systemic absorption of nasal merchandise, together with neffy.
Sufferers with sure medical situations or who take sure drugs for allergy symptoms, melancholy, thyroid problems, diabetes, and hypertension, could also be at larger threat for antagonistic reactions.
Epinephrine can quickly exacerbate the underlying situation or enhance signs in sufferers with the next: hyperthyroidism, Parkinson’s illness, diabetes, renal impairment. Epinephrine needs to be administered with warning in sufferers with these situations, together with aged sufferers and pregnant girls.
Hostile reactions to neffy could embrace throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, stomach ache, gingival ache, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.
These will not be the entire attainable unintended effects of neffy. To report suspected antagonistic reactions, contact ARS Prescription drugs Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For extra info on neffy, please see Full Prescribing Data at www.neffy.com.
About Sort I Allergic Reactions Together with Anaphylaxis
Sort I allergic reactions are critical and probably life-threatening occasions that may happen inside minutes of publicity to an allergen and require speedy therapy with epinephrine, the one FDA-approved treatment for these reactions. Whereas epinephrine autoinjectors have been proven to be extremely efficient, there are effectively revealed limitations that end in many sufferers and caregivers delaying or not administering therapy in an emergency scenario. These limitations embrace concern of the needle, lack of portability, needle-related security considerations, lack of reliability, and complexity of the gadgets. There are roughly 40 million individuals in the US who expertise Sort I allergic reactions. Of this group, during the last three years, roughly 20 million individuals have been identified and handled for extreme Sort I allergic reactions which will result in anaphylaxis, however (in 2023, for instance) solely 3.2 million stuffed their lively epinephrine autoinjector prescription, and of these, solely half constantly carry their prescribed autoinjector. Even when sufferers or caregivers carry an autoinjector, greater than half both delay or don’t administer the system when wanted in an emergency.
About ARS Prescription drugs, Inc.
ARS Prescription drugs is a biopharmaceutical firm devoted to empowering at-risk sufferers and their caregivers to raised defend sufferers from allergic reactions that might result in anaphylaxis. The Firm is commercializing neffy® 2 mg (commerce title EURneffy® within the EU) (beforehand known as ARS-1), an epinephrine nasal spray indicated within the U.S. for emergency therapy of Sort I allergic reactions, together with anaphylaxis, in grownup and pediatric sufferers who weigh 30 kg or larger, and within the EU for emergency therapy of allergic reactions (anaphylaxis) resulting from insect stings or bites, meals, medicinal merchandise, different allergens, in addition to idiopathic or train induced anaphylaxis in adults and kids who weigh 30 kg or larger. For extra info, go to www.ars-pharma.com.
Ahead-Trying Statements
Statements on this press launch that aren’t purely historic in nature are “forward-looking statements” inside the which means of the Non-public Securities Litigation Reform Act of 1995. These statements embrace, however will not be restricted to: the expectation that neffy will save lives; the effectiveness of neffy; the anticipated timing for receiving regulatory approval within the U.Ok. and Canada; the plans and anticipated timing for initiating a Part 2b medical trial to guage neffy for the therapy of persistent urticaria; and different statements that aren’t historic truth. As a result of such statements are topic to dangers and uncertainties, precise outcomes could differ materially from these expressed or implied by such forward-looking statements. Phrases reminiscent of “anticipate,” “expects,” “if,” “could,” “potential,” “on observe to,” “plans,” “will,” “would,” and related expressions are meant to establish forward-looking statements. These forward-looking statements are based mostly upon ARS Prescription drugs’ present expectations and contain assumptions which will by no means materialize or could show to be incorrect. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements because of varied dangers and uncertainties, which embrace, with out limitation: potential security and different problems from neffy; ARS Prescription drugs’ reliance on its licensing companions; the flexibility to acquire and keep regulatory approval for neffy in any indication within the U.Ok. and Canada; whether or not the finished research carried out shall be adequate to acquire regulatory approval for neffy within the U.Ok. and Canada; ARS Prescription drugs’ capability to realize the milestones wanted to obtain milestone funds below the ALK license settlement; the labelling for neffy in any future indication or affected person inhabitants, if authorised; the scope, progress and enlargement of growing and commercializing neffy; the potential for payors to delay, restrict or deny protection for neffy; the scale and progress of the market therefor and the speed and diploma of market acceptance thereof vis-à-vis intramuscular injectable merchandise; ARS Prescription drugs’ capability to guard its mental property place; and the impression of presidency legal guidelines and rules. Extra dangers and uncertainties that might trigger precise outcomes and outcomes to vary materially from these contemplated by the forward-looking statements are included below the caption “Threat Components” in ARS Prescription drugs’ Quarterly Report on Kind 10-Q for the quarter ended September 30, 2024, filed with the Securities and Change Fee (“SEC”) on November 13, 2024. These paperwork may also be accessed on ARS Prescription drugs’ web site at www.ars-pharma.com by clicking on the hyperlink “Financials & Filings” below the “Traders & Media” tab.
The forward-looking statements included on this press launch are made solely as of the date hereof. ARS Prescription drugs assumes no obligation and doesn’t intend to replace these forward-looking statements, besides as required by legislation.
ARS Investor Contact:
Justin Chakma
ARS Prescription drugs
justinc@ars-pharma.com
ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com
Observe of disclosure: ARS Pharma is an advertiser with SnackSafely.com
