Amyrt Pharma (AMYT ) announced that it has secured multi-regional distribution agreements with Medison Pharma (“Medison”) to distribute some of its lead products in Canada and Israel.
Medison is a global commercial partner to leading global biotech companies, providing the complete spectrum of integrated services for international companies looking to enter or expand their presence in Israel, Canada and all Central and Eastern European markets.
Canada
The biopharmaceutical company which is focused on treatments for serious and life-threatening rare diseases said it will distribute Juxtapid® (lomitapide) in Canada.
Juxtapid® (lomitapide) is an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH"). In the EU, lomitapide trades under the name Lojuxta®.
Israel
Medison will also distribute Lojuxta® (lomitapide), in Israel, as well as Myalept® (metreleptin), a product used as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL).
Generalised and partial lipodystrophy are rare disorders which result in loss or lack of adipose tissue resulting in the deficiency of the hormone leptin. It is associated with severe metabolic abnormalities including severe insulin resistance and hypertriglyceridemia.
“Today’s announcement is another positive development as we continue to grow our commercial assets in existing and new territories and we further progress towards our goal of becoming a global leader in rare and orphan diseases,” said CEO of Amryt, Dr Joe Wiley.
He added that, “We are excited to be working with Medison to leverage their expertise and presence in these territories.”
Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.
Madison has significant breadth and depth of expertise in selling and distributing therapeutics across this multi-regional distribution agreement is clearly positive news for shareholders as the Company expands its products reach into existing and new territories. Shares in Amryt Pharma have increased by nearly 10% since the beginning of 2021 to open 1.95% higher this morning at 209p following the announcement.
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Reasons to Follow AMYT
Portfolio
AMYT’s portfolio includes Amryt's lead development candidate, FILSUVEZ®, a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
Amryt continues to grow its existing commercial products while it is currently preparing for the launch of its FILSUVEZ® skin product in the US in 4Q21 and in Europe in 1Q22.
The anticipated launch of FILSUVEZ® follows recent positive results from Amryt’s Phase 3 EASE trial, the largest ever global Phase 3 trial conducted in patients with genetic skin disorder Epidermolysis Bullosa (EB), which was performed across 58 sites in 28 countries.
Amryt now intends to complete the submission of its rolling New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) and request priority review for FILSUVEZ®.
In a recent report, CEO,Wiley, highlighted the group’s products metreleptin and lomitapide as delivering growth across revenue, EBITDA, cash generation and market expansion.
Amyrt’s Myalept® / Myalepta® injection is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body. It is approved in the US under the trade name Myalept® and in the EU under Myalepta®.
Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan under the trade name Juxtapid® and in the EU under the trade name Lojuxta®.
Distribution
Amyrt recently signed a distribution agreement with Swixx BioPharma AG (“Swixx”), a Swiss pharmaceutical agent operating in Central and Eastern Europe (“CEE”) for Lojuxta®.
The agreement represents new territories for the Group to further accelerate its revenue growth, augmenting sales already being generated through its existing salesforce in the EU.
In recent weeks, Amryt received approval from the National Institute for Health and Care Excellence (“NICE”) for its leptin replacement therapy Myalepta® (metreleptin) in England and Wales, to treat partial and generalised lipodystrophy in adults and children 12+ years of age.
Outlook
Amryt is well positioned in the novel therapeutics market and strong momentum achieved in the year to date has prompted management to upgrade its guidance for FY20 by around 5% to be in the range of $180m-$182m compared to prior guidance of $170m -$175m.
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