Amryt Pharma (AMYT ) has signed a distribution agreement with Medison Pharma Canada (“Medison”) to distribute its Myalepta® (metreleptin) product in Canada.
Myalepta® (metreleptin), is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body (leptin deficiency).
“Today’s announcement represents continued progress as we grow our commercial assets and expand access to treatment for patients in existing and new territories,” commented Dr Joe Wiley, CEO of Amryt on the additional contract for Myalepta® (metreleptin) in Canada.
Amryt, a commercial-stage biopharmaceutical firm focused on developing novel treatments for rare diseases, secured multi-regional distribution agreements with Medison Pharma, a global commercial partner to leading global biotech companies, back in February 2021.
These distribution agreements enabled Amryt to distribute some of its lead products, Myalept® (metreleptin) and Lojuxta® (lomitapide) and Juxtapid® (lomitapide), into new territories; metreleptin and lomitapide in Israel and Juxtapid® (lomitapide) in Canada.
Juxtapid®, which is to be distributed in Canada, is an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia. In the EU, lomitapide trades under the name Lojuxta®.
Medison also distributes 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 Wiley back in February 2021.
Amryt Pharma previously told investors that it is excited to be working alongside Medison Pharma so that it can leverage both its expertise and presence across new global territories.
This further agreement with Madison, a company which has significant breadth and depth of expertise in selling and distributing therapeutics, marks another win for the Company as it expands the reach of its portfolio of products into both existing and new territories.Shares in Amryt Pharma have increased by nearly 15% since the beginning of 2021.
Reasons to Follow AMYT
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.
Leading 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®.
Expanding Distribution Capacity
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.
Positive Outlook
Last week, the Company released ‘record’ results for FY20 which it said were demonstrative of ‘the very positive performance and growth’ that its commercial products are delivering.
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. “Given the strong performance of our business in 2020, we are now issuing revenue guidance for FY21 of $200-$205m which demonstrates our confidence in our prospects,” Wiley told investors.
The Group said both metreleptin and lomitapide continue to deliver growth ‘across a host of metrics’ including revenue and EBITDA growth, cash generation and market expansion.
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