Amryt Announces New Patent for Mycapssa®

Rhea-AI Summary

Amryt Announces New Patent for Mycapssa®

On September 13, 2022, Amryt (Nasdaq: AMYT) announced the issuance of US Patent No. 11,400,159 by the USPTO for its product Mycapssa® (octreotide). This patent extends Mycapssa®'s protection until September 2029, part of nine Orange Book-listed patents offering protection through December 2040. CEO Dr. Joe Wiley emphasized the company's commitment to enhancing its intellectual property portfolio, highlighting the robust protection for Mycapssa®. Amryt focuses on developing novel treatments for rare diseases.

Positive

• Issuance of US Patent No. 11,400,159 for Mycapssa®, extending protection until September 2029.
• Total of nine Orange Book-listed patents for Mycapssa® providing protection until December 2040.
• Strengthened intellectual property portfolio enhances competitive position.

Negative

• None.

Amryt Announces New Patent for Mycapssa®

DUBLIN, Ireland, and Boston MA, September 13, 2022 Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, announces an update regarding the patents for its product Mycapssa® (octreotide).

Mycapssa®
The USPTO has issued to Amryt US Patent No. 11,400,159, with claims related to the Mycapssa® product.

This patent will expire in September 2029. Amryt has nine Orange Book-listed patents for Mycapssa® with patent protection through December 2040.   

Dr Joe Wiley, CEO of Amryt Pharma, commented: “We are always working to develop and extend our IP portfolio and today’s news further illustrates the robust IP protection enjoyed by Mycapssa®.”

About Amryt
Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative 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.

Amryt’s commercial business comprises four orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); lomitapide (Juxtapid®/ Lojuxta®); and Oleogel-S10 (Filsuvez®).

Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link.

Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA. Mycapssa® has also been submitted to the EMA and is not yet approved in Europe. For additional information, please follow this link.

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, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta®). For additional information, please follow this link.

Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of JEB and DEB, a rare and distressing genetic skin disorder affecting young children and adults. Filsuvez® has been selected as the brand name for Oleogel-S10. Filsuvez® is approved in the EU and Great Britain for the treatment of partial thickness wounds associated with JEB and DEB in patients 6 months and older.

Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders.

Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE^®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com.

Forward-Looking Statements
This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.

Contacts
Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com
Tim McCarthy, LifeSci Advisors, LLC, +1 (917) 679 9282, tim@lifesciadvisors.com

 

FAQ

What is the significance of the new patent for Mycapssa® announced by Amryt on September 13, 2022?

The new patent, US Patent No. 11,400,159, provides Amryt with extended protection for Mycapssa® until September 2029, bolstering its market position.

How many patents does Amryt hold for Mycapssa®?

Amryt holds a total of nine Orange Book-listed patents for Mycapssa®, ensuring protection through December 2040.

What type of product is Mycapssa®?

Mycapssa® is an oral somatostatin analog approved for long-term maintenance therapy in acromegaly patients.

How does the new patent affect Amryt's future prospects?

The new patent enhances Amryt's intellectual property portfolio, potentially improving its competitive edge and safeguarding revenue streams from Mycapssa®.