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Chiesi Farmaceutici S.p.A. has successfully completed the acquisition of Amryt Pharma Plc (NASDAQ: AMYT) in an effort to enhance patient access to innovative treatments for rare diseases. This strategic move aligns with Chiesi's growth ambitions and commitment to rare disease research and development. The acquisition is expected to leverage Amryt's clinically differentiated products and promising pipeline to better serve patients with high unmet medical needs. Chiesi aims to create a sustainable business model that emphasizes patient-centric solutions, thereby expanding its global footprint in the biopharmaceutical sector. The leadership of both companies expressed enthusiasm about the potential synergies that can improve patient outcomes.
The High Court of Justice of England and Wales has sanctioned the scheme of arrangement for the acquisition of Amryt Pharma (Nasdaq: AMYT) by Chiesi Farmaceutici. This ruling, announced on April 3, 2023, follows a hearing on March 31, 2023. The transaction is expected to close in mid-April 2023. Amryt Pharma focuses on developing treatments for rare diseases and comprises both commercial and developmental assets. The announcement contains forward-looking statements and highlights various risks associated with the completion of the acquisition, including potential shareholder litigation and unforeseen liabilities.
Amryt Pharma shareholders have approved the acquisition by Chiesi Farmaceutici, with all resolutions passed during the shareholder meetings held on March 22, 2023. The transaction, valued at approximately $1.1 billion, is set to close in Q2 2023, pending regulatory approvals and court sanctions. The acquisition is anticipated to enhance Amryt’s capabilities in developing treatments for rare diseases. However, it remains subject to conditions like regulatory approvals and potential shareholder litigation risks, which could affect timelines and integration processes.
Amryt Pharma Plc (Nasdaq: AMYT) announced the publication of a scheme circular regarding its proposed acquisition by Chiesi Farmaceutici S.p.A.. The shareholder meetings to vote on this acquisition will be held in London on March 22, 2023. Amryt's Board of Directors recommends shareholders vote in favor of the transaction. Shareholders with record holdings by 6:00 p.m. on March 20, 2023 can vote, while holders of American Depositary Shares can provide instructions but cannot attend. The announcement includes important forward-looking statements and urges shareholders to read the Scheme Circular for detailed voting processes.
Chiesi Farmaceutici has announced its acquisition of Amryt Pharma for US$14.50 per American Depositary Share (ADS), with a total transaction value of up to US$1.48 billion, including contingent value rights (CVRs) of up to US$2.50 per ADS based on milestones related to Filsuvez®.
This acquisition, unanimously approved by both companies' boards, is expected to close in the first half of 2023, enhancing Chiesi’s portfolio in rare disease treatments and securing backing from major shareholders.
Amryt (Nasdaq: AMYT) announced positive results from its Phase 3 APH-19 trial of lomitapide for treating Homozygous Familial Hypercholesterolemia (HoFH) in pediatric patients aged 5-17. The trial demonstrated a mean LDL-C reduction of 54% at week 24, statistically significant with p < 0.0001. Additionally, secondary endpoints showed significant reductions in non-HDL-C and total cholesterol. Safety results aligned with known profiles, with minimal adverse events. This trial outcome is pivotal for Amryt as it expands treatment options in a rare disease market.
Amryt (Nasdaq: AMYT) announced a positive opinion from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) regarding Mycapssa® for treating carcinoid syndrome associated with neuroendocrine tumors (NET). This orphan designation provides significant regulatory and financial incentives, including ten years of market exclusivity post-approval. This follows a similar positive recommendation for Mycapssa® in treating acromegaly. Mycapssa® is designed for oral delivery, offering potential advantages over injectable treatments.
European Commission approves Mycapssa® for the treatment of Acromegaly.
This marks Mycapssa® as the first and only oral somatostatin analog approved in the EU, based on the pivotal MPOWERED Phase 3 trial.
Amryt (AMYT) confirmed the approval for patients already treated with octreotide or lanreotide. The centralised marketing authorisation is valid across all EU Member States and additional European nations, reinforcing Amryt's commitment to rare disease treatments.
Amryt has announced the issuance of US Patent No. 11,510,963 for its product Mycapssa® (octreotide), extending its patent protection until February 2036. This addition brings the total to ten Orange Book-listed patents for Mycapssa®, securing patent protection through December 2040. With this development, Amryt emphasizes its commitment to strengthening its intellectual property portfolio, as stated by CEO Dr. Joe Wiley.
Amryt reported Q3 2022 results showing 8.2% year-over-year revenue growth to $61.1 million, with a positive EBITDA of $12.5 million for the 11th consecutive quarter. Mycapssa® revenues rose 292.8% YoY to $5.7 million, aided by a growing prescriber base. The company secured a $8.3 million tender in LATAM and reaffirmed its FY 2022 revenue guidance of $260-$270 million, reflecting 17-21% growth. Notable regulatory advancements include positive CHMP opinions and plans for a Phase 3 study for neuroendocrine tumors.
