8-K
AMICUS THERAPEUTICS, INC. (FOLD)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
WASHINGTON,D.C. 20549
FORM
8-K
CURRENTREPORT PURSUANT TO
SECTION13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): April 28, 2025
AMICUS THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Its Charter)
| Delaware | 001-33497 | 71-0869350 |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
47 Hulfish Street,
Princeton, New Jersey 08542
(Address of PrincipalExecutive Offices, and Zip Code)
609-662-2000
Registrant’sTelephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock Par Value $0.01 | FOLD | NASDAQ |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 1.01 – Entry into a Material DefinitiveAgreement.
Dimerix License Agreement
On April 30, 2025, Amicus Therapeutics, Inc. (“Amicus”) entered into a License Agreement, effective May 1, 2025 (the “Agreement”) with Dimerix Bioscience Pty Ltd. (“Dimerix”), pursuant to which, among other things, Dimerix granted Amicus the exclusive rights to develop, manufacture, and commercialize Dimerix’s small molecule inhibitor of the chemokine receptor 2 (CCR2) drug candidate known as DMX-200, and other related compounds, and products containing DMX-200 and other licensed compounds, in the United States for Focal Segmental Glomerulosclerosis (“FSGS”) and other indications.
Under the Agreement, Dimerix will continue to fund and execute the current and ongoing pivotal Phase 3 study for DMX-200 for FSGS. Dimerix and Amicus will collaborate with respect to regulatory matters relating to licensed products in the United States pursuant to the Agreement, with Amicus being responsible for submitting New Drug Applications (“NDAs”) for licensed products (including the NDA for DMX-200 for FSGS) in the United States and thereafter controlling, in collaboration with Dimerix, all regulatory matters in the United States for licensed products. Amicus is obligated to use commercially reasonable efforts to develop licensed products for indications beyond FSGS and to initiate clinical development in at least one indication other than FSGS, within an agreed time period after receipt of full regulatory approval of DMX-200 for FSGS in the United States, in order to retain rights to licensed products for all indications. Amicus is also obligated to use commercially reasonable efforts to commercialize licensed products in the United States following receipt regulatory approval and in a manner that is materially consistent with Amicus’s commercialization plan for the licensed products.
Dimerix will manufacture and supply DMX-200 and licensed products for Amicus using its existing third-party contract manufacturing organization under a supply agreement to be negotiated between Dimerix and Amicus following the effective date of the Agreement.
Amicus will grant Dimerix an exclusive license (with the right to sublicense) under certain know-how and patent rights generated through activities conducted by Amicus, its affiliates or sublicensees under the Agreement for Dimerix to use in the development, manufacture, or commercialization of DMX-200 and other licensed products outside of the United States.
Upon the effective date of the Agreement, Amicus will pay to Dimerix an upfront fee of $30 million US dollars. Amicus will also be obligated to pay Dimerix for certain (i) success-based development and regulatory milestones for FSGS of up to a maximum aggregate amount of $75 million US dollars, (ii) regulatory milestones for other indications of up to a maximum aggregate amount of $40 million US dollars and (iii) commercial milestones of up to a maximum aggregate amount of $445 million US dollars.
Amicus is also obligated to pay Dimerix royalties ranging from percentages in the low-teens to low-twenties on net sales of licensed products, subject to certain customary reductions and offsets. These royalties are payable, on a licensed product-by-licensed product basis, until the latest of (i) the expiration of certain patent rights covering the relevant licensed product in the United States, (ii) the expiration of all regulatory exclusivity for such licensed product in the United States, or (iii) an agreed period of time after the first commercial sale of such licensed product in the United States.
From the effective date of the Agreement until a specific period of time after receipt of the first regulatory approval for a licensed product in the United States, neither Amicus nor Dimerix may, directly or indirectly, conduct any clinical development or commercial activities in the United States involving (a) any product for the treatment of FSGS nor (b) any product that antagonizes CCR2 as its primary mechanism of action, other than with respect to a licensed product under the Agreement, and subject to certain exclusions for independent programs of an acquirer of either party that remain segregated following a change of control of the relevant party.
Unless earlier terminated, the Agreement will continue on a licensed product-by-licensed product basis, until there are no more royalty payments owed to Dimerix with respect to such licensed product and Amicus will have a non-exclusive, fully paid-up license after the expiration of the royalty term for a licensed product. Each party may terminate the Agreement in its entirety if the other party remains in material breach of the Agreement following a cure period to remedy the material breach. Amicus may terminate the Agreement in its entirety for convenience and after giving a specified amount of prior notice to Dimerix, but Amicus may not do so for a certain period of time after the effective date of the Agreement, unless the termination is based on the occurrence of a material adverse safety event with respect to a licensed product. Dimerix may additionally terminate the Agreement, subject to a specified cure period, if Amicus challenges any patents licensed to Amicus under the Agreement.
The foregoing description of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of such Agreement. Amicus intends to redact certain portions of the Agreement in accordance with applicable law and expects to file a copy of the Agreement as an exhibit to Amicus’ Quarterly Report on Form 10-Q for the quarter ending June 30, 2025.
Blackstone Agreement
On April 28, 2025, Amicus entered into an amendment (the “First Amendment”) to the Loan Agreement, dated October 2, 2023, by and among Amicus as the borrower, certain subsidiaries of Amicus as guarantors, Blackstone Alternative Credit Advisors LP and Blackstone Life Sciences Advisors L.L.C. (collectively, the “Blackstone Representative” and referred to herein as “Blackstone”) and Wilmington Trust, National Association, (the “Agent”) as the agent for certain lenders from time to time party thereto, governing the Company’s $400 million senior secured term loan. Capitalized terms used but not otherwise defined in this Item 1.01 under the heading “Blackstone Agreement” have the respective meanings ascribed to such terms in the Loan Agreement. The Blackstone Agreement was filed as Exhibit 10.1 to Amicus’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 2, 2023.
Pursuant to the terms of the First Amendment, Amicus, Blackstone and the Agent have agreed to amend the Loan Agreement to (i) include reference to the obtainment of the Dimerix License Agreement and (ii) revise the Permitted Acquisition Aggregate Consideration Limit to account for the $30 million up-front fee in connection with the Dimerix License Agreement.
A copy of the First Amendment is filed with this Current Report on Form 8-K as Exhibit 10.1 and is incorporated herein by reference. The foregoing description of the First Amendment is qualified in its entirety by reference thereto.
Item 7.01 – RegulationFD Disclosure.
On April 30, 2025, the Company issued a press release announcing its entry into the Agreement, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Act”), or otherwise subject to the liabilities of that Section. The information in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
Signature Page
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AMICUS THERAPEUTICS, INC. | ||
|---|---|---|
| Date: May 1, 2025 | By: | /s/ Ellen S. Rosenberg |
| Name: | Ellen S. Rosenberg | |
| Title: | Chief Legal Officer and Corporate Secretary |
Exhibit 10.1
FIRST AMENDMENT TO LOAN AGREEMENT
This FIRST AMENDMENT TO LOAN AGREEMENT, dated as of April 28, 2025 (this “Amendment”), is entered into among AMICUS THERAPEUTICS, INC., a Delaware corporation, as the Borrower (on its own behalf and on behalf of each other Credit Party), the Lenders party hereto, and WILMINGTON TRUST, NATIONAL ASSOCIATION, as the Agent.
RECITALS
WHEREAS, reference is made to the Loan Agreement, dated as of October 2, 2023 (as amended, restated, amended and restated, supplemented, waived, or otherwise modified prior to the effectiveness of this Amendment, the “Loan Agreement”), by and among the Borrower, the Lenders party thereto, the Agent, and Blackstone Alternative Credit Advisors LP and Blackstone Life Sciences Advisors L.L.C., collectively, as the Blackstone Representative;
WHEREAS, the Borrower intends to enter into that certain License Agreement, to be dated on or around April 30, 2025 (in the same form and substance as provided to the Blackstone Representative prior to the Effective Date (as defined below), the “Specified License Agreement”), by and between Dimerix Bioscience Pty Ltd, as licensor, and the Borrower, as licensee, pursuant to which the Borrower will obtain an exclusive license to the Licensed Compound (as defined in the Specified License Agreement) (such foregoing-described transaction, the “First Amendment Acquisition”);
WHEREAS, the Acquisition Consideration for the First Amendment Acquisition is in excess of $100,000,000;
WHEREAS, the upfront payment contemplated by Section 8.1 of the Specified License Agreement shall be funded with cash on hand as reflected on the balance sheet of Borrower; and
WHEREAS, in connection with the First Amendment Acquisition, the Borrower has requested that the Agent and the Required Lenders agree to amend certain provisions of the Loan Agreement, as more specifically set forth herein and, subject to the satisfaction of the terms and conditions set forth herein, the Agent and the Lenders party hereto (which Lenders constitute the Required Lenders) have agreed to consent to such amendment.
NOW, THEREFORE, in consideration of the premises and agreements, provisions and covenants herein contained, and for other valuable consideration (the receipt and sufficiency of which is acknowledged by all patties hereto), the parties hereto hereby agree as follows:
Section1. DefinedTerms; References. Unless otherwise specifically defined herein, each term used herein that is defined in the Loan Agreement has the meaning assigned to such term in the Loan Agreement. The rules of construction and other interpretive provisions specified in Section 1 (Accounting and Other Terms) of the Loan Agreement apply to this Amendment, mutatis mutandis.
Section2. Amendments.
| (a) | Section 14.1 (Definitions) of the Loan Agreement is hereby amended as follows: |
|---|---|
| (i) | The following definitions are added to such Section 14.1 in the appropriate alphabetical order: |
| --- | --- |
“First Amendment” means that certain First Amendment to Credit Agreement, dated as of April 28, 2025, by and among the Borrower, the Lenders party thereto, and the Agent.
“First AmendmentAcquisition” has the meaning set forth in the First Amendment.
“PermittedAcquisition Aggregate Consideration Limit” has the meaning set forth in the definition of “Permitted Acquisition”.
“SpecifiedLicense Agreement” has the meaning set forth in the First Amendment.
| (ii) | Clause (h) of the definition of “Permitted Acquisition” is amended and restated in its entirety<br>as follows: |
|---|
(h) the total Acquisition Consideration paid for all Permitted Acquisitions shall not exceed $100,000,000 in the aggregate (such limit, the “PermittedAcquisition Aggregate Consideration Limit”); provided, that (i) any Acquisition Consideration which is (A) paid in the form of Qualified Equity Interests in Borrower, or (B) funded with the proceeds of Qualified Equity Interests in Borrower, in each case of the foregoing subclauses (A) and (B), issued after the date hereof (collectively, “Equity Funded Consideration”), and (ii) any Acquisition Consideration with respect to an Acquisition which has been approved by the Blackstone Representative, in each case of the foregoing subclauses (i) and (ii), shall not be subject to the Permitted Acquisition Aggregate Consideration Limit; provided, further that, (x) for the avoidance of doubt the First Amendment Acquisition shall constitute a “Permitted Acquisition”, (y) if the First Amendment Acquisition is consummated, the Permitted Acquisition Aggregate Consideration Limit shall be reduced to $70,000,000, and (z) (1) the upfront payment contemplated by Section 8.1 of the Specified License Agreement shall be funded with cash on hand as reflected on the balance sheet of Borrower and (2) any subsequent payments in respect of the First Amendment Acquisition (including, without limitation, any Regulatory Milestone Payments, any Sales Milestone Payments, and any Royalty Payments (each, as defined in the Specified License Agreement)) shall not be funded, directly or indirectly, with the proceeds of any additional Indebtedness provided or arranged by a Blackstone Entity (it being understood that this shall not prohibit the use of Permitted Indebtedness that is not provided or arranged by a Blackstone Entity).
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| (iii) | Clause (e) of definition of “Permitted Investments” is amended and restated in its entirety<br>as follows: |
|---|
(e) Investments which are Permitted Acquisitions;
(b) Section 6.3(b) (Mergers, Acquisitions, Liquidations or Dissolutions) of the Loan Agreement is hereby amended and restated in its entirety as follows:
(b) make, or permit any of its Subsidiaries to make, Acquisitions, other than Permitted Investments.
Section3. Conditionsto Effectiveness. This Amendment shall become effective on the date and time (such date and time, the “Effective Date”) on which the Agent shall have received executed counterparts of this Amendment from the Agent, the Borrower and Lenders constituting the Required Lenders.
Section4. Effectof this Amendment; Reaffirmation. Except as expressly set forth herein, this Amendment shall not, by implication or otherwise, limit, impair, prejudice, constitute a waiver of, or otherwise affect the rights and remedies of the Lenders or the Agent under, the Loan Agreement or under any other Loan Document and shall not alter, modify, amend or in any way affect any of the terms, conditions, obligations, covenants or agreements contained in the Loan Agreement or any other provision of the Loan Agreement or of any other Loan Document, all of which are hereby ratified and affirmed by the Borrower (on its own behalf and on behalf of each other Credit Party) in all respects and shall continue in full force and effect. On and as of the Effective Date, (i) this Amendment shall be a Loan Document and (ii) each reference in the Loan Agreement to “this Agreement”, “hereof”, “hereunder”, “herein” and “hereby” and each other similar reference, and each reference in any other Loan Document to “the Loan Agreement”, “thereof”, “thereunder”, “therein” or “thereby” or any other similar reference to the Loan Agreement shall refer to the Loan Agreement as amended hereby.
Section5. CHOICEOF LAW, VENUE, AND JURY TRIAL WAIVER; COUNTERPARTS. The provisions of Section 10 (CHOICE OF LAW, VENUE, AND JURY TRIAL WAIVER)and Section 11.6 (Counterparts) of the Loan Agreement are incorporated herein by reference, mutatis mutandis.
Section6. AgentDirection. By its execution of this Amendment, each of the undersigned Lenders (which, collectively, constitute the Required Lenders) hereby authorizes and directs the Agent to execute and deliver this Amendment on the date hereof.
[Remainder of Page Intentionally Blank]
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IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed by their respective authorized officers as of the day and year first above written.
| AMICUS THERAPEUTICS,<br> INC., as the Borrower | |
|---|---|
| By: | /s/ Bradley Campbell_ |
| Name: Bradley L. Campbell | |
| Title: President and Chief Executive<br> Officer |
[Signature Page to First Amendment to Loan Agreement]
| WILMINGTON<br> TRUST, NATIONAL ASSOCATION, as the Agent | |
|---|---|
| By: | /s/Annmarie Warren |
| Name: Annmarie Warren | |
| Title: Assistant Vice President |
[Signature Page to First Amendment to Loan Agreement]
| BXLS YIELD<br> – BRIEF L.P., as a Lender | |
|---|---|
| By: | /s/ Robert Liptak |
| Name: Robert Liptak | |
| Title: Authorized Signatory |
[Signature Page to First Amendment to Loan Agreement]
| Armstrong Sub<br> LLC, as a Lender | |
|---|---|
| By: Akron Top Sub LLC, its sole<br> member | |
| By: Akron Topco LP, its sole<br> member | |
| By: Blackstone Rated Senior<br> Direct Lending Associates, LLC, its general partner | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory | |
| Anna Sub LLC,<br> as a Lender | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory | |
| Bella Sub LLC,<br> as a Lender | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory | |
| Cara Sub LLC,<br> as a Lender | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory | |
| BXCI Blossom<br> Credit Series Fund-C SPV LLC, as a Lender | |
| By: Blackstone Credit Series<br> Fund-C Associates LLC, as its manager | |
| By: GSO Holdings I, L.L.C.,<br> as its managing member | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory |
[Signature Page to First Amendment to Loan Agreement]
| BXCI Wedelia<br> Credit Series Fund-C SPV LLC, as a Lender | |
|---|---|
| By: Blackstone Credit Series<br> Fund-C Associates LLC, as its manager | |
| By: GSO Holdings I, L.L.C.,<br> as its managing member | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory |
[Signature Page to First Amendment to Loan Agreement]
| Bach Sub LLC,<br> as a Lender | |
|---|---|
| By: Berlin Top Sub LLC, its<br> sole member | |
| By: Berlin Topco LP, its sole<br> member | |
| By: Blackstone Rated Senior<br> Direct Lending Associates LLC, its general partner | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory | |
| Blackstone<br> Credit Hibiscus Fund LP, as a Lender | |
| By: Blackstone Credit Hibiscus<br> Associates LLC, its general partner | |
| By: GSO Holdings I LLC, its<br> managing member | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory | |
| Blackstone<br> Credit Orchid Fund II LP, as a Lender | |
| By: GSO Orchid Associates LLC,<br> its general partner | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory | |
| Blackstone<br> Multi-Asset Credit Holdings LP, as a Lender | |
| By: Blackstone Multi-Asset Credit<br> Associates LLC, its general partner | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory |
[Signature Page to First Amendment to Loan Agreement]
| BXC BXDR Sub-C<br> LLC, as a Lender | |
|---|---|
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory |
[Signature Page to First Amendment to Loan Agreement]
| Cook Sub LLC,<br> as a Lender | |
|---|---|
| By: Cambridge Top<br> Sub LLC, its sole member | |
| By: Cambridge Topco<br> LP, its sole member | |
| By: Blackstone Rated<br> Senior Direct Lending Associates LLC, its general partner | |
| By: | /s/<br> Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized<br> Signatory | |
| Darwin Sub<br> LLC, as a Lender | |
| By: Doncaster Top<br> Sub LLC, its sole member | |
| By: Doncaster Topco<br> LP, its sole member | |
| By: Blackstone Rated Senior Direct Lending Associates LLC, its general partner | |
| By: | /s/<br> Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized<br> Signatory | |
| Eisenhower<br> Sub LLC, as a Lender | |
| By: Eastland Top<br> Sub LLC, its sole member | |
| By: Eastland Topco<br> LP, its sole member | |
| By: Blackstone Rated<br> Senior Direct Lending Associates LLC, its general partner | |
| By: | /s/<br> Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized<br> Signatory |
[Signature Page to First Amendment to Loan Agreement]
| Aloe Sub LLC, as<br> a Lender | |
|---|---|
| By: Aloe Top Sub LLC, its sole member | |
| By: Aloe Topco LP, its sole member | |
| By: BXC Azul Associates LLC, its general<br> partner | |
| By: | /s/<br> Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory | |
| Alpaca Sub LLC, as<br> a Lender | |
| By: Alpaca Top Sub LLC, its sole member | |
| By: Alpaca Topco LP, its sole member | |
| By: BXC Jade Associates LLC, its general<br> partner | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory | |
| RLA Private Credit Number 1 Fund,<br> as a Lender | |
| Resolution Life Australasia Limited<br> in its capacity as manager for Equity Trustees Limited as trustee for RLA Private Credit Number 1 Fund | |
| By: Blackstone Alternative Credit<br> Advisors LP, pursuant to the power of attorney now and hereafter granted to it as Sub-Manager | |
| By: | /s/ Marisa Beeney |
| Name: Marisa Beeney | |
| Title: Authorized Signatory |
[Signature Page to First Amendment to Loan Agreement]
Exhibit 99.1
Dimerix and Amicus Therapeutics Announce ExclusiveLicense Agreement for DMX-200 in the United States
Amicus licenses exclusive U.S. rights tocommercialize DMX-200 for the treatmentof Focal Segmental Glomerulosclerosis (FSGS)
DMX-200 is in a pivotal Phase 3 trial forFSGS, a rare and fatal kidney diseasewith no FDA-approved therapies
Dimerix successfully completed Type C meetingwith the FDA in March 2025,aligning on proteinuria as the primary endpoint for approval
Dimerix to receive US$30 million (~AU$48million) upfront payment,up to US$560 million (~AU$892 million) for success-based milestone payments,in addition to tiered royalties on DMX-200 net U.S. sales
MELBOURNE, Australia, and PRINCETON, NJ, April30, 2025 – Dimerix Limited (ASX: DXB, “Dimerix”) and Amicus Therapeutics (Nasdaq: FOLD, “Amicus”) today announced that the two companies have entered into an exclusive license agreement for the commercialization of Dimerix’ Phase 3 drug candidate DMX-200 for all indications, including FSGS, in the United States (U.S.). Dimerix retains all rights to commercialize DMX-200 in all territories other than those already exclusively licensed.
DMX-200 is a small molecule inhibitor of the chemokine receptor 2 (CCR2) under development in a pivotal Phase 3 study, ACTION3, for the treatment of Focal Segmental Glomerulosclerosis (FSGS) kidney disease. In early 2024, Dimerix reported positive interim results from the ACTION3 trial in FSGS showing DMX-200 was performing better than placebo in reducing proteinuria with no safety concerns to date. Full enrollment of ACTION3 is expected by year-end 2025. An additional blinded interim analysis is planned once the revised primary and secondary endpoints have been pre-specified in the protocol and agreed with the FDA. In a March 2025 Type C meeting, Dimerix successfully aligned with the FDA on proteinuria as an appropriate primary endpoint for traditional marketing approval for DMX-200.
“Amicus is thrilled to enter into this collaboration with Dimerix to bring DMX-200 to patients in the U.S., and we are incredibly impressed by their achievements to date. We look forward to leveraging our regulatory, commercial, medical, and advocacy capabilities to bring this potentially transformative treatment to people living with FSGS in the U.S.,” said Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics. “This licensing agreement represents a major step forward in our strategy to strengthen our portfolio and fully aligns with our mission to develop and deliver transformative medicines for people living with rare diseases.”
“We are delighted to partner with Amicus in the United States. The Amicus team has a remarkable history of successfully delivering rare disease medicines to those in need. Their expertise and resources will be crucial to help achieve our mutual objective of commercializing this innovative treatment,” said Dr. Nina Webster, CEO and Managing Director of Dimerix. “I’m grateful to the dedicated Dimerix team, trial participants, and investigators for their continued commitment to developing a new therapy for patients with FSGS who currently have a poor prognosis and very limited treatment options.”
Dimerix will continue to fund and execute the ACTION3 study, and Amicus will be responsible for submission and maintenance of the regulatory dossier in the United States, as well as all costs of commercialization activities. Additionally, Amicus will have the exclusive rights to develop DMX-200 in other future indications in the United States. Amicus and Dimerix will form a Joint Steering Committee to align the development and commercialization of DMX-200 in FSGS in U.S. The agreement otherwise contains terms common for an arrangement of this kind.
In exchange for these rights, Dimerix will receive a US$30 million (~AU$48 million) upfront payment. The next potential milestone payment is based on positive data from the Phase 3 trial in FSGS. In total, Dimerix is eligible to receive potential success-based development and regulatory milestone payments of up to US$75 million (~AU$119 million) until FDA approval of DMX-200 in FSGS, US$35 million (~AU$56 million) on first sale, commercial sales milestone payments of up to US$410 million (AU$653 million), and tiered royalties from the low-teens to low-twenties percentages of DMX-200 net sales in the U.S. In addition, Dimerix is eligible to receive up to US$40 million (~AU$64 million) in milestone payments for potential future indications. The upfront payment from Amicus will be funded with cash on hand. All contracted financial terms are denominated in U.S. dollars.
Evercore Partners International LLP is acting as exclusive financial advisor to Dimerix, and Cooleys LLP is serving as Dimerix legal advisor. Wilson Sonsini Goodrich & Rosati is serving as Amicus legal advisor.
Authorized for lodgment with ASX by the Board of Dimerix.
About ACTION3 Phase 3 Study
The Phase 3 study, which is titled “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis”, or ACTION3 for short, is a pivotal (Phase 3), multi-center, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo.
The single Phase 3 trial in FSGS patients has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval. Further information about the study can be found on ClinicalTrials.gov (Study Identifier: NCT05183646) or Australian New Zealand Clinical Trials Registry (ANZCTR) (Study Identifier ACTRN12622000066785).
About DMX-200
DMX-200 is a chemokine receptor (CCR2) antagonist administered to patients already receiving an angiotensin II type I receptor (AT1R) blocker, the standard of care treatment for hypertension and kidney disease. DMX-200 is protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042, in addition to Orphan Drug Designation granted by the FDA in the United States.
About FSGS
FSGS is a rare, serious kidney disorder characterized by progressive scarring (sclerosis) in parts of the glomeruli—the kidney’s filtering units. This scarring leads to proteinuria, progressive loss of kidney function, and often end-stage renal disease. FSGS is increasingly understood to have an inflammatory component, with monocyte and macrophage activation contributing to glomerular injury. In the United States, more than 40,000 people are estimated to be living with FSGS, including both adults and children. There are no therapies specifically approved for FSGS in the U.S., and management relies on non-specific immunosuppressive and supportive therapies. In patients with progressive or treatment-resistant FSGS, the average time from diagnosis to end-stage kidney disease can be as short as five years. Even among those who undergo kidney transplantation, disease recurrence occurs in up to 60% of cases, underscoring the urgent need for new, disease-modifying treatments.
About Dimerix Limited
Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company working to improve the lives of patients with inflammatory diseases, including kidney diseases. Dimerix is currently focused on developing its proprietary Phase 3 product candidate DMX-200, for Focal Segmental Glomerulosclerosis (FSGS) kidney disease, and is also developing DMX-700 for respiratory disease. DMX-200 and DMX-700 were both identified using Dimerix’ proprietary assay, Receptor Heteromer Investigation Technology (Receptor-HIT), which is a scalable and globally applicable technology platform enabling the understanding of receptor interactions to rapidly screen and identify new drug opportunities. For more information, please visit the company’s website at www.dimerix.com and follow on X and LinkedIn.
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About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. For more information please visit the company’s website at www.amicusrx.com, and follow on X and LinkedIn.
Forward Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to: the Amicus collaboration and license agreement with Dimerix of DMX-200, the timing of Phase 3 clinical trial evaluating DMX-200; the likelihood of success of such clinical trial; the prospects for FDA approval of DMX-200 for FSGS or other indications; the estimated prevalence of FSGS; the achievement of any milestone and timing of any payments associated with milestones and the success of any efforts to commercialize DMX-200, including any projections of future financial performance or payments. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
DIMERIX CONTACTS:
Dr. Nina Webster
Dimerix Limited
Chief Executive Officer & Managing Director
Tel: +61 1300 813 321
E: investor@dimerix.com
Rudi Michelson
Monsoon Communications
Tel: +61 3 9620 3333
Mob: +61 (0)411 402 737
E: rudim@monsoon.com.au
AMICUS CONTACTS:
Investors:
Amicus Therapeutics
Andrew Faughnan
Vice President, Investor Relations
afaughnan@amicusrx.com
+1 (609) 662-3809
Media:
Amicus Therapeutics
Diana Moore
Head of Global Corporate Affairs and Communications
dmoore@amicusrx.com
+1 (609) 662-5079
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