Latest news with #DMX-200
Yahoo
01-05-2025
- Business
- Yahoo
Dimerix and Amicus to commercialise DMX-200 in US
Australian biopharmaceutical company Dimerix and Amicus Therapeutics have signed an agreement for the US commercialisation of the former's Phase III drug candidate DMX-200. The drug will be marketed for all indications, including the rare kidney disease focal segmental glomerulosclerosis (FSGS). Dimerix retains the drug's commercialisation rights in all territories, excluding the already licensed areas. Amicus will gain exclusive development rights to the drug for other potential future indications in the country. The companies will establish a joint steering committee to coordinate development and commercialisation strategies for DMX-200 in FSGS treatment in the US market. In return for these rights, Dimerix will obtain an upfront payment of $30m from Amicus, with the potential for additional milestone payments based on the success of the Phase III trial for treating FSGS. The upfront payment will be made by Amicus with cash on hand. Dimerix could receive up to $75m in development and regulatory milestone payments until US Food and Drug Administration (FDA) approval is gained, $35m upon first sales and commercial sales milestone payments up to $410m, along with tiered royalties on net sales in the country. The company may also receive up to $40m for potential future indications. Evercore Partners International is serving as Dimerix's exclusive financial advisor. Cooleys is the legal advisor. Amicus' legal advice is provided by Wilson Sonsini Goodrich & Rosati. Amicus Therapeutics CEO and president Bradley Campbell stated: 'Amicus is thrilled to enter into this collaboration with Dimerix to bring DMX-200 to patients in the US, 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 US.' A chemokine receptor 2 inhibitor, DMX-200 has shown promising interim outcomes in the ongoing pivotal Phase III ACTION3 trial. Dimerix will fund and manage the trial, while Amicus will handle the regulatory dossier submission and maintenance in the US, along with all commercialisation expenses. The drug is protected by patents until 2032, and these may extend to 2042 with further applications, including an orphan drug designation by the US regulator. "Dimerix and Amicus to commercialise DMX-200 in US" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
News.com.au
01-05-2025
- Business
- News.com.au
Health Check: Dimerix shares soar as the company hooks the billion-dollar big one in the US
Dimerix's tie-up with the Nasdaq-listed Amicus Therapeutics takes the kidney drug developer's potential payments from partners to more than A$1.4 billion Telix is roughed up in rare critical analyst report (and so is Impedimed) Memphasys says its sperm selection tool is pregnant with promise Dimerix (ASX:DXB) has filled the US gap in its network of global partnerships, today revealing a US tie-up potentially worth more than A$1 billion if the company's kidney drug candidate is commercialised there. Dimerix chief Dr Nina Webster dubs the compact, with the Nasdaq-listed rare diseases house Amicus Therapeutics, as 'one of the biggest deals in Australian biotech history'. Under the deal, Dimerix delivers to Amicus exclusive US rights to its drug candidate DMX-200, which is intended to treat the rare regressive fibrotic kidney disease focal segmental glomerulosclerosis (FSGS). Amicus also has dibs on any further indications. Amicus pays an upfront US$30 million ($48 million) to Dimerix, with the potential for up to US$520 million of success-based payments. These consist of US$410 million of sales milestones, US$75 million on regulatory approval and US$35 million on first sales. Dimerix is also entitled to tiered royalties on sales, in the 'low tens to low twenties' range. Except in Japan, Dimerix remains on the hook for the cost of the placebo-controlled trial, which is enrolling 286 patients across multiple sites. 'Ideal partner' Webster said Dimerix was 'absolutely thrilled' to be partnering with the US$2.2 billion market cap Amicus, which has two commercialised rare disease products and extensive regulatory expertise. 'This makes Amicus the ideal commercial partner for Dimerix,' she says. 'Collectively this puts us in a far stronger position to bring our exciting drug candidate to patients with limited treatment options.' The Amicus tie-up follows three earlier licensing deals. The four deals combined are worth a 'headline' potential $1.4 billion (excluding royalties) and have delivered $66 million in upfront payments. Unveiled in October 2023, Dimerix signed the Europe, Canada, Australia and New Zealand rights to Advanz Pharma. This deal delivered $10.8 million upfront and potential milestones of $219 million. In May last year the company struck a deal for Iraq and the Gulf Countries. This delivered $10.8 million upfront and another $120 million of potential milestones. In January this year, Dimerix struck a deal with Japanese company Fuso which delivered another $7.2 million upfront and $100 million of potential milestones. All eyes on phase III trial progress Of course, most of the funding is back-ended and depends on trial success and US Food & Drug Administration (FDA) approval. Following the failure of Opthea's (ASX:OPT) two phase III eye programs, investors won't be taking anything for granted. But Dimerix has the benefit of an unblinded interim readout, which showed efficacy on key primary endpoints that were better than the placebo control. 'Dimerix has good validation for the asset, both technically and commercially,' Webster says. "We have already demonstrated a strong safety profile and we have already collected encouraging efficacy data, across both the phase II trial and the first unblinded clinical analysis for the phase III trial.' Helpfully, the FDA has agreed to the use of a so-called surrogate endpoints – the level of a certain protein in the urine – in the trial. With no other dedicated FSGS treatment available, the FDA has accorded DMX-200 'orphan' drug designation. This confers benefits such as higher pricing and an exclusive marketing period. Similar orphan drugs in the US sell for between US$120,000 and US$500,000 for a year's treatment. In the meantime, Dimerix continues to pursue licensing deals in key remaining geographies including mainland China and Latin America. Dimerix shares soared close to 50% after a trading halt was lifted. Petra Capital analyst Tanushree Jain says the better-than-expected deal 'provides tangible evidence of industry interest in the DMX-200 asset and the continued exemplary execution capabilities of Dimerix management." Telix is well overvalued, claims analyst Research house Morningstar has gone against the grain of the consensus opinion on Telix Pharmaceuticals (ASX:TLX), describing the $9.5 billion golden child as overvalued by about 40%. This week, the FDA unexpectedly rejected the company's approval application for its brain cancer imaging tool, Pixclara. The agency wants Telix to produce more clinical evidence. Morningstar concurs the company is likely to do just that and eventually win FDA consent for its third approved product. 'We expect eventual approval of Pixclara in our base case but delay earnings contribution to 2026 from 2025 prior,' the firm says. Pixclara has been used on thousands of patients globally, as well as in a US compassionate use program. Telix's first approved agent, Illucix for prostate cancer, has been hugely successful in the US. The company also awaits approval of its kidney cancer imaging agent, Zircaix. But Morningstar opines the market 'appears overly excited about potential new earning streams from Telix's product pipeline, which remains commercially unproven in an increasingly competitive market.' The firm values the stock at $19.50, about 30% lower than the current valuation. … and Impedimed is taken to task for 'so-zo' performance Canaccord's healthcare team has taken ImpediMed (ASX:IPD) to task for overly slow US sales despite its catchment of 258 million patients. Impedimed's Sozo device measures lymphoedema (buildup of fluid in the limbs) in breast cancer patients. Describing Impedimed's March quarter only as "so-zo" – the firm has been 'consistently disappointed in Impedimed's lack of pipeline conversion into real sales'. Under new management, the company has revamped its sales team. 'However, we're still bereft in confidence a material sales uplift, which is needed to restore confidence and drive a re-rate," says Canaccord. There's a twist in the tale: the firm still rates the stock as 'speculative buy' with a 9-cent valuation, compared with Wednesday's close of 4 cents. Memphasys gets to the pointy end of the tadpole – but needs cash After a lengthy gestation period, Memphasys (ASX:MEM) is getting tantalisingly close to an endgame with its sperm selection device for assisted reproduction. But the company needs more funds, having ended the March quarter with a slender $287,000 cash balance after burning $697,000 during the period. In March the company announced the results of its phase III trial of its Felix device. Undertaken with Monash IVF Group (ASX:MVF), the trial met its primary endpoint of a superior embryo utilisation rate. Approval decisions pending in Europe, India and locally. Felix uses electrical charges to separate the decent tadpoles from the duds – and most fall in the latter category. The company claims Felix is 'statistically superior' to the current centrifuging method – which is a bit rough on the taddies. It is also 'non inferior' to the alternative method of 'swim up' – a Darwinian process of sorting the swimmers from the floaters. Post balance date the company raised $1.275 million in a placement and has a $473,000 on a $900,000 R&D tax rebate due in September. The company is in discussions with 'industry and strategic investors, which may involve licensing, joint venture and/or distribution agreements."
Yahoo
30-04-2025
- Business
- Yahoo
Dimerix and Amicus Therapeutics Announce Exclusive License Agreement for DMX-200 in the United States
MELBOURNE, Australia and PRINCETON, N.J., April 30, 2025 (GLOBE NEWSWIRE) -- 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 StudyThe 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 (Study Identifier: NCT05183646) or Australian New Zealand Clinical Trials Registry (ANZCTR) (Study Identifier ACTRN12622000066785). About DMX-200DMX-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 FSGSFSGS 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 and follow on X and LinkedIn. 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 and follow on X and LinkedIn. Forward Looking StatementThis 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 WebsterDimerix LimitedChief Executive Officer & Managing DirectorTel: +61 1300 813 321E: investor@ Rudi MichelsonMonsoon CommunicationsTel: +61 3 9620 3333Mob: +61 (0)411 402 737E: rudim@ AMICUS CONTACTS: Investors: Amicus Therapeutics Andrew Faughnan Vice President, Investor Relations afaughnan@ (609) 662-3809 Media: Amicus Therapeutics Diana Moore Head of Global Corporate Affairs and Communications dmoore@ (609) 662-5079 FOLD-GSign in to access your portfolio
