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Dr Boreham's Crucible: The wheels keep turning for Dimerix and its kidney drug candidate
Dr Boreham's Crucible: The wheels keep turning for Dimerix and its kidney drug candidate

News.com.au

time12-05-2025

  • Business
  • News.com.au

Dr Boreham's Crucible: The wheels keep turning for Dimerix and its kidney drug candidate

As a former bus driver, Dimerix (ASX:DXB) CEO Dr Nina Webster knows that the drug development journey is just as important as the destination when it comes to delivering value to shareholders. The therapeutic trip can be painfully long, especially when investors are in the back street screaming: 'are we there yet'? The developer of a drug for a rare kidney disease, Dimerix is out of the depot and down the road. But with the results of its phase III trial not due for some years, the company needs to navigate a few more twists and turns. At least it's keeping the kids in the back – er, shareholders – entertained with some scenic road stops and ice cream along the way. Last week, Dimerix shares rocketed after the company announced its fourth – and largest – geographic partnership, with the Nasdaq-listed rare diseases house Amicus Therapeutics. The deal delivers US$30 million ($48 million) upfront to Dimerix, with the potential for up to US$520 million of success-based payments. That's a lot of Choc Wedges. Dimerix CEO Dr Nina Webster dubs the deal as 'likely to be one of the biggest in the history of Australian biotech'. Who are we to argue? 'We are absolutely thrilled to be partnering with Amicus,' she adds. The four deals have delivered $66.5 million in upfront cash, with $1.4 billion of potential milestones – payable mainly when the company reaches its destination of US Food and Drug Administration (FDA) approval (see 'finances and performance'). But what's the point of the journey? Dimerix is developing its lead compound, DMX-200, for the rare and regressive kidney disease focal segmental glomerulo-sclerosis (FSGS). FSGS attacks the kidney's filtering units – glomeruli – causing irreversible scarring and permanent kidney damage. Kidney failure typically happens within five years of diagnosis, with 60 % of patients receiving a transplant experiencing recurring FSGS. With no other disease-specific treatment available, the FDA has accorded the condition orphan drug designation. This confers benefits such as marketing exclusivity, higher prices and other regulatory leg-ups. Currently, FSGS is treated with blood pressure medications known as angiotensin receptor blockers. A bit of history Dimerix was founded in 2004 by Dr James Williams and former Macquarie Group adviser Liddy McCall, based on technology developed at the University of Western Australia. Dimerix Bioscience was acquired in July 2015 by the ASX-listed Sun Biomedical, which was developing saliva-based drug tests. The company changed its name to Dimerix Limited in November 2015. Patent lawyer and scientist Kathy Harrison was appointed inaugural CEO in August 2017, having been the company's sole employee when she joined in 2014. A year later she was replaced by Webster. Also, a patent lawyer – as well as a former bus driver – Webster held senior positions at drug companies including Wyeth Pharmaceuticals (now Pfizer), Acrux and Immuron. Amic-able deal Webster says the US$2.2 billion Amicus is an ideal partner because it already has two rare disease medicines and considerable commercial and regulatory experience. 'Collectively this puts us in a far stronger position to bring our exciting drug candidate to patients with limited treatment options.' Here's the nitty-gritty: Amicus pays an upfront US$30 million ($A48 million) to Dimerix, with the potential for up to US$520 million of success-based payments. These milestones 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' percentage range. 'The royalties we have achieved are very good for a deal of this structure and fit very much with the industry standard,' Webster says. Amicus becomes responsible for the FDA approval process and selling the drug, while Dimerix bears the ongoing phase III trial costs. Webster says the Amicus deal had been negotiated in earnest since last November, in a competitive tender process. Past – and future – deals Unveiled in October 2023, Dimerix signed the European, Canadian, Australia and New Zealand rights to the London-based 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 with the World Health Organisation. In January this year, Dimerix then signed on the dotted line with Japanese company Fuso, which delivered another $7.2 million upfront and $100 million of potential milestones. Investor attention now turns to likely follow-on deals in the major territories still up for grabs. These include China, Latin America and South Korea. Webster cites 'significant interest' from potential partners, but 'deals get done when they get done'. Action stations Dimerix's centrepiece is its ongoing phase III trial, dubbed Action 3, which combines DMX-200 with the standard-of care blood pressure drugs. The trial aims for 286 patients across multiple sites, with 185 already randomized and dosed. The study is blinded and placebo-controlled, with the patients medicated for two years, at 70 sites in 11 countries. The primary endpoint is the reduction in the amount of protein seeping from blood in the urine – proteinuria – a telltale sign of kidney disease. This is a similar endpoint to the company's phase II trial. In 2020, the company reported the phase II showed a circa 17% proteinuria reduction relative to placebo, on top of a 15 to 20% benefit from the standard-of-care drug (as measured by published data). In a March 2024 interim phase III analysis of the first 72 patients, the company reported DMX-200 performing better than placebo in reducing proteinuria. Because the trial was blinded, this finding stemmed from statistical modelling. 'This suggests DMX-200 may achieve a statistically significant and clinically meaningful result at the end of the study,' Webster says. 'The results are very encouraging, especially for FSGS patients who currently have very limited treatment options.' The company adds that 42 patients have completed the two-year treatment and rolled on to the open-label extension trial. What's next? Dimerix expects Action 3 enrolment to complete by the end of 2025. Then there's a two-year wait for all of them to finish the treatment and then a few months of analysis before a final read-out. Equating progress to a Melbourne-to-Sydney slog up the Hume Highway, we're at Gundagai. But there are diversions along the Action 3 highway far more interesting than the dog on the tucker box. Sometime before the end of calendar 2025, Dimerix should produce a second interim analysis, which could pave the way for an FDA accelerated approval application. This means that while the company would have to complete the trial, it would be able to sell the drug before then. Last week, the FDA told the company it would accept proteinuria as a so-called 'surrogate endpoint' for the trial. The alternative is to wait for the incidence of kidney end failure, which could take years. The company can use the proportion of patients either achieving a defined proteinuria reduction relative to placebo, or the percentage change in proteinuria from baseline. In any event, the company has been keeping data on both proteinuria trends and estimated glomerular filtration rate (EGFR), which measures the loss of kidney function more directly. 'Proteinuria is far easier to measure because it has far fewer variabilities, so you will get better statistical powering with it,' Webster says. Meanwhile, Dimerix is liaising with a third-party working group called Parasol, which will advise on an 'appropriate endpoint for accelerated approval in FSGS'. This work should take three to six months. Because the next analysis is also blinded, the company needs to discuss the parameters for unblinding with the FDA. Finances and performance At the end of March, Dimerix had cash of $17.5 million and this week banked the $48 million Amicus upfront payment. The company expects the $4.1 million from the Fuso agreement to lob this quarter. So, let's say Dimerix has a smidge under $70 million of cash. There are more riches on the way, with options worth up to $6.2 million due to expire in June 2025. These options are exercisable at 15.3 cents, so there's a handy 360% gain on the table. Any investor who forgets to convert will be kicking themselves. Webster says Dimerix has spent around $60 million on the Action 3 trial to date. But having broken the back of the recruitment stage – the most expensive stanza – outgoings should moderate. Webster says the company is well-funded to pursue its development pipeline and other potential opportunities (see below). On potential drug pricing, there's no directly comparable FSGS therapy. Webster says rare disease drugs in the US typically sell for US$120,000 to US$500,000 per patient per year. Over the last 12 months Dimerix shares have traded between 31 cents in late December last year and 76 cents last Friday. The shares could be picked up for a mere six cents in late 2023. Interestingly, in September 2020 the stock traded at around 74 cents – not far off-peak levels – well before the four company-transforming partnerships. Other diseases? While the US deal involves all DMX-200 indications, the company is free to ponder other therapies. Dimerix has another pre-clinical drug candidate called DMX-700, which targets major lung ailments including chronic obstructive pulmonary disease (COPD). DMX700 works by blocking the interleukin-8 (IL-8) receptor, which is expressed at elevated levels in sick patients. This in turn causes lung tissue damage. Cystic fibrosis also has been mentioned in dispatches. The company has mulled diabetic kidney disease (DKD) in the past. The DKD market has heavy competition and would require much bigger trials, while the advent of anti-obesity GLP-1 drugs may ameliorate the incidence of the disease. Dr Boreham's diagnosis The spectre of eye drug developer Opthea's recent two-phase III trial results cast a dark shadow over the sector. In road trip terms, Opthea followed Siri (the FDA's guidance) to the word but still ended up a dead-end. So why should Dimerix holders be reassured? Apart from the company's positive interim data readout, Webster says the four global partners all underwent extensive due diligence. 'Dimerix has good validation of the asset, both technically and commercially,' she says. 'We have already demonstrated a strong safety profile and have collected encouraging efficacy data, across both the phase II trial and the first unblinded clinical analysis of the phase III trial.' FSGS is a worthwhile journey for the company to make, with the potential market estimated at US$6 billion a year by 2032, across eight key geographies (including US$2 billion in the US). That said, Dimerix is wise in organising some 'side trips' by way of its secondary programs as the risks with DMX-200 – which combines two compounds – always will remain. As Opthea has attested, driving miles and miles only to find a flea-ridden BnB is no one's idea of fun. At a glance ASX code: DXB Share price: 61 cents Shares on issue: 563,520,000 Market cap: $343.75 million Chief executive officer: Dr Nina Webster Financials (March 2025 quarter): customer receipts $3.5 million, cash outflows $4.3 million, cash of circa $70 million (after $52.1 million payments from Amicus and Fuso) Identifiable major holders: Peter Meurs 13.6%, Precision Opportunities Fund 1.8%, Bavaria Bay Pty Ltd (Perth high net worth individuals) 1.3% Dr Boreham is not a qualified medical practitioner and does not possess a doctorate of any sort. Being old fashioned, his guiding star is Melways, not Siri and Gen Y-ers will need to Google this reference.

Health Check: Dimerix shares soar as the company hooks the billion-dollar big one in the US
Health Check: Dimerix shares soar as the company hooks the billion-dollar big one in the US

News.com.au

time01-05-2025

  • 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."

Dimerix and Amicus Therapeutics Announce Exclusive License Agreement for DMX-200 in the United States
Dimerix and Amicus Therapeutics Announce Exclusive License Agreement for DMX-200 in the United States

Yahoo

time30-04-2025

  • 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

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