Latest news with #MaynePharma
AU Financial Review
10-07-2025
- Business
- AU Financial Review
Hedge fund bets US suitor won't get out of Mayne Pharma takeover
Ben Bailey helps oversee Harvest Lane Asset Management's Absolute Return Fund. The Sydney-based mergers and acquisition's arbitrage fund oversees about $200 million in assets. On Mayne Pharma, why are you betting the company will succeed in forcing US private equity suitor Cosette to complete its $672 million takeover, despite it terminating the deal last month?
News.com.au
18-06-2025
- Business
- News.com.au
Health Check: Mayne Pharma shareholders back $600m ‘phantom' takeover offer
Mayne investors today strongly endorsed Cosette's non-existent takeover offer Audeara's improving sales are loud and clear We ferret around for all the latest clinical trial news Mayne Pharma (ASX:MYX) shareholders have overwhelmingly approved the company's $600 million takeover scheme of arrangement, even though suitor Cosette has terminated the deal. At the Melbourne meeting, the company reported 699 proxy votes in favour of 98.57%, compared with four 'nays' accounting for 0.95%. Open proxies accounted for a further 0.47% or so. The deal is a phantom one, in the sense that Cosette pulled out on the grounds that adverse material events had occurred. Such a withdrawal is allowable under the scheme implementation deed (SID). In a cross claim, Cosette alleges Mayne engaged in misleading or deceptive conduct. Mayne disputes these allegations and says the SID – now glowingly endorsed by investors – remains valid. The company has filed NSW Supreme Court proceedings to seek such a ruling. Chairman Frank Condella told holders the SID was subject to a favorable court adjudication, 'in the absence of any other agreement being able to be reached with Cosette in relation to the dispute.' He warned that if Mayne's legal quest fails, the company may be subject to 'financial detriment, including damages claims and/or costs orders and the payment of a break fee to Cosette ." That said, Mayne directors believe that it's in the shareholders' best interest to pursue litigation. Hear! Hear! Audeara in bullish trading update The maker of own-brand and white label devices to assist hearing, Audeara (ASX:AUA) says it is poised for a record year on the back of sales orders from two key clients. The company reported unaudited revenue for the year to June (eleven months) of $3.64 million, up 14% on the previous year and 25% higher than in the 2022-23 year. Audeara's fortunes have been underpinned by the launch of Taiwan hearing device leader Clinico's co-branded sound buds, which imbed Audeara's 'secret sauce' tech. This tie up resulted in an initial $570,000 order. The company also received a follow-up order of $917,000 from 400-year-old musical instrument maker Avedis Zildjian. Audeara also grew Australian wholesale sales by 16%, to $1.67 million. Management expects additional growth in coming weeks, including sales to wholesalers, retailers and resellers. We're 'earing different things about Cochlear Still on hearing devices, broking analysts have offered different takes on Cochlear's (ASX:COH) prospects after the company last Thursday downgraded full-year earnings expectations by 2-5%. And that's okay – it's a democracy after all. The company said its moderated outlook resulted from slowing growth for both cochlear implants and sound processors in its developed markets. Investors ponder to what degree Cochlear's new off-the-ear (OTE) Kanso 3 sound processor – and the next-gen implant Nucleus Nexa – will rev up sales. UBS has upped its call on the stock from neutral to a buy, with a new price target of $325 compared with $285 previously. The company believes Cochlear's new implants can boost its compound annual revenue growth by 10% over the next three year. Over this period, the firm expects Nucleus Nexa to increase Cochlear's global implant share by 3%, to 63%. Cochlear this month is launching the device in Europe and the Asia Pacific. Maintaining a 'hold', Morgans lowers its 'target price' from $286.24 to $281.36. 'While new systems tend to precede re-rates, we remain cautious,' the firm says. Morgans notes Nucleus Nexa 'appears more about refining the user experience as opposed to offering technological advancements as seen with prior implant iterations.' Sounds like the Iphone phenomenon, in that the 'wow factor' is dulled with every new release. Argenica pursues brain damage study Today's clinical trial updates come courtesy of rats, mice and ferrets and we thank these rodents and weasels for their sacrifice. In the case of Argenica Therapeutics (ASX:AGN), the brain and neurogenerative injuries specialist will forge head with a trial of its drug candidate ARG-007. This is for the hard-to-treat traumatic brain injury (TBI). This go-ahead follows a second preclinical study in a large cohort ferret. This showed ARG-007 resulted in 'significant long-lasting reduction in brain cell damage and inflammation following injury.' This 14-day study extended an initial three-day pilot effort. Aregenica says the ferret model 'closely resembles the gross anatomy of the human brain'. Combined with previous rat studies and the pilot ferret trial, this provides a 'robust preclinical data package'. TBI affects 69 million people globally annually, with no approved therapies. The University of Adelaide carried out the study, partly funded by a federal grant. The results should soothe investor disappointment over last week's setback, when the FDA placed a 'clinical hold' on Argenica's request to carry out a US ischaemic stroke trial. However, the company says its local phase II trial, now at dosing stage, is unaffected. Inoviq's (Exo) Ace trial news Inoviq (ASX:IIQ) reports that in vitro lab work has shown that one of its drug candidates killed 88% of aggressive triple negative breast cancer and lung cancer cells. The treatment deploys exosomes: tiny particles that deliver targeted therapies. The story gets complex because Inoviq uses engineered immune cell particles called CAR-NK-EVs, overlaid with its special process called Exo-Ace. The short explanation is the efforts could lead to an 'off the shelf' therapy that is faster, safer and more effective than traditional cell therapies (such as burgeoning CAR-T treatments that involve tricking up the T cells). Inoviq now will test the treatment in mice. It's very early days, but Inoviq shares this morning surged as much as 21%. Lumos enrolls its 500th patient Meanwhile, Lumos Diagnostics (ASX:LDX) has enrolled its 500 th patient in a study to clear its Febridx assay for US sale. A point-of-care test, Febridx rapidly distinguishes between bacterial and viral infections. The tricky bit is enrolling enough bacteria-positive patients and to date the company has corralled 78 of the requisite 120. By reaching 500 patients, Lumos has pocketed a US$298,457 milestone payment from its partner, the Biomedical Advanced Research and Development Authority (BARDA). BARDA hands over another US$746,143 when the trial enrols the last patients. Lumos doesn't specific a number, but expects the process to complete by the end of 2025. Lumos is seeking so-called CLIA (Clinical Laboratory Improvements Amendment) waiver. This enables simple tests to be used by less trained staff such as nurses and receptionists.
AU Financial Review
09-06-2025
- Business
- AU Financial Review
Proxy advisers support Mayne Pharma deal as suitor tries to exit
A legal dispute between Mayne Pharma and private equity suitor Cosette, which has terminated its $672 million takeover offer for the Adelaide-based target, may drag on in the courts for years unless the bidding parties settle their dispute ahead of a shareholder vote on the deal in two weeks. Shareholders and sources close to the transaction, who were not authorised to speak publicly, said there was no legal precedent in Australia for Cosette's termination based on its claim that there has been a material adverse change in Mayne Pharma's financial position.
News.com.au
05-06-2025
- Business
- News.com.au
Health Check: Medical device makers Trump drug developers in volatile US healthcare climate
Medical device makers – including ASX-listed heart plays – are the likely winners from the US healthcare chaos Painchek hopes for US device approval by September Mayne Pharma flags legal action over Cosette bid but also waves an olive branch Medical device makers are better placed than drug companies to withstand the volatile US healthcare climate, according to broker Canaccord. In a report, the firm notes that while the US biotech sector has fallen in value over the past 12 months, medtechs have gained ground. The overall measure, the Nasdaq Biotechnology Index, has lost 8% over the past year and 1.25% over the past month. But the benchmark Ishares US Medical Devices ETF (IHI) has gained 10% over the past year and 12% over the past month. The firm says the performance is supported by recent earnings announcements, with 15 of the top 16 stocks reporting higher than expected profits. The firm opines the device makers look a safer bet because they are not caught up in the debate about lower drug prices, following Donald Trump's 'Most Favoured Nation' (MFN) decree (see below). 'Medical device/tech companies also appear to have more clarity regarding how/if tariffs may or may not impact their businesses.' ASX device makers active in the US include the ginormous ResMed (ASX:RMD) and Cochlear (ASX:COH), as well as Telix Pharmaceuticals (ASX:TLX). In April EBR Systems (ASX:EBR) won US approval for its Wise pacemaker, the world's first ventricular assist device. Also in the heart space, the agency approved Echo IQ (ASX:EIQ) aortic stenosis tool, Echo AS. In April 2023 Cardiex (ASX:CDX) won FDA assent for Conneqt Pulse, its vascular biometric heart monitor. This week, the local Therapeutic Goods Administration followed suit. Drug makers 'in the dark' on pricing MFN means US drug prices would be benchmarked against the lowest prevailing price across developed countries. The drug debate originated in the Biden era, with the Inflation Reduction Act (IRA) requiring the Medicare system to negotiate prices for certain high-cost drugs. 'Pharma/biotech companies seem somewhat in the dark regarding proposed MFN policies, but recent discussions have suggested decisions may be set to come through in the next 30 to 60 days,' Canaccord says. 'The push to lower drug prices could be a long-drawn-out legal battle, which may ultimately fail to move beyond the IRA, or contain a number of exemptions and loopholes.' The firm says ASX healthcare stocks 'have not been immune to the chaos' engulfing the US. But US biotech earnings momentum has turned positive. This likely will result in improved share valuations 'which the ASX is likely to follow.' Painchek has nice chat with FDA Still on Trumpian shores, PainChek (ASX:PCK) said it has a 'successful' follow-up meeting with the FDA that sought feedback ahead of its intended US marketing application. Painchek is the world's first mobile-based pain assessment and monitoring device for patients unable to enunciate their discomfort (such as dementia patients). Held on June 3, the second meeting focused on Painchek addressing the FDA's final questions about the company's recent US trial results. 'The meeting was a positive two-way conversation providing feedback and clarity for both parties.' The company hopes to lodge its submission this month, under the new device pathway. Under the FDA's timelines, the company should have an answer by late September. FDA consent would be a company maker for Painchek, which already has a foothold in the local and UK aged-care sectors. Share fever as Clarity trial proves a DISCO hit Shares in radiotherapy play Clarity Pharmaceuticals (ASX:CU6) today bounded up to 11% after the company reported top-line results from its groovily-monikered DISCO trial. The study blew the (strobe) lights out by showing its copper-isotope based candidate to be highly effective in detecting neuroendocrine tumours (NETs) NETs most commonly occur in the gastrointestinal tract, lung and pancreas, but may also originate in other areas including the breast, prostate and skin. The phase II study compared Clarity's 64Cu-Sartate against standard of care imaging. 64 Cu-Sartate 'substantially outperformed' the standard gallium isotope-based therapy, detecting 393 to 488 lesions among 45 participants. Of these lesions, 230-251 were deemed 'discordant', that is, identified on only one of the scans. And guess what? Clarity's method accounted for 93% of them. Clarity initially designed the trial to enrol up to 63 patients. But after early analysis the company was able to reduce the sample size to 45 and thus expedite the study. Clarity is now eyeing FDA assent for a phase III registrational trial. And if you really want to know, DISCO stands for 'Diagnostic Imaging Study of 64COpper-Sartate'. Who would have predicted a 'massive oversubscription'? Predictive diagnostics play Proteomics International Laboratories (ASX:PIQ) says its $7.5 million share purchase plan (SPP) was 'massively oversubscribed' – a rare event for such funding mechanisms. The SPP follows a $4.5 million into raising and a $500,000 board and management whip 'round. The funds were raised at 37 cents a share, a 17% discount, with an attached option on every second share subscribed for. The $12 million will support the company's commercialisation of its three tests. These are for diabetic kidney disease (PromarkerD), Promarker Eso (esophageal cancer) and endometriosis (Promarker Endo). Also today, the company pointed to a write up of its Promarker Eso study in the peer-reviewed tome Proteomes. For the few of us who don't subscribe, the assay detected esophageal carcinomas accurately across 259 serum samples. As we opined last week, its hard to know whether peer-reviewed pronouncements reiterate old announcements, or are 'new news'. In this case, the company says the published stuff 'builds upon and extends' earlier announced study results. Mayne, Mayne won't go away Mayne Pharma (ASX:MYX) is far from conceding that its $600 million takeover has been blown away, despite suitor Cosette terminating the deal on the grounds of 'material adverse events'. The company releasetoday noted the scheme meeting would go ahead on June 18, as scheduled. 'Mayne Pharma directors continue to unanimously recommend that vote in favour of the scheme resolution at the scheme meeting, in the absence of a superior proposal," intoned chairman Frank Condella. There's a big proviso, though: the company needs a court decision to affirm its view that the 'material adverse events' were not, in fact, material. While the company will go legal if needs be, it is open to 'seeking to find a path forward with the scheme that does not involve pursuing litigation'. Mayne shares today edged up around 3%, having plunged 14% yesterday after Cosette's withdrawal.
AU Financial Review
04-06-2025
- Business
- AU Financial Review
Cosette terminates Mayne Pharma deal as legal challenge looms
US pharmaceutical giant Cosette has terminated its $672 million takeover bid for Adelaide-based drug company Mayne Pharma, but the target company says it will challenge the move in the courts. Mayne Pharma shares fell as much as 7 per cent on Wednesday after it told investors it had received notice from private equity-backed Cosette that it would terminate the $7.40 per share offer, setting the stage for a potential legal battle.
