Latest news with #Althea
News.com.au
07-05-2025
- Business
- News.com.au
Health Check: It's sale time as Medadvisor mulls Aussie exit and Althea renounces medicinal cannabis
Medadvisor shares soar up to 60% after the company flags the sale of its Australian business Pot stock Althea sees better fortunes in the THC-infused beverage sector Clinuvel's phase III vitiligo trial is fully recruited With operations in Australia and the US, 'patient engagement' platform Medadvisor (ASX:MDR) has long believed the value of the former has not been reflected in the company's valuation. Last November the company launched a strategic review to test this theory and it's now bearing fruit. Today, Medadvisor disclosed it had received a non-binding letter of intent from a 'prominent multinational listed software business' interested in buying the Australian arm. While the cash offer remains commercial in confidence, the board believes the offer is 'materially' higher than what's implied in the company's share price. Investors agreed, sending the stock up to six cents, or 60%, higher this morning. The company then requested a trading halt pending a further update on Friday. Medadvisor's premise is that despite the billions of dollars spent on developing new drugs, many of them are ineffective for many patients. Around one-fifth of adults with chronic health conditions don't fill their prescriptions in the first place. Of the remainder who do, half of them stop taking the treatment after 90 days. In the US, Medadvisor conducts education campaigns for pharma companies. There, the company has been affected by a lull in vaccination rates, which has crimped spending on vaccine drug launches. Locally, the company operates Medadvisor for Pharmacy, a cloud-based workflow tool for prescription reminders, scheduling flu shots and the like. The company has signed up more than 95% of pharmacies accounting for 3.7 million prescriptions annually. The Australian business accounted for 20% of Medadvisor's total December half revenue of $57.1 million, down an overall 24%. Medadvisor says the Australian business continues to perform strongly, with record revenue of $2.9m in the month of April. The company cites a timeline of five to seven weeks for a deal to be done. 'We are pleased to have received a compelling offer which validates our view of the significant strategic value of ,' Medadvisor chief Rick Ratliff says. THC beverages? We'll drink to that, says Althea Amid a domestic oversupply of the green stuff, Althea Group (ASX:AGH) has sold its local medical cannabis business following a strategic review. Instead, Althea will focus on the fast-growing THC-infused beverage market in the US. THC is the active ingredient in cannabis. As outlined in a binding term sheet, Althea will sell its pharmaceutical assets to Tasmanian Botanics Pty Ltd for $1 million. This includes a revenue-sharing arrangement on residual inventory sales. 'The medicinal cannabis landscape in Australia has shifted in recent years, and this transaction represents a thoughtful and strategic response to those changes,' Althea CEO Joshua Fegan says. Althea's beverage business operates via its subsidiaries Peak Canada and Peak US. These arms have established production facilities and own an emulsion tech that ensures 'fast-acting, consistent and high-quality THC-infused beverages'. Given the sale, Althea has withdrawn its full-year guidance of revenue between $26-33 million and underlying earnings of $800,000 to $1.1 million. No bula! Calmer Co inks a US kava deal Still on alternative bevvies, The Calmer Co International (ASX:CCO) is tapping in on the proliferation of kava in the US. There, dedicated bars sell the mildly stimulating/relaxing South Pacific substance as an alternative to alcohol. Formerly known as Fiji Kava, Calmer has penned a memorandum of understanding with 'functional beverage' company Leilo, to provide high-grade kava powders. Calmer hopes a phase one pilot study in the December quarter will pave the way for a formal long-term supply deal. Leilo supplies some of the 500 kava bars that have proliferated in the US, with each bar consuming an average 20 to 30 kilograms of the stuff per month. There's a Trumpian angle to it all. 'By adding The Calmer Co to our existing roster of top-tier suppliers … we are able to better hedge against supply chain shocks and tariffs,' says Leilo founder and CEO Sol Broady. The Calmer Co reported March quarter revenue of $1.8 million, down 12% and a $923,000 loss. Clinuvel hits its skin trial numbers Skin diseases house Clinuvel Pharmaceuticals (ASX:CUV) has hit its recruitment target of 200 patients for its phase III study, to treat the common condition vitiligo. The study tests Clinuvel's drug Scenesse, which is already approved for a rare sun intolerance disorder. The trial, CUV-105 is across 37 study sites in North America, Africa and Europe, but with 57% of patients enrolled in the US. Affecting 1-2% of the population, vitiligo is an acquired depigmentation disorder causing loss of melanin producing skin cells. This leads to disfiguration and 'psychosocial distress'. While vitiligo affects all racial groups, it most affects darker-skinned people. Patients will receive Scenesse every three weeks for 20 weeks, alongside the standard ultraviolet phototherapy. For the sake of comparison, some patients receive the phototherapy alone but can opt to take Scenesse post-trial completion. The study's primary endpoint is a minimum 50% repigmentation across the total body surface area. Secondary endpoints include repigmentation on the face, neck and head. In a sneak peek, the company has released case studies of five patients showing the drug appears to be effective and well tolerated. Oncosil hits the mark with pancreatic cancer study Speaking of trials – or studies, strictly speaking – Oncosil Medical (ASX:OSL) reports that its eponymous targeted radiation therapy comes up trumps against the standard treatment called stereotactic body radiation therapy (SBRT). The Royal Adelaide Hospital comparison covered 101 patients treated over eight years. Of these, 42 received Oncosil plus chemotherapy and 59 were given chemo followed by SBRT. These patients either had with unresectable (inoperable) or borderline-resectable locally advanced forms of the cancer. The first analysis directly comparing the two treatments, the study found Oncosil was superior in extending overall survival and progression-free survival. The study showed a median survival of 22 months for Oncosil, compared with 14 months for SBRT. Furthermore, 24% of Oncosil patients were 'downstaged' to operable status, compared with 4.7% for SBRT. The study was investigator led, meaning it was off the hospital's own bat. Oncosil is approved for use in 30 jurisdictions, most notably Europe and the UK. Oncosil chief Nigel Lange says the data provides 'further evidence of the efficacy and safety of Oncosil added to standard-of-care chemotherapy.'
AFP
02-05-2025
- Business
- AFP
Part of $1 Billion Investment Strategy, PCI Pharma Services Completes Acquisition of Ajinomoto Althea, Enhancing US Drug Product Manufacturing for Aseptic Filling of Prefilled Syringes & Cartridges
PCI Pharma Services ('PCI') – a leading global contract development and manufacturing organization (CDMO) focused on innovative biopharma therapies – has completed its acquisition of Ajinomoto Althea, Inc. ('Althea'), a US-based sterile fill-finish CDMO and subsidiary of Japan-based Ajinomoto Co., Inc. For PCI, the acquisition is a cornerstone of a multi-year investment strategy spanning facilities in the United States and Europe. In the United States, Althea's assets combine with PCI's existing sterile fill-finish and advanced drug delivery operations to form a world-class, large-scale manufacturing hub in San Diego, complete with state-of-the-art large-scale aseptic facilities for prefilled syringes and cartridges. Among other categories, Althea's campus specializes in customized, scalable oligonucleotides and peptides, supporting PCI's existing manufacturing of complex formulations and lyophilization for a broad range of injectables – including nanoparticles, mRNA, MABs, proteins and other biologics. This press release features multimedia. View the full release here: PCI Pharma Services enhances US manufacturing of prefilled syringes & cartridges through acquisition of Ajinomoto Althea. Additional information regarding this acquisition is available at a dedicated webpage on PCI's website. The acquisition also adds high potent vial filling with lyophilization, expanding PCI's sterile fill-finish capacity and serving as an expedient entrée into the rapidly emerging oncology modality of high potent antibody-drug conjugates (ADCs). In fact, the move places PCI among the few US-based CDMOs capable of filling ADCs – a category the company initially began building toward earlier this year, with a sophisticated new pharmaceutical development lab for potent and non-potent compounds at its manufacturing Center of Excellence in Bedford, NH. The Bedford sterile fill-finish expansion strategy started with a large investment in a purpose-built facility featuring twin lyophilizers and a state-of-the-art large-scale isolator filling line compliant with Annex 1. That facility will be GMP ready this summer; since the plant's 2022 groundbreaking, PCI has methodically developed aseptic-by-design processes as part of its commitment to providing fully isolated high-volume vial filling and lyophilization solutions. Considering this, the acquisition is a natural next step in PCI's evolution in advanced drug delivery systems like prefilled syringes, cartridges and autoinjectors. Last year, PCI announced investments exceeding $365 million to support the clinical- and commercial-scale final assembly and packaging of drug-device combination products utilizing advanced delivery systems, with an emphasis on injectable formats. Comprising new and expanded infrastructure in both the United States and Europe, the effort bolsters PCI's ability to manage the full lifespan of DDCs, from sterile drug product development and manufacturing through clinical trial supply, product launch and commercialization. In the United States, the investment includes two new large-scale facilities at PCI's Rockford, Illinois campus. Building upon the company's successful Philadelphia Biotech Center of Excellence, the facilities will house over 25 dedicated suites with high-speed, multiformat lines for clinical- and commercial-scale assembly and packaging of prefilled syringes, autoinjectors, vials and pen-cartridge combinations, and incorporate extensive ISO-standard product testing capabilities and premium top-load cartoning technology. The campus also comprises capabilities for low- to medium-volume DDC assembly and packaging. Both facilities will be GMP ready in fall 2025. In Europe, PCI recently acquired a packaging and device assembly facility in Dundalk, Ireland, which provides commercial-scale operations for injectables and oral solid dose products. At its City North Dublin campus, PCI also expanded and constructed a 120,000-sq-ft packaging and device assembly services facility, which is slated to commence operations in summer 2025. Elsewhere in Europe, as part of an additional $25 million investment in its Leon, Spain facility, PCI is currently incorporating a sophisticated new high-speed filling line for syringes and cartridges. Equipped with isolator technology, the automated line delivers unsurpassed flexibility and reliability for biopharma customers. The effort also includes a recently completed state-of-the-art biologics development lab, further enhancing PCI's upstream capabilities. Assisted by the Althea acquisition, PCI's goal is to be among the first CDMOs to bring the whole lifespan of advanced drug delivery and drug-device combination products under one corporate roof – a journey spanning PCI's clinical trial supply network with cold chain storage solutions straight through launch and commercialization. 'Our pharma customers and the healthcare personnel and patients they serve are the heartbeat behind each stride we've made throughout this ambitious investment plan in sterile fill-finish and advanced drug delivery solutions,' said Salim Haffar, CEO of PCI Pharma Services. 'Concerning this latest step, Ajinomoto Althea enjoys a longstanding, well-earned reputation for producing novel biologics in various injectable formats. Welcoming Althea's talented professionals into the PCI family strengthens our commitment to turnkey customer partnerships and, ultimately, our dedication to helping improve patient outcomes through life-changing therapies.' About PCI Pharma Services PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products' speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 35 sites across seven countries (United States, Canada, United Kingdom, Ireland, Germany, Spain and Australia), and over 8,000 employees working to bring life-changing therapies to patients. Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients' lives. For more information, visit View source version on PCI Pharma Services Christopher Dale, Turchette Agency (973) 227-8080, ext. 116; cdale@ © Business Wire, Inc. Aviso legal : Este comunicado de imprensa não é um documento produzido pela AFP. A AFP não será responsável por este conteúdo. Para mais informações, por favor entre em contato com as pessoas ou entidades mencionadas no comunicado.
National Post
01-05-2025
- Business
- National Post
Part of $1 Billion Investment Strategy, PCI Pharma Services Completes Acquisition of Ajinomoto Althea, Enhancing US Drug Product Manufacturing for Aseptic Filling of Prefilled Syringes & Cartridges
Article content Along with PCI's own robust infrastructure expansions, acquisition furthers CDMO's recent growth in sterile fill-finish, advanced drug delivery systems like prefilled syringes and cartridges, and biologics – including high potent assets for antibody-drug conjugates. Article content Article content PHILADELPHIA — PCI Pharma Services ('PCI') – a leading global contract development and manufacturing organization (CDMO) focused on innovative biopharma therapies – has completed its acquisition of Ajinomoto Althea, Inc. ('Althea'), a US-based sterile fill-finish CDMO and subsidiary of Japan-based Ajinomoto Co., Inc. For PCI, the acquisition is a cornerstone of a multi-year investment strategy spanning facilities in the United States and Europe. In the United States, Althea's assets combine with PCI's existing sterile fill-finish and advanced drug delivery operations to form a world-class, large-scale manufacturing hub in San Diego, complete with state-of-the-art large-scale aseptic facilities for prefilled syringes and cartridges. Among other categories, Althea's campus specializes in customized, scalable oligonucleotides and peptides, supporting PCI's existing manufacturing of complex formulations and lyophilization for a broad range of injectables – including nanoparticles, mRNA, MABs, proteins and other biologics. Article content Additional information regarding this acquisition is available at a dedicated webpage on PCI's website. Article content The acquisition also adds high potent vial filling with lyophilization, expanding PCI's sterile fill-finish capacity and serving as an expedient entrée into the rapidly emerging oncology modality of high potent antibody-drug conjugates (ADCs). In fact, the move places PCI among the few US-based CDMOs capable of filling ADCs – a category the company initially began building toward earlier this year, with a sophisticated new pharmaceutical development lab for potent and non-potent compounds at its manufacturing Center of Excellence in Bedford, NH. The Bedford sterile fill-finish expansion strategy started with a large investment in a purpose-built facility featuring twin lyophilizers and a state-of-the-art large-scale isolator filling line compliant with Annex 1. That facility will be GMP ready this summer; since the plant's 2022 groundbreaking, PCI has methodically developed aseptic-by-design processes as part of its commitment to providing fully isolated high-volume vial filling and lyophilization solutions. Considering this, the acquisition is a natural next step in PCI's evolution in advanced drug delivery systems like prefilled syringes, cartridges and autoinjectors. Last year, PCI announced investments exceeding $365 million to support the clinical- and commercial-scale final assembly and packaging of drug-device combination products utilizing advanced delivery systems, with an emphasis on injectable formats. Comprising new and expanded infrastructure in both the United States and Europe, the effort bolsters PCI's ability to manage the full lifespan of DDCs, from sterile drug product development and manufacturing through clinical trial supply, product launch and commercialization. Article content In the United States, the investment includes two new large-scale facilities at PCI's Rockford, Illinois campus. Building upon the company's successful Philadelphia Biotech Center of Excellence, the facilities will house over 25 dedicated suites with high-speed, multiformat lines for clinical- and commercial-scale assembly and packaging of prefilled syringes, autoinjectors, vials and pen-cartridge combinations, and incorporate extensive ISO-standard product testing capabilities and premium top-load cartoning technology. The campus also comprises capabilities for low- to medium-volume DDC assembly and packaging. Both facilities will be GMP ready in fall 2025. Article content In Europe, PCI recently acquired a packaging and device assembly facility in Dundalk, Ireland, which provides commercial-scale operations for injectables and oral solid dose products. At its City North Dublin campus, PCI also expanded and constructed a 120,000-sq-ft packaging and device assembly services facility, which is slated to commence operations in summer 2025. Article content Elsewhere in Europe, as part of an additional $25 million investment in its Leon, Spain facility, PCI is currently incorporating a sophisticated new high-speed filling line for syringes and cartridges. Equipped with isolator technology, the automated line delivers unsurpassed flexibility and reliability for biopharma customers. The effort also includes a recently completed state-of-the-art biologics development lab, further enhancing PCI's upstream capabilities. Article content Assisted by the Althea acquisition, PCI's goal is to be among the first CDMOs to bring the whole lifespan of advanced drug delivery and drug-device combination products under one corporate roof – a journey spanning PCI's clinical trial supply network with cold chain storage solutions straight through launch and commercialization. Article content 'Our pharma customers and the healthcare personnel and patients they serve are the heartbeat behind each stride we've made throughout this ambitious investment plan in sterile fill-finish and advanced drug delivery solutions,' said Salim Haffar, CEO of PCI Pharma Services. 'Concerning this latest step, Ajinomoto Althea enjoys a longstanding, well-earned reputation for producing novel biologics in various injectable formats. Welcoming Althea's talented professionals into the PCI family strengthens our commitment to turnkey customer partnerships and, ultimately, our dedication to helping improve patient outcomes through life-changing therapies.' Article content PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products' speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 35 sites across seven countries (United States, Canada, United Kingdom, Ireland, Germany, Spain and Australia), and over 8,000 employees working to bring life-changing therapies to patients. Article content Article content Article content Article content Article content
San Francisco Chronicle
25-04-2025
- Entertainment
- San Francisco Chronicle
Grateful Dead introduce ‘Gratest Hits' album amid 60th anniversary celebrations
Grateful Dead is celebrating its 60th anniversary with a new collection of studio recordings this summer. The album, fittingly titled 'Gratest Hits,' includes nine of the band's most recognizable tunes, from 'Case Jones' (1970) and 'Scarlet Begonias' (1974) to 'Touch of Grey' (1987). Though there have been several compilation records honoring the Dead over the years, this upcoming release is being touted as 'the Dead's first real greatest hits collection.' 'Gratest Hits,' due out June 13, is now available for preorder on CD and vinyl. It will also be released digitally. Along with the news, the Bay Area jam band — founded by guitarists Jerry Garcia and Bob Weir, bassist Phil Lesh, drummer Bill Kreutzmann and keyboardist Ron 'Pigpen' McKernan — gave fans a preview of its upcoming 60-disc live set by dropping an unreleased version of the track 'Althea,' recorded during a 1981 concert at the Hartford Civic Center in Connecticut. 'This 'Althea' is widely considered one of the greatest versions of the song the Dead ever played,' David Lemieux, the band's archivist and legacy manager, said in a statement about the song released in 1980. 'Coupled with Jerry's emotional, powerful vocal delivery, this is an 'Althea' against which all other 'Altheas' can be measured.' The previously announced collector's item, 'Enjoying the Ride,' is limited to 6,000 individually numbered copies and will be available exclusively on on May 30. It will feature live recordings from 20 of the band's most beloved venues, including Winterland and the Fillmore West in San Francisco and Frost Amphitheater at Stanford University, spanning 1969 to 1994. Weir and Kreutzmann are the only surviving founding members of the band after recently losing Lesh, who died in October. McKernan was the first of the original members to die, in 1973, while the band's frontman, Garcia, died in 1995. In honor of Garcia's legacy, the San Francisco Board of Supervisors voted this week to rename a portion of Harrington Street Jerry Garcia Street. Garcia spent part of his childhood in a home on Harrington in San Francisco's Excelsior District. He lived with his grandparents following his father's death and attended nearby Monroe Elementary School. New signage for Harrington Street, between Alemany Boulevard and Mission Street, will be unveiled on Aug. 2, coinciding with the 23rd Annual Jerry Day festivities.
National Post
24-04-2025
- Business
- National Post
PCI Pharma Services to Acquire US-based Aseptic Fill-Finish CDMO Ajinomoto Althea
Article content Acquisition creates a world-class large-scale manufacturing hub in San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high potent formulations such as ADCs, complementing existing global sterile fill-finish and advanced drug delivery operations. Article content Article content PHILADELPHIA — PCI Pharma Services ('PCI') – a leading global contract development and manufacturing organization (CDMO) focused on innovative biopharma therapies – is acquiring an entire equity stake in Ajinomoto Althea, Inc. ('Althea'), a US-based sterile fill-finish CDMO and 100% subsidiary of Japan-based Ajinomoto Co., Inc. Scheduled for completion in May 2025, the acquisition provides PCI with its first-ever North American manufacturing location for prefilled syringes and cartridges – including isolator technology for these formats – as well as high potent manufacturing suitable for antibody-drug conjugates (ADCs). Article content Althea's robust clinical- and commercial-stage services for injectable drug products augments PCI's deep industry experience, aligning with the company's global sterile fill-finish capabilities and established expertise in advanced drug delivery. In addition, Althea's substantial knowledge base, skillsets and capacity in scalable, custom oligonucleotides and peptides complements PCI's existing manufacturing capabilities in complex formulations and lyophilization across a broad range of injectables – including nanoparticles, mRNA, MABs, proteins, and other biologics for delivery formats such as vials, bottles, prefilled syringes and autoinjectors. Article content The acquisition also adds high potent vial filling with lyophilization, making PCI one of very few US-based CDMOs capable of producing the emerging oncology modality of antibody-drug conjugates (ADCs). Building upon PCI's legacy in high potent molecules, the strategy creates an end-to-end offering for clients via specialized capabilities across the globe, and broadens its biologics development and manufacturing leadership. Article content For PCI's advanced drug delivery systems and drug-device combination business, Althea's assets supplement PCI's leadership position in final device assembly and packaging facilities in both Europe and North America. Acquiring Althea's San Diego campus also makes PCI one of the largest manufacturing centers in the US West Coast's biopharma stronghold and is a natural extension of PCI's current clinical trial services and early phase robotic sterile fill-finish capabilities, creating a scalable, flexible manufacturing complex with state-of-the-art facilities within minutes of each other. Article content 'To continue supporting the needs of our customers in their endeavors to bring life-changing therapies to patients, PCI continues to make sizable investments in the sterile fill-finish category that bring additional capabilities, capacity and technologies into our portfolio,' said Salim Haffar, CEO of PCI Pharma Services. 'Welcoming Althea into the PCI family expands our capabilities to support several therapeutic and drug delivery modalities, including the emerging ADC marketplace, and complements our broad end-to-end solutions alongside clinical trial services and advanced drug delivery.' Article content PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products' speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain), and over 7,000 employees working to bring life-changing therapies to patients. Article content Article content Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients' lives. For more information, visit Article content Article content Article content Article content Article content Article content
