Is Allergan unloading 2 drugs enough to sell FTC on AbbVie buy? Analysts arent so sure

Allergan has confirmed it will hive off two drugs so that AbbVies 63 billion dollars takeover offer could pass U.S. antitrust scrutiny. But recent regulatory decision and indecision on pharma deals has analysts worried whether that would be enough. In an investor Q and A published Tuesday, Allergan said it will sell brazikumab and Zenpep as part of the merger process, “irrespective of whether such divestitures are required by the regulators.” Those two have been suspected for-sale targets since the deal was announced, given their overlap with existing AbbVie drugs in their respective fields. Brazikumab and AbbVie’s recently approved psoriasis therapy Skyrizi are both IL-23 inhibitors. Allergan is testing brazikumab in phase 2/3 for ulcerative colitis and Crohn’s disease, just as AbbVie aims for the exact same indication as a label add-on for Skyrizi. Besides, AbbVie’s Humira already has a tight grip on the inflammatory bowel disease market. Meanwhile, Zenpep competes directly against AbbVie’s Creon as pancreatic replacement enzymes. Because Creon is making more money than Zenpep—with 2019 first-half sales of $484 million versus $133 million—the Allergan drug ended up on the chopping board.

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Exclusive Agreement: Specialised Therapeutics & Ascendis Pharma to Distribute Three Endocrinology Therapies in Australia & Select SE Asia Countries

PR Newswire | January 08, 2024

Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) has added three new endocrinology therapies to its specialist portfolio, following an exclusive distribution agreement with Danish company Ascendis Pharma A/S. Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFA (lonapegsomatropin), hypoparathyroidism treatment YORVIPATH (palopegteriparatide) and investigational achondroplasia therapy TransCon CNP (navepegritide). The agreement spans ST's key regions of Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam. Two of the products included in this agreement are already internationally approved: Once-weekly SKYTROFA is a human growth hormone (hGH) approved in the United States for the treatment of paediatric patients aged >1 years weighing >11.5 kg with growth failure due to inadequate secretion of endogenous growth hormone (GH)1 and in the European Union for growth failure in children and adolescents aged from 3 to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]). YORVIPATH is a first-in-class parathyroid hormone (PTH) replacement therapy to treat chronic hypoparathyroidism, a rare and potentially serious condition where the body produces no or abnormally low levels of PTH. It is approved in the European Union for the treatment of adults with chronic hypoparathyroidism. The third product – TransCon CNP – is in development by Ascendis Pharma for the treatment of achondroplasia (ACH), the most common genetic form of skeletal dysplasia and resulting disproportionate short stature, following successful Phase 2 trial results. Australian endocrinologist Dr Veronica Preda noted that YORVIPATH would be the first specialist therapeutic option for Australian patients living with hypoparathyroidism. "Hypoparathyroidism can seriously impact quality of life and has potentially life-threatening consequences," Dr Preda said. "To have an option that is able to treat the underlying cause of the disease, moving beyond standard oral calcium and active Vitamin D, is a great step forward." Announcing the partnership, ST Chief Executive Officer Carlo Montagner said this agreement was an important company milestone, signalling ST's expansion into both endocrinology and paediatric medicine. Mr Montagner commented: "We are delighted to have been selected as Ascendis Pharma's exclusive partner for commercialising their portfolio in Oceania and these South-East Asia countries and look forward to launching these critical endocrinology products in our regions as soon as possible. "All three products are valuable inclusions to our broad therapeutic pipeline and our international business, as we continue to leverage our substantial experience commercialising specialist medicines across multiple regions. "We look forward to working with endocrinologists across our territories to make these endocrine therapies available to all eligible patients who may benefit." Ascendis Pharma Executive Vice President and Chief Commercial Officer Camilla Harder Hartvig said ST had been selected to launch the endocrinology portfolio in these countries based on its strong track record commercialising specialist products in multiple regions. "We are delighted to partner with Specialised Therapeutics to broaden the reach of our endocrinology rare disease portfolio, contributing to our shared goal of making a meaningful difference for patients facing unmet medical needs," she said. About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA).

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SHL Medical partners with SteriPack Group to set up final assembly service

PR Newswire | January 25, 2024

SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack facility in Poland, enhancing the overall flexibility of supply chain strategies for their customers. In addition to SHL Medical's existing final assembly, labeling, and packaging¬ services in the United States, this collaboration extends high-quality CMO options to Europe. Markus Puusepp, SHL Medical's Chief Growth Officer, expressed enthusiasm about the partnership, stating "This partnership is a significant addition to the Molly platform value proposition. We share common values with SteriPack, from focus on the customer to a commitment to quality, making the decision to collaborate straightforward." Recognizing the importance of flexibility and time-to-market, especially in clinical production, the partnership with SteriPack will offer SHL Medical's customers highly flexible and personalized final assembly and packaging solutions. This is particularly beneficial for small batch handling in clinical supply and niche markets like rare diseases. Emphasizing the comprehensive capabilities of the Molly platform, SHL Medical aims to deliver right-sized solutions that ensure improved service, faster timelines, and a more streamlined supply chain for its diverse customer base. John Ward, SteriPack Group's VP Pharmaceutical Solutions commented "SteriPack Group looks forward to supporting SHL Medical and their customers in providing quality and flexible solutions to a fast- moving market. With an emphasis on creating service solutions designed around specific customer requirements, this partnership will make the process of working with the Molly platform an easy decision." About SHL Medical As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by its company purpose – Enabling Patients' Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. It also offers final assembly, labeling, and packaging solutions for its drug delivery systems. In response to the rising trend in home therapy, SHL Medical has increased its developmental work in the digital healthcare sector to help improve the drug delivery ecosystem. Located across Switzerland, Taiwan, Sweden, and the US, SHL Medical's global team of experts collaborate seamlessly as one team in utilizing its comprehensive in-house manufacturing capabilities. Its solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into its designs and processes to contribute to a cleaner earth. About SteriPack Group SteriPack Group is a globally renowned contract packing and manufacturing organisation serving the pharmaceutical and medical device sectors respectively. With a strong emphasis on innovation, quality and compliance, SteriPack's services to the pharmaceutical industry include device design and development, final assembly, labelling, secondary packing, serialisation and aggregation of injectable formats including vials, pre-filled syringes, and autoinjectors. SteriPack's tailored customer-focused solutions make it an ideally suited supplier for small to medium-sized batch volumes required for a growing market of targeted therapies as well as clinical trials. Its proven capabilities in cleanroom assembly and labelling as well as secondary packing services for drug delivery systems and medical devices, combined with significant investment into growing cold chain storage capacity, have helped to make it a trusted partner to top global pharmaceutical companies.

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Flagship Pioneering and Samsung Announce Collaboration to Advance Groundbreaking Technologies in Translational Science and Medicine

PR Newswire | January 09, 2024

Flagship Pioneering, the bioplatform innovation company, and Samsung today announced a collaboration aimed at fostering cutting-edge biopharmaceutical innovation poised to transform the world of healthcare through groundbreaking advancements in translational science and medicine. Through this collaboration, Samsung will work alongside Flagship-founded companies, leveraging Samsung's leading technologies and capabilities to accelerate first and best-in-class therapies. The newly formed strategic partnership is an expansion of the ongoing cooperation between Samsung and Flagship. The collaboration between Samsung and Flagship leverages the expertise of both organizations in the areas of life science technology, artificial intelligence, and CDMO services, and extends across Flagship's ecosystem of companies. Key Highlights of the Collaboration: Revolutionary Technology: The collaboration will leverage state-of-the-art technology including artificial intelligence, translational medicine, access to high quality clinical samples and Samsung's clinical trials infrastructure, and investment by Samsung in Flagship-founded companies. Shared Vision: Flagship Pioneering and Samsung share a common vision of transforming conventional drug discovery and development approaches to help bring new targeted therapeutic solutions to patients. The collaboration is driven by a commitment to pushing the boundaries of what is possible in the bio-pharmaceutical industry. "This collaboration represents a significant milestone in the pursuit of innovation and scientific excellence," said Stephen Berenson, Managing Partner, Flagship Pioneering. "As partners, we will bring together Flagship Pioneering's unparalleled expertise in inventing and developing revolutionary bioplatform companies with Samsung's strategic capabilities to reshape and empower the bio-pharmaceutical landscape, ultimately resulting in bigger leaps for patient care." "This newly formed collaboration is an important evolution of the ongoing relationship between two companies," said Jaywoo Kim, executive vice president, Samsung C&T. "We look forward to seeing the accelerating effect of Samsung's various technical expertise and extensive commercial capabilities on the future innovations Flagship and its ecosystem of companies will bring to market." About Flagship Pioneering: Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $70 billion in aggregate value. To date, Flagship has deployed over $3.6 billion in capital toward the founding and growth of its pioneering companies alongside more than $27 billion of follow-on investments from other institutions. About Samsung C&T: Samsung C&T Corporation, a dynamic player in industries ranging from construction, trading, fashion and resorts, is actively expanding its portfolio with strategic investments in the biopharmaceutical industry. Since its investing in Samsung Biologics and Bioepis, Samsung Biologics' CDMO production capacity has grown to over 600 kilo liters and contribute greatly to the stabilization of the biopharmaceutical supply chain. In addition, Samsung Bioepis has improved the accessibility of many patients around the world by successfully launching seven biosimilar products. Samsung C&T will continue investment in innovative technologies and businesses that contribute to 'improving quality of life' in various areas of bio & healthcare.

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