J&J finds competitive edge with latest Erleada approval

BioPharma Dive | September 18, 2019

Generic competition is eating away at J&J's prostate cancer empire. Sales of Zytiga (abiraterone acetate) totaled $698 million in the second quarter, reflecting a 23% decline year over year. According to Iqvia data cited by SVB Leerink, J&J held 56% of the abiraterone acetate market for the week ending Sept. 6, a slip from the 63% it held a week prior. Apotex and Mylan, which each launched a generic form of Zytiga over the last year, had market shares of 26% and 16%, respectively. While Erleada (apalutamide) isn't big enough to warrant a line item in J&J's financial reports, its early growth is helping offset the Zytiga troubles. Chris DelOrefice, vice president of investor relations, said on the company's second quarter earnings call that the drug had gained four points of market share in the U.S. for its initial indication: non-metastatic castration-resistant prostate cancer. Xtandi (enzalutamide) presents a barrier to growth, however. Pfizer has touted how Xtandi outpaced Erleada early on in the non-metastatic, castration-resistant setting — and how, more recently, it overtook Zytiga to become the leading branded agent for metastatic castration-resistant prostate cancer monotherapy.

Spotlight

The average cost of bringing a new drug to market continues to rise, with varying levels of investments across the highly competitive biopharmaceutical industry. To assess the potential effect of varying investments on trial activity and operations, this article reviews trial benchmarks within the active oncology therapeutic area.


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Daewoong Pharmaceutical and HanAll Biopharma Invest in Turn Biotechnologies to Expand Growth Initiative

Daewoong Pharmaceutical and HanAll Biopharma | April 12, 2022

Daewoong Pharmaceutical and HanAll Biopharma announced expansion of their open collaboration strategy by investing in Turn Biotechnologies, a Silicon Valley based company focused on developing novel mRNA medicines. The companies are supporting Turn Bio's continued development of a high-potential platform and are considering future long-term collaborations. Turn Bio is a pre-clinical-stage biopharmaceutical company focused on cellular repair via epigenetic reprogramming of cells. The technological foundation for Turn Bio's proprietary Epigenetic Reprogramming of Age (ERA™) methodology was developed by Turn Bio's co-founders in the Sebastiano Lab, Institute for Stem Cell Biology and Regenerative Medicine, Stanford School of Medicine. The technology has since been patented and Turn Bio is currently using it to complete pre-clinical research on therapies targeting indications in dermatology and immunology, as well as developing therapies for ophthalmology, osteoarthritis and the muscular system. "Many age-related diseases have long been significant areas of patients' unmet need. Turn Bio's innovative platform may bring a pivotal transformation to a wide array of therapeutic areas. HanAll is committing support and investment to help realize the full potential of this pioneering technology as Turn Bio advances to a new phase of growth." Dr. Almira Chabi, chief medical officer and chief development officer at HanAll Pharmaceutical International "The support of Daewoong Pharmaceutical and HanAll Biopharma validates our approach to cellular rejuvenation and enables Turn to expand its efforts in multiple therapeutic indications," said Anja Krammer, the company's CEO. "We are thrilled that a company as well known for its innovation, has taken interest in our promise to transform the way medicine treats diseases of aging and we look forward to further collaborations to help change quality of life and healthcare economics globally." The proceeds from this round of financing will support Turn Bio's advancement towards a phase 1 trial of its mRNA therapy candidate TRN-001, which targets indications in dermatology. About HanAll Biopharma Co., Ltd. HanAll Biopharma is a global biopharmaceutical company founded in 1973, with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas ranging from endocrine, circulatory, and urologic diseases for more than 48 years. HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. A leading pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase 3 and Phase 2 trials across the world for the treatment of rare autoimmune disorders including myasthenia gravis, thyroid eye disease, warm autoimmune hymolytic anemia, neuromyelitis optica, and immune thrombocytopenia. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha protein drug, is in Phase 3 clinical trials in the US and China for the treatment of dry eye disease. About Daewoong Pharmaceutical. Co., Ltd. Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With a strong and innovative in-house R&D and advanced manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Continuing on its course of building a strong global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Daewoong has also expanded strategic partnerships in more than 100 countries worldwide. About Turn Biotechnologies Turn Bio is a pre-clinical-stage company focused on repairing tissue at the cellular level. The company's proprietary mRNA platform technology, ERA™, restores optimal gene expression by combatting the effects of aging in the epigenome. This restores the cells' ability to prevent or treat disease, and heal or regenerate tissue and will help to fight incurable chronic diseases.

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Agilent Announces the Innovative Seahorse XF Pro Analyzer

Agilent Technologies Inc. | January 25, 2022

Agilent Technologies Inc. announced the release of the Agilent Seahorse XF Pro Analyzer, featuring new pharma-oriented workflow solutions incorporating advanced experimental design and analysis tools. With enhanced performance, more robust and efficient workflows, and an optimized user experience, the XF Pro enables operators at any skill level to access the most advanced cellular metabolism analysis technology for understanding cellular fate, fitness, and function. Preclinical therapeutic discovery workflows place high demands on cellular analysis, with immunology and disease researchers increasingly using rare, ex vivo, and genetically engineered cells to build better disease models. To address the increasing interest in monitoring live cells in real-time, the new XF Pro Analyzer incorporates a suite of hardware and software enhancements that improve measurement performance and data interpretation. These enhancements will make it easier to identify novel drug targets, validate target effect on cellular function, optimize disease models, and determine drug safety and antitumor potential of T cell therapies. “With dedicated workflow solutions the XF Pro provides enhanced performance and customer experience, particularly within pharma and biopharma therapeutic development, and toxicity programs. This underlines Agilent’s commitment towards developing intentional end-to-end solution-focused innovations that continue to lead the way for applied analytical and research applications, including direct metabolic analysis.” Richard Fernandes, associate vice president and general manager of Agilent’s Cell Analysis, Seahorse, Luxcel, and microplates businesses "The launch of the XF Pro is very much a customer-driven event. Through collaboration and intentional conversations with our customers and key opinion leaders, we recognized the need for a live-cell metabolic analysis platform which makes sophisticated analysis even more accessible for both experienced users as well as novices,” added Chris Braun, associate vice president of Marketing for Agilent’s Cell Analysis Division. “Primarily targeting the pharma/biopharma sector, but beneficial to all our customers, the XF Pro incorporates critical metabolic insights into researchers’ discovery workflows to facilitate even higher quality data where it matters most.” The XF Pro Analyzer is expected to enhance critical aspects of live-cell analysis, particularly for researchers working in immunotherapy, early drug discovery, and preclinical safety assessment. By delivering better precision at a low oxygen consumption rate (OCR), the XF Pro Analyzer allows analysts to confidently interrogate more immune cell types, as well as cell types that are bioenergetically compromised. The instrument also features pharma-tailored workflows for harnessing robust cellular metabolism measurements while handling suspension cell types, along with simplified automation enablement and analytical instrument qualification (AIQ). About Agilent Technologies Agilent Technologies Inc. is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.

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TendoNova wins FDA Clearance for Its New Microinvasive Ocelot Surgical Tool

TendoNova | March 24, 2022

TendoNova, an emerging leader in microinvasive sports medicine procedures, is pleased to announce the FDA 510 clearance of its new Ocelot surgical tool, which uses an innovative technology for fragmentation or debridement of soft tissue. The FDA found the Ocelot TDS 1000 substantially equivalent to the Tenex TX1 which is routinely used for percutaneous tenotomy in orthopedics, sports medicine, pain management, and podiatry. The Ocelot System's form factor and price point make it an exciting alternative to existing tools. Using technology licensed from Georgia Institute of Technology and Emory University School of Medicine, the Ocelot facilitates procedures that require fragmentation and debridement of soft tissue under external image guidance in a simple hand-held format. TendoNova was able to achieve this success through grants and investor backing of groups such as the Georgia Research Alliance and the NFL Players' Association. "According to studies cited by the Centers for Disease Control and Prevention, more than 30 million people in the U.S. suffer from chronic tendon pain, and half of those have little or no relief from physical therapy or medication. The Ocelot is the company's first product and was conceived in response to a request by Atlanta Hawks head team physician Dr. Ken Mautner for an improved tool." TendoNova CEO, Mark A Samuels Dr. Mautner, who practices at Emory, commented that, "After 15 years of treating elite and recreational athletes for tendinopathy, I have been frustrated by the tools we have had to help heal these injuries. The TendoNova device could be a game changer in getting our athletes back to the healthiest level possible." The Ocelot System performs mechanical fragmentation or debridement of a targeted area. The use of fragmentation and debridement is part of a common treatment for encouraging the growth of healthy tendon to supplant painful pathologic tendon tissue. Chronic tendon pain disorders, or tendinopathies, include tennis elbow, plantar fasciitis, and jumper's knee. Tendinopathy is prevalent in athletes and anyone else who engages in repetitive tasks. If left untreated, can lead to months or years of pain and even career-ending injuries. TendoNova plans to manufacture the Ocelot in Georgia and is presently working to validate the Ocelot disposable component production. The Ocelot is expected to be available to physicians in the second half of 2022. About TendoNova Founded in 2017, TendoNova is a medical device company that is an emerging leader in microinvasive sports medicine procedures. The company's initial product is the Ocelot™ TSD 1000, a patented, FDA cleared medical device for fragmentation or debridement of soft tissue. TendoNova is also working on a digital health solution projected to provide device operating feedback during a procedure to reduce training times and improve outcomes. Dedicated to helping people live healthier lives with less pain and fewer injuries, the company plans a series of instrumented microinvasive tools designed to help physicians better heal patients suffering from advanced tendon and other pathologies.

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Sandoz targets growth opportunities in respiratory and complex generics through acquisition of respiratory device company Coalesce

Novartis Pharma AG | March 14, 2022

Sandoz, a Novartis division, announced that it has successfully acquired the UK-based medical and drug delivery device development company, Coalesce Product Development Limited. Through this deal, Sandoz has acquired the significant capabilities and assets of Coalesce, which will help it build on its existing portfolio of respiratory medicines and further improve patient access to these high-quality, complex therapies. “Respiratory and complex generics are areas of relatively high unmet medical need, due largely to their comparatively high technical complexity,” Sandoz CEO, Richard Saynor “At Sandoz, we have the experience and expertise to succeed in these fields and this acquisition offers us a significant new growth platform, particularly in the US and Europe, reinforcing our commitment to pioneer access for patients.” Respiratory diseases are leading causes of death and disability worldwide.1 Asthma is a major non-communicable disease affecting both children and adults, and in 2019 it affected an estimated 262 million people.2 In the same year, about 3.23 million deaths were attributed to chronic obstructive pulmonary disease (COPD).3 The resulting burden of respiratory diseases on healthcare systems and productivity amounted to more than USD 380 billion per year across 28 EU member states.4 With an existing portfolio of six in market-products and nearly twice as many more in the pipeline, Sandoz sees respiratory as a key pillar of its ambitious long-term growth strategy and intends to actively explore further opportunities both in-house and externally. More generally, Sandoz is determined to grow its portfolio in the complex generics space, including complex injectables. About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.

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Spotlight

The average cost of bringing a new drug to market continues to rise, with varying levels of investments across the highly competitive biopharmaceutical industry. To assess the potential effect of varying investments on trial activity and operations, this article reviews trial benchmarks within the active oncology therapeutic area.

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