J&J eyes Darzalex convenience, safety boost with subcutaneous win

fiercepharma | June 03, 2019

Right now, the first infusion of Johnson & Johnson multiple myeloma fighter Darzalex can take between seven and eight hours. But data on a new formulation could be a game changer. At the American Society of Clinical Oncology annual meeting, the New Jersey drugmaker trumpeted results from a phase 3 study showing that a subcutaneous form of Darzalex could measure up to the original and with an average injection time of just five minutes. At a median 7.5 months of follow-up, 41% of patients in the head-to-head study which enrolled relapsed or refractory patients had seen benefits after receiving the subcutaneous drug, while 37% of those taking the infused drug could say the same. And without skimping on efficacy, subcutaneous Darzalex recorded a big win, too. Only 12.7% of patients receiving the subcutaneous drug experienced infusion-related side effects a big drop from the 34.5% of patients in the control group who reported them. Majorly cutting down on the time it takes to administer Darzalex could help not just patients, but healthcare providers, too, Tendler said. There are “a lot of nursing staff and personnel that are watching the patient closely with the first infusion,” he said. And if that first dose can wrap up in three to five minutes, “you could free up resources in the office for other things.”As Credit Suisse analyst Vamil Divan pointed out in a note to clients, though, post-administration reactions took longer to show up in subcutaneous patients, with average onset times of 3.6 hours versus 1.5 hours meaning additional monitoring may still be required. “The [new formula] should help address the prolonged infusion time that is needed for the IV formulation, although it was noted in the discussion that for the first subcutaneous dose an observation time of about 3-4 hours may still be needed,” he wrote.

Spotlight

As pharma companies expand, they are looking more and more to biologics for their next potential blockbusters. However, this class of product ranging from well-established large molecule drugs to truly novel therapies poses major challenges because of their scientific complexity and sophisticated development requirements. Furthermore, expanding the drug pipeline isn’t the only growth strategy most companies are pursuing: They are also planning to expand geographically and expect to face various risks doing so, including unfamiliar regulatory environments, shifts in pricing and customers’ ability to pay.

Spotlight

As pharma companies expand, they are looking more and more to biologics for their next potential blockbusters. However, this class of product ranging from well-established large molecule drugs to truly novel therapies poses major challenges because of their scientific complexity and sophisticated development requirements. Furthermore, expanding the drug pipeline isn’t the only growth strategy most companies are pursuing: They are also planning to expand geographically and expect to face various risks doing so, including unfamiliar regulatory environments, shifts in pricing and customers’ ability to pay.

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PHARMA TECH

CPhI partners with Informa Pharma Intelligence to present the 2021 Hybrid Edition of CPhI - P-MEC Expo in the National Capital Region ( NCR)

Informa Pharma Intelligence | November 26, 2021

Informa Pharma Intelligence, one of the leading business intelligence providers and knowledge partners, is pleased to announce the 2021 hybrid edition of CPhI – P-MEC conducted by CPhI Conference. The Online Conference & Networking is being held between 15th to 30th Nov 2021, while the In-Person event is being held between 24th to 26th Nov 2021 at India Expo Centre– Greater Noida, Delhi. In a bid to stay afloat towards increasing contemporary demand towards high quality, low cost pharma solutions, CPhI & P_MEC India has curated a platform through this event for a gateway to latest trends and innovative solutions that the market has to offer. The event aims to build better pharma community engagements, network amongst the fraternity and source innovative solutions on-site from exhibitors who have footprints both domestically and globally, and covering the entire pharma supply chain - from APIs, machinery, technology, packaging, outsourcing, finished products and biopharmaceuticals. The industry is anticipated to have a steady growth trajectory and the event organised by CHhI India has focused on the key driving factors for the same. The expansion of medicine manufacturing pertaining to the evolving epidemiological profile of the country will be instrumental for India being the preferred drug manufacturing destination on a global scale. Additionally the event aims to encourage the development of the research-based pharma fraternity. "The Indian pharmaceutical industry has been growing at double digits year-on-year, and remains committed to not only providing solutions to the healthcare needs of the country, but also to the world. As the world is battling the pandemic at different levels, here in India, we remain committed to ramping up production capabilities of some key medicines across infectious and non-infectious diseases to ensure their availability and accessibility to the country and the world. The CPhI – P-MEC India show is the single location for all pharmaceutical and allied companies to get together and share insights, techniques and technology that will help meet these demands." Speaking at the sidelines of the CPhI – P-MEC India show, Mr Yogesh Mudras, Managing Director, Informa Markets in India As a part of the management team of the CPhI – P-MEC 2021 event, Mr Poornachandra Tejasvi, Senior Director, Emerging Markets, India, at Informa Pharma Intelligence said, "As a representative of the world's leading pharmaceutical business intelligence provider, its heart-warming to be a part of the CPhI – P-MEC event where we get to share meaningful insights drawn from real-time news, trends, market analysis, special reports, to key pharmaceutical companies in the country and the world. Globally we provide intelligence to over 10,000 customers and 3,000 of the top pharma, biotech and biosimilar companies with the collective support of more than 300 respected Business Intelligence subject matter analysts, editors, and thought leaders located across countries. The 2021 CPhI – P-MEC event will be a great opportunity to reconnect with the stakeholders of the pharmaceutical world and provide them with any form of data intelligence and analysis as needed." The Indian pharmaceutical market is growing at 15% annually, twice the world market growth rate. While its generics market is growing strong, it is also evolving into a cradle for new drugs. Therefore, with India being one of the strongest emerging markets in the global pharma industry, it presents great opportunities for all international pharmaceutical companies to explore, the platform by CPhI & P-MEC provides full access to the exhibitors to source new pharma solutions and find the right partners for your business with the ongoing hybrid expo showcasing the full drug development supply-chain from exporting, outsourcing, manufacturing, machinery, regulations, pricing, and market access to, packaging, labelling, and digitalization. The P-MEC event is the single destination in the country today for all things associated with the latest innovative pharma solutions that the world has to offer. The venue will also host the latest types of equipment associated with research and development and analytical solutions followed by cleanroom engineering design, certifications and the latest types of air purification solutions. The packaging technology on display will include a comprehensive range of glass, pouches, bottles, caps, tubes and plastic packages as well as printing and trademark solutions. CPhI India is a sister brand of CPhI Worldwide – A key event that all professionals from the international pharmaceutical and allied industries look forward to year on year. CPhI India and its co-located event, P-mec India, are the largest and most comprehensive pharmaceutical industry events in South Asia. This event is specifically important to the country as India is already labelled as the pharmacy of the world in addition to the vaccine manufacturing prowess showcased in 2019-2020. About Informa Pharma Intelligence Trusted by over 3,000 of the world's leading pharmaceutical, biotech, medical device companies, and CROs, the Pharma Intelligence suite of intelligence solutions, which include Datamonitor Healthcare™, Sitetrove™, Trialtrove™, Pharmaprojects™, Biomedtracker™, Scrip™, Pink Sheet™ and In Vivo™, deliver vital, accurate, and timely intelligence and analysis about the drug development pipeline to pharmaceutical and biomedical decision makers around the world. A global team of subject area experts track and analyse key diseases, clinical trials, drug approvals and R&D activities, to deliver data needed to make decisions and create real-world opportunities for growth. About CPhI Conferences The world's largest pharmaceutical exhibition, CPhI Worldwide represents every stage of the pharmaceutical supply chain - from ingredients and FDF, to machinery, packaging, outsourcing and biopharmaceuticals. Each year the CPhI brand unites more than 100,000 pharmaceutical professionals from all over the world through exhibitions, conferences and online communities. CPhI offers healthcare experts a chance to network, identify business opportunities and expand the global market through online and in-person interactions, with events in Europe, China, Korea, India, Japan, Southeast Asia and North America.

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BUSINESS INSIGHTS

Zenas BioPharma Acquires Exclusive Worldwide Rights to Obexelimab from Xencor

Xencor, Zenas BioPharma | November 22, 2021

Xencor, Inc. a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, and Zenas BioPharma (“Zenas”), a global biopharmaceutical company based in the USA and China committed to the development and delivery of immune-based therapies, today announced that Zenas has acquired from Xencor exclusive worldwide rights to develop, manufacture and commercialize the investigational antibody obexelimab. Obexelimab is a potential first-in-class bifunctional antibody that targets CD19 with its variable domain and uses Xencor's XmAb® Immune Inhibitor Fc Domain to target FcγRIIb, a receptor that inhibits the function of B-cells, which are important components in the immune system. Xencor demonstrated through early-stage clinical studies that obexelimab effectively inhibits B-cell function without depleting the cells and generates an encouraging treatment effect in patients with multiple autoimmune diseases. “Zenas is advancing a broad pipeline of differentiated drug candidates that are intended to bring best-in-class innovation to patients with underserved medical needs. Today, we are pleased to add obexelimab to our portfolio, and based on its clinical profile, we believe it is positioned as a first-in-class candidate with the potential to treat numerous autoimmune diseases.” Hua Mu, Ph.D., MD, president and chief executive officer at Zenas “Obexelimab’s highly potent and broad blockade of B-cell activation—without depleting B cells—differentiates it from other B-cell targeting therapies, and it has demonstrated disease-modifying activity in settings where B-cell inhibition is a proven strategy,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “In Zenas BioPharma, we have found a partner committed to broadly and aggressively developing therapeutics like obexelimab for patients with autoimmune diseases, enabling Xencor’s continued focus on the growing opportunities provided by our XmAb bispecific antibody and cytokine pipeline.” Under the terms of the new agreement, Zenas will issue to Xencor a warrant giving Xencor the right to acquire additional Zenas equity, such that Xencor’s total equity in Zenas would be 15% of its fully diluted capitalization following the closing of Zenas’ next round of equity financing, subject to certain requirements. Xencor previously received equity in Zenas under a separate license agreement. Xencor is also eligible to receive up to $480 million based on the achievement of certain clinical development, regulatory and commercialization milestones and is eligible to receive tiered, mid-single digit to mid-teen percent royalties upon commercialization of obexelimab, dependent on geography. Zenas will have sole responsibility for advancing the research, development, regulatory and commercial activities of obexelimab worldwide. About Xencor, Inc. Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases. Currently, 22 candidates engineered with Xencor's XmAb® technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of proteins resulting in new mechanisms of therapeutic action. About Zenas BioPharma Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and delivery of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. Xencor Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by our use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to the development of obexelimab as a potential treatment for patients with autoimmune diseases; the commercial potential of obexelimab; the safety, tolerability, efficacy and pharmacokinetics of obexelimab; the quotations from Xencor’s president and chief executive officer; and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2020 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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BUSINESS INSIGHTS

Glaukos Announces Licensing Agreement with Attillaps Holdings, Inc.

Glaukos | September 20, 2021

Glaukos Corporation, an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced today that it has entered into a licensing agreement with Attillaps Holdings, Inc. under which Attillaps has granted Glaukos a global exclusive license to research, develop, manufacture and commercialize Attillaps’ proprietary library of investigational pharmaceutical compounds that target the eradication of Demodex mites, which are the root cause of Demodex blepharitis and often associated with meibomian gland dysfunction and related ophthalmic diseases. Demodex blepharitis and Demodex-driven meibomian gland dysfunction are caused by an infestation of Demodex mites, the most common ectoparasite found on human skin. Demodex blepharitis is characterized by eyelid inflammation and irritation resulting in eyelid redness, discomfort and debris. Demodex-driven meibomian gland dysfunction is characterized by decreased lipid secretion into the tear film and is a leading cause of dry eye disease. Under the agreement, Glaukos has the exclusive global right to research, develop, manufacture and commercialize products using certain acetylcholinesterase (AChE) inhibitors for the treatment of ophthalmic diseases caused by Demodex mites. Attillaps’ lead compounds have demonstrated promising in-vitro results in preclinical settings. We are incredibly excited about the development and commercial prospects of our novel platform in various therapeutic applications, particularly in the ophthalmology sector. Glaukos is a world-class ophthalmic company, and we couldn’t envision a more compelling licensing partner to advance our platform as a potential solution for the many patients suffering from these challenging conditions that currently have no approved treatments. - Frank Spallitta, founder and chief executive officer of Attillaps About Attillaps Attillaps is a developmental-stage pharmaceutical company pioneering novel drug platforms for the treatment of ophthalmology and dermatology conditions such as rosacea and blepharitis, with other indications of interest that include meibomian gland dysfunction, atopic dermatitis, acne vulgaris, ocular rosacea and hidradenitis suppurativa. The proprietary unique applications of these AChE inhibitors limit systemic exposure, further increasing the known safety of these molecules while effectively targeting the cutaneous inflammation. About Glaukos Glaukos is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012, its next-generation iStent inject® device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.

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