RESEARCH

Eli Lilly wins FDA's emergency nod for COVID-19 antibody—but, thanks to mixed data, it's limited

Eli Lilly | November 11, 2020

The U.S. just had another COVID-19 drug authorized for emergency use. But the approval is limited—and, with at least one vaccine launch on the horizon, industry watchers wonder whether drugs to treat the illness have any staying power. The FDA authorized Eli Lilly’s bamlanivimab for emergency use on Monday, making it the first antibody therapy to win that distinction. Dubbed LY-CoV555, it's an anti-SARS-CoV-2 antibody therapy the Indianapolis pharma is co-developing with AbCellera. The OK comes with some caveats: It's limited to patients 12 years and older who aren't hospitalized but who are at high risk of developing severe illness, including elderly people and those with certain underlying conditions. And Lilly is advising infusion within 10 days of symptom onset.

Spotlight

In the last few years, pharmaceutical companies have become increasingly interested in biomarkers and their incorporation into company drug development programmes and use as companion tests for targeted therapeutics. Identifying patients that will benefit from a drug and eliminating those that will not is increasingly important. A simple analysis of the number of biomarker deals recorded in PharmaVentures' PharmaDeals database shows a rise from just seven in 2001 to 130 in 2007. There are a number of drivers for this, and these include: the increasing cost of drug development and associated decline in new molecular entities (NMEs) achieving registration; patient and regulatory authorities requesting upfront evidence of therapeutic benefit; and reimbursing bodies requiring proof of likely beneficial outcomes before payment. One would imagine that the combination of these factors would result in a highly positive outlook for biomarker researchers and developers. However, the situation is not as simple as it appears because, despite the factors listed above, it is hard to capture the value created by the addition of a biomarker into the drug development or patient identification process, and thus to apportion returns from subsequent commercialization of the drug and/or biomarker.

Spotlight

In the last few years, pharmaceutical companies have become increasingly interested in biomarkers and their incorporation into company drug development programmes and use as companion tests for targeted therapeutics. Identifying patients that will benefit from a drug and eliminating those that will not is increasingly important. A simple analysis of the number of biomarker deals recorded in PharmaVentures' PharmaDeals database shows a rise from just seven in 2001 to 130 in 2007. There are a number of drivers for this, and these include: the increasing cost of drug development and associated decline in new molecular entities (NMEs) achieving registration; patient and regulatory authorities requesting upfront evidence of therapeutic benefit; and reimbursing bodies requiring proof of likely beneficial outcomes before payment. One would imagine that the combination of these factors would result in a highly positive outlook for biomarker researchers and developers. However, the situation is not as simple as it appears because, despite the factors listed above, it is hard to capture the value created by the addition of a biomarker into the drug development or patient identification process, and thus to apportion returns from subsequent commercialization of the drug and/or biomarker.

Related News

BUSINESS INSIGHTS

EditForce and Mitsubishi Tanabe Pharma Enter into License Agreement

EditForce, Inc. | July 06, 2022

EditForce, Inc. has entered into a License Agreement with Mitsubishi Tanabe Pharma Corporation to research, develop and commercialize potential gene therapy products for a specific target disease in the field of CNS by utilizing EditForce's proprietary PPR protein platform technology. In this alliance, MTPC and EditForce aim to create potential novel pharmaceuticals for the specific CNS disease by utilizing the drug R&D know-how and global business experience of MTPC and the novel biotechnology of EditForce. MTPC will acquire the exclusive right to conduct the selection of drug candidate molecules, preclinical and clinical development, manufacturing, and commercialization worldwide. Under the terms of the Agreement, EditForce will receive an upfront payment and milestone payments amounting to over 20 billion yen depending on the development stage and commercialization progress, and royalties based on worldwide sales after the launch. "I am so delighted to reach the agreement with MTPC, which has an interest in our proprietary PPR protein platform technology. We look forward to working closely with MTPC to develop and deliver breakthrough pharmaceutical products with our technology to patients suffering from diseases." Takashi Ono, President and CEO of EditForce About EditForce, Inc. EditForce, Inc., a Kyushu University-originated venture company developing a unique DNA/RNA editing technology (PPR platform technology (*)), was established in May 2015 by KISCO Ltd. and Prof. Takahiro Nakamura of Kyushu University (former president of EditForce and currently its scientific advisor) and funded by companies and funds that have track records of investing in life sciences and biotechnology. EditForce aims for drug discovery that applies the PPR technology through joint research with universities and private companies. Pentatricopeptide repeat protein platform technology PPR is a protein discovered in plants that regulates gene expression by binding to DNA and RNA in a sequence-specific manner. The PPR proteins are also found in humans and yeasts, and they have similar functions. Prof. Takahiro Nakamura and Dr. Yusuke Yagi, CTO of EditForce, have focused on the PPR proteins and elucidated the mechanism that determines sequence specificity, and established a technology for creating various PPR proteins, each of which binds to a specific target DNA or RNA sequence. Furthermore, it is possible to manipulate and modify the target genome and RNA both inside and outside the cell by fusion with effector proteins. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation the pharma arm of Mitsubishi Chemical Group is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future." MTPC sets the MISSION of "Creating hope for all facing illness." To that end, MTPC is prioritizing work on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of the central nervous system and immuno-inflammation. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis.

Read More

BUSINESS INSIGHTS

Septerna Strengthens Leadership Team to Advance Novel Small Molecule GPCR Medicines

Septerna | July 29, 2022

Septerna, a biotechnology company discovering and advancing novel small molecule medicines targeting G protein-coupled receptors announced the addition of Liz Bhatt, MS, MBA, as Chief Operating Officer, and Ran Xiao as Vice President of Finance and Business Operations to its leadership team. Septerna launched in January 2022 and is growing a pipeline of differentiated products using its GPCR Native Complex™ platform to unlock the vast untapped potential of GPCR drug targets for a wide range of diseases. We are thrilled to welcome Liz and Ran as we continue to build our exceptional team. Together, they bring deep experience in corporate, commercial, and business strategy. They also have significant operational expertise building and supporting both private and public companies,” said Jeffrey Finer, MD, PhD, Chief Executive Officer and Co-founder of Septerna and Venture Partner at Third Rock Ventures. “Since our launch in January, we’ve made rapid progress advancing our platform and early discovery programs, and now expanding our focus to strategic growth and operational excellence is absolutely critical so that we can fully realize the untapped opportunity space for new GPCR medicines.” “Septerna launched with the ambitious plan to expand the GPCR target landscape by developing and industrializing new drug discovery technologies and processes that can convert this target-rich superfamily of proteins into impactful new therapies for patients across a range of therapeutic areas. I’m excited to be working with a team of talented GPCR scientists and drug hunters and look forward to using my experience leading teams and developing corporate and product strategies to build Septerna into a robust company poised for long-term growth.” Ms. Bhatt Liz Bhatt brings more than 25 years of strategy, deal-making and company-building experience across a range of biotech and pharmaceutical companies. Liz was previously Chief Business & Strategy Officer at Applied Molecular Transport where she oversaw corporate development, portfolio and project management, and commercial strategy. Prior to AMT, Liz was Chief Operating Officer at Achaogen where she held various strategic and operational roles. Liz spent over a decade at Gilead Sciences as VP, Corporate Development leading deals across all therapeutic areas and as Senior Director, Commercial Strategy leading long-term global commercial and strategic planning, and supporting the launch of several products. Liz also held management roles at Eli Lilly and Maxygen and started her career in research at Affymax. She currently serves as an independent director on the board of eFFECTOR Therapeutics. Liz earned a BA in chemistry from Pomona College, an MS in biomedical sciences from the University of California San Diego, and an MBA from the Kellogg School of Management at Northwestern University. Ran Xiao has more than 20 years of experience in corporate accounting, finance, and business operations in the biotech industry. Prior to Septerna, Ran was the VP of Finance and Corporate Controller at Ambys Medicines, Inc, where she supported the company launch and managed various general and administrative functions through a rapid growth period. Before joining Ambys, Ran was the Corporate Controller at Corvus Pharmaceuticals, where she played a key role in the company’s initial public offering. Prior to Corvus, Ran held various managerial positions at Intermune, Natus Medical, Celera Genomics and CV Therapeutics. Ran has a BS in accounting from Shanghai University of Finance and Economics and an MBA from the Illinois Institute of Technology. Ran is a Chartered Financial Analyst. About GPCRs G protein-coupled receptors are the largest and most diverse family of cell membrane receptors, and humans have hundreds of different GPCRs, each involved in controlling specific biological functions. GPCRs on the surface of each cell bind a wide range of external signaling molecules from throughout the body, and the GPCR transmits the signal across the cell membrane to drive internal cellular mechanisms. GPCRs have been widely studied as drug targets and are the largest family of proteins targeted by approved drug products. An estimated 700 approved drugs target GPCRs, representing approximately one-third of all currently approved drugs. Despite the pharmacological success of GPCRs as a drug class to date, the large majority of potential therapeutic GPCR targets remain undrugged. About Septerna Septerna, Inc., is a biotechnology company creating broad new drug discovery opportunities across many disease areas for the abundant drug target class of G protein-coupled receptors. The company’s Native Complex™ Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular environment to enable new technologies for industrial-scale drug discovery for the entire GPCR target class for the first time. Septerna has an emerging pipeline of GPCR-targeted small molecule drug discovery programs, along with growth potential to reach many GPCRs that have been undruggable and unexploited to date. Septerna was launched in 2022 by scientific founders who have made groundbreaking GPCR discoveries and by founding investor Third Rock Ventures.

Read More

BUSINESS INSIGHTS

WuXi STA Breaks Ground for New Pharmaceutical Manufacturing Facility in Middletown, Delaware

WuXi AppTec | August 17, 2022

WuXi STA, a leading Contract Research, Development, and Manufacturing Organization is pleased to announce the groundbreaking for its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware. First announced in June 2021, this site will be WuXi STA's second facility in the United States, offering expanded capacity and greater flexibility to meet the needs of customers in the U.S. and around the world. The WuXi STA Middletown site is located in the Middletown Business Center at 1091 Industrial Drive, and the new state-of-the-art facility will create approximately 500 full-time jobs by 2026. Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labeling, storage and distribution services for clinical trial materials and commercial drug products. WuXi STA has 12 sites across the U.S., Europe and Asia that offer a range of services and meet or exceed all regulatory standards. Together with three other drug product manufacturing sites in Couvet Wuxi City (China) and Shanghai this new facility will further enhance the company's global drug production capacity and capabilities. "The biopharmaceutical industry is part of Delaware's DNA. Over the next five years, WuXi STA plans to build a state-of-the-art pharmaceutical manufacturing campus in one of Delaware's fastest-growing communities, bringing with it good jobs and economic growth. This campus is only possible because of Delaware's world-class, innovative workforce. Thank you to WuXi STA, Middletown Mayor Kenny Branner and everyone who made this project possible." Delaware Governor John Carney "The First State continues to be a first-rate destination for businesses looking to innovate and grow," said Senator Tom Carper. "This investment by WuXi STA helps position Delaware as a continued global leader in biopharmaceuticals, further cementing the manufacturing might of one of our fastest growing communities. Delaware's workforce is ready to help build the future of our life-saving pharmaceuticals. This state-of-the-art campus will create good jobs and help fortify our supply chains here at home." "This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region," said Senator Chris Coons. "I am excited about WuXi STA's decision to choose Middletown for one of their new manufacturing facilities. This isn't just the largest private-sector investment in Middletown's history – it's a defining moment that will bring many more good-paying jobs to Delaware and will further cement the First State as a world leader in biopharmaceutical research and manufacturing. Thanks are due to everyone from Middletown to Dover to Washington who helped us get to this point, whether by making continued investments in NIIMBL, improving our education system from kindergarten to our universities, or ensuring that Delaware workers have the skills manufacturers like WuXi AppTec are looking for." "As the First State, Delaware has always had a spirit of innovation – constantly seeking new opportunities and ventures that will strengthen our economy and our state as a whole," said Rep. Lisa Blunt Rochester. "Today's groundbreaking of the WuXi STA pharmaceutical manufacturing plant represents another step in that spirit of innovation – bringing good-paying jobs to Middletown and strengthening communities throughout Delaware. The state-of-the-art facility will bring 500 full-time jobs over the next several years, growing our state's workforce and allowing us to manufacture more goods domestically - enhancing our economic competitiveness on the global stage." "We are truly looking forward to our partnership with WuXi STA, as the groundbreaking today marks the kick-off to them making their new home in Middletown, Delaware. WuXi STA will be joining our bustling industrial area, just steps away from Clarios, Datwyler, Amazon and Breakthru Beverage, just some of the companies that have invested in Middletown. When asked by WuXi STA about our business-friendly attitude, these businesses expressed their wholehearted support for how we do business and we couldn't be more excited about WuXi STA wanting to join them, and the Town of Middletown, in our journey together," said Middletown Mayor Ken Branner. Branner added he was thankful for the support of Gov. John Carney and the Delaware Prosperity Partnership. "I would like to thank our federal, state and local partners in Delaware for their continued support in the establishment of this site," said Dr. Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA. "WuXi STA continues to increase our capabilities and capacities to better serve our customers through a more robust and reliable supply chain. With our integrated Contract Research, Development, and Manufacturing Organization platform and proven quality system, we look forward to working with our customers to swiftly deliver their innovative therapies to market in order to save lives and improve healthcare for patients." About WuXi STA WuXi STA a subsidiary of WuXi AppTec is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier Contract Research, Development, and Manufacturing Organization WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. About WuXi AppTec As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,850 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."

Read More