PHARMACY MARKET

Ionis and AstraZeneca close deal to develop and commercialize eplontersen

Ionis Pharmaceuticals, Inc. | December 30, 2021

Ionis Pharmaceuticals, Inc.  the leader in RNA-targeted therapies,  announced the closing of the collaboration agreement with AstraZeneca to develop and commercialize eplontersen, Ionis' investigational antisense medicine for the treatment of transthyretin amyloidosis, following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Eplontersen, formerly known as IONIS-TTR-LRx, is designed to reduce the production of transthyretin, or TTR protein, to treat ATTR, a systemic, progressive and fatal disease. It uses Ionis' advanced LIgand-Conjugated Antisense technology.

As previously announced, the companies will jointly develop and commercialize eplontersen in the U.S. AstraZeneca has an exclusive license for eplontersen outside the U.S., except certain countries in Latin America. Under the terms of the agreement, Ionis will receive a $200 million upfront payment, up to $485 million in development and approval milestones, and up to $2.9 billion in sales-related milestone payments. The collaboration includes territory-specific development, commercial and medical affairs cost-sharing provisions. Ionis is also eligible to earn royalties in the range of low double-digit to mid-20s percentage depending on region. Additional details about the agreement can be found in Ionis' Form 8-K filed with the Securities and Exchange Commission on Dec. 7, 2021.

About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading neurological and cardiometabolic franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision of becoming one of the most successful biotechnology companies.

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LTS takes next step in its Growth Journey with the acquisition of Tapemark Inc.

LTS Lohmann Therapie-Systeme AG | August 23, 2022

LTS LOHMANN Therapie-Systeme AG announces the closing of the acquisition of Tapemark Inc. located in St. Paul, MN, USA. This acquisition combines Tapemark, a world-class CDMO specialized in transdermal drug delivery systems and oral thin films as well as unit dose semi-solid drug and iontophoresis products with LTS, a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches Oral Thin Films and Micro Array Patches (MAP) for major Bio- /Pharmaceutical, Generic, and Consumer Health companies. With the acquisition, Tapemark´s St. Paul facility will become part of the worldwide operations network of LTS, along with LTS' existing facilities in Andernach, Germany and West Caldwell, NJ in the US. Bas van Buijtenen, CEO of LTS, commented, "We are very pleased to welcome the Tapemark team to the LTS family. This strategic acquisition demonstrates our commitment to continue to set the standard as the best CDMO in TTS and OTF and to strengthen our footprint in the US, the world's most important pharma market. We will offer an even more complete portfolio of drug delivery expertise and expanded manufacturing capabilities to our customers and their patients, and we are excited to welcome Tapemark's customers to LTS' global network. The acquisition strengthens our R&D capabilities in North America, allowing us to bring ever more innovation and development support to players developing innovative therapies and new drug delivery systems. With that, we're even better positioned to address our customers' desire for a single partner to support them from feasibility through commercialization. We are particularly pleased that such a talented team is joining our organization. I am delighted that Beau Garrett will be strengthening our Global Leadership Team in the role of SVP Strategy and Corporate Development. His track record as a leader successfully driving growth will bolster our LTS Growth Journey." "Joining LTS strengthens our ability to craft the best product development and manufacturing strategy to deliver complex drugs for our customers who ultimately bring these to market and help patients around the world. Having spoken to our customers, I know they are excited to benefit from the breadth of LTS's global technology portfolio, its product development capabilities, and the vast global network. Together, we will reach more pharmaceutical partners and ultimately help more patients. Personally, I am pleased our executive team is joining such a strong team at LTS. From the day I met Bas and several of the senior leaders at LTS, I knew this was the right fit for both companies, our employees, and our customers." Beau Garrett, CEO of Tapemark The transaction has obtained the necessary regulatory approvals and has closed as of August 19, 2022. Financial details of the transaction are not disclosed. Bourne Partners served as the exclusive financial advisor to Tapemark. About LTS LTS LOHMANN Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches and Oral Thin Films for the pharmaceutical industry. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches for the transdermal delivery of large molecule, biological actives and vaccines. Founded in 1984, LTS operates today from three sites: in Andernach, Germany, West Caldwell, NJ, USA and St. Paul, MN, USA. LTS has also a representative office in Shanghai, China.

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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.

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PHARMA TECH

Nucleai Announces a Partnership with Sirona Dx for AI-Driven Discovery of Novel Spatial Biomarkers in Solid Tumors

Nucleai and Sirona Dx | July 14, 2022

Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, and Sirona Dx, a leading provider of multiomic single-cell analytical services, today announced a collaboration to advance the discovery of novel spatial biomarkers in solid tumors. The partnership combines Nucleai’s powerful AI spatial analytics platform with Sirona Dx’s leading multiplex assay development expertise to identify novel spatial signatures in high-plex assays that predict response to therapy and inform treatment decisions. Through this strategic collaboration, Sirona Dx will provide Nucleai and its customers with a CRO partner that will enable the deployment of AI-based diagnostic algorithms to support biopharma clinical trials. Nucleai’s robust computational AI-powered spatial biology algorithm supports various image modalities and cancer indications, offering a highly customizable, deployable solution across the drug development ecosystem. These capabilities earned Nucleai the position of one of the top 10 spatial biology companies in 2022. “Multiplex imaging technologies have improved rapidly over the years; however, identifying actionable insights from all the data collected remains immensely challenging. This powerful synergy between Sirona Dx and Nucleai is very exciting as it will allow us to identify actionable spatial signatures that can predict response to immunotherapy.” Avi Veidman, Co-Founder & Chief Executive Officer of Nucleai Sirona Dx is recognized as the original pioneers of spatial biology, having launched the first spatial-omics CRO service to biopharma in 2018. Today, their technology-agnostic, spatial biology suite includes the leading multiplexed imaging platforms and combines deep technical expertise required to develop high-performance multiplexed assays as large as 50 markers. Sophisticated multiplexed tissue imaging capabilities contributed to their selection as a Top 10 CRO of 2021 by Medhealth Outlook. “We are delighted to announce a partnership with Nucleai,” said Andrew Brown, Ph.D. Chief Commercial Officer at Sirona Dx. “Nucleai’s AI-driven analytical capabilities are exceptional. Our combined expertise in multiplexed tissue assay development, data generation and state-of-the-art analysis will unlock new spatial insights and accelerate the spatial biology revolution in precision medicine.” About Nucleai Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, contract research organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making. About Sirona Dx Sirona Dx is a technical, CLIA accredited CRO, founded in 2016 to accelerate the pace of immunotherapy and targeted therapy development. With a leading-edge menu of specialized high complexity, single-cell proteomics and genomics services, Sirona Dx supports exploratory biomarker programs and advanced precision medicine initiatives to deliver safer and more effective treatment solutions.

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