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AbCellera and Everest Medicines Announce Multi-Target Collaboration to Advance New Antibody Therapies

Everest Medicines | September 23, 2021

AbCellera and Everest Medicines Limited announced that they have entered into a multi-year collaboration and license agreement to discover therapeutic antibodies for up to 10 targets selected by Everest. The partnership will help to expand Everest’s portfolio of novel medicines across multiple indications, with the initial programs focusing on targets in oncology.

We are proud to partner with Everest as they build a robust pipeline of innovative medicines for patients in Asia and beyond, We believe our full-stack discovery engine, combined with Everest’s clinical development capabilities, creates synergy and the opportunity to speed the delivery of therapies to patients around the world.

- Carl Hansen, Ph.D., CEO and President of AbCellera.

By partnering with AbCellera, Everest will benefit from an operating system that supports many antibody modalities to unlock new target classes and open new disease areas to therapeutic access. The collaboration will leverage the full breadth of AbCellera’s technology stack, including sourcing fully humanized antibodies from the Trianni Mouse®, sourcing single domain antibodies from camelids, and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.

This collaboration will allow us to gain access to AbCellera’s cutting edge, AI-powered antibody discovery platform, which will greatly accelerate and increase the efficiency of our internal discovery efforts.

- Jennifer Yang, Ph.D., Chief Scientific Officer of Everest Medicines.

Under the terms of the agreement, Everest will have the rights to develop and commercialize antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive from Everest downstream clinical and commercial milestone payments and royalties on net sales of products.

About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations in Asia and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of ten potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.

About AbCellera Biologics Inc.
AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.

AbCellera Forward-looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

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Ardelyx Announces Acceptance of New Drug Application for Tenapanor for Hyperphosphatemia in China

Globenewswire | July 14, 2023

Ardelyx, Inc. a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that a New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). A potential approval of the NDA submission in China is expected by the end of 2024. “The NDA acceptance for tenapanor for hyperphosphatemia in China marks a significant step forward in Ardelyx’s commitment to bringing our novel therapies to patients with unmet medical needs and our desire to expand internationally alongside best-in-class partners who complement our capabilities and share our mission,” said Mike Raab, president and chief executive officer of Ardelyx. “I commend our collaboration partner, Fosun Pharma, on the impressive clinical results they generated which demonstrate the important role that tenapanor can play in offering a new treatment option for patients with hyperphosphatemia. We look forward to further collaboration as Fosun Pharma brings this treatment to patients.” Under the terms of its agreement with Fosun Pharma, Ardelyx received an upfront payment of $12 million and is eligible to receive additional developmental and commercialization milestones of up to $110 million and tiered royalty payments on net sales ranging from the mid-teens to 20 percent. Fosun Pharma has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau. About Ardelyx, Inc. Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products.

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Pharmacy Market

Harrow Launches VIGAMOX® in the U.S.

Businesswire | August 01, 2023

Harrow a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. The U.S. commercial rights to VIGAMOX werepurchasedby Harrow in January of 2023, and VIGAMOX is the fourth FDA-approved ophthalmic product from that acquisition to have completed the NDA transfer process and become commercially available under the Harrow name. “Having now completed the NDA transfer of VIGAMOX, we are excited to begin the implementation of the market access, marketing, inventory management, national sales detailing, and other brand‑leveraging strategies that we have developed during this transfer period,” said Mark L. Baum, Chief Executive Officer of Harrow. “With an exceptional record of safety and efficacy, VIGAMOX is a well-known, reliable, and trusted product by U.S. eyecare professionals, many of whom regard VIGAMOX as the preferred broad-spectrum topical antibiotic to treat patients for bacterial conjunctivitis (sometimes referred to as 'pink eye') as well as many other common bacterial-based infections.” Product orders for VIGAMOX can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen. About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%: INDICATIONS AND USAGE VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis. Efficacy for this organism was studied in fewer than 10 infections. IMPORTANT SAFETY INFORMATION Contraindications VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. Warnings and Precautions Hypersensitivity Reactions –Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin. Prolonged Use –May result in overgrowth of non-susceptible organisms, including fungi. Avoid Contact Lens Wear –Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients. Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis. About Harrow Harrow Health, Inc. is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year.

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Cytel Acquires French Group stève consultants to Further Expand Value Evidence and Real-World Analytics Capabilities

Businesswire | July 07, 2023

Cytel Inc., provider of quantitative insights and health data analytics to leaders in life sciences, has acquired stève consultants, specialists in market access, real-world (RWE), and health economics and outcomes research (HEOR). The acquisition further expands Cytel’s real-world & advanced analytics (RWAA) capabilities, giving sponsors an expanded global offering, with access to additional specialists and localized expertise. This acquisition continues the company’s growth in key European markets, following the recent acquisition of Nordic regulatory affairs and RWE experts SDS Life Science. Cytel now stands as one of the largest global providers of HEOR, RWE, global value strategy and market access consulting. Achieving favorable market access is crucial in today’s highly competitive clinical development environment. But doing so is challenging and requires access to deep region-specific expertise. Cytel has long excelled at using proven quantitative techniques to transform real-world data into actionable insights to help sponsors successfully tap into new markets. The acquisition of stève consultants continues this journey, augmenting and extending the localized market access, product launch, and regulatory support it can offer in France, a critical European market. "stève consultants have crafted a team of unparalleled know-how in regional market access, HEOR, and RWE,” said Radek Wasiak, General Manager, Real-World and Advanced Analytics (RWAA), Cytel. “We look forward to welcoming them to Cytel as together we can now provide an exceptional service at the local level in France but also plug into the global dossier needs of our clients. For sponsors, this means a more global strategic offering, deeper connectivity to world-class expertise in France, and greater product launch success.” stève consultants has spent 17 years optimizing the value of its customers’ healthcare products for the French market, with deep expertise in market access, HEOR, and RWE. stève consultants is a leader in market access and one of the largest and most accomplished RWE services providers in France. “Joining forces with Cytel further expands the insight and support we can offer for market access and market maintenance in France,” said Stève Bénard, Executive Manager, stève consultants. “Both companies share a pioneering spirit, long-held market reputations for scientific rigor, and an excellent client service ethos. We’re proud to play a critical role in augmenting the way sponsors tap into markets and transform patients’ lives.” The transaction was closed on June 30, 2023. Terms were not disclosed. About Cytel Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 2,000 employees across North America, Europe and Asia. About stève consultants stève consultants, founded in 2006, is a consulting and research company specializing in optimizing the value of healthcare products on the French market. stève consultants supports its biotech and pharmaceutical clients in the development and the implementation of their regional market access strategy, including the implementation of early access programs, the demonstration of health-economic value, the generation of real-life data and the writing of HTA dossiers. stève consultants is a leader in market access, and one of the most accomplished RWE service providers in France. stève consultants has extensive experience and works on the latest therapeutic innovations.

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Pharmacy Market

Ardelyx Announces Acceptance of New Drug Application for Tenapanor for Hyperphosphatemia in China

Globenewswire | July 14, 2023

Ardelyx, Inc. a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that a New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). A potential approval of the NDA submission in China is expected by the end of 2024. “The NDA acceptance for tenapanor for hyperphosphatemia in China marks a significant step forward in Ardelyx’s commitment to bringing our novel therapies to patients with unmet medical needs and our desire to expand internationally alongside best-in-class partners who complement our capabilities and share our mission,” said Mike Raab, president and chief executive officer of Ardelyx. “I commend our collaboration partner, Fosun Pharma, on the impressive clinical results they generated which demonstrate the important role that tenapanor can play in offering a new treatment option for patients with hyperphosphatemia. We look forward to further collaboration as Fosun Pharma brings this treatment to patients.” Under the terms of its agreement with Fosun Pharma, Ardelyx received an upfront payment of $12 million and is eligible to receive additional developmental and commercialization milestones of up to $110 million and tiered royalty payments on net sales ranging from the mid-teens to 20 percent. Fosun Pharma has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau. About Ardelyx, Inc. Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products.

Read More

Pharmacy Market

Harrow Launches VIGAMOX® in the U.S.

Businesswire | August 01, 2023

Harrow a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. The U.S. commercial rights to VIGAMOX werepurchasedby Harrow in January of 2023, and VIGAMOX is the fourth FDA-approved ophthalmic product from that acquisition to have completed the NDA transfer process and become commercially available under the Harrow name. “Having now completed the NDA transfer of VIGAMOX, we are excited to begin the implementation of the market access, marketing, inventory management, national sales detailing, and other brand‑leveraging strategies that we have developed during this transfer period,” said Mark L. Baum, Chief Executive Officer of Harrow. “With an exceptional record of safety and efficacy, VIGAMOX is a well-known, reliable, and trusted product by U.S. eyecare professionals, many of whom regard VIGAMOX as the preferred broad-spectrum topical antibiotic to treat patients for bacterial conjunctivitis (sometimes referred to as 'pink eye') as well as many other common bacterial-based infections.” Product orders for VIGAMOX can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen. About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%: INDICATIONS AND USAGE VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis. Efficacy for this organism was studied in fewer than 10 infections. IMPORTANT SAFETY INFORMATION Contraindications VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. Warnings and Precautions Hypersensitivity Reactions –Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin. Prolonged Use –May result in overgrowth of non-susceptible organisms, including fungi. Avoid Contact Lens Wear –Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients. Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis. About Harrow Harrow Health, Inc. is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year.

Read More

Pharmacy Market

Cytel Acquires French Group stève consultants to Further Expand Value Evidence and Real-World Analytics Capabilities

Businesswire | July 07, 2023

Cytel Inc., provider of quantitative insights and health data analytics to leaders in life sciences, has acquired stève consultants, specialists in market access, real-world (RWE), and health economics and outcomes research (HEOR). The acquisition further expands Cytel’s real-world & advanced analytics (RWAA) capabilities, giving sponsors an expanded global offering, with access to additional specialists and localized expertise. This acquisition continues the company’s growth in key European markets, following the recent acquisition of Nordic regulatory affairs and RWE experts SDS Life Science. Cytel now stands as one of the largest global providers of HEOR, RWE, global value strategy and market access consulting. Achieving favorable market access is crucial in today’s highly competitive clinical development environment. But doing so is challenging and requires access to deep region-specific expertise. Cytel has long excelled at using proven quantitative techniques to transform real-world data into actionable insights to help sponsors successfully tap into new markets. The acquisition of stève consultants continues this journey, augmenting and extending the localized market access, product launch, and regulatory support it can offer in France, a critical European market. "stève consultants have crafted a team of unparalleled know-how in regional market access, HEOR, and RWE,” said Radek Wasiak, General Manager, Real-World and Advanced Analytics (RWAA), Cytel. “We look forward to welcoming them to Cytel as together we can now provide an exceptional service at the local level in France but also plug into the global dossier needs of our clients. For sponsors, this means a more global strategic offering, deeper connectivity to world-class expertise in France, and greater product launch success.” stève consultants has spent 17 years optimizing the value of its customers’ healthcare products for the French market, with deep expertise in market access, HEOR, and RWE. stève consultants is a leader in market access and one of the largest and most accomplished RWE services providers in France. “Joining forces with Cytel further expands the insight and support we can offer for market access and market maintenance in France,” said Stève Bénard, Executive Manager, stève consultants. “Both companies share a pioneering spirit, long-held market reputations for scientific rigor, and an excellent client service ethos. We’re proud to play a critical role in augmenting the way sponsors tap into markets and transform patients’ lives.” The transaction was closed on June 30, 2023. Terms were not disclosed. About Cytel Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 2,000 employees across North America, Europe and Asia. About stève consultants stève consultants, founded in 2006, is a consulting and research company specializing in optimizing the value of healthcare products on the French market. stève consultants supports its biotech and pharmaceutical clients in the development and the implementation of their regional market access strategy, including the implementation of early access programs, the demonstration of health-economic value, the generation of real-life data and the writing of HTA dossiers. stève consultants is a leader in market access, and one of the most accomplished RWE service providers in France. stève consultants has extensive experience and works on the latest therapeutic innovations.

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