Novartis names Bulto new U.S. pharma chief as exec reshuffle continues

FiercePharma | August 13, 2019

Novartis leadership shakeup under CEO Vas Narasimhan has led to a new U.S. pharmaceutical chief. Fabrice Chouraqui, who took on the U.S. job in 2016 from now-Gilead exec Christi Shaw, will step down at the end of August, Novartis said. He will be replaced by Victor Bulto, who currently serves as the head of Novartis U.S. immunology, hepatology and dermatology franchise. The Swiss drugmaker didn’t offer a reason for Chouraqui’s departure but praised his “strong leadership, ethics and integrity.” Bulto, a 14-year Novartis exec, was key in driving the U.S. success of psoriasis drug Cosentyx, which enjoyed 31% second-quarter sales growth in the U.S., to $534 million. He has also worked across every therapeutic area at Novartis, the company said. He will report to Marie France Tschudin, president of Novartis Pharmaceuticals globally, who just herself came onto that role after Paul Hudson left to take the helm at Sanofi from retiring Olivier Brandicourt. Tschudin and Bulto are just the latest examples of senior leadership changes at Novartis. Richard Saynor, a former GlaxoSmithKline exec, just took over the Sandoz CEO title from Richard Francis, who left amid a multiyear transformation Narasimhan initiated that's aiming to turn the generics business into a standalone unit within Novartis.

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BUSINESS INSIGHTS, PHARMA TECH

Northstar and Inhibrx Join Hands to Develop Radiopharmaceutical Candidates

Northstar and Inhibrx | January 09, 2023

NorthStar Medical Radioisotopes, LLC, announced a collaboration with Inhibrx, Inc., to develop and produce new radiopharmaceuticals for cancer treatment. Inhibrx will develop a new generation of targeted alpha treatments utilizing its improved single-domain antibodies (sdAbs). With a long history of sdAb innovation, it has created a library of sdAbs targeting tumor-associated antigens. Its high binding affinity and specificity for tumor cells or antigen-expressing cells within the tumor microenvironment make sdAbs an ideal biological targeting agent for radioisotope delivery. In addition, alpha-emitting radioisotopes have a small range of activity and high energy transfer, allowing for the targeted destruction of cancer cells with minimum damage to adjacent healthy tissue. NorthStar is expanding its position as an industry leader in the rapidly-growing field of therapeutic radioisotopes, and it is now prepared to become the first commercial-scale manufacturer of non-carrier added (n.c.a.) actinium-225 (Ac-225) and copper-67 (Cu-67). Under the terms of this agreement, NorthStar will provide the supply of Ac-225 and access to its comprehensive radiopharmaceutical contract development and manufacturing organization (CDMO) services to assist the development of a predetermined number of Inhibrx's novel biologic medicines. NorthStar will also prepare Inhibrx patient dosages for clinical studies and, upon approval, may manufacture and supply radionuclides for its commercial use. About NorthStar Medical Radioisotopes, LLC NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company with a mission to provide patients with global access to game-changing radiopharmaceuticals. The company uses ecologically preferable technologies to create, manufacture, and distribute diagnostic imaging and therapeutic radiopharmaceuticals. It is the only commercial U.S. producer of molybdenum-99, an essential diagnostic imaging radioisotope (Mo-99). The FDA-approved RadioGenix® System (technetium Tc 99m generator) uses US-manufactured, non-uranium-based Mo-99 as the source material to generate technetium-99m (Tc-99m), which is used to assess heart disease and cancer.

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PHARMACY MARKET, PHARMA TECH

Jazz Pharmaceuticals Maintains Exclusive Rights to Develop and Sell Zymeworks' Zanidatamab

Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022

Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022. A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found. Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers. Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug. Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022. About Jazz Pharmaceuticals Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible. About Zymeworks Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.

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BUSINESS INSIGHTS

Indivior To Acquire Opiant Pharmaceuticals

Indivior | November 21, 2022

Indivior PLC and Opiant Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which Indivior will acquire Opiant for an upfront consideration of $20.00 per share, in cash plus up to $8.00 per share in contingent value rights that may become payable in the event that certain net revenue milestones are achieved during the relevant seven-year period by OPNT003 after its approval and launch. The transaction has been unanimously approved by the boards of directors of each company. "Our work in combatting addiction has never been more critical, with overdose deaths in the United States occurring at near record numbers1," said Mark Crossley, Chief Executive Officer of Indivior. "Opiant's portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior's strong commercial capabilities are expected to propel a combined product pipeline with the potential to help patients along a continuum from substance use disorder and rescue to recovery. The combination with Opiant will provide Indivior with one of the most comprehensive and relevant treatment platforms to address the ongoing U.S. opioid and overdose epidemic and extends our leadership position in addiction treatments. We look forward to working with Opiant's talented team as we undertake our shared mission of changing patients' lives through access to life-transforming treatment for substance use disorders." Acquisition Strengthens and Extends Indivior's Position as a Leader in Addiction Treatment "We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines. This transaction combines Opiant with an organization that shares our patient-focused mindset, and we believe creates immediate value for patients, our employees and our stockholders. It will enable us to leverage Indivior's global scale, commercial strength and scientific expertise to accelerate our mission to create best-in-class medicines for the treatment of substance use disorders and drug overdose." Roger Crystal, M.D., Opiant's President and Chief Executive Officer Opiant is a biopharmaceutical company developing treatments for addiction and drug overdose leveraging intranasal and injectable delivery technologies. Opiant contributed to the development of the formulation of NARCAN® Nasal Spray, a treatment to reverse opioid overdose. In addition to OPNT003, nasal nalmefene, the pipeline includes OPNT002, nasal naltrexone, which is currently in a Phase II trial to assess its potential as a treatment for alcohol drinking and cravings, and OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose ("ACO"). OPNT003 is an investigational opioid overdose reversal agent that Opiant has been developing alongside a worsening opioid crisis, driven by the increased prevalence of synthetic opioids, such as illicit fentanyl. These powerful drugs are responsible for the surge of overdose deaths in the United States (103,000-plus overdose deaths reported in the latest annual period, of which over 75% were driven by opioids, mainly fentanyl and synthetic opioids1). OPNT003 is designed to be used by non-healthcare individuals and delivered intranasally. Observations from multiple clinical studies reinforce its potential rapid onset and long duration of action. Opiant received FDA Fast Track Designation for OPNT003 in November 2021 and is expected to complete its New Drug Application submission for OPNT003 with the FDA in the fourth quarter of 2022. Subject to approval by the FDA, anticipated approval for a fast-track application is third quarter 2023, with launch in the United States expected in the ensuing months. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

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