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AstraZeneca and Daiichi Sankyo’s Enhertu met prespecified criteria for objective response rate and duration of response

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AstraZeneca and Daiichi Sankyo’s Enhertu met prespecified criteria for objective response rate and duration of response

March 06, 2023: “Positive high-level results from an analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) met the prespecified target for objective response rate (ORR) and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pretreated patients.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The DESTINY-PanTumor02 Phase II trial is evaluating the efficacy and safety of Enhertu in patients with locally advanced, unresectable, or metastatic previously treated, HER2-expressing solid tumours not eligible for curative therapy, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and rare cancers.

The primary endpoint of the trial is investigator-assessed confirmed ORR and investigator-assessed duration of response (DoR) is a key secondary endpoint.

The data will be presented at an upcoming medical meeting and shared with global regulatory authorities.

HER2 is a tyrosine kinase receptor protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth.

In some cancer cells, HER2 expression is amplified or the cells have activating mutations.

While HER2-directed therapies have been used to treat breast, gastric and lung cancers, more research is needed evaluating their potential role in treating other HER2-expressing tumour types.

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said, “Enhertu has already demonstrated its potential to improve outcomes for patients with HER2-targetable breast, gastric and lung cancers, and these positive initial results in other tumour settings with significant unmet need are very encouraging.

The DESTINY-PanTumor02 results mark an important step forward in our understanding of the potential role of Enhertu across multiple HER2-expressing tumour types.”

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said, “The clinically meaningful responses seen in the DESTINY-PanTumor02 trial reaffirm our belief in the potential of Enhertu across multiple HER2-expressing cancers.

The results seen so far across multiple cohorts of the trial will inform next steps of our broad development programme as we look to bring this important medicine to as many patients as quickly as possible.”

The safety profile observed in patients treated with Enhertu in the DESTINY-PanTumor02 trial was consistent with that seen in other trials of Enhertu with no new safety signals identified.​”

DESTINY-PanTumor02
DESTINY-PanTumor02 is a global, multicentre, multi-cohort, open-label Phase II trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) for the treatment of HER2-expressing tumours, including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer and rare tumours.

The primary efficacy endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DoR, disease control rate, progression-free survival, overall survival, safety, tolerability and pharmacokinetics.

DESTINY-PanTumor02 has enrolled 268 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. 

Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial and/or DESTINY-Gastric02 trial.

Enhertu development programme
A comprehensive global development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers.

Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.”

https://www.astrazeneca.com/media-centre/press-releases/2023/enhertu-destiny-pantumor02-shows-positive-results.html

FDA Outlines Steps to Strengthen Tobacco Program

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FDA Outlines Steps to Strengthen Tobacco Program

February 24, 2023: “The U.S. FDA’s Center for Tobacco Products (CTP) outlined the steps it plans to take in response to an external evaluationExternal Link Disclaimer I commissioned last year from an independent panel of evaluators working through the Reagan-Udall Foundation.

The evaluation was an important opportunity to take a critical look at the Tobacco Program’s regulatory processes and operations.We have made tremendous progress preventing death and disability caused by tobacco use, but I am a strong believer that we can always benefit from examining how we can work most effectively and proactively to protect public health, support our staff, and be as responsive as possible to external stakeholders.

When I started my career in intensive cardiac care, hospitals were full of relatively young people with sudden death, heart attacks, strokes and cancer attributable to tobacco use.

The effectiveness of the public health and medical communities to reduce the toll of tobacco products was enhanced when the FDA was granted the authority to regulate tobacco. 

As we enter this era of declining use of combustible tobacco and continued innovation in the e-cigarette industry, the societal concerns are not subtle.

Our ability to keep pace with these changes will depend on immediate, short-term and long-term actions the center is taking that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products. 

CTP Director Brian King, Ph.D., M.P.H., has provided more detail about our approach to respond to the evaluation recommendations and our new plans, which will include the release of a 5-year strategic plan and comprehensive policy agenda by the end of the year.

CTP has committed to providing regular updates on the progress of these activities, including some noted here.

Application Review

In the past several years in particular, CTP has made important progress in the review of applications for e-cigarette products – authorizing several tobacco-flavored e-cigarette products and devices and rejecting marketing applications for millions of products that did not meet the requirements in the law.

Given the ever-evolving tobacco marketplace, it is imperative that we optimize the framework for application reviews to ensure any products marketed meet the law’s public health and regulatory standards.

This work will include, among other things: 

  • further streamlining of reviews when appropriate; 
  • increasing the use of the Tobacco Products Scientific Advisory Committee to discuss broader scientific matters central to premarket evaluation and individual product applications; 
  • posting current and future scientific policy memos and reviewer guides when appropriate; and
  • working internally and through engagement with external stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness, and transparency. These critical efforts will be bolstered by a new director in CTP’s Office of Science, who will begin in late March.

To achieve these goals, we need to have the appropriate resources to hire and retain staff with the skills needed to effectively meet our public health mandate around tobacco.

Since the agency’s fiscal year 2020 budget request, the FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products.

The FDA also continues to explore ways, including engaging with the U.S. Department of Health and Human Services and the Office of Personnel Management, to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals that match CTP’s needs.  

Compliance and Enforcement

As the agency continues to make progress on its review of new and pending applications for novel products like e-cigarettes, the FDA will take additional action to remove illegal products from the market—particularly ones that have led to e-cigarettes being the most commonly used tobacco product among youth.

Between January 2021 and February 17, 2023, the FDA has issued more than 550 warning letters to companies for continuing to sell e-cigarette products that lacked the required FDA marketing authorization.

These companies had millions of products listed with the FDA. After receiving warning letters, a majority of these companies have complied and removed their products from the market. However, in cases where companies did not do so, the FDA can pursue further enforcement action.

For example, the FDA recently worked with the Department of Justice (DOJ) to file the first complaints for permanent injunctions against six e-cigarette manufacturers.

Additionally, for the first time, the FDA this week filed civil money penalty complaints against four tobacco product manufacturers for manufacturing and selling new e-liquids without marketing authorization.

The agency will continue to work as expeditiously as possible to remove illegal products from the market while identifying new ways to strengthen compliance and enforcement.  

As recommended by the external evaluation, effective immediately, the FDA will begin planning to convene a summit with senior officials from the HHS and DOJ related to enforcement.

The agency will also continue to work with other government agencies, such as U.S. Customs and Border Protection, the U.S. Postal Service, the Federal Trade Commission, Bureau of Alcohol, Tobacco, Firearms and Explosives, as well as with our compliance and enforcement partners at the state/local/territorial/tribal levels.”

This work will maximize compliance and enforcement activities where there are shared interests. Additionally, the FDA will explore alternative approaches to achieve compliance outside of judicial enforcement actions.”

https://www.fda.gov/news-events/press-announcements/fda-outlines-steps-strengthen-tobacco-program

AZ’s acquisition with CinCor Pharma completed

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AZ’s acquisition with CinCor Pharma completed

February 24, 2023: “AstraZeneca announced the successful completion of the acquisition of CinCor Pharma, Inc. (CinCor), a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension as well as chronic kidney disease.

The acquisition bolsters AstraZeneca’s cardiorenal pipeline by adding baxdrostat (CIN-107), an aldosterone synthase inhibitor (ASI) for blood pressure lowering in treatment-resistant hypertension, to its cardiorenal portfolio.

Baxdrostat represents a potentially leading next-generation ASI as it is highly selective for aldosterone synthase and spares the cortisol pathway in humans.

The opportunity also brings the potential for combination with Farxiga and complements AstraZeneca’s strategy to provide added benefit across cardiorenal diseases, where there is a high unmet medical need.

The acquisition was completed through a tender offer to purchase all outstanding shares of CinCor for approximately $1.3bn upfront.

As part of the transaction, AstraZeneca acquired the cash and marketable securities on CinCor’s balance sheet, which totalled approximately $500 million as of the closing, excluding transaction-related expenses. Under the terms of the agreement, CinCor shareholders also received a non-tradable contingent value right, payable upon a specified regulatory submission of a baxdrostat product.

Combined, the upfront and contingent value payments represent, if achieved, a transaction value of approximately $1.8bn.

As of the expiration of the tender offer, 39,580,275 shares of CinCor were validly tendered and not validly withdrawn from the tender offer, representing approximately 86.3% of the outstanding shares of common stock of CinCor, and such shares have been accepted for payment in accordance with the terms of the tender offer.

CinCor’s shares will be delisted from the Nasdaq Stock Market, and CinCor will terminate its registration under the U.S. Securities Exchange Act of 1934 as soon as practicable following completion of the acquisition.

Forward-looking statements
This announcement may include statements that are not statements of historical fact, or “forward-looking statements,” including with respect to AstraZeneca’s acquisition of CinCor.

Such forward-looking statements include, but are not limited to, AstraZeneca’s and CinCor’s beliefs and expectations and statements about the benefits sought to be achieved in AstraZeneca’s acquisition of CinCor, the potential effects of the acquisition on both AstraZeneca and CinCor, as well as the expected benefits and success of baxdrostat and any combination product.

These statements are based upon the current beliefs and expectations of AstraZeneca’s and CinCor’s management and are subject to significant risks and uncertainties.

There can be no guarantees that baxdrostat or any combination product will receive the necessary regulatory approvals or prove to be commercially successful if approved.

If underlying assumptions prove inaccurate or risks or uncertainties materialise, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, the possibility that the milestone related to the contingent value right will not be achieved; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of COVID-19; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; competition from other products; and challenges inherent in new product development, including obtaining regulatory approval.

Neither AstraZeneca nor CinCor undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law.

Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in AstraZeneca’s Annual Report on Form 20-F for the year ended 31 December 2022, CinCor’s Annual Report on Form 10-K for the year ended 31 December 2021 and CinCor’s Quarterly Reports on Form 10-Q for the three months ended 31 March 2022, 30 June 2022 and 30 September 2022, in each case as amended by any subsequent filings made with the SEC. 

https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-acquires-cincor-for-cardiorenal-asset.html

Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance

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Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance

February 22, 2023: “Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

Priority Review is intended to direct attention and resources from regulatory authorities toward drugs that, if approved, could offer significant improvements over existing options for serious conditions in order to make these drugs available to patients faster.

The FDA’s decision on the application is expected in 2023. The European Medicines Agency (EMA) has also accepted elranatamab’s marketing authorization application (MAA).

The company is working closely with the EMA to facilitate their review and will provide updates on timing as appropriate.

“Today, multiple myeloma is a fatal hematologic malignancy, with a median survival of just over five years. As an off-the-shelf treatment, BCMA bispecific antibodies are heralding a new treatment paradigm that can greatly impact the lives of people with this disease.” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.

“We believe that elranatamab, if approved, has the potential to become the next standard of care for multiple myeloma given its favorable clinical results and convenient subcutaneous route of administration.

We look forward to working with the FDA and EMA to bring this new innovative medicine to patients globally.”

Elranatamab is designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma (MM) cells, and CD3 receptors found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells.

The BLA and MAA for elranatamab are primarily based on data from cohort A (BCMA-naïve – n=123) of MagnetisMM-3 (NCT04649359), an ongoing, open-label, multicenter, single-arm, Phase 2 study designed to evaluate the safety and efficacy of elranatamab monotherapy in patients with RRMM.

Enrolled patients represent a heavily pretreated population, who previously received at least three classes of therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

With a median follow up of 10.4 months, patients who received elranatamab as their first BCMA-targeted therapy achieved a high objective response rate of 61% (55% had a very good partial response rate or better), with an 84% probability of maintaining the response at nine months.

The MagnetisMM-3 results also suggest elranatamab has a manageable safety profile. The two-step-up priming dose regimen (12/32 mg) helped mitigate the rate and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) among the 119 patients in cohort A who were treated with this priming regimen.

All cases of CRS were Grade 1 or 2 and the majority occurred after the first (43% of patients) or second (24% of patients) dose, with only 6% of patients experiencing CRS after dose 3 and fewer than 1% experiencing CRS after dose 4.

Observed cases of ICANS (3%) were neither common nor severe (Grade 1/2 only were reported). No fatal neurotoxicity events were observed.

These data were presented at the 64th American Society of Hematology Annual Meeting and Exposition in December 2022.

This study is part of the MagnetisMM clinical research program that expands to additional patient populations over time, with ongoing registrational-intent trials that explore elranatamab both as monotherapy and in combination with standard or novel therapies, spanning multiple patient populations, from newly diagnosed MM to RRMM.

This includes MagnetisMM-5 (NCT05020236) in the double class exposed setting, MagnetisMM-6 (NCT05623020) in transplant ineligible newly diagnosed patients, and MagnetisMM-7 (NCT05317416) as maintenance treatment in newly diagnosed patients after transplant, all of which are currently enrolling.

In November 2022, Pfizer announced that elranatamab was granted Breakthrough Therapy Designation by the FDA.

In addition, elranatamab has been granted Orphan Drug Designation by the FDA and the EMA for the treatment of MM.

The FDA and EMA have also granted elranatamab Fast Track Designation and the PRIME scheme, respectively, for the treatment of patients with RRMM.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted elranatamab Innovative Medicine Designation and the Innovation Passport for the treatment of MM.

The FDA has accepted elranatamab for Project ORBIS, which is a framework for the concurrent submission and review of oncology products to potentially expedite approvals in certain countries outside of the US; currently 5 countries (Switzerland, Brazil, Canada, Australia, and Singapore) have accepted to participate.

About Elranatamab

Elranatamab is an investigational, off-the-shelf, humanized BCMA CD3-targeted BsAb. BsAbs are a novel form of cancer immunotherapy that bind to and engage two different targets at once. One arm binds directly to specific antigens on cancer cells and the other arm binds to T-cells, bringing both cell types together.

The binding affinity of elranatamab for BCMA and CD3 has been engineered to elicit potent T-cell-mediated anti-myeloma activity. Elranatamab is administered subcutaneously, which offers more convenience over intravenous administration.

About MagnetisMM-3

MagnetisMM-3 (NCT04649359) is an ongoing, open-label, multicenter, single-arm, Phase 2 study designed to evaluate the safety and efficacy of elranatamab monotherapy in patients with RRMM.

Patients received subcutaneous (SC) elranatamab 76 mg weekly (QW) on a 28-day cycle with a step-up priming dose regimen, wherein 12 mg and 32 mg are administered on Day 1 and Day 4, respectively, during Cycle 1.

For patients receiving 6 or more cycles and achieving a partial response or better for at least 2 months, the dosing interval was once every two weeks (Q2W).

About Multiple Myeloma

MM is a blood cancer that affects plasma cells made in the bone marrow. Healthy plasma cells make antibodies that help the body fight infection.

There are over 34,000 new cases of MM diagnosed annually in the U.S. and 176,000 globally.

Despite treatment advances, there is currently no cure. The median survival is just over five years, and most patients receive four or more lines of therapy.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizers-elranatamab-receives-fda-and-ema-filing-acceptance

FDA Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers

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FDA Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers

February 22, 2023: “The U.S. FDA announced draft recommendations for industry on the naming of plant-based foods that are marketed and sold as alternatives to milk.

The draft guidance also recommends voluntary nutrient statements for the labeling of some plant-based milk alternatives. 

“Today’s draft guidance was developed to help address the significant increase in plant-based milk alternative products that we have seen become available in the marketplace over the past decade,” said FDA Commissioner Robert M. Califf, M.D.

“The draft recommendations issued today should lead to providing consumers with clear labeling to give them the information they need to make informed nutrition and purchasing decisions on the products they buy for themselves and their families.” 

In addition to the increase in market availability and consumption, the variety of alternative products available in the marketplace has also greatly expanded from soy, rice and almond to include cashew, coconut, flaxseed, hazelnut, hemp seed, macadamia nut, oat, pea, peanut, pecan, quinoa and walnut-based beverages. Although these products are made from liquid-based extracts of plant materials, such as tree nuts, legumes, seeds or grains, they are frequently labeled with names that include the term “milk.”
 
The draft guidance, “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry,” recommends that a plant-based milk alternative product that includes the term “milk” in its name (e.g., “soy milk” or “almond milk”), and that has a nutrient composition that is different than milk, include a voluntary nutrient statement that conveys how the product compares with milk based on the U.S. Department of Agriculture’s (USDA) Food and Nutrition Service fluid milk substitutes nutrient criteria.

For example, the label could say, “Contains lower amounts of Vitamin D and calcium than milk.” 

In September 2018, the FDA requested information on the labeling of plant-based milk alternatives (PBMA) with terms that include the names of dairy foods such as “milk.”

More than 13,000 comments were received, and the FDA determined that consumers generally understand that PBMA do not contain milk and choose to purchase PBMA because they are not milk.

However, many consumers may not be aware of the nutritional differences between milk and PBMA products.

For example, almond- or oat-based PBMA products may contain calcium and be consumed as a source of calcium, but their overall nutritional content is not similar to milk and fortified soy beverages, and they are not included as part of the dairy group in the Dietary Guidelines 2020-2025.

Dairy foods, including milk, are recommended by the Dietary Guidelines as part of a healthy eating pattern and contribute multiple key nutrients, including protein and vitamins A and B-12, along with calcium, potassium and vitamin D, which are currently under-consumed.

The Dietary Guidelines only includes fortified soy beverages in the dairy group because their nutrient composition is similar to that of milk.

However, the nutritional composition of PBMA products varies widely within and across types, and many PBMAs do not contain the same levels of key nutrients as milk. 

“Getting enough of the nutrients in milk and fortified soy beverages is especially important to help children grow and develop, and parents and caregivers should know that many plant-based alternatives do not have the same nutrients as milk,” said Susan T. Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition.

“Food labels are an important way to help support consumer behavior, so we encourage the use of the voluntary nutritional statements to better help customers make informed decisions.” 

To support consistency across federal nutrition policies, the draft guidance recommends that industry use the USDA’s Food and Nutrition Service fluid milk substitutes nutrient criteria to determine if a PBMA is nutritionally similar to milk.

Also, the FDA encourages consumers to use the Nutrition Facts label to compare the nutrient content of different products to help make informed choices.

The FDA is accepting comments on the draft guidance. A manufacturer may choose to implement the recommendations in a draft guidance before the guidance becomes final.

Labels provide consumers with valuable information to help choose healthier foods.

It is one of the priorities of the FDA’s nutrition efforts to ensure people in the U.S. have greater access to healthier foods and nutrition information to help make healthy choices more easily.

The draft guidance issued today does not apply to other plant-based dairy alternatives, such as plant-based cheese or yogurt alternatives.

The FDA is in the process of developing a draft guidance to address the labeling and naming of other plant-based alternative products and will communicate updates when available.”

https://www.fda.gov/news-events/press-announcements/fda-provides-draft-labeling-recommendations-plant-based-milk-alternatives-inform-consumers

FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers

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FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers

February 22, 2023: “The U.S. FDA announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization.

This is the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.

It is illegal to manufacture, sell, or distribute e-liquids that the FDA has not authorized.

The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s premarket requirements for tobacco products and that failure to correct these violations could lead to an enforcement action, such as a CMP.

Despite the agency’s warning, these companies continue to make and sell their unauthorized e-liquids to consumers. 

“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products.

“We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.” 

As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:

  • BAM Group LLC doing business as VapEscape
  • Great American Vapes LLC doing business as Great American Vapes
  • The Vapor Corner Inc. doing business as Vapor Corner Inc., The Vapor Corner, and Vapor Corner
  • 13 Vapor Co. LLC doing business as 13 Vapor

Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases.

The companies the FDA has filed CMP complaints against can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing.

Companies that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.  

“These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” said Dr. King. “These actions should be a wakeup call that all tobacco product manufacturers—big or small—are required to obey the law.”    

All new tobacco products, including all e-cigarettes, on the market without the statutorily required premarket authorization are marketed illegally and are subject to FDA enforcement action.

The FDA closely monitors manufacturer compliance with the law and may take action when violations occur. Between Jan. 2021 through Feb. 17, 2023, the FDA has issued more than 550 warning letters to firms—both large and small—for manufacturing, selling, and/or distributing new tobacco products without marketing authorization from the FDA.

After receiving warning letters, a majority of these companies have complied and removed their products from the market. Manufacturers that continue to violate the law risk subsequent enforcement.

In addition to CMPs, the agency also has authority to take other enforcement action, as appropriate, including seizures, injunctions, and criminal prosecutions.   

Manufacturers must submit a marketing application to the FDA and receive authorization to legally sell a new tobacco product in the United States.

The FDA encourages manufacturers to learn more about the three pathways to submit an application for new tobacco products.”

https://www.fda.gov/news-events/press-announcements/fda-files-civil-money-penalty-complaints-against-four-e-cigarette-product-manufacturers

Pediatric research at ReSViNET 2023 underscores Beyfortus’ potential to prevent RSV disease in infants

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Pediatric research at ReSViNET 2023 underscores Beyfortus’ potential to prevent RSV disease in infants

Feb 21, 2023: “Research reinforcing Beyfortus’ consistency in reducing respiratory syncytial virus (RSV) lower respiratory tract infections requiring medical care in infants, presented at the 7th Respiratory Syncytial Virus Foundation (ReSViNET) Conference in Lisbon, Portugal from February 22-24, 2023.

Jean-François Toussaint
Global Head of Research and Development Vaccines, Sanofi
“The winters’ surges in RSV disease highlight again how this seasonal respiratory virus causes immense disruption to families and health systems every year. 

The new Beyfortus data are consistent with all data accumulated to date and confirm its strong profile, with an almost 80 percent reduction in medically attended RSV infections in the lungs of infants. We are on the precipice of reaching this much needed public health goal.”

MELODY full cohort data confirms high and consistent efficacy results

Among the key data to be presented at ReSViNET are the safety and efficacy findings from the full cohort of the phase 3 MELODY clinical trial investigating Beyfortus in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.

These presentations strengthen Beyfortus’ consistency in demonstrating an efficacy of approximately 80% against medically attended RSV lower respiratory tract infections. The safety profile of Beyfortus was similar to placebo.

Along with the MELODY full cohort data, 24 abstracts and presentations at ReSVinet will detail the seasonal burden of RSV and the importance of a preventative option that could help protect the broad infant population with one dose for the entire RSV season.
Featured RSV presentations at ReSViNET 2023:

  • Safety and Efficacy of Nirsevimab for Prevention of Medically Attended RSV Lower Respiratory Tract Infection in All Infants Enrolled in the Phase 3 Melody Trial. Oral presentation number 35; Session III (11:40am-1pm); EPIC SANA Lisboa Hotel, Morus Hall.
  • Evaluating the Disease Burden of RSV Infections in Young Children in Primary Care: a Systematic Literature Review. Poster presentation number 115; EPIC SANA Lisboa Hotel, Foyer.
  • Seasonality of Infant Lower Respiratory Tract Infections, Including those Caused by RSV, Was Altered During the COVID-19 Pandemic: Results from Four US Health Systems. Poster presentation number 84; EPIC SANA Lisboa Hotel, Foyer.
  • Infant hospitalizations and ICU Admissions for Bronchiolitis and RSV-BRONCHIOLITIS Are at Historic Highs During 2022 Early Seasonal Disease: Results From Four US Health Systems. Poster presentation number 85; EPIC SANA Lisboa Hotel, Foyer.

Beyfortus, being developed by Sanofi and AstraZeneca, is the only RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.

Beyfortus’ single administration can be timed to correspond with the beginning of the RSV season for babies born prior to the season and at birth for those born during the RSV season (November to March).

In clinical trials, Beyfortus demonstrated protection for at least five months.

RSV is the most common cause of lower respiratory infections, including bronchiolitis and pneumonia in infants.

It is also a leading cause of hospitalization in all infants. Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.

RSV-related direct medical costs, globally – including hospital, outpatient and follow-up care – were estimated at €4.82 billion in 2017.

About Beyfortus

Beyfortus®, a long-acting antibody designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose, is developed jointly by Sanofi and AstraZeneca.

Beyfortus has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent medically attended lower respiratory tract infections caused by RSV.

Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against the disease.

Beyfortus has been granted marketing authorization in the European Union and the United Kingdom for the prevention of RSV lower respiratory tract disease in newborns and infants from birth during their first RSV season.4

In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize Beyfortus. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi will lead commercialization activities and record revenues.

Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid development and regulatory milestones of €55m and will pay up to a further €440m upon achievement of certain regulatory and sales-related milestones.

The two companies share all costs and profits.

Beyfortus has been granted designations to facilitate expedited development by several regulatory agencies around the world.

These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines (PRIME) scheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and has been named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED).

The safety and efficacy of Beyfortus was evaluated under an accelerated assessment procedure by the EMA.”

https://www.sanofi.com/en/media-room/press-releases/2023/2023-02-21-13-16-26-2612125

AZ enters license agreement with KYM Biosciences for CMG901, a Claudin-18.2 antibody drug conjugate

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AZ enters license agreement with KYM Biosciences for CMG901, a Claudin-18.2 antibody drug conjugate

February 23, 2023: “AstraZeneca and KYM Biosciences Inc.i have entered into a global exclusive licence agreement for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, a promising therapeutic target in gastric cancer.

Under the licence agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialisation of CMG901 globally.

CMG901 is currently being evaluated in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumours, including gastric cancer. Preliminary results from the Phase I trial have shown an encouraging clinical profile for CMG901, with early signs of anti-tumour activity across the dose levels tested.

Puja Sapra, Senior Vice President, Biologics Engineering & Oncology Targeted Delivery, Oncology R&D, AstraZeneca, said, “We are excited by the opportunity to accelerate the development of CMG901, a potential new medicine for patients with Claudin18.2-expressing cancers.

CMG901 strengthens our growing pipeline of antibody drug conjugates and supports our ambition to expand treatment options and transform outcomes for patients with gastrointestinal cancers.”

Dr Bo Chen, Chief Executive Officer of Keymed and Board Chairman of KYM Biosciences, said, “We are pleased to announce our agreement with AstraZeneca, a global biopharmaceutical company with leadership in developing and commercializing novel anti-cancer therapies.

This is not only a recognition of CMG901, a potential first-in-class Claudin 18.2 ADC, but also Keymed’s internal discovery and development capabilities. The global scope of this agreement has the potential to benefit patients in China, and throughout the world.”

Financial considerations
AstraZeneca will make an upfront payment of $63m on transaction closing and additional development and sales-related milestone payments of up to $1.1bn to KYM Biosciences as well as tiered royalties up to low double digits.

The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca’s financial guidance for 2023.”

https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-enters-license-agreement-with-kym-biosciences-for-cmg901-a-claudin-182-antibody-drug-conjugate.html

ReSViNet 2023 data reinforce AZ’s commitment to help prevent Respiratory Syncytial Virus in infants

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ReSViNet 2023 data reinforce AZ’s commitment to help prevent Respiratory Syncytial Virus in infants

February 21, 2023: “AstraZeneca will showcase new data across its Vaccines and Immune Therapies Respiratory Syncytial Virus (RSV) portfolio at the 7th Respiratory Syncytial Virus Foundation (ReSViNET) Conference in Lisbon, Portugal from 22-24 February 2023, reinforcing its commitment to help protect infants from RSV.

The Company is set to present five abstracts and posters at the event, including new data featuring Beyfortus (nirsevimab) and Synagis (palivizumab).

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “I am proud of AstraZeneca’s commitment to respiratory syncytial virus (RSV) and our continued focus on innovating antibodies to provide protection to the most vulnerable.

We believe that Beyfortus has the potential totransform the medical community’s approach to preventing RSV infections in infants, and this is of particular importance given the recent surges of the virus amongst infants this past winter season.”

Underscoring the continued need for RSV protection
AstraZeneca is working with the global clinical community to advance the understanding of RSV and is partnering with the ReSViNET Foundation to create the first global RSV surveillance dashboard set to launch in March 2023. 

RSV is a highly contagious virus that causes respiratory illness in infants, including lung infections such as bronchiolitis and pneumonia.

This seasonal respiratory virus is the most common cause of lower respiratory tract infections and a leading cause of hospitalisation in infants.1-5

Dr. Louis Bont, Pediatrician Infectologist at the Wilhelmina Children’s Hospital in the University Medical Center Utrecht, The Netherlands, and the founder and chairman of ReSViNET, said: “The ReSViNET Foundation’s new dashboard will make it easier and more accessible to track worldwide changes in RSV seasonality, helping clinicians to protect babies and prevent the rise in hospitalisations that RSV can cause.”

Pursuing a breakthrough for broad RSV prevention
AstraZeneca is presenting the safety and efficacy findings from the full cohort of the Phase III MELODY clinical trial investigating Beyfortus in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.

These data reinforce Beyfortus’ consistent efficacy across endpoints and studies with approximately 70-80% efficacy against medically attended RSV lower respiratory tract infections vs placebo, including hospitalisations.

New cost effectiveness data for high-risk infant protection
Synagis continues to build on 25 years of real-world usage with a new cost effectiveness analysis being presented at ReSViNet. 

This analysis is the first to incorporate the International Risk Scoring Tool, which helps clinicians identify pre-term infants with the highest risk of hospitalisation.

Key AstraZeneca presentations during ReSViNet Conference 2023

Abstract titlePresentation details
Safety and efficacy of nirsevimab for prevention of medically attended RSV lower respiratory tract infection in all infants enrolled in the Phase III MELODY trialOral presentation #35; Session III: (Thursday 23 February, 11:40am-1pm) EPIC SANA Lisboa Hotel, Morus Hall
Safety and pharmacokinetics of nirsevimab for prevention of RSV disease in children with congenital heart disease or chronic lung disease of prematurityPoster #127; EPIC SANA Lisboa Hotel, Foyer
Fc mediated function of nirsevimab complements direct RSV neutralisation but is not required for optimal protection in preclinical modelsPoster #184; EPIC SANA Lisboa Hotel, Foyer
Genotypic and phenotypic features of RSV infections in MEDLEY, a randomised double-blind Phase III study of nirsevimab in children at high risk of severe diseasePoster #170; EPIC SANA Lisboa Hotel, Foyer
New cost-effectiveness analysis of palivizumab for the prevention of RSV infection in otherwise healthy Canadian infants born 29-35 weeks’ gestational age (wGA)Poster #155; EPIC SANA Lisboa Hotel, Foyer

https://www.astrazeneca.com/media-centre/press-releases/2023/resvinet-2023-data-reinforce-astrazenecas-commitment-to-help-prevent-respiratory-syncytial-virus-in-infants.html

Opdivo® with CABOMETYX® Shows Durable Survival with Over Three Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma

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Opdivo® with CABOMETYX® Shows Durable Survival with Over Three Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma

Feb 13, 2023: “Bristol Myers Squibb and Exelixis, Inc. announced three-year (36.5 months minimum; 44.0 months median) follow-up results from the Phase 3 CheckMate -9ER trial, demonstrating sustained survival and response rate benefits with the combination of Opdivo® (nivolumab) and CABOMETYX® (cabozantinib) versus sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC).

Additionally, a biomarker analysis showed that improvements in median progression-free survival (PFS) and overall survival (OS) were sustained with the combination of Opdivo and CABOMETYX regardless of PD-L1 status.

These updated results will be featured in one oral and one poster presentation at the American Society of Clinical Oncology (ASCO) 2023 Genitourinary Cancers Symposium from February 16-18, 2023.

“Despite the progress made through science and medicine, there remains a need for treatment options that can durably extend survival for patients with metastatic renal cell carcinoma, especially for those classified as higher risk,” said Mauricio Burotto, M.D., medical director, Bradford Hill Clinical Research Center, Santiago, Chile.

“With these updated results from CheckMate -9ER, we’ve now seen nivolumab in combination with cabozantinib durably extend survival and sustain response benefits compared to sunitinib for over three years, regardless of patients’ risk classification.

These results reinforce the importance of this immunotherapy-tyrosine kinase inhibitor regimen for patients and its potential to help change survival expectations for patients with this challenging cancer.”

Abstract #603: Nivolumab plus cabozantinib vs sunitinib for first-line treatment of advanced renal cell carcinoma (aRCC): 3-year follow-up from the phase 3 CheckMate -9ER trial (Burotto, et. al.)


With a median follow-up of 44.0 months (36.5 months minimum), Opdivo in combination with CABOMETYX (n=323) continued to show superior OS, PFS, objective response rate (ORR), duration of response (DoR) and complete response (CR) rates versus sunitinib (n=328).

No new safety signals were seen with extended follow-up. Within the full study population:

  • OS: Treatment with Opdivo in combination with CABOMETYX continued to show a 30% reduction in the risk of death (Hazard Ratio [HR] 0.70; 95% Confidence Interval [CI]: 0.56 to 0.87), and improvement in median OS vs. sunitinib (49.5 months vs. 35.5 months, respectively).
    Additionally, median OS improved by 11.8 months since the previous data cut at 32.9 months median follow-up.
  • PFS: PFS benefits were sustained, with the combination continuing to double median PFS vs. sunitinib (16.6 months vs. 8.4 months, respectively; HR 0.58; 95% CI: 0.48 to 0.71).
  • ORR and DoR: ORR benefits were maintained, with nearly twice as many patients
    responding to Opdivo in combination with CABOMETYXvs. sunitinib (55.7% vs. 28.4%). Responses also continued to be more durable with the combination, with a median DoR of 23.1 months compared to 15.2 months with sunitinib.
  • CR: CR rates were also sustained, with 12.4% of those treated with Opdivo in combination with CABOMETYX having a CR vs. 5.2% of those treated with sunitinib.
  • Safety: 97% of patients treated with Opdivo in combination with CABOMETYX experienced a treatment-related adverse event (TRAE) of any grade compared to 93% of patients treated with sunitinib; 67% vs. 55% had a grade ≥3 TRAE, respectively.

Results were also assessed by the following International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk scores: favorable, intermediate, intermediate/poor and poor. Benefits were seen with Opdivo in combination with CABOMETYX across all efficacy measures (OS, PFS, ORR and CR), regardless of IMDC risk.

Abstract #608: Biomarker analysis from the phase 3 CheckMate 9ER trial of nivolumab + cabozantinib v sunitinib for advanced renal cell carcinoma (aRCC) (Choueiri, et. al.)
In an exploratory post-hoc analysis from CheckMate -9ER with 44.0 months median follow-up, improvements were observed in both median PFS and OS with Opdivo in combination with CABOMETYX regardless of PD-L1 status.

PFS and OS were evaluated by tumor PD-L1 expression (<1% or ≥1%), CD8% (low, medium, high by tertiles), and CD8 topology phenotype (cold, excluded, inflamed), and assessed for association using Kaplan-Meier (KM) methods with log-rank test (PD-L1 and CD8), and Cox proportional hazard (Cox PH) models (CD8).

Biomarkers previously found to be predictive of anti-PD-L1 + anti-VEGF outcomes, including established gene expression signatures, were not necessarily predictive of efficacy with anti-PD-1 + anti-VEGF targeted therapy, suggesting that key determinants of response to anti-PD-1 vs. anti-PD-L1 therapies may differ.

“We have a strong heritage of bringing immunotherapy-based combinations to patients with advanced renal cell carcinoma and transforming patient outcomes with Opdivo-based combinations across several cancer types,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb.

“The updated data from CheckMate -9ER further reinforce the use of Opdivo in combination with CABOMETYX for the first-line treatment of patients with advanced renal cell carcinoma.

We remain committed to collaboration across the scientific community and our ongoing exploration of combination approaches with our proven cancer agents in the pursuit of solutions that may help improve long-term outcomes for as many patients as possible.”

“With forty-four months median follow-up, the compelling survival benefit further reinforces the value of the CABOMETYX and Opdivo combination regimen as a first-line option for patients with advanced kidney cancer,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis.

“We are pleased to share these long-term findings at ASCO GU and remain steadfast in our longstanding commitment to improving outcomes for patients living with advanced kidney cancer.”

Bristol Myers Squibb and Exelixis thank the patients and investigators involved in the CheckMate -9ER clinical trial.”

https://news.bms.com/news/corporate-financial/2023/Opdivo-nivolumab-in-Combination-with-CABOMETYX-cabozantinib-Shows-Durable-Survival-with-Over-Three-Years-of-Follow-Up-in-the-CheckMate–9ER-Trial-in-First-Line-Advanced-Renal-Cell-Carcinoma/default.aspx

Bayer completes acquisition of Blackford Analysis Ltd.

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Bayer completes acquisition of Blackford Analysis Ltd.

February13,2023: “Bayer announced that the company has completed the acquisition of the global strategic imaging AI platform and solutions provider Blackford Analysis Ltd. As a result, Blackford, which has a presence in the United Kingdom and the United States, is now a wholly owned subsidiary of Bayer AG.

The company provides infrastructure and access to a rich clinical application ecosystem focused on imaging and analytics.

It continues to operate on an arm’s length basis to preserve its entrepreneurial culture as an essential pillar for nurturing successful innovation.

Blackford remains accountable to advance its technology, channel partnerships and ClinApp portfolio while benefiting from the experience, infrastructure and reach of Bayer as a global pharmaceutical company.

“Today’s official closing of the acquisition of Blackford marks an important step in implementing our strategy to drive innovation in radiology, including the development and adoption of AI within the clinical workflow,” said Gerd Krüger, President Radiology, Bayer.

“Bayer is a leader in key radiology areas with a comprehensive portfolio and a deep medical understanding across a multitude of diseases.

We are excited that we are now able to join forces with the exceptional Blackford team to use our combined expertise for the benefit of patients and their treating physicians.”

“Blackford has built a strong reputation in the AI platform segment for radiology, with a wide portfolio of 3rd party products and a strong deployed base of hospitals, radiology groups and imaging centers,” said Ben Panter, Chief Executive Officer of Blackford.

“Combining our knowledge and experience with Bayer will enable us to provide solutions to deliver ongoing clinical value to radiologists and their referrers.”

About AI in Radiology
The overall global medical imaging AI field had sales worth more than USD 400 million in 2021.

This is expected to continue growing dynamically, with an estimated compounded annual growth rate of more than 26 percent (2020 to 2026) reaching USD 1.36 billion by 2026.

Innovation powered by AI is needed more than ever before. Aging populations and changing lifestyles are leading to an increase in chronic conditions, such as cardiovascular disease and cancer.

Consequently, the demand for medical imaging to detect diseases, guide treatment decisions and support therapy planning is growing. AI comes with the value proposition to aid diagnosis and increase the throughput of radiological examinations.

Against this backdrop, driving innovation in AI is a key pillar in Bayer’s innovation strategy in radiology.

The acquisition of Blackford bolsters Bayer’s position in digital medical imaging and follows a development and license agreement between both companies in 2020 that laid the foundation for Bayer’s recently launched medical imaging platform, Calantic™ Digital Solutions.

Building on technology from Blackford and adding additional workflow and analytics components, Calantic Digital Solutions delivers access to applications, including those enabled by AI, for medical imaging.

The collaboration with Bayer has its roots in 2019, when Blackford was among the selected start-ups of Bayer’s G4A Digital Health Partnerships Program that year.

About Radiology at Bayer
As a true life-science company with a heritage of over 100 years in Radiology, Bayer is committed to providing excellence, from innovative products to high-quality services, to support efficient and optimized patient care.

Bayer offers a leading portfolio of contrast media for computed tomography (CT), X-Ray, and magnetic resonance imaging (MRI), devices for their precise administration, informatics solutions and a medical imaging platform delivering access to applications, including those enabled by AI.

Bayer’s Radiology products generated a total of €1.8bn sales in 2021. Based on the company’s ambition to outperform the radiology market’s average annual growth rate of 5% by 2030, Bayer is highly committed to research and development, which includes leveraging artificial intelligence and driving innovation in medical imaging.

Each of these offerings provides effective tools to support radiologists in their mission to deliver treatment-critical answers and a clear direction – from diagnosis to care.”

https://www.bayer.com/media/en-us/bayer-completes-acquisition-of-blackford-analysis-ltd/

Sanofi announces change in R&D leadership

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Sanofi announces change in R&D leadership

February 13, 2023: “Sanofi announced that Dr. John Reed, its Global Head of R&D, will be leaving the company to pursue a new opportunity outside Sanofi. The company warmly thanks Dr. Reed for his leadership over these last years.

Since joining Sanofi in 2018, John has laid the foundation for the company’s R&D transformation.

He helped reshape Sanofi’s discovery and development of therapeutics, focusing efforts on first and best in class medicines that have the potential to transform the practice of medicine and improve the lives of people with serious diseases, whilst managing the integration and development of new technology platforms and partnerships, and driving R&D productivity.

In 2023, Sanofi will launch two first or best-in-class medicines that will address major needs in hemophilia and respiratory syncytial virus.

The company expects in the next 15 months 27 scientific readouts and two pivotal readouts in multiple sclerosis and COPD/chronic bronchitis, also within this year. A clear step forward in Sanofi’s scientifically-driven roadmap.

While an internal and external search has already started to identify the successor to Dr. Reed, Dr. Dietmar Berger, has agreed to take the leadership of the team ad interim.

Dr. Berger has been serving as Chief Medical Officer and Global Head of Development since he joined Sanofi in 2019, after an extensive and successful career at various other pharmaceutical companies including Genentech, Bayer and Amgen.

Paul Hudson
CEO, Sanofi
“Under John’s leadership, our R&D organization has built a robust pipeline and sharpened its research focus, employing cutting-edge therapeutic platforms and creating a culture that responds to the urgent needs of patients.

His contribution to our company’s transformation has helped pave the way for Sanofi’s emergence as a science-driven and innovation leader in our industry.

As we continue to build an exciting Specialty Care and Vaccines portfolio, we look forward to the growing momentum of our pipeline.

This is what we were aiming for when we laid our strategy in 2019, and the 2022 results we recently published confirmed our choices. 2023 will only strengthen our commitment to transform the practice of medicine.”

https://www.sanofi.com/en/media-room/press-releases/2023/2023-02-13-07-30-00-2606338

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