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Sanofi to launch “Action 2020” stock purchase plan

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Sanofi to launch “Action 2020” stock purchase plan
June 3, 2020: “Sanofi announces the launch of “Action 2020” on June 8, 2020, a worldwide stock purchase plan reserved for its employees, which should take place in almost 75 countries.

Sanofi’s strategy aims at providing long-term growth and value for its stakeholders while turning innovation into transformative medicines for patients.

By doing such a capital increase, Sanofi intends to better associate its employees who are key contributors in this value creation, to the future development and results of the company.

On February 5, 2020 the Board of Directors authorized an issuance of ordinary shares of Sanofi for the benefit of employees participating in the Group Savings Plan.

The subscription price is €70.67. It is equal to 80 % of the average of the opening price of the Sanofi share on Euronext Paris over the 20 stock exchange trading sessions preceding June 2, 2020.

Any subscription per five shares as part of such issuance shall entitle the employee to one matching share. Subscriptions equal to or higher than 20 shares shall give a right to 4 matching shares as an employer contribution.

Employees may choose to subscribe a maximum of 1,500 shares within the limit of a maximum subscription amount which does not exceed 25% of their gross annual remuneration.

An eligibility condition of three months of seniority as at the closing date of the subscription period will be applied.

The subscription period will run from June 8, 2020 (inclusive) until June 26, 2020 (inclusive).

The issuance of new shares and the share delivery process should occur at the end of July 2020.

The total number of Sanofi shares that may be issued under the plan is limited to 6,269,231 shares (corresponding to a share capital increase in terms of par value of up to €12,538,461, representing 0.5 % of the share capital).

The newly issued shares, including the matching shares (the “Shares”) will be subscribed (or delivered) either directly or through employee shareholding funds (“FCPE”), depending on the legal and/or tax regulations applicable in the various countries of residence of the beneficiaries of the capital increase.

The Shares will be fully fungible with the existing ordinary shares of Sanofi and will be entitled to dividends distributed on benefits relating to the fiscal year starting as of January 1, 2020.

The voting rights attached to the Shares subscribed will be directly exercised by the employees.

The subscribers to the plan will be required to hold the Shares or the corresponding “FCPE” units during a period of approximately five years, i.e. until May 31, 2025, except upon the occurrence of an early exit event provided in Article R. 3324-22 of the French Labor Code and authorized in the country of the subscriber.

The listing of the Shares on the Euronext Paris market (ISIN Code: FR0000120578) on the same listing line as the existing shares will be requested as soon as possible after the completion of the capital increase.

This press release does not constitute an offer to sell or a solicitation to purchase Sanofi shares.

The offering of Sanofi shares reserved for employees will be conducted only in countries where such an offering has been registered or notified to the competent local authorities and/or following approval of a prospectus by the competent local authorities or in consideration of an exemption to prepare a prospectus or to make any registration or notification of the offering when such a procedure is required.

More generally, the offering will only be conducted in countries where all required filing procedures and/or notifications have been completed and the authorizations have been obtained, and procedures for consultation or information of staff representatives have been fulfilled.

This press release is not intended for, and copies thereof should not be sent to, countries in which such a prospectus has been approved or such an exemption is not available or where all of the required filing procedures, notifications, consultation and/or information required have been completed or where the authorizations have been obtained.

This applies in particular to Cameroon and Morocco, where the formalities are still pending with the authorities, but could also involve other countries.

For any questions related to the following share capital increase, each beneficiary may consult the information booklet and all other documents made available and/or contact his/her human resources manager.”
http://www.globenewswire.com/news-release/2020/06/03/2043122/0/en/Sanofi-to-launch-Action-2020-a-worldwide-employee-stock-purchase-plan.html?print=1

Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020

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Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020

June 02, 2020:”The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The agency issued a new FDA Voices, titled Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety, and bylined by Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response.

    In March, the FDA was a few days away from announcing the release of the New Era of Smarter Food Safety Blueprint when the FDA’s focus turned to the COVID-19 pandemic.

    Plans for the New Era initiative were rightfully put on hold in order to prioritize the agency’s COVID-19 response.

    The FDA will release the blueprint in the coming weeks, outlining plans over the next decade to create a more digital, traceable, and safer food system.
  • The FDA published guidance, titled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators, which includes recommendations regarding procedures for single IRB member review.

    This is in response to physician requests for a waiver from the requirement for full IRB review. The guidance recommendations also address factors to consider when assessing potential benefits and risks for a particular patient being treated under expanded access.
  • The FDA added a second ventilator developed by NASA to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA) that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic.

    The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored to provide respiratory support for COVID-19 patients who are experiencing respiratory failure or insufficiency.

    Where the first NASA ventilator relied on wall gas as the pressure source, the second ventilator uses an internal compressor for its energy source.

    The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators.
  • The FDA added an emergency resuscitator for the Fitbit Flow to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA).

    The Fitbit Flow is a continuous respiratory support system that includes an FDA-cleared Manual Resuscitator.

    The accessory is an AMBU bag with audible and visual alarms that aid the performance of the manual resuscitator for continuous breathing. This design is intended for use in treating patients with COVID-19.
  • The FDA, in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of pediatric product development plans for the treatment and prevention of COVID-19.

    In issuing this Common Commentary, the FDA and EMA aspire to streamline administrative processes and facilitate efficient submission of an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP).
  • The FDA recognizes the vital role of health professionals in the fight against COVID-19.

    In order to help health professionals quickly and easily access FDA resources, we created a new web page, titled Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals.

    This page contains links to FDA emergency use authorizations; information about personal protective equipment and other medical products for use during COVID-19.

    Related News: https://lifepronow.com/blog/2020/06/02/coronavirus-covid-19-update-daily-roundup-june-1-2020/

    Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 119 tests under EUAs, which include 103 molecular tests, 15 antibody tests, and 1 antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-2-2020

Pfizer Establishes New Program To Support Continued Biotechnology Innovation

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Pfizer Establishes New Program To Support Continued Biotechnology Innovation
June 02, 2020: “Pfizer announced that the establishment of the Pfizer Breakthrough Growth Initiative, through which Pfizer will invest up to $500 million in biotechnology companies to help provide funding and access to Pfizer’s scientific expertise to ensure continuity of the biotechnology companies’ most promising clinical development programs.

“There has never been a more important moment to pursue new collaborations in our industry,” said John Young, Pfizer’s Chief Business Officer.

“The Pfizer Breakthrough Growth Initiative seeks to do just this by injecting crucial capital into biotechnology companies that share our commitment to delivering transformative therapies for patients.”

The Pfizer Breakthrough Growth Initiative will focus on making non-controlling equity investments in clinical-stage public companies, with a primary focus on companies with small- to medium-sized market capitalizations across a range of therapeutic categories that are consistent with Pfizer’s core areas of focus: Internal Medicine, Inflammation & Immunology, Oncology, Rare Disease, Vaccines and Hospital. Pa

rtner companies may also have the opportunity to access Pfizer’s significant expertise and resources in research, clinical development and manufacturing.

Today’s announcement builds on Pfizer’s long history of successfully collaborating across the healthcare innovation ecosystem, through a wide range of flexible partnering and funding models, with the shared goal of turning great science into innovative new medicines.

Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-establishes-new-program-support-continued

Novartis provides an update on FDA review of ofatumumab for relapsing multiple sclerosis

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Novartis provides an update on FDA review of ofatumumab for relapsing multiple sclerosis
June 02, 2020: “Novartis announced that it has received notice from the US FDA that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis.

Regulatory action is now expected in September 2020.

“Novartis will continue to work with the FDA to complete the review as soon as possible,” said Marie-France Tschudin, President, Novartis Pharmaceuticals.

“We are well prepared and ready to launch ofatumumab upon approval. We are committed to the MS community and look forward to bringing this important advancement to patients with MS.”

Additional regulatory filings are currently underway and regulatory approval for ofatumumab in Europe is expected by Q2 2021.

Related News: Novartis announces new late-breaking ofatumumab data at EAN

Novartis announces FDA and EMA filing acceptance of ofatumumab (OMB157), a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

Ofatumumab
Ofatumumab (OMB 157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-adminstered by a once-monthly injection, delivered subcutaneously.

As shown in preclinical studies, ofatumumab is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion.

The selective mechanism of action and subcutaneous administration of ofatumumab allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed and may preserve the B-cells in the spleen, as shown in preclinical studies.

Once-monthly dosing of ofatumumab also allows fast repletion of B-cells and offers more flexibility.

Ofatumumab was originated by Genmab and licensed to GlaxoSmithKline; Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015.”
https://www.novartis.com/news/media-releases/novartis-provides-update-fda-review-ofatumumab-self-administered-targeted-b-cell-therapy-patients-relapsing-multiple-sclerosis.

AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ for Psoriatic Arthritis

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AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ for Psoriatic Arthritis
June 1, 2020: “AbbVie, a research-based global biopharmaceutical company, today announced that it has submitted applications for a new indication to the U.S. FDA and European Medicines Agency (EMA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis.

“Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness,” said Michael Severino, M.D., vice chairman and president, AbbVie.

“We look forward to working with regulatory authorities and hope to bring RINVOQ to people living with this debilitating disease as quickly as possible.”

The applications are supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active psoriatic arthritis.

In both studies, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo.

RINVOQ 15 mg also achieved non-inferiority versus adalimumab in terms of ACR20 response at week 12. 

Patients receiving RINVOQ also experienced greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75), and a greater proportion achieved minimal disease activity.

Overall, the safety profile of RINVOQ in psoriatic arthritis was consistent with previously reported results across the Phase 3 rheumatoid arthritis clinical trial program, with no new significant safety risks detected.1-3

*Physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Skin symptoms were measured by a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75).

Minimal disease activity is defined as the fulfillment of five of seven outcome measures: Tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or body surface area-psoriasis ≤3 percent; Patient’s Assessment of Pain Numerical Rating Scale (NRS) ≤1.5; Patient Global Assessment-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and Leeds Enthesitis Index ≤1.

RINVOQ™ (upadacitinib)

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.

In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severely active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.

The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.

Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

Important Safety Information about RINVOQ (upadacitinib)

RINVOQ U.S. Use and Important Safety Information
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

What is the most important information I should know about RINVOQ?
RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

  • Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

    Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).

    Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.
  • Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.
  • Tears in the stomach or intestines and changes in certain laboratory tests can happen.

    Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or have symptoms of an infection such as:
    • Fever, sweating, or chills
    • Shortness of breath
    • Warm, red, or painful skin or sores on your body
    • Muscle aches
    • Feeling tired
    • Blood in phlegm
    • Diarrhea or stomach pain
    • Cough
    • Weight loss
    • Burning when urinating or urinating more often than normal
  • Have TB or have been in close contact with someone with TB.
  • Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
  • Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
  • Live, have lived, or have traveled to parts of the country that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you’ve been to these areas, ask your HCP.
  • Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
  • Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ.

    You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.

  • Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

  • Medicines for fungal or bacterial infections
  • Rifampicin or phenytoin
  • Medicines that affect your immune system

Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

What should I tell my HCP AFTER starting RINVOQ?
Tell your HCP right away if you:

  • Have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
  • Have any signs or symptoms of blood clots during treatment with RINVOQ, including:
    • Swelling
    • Sudden unexplained chest pain
    • Pain or tenderness in the leg
    • Shortness of breath
  • Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are the common side effects of RINVOQ?
These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.”
https://news.abbvie.com/news/press-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-rinvoq-upadacitinib-for-treatment-adults-with-active-psoriatic-arthritis.htm

AbbVie and Jacobio Announce Strategic Collaboration to Advance SHP2 Inhibitors

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AbbVie and Jacobio Announce Strategic Collaboration to Advance SHP2 Inhibitors
 June 01, 2020: “AbbVie, a research-based global biopharmaceutical company, and Jacobio Pharmaceuticals, a clinical-stage pharmaceutical company announced that a global, strategic collaboration to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells.

SHP2 is an important protein mediator of cellular signaling through RAS/MAP kinase pathway. Many tumors have genetic mutations, driving abnormal cancer cell growth which relies on SHP2 activity. SHP2 also plays a key role to control cytokine production and immune cell response.

Therefore, inhibition of SHP2 is believed to have dual effects by potentially reducing cancer cell growth and modulating immune responses to generate anti-tumor activities.

Jacobio’s early clinical stage SHP2 assets, JAB-3068 and JAB-3312, are oral small molecules designed to specifically inhibit SHP2 activity.

“Identifying promising new targeted approaches for solid tumor patients is a high priority for us,” said Mohit Trikha, Ph.D., vice president and head, early development oncology and Bay Area site head, AbbVie.

“Jacobio’s SHP2 program has the potential to treat cancer patients across many tumor types.

By targeting a key node in both cancer and immune cell signaling pathways, SHP2 inhibition, both as a monotherapy and potentially in combination with other agents, may rapidly advance new treatment options for cancer patients.”    

“We are excited to expand our efforts in global development of delivering breakthrough innovation to not just Chinese, but global patients with cancer,” said Yinxiang Wang, Ph.D., CEO and Chairman, Jacobio. 

“We look forward to a productive collaboration with AbbVie focused on rapidly advancing this novel SHP2 first-in-class therapy as a new approach for multiple cancer types. I am confident that this partnership will strengthen our R&D capabilities and ultimately bring benefits to cancer patients.”

Under the terms of the agreement, AbbVie will be granted an exclusive license to the SHP2 portfolio. Jacobio will continue to conduct early global clinical trials of JAB-3068 and JAB-3312 with AbbVie covering R&D expenses.

Upon completion, AbbVie will assume global development and commercialization responsibilities.

Jacobio has an option, exercisable before the initiation of registrational trials, to exclusively develop and commercialize the SHP2 program in mainland China, Hong Kong, and Macau.

Financial terms were not disclosed and the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.”
https://news.abbvie.com/news/press-releases/abbvie-and-jacobio-announce-strategic-collaboration-to-advance-shp2-inhibitors.htm

Coronavirus (COVID-19) Update: Daily Roundup June 1, 2020

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Coronavirus (COVID-19) Update: Daily Roundup June 1, 2020
June 02, 2020: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
  • On May 29, the FDA issued a new FDA Voices, Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic.

    It explains how the agency plays a pivotal role in helping to both move new medical products to patients as soon as possible and evaluate the potential benefits and risks of these new products.
  • The FDA issued a Consumer Update, Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19.

    Scientists are working hard to develop a number of potential drugs for the prevention or treatment of coronavirus, but none are currently approved by the FDA for these purposes.

    The language used to describe potential therapies can be confusing, and there’s public interest around the FDA’s work to ensure access to potentially life-saving treatments.

    This Consumer Update explains some of the regulatory terminologies.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 117 tests under EUAs, which include 101 molecular tests, 15 antibody tests, and 1 antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-1-2020

EC approves Sarclisa® for adults with relapsed and refractory multiple myeloma

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EC approves Sarclisa® for adults with relapsed and refractory multiple myeloma
June 02, 2020: The EC has approved Sarclisa® (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

Sarclisa is a monoclonal antibody (mAb) that binds to a specific epitope on the CD38 receptor of MM cells.

“The EC approval of Sarclisa represents an important additional therapeutic option and may set a new standard of care for myeloma patients in Europe who are in need of new effective treatments because their disease has returned or they have become refractory to their previous treatment,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi.

 “Sarclisa in combination with pom-dex demonstrated median progression-free survival of nearly one year, a five-month improvement over pom-dex alone, in patients who had already failed at least two prior therapies.”

Related News: Sarclisa® (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma

CHMP gives Sanofi positive opinion for Sarclisa for the treatment of relapsed and refractory multiple myeloma

Sanofi to present oncology strategy: Update on portfolio and emerging pipeline

Sarclisa Efficacy and Safety Profile in Difficult-to-Treat Patients 

In the Phase 3 ICARIA-MM study, Sarclisa added to pom-dex (Sarclisa combination therapy, n=154) demonstrated a statistically significant improvement of progression-free survival (PFS), with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone (n=153) (HR 0.596, 95% CI: 0.44-0.81, p=0.001).

Sarclisa combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone (60.4% vs. 35.3%, p<0.0001).

In additional analyses, Sarclisa combination therapy compared to pom-dex alone showed a treatment benefit consistent across select subgroups reflective of real-world practice, including patients with high-risk cytogenetics, those aged 75 years and older, patients with renal insufficiency and patients who were refractory to lenalidomide.

“As patients experience relapse of their multiple myeloma or become refractory to their current therapy, they become more difficult to treat with increasingly poor prognoses.

In the ICARIA-MM trial, Sarclisa combination therapy showed a treatment benefit consistent across relapsed and refractory multiple myeloma subgroups,” said Philippe Moreau, M.D., Department of Hematology, University Hospital of Nantes, France. 

“Sarclisa offers an important new treatment option and a potentially new standard of care for these patients with relapsed, refractory disease.”

As outlined in the Summary of Product Characteristics (SmPC), the most frequent adverse reactions observed with Sarclisa (occurring in 20% or more of patients) are neutropenia (46.7%), infusion reactions (38.2%), pneumonia (30.9%), upper respiratory tract infection (28.3%), diarrhea (25.7%) and bronchitis (23.7%).

The most frequent serious adverse reactions are pneumonia (9.9%) and febrile neutropenia (6.6%).

For more information on the safety of Sarclisa, please refer to the SmPC.

An Important New Option for Treating Multiple Myeloma

Sarclisa is administered by intravenous (IV) administration and is dosed at 10 mg/kg, in combination with pom-dex, every week for four weeks and then every two weeks, until disease progression or unacceptable toxicity.

Assuming no rate adjustments based on infusion-related reactions, the first infusion takes three to four hours, the second infusion takes less than two hours, and the remaining infusions can decrease to 75 minutes from the third infusion onwards.

A treatment cycle is 28 days. The EC marketing authorization for Sarclisa is applicable to the 27 member states of the European Union (EU), plus the UK, Iceland, Liechtenstein and Norway.

Multiple Myeloma: A Significant Burden to Patients

MM is the second most common hematologic malignancy, with more than 138,000 new cases worldwide each year.

In Europe, approximately 40,000 patients are diagnosed with MM yearly. MM remains incurable in the vast majority of patients, resulting in significant disease burden.

Sarclisa

Sarclisa is a mAb that binds to a specific epitope on the CD38 receptor. CD38 is highly and uniformly expressed on MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

It is designed to induce programmed tumor cell death (apoptosis) and immunomodulatory activity.

In addition to the EU, Sarclisa has also been approved in the U.S., Switzerland, Canada and Australia in combination with pom-dex for the treatment of certain adults with relapsed refractory MM.

In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum.

It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.
https://www.sanofi.com/en/media-room/press-releases/2020/2020-06-02-12-47-38

Sanofi to present oncology strategy: Update on portfolio and emerging pipeline

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Sanofi to present oncology strategy: Update on portfolio and emerging pipeline
June 02, 2020: “Sanofi Chief Executive Officer Paul Hudson along with R&D and commercial leaders will provide an overview of Sanofi’s oncology strategy and progress update of its related key products and pipeline programs.

Sanofi’s oncology strategy is focused on four core therapeutic areas with four anchor treatments the company believes have the potential to transform patient care.

The four areas of strategic focus within oncology, including multiple myeloma, skin, lung, and breast cancers. Sanofi’s four anchor oncology treatments include Sarclisa® (isatuximab-irfc), an anti-CD38 monoclonal antibody and Libtayo® (cemiplimab-nwlc), a PD-1 checkpoint inhibitor and the pipeline programs – an investigational anti-CEACAM 5 antibody drug conjugate and SERD (‘859), an investigational oral selective estrogen receptor degrader.

“We are rapidly building momentum with the execution of our oncology strategy, with several developments on both our pipeline and marketed treatments.

Additionally, we are assembling a world-class development and marketing team to support our growth in this core area,” said Hudson. “We believe our efforts and treatments have the potential to make a significant difference in the lives of people living with cancer.”

“We’ve developed a focused oncology strategy, and are making significant clinical progress to support our ambitions,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi.

“With a deep toolbox of therapeutic platforms enabling us to discover highly differentiated molecules, Sanofi has a tremendous opportunity to continue our momentum and build a sustainable presence in oncology.”

The virtual investor event will be held today from 4:00-5:30 pm CET/10:00-11:30 am EST. Sanofi speakers include:

FDA Ok’s Roche’s Tecentriq in combination with Avastin for liver cancer

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FDA Ok’s Roche’s Tecentriq in combination with Avastin for liver cancer
June 02, 2020: “Roche announced that the US FDA has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

“We’re excited that today’s approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development.

“The application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this new treatment option rapidly to patients in the United States and around the world.”

“The results of the IMbrave150 study are really transformative for patients with advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting,” said Dr Richard Finn, Professor of Medicine at the David Geffen School of Medicine at UCLA and Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center.

Related News: NICE u-turn backs Roche’s Tecentriq for small-cell lung cancer

FDA’s OK for Roche’s Tecentriq for metastatic non-small cell lung cancer


Roche presents pivotal First Phase III cancer immunotherapy Tecentriq in combination with Avastin to show an improvement in liver cancer patients

“For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favourable tolerability profile.”

The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners.

According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions.

Simultaneous applications were submitted to regulators in the United States, Australia, Canada and Singapore under Project Orbis.

Additionally, the FDA rapidly reviewed and approved the application under its Real-Time Oncology Review (RTOR) pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

The approval was based on results from the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 41% (HR=0.59; 95% CI: 0.47-0.76; p<0.0001), compared with sorafenib.

IMbrave150 is the first Phase III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib.

Serious adverse reactions (Grade 3-4) occurred in 38% of people in the Tecentriq and Avastin arm. The most frequent serious adverse reactions (≥2%) were bleeding in the gastrointestinal tract, infections and fever. These results were published in the New England Journal of Medicine on 14 May 2020.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers.

This includes studies evaluating Tecentriq both alone and in combination with other medicines.

IMbrave150 study
IMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable or metastatic HCC who had not received prior systemic therapy.

People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle.

Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until disease progression or unacceptable toxicity.

The two primary endpoints were OS and independent review facility (IRF)-assessed PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

Additional study endpoints were IRF-assessed overall response rate (ORR) per RECIST and mRECIST.”
https://www.roche.com/media/releases/med-cor-2020-06-02.htm

COVID-19 significantly impacts health services for noncommunicable diseases

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COVID-19 significantly impacts health services for noncommunicable diseases
June 01, 2020: “Prevention and treatment services for noncommunicable diseases (NCDs) have been severely disrupted since the COVID-19 pandemic began, according to a WHO survey released.

The survey, which was completed by 155 countries during a 3-week period in May, confirmed that the impact is global, but that low-income countries are most affected.

This situation is of significant concern because people living with NCDs are at higher risk of severe COVID-19-related illness and death.

“The results of this survey confirm what we have been hearing from countries for a number of weeks now,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization.

“Many people who need treatment for diseases like cancer, cardiovascular disease and diabetes have not been receiving the health services and medicines they need since the COVID-19 pandemic began.

It’s vital that countries find innovative ways to ensure that essential services for NCDs continue, even as they fight COVID-19.”

Service disruptions are widespread

The main finding is that health services have been partially or completely disrupted in many countries.

More than half (53%) of the countries surveyed have partially or completely disrupted services for hypertension treatment; 49% for treatment for diabetes and diabetes-related complications; 42% for cancer treatment, and 31% for cardiovascular emergencies. 

Rehabilitation services have been disrupted in almost two-thirds (63%) of countries, even though rehabilitation is key to a healthy recovery following severe illness from COVID-19.

Reassignment of staff and postponing of screening

In the majority (94%) of countries responding, ministry of health staff working in the area of NCDs were partially or fully reassigned to support COVID-19.

The postponement of public screening programmes (for example for breast and cervical cancer) was also widespread, reported by more than 50% of countries.

This was consistent with initial WHO recommendations to minimize non-urgent facility-based care whilst tackling the pandemic.

But the most common reasons for discontinuing or reducing services were cancellations of planned treatments, a decrease in public transport available and a lack of staff because health workers had been reassigned to support COVID19 services.

In one in five countries (20%) reporting disruptions, one of the main reasons for discontinuing services was a shortage of  medicines, diagnostics and other technologies.

Unsurprisingly, there appears to be a correlation between levels of disruption to services for treating NCDs and the evolution of the COVID-19 outbreak in a country. 

Services become increasingly disrupted as a country moves from sporadic cases to community transmission of the coronavirus.

Globally, two-thirds of countries reported that they had included NCD services in their national COVID-19 preparedness and response plans; 72% of high-income countries reported inclusion compared to 42% of low-income countries.

Services to address cardiovascular disease, cancer, diabetes and chronic respiratory disease were the most frequently included. Dental services, rehabilitation and tobacco cessation activities were not as widely included in response plans according to country reports.

Seventeen percentof countries reporting have started to allocate additional funding from the government budget to include the provision of NCD services in their national COVID-19 plan.

Alternative strategies for continuing care being implemented

Encouraging findings of the survey were that alternative strategies have been established in most countries to support the people at highest risk to continue receiving treatment for NCDs.

Among the countries reporting service disruptions, globally 58% of countries are now using telemedicine (advice by telephone or online means) to replace in-person consultations; in low-income countries this figure is 42%.

Triaging to determine priorities has also been widely used, in two-thirds of countries reporting. 

Also encouraging is that more than 70% of countries reported collecting data on the number of COVID-19 patients who also have an NCD.

”It will be some time before we know the full extent of the impact of disruptions to health care during COVID-19 on people with noncommunicable diseases,” said Dr Bente Mikkelsen, Director of the Department of Noncommunicable Diseases at WHO.

“What we know now, however, is that not only are people with NCDs more vulnerable to becoming seriously ill with the virus, but many are unable to access the treatment they need to manage their illnesses.

It is very important not only that care for people living with NCDs is included in national response and preparedness plans for COVID-19 -̶  but that innovative ways are found to implement those plans. “

We must be ready to “build back better”  ̶  strengthening health services so that they are better equipped to prevent, diagnose and provide care for NCDs in the future, in any circumstances.”

https://www.who.int/news-room/detail/01-06-2020-covid-19-significantly-impacts-health-services-for-noncommunicable-diseases

Lynparza recommended for approval in EU by CHMP

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Lynparza recommended for approval in EU by CHMP
June 01, 2020: “AstraZeneca and MSD announced that Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III POLO trial, which were published in The New England Journal of Medicine.

The trial demonstrated that Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo.

The safety and tolerability profile of Lynparza in the POLO trial was consistent with previous trials.

José Baselga, Executive Vice President, Oncology R&D, said: “Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades.

We are now one step closer to bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “A pancreatic cancer diagnosis is devastating, and we are committed to research that aims to change the prognosis for patients.

Related News: FDA OK’s for Lynparza for metastatic castration-resistant prostate cancer

Lynparza approved in the US as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer

Lynparza demonstrated overall survival benefit in Phase III PROfound trial for BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer, not Progressed on Platinum-Based Chemotherapy

The POLO Phase III trial demonstrated that treatment with Lynparza extended time without disease progression in certain patients with advanced pancreatic cancer – we are hopeful that we will be able to bring this treatment to patients in the EU soon.”

The CHMP recommendation is for maintenance treatment with Lynparza for adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a 1st-line  chemotherapy regimen.

Lynparza is approved in the US and several other countries as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer based on the Phase III POLO trial, with ongoing regulatory reviews in the EU and other jurisdictions.

Lynparza was recently approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.

It was also approved in the US as a 1st-line maintenance treatment with bevacizumab for patients with homologous recombination deficiency (HRD)-positive advanced ovarian cancer.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/lynparza-recommended-for-approval-in-eu-by-chmp-for-brca-mutated-metastatic-pancreatic-cancer.html

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