On May 25, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported the launch of ENHERTU (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate (ADC), in Japan for the treatment of patients with HER2 positive unresectable or recurrent breast cancer after prior chemotherapy (limit the use to patients who are refractory or intolerant to standard treatments) (Press release, Daiichi Sankyo, MAY 25, 2020, View Source [SID1234558426]).

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Marketing approval of ENHERTU by Japan’s Ministry of Health, Labor, and Welfare (MHLW) in March 2020 was based on the results of the open-label, single-arm, pivotal phase 2 DESTINY-Breast01 trial that demonstrated a confirmed objective response rate of 64.1% [95% CI: 56.3-71.3] in the response evaluable set of 107 of 167 patients, which included 26 Japanese women, at a data cut-off of March 21, 2019. Data from the DESTINY-Breast01 trial were published in The New England Journal of Medicine.

"Now patients in Japan with HER2 positive metastatic breast cancer who progress following treatment with at least two HER2 directed therapies and chemotherapy have access to ENHERTU, an important new medicine that may transform the way these patients are treated. We are proud of how quickly we have delivered ENHERTU, making it available only four years after treating the first patient in Japan," said Hideaki Noji, Vice President, Head of Specialty Marketing in Japan, Daiichi Sankyo. "ENHERTU also represents the second innovative oncology medicine to be launched in Japan from the oncology pipeline of Daiichi Sankyo in the past year, another milestone we are honored to have achieved."

Safety and efficacy of ENHERTU (5.4 mg/kg) in patients without prior trastuzumab, taxane and trastuzumab emtansine treatment have not been established. ENHERTU is approved in Japan with a Warning for Interstitial Lung Disease (ILD). As cases of ILD, including fatal cases, have occurred in ENHERTU-treated patients, ENHERTU is to be used in close collaboration with a respiratory disease expert. Closely observe patients during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and regularly perform peripheral artery oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of ENHERTU, and take appropriate measures such as corticosteroid administration. Prior to initiation of ENHERTU therapy, perform a chest CT scan and interview to confirm the absence of any comorbidity or history of ILD with the patient, and carefully consider the eligibility of the patient for ENHERTU therapy.

Adverse reactions (from ENHERTU Japan Prescribing Information) occurred in 182 of 184 patients (98.9%) who received ENHERTU. The most common adverse reactions were nausea in 140 patients (76.1%), alopecia in 85 patients (46.2%), fatigue in 81 patients (44.0%), vomiting in 78 patients (42.4%), neutrophil count decreased in 55 patients (29.9%), decreased appetite in 52 patients (28.3%), anemia in 40 patients (21.7%) and diarrhea in 40 patients (21.7%). Overall incidence of ILD was 8.2%. ILD occurred in 23% of Japanese patients (7 out of 30) with no grade 3 or above events including no ILD-related deaths.

About ENHERTU

ENHERTU (trastuzumab deruxtecan outside the U.S.; fam-trastuzumab deruxtecan-nxki in the U.S. only), is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC Scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is comprised of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker.

ENHERTU has been approved for use only in the U.S. and Japan. ENHERTU has not been approved in the EU, or countries outside of Japan and the United States, for any indication. It is an investigational agent globally for various indications.

About the ENHERTU Clinical Development Program

A comprehensive development program for ENHERTU is underway globally with six pivotal trials evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

About the Collaboration between Daiichi Sankyo and AstraZeneca

In March 2019, Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for the manufacturing and supply.

U.S. FDA-Approved Indication for ENHERTU

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY

●　Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.

●　Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

Contraindications
None.

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease / Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients treated with ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to 8.3).

Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg prednisolone or equivalent). Upon improvement, follow by gradual taper (e.g., 4 weeks).

Neutropenia

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, a decrease in neutrophil count was reported in 30% of patients and 16% had Grade 3 or 4 events. Median time to first onset was 1.4 months (range: 0.3 to 18.2). Febrile neutropenia was reported in 1.7% of patients.

Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. Based on the severity of neutropenia, ENHERTU may require dose interruption or reduction. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.

Left Ventricular Dysfunction

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. Permanently discontinue ENHERTU if LVEF of <40% or absolute decrease from baseline of >20% is confirmed. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure.

Embryo-Fetal Toxicity
ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.

Adverse Reactions
The safety of ENHERTU was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 7 months (range: 0.7 to 31).

Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were interstitial lung disease, pneumonia, vomiting, nausea, cellulitis, hypokalemia, and intestinal obstruction. Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock.

ENHERTU was permanently discontinued in 9% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 33% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, thrombocytopenia, leukopenia, upper respiratory tract infection, fatigue, nausea, and ILD. Dose reductions occurred in 18% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, and neutropenia.

The most common adverse reactions (frequency ≥20%) were nausea (79%), fatigue (59%), vomiting (47%), alopecia (46%), constipation (35%), decreased appetite (32%), anemia (31%), neutropenia (29%), diarrhea (29%), leukopenia (22%), cough (20%), and thrombocytopenia (20%).

Use in Specific Populations

Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months following the last dose of ENHERTU.

Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.

Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months following the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.

Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.

Geriatric Use: Of the 234 patients with HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, 26% were ≥65 years and 5% were ≥75 years. No overall differences in efficacy were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (53%) as compared to younger patients (42%).

Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor.

On May 25, 2020 Nail Imune Biotech Co., Ltd. (Location: Minato-ku, Tokyo, hereinafter "Noil Imune") and C4U Co., Ltd. (Location: Suita, Osaka Prefecture, hereinafter "C4U") are now editing the next-generation genome of C4U (Press release, Noile-Immune Biotech, MAY 25, 2020, View Source [SID1234561509]). Combining the CRISPR/Cas3 technology, which is a technology, with the PRIME (Proliferation inducing and migration enhancing) technology for adapting genetically modified immune cell therapies such as CAR-T and TCR-T possessed by Noil Imune to solid cancer We would like to inform you that we have signed an agreement for joint research and commercialization of cross-type allogeneic genetically modified immune cell therapy technology.

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The CRISPR/Cas3 technology, which is the basic technology of C4U, is the research result of Prof. Tomoshi Mashita of the Institute of Medical Science, University of Tokyo, who is the founding member of C4U and advisor of science and technology, and Professor Junji Takeda of the Institute of Microbial Diseases, Osaka University. A new genome editing technology using the CRISPR/Cas3 system developed based on It is a technology that can counter the CRISPR/Cas9 system, which is currently being researched all over the world, and is attracting attention as a promising genome editing technology that is not affected by the complicated patent situation regarding Cas9.

In addition, PRIME technology, which is the basic technology of Noyle Immune, is the scientific founder and director of Noyle Immune, and Professor Koji Tamada of the Graduate School of Medicine, Yamaguchi University (Professor, Gene and Cell Therapy Center, Institute of Medical Science, University of Tokyo). It is a technology related to cancer immune cell therapy such as CAR-T developed by et al. CAR-T is a technology that not only enhances the functions of CAR-T, etc. by producing cytokines and chemokines, but also causes cancer injury by cancer patients’ own endogenous immune cells.

"I am very pleased to be able to form a business alliance with C4U, which has excellent genome editing technology of its own." In this project, we will combine the PRIME CAR-T technology of Noil Imune and the genome editing technology of C4U. By combining these, we will promote the development of highly active CAR-T cells that utilize immune cells derived from alleles.The combination of domestic technologies is highly versatile and can exert therapeutic effects even on solid cancers. We hope that next-generation CAR-T cells will be developed and a treatment method that will save more patients will be created.This project is based on the Ministry of Education, Culture, Sports, Science and Technology subsidy project "Regional Innovation Ecosystem Formation Program". We are aiming to develop the world’s most advanced cancer immunotherapy with the help of various researches including the beginning."

In addition, C4U’s Satoshi Mashita said, "The PRIME CAR-T technology possessed by Noyle Imune is a wonderful technology that can be proud of in the world, which has successfully overcome the effects of CAR-T cells on solid cancer, which was a weak point, and the sustainability of the effects. By adding our newly developed CRISPR/Cas3 genome editing technology to this technology, it is possible to achieve a more inexpensive, more effective and superior allogeneic CAR-T cell therapy compared to the existing CAR-T cell therapy. I am confident that we will be able to provide to many suffering patients."

Neil Imune and C4U will collaborate on allogeneic genetically modified immune cell therapy under this partnership. Neil Imune will bear part of the costs necessary to carry out this joint research. In addition, both companies have the right to commercialize the results obtained by this joint research, and the right to mutually receive royalties based on the contract. Noil Imune will pay the access fee for the basic technology of C4U when commercializing. Further details of the contract are not disclosed.

On May 25, 2020 Imago BioSciences, Inc. ("Imago"), a clinical stage biopharmaceutical company developing innovative treatments for myeloid diseases, reported that positive Phase 2 data from its lead pipeline program bomedemstat (IMG-7289), will be presented at the Virtual Edition of the 25th EHA (Free EHA Whitepaper) Annual Congress beginning June 12, 2020 (Press release, Imago BioSciences, MAY 25, 2020, View Source [SID1234558429]).

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Title: A PHASE 2 STUDY OF BOMEDEMSTAT (IMG-7289), A LYSINE-SPECIFIC DEMETHYLASE-1 (LSD1) INHIBITOR, FOR THE TREATMENT OF LATER-STAGE MYELOFIBROSIS (MF)

Session Topic: 16. Myeloproliferative Neoplasms

Final Abstract Code: EP1080

The data demonstrates the potential of bomedemstat as a monotherapy in intermediate-2 and high-risk patients with myelofibrosis who have become intolerant of, or resistant to, or are ineligible for a Janus Kinase (JAK) inhibitor.

Imago is currently conducting a Phase 2 study of bomedemstat in five countries. Clinical endpoints include spleen volume reduction, reduction in total symptom scores, and improvement in circulating inflammatory cytokines, anemia, bone marrow fibrosis and blast count. For additional information, visit cliniciatrials.gov (NCT03136185).

About Bomedemstat (IMG-7289)

Bomedemstat is being evaluated in an open-label Phase 2 clinical trial for the treatment of advanced myelofibrosis (MF), a bone marrow cancer that interferes with the production of blood cells. The endpoints include spleen volume reduction and symptom improvement at 12 and 24 weeks of treatment. Bomedemstat is used as monotherapy in patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor.

Bomedemstat is a small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat (IMG-7289) is an investigational agent currently being evaluated in ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185 and NCT02842827). Bomedemstat has FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, and Orphan Drug Designation for treatment of acute myeloid leukemia.

On May 25, 2020 Portage Biotech Inc. (CSE: PBT.U, OTC Markets: PTGEF) ("Portage" or the "Company") reported that, in addition to completing its previously approved plan to consolidate (reverse stock split) its common shares, it will be conducting a non-brokered private placement of post-consolidation common shares for gross proceeds of up to US$10,000,000 (the "Offering") at a price of US$10.00 per post-consolidated common share (the "Offering Price") (Press release, Portage Biotech, MAY 25, 2020, View Source [SID1234558432]). The Offering Price is based on a 20 day weighted moving average of the common shares on the CSE less a 10% discount. The Offering may close in one or more tranches at the discretion of the Company. The Company also has the discretion to increase the maximum offering amount by up to 10% to cover over-subscriptions.

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Two of the Company’s directors, Dr. Gregory Bailey and Mr. James Mellon, have agreed to provide standby commitments in respect of the Offering by subscribing for that portion of the Offering not otherwise subscribed for by outside investors, up to an aggregate of US$2,000,000. This commitment would be reduced if the Offering is oversubscribed.

Ian B. Walters, MD, CEO of Portage, said "this financing expands our investor base while existing investors continue to support the mission. As released recently, several portfolio companies have achieved development milestones and we are advancing products into human testing requiring more funding. Our discussions with institutional investors and banks have necessitated the consolidation in an effort to prepare for movement to a senior exchange. We are excited by the prospects that this financing will bring for the future growth of Portage and its shareholders."

This Offering is only open to residents of the United States and Canada who are "Accredited Investors" as defined under applicable securities legislation in the United States and Canada and for accredited investors in other international jurisdictions pursuant to applicable exemptions from prospectus and registration requirements. The minimum subscription amount is US$25,000 per investor. Accredited investors who are interested in participating may obtain offering materials from Ian Walters, CEO, at [email protected].

The net proceeds of the Offering will be used for a number of different purposes including: (i) further development of the Company’s immune-oncology portfolio towards clinical testing; (ii) the formation of one to two new companies; and (iii) enable the Company to pursue an additional listing of its common shares on a senior stock exchange.-2-Prior to and as a condition of closing, the Company will be completing, subject to CSE approval, a consolidation (the "Consolidation") (also known as a reverse stock split) of its issued and outstanding common shares on the basis of 100 pre-consolidation common shares for each post-consolidation common share. The Consolidation was approved by shareholders at an annual meeting held on January 8, 2019 with the consolidation ratio being approved by the directors of the Company on May 19, 2020. More details regarding the effective date of the Consolidation and other relevant information including a new CUSIP number for the postconsolidated common shares will be disclosed in a separate news release.

Closing of a first tranche of the Offering is expected to occur on or about June 8, 2020 (the "Closing") subject to completion of the Consolidation and any regulatory approval including that of the CSE. The Company may pay a finder’s fee on the non-insider portion of the Offering within the amount permitted by the policies of the CSE. The potential issuance of any securities to Messrs. Bailey and Mellon at the closing of the Offering will be considered related party transactions within the meaning of Multilateral Instrument 61-101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company intends to rely on appropriate exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101 in respect of any insider participation.

All securities issued in connection with the Offering will be subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities legislation.

On May 25, 2020 Sanofi reported its intent to sell its equity investment in Regeneron (NASDAQ: REGN) through a registered public offering and related share repurchase by Regeneron (Press release, Sanofi, MAY 25, 2020, View Source [SID1234558465]). The registered offering and share repurchase will have no impact on the ongoing collaboration between Sanofi and Regeneron.

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A preliminary prospectus supplement relating to the offering of Regeneron’s shares will be filed with the U.S. Securities and Exchange Commission. Sanofi currently holds approximately 23.2 million shares of Regeneron’s common stock, representing approximately 20.6% ownership.

Regeneron has agreed to repurchase $5 billion of its stock from Sanofi conditional on completion of the proposed public offering. If the offering and repurchase are completed and the underwriters fully exercise their option to purchase additional shares1, Sanofi will continue to own approximately 400,000 shares of Regeneron’s common stock, which Sanofi is retaining in support of the ongoing collaboration with Regeneron.

"Sanofi and Regeneron’s collaboration has been one of the most productive in the industry, creating significant value for both companies but more importantly, resulting in five important medicines for patients. Sanofi remains committed to continuing our collaboration with Regeneron which remains an integral part of our overall strategy, and this decision was fully aligned with Regeneron, said Paul Hudson, Chief Executive Officer, Sanofi. "The decision to divest our holdings is consistent with our efforts to enhance value creation for our shareholders. We believe the proceeds from this transaction will help further our ability to execute on our strategy to drive innovation and growth."

Following completion of the proposed public offering and share repurchase, Sanofi will discontinue accounting for its ownership in Regeneron’s common shares under the equity method. After restatement of Sanofi previously reported non-GAAP indicator (Business Net Income) and change of its definition to exclude the effect of equity method accounting for Regeneron investment, Sanofi business EPS is expected to grow by approximately +5% in 2020 at constant exchange rate compared to 2019 restated business EPS of €5.64, which is in line with Sanofi’s 2020 business EPS growth guidance.

In connection with the offering, the underwriters will have an option to purchase up to an additional 10% of Regeneron’s shares offered, exercisable within 30 days following the pricing of the offering.

The Companies have had a successful and long-standing clinical and commercial collaboration dating back to 2003 that has resulted in five approved treatments to date with additional candidates currently in clinical development. Sanofi originally purchased a shareholding in Regeneron in 2004. Sanofi’s decision to sell its Regeneron common shares was made in consultation with Regeneron and the contemplated structure will allow both companies to achieve their mutual objectives.

The transaction has been approved by Sanofi and Regeneron’s Boards of Directors.

The public offering will occur simultaneously in the United States and internationally through underwriters led by BofA Securities and Goldman Sachs as joint book-running managers.

The shares offered to the public are being offered pursuant to an existing effective shelf registration statement (including a base prospectus) that has been filed by Regeneron with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement relating to and describing the terms of the offering will be filed by Regeneron with the SEC and will be available on the SEC website at www.sec.gov. Alternatively, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and the prospectus supplement, when available, if you request them by contacting: (1) BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at [email protected], or (2) Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: 1-866-471-2526, or via email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.