Sandoz submits Marketing Authorization Application for proposed biosimilar trastuzumab to EMA

On December 22, 2021 Sandoz, a global leader in generic and biosimilar medicines, reported that it has submitted a Marketing Authorization Application for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc. to the European Medicines Agency (EMA) (Press release, Sandoz, DEC 22, 2021, View Source [SID1234597614]).

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Trastuzumab is a monoclonal antibody used for the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers2. Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical, and clinical data.

"In 2020, breast cancer accounted for 28.7% of all new cancer cases diagnosed, making it the most frequently occurring cancer and first cause of cancer death among women in Europe1", said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. "Biosimilars have enormous potential to improve cancer care. Today’s submission is an encouraging step forward in our mission to expand access to advanced biologics treatments to address the evolving needs of patients, healthcare professionals and healthcare systems."

As part of the license agreement signed in April 2019, EirGenix, Inc. is responsible for development and manufacturing and Sandoz will have the right to commercialize the medicine upon approval in all markets excluding China and Taiwan. On December 20, 2021, Sandoz announced submission of a Biologics License Application for a proposed biosimilar trastuzumab (150 mg) to the US Food and Drug Administration.

Sandoz has been developing and providing oncology medicines for over 30 years. Today, it has more than 50 such medicines, including chemotherapeutics, biologics, hormones and supportive care treatments, for the treatment of a wide range of cancers. The collaboration with EirGenix, Inc. will enable Sandoz to build on its leading generic and biosimilar oncology portfolio to further expand patient access, while contributing to the sustainability of healthcare systems.

Zai Lab announces promotion of Harald Reinhart M.D. to President and Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases

On December 22, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, reported the promotion of Harald Reinhart, M.D., from his current role as Chief Medical Officer (CMO) to President and Head of Global Development for Neuroscience, Autoimmune and Infectious Diseases (Press release, Zai Laboratory, DEC 22, 2021, View Source [SID1234597609]). Dr. Reinhart has been with the company since inception, first as an advisor and since 2017, as Chief Medical Officer responsible for the autoimmune and infectious diseases portfolio.

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"Harald has played a pivotal role in building Zai Lab’s broad and deep pipeline in autoimmune, infectious diseases and neuroscience," said Dr. Samantha Du, Founder, Chairperson and CEO at Zai Lab. "This promotion not only recognizes Harald’s tremendous contributions but will also empower him to further build a leading clinical team across these therapeutic areas."

Prior to joining Zai Lab, Dr. Reinhart served at Shionogi U.S. as Senior Vice President and Head of Clinical Development and Medical Affairs directing a broad portfolio of antibiotics, diabetes, allergy, and pain medications. Between 2003 and 2011, he was with Novartis as Vice President and Therapeutic Area Head, Clinical Development and Medical Affairs, where he oversaw successful regulatory filings for Coartem, Famvir, Sebivo, and Cubicin, and managed clinical development teams for infectious disease, immunity, transplantation, and renal disease. At Bayer Corp, he was international clinical project lead for ciprofloxacin and acarbose, and managed various other compounds.

Dr. Reinhart holds a doctorate in medicine from the University of Würzburg in Germany where he trained in surgery, anesthesiology, and internal medicine. He completed his medical and subspecialty training in the U.S. with board-certifications in internal medicine and infectious diseases. He is currently on faculty at Yale School of Medicine as Adjunct Clinical Professor of infectious diseases.

"It has been a phenomenal experience working at Zai Lab for the last seven years helping to bring transformative medicines to patients. I’m grateful for Samantha’s support and look forward to developing more medicines that truly make a difference in the lives of patients," said Dr. Reinhart. "I feel privileged to work every day with world-class colleagues at Zai Lab who share a unified vision for innovative drug development."

Syndax Announces Orphan Drug Designation Granted to SNDX-5613 by European Commission for the Treatment of Acute Myeloid Leukemia

On December 22, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that the European Commission has granted Orphan Drug Designation to SNDX-5613, the Company’s highly selective oral menin inhibitor, for the treatment of acute myeloid leukemia (AML) (Press release, Syndax, DEC 22, 2021, View Source [SID1234597607]).

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"Supported by a growing body of clinical data, we firmly believe that SNDX-5613 is ideally positioned to serve as a best-in-class, meaningful intervention for patients with NPM1 and MLLr acute leukemias," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Receipt of Orphan Drug Designation from the European Commission further validates the important role that SNDX-5613 could play in the treatment of this highly underserved patient population, and we are fully committed to ensuring that it is able to reach as many of these patients as possible."

The European Commission grants Orphan Drug Designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union (EU) and when no satisfactory method of diagnosis, prevention, or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.

SNDX-5613 was previously granted Orphan Drug Designation for the treatment of adult and pediatric AML by the U.S. Food and Drug Administration.

About SNDX-5613

SNDX-5613 is a potent, selective, small molecule inhibitor of the menin-MLL binding interaction that is being developed for the treatment of mixed lineage leukemia rearranged (MLLr) acute leukemias including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), and NPM1 mutant AML. In preclinical models of MLLr acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit. Menin-MLL interaction inhibitors have also demonstrated robust treatment benefit in multiple preclinical models of NPM1 mutant AML, which represents the most frequent genetic abnormality in adult AML. SNDX-5613 is currently being evaluated in the Company’s AUGMENT-101 Phase 1/2 open-label clinical trial for the treatment of relapsed/refractory (R/R) acute leukemias. SNDX-5613 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and European Commission for the treatment of patients with AML, and Fast Track designation by the U.S. FDA for the treatment of adult and pediatric patients with R/R acute leukemias harboring a mixed lineage leukemia rearranged MLLr or NPM1 mutation.

Regeneron Announces Presentation at the 40th Annual J.P. Morgan Healthcare Conference

On December 22, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast its presentation at the 40th Annual J.P. Morgan Healthcare Conference on Monday, January 10, 2022 (Press release, Regeneron, DEC 22, 2021, View Source [SID1234597603]). The presentation is scheduled for 10:30 a.m. Eastern Time and may be accessed from the "Investors & Media" page of Regeneron’s website at View Source An archived version of the presentation will be available for at least 30 days.

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Entry into a Material Definitive Agreement

On December 22, 2021, Achieve Life Sciences, Inc. ("Achieve") reported that entered into a contingent convertible debt agreement (the "Debt Agreement") with Silicon Valley Bank, in its capacity as administrative agent and lender (in such capacity, "Agent"), Silicon Valley Bank, as a lender ("SVB"), and SVB Innovation Credit Fund VIII, L.P., as a lender (together with SVB, the "Lenders"), pursuant to which the Lenders provided term loans having an aggregate original principal amount of $15.0 million (the "Convertible Term Loan") (Filing, 8-K, OncoGenex Pharmaceuticals, DEC 22, 2021, View Source [SID1234597601]). Subject to the terms and conditions of the Debt Agreement, upon Achieve’s request on or prior to December 31, 2022 and Agent’s and each Lender’s receipt of all necessary internal and credit approvals, Achieve may borrow additional term loans in an aggregate original principal amount of up to $10.0 million. Achieve’s obligations under the Debt Agreement are secured by substantially all of Achieve’s assets, other the intellectual property.

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The Convertible Term Loan matures on December 22, 2023; provided that such date will be extended to December 22, 2024 upon the occurrence of both (i) Achieve’s written request and (ii) Agent’s confirmation that the Agent and Lenders agree to extend the maturity date upon receipt of all necessary internal and credit approvals for such extension. Interest is calculated on the outstanding principal amount of the Convertible Term Loan at the aggregate of (a) a floating rate per annum equal to the greater of (i) 2.25% and (ii) the prime rate minus 1.0%, which interest shall be payable in cash monthly in arrears, and (b) 7.0% per annum, compounded monthly, which shall be payable on the earlier to occur of the maturity date and the date that the Convertible Term Loan is converted in to Achieve’s common stock.

The conversion feature grants the Lenders or, pursuant to an assignment, any designee thereof (each, a "Conversion Right Holder", and collectively, the "Conversion Right Holders") the right to convert part or all of the outstanding principal of the Convertible Term Loan, plus accrued and unpaid interest into shares of Achieve’s common stock at a conversion price equal to $9.34, as may be adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like (the "Conversion Price"). The conversion rights may be exercised at each Conversion Right Holder’s option any time prior to repayment of the Convertible Term Loan. Additionally, the outstanding principal of the Convertible Term Loan, plus accrued and unpaid interest, will be converted into shares of Achieve’s common stock at the Conversion Price on the date where the closing price per share of Achieve’s common stock is equal to or greater than $24.00 for thirty consecutive trading days prior to such date.

The Convertible Term Loan may be repaid at Achieve’s election by paying the Lenders an amount equal to (i) if such repayment is made on or before the eighteen month anniversary of the closing date, 125% of the outstanding principal balance (including compounded interest), plus accrued and unpaid interest, and (ii) if such repayment is made after the eighteen month anniversary of the closing date, 150% of the outstanding principal balance (including any compounded interest), plus accrued and unpaid interest. Notwithstanding the foregoing, if Achieve elects to repay the Lenders and in the twelve month period following such repayment enters to an agreement, commitment, letter of intent or memorandum of understanding or the like, binding or nonbinding, with any third party respecting an acquisition, and such acquisition is subsequently consummated, if the aggregate gross proceeds that would have been payable to the Conversion Right Holders in connection with such acquisition had Achieve not repaid the Convertible Term Loan and the Conversion Right Holders had exercised, in connection with such acquisition, the right to convert the Convertible Term Loan into shares of Achieve’s common stock, then Achieve shall pay to the Lenders as an additional call price, the difference between such proceeds as would have been payable to the Conversion Right Holders in connection with such acquisition and the payment actually paid to the Lenders.

The Debt Agreement contains customary affirmative and restrictive covenants, including covenants regarding the incurrence of additional indebtedness or liens, investments, transactions with affiliates, delivery of financial statements, payment of taxes, maintenance of insurance, dispositions of property, mergers or acquisitions, among other customary covenants. Achieve is also restricted from paying dividends or making other distributions or payments on its capital stock, subject to limited exceptions. The Debt Agreement also includes customary representations and warranties, events of default and termination provisions. The Lenders may not engage in any short sales of, or other hedging transactions in, Achieve’s common stock while any amounts are outstanding under the Debt Agreement.

In connection with the Debt Agreement, Achieve entered into a Registration Rights Agreement (the "RRA") with the Lenders, pursuant to which Achieve may be required to register for resale shares of its common

stock issued to the Conversion Right Holders upon the conversion of outstanding debt under the Debt Agreement. Achieve’s obligations under the RRA will terminate with respect to a holder of applicable registrable securities upon the earlier to occur of (a) the time when such holder delivers a notice demanding registration or (b) Achieve would be required to give notice to such holder of its intention to file an applicable registration statement, in either case if (x) the aggregate number of registrable securities then issued and issuable to such holder and to such holder’s affiliates, together with all other shares then held beneficially and/or of record by such holder and its affiliates, does not exceed seven percent (7%) of Achieve’s then-total shares issued and outstanding (calculated including all such registrable securities and other shares), or (y) Achieve and such holder mutually reasonably agree that all registrable securities then issued and issuable to such holder and its affiliates may then be sold by such holder without the requirement to be in compliance with Rule 144 promulgated under the Securities Act of 1933, as amended (the "Rule 144") and otherwise without restriction or limitation pursuant to Rule 144.

The foregoing descriptions of the Debt Agreement, the Convertible Term Loans and RRA do not purport to be complete and are subject to, and qualified in their entirety by, such documents attached as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K, which are incorporated herein by reference.