Pelabresib

BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line!Today, were interrupting our usual rundown of industry news to highlight notable clinical trial updates ahead of next weeks American Society of Clinical Oncologys annual meeting. On Thursday, conference organizers released abstracts, or snapshots, of most of the studies set to be presented at the meeting, which will be held in Chicago from May 31 to June 4.Note: So-called late-breaking abstracts, which often feature particularly consequential trial findings, arent available until the day the relevant studies are presented. This year, that group includes anticipated data on Novartis therapy Scemblix in leukemia, GSKs Blenrep in multiple myeloma and AstraZeneca and Daiichi Sankyos Enhertu treatment in breast cancer.Abstract #9507: Analysts have closely tracked a dual-targeting antibody drug that Immunocore is developing for a type of skin cancer called cutaneous melanoma. Trial results included in an ASCO abstract showed that, among 31 evaluable people who previously received immunotherapy, Immunocores drug led to partial tumor responses in four, or 13%. Including study participants whose disease was considered stable, the so-called clinical benefit rate was 61%. Though slightly below analysts expectations, the data are roughly similar to the results for Bristol Myers Squibbs Odualag in a comparable patient population. Immuncore recently began a Phase 3 trial of its drug, called brenetafusp. Ned PagliaruloAbstracts #5502, 9506: Drugmakers have hoped that targeting an immune cell protein called TIGIT could build on the success seen with checkpoint inhibitors like Merck & Co.s Keytruda and Bristol Myers Squibbs Opdivo. But trial results to date have been mixed and new data included in ASCO abstracts Thursday probably wont settle any debates. On one hand, Phase 2 trial findings for Mercks TIGIT-targeting drug vibostolimab coformulated with Keytruda shrank or eliminated tumors in a larger share of women with a type of endometrial cancer than Keytruda alone. On the other, data from a Phase 1/2 trial of Keytruda, vibostolimab and a third experimental immunotherapy called quavonlimab in advanced melanoma patients werent good enough for the Merck to continue enrolling patients. Jonathan GardnerAbstract #3508: An experimental cocktail of six drugs substantially extended survival and delayed tumor growth, compared to a standard therapy, in people with previously treated metastatic colon cancer, according to an ASCO abstract. The regimen includes two drugs developed by Arcus Biosciences: etrumadenant, a so-called adenosine receptor antagonist, and zimberelimab, a checkpoint inhibitor. Median overall survival among the 75 patients randomized to the cocktail was 19.7 months, versus 9.5 months for the 37 given Stivarga in the Phase 1b/2 study. Arcus is closely partnered with Gilead Sciences, although their focus has been on developing zimberelimab and another immunotherapy. Ned PagliaruloAbstract #5010: Johnson & Johnson is one of many companies now exploring radiopharmaceuticals, which deliver radiation directly to a tumor. Its first chance to break into the field could be JNJ-6420, a drug that executives already billed as a potential future blockbuster. J&J aims to show the drug can slow tumor progression in men whose prostate cancer has progressed after hormone therapies. Early-stage study results disclosed in an abstract show the company may need to manage safety concerns. While 46% of men treated with a select drug dose had a 50% decrease in a marker associated with improved survival, 61% experienced an adverse event graded as severe or medically significant. Four of the 67 patients who received J&Js drug overall in the study died from adverse events. Jonathan GardnerAbstract #6502: Anyone looking for updated trial results on MorphoSys myelofibrosis drug pelabresib will have to wait for ASCO itself, as an abstract for the biotechnology companys MANIFEST-2 study only includes previously presented data. The drug is at the center of Novartis pending $2.9 billion acquisition of MorphoSys, but there are questions about its safety after a Stat report highlighted multiple cases of acute myeloid leukemia developing in pelabresib-treated patients. Ned Pagliarulo '

Novartis secured 79.6 percent acceptance by MorphoSys shareholders during the initial acceptance period, reaching the minimum 65% acceptance thresholdSettlement of the shares tendered during the initial acceptance period is expected to occur on 23 May 2024Additional statutory acceptance period is expected to end on 30 May 2024 at 24:00 hours CESTTransaction strengthens the Novartis pipeline in oncology, adding pelabresib, a late-stage BET inhibitor for myelofibrosis and tulmimetostat, an early-stage investigational dual inhibitor of EZH2 and EZH1 for solid tumors or lymphomas Basel, 16 May 2024 – Today, Novartis BidCo AG, an (indirect) wholly owned subsidiary of Novartis AG, announced the result of its voluntary public takeover offer (the “Offer”) for the shares of MorphoSys AG (“MorphoSys”), including all shares represented by MorphoSys American Depositary Shares (“ADS”). As of the expiry of the acceptance period at 24:00 hours CEST on 13 May 2024, the Offer has been accepted by approximately 79.6 percent of the total share capital of MorphoSys, including purchases by Novartis BidCo AG outside the Offer for approximately 11.6 percent of the share capital. All conditions of the Offer, including the minimum acceptance threshold of 65%, were fulfilled by the end of the acceptance period. The settlement of the shares tendered during the initial acceptance period is scheduled for 23 May 2024. The statutory two-week additional acceptance period for the Offer will commence on 17 May 2024 and end on 30 May 2024 at 24:00 hours CEST and 18:00 hours EDT (also on 30 May 2024). During this time, shareholders who have not tendered their MorphoSys shares, including shares represented by MorphoSys ADS, can still accept the Offer.With all offer conditions fulfilled, Novartis can now begin the necessary steps to progress the integration of MorphoSys, including full access to pelabresib (CPI-0610), a novel BET inhibitor in combination with ruxolitinib for patients with myelofibrosis. The integration also allows full access to tulmimetostat (CPI-0209), an early-stage investigational dual inhibitor of EZH1 and EZH2 currently being tested in patients with solid tumors or lymphomas, as well as a broad portfolio of partnered assets, some of which are in partnership with Novartis, including ianalumab (VAY736). In the context of the integration Novartis continues to progress the workstreams for implementation of both a delisting of MorphoSys and a domination and profit and loss transfer agreement with MorphoSys. Georgeson is acting as information agent for Novartis for the Offer. Deutsche Bank is acting as share tender agent and The Bank of New York Mellon is acting as ADS tender agent for the Offer. The offer document for the Offer and additional information are available at www.novartis.com/investors/morphosys-acquisition. A takeover offer hotline for retail shareholders is available between 9:00-18:00 hours CEST from Monday through Friday at +49 89 38038187 (for German callers) and +44 203 005 6716 (for international callers). A takeover offer hotline for ADS holders is available between 9:00-23:00 hours EDT from Monday through Friday and 12:00-18:00 hours EDT on Saturdays at +1 (866) 356-7344 (for U.S. callers) and +1 (781) 236-4704 (for callers outside the U.S.). Additional Information and Where to Find it This communication is neither an offer to purchase nor a solicitation of an offer to sell shares of MorphoSys. The final terms and further provisions regarding the Offer are available in the offer document published by Novartis BidCo AG (formerly known as Novartis data42 AG) (the “Bidder”). The offer document has been approved by the BaFin and has been filed with the U.S. Securities and Exchange Commission (the “SEC”). The solicitation and offer to buy shares of MorphoSys is only being made pursuant the offer document. In connection with the Offer, the Bidder and Novartis AG have filed Tender Offer Statement on Schedule TO with the SEC (together with the offer document, an Offer to Purchase including the means to tender and other related documents, the “Offer Documents”), the management board and supervisory board of MorphoSys have issued a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act and MorphoSys has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC (together with the joint reasoned statement, the “Recommendation Statements”). THE MORPHOSYS SHAREHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE OFFER DOCUMENTS AND THE RECOMMENDATION STATEMENTS BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE OFFER. The Offer Documents and the Recommendation Statements will be distributed to all stockholders of MorphoSys in accordance with German and U.S. securities laws. The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 are available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting the Bidder or MorphoSys. Free copies of these materials and certain other offering documents are available on the Bidder’s website at www.novartis.com/investors/morphosys-acquisition or by contacting the Bidder’s investor relations department at +41 61 324 7944. In addition to the Offer to Purchase, including the means to tender and certain other Offer Documents, as well as the Solicitation/Recommendation Statement, MorphoSys and the Bidder will file other information with the SEC. Filings by Novartis AG and the Bidder with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov. In order to reconcile certain areas where German law and U.S. law conflict, Novartis AG and the Bidder have requested and received no-action and exemptive relief from the SEC to conduct the Offer in the manner described in the offer document. Acceptance of the Offer by stockholders residing outside Germany and the U.S. may be subject to further legal requirements. With respect to the acceptance of the Offer outside Germany and the U.S., no responsibility is assumed for the compliance with such legal requirements applicable in the respective jurisdiction. DisclaimerThis press release contains forward-looking statements concerning Novartis AG, the Bidder, MorphoSys and the Offer that involve substantial risks and uncertainties. Forward-looking statements include any statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “goal,” “may,” “might,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions. In this communication, forward-looking statements include statements about the parties’ ability to satisfy the conditions to the consummation of the Offer; statements about the expected timetable for the consummation of the Offer; the plans, objectives, expectations and intentions of Novartis AG and the Bidder; and the financial condition, results of operations and business of MorphoSys and Novartis AG. The forward-looking statements contained in this communication represent the judgment of the Bidder and Novartis AG as at the date of this communication and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of Novartis AG, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if the results, performance, financial condition and liquidity of Novartis AG, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: uncertainties as to the timing of the Offer; uncertainties as to how many of the MorphoSys stockholders will tender their stock in the Offer; the possibility that competing offers will be made; the possibility that various conditions for the Offer may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Offer; the effects of the Offer on relationships with employees, other business partners or governmental entities; that the Bidder and Novartis AG may not realize the potential benefits of the Offer; transaction costs associated with the Offer; that expectations may be incorrect; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission, as well as the Solicitation/Recommendation Statement on Schedule 14D-9 to be filed by MorphoSys and the Tender Offer Statement on Schedule TO and related Offer Documents to be filed by the Bidder and Novartis AG. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this communication. The Bidder, Novartis AG and MorphoSys expressly disclaim any obligation to update any such forward-looking statements in this communication to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Anja von Treskow +41 79 392 9697 Michael Meo +1 862 274 5414 Anna Schäfers +41 79 801 7267 Marlena Abdinoor +1 617 335 9525 SwitzerlandSatoshi Sugimoto +41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Isabella Zinck +41 61 324 7188 Sloan Simpson +1 862 345 4440 Nicole Zinsli-Somm +41 61 324 3809 Jonathan Graham +1 201 602 9921 Imke Kappes +41 61 324 8269 Parag Mahanti +1 973 876 4912