BELLUS Health Inc. (NASDAQ: BLU)(TSX: BLU) (the "Company" or "BELLUS Health") announced today that it has completed its previously-announced underwritten public offering in Canada and the United States (the "Offering") of 16,540,541 common shares at a price to the public of US$9.25 per common share. The total gross proceeds to the Company were US$153 million, before deducting the underwriting commissions and any expenses related to the Offering. Bellus has also granted to the underwriters an option exercisable by the underwriters within 30 days of the date of the underwriting agreement to purchase up to an additional 2,481,081 common shares of the Company.
BELLUS Health's common shares are dual-listed on the Nasdaq Global Market ("Nasdaq") and the Toronto Stock Exchange ("TSX") under the trading symbol "BLU". For the purposes of the TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.
The Company intends to use the net proceeds of the Offering primarily to fund BLU-5937 research and development activities, working capital needs and other general corporate purposes, as set out in the Supplement (as defined below).
Jefferies, Evercore ISI and RBC Capital Markets acted as joint book-running managers and LifeSci Capital acted as lead manager.
The Offering was made in Canada pursuant to a prospectus supplement dated July 13, 2022 (the "Supplement") to the Company's amended and restated short form base shelf prospectus dated December 14, 2021 (the "A&R Base Prospectus") and in the United States pursuant to a registration statement on Form F-10, which went effective automatically upon its filing with the U.S. Securities and Exchange Commission (the "SEC") on December 14, 2021 (the "Registration Statement"), containing the Supplement and A&R Base Prospectus filed with the SEC in accordance with the Multijurisdictional Disclosure System established between Canada and the United States.
The Supplement and the accompanying A&R Base Prospectus contain important detailed information about the Offering. The Supplement and the accompanying A&R Base Prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying A&R Base Prospectus may also be obtained from the Company, by telephone at 450-680-4500 or by email at email@example.com or you may request them from, in the United States, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at firstname.lastname@example.org , or Evercore Group L.L.C., Attention: Equity Capital Markets , 55 East 52 nd Street, 35 th Floor, New York, NY 10055, by telephone at 888-474-0200 or by email at email@example.com , or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at 877-822-4089 or by email at firstname.lastname@example.org or, in Canada, Jefferies Securities, Inc., Attention: General Counsel, 161 Bay Street, Suite 2600, Toronto, ON M5J 2S1 by email at email@example.com , or RBC Dominion Securities Inc., Attention: Distribution Centre, 180 Wellington Street West, 8th Floor, Toronto, ON M5J 0C2, by telephone at 1-416-842-5349 or by email at Distribution.RBCDS@rbccm.com . Prospective investors should read the Supplement and accompanying A&R Base Shelf Prospectus and the other documents the Company has filed before making an investment decision.
No regulatory authority has either approved or disapproved the contents of this news release. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.
About BELLUS Health
BELLUS Health Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough ("RCC") and other hypersensitization-related disorders. The Company's product candidate, BLU-5937, is being developed for the treatment of adults with RCC.
Cautionary Note Regarding Forward-Looking Statements
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the meaning of Canadian securities legislation and regulations, the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other applicable securities laws. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown. In this news release, such forward-looking statements include, but are not limited to, the anticipated use of proceeds from the Offering. Actual future events may differ from the anticipated events expressed in such forward-looking statements. BELLUS Health believes that expectations represented by forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These forward-looking statements speak only as of the date made, and BELLUS Health is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable securities laws.
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— New Agreement Continues to Enable Rapid and Equitable Access to Veklury for COVID-19 Patients in EU and EEA Countries —
Gilead Sciences and the European Commission today signed a new joint procurement agreement (JPA) that will ensure continued rapid and equitable access to Veklury ® (remdesivir) for participating Member States across the European Union (EU) and European Economic Area (EEA).
The agreement covers purchases of Veklury over the next twelve months and has the option to be extended for an additional six months. It follows the expiration of the original JPA agreement, the first for a COVID-19 therapeutic, signed in October 2020.
"We welcome this new JPA for Veklury which will continue to help governments across Europe ensure they have rapid access to this critical treatment," said Johanna Mercier, Chief Commercial Officer, Gilead Sciences. "Veklury is the antiviral standard-of-care treatment for appropriate hospitalized patients across a spectrum of COVID-19 disease severity. It has helped hundreds of thousands of patients across Europe recover faster and reduce hospital stays, which generate savings for healthcare systems. Following the recent expanded indication to patients at risk for disease progression, Veklury now has the potential to help even more patients so we are pleased this JPA will help ensure Veklury is available for patients when they need it."
In the EU and EEA Veklury is the only antiviral indicated for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation). In December 2021, the European Commission expanded the indication for Veklury to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.
The expanded European conditional marketing authorization was supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for the treatment of COVID-19 in patients at high risk for disease progression. In this study, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008; in the study, there were no deaths in either arm through the primary endpoint. The study was also the basis for the World Health Organization's updated Therapeutics and COVID-19 living guideline, which now conditionally recommends Veklury for use in patients with non-severe COVID-19 at the highest risk of hospitalization.
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company's antiviral research. Veklury is the antiviral standard of care treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and minimal drug interactions in diverse populations. It can help reduce disease progression across a broad spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and generating savings to healthcare systems.
Veklury is a nucleotide analog that directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. In vitro laboratory testing in multiple independent studies show that Veklury continues to retain activity against SARS-CoV2 as it evolves, including the Omicron variant and its subvariants BA.1 and BA.2. As new SARS-CoV-2 variants of concern emerge around the world, Gilead continuously evaluates the effectiveness of Veklury against viral variants.
Veklury is approved or authorized for temporary use in approximately 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 11 million patients around the world, including more than 7 million people in 127 middle- and low-income countries through Gilead's voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead's existing commitment to enabling broad patient access to remdesivir.
U.S. Indication for Veklury
Veklury ® (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are:
For more information, please see the U.S. full Prescribing Information available at www.gilead.com .
U.S. Important Safety Information for Veklury
Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.
Warnings and precautions
Dosage and administration
Dose preparation and administration:
Pregnancy and lactation
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to effectively manage the supply and distribution of Veklury; Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Veklury; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
U.S. full Prescribing Information for Veklury is available at www.gilead.com .
Veklury, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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Bristol Myers Squibb (NYSE:BMY) today has announced that Rhumba Merger Sub Inc. ("Offeror"), a wholly owned subsidiary of Bristol Myers Squibb, has extended the expiration date of its offer (the "Offer") to acquire (the "Acquisition") all of the outstanding shares of common stock, par value $0.0001 per share ("Common Stock"), of Turning Point Therapeutics, Inc. (NASDAQ: TPTX), ("Turning Point") at a price of $76.00 per share, in cash, without interest, subject to any applicable withholding of taxes, pursuant to the terms of the Agreement and Plan of Merger, dated as of June 2, 2022, among Bristol Myers Squibb, Offeror and Turning Point (the "Merger Agreement"). The Acquisition is expected to close during the third quarter of 2022.
The Offer, which was previously scheduled to expire one minute following 11:59 p.m., Eastern Time, on July 18, 2022, has been extended until 5:00 p.m., Eastern Time, on August 15, 2022.
Equiniti Trust Company, the depositary for the Offer, has advised the Offeror that as of 5:30 p.m., Eastern Time, on July 18, 2022, 34,447,733 shares of Turning Point, representing approximately 69.0% of the issued and outstanding shares of Common Stock, have been validly tendered and not properly validly withdrawn pursuant to the Offer. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to this extension.
The Offer is being made pursuant to the terms and conditions described in the Offer to Purchase, dated June 17, 2022 (as it may be amended or supplemented from time to time, the "Offer to Purchase"), the related Letter of Transmittal and certain other offer documents, copies of which are attached to the Tender Offer Statement on Schedule TO (together with any amendments or supplements thereto, the "Tender Offer Statement") filed by Bristol Myers Squibb and Offeror with the U.S. Securities and Exchange Commission (the "SEC") on June 17, 2022, as amended.
The Offer is conditioned upon the fulfillment of certain conditions described in "The Offer—Section 15—Conditions to the Offer" of the Offer to Purchase, including, but not limited to, the termination or expiration of any applicable mandatory waiting period (and any extensions thereof) imposed under the Hart-Scott-Rodino Act.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook , and Instagram .
Additional Information about the Offer and Where to Find It
This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities, nor is it a substitute for the tender offer materials that Bristol Myers Squibb and Offeror filed with the SEC. At the time the tender offer was commenced, Bristol Myers Squibb caused Offeror to file a tender offer statement on Schedule TO and Turning Point filed a recommendation statement on Schedule 14D-9. INVESTORS AND TURNING POINT'S STOCKHOLDERS ARE STRONGLY ADVISED TO READ THE TENDER OFFER STATEMENT AND THE RELATED SOLICITATION/ RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 FILED BY TURNING POINT WITH THE SEC, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT SHOULD BE CONSIDERED BY TURNING POINT'S INVESTORS BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. These documents are available at no charge on the SEC's website at www.sec.gov . In addition, a copy of the offer to purchase, letter of transmittal and certain other related tender offer documents may be obtained free of charge at www.bms.com or by directing a request to Bristol Myers Squibb, Office of the Corporate Secretary, 430 East 29th Street, 14th Floor, New York, New York 10154-0037. A copy of the tender offer statement and the solicitation/recommendation statement are made available to all stockholders of Turning Point free of charge at www.tptherapeutics.com .
In addition to the offer to purchase, the related letter of transmittal and certain other offer documents, as well as the solicitation/recommendation statement, Bristol Myers Squibb and Turning Point file annual, quarterly and special reports, proxy statements and other information with the SEC. You may read any reports, statements or other information filed by Bristol Myers Squibb or Turning Point with the SEC at no charge on the SEC's website at www.sec.gov .
Cautionary Statement Regarding Forward-Looking Statements
This communication contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the acquisition of Turning Point by Bristol Myers Squibb. These statements may be identified by the fact they use words such as "should," "could," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe," "will" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. These statements are only predictions, and such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Actual results may differ materially from current expectations because of numerous risks and uncertainties including with respect to (i) the timing of the Offer and the subsequent merger, (ii) the number of shares of Turning Point's common stock that will be tendered in the Offer, (iii) the risk that the expected benefits or synergies of the acquisition will not be realized, (iv) the risk that legal proceedings may be instituted related to the merger agreement, (v) any competing offers or acquisition proposals for Turning Point, (vi) the possibility that various conditions to the consummation of the Offer or the acquisition 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 or the acquisition and (vii) unanticipated difficulties or expenditures relating to the proposed transaction, the response of business partners and competitors to the announcement of the proposed transaction and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction. Forward-looking statements in this communication should be evaluated together with the many uncertainties that affect Bristol Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2021, and its subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and in Turning Point's Annual Report on Form 10-K for the year ended December 31, 2021 and its subsequent Quarterly Reports on Form 10-Q , as well as other documents that may be filed by Bristol Myers Squibb or Turning Point from time to time with the SEC. Neither Bristol Myers Squibb nor Turning Point undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made.
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Genmab A/S (Nasdaq: GMAB) today announced that AbbVie (NYSE: ABBV) will submit a conditional marketing authorization application (MAA) with the European Medicines Agency (EMA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), in the second half of 2022. Genmab recently announced that the company will submit a biologics license application (BLA) for epcoritamab with the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), also in the second half of 2022.
The MAA submission is supported by results from the large b-cell lymphoma (LBCL) cohort of the pivotal EPCORE™ NHL-1 open-label, multi-center trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), including DLBCL. In April 2022, Genmab and AbbVie announced the topline results from the Phase II expansion part of the EPCORE™ NHL-1 trial. In June 2022, primary results were presented in a late-breaking oral presentation as part of the Presidential Symposium at the 27 th Annual Meeting of the European Hematology Association (EHA2022) in Vienna, Austria.
"The MAA submission will mark the next step towards potentially obtaining marketing approval in Europe and being able to deliver a new therapeutic option to patients with relapsed or refractory DLBCL," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "While there are existing treatments for DLBCL patients across Europe, we recognize the significant medical need for alternative therapeutic options for patients unable to tolerate current treatments or whose treatments have failed."
Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. The companies are committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies, including an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory DLBCL (NCT: 04628494).
About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is a fast-growing type of NHL that affects B-cell lymphocytes, a type of white blood cell. DLBCL, the most common type of NHL worldwide, accounts for about 25 percent of diagnosed cases of B-cell NHL worldwide. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system. The disease occurs more commonly in the elderly and is slightly more prevalent in men. i,ii
About the EPCORE™ NHL-1 Trial
EPCORE™ NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab including a phase 1 first-in-human, dose escalation part; a phase 2 expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL, including LBCL and DLBCL. Data from the dose escalation part of the study, which determined the recommended phase 2 dose, were published in The Lancet in 2021. In the phase 2 expansion part, additional patients are treated with epcoritamab to further explore the safety and efficacy of epcoritamab in patients with different types of relapsed/refractory B-NHLs who had limited therapeutic options.
The primary endpoint of the phase 2 expansion part was overall response rate (ORR) as assessed by an IRC. Secondary efficacy endpoints included duration of response, complete response rate, progression-free survival, overall survival, time to response, time to next therapy, and rate of minimal residual disease negativity.
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells. iii CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia. iv,v
Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab's vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people's lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab's proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab .
Genmab Forward-Looking Statements
This Media Release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov . Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ® ; the Y-shaped Genmab logo ® ; Genmab in combination with the Y-shaped Genmab logo ® ; HuMax ® ; DuoBody ® ; DuoBody in combination with the DuoBody logo ® ; HexaBody ® ; HexaBody in combination with the HexaBody logo ® ; DuoHexaBody ® ; HexElect ® ; and UniBody ® .
i Diffuse Large B-Cell Lymphoma." Lymphoma Research Foundation, https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/ . Accessed 11 February 2022.
ii Sandeep A. Padala; Avyakta Kallam. "Diffuse Large B-Cell Lymphoma." National Institutes of Health, National Library of Medicine, https://www.ncbi.nlm.nih.gov/books/NBK557796/#article-24581.s4 . Accessed 22 June 2022.
iii Engelberts et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625
iv Rafiq, Butchar, Cheney, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties." J. Immunol. 2013;190(6):2702-2711. DOI: 10.4049/jimmunol.1202588
v Singh, Gupta, Almasan. "Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." J Cancer Sci Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373
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ABBVie (NYSE: ABBV) today announced it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in adult patients who have at least four migraine days per month. The application is supported by the pivotal Phase 3 ADVANCE and PROGRESS studies evaluating the safety, efficacy, and tolerability of atogepant in adult patients with episodic migraine and chronic migraine, respectively. 1,2
Migraine is a complex neurological disease and one of the leading causes of disability worldwide. 3 It is highly prevalent, affecting more than 1 billion people worldwide, 3 including an estimated 11.4 percent of the population in Europe . 4 If approved, atogepant would be the first daily oral CGRP receptor antagonist for the prophylaxis of migraine for adult patients in Europe .
"Far too many people around the world are impacted from the debilitating challenges of migraine, which places a significant social and work-life burden for patients and care partners," said Michael Gold , M.D., therapeutic area head, neuroscience development, AbbVie. "At AbbVie, we are committed to advancing science to provide patients impacted by migraine with effective treatment options. If approved, atogepant will provide a prophylactic treatment option for adult migraine patients suffering for more than four days a month."
The pivotal, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial evaluated the efficacy, safety, and tolerability of once daily (QD) oral atogepant for the prophylaxis of episodic migraine. The study met its primary endpoint of a statistically significant reduction in mean monthly migraine days across the 12-week treatment period compared to placebo. This was found across all active treatment arms of atogepant – 10 mg, 30 mg, and 60 mg QD doses. The adult patients enrolled met the International Classification of Headache Disorders (ICHD) criteria for a diagnosis of migraine with or without aura. The study also found that a greater proportion of atogepant-treated participants achieved at least a 50% reduction in mean monthly migraine days for all doses compared to placebo and met other key secondary endpoints.
The pivotal, Phase 3, global, randomized, double-blind, placebo-controlled, parallel-group PROGRESS study, evaluating the safety, efficacy, and tolerability of oral atogepant in adult patients for the prophylaxis of chronic migraine, met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period. The trial also demonstrated that treatment with atogepant 60 mg once daily (QD) and 30 mg daily (BID), resulted in statistically significant improvements in all secondary endpoints. This includes a key secondary endpoint that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period.
In both, the Phase 3 PROGRESS and Phase 3 ADVANCE studies, all doses were well tolerated, and the overall safety profiles were consistent with safety findings observed in previous studies for the prophylaxis of episodic migraine and chronic migraine populations. The most common adverse events were constipation and nausea.
The atogepant MAA will be reviewed by the Committee for Medicinal Products for Human Use, which will issue an opinion that will be valid for all member states of the European Union, as well as Iceland , Lichtenstein, Northern Ireland and Norway .
Atogepant is an orally administered, CGRP receptor antagonist (gepant) specifically developed for the prophylaxis treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.
The pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the prevention of migraine in those with 4 to 14 migraine days per month. A total of 910 patients were randomized to one of four treatment groups evaluating 10 mg, 30 mg, or 60 mg of atogepant once daily, or placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) population of 873 patients.
The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All atogepant dose groups met the primary endpoint and demonstrated statistically significantly greater decreases in mean monthly migraine days compared to placebo. Patients treated in the 10 mg/30 mg/60 mg atogepant arms experienced a decrease of 3.69/3.86/4.2 days, respectively, all compared to patients in the placebo arm, who experienced a decrease of 2.48 days (all dose groups vs. placebo, p=<.0001>
A key secondary endpoint measured the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. The trial demonstrated that 55.6%/58.7%/60.8% of patients in the 10 mg/30 mg/60 mg atogepant arms, respectively, achieved at least a 50% reduction, compared to 29.0% of patients in the placebo arm (all dose groups vs. placebo, p=<.0001>
Additional secondary endpoints measured across the 12-week treatment period included change from baseline in mean monthly headache days, mean monthly acute-medication use days, and mean monthly performance of daily activities and physical impairment domain scores of the Activity Impairment in Migraine-Diary (AIM-D), and change from baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role Function-Restrictive domain score at week 12. The trial demonstrated that treatment with 30 mg and 60 mg doses resulted in statistically significant improvements in all secondary endpoints, while treatment with the 10 mg dose resulted in statistically significant improvements in four out of the six secondary endpoints.
No new safety risks were observed compared to the safety profile observed in the previous trial evaluating atogepant. Serious adverse events occurred in 0.9% of patients treated in the atogepant 10 mg arm and 0.9% of patients in the placebo arm. No patients in the atogepant 30 mg or 60 mg treatment arms experienced a serious adverse event. The most common adverse events reported with a frequency ≥ 5% in at least one atogepant treatment arm, and greater than placebo, were constipation (7.7%, 7.0% and 6.9% in the 10 mg/30 mg/60 mg atogepant arms, respectively vs. 0.5% for placebo), nausea (5.0%, 4.4% and 6.1% in the 10 mg/30 mg/60 mg atogepant arms, respectively vs. 1.8% for placebo), and upper respiratory tract infection (4.1%, 5.7% and 3.9% in the 10 mg/30 mg/60 mg atogepant arms, respectively vs. 4.5% for placebo). The majority of cases of constipation, nausea and upper respiratory tract infection were mild or moderate in severity and did not lead to discontinuation. There were no hepatic safety issues identified in this trial.
The Phase 3 PROGRESS clinical trial evaluated the safety, tolerability and efficacy of oral atogepant for the prophylaxis treatment of chronic migraine. The patient population for the study included patients with a diagnosis of chronic migraine for at least one year, and ≥ to 15 headache days with eight migraine days in the 28 days prior to randomization. The primary endpoint measured the reduction from baseline in mean monthly migraine days compared to placebo, for both doses, including 60 mg once daily (QD) and 30 mg twice daily (BID), across a 12-week treatment period. The overall safety profile of the Phase 3 PROGRESS study was consistent with safety findings observed in previous studies in an episodic migraine population.
Key secondary endpoints for all regions included: Change from baseline in mean monthly headache days across the 12-week of treatment period (baseline is defined as the number of migraine days during the last 28 days prior to the randomization date); Change from baseline in mean monthly acute medication use days across the 12-week treatment period (baseline is defined as the number of migraine days during the last 28 days prior to the randomization date); Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12-week treatment period; and change from baseline in MSQ v2.1 Role Function-Restrictive domain score at Week 12. The MSQ v2.1 is a questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past four weeks. It is divided into three domains, assessing how a patient's daily, social, and work activities are limited by migraine; how migraine prevents these activities; and assesses the emotional function related with migraine.
For a full listing of secondary endpoints across all regions, please go to www.clinicaltrials.gov (NCT03855137).
At AbbVie, our commitment to preserving personhood for those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory drives us to discover and deliver solutions for patients, care partners and clinicians. AbbVie's Neuroscience portfolio consists of approved therapies and a robust pipeline in neurological and psychiatric disorders, including Alzheimer's disease, bipolar disorder and depression, cervical dystonia, major depressive disorder, migraine, Parkinson's disease, spinal cord injuries, post-stroke spasticity, schizophrenia, stroke and others.
We have a strong investment in neuroscience research to help us better understand the pathophysiology of neurological and psychiatric disorders and identify targets for potential disease-modifying therapeutics aimed at making a difference in people's lives. For more information, visit www.abbvie.com .
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com .
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Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03777059 . Accessed on July 6, 2022.
2 Efficacy, Safety, and Tolerability, of Atogepant for the Prevention of Chronic Migraine. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03855137?term=NCT03855137&draw=2&rank=1 . Accessed on July 6, 2022.
3 The Facts About Migraine. American Migraine Foundation. Available at: https://americanmigrainefoundation.org/resource-library/migraine-facts/ . Accessed on July 6, 2022.
4 Woldeamanuel YW, Cowan RP. Migraine affects 1 in 10 people worldwide featuring recent rise: a systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017;372:307–315. doi: 10.1016/j.jns.2016.11.071.
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CSE leads domestic exchanges with 16 IPOs during first half 2022
The Canadian Securities Exchange ("CSE" or "the Exchange") today announced its market statistics for the month of June 2022.
June 2022 Operating Statistics
"The Canadian Securities Exchange maintained its leading position in Canadian initial public offerings in the first half of 2022," said Richard Carleton, CSE Chief Executive Officer. "We had 16 companies go public via IPO on our exchange. That accounted for more than half of all IPOs completed on Canadian exchanges during this period, according to CPE Analytics. We are delighted that entrepreneurs from around the world continue to recognize the significant benefits of a CSE listing."
What's On at the CSE
Tech Tuesdays recently wrapped up the first half of its second season. The 19 episodes featured interviews with executives from cutting-edge technology companies involved in diverse industries such as telehealth, data security, medical devices, mining, AgTech and much more. The episodes can be viewed on CSE TV, the Exchange's YouTube channel. Tech Tuesdays will return in the fall for the second half of Season 2, so the summer is a great time to catch up on any episodes of interest!
The CSE is pleased to be sponsoring and participating in the 27th annual Canadian Security Traders Association (CSTA) Conference, taking place in Niagara-on-the-Lake, Ontario on August 18-21. Conference panelists will tackle issues including diversity in investing, trading digital assets, regulation, and fintech innovations. Further information, including registration details and a preliminary conference agenda, is available here.
New Listings in June 2022
Yellow Stem Tech Inc. (YY)
G2 Energy Corp. (GTOO)
The Gummy Project Inc. (GUMY)
Avila Energy Corporation (VIK) – Fundamental Change
Arctic Fox Minerals Corp. (FOXY)
Tana Resources Corp. (TANA)
Li-FT Power Ltd. (LIFT)
Terra Balcanica Resources Corp. (TERA)
Great Republic Mining Corp. (GRM)
X1 Esports and Entertainment Ltd. (XONE)
Carmanah Minerals Corp. (CARM)
Copper Ridge Exploration Inc. (COP)
Clear Sky Lithium Corp. (POWR)
Origin Therapeutics Holdings Inc. (ORIG)
Miza II Resources Inc. (MIA)
About the Canadian Securities Exchange:
The Canadian Securities Exchange is a rapidly growing stock exchange focused on working with entrepreneurs to access the public capital markets in Canada and internationally. The Exchange's efficient operating model, advanced technology and low fee structure help companies of all sizes minimize their cost of capital and maximize access to liquidity.
The CSE offers investors in Canada and abroad access to a multi-sector collection of growth companies through a liquid, reliable and highly regulated trading platform. The Exchange is dedicated to entrepreneurship and has established itself as a leading hub for discourse in the entrepreneurial community.
STAY CONNECTED WITH THE CSE
CSE TV on YouTube: https://www.youtube.com/csetv
Richard Carleton, CEO
 Excluding Capital Pool Companies and Special Purpose Acquisition Companies.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/131021
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Click here to read the previous top Canadian biotech stocks article.
Although it’s not as large as the US biotech industry, the Canadian biotech market is still making a name for itself on the global investment stage in terms of size and opportunities.
In recent years, tech advancements in drug research and development have helped the biotech sector worldwide become a “real industry” that has brought “spectacular” returns for mid-cap companies, according to Jessica Chutter, managing director and chairman of biotechnology investment banking with Morgan Stanley (NYSE:MS).
Looking specifically at Canada, in 2021, the country's government committed to investing C$2.2 billion over seven years toward “growing a strong, competitive biomanufacturing and life sciences sector” through a strategy that includes “foster(ing) the growth of Canadian life sciences firms.”
Although 2021 was a rough year for biotech companies, many of the top Canadian biotech stocks managed to perform well, and some have continued that solid performance into 2022.
Below the Investing News Network profiles the three top Canadian biotech stocks on the TSXV. TSX- and CSE-listed stocks were considered, but didn’t make the cut. Yearly performance and share price data was compiled on July 12, 2022, using TradingView’s stock screener. All top Canadian biotech stocks listed had market caps between C$10 million and C$500 million at that time.
Market cap: C$16.722 million; year-to-date gain: 37.5 percent
Hemostemix is a clinical-stage autologous stem cell therapy company. Founded in 2003, the firm develops, manufactures and commercializes blood-derived cell therapies from each patient's own blood.
Hemostemix’s lead product, ACP-01, is designed for the treatment of critical limb ischemia, peripheral artery disease, angina, ischemic cardiomyopathy and dilated cardiomyopathy. Shares of the top Canadian biotech stock hit a 2022 high point on May 11, clocking in at the C$0.42 level.
Market cap: C$56.237 million; year-to-date gain: 17.95 percent
Sirona Biochem’s platform for developing safer, more effective cosmetic and pharmaceutical active ingredients is based on proprietary fluorination chemistry developed by the company’s wholly owned French subsidiary, called TFChem. Sirona’s pipeline of products includes therapeutics targeting diabetes, anti-inflammatories and anti-infectives; cosmeceuticals such as anti-aging and depigmenting agents (skin lighteners); and biological ingredients such as inducers and adjuvants for biological development and preservation.
In mid-June, the biotech company announced a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie (NYSE:ABBV) company. "We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing."
Company shares reached a year-to-date high of C$0.35 on June 20.
Market cap: C$43.505 million; year-to-date gain: 9.09 percent
Ceapro is a growth-stage biotech firm that is developing proprietary extraction technology to isolate active ingredients from oats and other plant resources for the healthcare and cosmetic industries. The company is leveraging its expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions.
In May, Ceapro released its Q1 financials, highlighting sales totaling C$6,172,000 for the quarter, up 31 percent from the same period the previous year. Shares marked a year-to-date high of C$0.67 on May 26.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: Sirona Biochem is a client of the Investing News Network. This article is not paid-for content.