The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE: ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period").
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LEAD PLAINTIFF DEADLINE:JUNE 6, 2022 CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021
CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS: James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com
Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.
AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.
As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.
However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.
Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.
After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.
The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.
AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.
CLICK HERE TO SIGN UP FOR THE CASE
WHO CAN BE A LEAD PLAINTIFF?
A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.
ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP
Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.
Kessler Topaz Meltzer & Check, LLP James Maro, Jr., Esq. 280 King of Prussia Road Radnor, PA 19087 (484) 270-1453 info@ktmc.com
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Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.
"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. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."
"Allergan Aesthetics' global presence in the aesthetic space and goal to further enhance aesthetic medicine combined with Sirona's disruptive technology made this all possible," reports Dr. Linda Pullan, of Pullan Consulting.
Under the license agreement, Sirona will a receive an upfront payment and further payments on achievement of milestones and royalties on product sales and has also agreed to financial terms as a supplier of its compounds.
About Sirona Biochem Corp. Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona's current pipeline includes further cosmetic related products for cell preservation and repair, keloid therapy, scar therapy, anti-aging, anti-wrinkle, and cellulite treatment. In the pharmaceutical space, Sirona Biochem is working on a therapeutic for diabetic animals and new anti-viral therapies for humans. An extensive list of viable options for future programs applicable to the platform technology is maintained by Sirona's chemistry team in France to ensure continued growth of the company.
Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona's scientific development unit, TFChem in France, is recipient of multiple scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com .
For more information regarding this press release, please contact:
Investor Enquiries: Jonathan Williams Managing Director Momentum PR Phone: 1.450.332.6939 Email: jwilliams@momentumpr.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: uncertainty and risks relating to the progress and timing of development and commercialization of products licensed to Allergan Aesthetics, the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its or licensed products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its or licensed products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
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CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for ZINBRYTA™ (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. ZINBRYTA is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. ZINBRYTA is also currently under regulatory review in the United States, Switzerland, Canada and Australia. “For people with relapsing forms of MS (RMS) and active disease, ZINBRYTA has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “ZINBRYTA may offer another option for people with multiple sclerosis (MS) with its targeted mechanism of action (MOA) which did not cause broad and prolonged immune cell depletion.” The CHMP positive opinion is now referred to the European Commission (EC), which grants marketing authorizations for centrally authorized medicines in the European Union. A decision from the EC is expected within the coming months. “Together with Biogen, AbbVie is committed to meeting the needs of patients with MS, and the positive opinion issued by the CHMP is a critical step that moves us closer to bringing ZINBRYTA to patients in Europe,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. According to the CHMP opinion, the benefits of ZINBRYTA are its ability to reduce the annualized relapse rate (ARR), as well as the risk of 24-week confirmed disability progression. The opinion is based on results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA 150 mg, administered subcutaneously every four weeks improved results on key measures of MS disease activity in patients with RMS compared to AVONEX 30 mcg intramuscular injection administered weekly and placebo, respectively. In the DECIDE study, the overall incidence of adverse events was similar in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA compared to AVONEX, there was an increased incidence of serious infections (4% versus 2%), serious cutaneous reactions (2% versus <1%), elevations of liver transaminases greater than five times the upper limit of normal (6% versus 3%), gastrointestinal disorders (31% versus 24%), and depression (8% versus 6%). About ZINBRYTA™ (daclizumab) ZINBRYTA (daclizumab) is an investigational compound being developed for the treatment of relapsing forms of MS. ZINBRYTA is a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become activated in people with MS. ZINBRYTA modulates IL-2 signaling without general immune cell depletion. Biogen and AbbVie are jointly developing ZINBRYTA. About Biogen Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter. Biogen Safe Harbor This press release contains forward-looking statements, including statements about the anticipated timing of the EC’s decision on the marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA, if approved. These statements may be identified by words such as “believe,” “expect,” “may,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. You should not place undue reliance on these statements. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that the EC may fail to approve or may delay approval of ZINBRYTA or may not follow the recommendation of the CHMP, uncertainty of success in commercialization of ZINBRYTA For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities and risks relating to our collaborations with third parties, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page. Forward-Looking Statements Some statements in this news release may be 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, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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,” in AbbVie’s 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. 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.
The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel. According to Fierce Biotech:
Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung. Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars. The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion. Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.
Click here to read the full article on Fierce Biotech.
Boosh Plant-Based Brands Inc.(CSE: VEGI) (OTCQB: VGGIF) (FSE: 77i) ("Boosh" or the "Company") a premier plant-based brand in the "better for you" food sector, provides the following corporate update.
The Company reports that: (i) there are no changes to the information contained in the bi-weekly status updated dated August 2, 2022, that would reasonably be expected to be material to an investor; (ii) the Company is satisfying and confirms that it intends to continue to satisfy the provisions of the alternative information guidelines under NP 12-203 and issue bi-weekly default status reports for so long as the delay in filing the Documents is continuing, each of which will be issued in the form of a press release; (iii) there has not been any other specified default by the Company under NP 12-203, and, except as set forth below, no such other default is anticipated; (iv) the Company is not subject to any insolvency proceedings; and (v) there is no material information concerning the affairs of the Company that has not been generally disclosed.
The Company continues to work with its auditors to complete the audit of the Company's consolidated financial statements and expects to file the Documents by August 31, 2022. The delays primarily result from the close proximity of the Company's acquisition of substantially all of the assets of Beanfields, Inc. on February 16, 2022 and the Company's financial year end of March 31 and the work required to consolidate those operations.
Connie Marples Founder/President connie@booshfood.com
About Boosh Plant-Based Brands Inc.:
Boosh Plant-Based Brands Inc., through its wholly owned subsidiary, Boosh Food (www.booshfood.com), offers high quality, non-GMO, gluten free, 100% plant-based nutritional comfort foods for the whole family. Through a separate subsidiary, Beautiful Beanfields, the Company owns Beanfields, a plant-based chips brand sold in over 7,000 stores throughout North America. Boosh, good for you and good for planet earth.
The information in this news release includes certain information and statements about management's view of future events, expectations, plans and prospects that constitute forward-looking statements. These statements are based upon assumptions that are subject to significant risks and uncertainties. Because of these risks and uncertainties and as a result of a variety of factors, the actual results, expectations, achievements or performance may differ materially from those anticipated and indicated by these forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the Company's expectations concerning the size of the Financing, its ability to close the Financing in whole or in part or at all and its plan for the proceeds of the Financing. Any number of factors could cause actual results to differ materially from these forward-looking statements as well as future results. Although the Company believes that the expectations reflected in forward-looking statements are reasonable, it can give no assurances that the expectations of any forward-looking statements will prove to be correct. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Click here to connect with Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77i) to receive an Investor Presentationto receive an Investor Presentation
Gilead Will Provide $4.5 Million in Funding to Help Improve Health Outcomes for Black Americans in the Southern United States –
– Investment Reflects Gilead's Broad and Ongoing Commitment to Advancing Health Equity –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced a new health equity collaboration with the Satcher Health Leadership Institute (SHLI) at Morehouse School of Medicine and the Center for Minority Health and Health Disparities Research and Education (CMHDRE) at Xavier University of Louisiana's College of Pharmacy. The collaboration is focused on addressing the inequities in HIV care for Black communities in the Southern United States. Gilead has a broad and long-standing commitment to advancing global health equity, which it regards as critical to helping to end the HIV epidemic and improving health outcomes for all. The company's health equity strategy focuses on collaborating with organizations that reach underrepresented and disproportionately impacted communities.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220816005886/en/
Research shows that inequities drive higher rates of HIV infection, as well as worse HIV clinical outcomes among Black Americans. The COVID-19 pandemic has further highlighted and exacerbated such health inequities, especially in the Southern United States. SHLI and CMHDRE are at the forefront of efforts to improve access to HIV care for Black communities in the Southern U.S. region. Gilead will award a total of $4.5 million in funding over a three-year period to support their work in three cities: Atlanta, Baton Rouge, La., and New Orleans.
The partnership between SHLI and CMHDRE, with support from Gilead, is intended to close critical gaps in care by:
"Gilead knows that scientific innovation has the most impact on patients when we help remove societal barriers to care, such as discrimination and stigma. We are committed to investing in organizations, community leaders and experts working to address the underlying determinants of health outcomes," said Rashad Burgess, Vice President of Advancing Health and Black Equity, Gilead Sciences. "This collaboration will focus on the barriers that are most prevalent in Black communities and help increase access to HIV care to produce better outcomes for Black people."
"Though the COVID-19 pandemic was a setback to the American healthcare system overall, we must bring to the forefront disproportionately impacted communities who were already historically marginalized prior to the pandemic, including people living with HIV," said Daniel E. Dawes, J.D., Executive Director, Satcher Health Leadership Institute at Morehouse School of Medicine, and author of The Political Determinants of Health. "The Satcher Health Leadership Institute will collaborate with Gilead and Xavier University of Louisiana to ensure these communities are not an afterthought."
"Xavier's Center for Minority Health and Health Disparities Research and Education in the College of Pharmacy is proud to partner with Gilead and the Satcher Health Leadership Institute at Morehouse School of Medicine for such an important initiative," said Dr. Kathleen Kennedy, Dean of Xavier University of Louisiana's College of Pharmacy. "Xavier is a top producer of African Americans with a Doctor of Pharmacy degree, and we instill in our graduates the mission of Xavier and the desire to serve the underserved with an effort to mitigate health disparities for underrepresented communities."
This latest collaboration is part of Gilead's broader health equity strategy to support community organizations across the globe in addressing social determinants of health. A recent report commissioned by Gilead, " HIV In The Time of COVID-19: Leaving No-One Behind to Truly End the HIV Epidemic ," details a broad range of barriers to health equity including social and economic factors. While predictors of health outcomes such as race, ethnicity and gender have long existed, the COVID-19 pandemic has exacerbated health inequities, especially for marginalized communities and those affected by HIV. Gilead is increasing investment to address these underlying inequities highlighted by the intersection of the two health crises.
Other Gilead programs that address health equity include the COMPASS Initiative ® , a ten-year, $100 million commitment toward addressing HIV/AIDS inequities in the U.S. South, which continues to challenge the structural barriers that are most prevalent in Black communities. Gilead's Zeroing In™ program supports communities in 41 countries that have been hit doubly hard by HIV and the COVID-19 pandemic. Gilead also created a $10 million Racial Equity Community Impact Fund to support organizations fighting the racial inequities that affect Black communities. In its most recent report, the Funders Concerned About AIDS named Gilead the number one overall philanthropic funder of HIV/AIDS programs.
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, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Gilead has promoted equity, particularly healthcare equity, since the company brought its first therapies to the market. Through global partnerships, Gilead's medicines today reach millions of people in low- and middle-income countries around the world. In the United States, Gilead has committed more than $100 million over 10 years through the COMPASS Initiative ® to community organizations that are working to combat HIV in the U.S. South. In 2020, Gilead launched the Racial Equity Community Impact Fund to support organizations tackling racial inequities affecting Black communities across the United States.
About Satcher Health Leadership Institute at Morehouse School of Medicine
The Satcher Health Leadership Institute (SHLI) at Morehouse School of Medicine aims to be the leading transformational force for health equity in policy, leadership development and research. Rooted in the legacy of its founder, the 16th U.S. Surgeon General, Dr. David Satcher, SHLI's mission is to create systemic change at the intersection of policy and equity by focusing on three priority areas: the political determinants of health, health system transformation, and mental and behavioral health. In conjunction with key strategic partners, SHLI enhances leadership among diverse learners, conducts forward-thinking research on the drivers of health inequities and advances evidence-based policies, all in an effort to contribute to the achievement of health equity for all population groups. Learn more at https://satcherinstitute.org ; https://healthequitynetwork.org .
About Xavier University of Louisiana and the Center for Minority Health and Health Disparities Research and Education
Established in 1925, Xavier University of Louisiana is the nation's only historically Black and Catholic University. Located in New Orleans, La., its liberal arts-based programs in diverse fields offer students an unbeatable combination of traditional classroom study, hands-on research, service-learning opportunities and life experiences. Xavier is recognized by the United Negro College Fund (UNCF) as the most successful HBCU in terms of graduates' upward mobility (2022) and is a nationally recognized leader in STEM and the health sciences. Xavier is known for producing more African American students who graduate from medical schools each year than any other university in the country, and its College of Pharmacy is among the top producers of African American pharmacists. Visit www.xula.edu to learn more.
The Center for Minority Health and Health Disparities Research and Education (CMHDRE) within Xavier's College of Pharmacy was founded in 2004 to improve the health outcomes of racial and ethnic minorities. The CMHDRE's mission is to provide the infrastructure required to conduct research and provide community education and clinical services to eliminate health disparities using community engagement and collaborative partnerships. It conducts basic and translational research, provides culturally relevant education and clinical services in the community, and educates current and future health care providers as a forefront leader in the initiative to improve health outcomes for minority populations in the region.
Gilead and the Gilead logo are 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220816005886/en/
Jareese K. Stroud, SHLI (404) 752-1907
Regi Reyes, Xavier University of Louisiana (504) 520-5240
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Allē Double Point Promotion Encourages Consumers to See the JUVÉDERM ® Difference
Allergan Aesthetics, an ABBVie company (NYSE: ABBV), invites consumers to experience the JUVÉDERM ® difference. The JUVÉDERM ® Collection of Fillers is the number one selling collection of dermal fillers on the market and offers the largest portfolio of fillers specifically designed for different areas of the face to address key patient concerns, enabling a customized treatment approach. 1 Injectable dermal fillers are highly sought-after treatments among consumers who are looking to address key signs of aging or to simply accentuate what is already naturally theirs.
Right now, consumers can earn double points in Allē, Allergan Aesthetics' loyalty rewards program, when treated with two or three syringes from the JUVÉDERM ® Collection of Fillers during the same visit. Allē points can be redeemed for future Allē-eligible treatments or products. The promotion runs through Friday, September 30, 2022 . Allē members can also use the Allē Flash program to determine if they are eligible for additional savings.
"We estimate that in the U.S., 20 million consumers are interested in receiving treatment with a dermal filler in the next two years. 2 We help support and grow the filler market while ensuring that all consumers who are interested in talking to their specialist about treatment with the JUVÉDERM ® Collection of Fillers have access to education and the product. Recently, we launched a YouTube channel to provide deeper patient education and it has more than five million views since launch," said Carrie Strom , Global President Allergan Aesthetics. "The JUVÉDERM ® Collection of Fillers is the number one chosen dermal filler collection in the U.S. and approved for all skin tones. 1, 3-5 We are excited to share our passion for the JUVÉDERM ® Collection of Fillers with consumers through this limited time offer. We invite them to talk to their specialist and experience the JUVÉDERM ® difference for themselves."
The JUVÉDERM ® difference is achieved with a wide range of minimally invasive treatment options that provides instant results that are long-lasting and natural-looking. 6-12 Additionally, the JUVÉDERM ® Collection of Fillers' VYCROSS ® technology is the number one chosen dermal filler technology worldwide. 1 As the number one chosen dermal filler collection worldwide, JUVÉDERM ® boasts the top chosen fillers for cheeks (JUVÉDERM ® VOLUMA ® XC), lower face wrinkles and folds (JUVÉDERM ® Ultra Plus XC and JUVÉDERM ® VOLLURE ® XC), lips (JUVÉDERM ® Ultra XC and JUVÉDERM ® VOLBELLA ® XC), and perioral lines (JUVÉDERM ® VOLBELLA ® XC). 1
"I use the full JUVÉDERM ® Collection of Fillers to achieve optimal aesthetic outcomes for my patients," said Dr. Deborah Sherman , board certified, fellowship trained ophthalmic plastic surgeon and master injector. "As one of the longest standing filler manufacturers in the industry, it's a brand I trust due to the years of clinical studies and safety data available to help me feel confident in the product I'm offering to my patients. Even the JUVÉDERM ® syringe itself is innovative – it's the first and only certified ergonomic syringe that helps minimize hand fatigue so I can comfortably treat patients all day long. JUVÉDERM ® enables me to offer my patients a suite of premium products that deliver smooth, natural-looking, and long-lasting results 6-12 so my patients keep coming back time and again."
About the JUVÉDERM ® Double Points Promotion Consumers can experience the JUVÉDERM ® difference while earning double points in Allē towards a future JUVÉDERM ® or other Allē eligible treatment when treated with two or three syringes from the JUVÉDERM ® Collection of Fillers during the same visit through Friday, September 30, 2022 . Consumers who take the challenge and experience the JUVÉDERM ® difference will be treated with products that are:
Consumers are encouraged to enroll in Allē to unlock access to the current promotion, subject to applicable program terms and conditions. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 40 non-Allergan Aesthetics treatments and brands. To learn more about Allē, visit Alle.com.
For more information on the JUVÉDERM ® Collection of Fillers, visit Juvéderm.com, follow @JUVÉDERM on Instagram and subscribe to the JUVÉDERM ® Collection of Fillers channel on YouTube.
About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com .
About AbbVie 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 . Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
JUVÉDERM ® Injectable Gel Fillers Important Information
JUVÉDERM ® VOLUMA ® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM ® VOLUX™ XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.
JUVÉDERM ® VOLLURE ® XC, JUVÉDERM ® Ultra Plus XC, and JUVÉDERM ® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM ® VOLLURE ® XC injectable gel is for adults over 21.
JUVÉDERM ® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM ® VOLBELLA ® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
Are there any reasons why I should not receive any JUVÉDERM ® formulation? Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
What warnings should my doctor advise me about?
What precautions should my doctor advise me about?
What are possible side effects of treatment? The most commonly reported side effects with JUVÉDERM ® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM ® VOLBELLA ® XC, dryness was also reported.
These side effects are consistent with other facial injection procedures, and most will resolve with time. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM ® Collection, please call the Allergan ® Product Support Department at 1‑877‑345‑5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM ® Collection are available only by a licensed physician or properly licensed practitioner.
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Bristol Myers Squibb (NYSE:BMY) announced today that it has successfully completed its acquisition of Turning Point Therapeutics, Inc. ("Turning Point"), in an all-cash transaction. With the completion of the acquisition, Turning Point shares have ceased trading on the NASDAQ Global Select Market and Turning Point is now a wholly owned subsidiary of Bristol Myers Squibb.
"Turning Point has distinguished itself in the field of precision oncology, and this acquisition will further strengthen our leading oncology franchise," said Elizabeth Mily, Executive Vice President, Strategy & Business Development, Bristol Myers Squibb. "With Turning Point's lead asset, repotrectinib, Bristol Myers Squibb will be positioned to address a significant unmet medical need for ROS1-positive non-small cell lung cancer patients. We look forward to bringing this promising, innovative medicine to patients in the second half of 2023."
Through the transaction, Bristol Myers Squibb gains a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis, including repotrectinib. Repotrectinib is a next-generation, potential best-in-class tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumors. In the Phase 1/2 TRIDENT-1 clinical trial, longer duration of response has been observed in the landmark analysis with repotrectinib than with existing ROS1 agents in first-line NSCLC. The asset has been granted three Breakthrough Therapy Designations from the U.S. Food and Drug Administration.
Bristol Myers Squibb expects repotrectinib to be approved in the U.S. in the second half of 2023 and become a new standard of care for patients with ROS1-positive NSCLC in the first-line setting. Bristol Myers Squibb also plans to continue to explore the potential of Turning Point's promising pipeline of novel compounds.
Bristol Myers Squibb's previously announced tender offer for all outstanding shares of common stock of Turning Point for $76.00 per share expired at 5:00 p.m. Eastern Time on August 15, 2022. Approximately 41,896,678 shares of Turning Point common stock were validly tendered, and not validly withdrawn from the tender offer, representing approximately 84% of Turning Point's issued and outstanding shares of common stock. In accordance with the terms of the tender offer, all shares that were validly tendered and not validly withdrawn have been accepted for payment and Bristol Myers Squibb expects to promptly pay for all such shares.
Following completion of the tender offer, Bristol Myers Squibb completed the acquisition of Turning Point through the merger of its wholly owned subsidiary, Rhumba Merger Sub Inc., with and into Turning Point, without a vote of Turning Point's stockholders pursuant to Section 251(h) of the General Corporation Law of the State of Delaware. As a result of the merger, each share of common stock of Turning Point issued and outstanding and not tendered in the tender offer was automatically converted into the right to receive an amount in cash equal to $76.00, without interest, subject to any applicable withholding of taxes, the same price offered in the tender offer.
Turning Point shareholders can direct questions regarding the tender offer to MacKenzie Partners, Inc., the information agent for the tender offer, toll free, at 1-800-322-2885.
Gordon Dyal & Co., LLC, is serving as the exclusive financial advisor to Bristol Myers Squibb, and Kirkland & Ellis, LLP, is serving as legal counsel. Goldman Sachs & Co., LLC, is serving as the exclusive financial advisor to Turning Point Therapeutics, and Cooley, LLP, is serving as legal counsel.
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 .
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 risk that the expected benefits or synergies of the acquisition will not be realized, (ii) the risk that legal proceedings may be instituted related to the merger agreement, and (iii) unanticipated difficulties or expenditures relating to the transaction, the response of business partners and competitors to the consummation of the transaction and/or potential difficulties in employee retention as a result of the consummation of the 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 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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Media: media@bms.com Investors: investor.relations@bms.com
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Bristol Myers Squibb (NYSE:BMY) and Turning Point Therapeutics, Inc. (NASDAQ:TPTX) ("Turning Point") today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR Act"), and the receipt of merger control clearance from the Federal Cartel Office of Germany ("FCO"), in connection with the previously announced offer (the "Offer") to acquire all outstanding shares of common stock of Turning Point at a price of $76.00 per share in an all-cash transaction for total consideration of approximately $4.1 billion. The expiration of the HSR Act waiting period occurred at 11:59 p.m. Eastern Time on August 15, 2022, and the FCO clearance was received on August 15, 2022. The Offer expired at 5:00 p.m. Eastern Time on August 15, 2022 (the "Expiration Time"), and the Offer was not extended.
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Equiniti Trust Company, the depositary for the Offer, has advised that, as of the Expiration Time, approximately 41,896,678 shares of common stock were validly tendered, and not validly withdrawn pursuant to Offer, representing approximately 84% of the issued and outstanding shares of common stock.
The parties expect the transaction to close on August 17, 2022, promptly following the acceptance of all shares of common stock validly tendered and not validly withdrawn pursuant to the Offer.
Turning Point shareholders can direct questions regarding the Offer to MacKenzie Partners, Inc., the information agent for the Offer, toll free, at 1-800-322-2885.
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 .
About Turning Point Therapeutics Inc.
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational drugs designed to address key limitations of existing cancer therapies. The company's lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company's pipeline of precision oncology drug candidates is being studied across a variety of solid tumors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com .
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 Rhumba Merger Sub Inc. ("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 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 closing of the merger, (ii) the risk that the expected benefits or synergies of the acquisition will not be realized, (iii) the risk that legal proceedings may be instituted related to the merger agreement, and (iv) unanticipated difficulties or expenditures relating to the proposed transaction, the response of business partners and competitors to the consummation of the transaction and/or potential difficulties in employee retention as a result of the consummation 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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Bristol Myers Squibb Media: media@bms.com Investor Relations: investor.relations@bms.com
Turning Point Therapeutics Media and Investor Relations: ir@tptherapeutics.com
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Gilead will Assume Responsibility for Clinical Development and Commercialization in Greater China and South Korea, among Other Asian Markets –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement with Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy ® (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia.
In China mainland and Singapore, Trodelvy is approved for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Gilead continues to work closely with regulatory bodies in Hong Kong, South Korea and Taiwan, where New Drug Applications, filed by Everest Medicines for metastatic TNBC, are currently under review.
"Trodelvy is approved for second-line metastatic TNBC in over 35 countries. We thank Everest Medicines for their partnership and important contributions in the development of Trodelvy in Asia. Their collaboration has brought us closer to bringing Trodelvy to patients who need alternative options," said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Research, Gilead Sciences. "Trodelvy is the cornerstone of our solid tumor portfolio, and we are committed to bringing this transformative therapy to as many patients as possible. We look forward to rapidly advancing our development program in Asia and to realizing the clinical potential of Trodelvy across diverse tumor types."
In April 2019, Everest Medicines and Immunomedics entered into an agreement granting Everest Medicines an exclusive license to develop and commercialize Trodelvy in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia, excluding Japan. Gilead subsequently acquired Immunomedics in October 2020 and created an extensive global clinical development program, including investigating Trodelvy as a monotherapy and in novel combinations, across multiple disease areas including non-small cell lung cancer, metastatic urothelial cancer and gastrointestinal cancers.
"We welcome the opportunity to restructure our partnership with Gilead, which has been built on a shared vision of providing innovative oncology solutions for patients in need. With capital resources and a track record of successful therapeutic development and commercialization for Trodelvy in the U.S., Gilead is an ideal partner to further develop and commercialize Trodelvy in Asia Pacific regions to maximize patient access," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "I am exceedingly proud of what Everest has accomplished in advancing Trodelvy in China and other Asia territories, and we will continue to bring more transformational therapies to patients in China and worldwide with our extensive pipeline of clinical and pre-clinical stage assets."
Under the terms of the agreement, Gilead will make a $280 million upfront payment to Everest. In addition, Everest is eligible to receive up to $175 million in potential additional payments upon achievement of certain regulatory and commercial milestones. Gilead will also have the opportunity to recruit Everest employees working directly on the Trodelvy program. The transaction is expected to close later this year, and will be subject to customary closing conditions, including approval by Everest's shareholders.
Trodelvy U.S. Prescribing Information has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.
Trodelvy ® (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.
Trodelvy is approved in over 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Trodelvy is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.
U.S. Indications for Trodelvy
In the United States, Trodelvy is indicated for the treatment of:
U.S. Important Safety Information for Trodelvy
BOXED WARNING: NEUTROPENIA AND DIARRHEA
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may require dose modification. Neutropenia occurred in 61% of patients treated with Trodelvy. Grade 3-4 neutropenia occurred in 47% of patients. Febrile neutropenia occurred in 7%. Withhold Trodelvy for absolute neutrophil count below 1500/mm 3 on Day 1 of any cycle or neutrophil count below 1000/mm 3 on Day 8 of any cycle. Withhold Trodelvy for neutropenic fever.
Diarrhea: Diarrhea occurred in 65% of all patients treated with Trodelvy. Grade 3-4 diarrhea occurred in 12% of patients. One patient had intestinal perforation following diarrhea. Neutropenic colitis occurred in 0.5% of patients. Withhold Trodelvy for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with Trodelvy. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 37% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of Trodelvy was 0.3%. The incidence of anaphylactic reactions was 0.3%. Pre-infusion medication is recommended . Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Medication to treat such reactions, as well as emergency equipment, should be available for immediate use. Permanently discontinue Trodelvy for Grade 4 infusion-related reactions.
Nausea and Vomiting: Nausea occurred in 66% of all patients treated with Trodelvy and Grade 3 nausea occurred in 4% of these patients. Vomiting occurred in 39% of patients and Grade 3-4 vomiting occurred in 3% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold Trodelvy doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with Trodelvy. The incidence of Grade 3-4 neutropenia was 67% in patients homozygous for the UGT1A1*28, 46% in patients heterozygous for the UGT1A1*28 allele and 46% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 25% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 11% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue Trodelvy based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Trodelvy contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Trodelvy and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Trodelvy and for 3 months after the last dose.
In the ASCENT study (IMMU-132-05) , the most common adverse reactions (incidence ≥25%) were fatigue, neutropenia, diarrhea, nausea, alopecia, anemia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.
In the TROPHY study (IMMU-132-06) , the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, neutropenia, nausea, any infection, alopecia, anemia, decreased appetite, constipation, vomiting, abdominal pain, and rash. The most frequent serious adverse reactions (SAR) (≥5%) were infection (18%), neutropenia (12%, including febrile neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%), and sepsis or bacteremia (5%). SAR were reported in 44% of patients, and 10% discontinued due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPHY study were reduced neutrophils, leukocytes, and lymphocytes.
UGT1A1 Inhibitors: Concomitant administration of Trodelvy with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with Trodelvy.
UGT1A1 Inducers : Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with Trodelvy.
Please see full Prescribing Information , including BOXED WARNING.
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 the possibility that various closing conditions for the transaction may not be satisfied or waived; the risk that Gilead may not realize the potential benefits of this transaction; 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 Trodelvy; uncertainties relating to regulatory applications for Trodelvy and related filing and approval timelines, including for the treatment of metastatic TNBC, mUC, HR+/HER2- breast cancer, NSCLC, SCLC, head and neck cancer, and endometrial cancer, in the currently anticipated timelines or at all; Gilead's ability to receive regulatory approvals for such indications in a timely manner or at all, including regulatory approvals in Hong Kong, South Korea and Taiwan for metastatic TNBC, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of Trodelvy for such indications and as a result, Trodelvy may never be commercialized for these indications; the risk that physicians may not see the benefits of prescribing Trodelvy; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 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. Prescribing Information for Trodelvy including BOXED WARNING , is available at www.gilead.com .
Trodelvy, Gilead and the Gilead logo are 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 (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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Jacquie Ross, Investors investor_relations@gilead.com
Karley Ura, Media Karley.ura@gilead.com
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