Revance Provides Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines

Revance Provides Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines




Revance Provides Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines

NASHVILLE, Tenn.–(BUSINESS WIRE)–Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug Administration (FDA) has issued a Complete Response Letter, or CRL, regarding the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, for the treatment of moderate to severe glabellar (frown) lines.

In a communication received on October 15, the FDA has determined it is unable to approve the BLA in its present form, and indicated that there are deficiencies related to the FDA’s onsite inspection at Revance’s manufacturing facility. Revance plans to request a Type A meeting with the FDA as soon as possible to address the deficiencies raised. No other deficiencies were identified in the CRL.

“We are very disappointed by this unanticipated response from the FDA and are seeking further clarity from the agency. We remain committed to bringing our next-generation neuromodulator product to market in both aesthetic and therapeutic indications,” said Mark Foley, President and Chief Executive Officer.

About Revance

Revance is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in two therapeutic indications – cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the OPUL™ Relational Commerce Platform. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

BOTOX® is a registered trademark of Allergan, Inc.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to statements about our ability to obtain, and the timing relating to the Type A meeting with the FDA with respect to DaxibotulinumtoxinA for Injection; our ability to address the deficiencies raised and obtain approval of and commercialize DaxibotulinumtoxinA for Injection for aesthetic or therapeutic indications; development of a biosimilar to BOTOX®; and statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including our ability to obtain FDA approval of the BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of observations made by the FDA during the site inspection or other reasons; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, regulatory approvals, clinical trials and other aspects of our business and on the market; our ability and the ability of our partners to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, the safety, efficacy, commercial acceptance and the market, competition, size and growth potential of the RHA® Collection of dermal fillers, OPUL™, and our drug product candidates, if approved; our ability to continue to successfully commercialize the RHA® Collection of dermal fillers and OPUL™ and our ability to successfully commercialize DaxibotulinumtoxinA for Injection, if approved, and the timing and cost of commercialization activities; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with privacy and data protection laws; our ability to effectively manage our expanded operations in connection with the acquisition of Hint, Inc; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements, our financial performance and the economics of DaxibotulinumtoxinA for Injection; the cost and our ability to defend ourselves in product liability, intellectual property or other lawsuits; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled “Risks Factors” on our Form 10-K filed with the SEC on February 25, 2021 and including, without limitation, our Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 5, 2021. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

Contacts

Media
Revance:

Sara Fahy, 949-887-4476

sfahy@revance.com

Investors
Revance:

Jessica Serra, 626-589-1007

Jessica.serra@revance.com
or

Gilmartin Group, LLC.:

Laurence Watts, 619-916-7620

laurence@gilmartinir.com

TherapeuticsMD Announces Appointment of Mark Glickman as Chief Business Officer

TherapeuticsMD Announces Appointment of Mark Glickman as Chief Business Officer




TherapeuticsMD Announces Appointment of Mark Glickman as Chief Business Officer

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced the appointment of Mark Glickman as the Company’s Chief Business Officer.

Mr. Glickman previously served as Chief Commercial Officer of Esperion and Aralez Pharmaceuticals, and Executive Vice President, Sales and Marketing, of Auxilium Pharmaceuticals, among other global pharmaceutical roles. Mr. Glickman received his MBA in Finance and International Management from New York University and his BA from State University of New York College at Oswego.

Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

As a material inducement to Mr. Glickman’s acceptance of the appointment, TherapeuticsMD granted Mr. Glickman an award of 660,000 restricted stock units (“RSUs”) and 260,000 performance stock units (“PSUs”) corresponding to shares of common stock of the Company, outside of the Company’s 2019 Stock Incentive Plan (the “2019 Plan”). 400,000 of the RSUs will vest at the end of three years, and 260,000 of the RSUs will vest in equal annual installments over three years beginning October 15, 2022, in each case subject to Mr. Glickman’s continuous service with the Company. The PSUs will vest based on certain performance metrics related to revenue and the timing in which the Company achieves EBITDA break even, and are subject to Mr. Glickman’s continuous service with the Company. The actual number of PSUs that will vest will be between zero and two times the base number of PSUs depending on the milestones achieved. The inducement grant was approved on October 15, 2021 by a majority of the independent directors of the Company’s Board of Directors in reliance on the employment inducement exception to shareholder approval provided under NASDAQ Stock Market Listing Rule 5635(c)(4).

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward-Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest, or obtain an investment in, its vitaCare business and how the proceeds that may be generated by any such divestiture or investment will be utilized; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

Contacts

Marlan Walker

General Counsel

561-961-1900

Lisa M. Wilson

In-Site Communications, Inc.

212-452-2793

lwilson@insitecony.com

Trane Technologies Completes Acquisition of Farrar Scientific, a Leader in Ultra-Low Temperature Control

Trane Technologies Completes Acquisition of Farrar Scientific, a Leader in Ultra-Low Temperature Control




Trane Technologies Completes Acquisition of Farrar Scientific, a Leader in Ultra-Low Temperature Control

SWORDS, Ireland–(BUSINESS WIRE)–Trane Technologies (NYSE: TT), a global climate innovator, has completed the acquisition of Farrar Scientific, which the company announced in a press release on September 13, 2021.


Farrar Scientific is a critical supplier for bioscience and biopharmaceutical customers that provides proprietary technology to fill an unmet need for flexible, modular, and efficient ultra-low temperature processing and storage, including cooling and heating/thawing.

“We are delighted to officially welcome Farrar Scientific associates,” said Holly Paeper, who has been appointed as president of Trane Technologies’ new Life Science Solutions business, which operates as part of the company’s Commercial HVAC business unit. “Trane Technologies’ world-class business operating system and expertise in refrigeration, cold chain and sustainable climate controls combined with Farrar’s specialized expertise in ultra-low temperature control will enable us to deliver even greater value to customers around the world in the critical biopharmaceutical and life science industries.”

About Trane Technologies

Trane Technologies is a global climate innovator. Through our strategic brands Trane® and Thermo King®, and our portfolio of environmentally responsible products and services, we bring efficient and sustainable climate solutions to buildings, homes and transportation. Learn more at tranetechnologies.com.

This news release includes “forward-looking statements,” which are statements that are not historical facts, including statements about the expected benefits of the proposed transaction and the growth of the business. These forward-looking statements are based on our current expectations and are subject to risks and uncertainties, which may cause actual results to differ materially from our current expectations. Such factors include, but are not limited to, our ability to timely obtain necessary regulatory approvals of the proposed transaction and to timely complete the proposed transaction; our ability to fully realize the expected benefits of the proposed transaction; negative effects of announcement or consummation of the proposed transaction on the market price of the company’s ordinary shares; significant transaction costs and/or unknown liabilities; general economic and business conditions that may impact the companies in connection with the proposed transaction; the impact of the proposed transaction on the company’s employees, customers and suppliers; and the ability of the companies to successfully integrate operations after the transaction. Additional factors that could cause such differences can be found in our Form 10-K for the year ended December 31, 2020, as well as our subsequent reports on Form 10-Q and other SEC filings. We assume no obligation to update these forward-looking statements.

Contacts

Media Contact:
Jennifer Regina

+1-630-390-8011

jennifer.regina@tranetechnologies.com

Investors Contact:
Zachary Nagle

+1-704-990-3913

zachary.nagle@tranetechnologies.com

Geron to Host a Virtual Investor Event in November

Geron to Host a Virtual Investor Event in November




Geron to Host a Virtual Investor Event in November

FOSTER CITY, Calif.–(BUSINESS WIRE)–Geron Corporation (Nasdaq: GERN) will host a virtual investor event on November 9 at 4:00 p.m. ET. Topics to be covered at the event, include:

  • The unmet medical needs in lower risk myelodysplastic syndromes and refractory myelofibrosis and the disease modification potential of imetelstat, Geron’s first-in-class telomerase inhibitor.
  • Expansion opportunities for imetelstat into new indications and in combination with other drugs.
  • A live physician panel discussion and question-and-answer session with:

    • Dr. Swaminathan Iyer, Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
    • Dr. John Mascarenhas, Associate Professor of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
    • Prof. Uwe Platzbecker, Director, Clinic and Policlinic for Hematology, Cell Therapy and Hemostaseology, University Hospital, Leipzig, Germany

A live webcast of the presentation will be available through the Investor Relations section of Geron’s website under Events. Following the presentation, the webcast will be archived and available for replay for a period of 30 days.

About Geron

Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in myeloid hematologic malignancies. The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis. For more information about Geron, visit www.geron.com.

Contacts

Olivia Bloom

Chief Financial Officer

investor@geron.com
media@geron.com

Dicerna Announces Data to Be Presented at American Society of Nephrology (ASN) Kidney Week 2021

Dicerna Announces Data to Be Presented at American Society of Nephrology (ASN) Kidney Week 2021




Dicerna Announces Data to Be Presented at American Society of Nephrology (ASN) Kidney Week 2021

– Data From PHYOX™2 Pivotal Trial of Nedosiran for Treatment of Primary Hyperoxaluria (PH) Accepted as Late-Breaker Poster Presentation –

– Company on Track to Submit Nedosiran New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Treatment of PH Type 1 (PH1) in Fourth Quarter of 2021 –

– Dicerna Continues to Evaluate PH2 Outcomes in Consultation With Scientific Advisors, Clinicians and the Patient Community –

LEXINGTON, Mass.–(BUSINESS WIRE)–Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced an abstract on clinical data from the Company’s PHYOX™2 trial of nedosiran, an investigational GalXC™ RNAi candidate for the treatment of primary hyperoxaluria (PH), has been accepted as a late-breaker poster presentation at the American Society of Nephrology (ASN) Kidney Week 2021 taking place Nov. 4-7, 2021.

“PHYOX2 generated robust data in patients with PH1, meeting the primary and key secondary efficacy endpoints, while also showing that nedosiran was safe and generally well tolerated in the trial,” said Douglas Fambrough, Ph.D., President and Chief Executive Officer at Dicerna. “We are excited to share these results and believe that the selection of nedosiran data for a late-breaker presentation at ASN Kidney Week underscores the importance of providing the medical community with new information about potential therapy options for the treatment of patients with PH1. We continue to believe that these data support potential approval of nedosiran for the treatment of PH1 in the U.S., Europe, Japan and other markets, and we remain on track to submit an NDA to the FDA in the fourth quarter.”

Dr. Fambrough continued, “We continue to work in consultation with scientific advisors, clinicians and the patient community to evaluate the outcomes observed in patients with PH type 2 (PH2). Given the significant unmet medical need, we believe further assessment of nedosiran’s potential in treating PH2 is warranted. We are actively engaged in out-licensing discussions to commercialize nedosiran for patients with PH1 and have expanded these interactions to include the potential for continued research and clinical development in PH2.”

The schedule for Dicerna’s presentations is as follows:

Session: Late-Breaking Clinical Trial Posters

Poster Title: PHYOX™2: Nedosiran Reduced Urinary Oxalate Excretion in Patients With Primary Hyperoxaluria

Poster #: PO2538

A poster summarizing an analysis of healthcare utilization and outcomes in patients with PH and an informational poster on additional trials in the PHYOX clinical development program will also be presented.

Session: Genetic Diseases of the Kidneys: Non-Cystic – 1

Poster Title: Real-World Healthcare Utilization and Clinical Markers Preceding Dialysis in Patients with Primary Hyperoxaluria (PH) in the United States

Poster #: PO1317

Session: Informational Posters

Poster Title: The PHYOX™ Clinical Program for Primary Hyperoxaluria

Poster #: INFO22

All three posters will be available on the ASN website starting Thursday, Nov. 4 at 10:00 a.m. PDT/1:00 p.m. EDT.

About Primary Hyperoxaluria (PH)

Primary hyperoxaluria (PH) is a family of ultra-rare, life-threatening genetic disorders that initially manifest with complications in the kidneys. There are three known subtypes of PH (PH1, PH2 and PH3), each resulting from a mutation in one of three different genes. These genetic mutations cause enzyme deficiencies that result in the overproduction of oxalate, which is an end-product of metabolism. Excess production and accumulation of oxalate leads to recurrent kidney stones, nephrocalcinosis and chronic kidney disease that may progress to end-stage renal disease requiring intensive dialysis. Compromised renal function eventually results in the accumulation of oxalate in a wide range of organs including the skin, bones, eyes and heart. In the most severe cases, symptoms start in the first year of life. A combined liver-kidney transplant may be undertaken to resolve PH1 or PH2, but it is an invasive solution with limited availability and high morbidity that requires lifelong immune suppression to prevent organ rejection. Genetic studies suggest approximately 8,500 people in the U.S. are affected by PH, and researchers estimate that more than 80% of patients remain undiagnosed.1 There is currently only one approved therapy available that is limited to the treatment of patients with PH1.

About Nedosiran

Nedosiran is in development for the treatment of primary hyperoxaluria (PH) as part of the PHYOX™ clinical development program and is Dicerna’s most advanced RNAi drug candidate utilizing our proprietary GalXC™ RNAi technology. Nedosiran is designed to inhibit production of the hepatic lactate dehydrogenase (LDH) enzyme – an enzyme that catalyzes the final step in the glyoxylate metabolism pathway that can lead to oxalate overproduction in patients with PH.

About Dicerna Pharmaceuticals, Inc.

Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) is a biopharmaceutical company focused on discovering, developing and commercializing medicines that are designed to leverage ribonucleic acid interference (RNAi) to silence selectively genes that cause or contribute to disease. Using our proprietary GalXC™ and GalXC-Plus™ RNAi technologies, Dicerna is committed to developing RNAi-based therapies with the potential to treat both rare and more prevalent diseases. By silencing disease-causing genes, Dicerna’s GalXC platform has the potential to address conditions that are difficult to treat with other modalities. Initially focused on disease-causing genes in the liver, Dicerna has continued to innovate and is exploring new applications of its RNAi technology with GalXC-Plus, which expands the functionality and application of our flagship liver-targeted GalXC technology to tissues and cell types outside the liver, and has the potential to treat diseases across multiple therapeutic areas. In addition to our own pipeline of core discovery and clinical candidates, Dicerna has established collaborative relationships with some of the world’s leading pharmaceutical companies, including Novo Nordisk A/S, Roche, Eli Lilly and Company, Alexion Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH and Alnylam Pharmaceuticals, Inc. Between Dicerna and our collaborative partners, we currently have more than 20 active discovery, preclinical or clinical programs focused on cardiometabolic, viral, chronic liver and complement-mediated diseases, as well as neurodegenerative diseases and pain. At Dicerna, our mission is to interfere – to silence genes, to fight disease, to restore health. For more information, visit www.dicerna.com.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements including (a) the expected timing of submitting our NDA for nedosiran to the FDA for the treatment of PH1, our belief that data from PHYOX2 in patients with PH1 support potential approval of nedosiran for the treatment of PH1 in the U.S., Europe, Japan and other markets, and our belief that further assessment of nedosiran’s potential in treating PH2 is warranted; as well as (b) such statements pertaining to the Company’s planned participation at a scientific conference, which may include discussion of the Company’s business and operations, including the discovery, development and commercialization of our product candidates and technologies, and the therapeutic potential thereof, the success of our collaborations with partners and any potential future collaborations. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those relating to our preclinical research and clinical programs and other risks identified under the heading “Risk Factors” included in our most recent Form 10-Q and Form 10-K filings and in other future filings with the SEC. The forward-looking statements contained in this press release reflect Dicerna’s current views with respect to future events, and Dicerna does not undertake and specifically disclaims any obligation to update any forward-looking statements.

GalXC™, PHYOX™ and GalXC-Plus™ are trademarks of Dicerna Pharmaceuticals, Inc.

1 Hopp K, et al. J Am Soc Nephrol. 2015;26(10):2559-2570 and U.S. Census Bureau population on a date: February 20, 2020. United States Census Bureau website, 2020.

Contacts

Media:

Amy Trevvett

+1 617-612-6253

atrevvett@dicerna.com

Investors:

Kristen Sheppard, Esq.

+ 1 617-514-2275

ksheppard@dicerna.com

IGC Announces Results of its 2021 Annual Stockholders Meeting

IGC Announces Results of its 2021 Annual Stockholders Meeting




IGC Announces Results of its 2021 Annual Stockholders Meeting

POTOMAC, Md.–(BUSINESS WIRE)–#Alzheimers–India Globalization Capital, Inc. (NYSE AMERICAN: IGC) announces that during its Annual Meeting of Shareholders scheduled for and convened on October 15, 2021, voting on all matters as disclosed on the Definitive Proxy on Form 14A filed with the SEC on September 15, 2021, were passed. Only stockholders of record on the record date of September 10, 2021, were entitled to and were being requested to vote.

At the Annual Meeting, the following proposals were approved: (i) the proposal to elect Mr. Richard Prins to the Company’s board of directors to serve as a Class B director until the 2024 annual meeting of Stockholders; (ii) the proposal to ratify Manohar Chowdhry & Associates (“MCA”) as the Company’s independent registered public accounting firm for the 2022 fiscal year; (iii) the grant of 3,500,000 shares of common stock to be granted from time to time to the Company’s current and new employees, advisors, directors, and consultants by the board of directors, pursuant to certain metrics including performance, vesting, and incentive as set by the board of directors and or the CEO; and (iv) the proposal to adjourn or postpone of the Annual Meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies.

About IGC

India Globalization Capital, Inc. (IGC) engages in the development of cannabinoid-based therapies for indications such as Alzheimer’s disease and pain. It operates in two lines of business, Infrastructure and Life Sciences and is headquartered in Potomac, MD.

www.igcinc.us, www.igcpharma.com, Twitter @IGCIR.

Contacts

Claudia Grimaldi

Email: info@igcinc.us
Phone: 301-983-0998

Dr. Reddy’s Laboratories Announces the Launch of Carmustine for Injection, USP in the U.S. Market

Dr. Reddy’s Laboratories Announces the Launch of Carmustine for Injection, USP in the U.S. Market




Dr. Reddy’s Laboratories Announces the Launch of Carmustine for Injection, USP in the U.S. Market

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Carmustine for Injection, USP, a therapeutic equivalent generic version of BiCNU® (carmustine for injection) approved by the U.S. Food and Drug Administration (USFDA).

The BiCNU® brand and generic market had U.S. sales of approximately $19.4 million MAT for the most recent twelve months ending in August 2021 according to IQVIA Health*.

Dr. Reddy’s Carmustine for Injection, USP is a lyophilized powder available as a package which includes a single-dose vial containing 100 mg Carmustine USP and a vial containing 3 mL sterile diluent.

Please click here for full prescribing information including boxed warning: https://www.drreddys.com/media/1019198/carmustine-for-inj-leaflet.pdf

WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY

Myelosuppression

Carmustine causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [see Warnings and Precautions (5.1) and Adverse Reactions (6)]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [see Dosage and Administration (2.1)].

Do not administer a repeat course of Carmustine until blood counts recover.

Pulmonary Toxicity

Carmustine causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg/m2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4)].

iCNU is a trademark owned or licensed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

*IQVIA Retail and Non-Retail MAT June 2021

RDY-0821-368

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the “Risk Factors” and “Forward-Looking Statements” sections of our Annual Report on Form 20-F for the year ended March 31, 2021. The company assumes no obligation to update any information contained herein.

Contacts

INVESTOR RELATIONS
AMIT AGARWAL

AMITA@DRREDDYS.COM

MEDIA RELATIONS
USHA IYER

USHAIYER@DRREDDYS.COM

Global Automated and Rapid Microbiological Tests Market Trajectory & Analytics Report 2021-2026 – ResearchAndMarkets.com

Global Automated and Rapid Microbiological Tests Market Trajectory & Analytics Report 2021-2026 – ResearchAndMarkets.com




Global Automated and Rapid Microbiological Tests Market Trajectory & Analytics Report 2021-2026 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Automated and Rapid Microbiological Tests – Global Market Trajectory & Analytics” report has been added to ResearchAndMarkets.com’s offering.

Amid the COVID-19 crisis, the global market for Automated and Rapid Microbiological Tests estimated at US$5.3 Billion in the year 2020, is projected to reach a revised size of US$7.6 Billion by 2026, growing at a CAGR of 6.1% over the analysis period.

GC/CRT (Clinical), one of the segments analyzed in the report, is projected to grow at a 7.4% CAGR to reach US$1 Billion by the end of the analysis period. After a thorough analysis of the business implications of the pandemic and its induced economic crisis, growth in the AISS (clinical) segment is readjusted to a revised 3.4% CAGR for the next 7-year period.

This segment currently accounts for a 10.4% share of the global Automated and Rapid Microbiological Tests market. The surge in the occurrences of STDs, such as GC/Chlamydia, HIV and Syphilis, has turned STD rapid tests into the most dynamic and vigorous segment of the market.

Growth in the global is set to be fueled by rising global prevalence of chronic infectious diseases, increasing food safety concerns, growing need for fast and easy diagnosis, rising public-private investments, funding, and research grants, and sustained technological advancements.

Continued technological advancements in terms of improved functionality, efficiency, efficacy, faster results, and accuracy are driving the adoption of microbial testing in academic institutes, research laboratories, hospitals, clinical laboratories, and biotechnology and pharmaceutical companies.

Rapid advancements in microbial testing help in overcoming limitations such as an extensive period of exposure to pathogenic strains and long procedural times associated with traditional testing methods. In addition, these tests serve as a cost-effective alternative to microbial identification by enabling reduction in the consumable cost per procedure.

Key Topics Covered:

I. METHODOLOGY

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW

  • Impact of COVID-19 Pandemic and Looming Global Recession
  • Clinical Microbiology Gains Prominence as Scientists Mobilize United Efforts to Find Ways to Detect, Treat & Vaccinate People Against the Novel Coronavirus: COVID-19 Tests Per Million Population by Country (As of 15 June 2021)
  • A New, 20-Minute Assay for COVID-19 Diagnosis
  • Automated and Rapid Microbiological Tests: An Introduction
  • Enabling Technologies of Automated & Rapid Microbiological Tests
  • Clinical Applications of Automated & Rapid Microbiological Tests
  • Applications in Non-Clinical Investigations
  • Global Market Prospects & Outlook
  • Evolutionary Battle against Microbes Drives Market Future
  • Clinical Applications Lead the Global Market for Automated and Rapid Microbiological Testing
  • Developed Regions Lead, Developing Economies to Boost Future Growth
  • Competition
  • Recent Market Activity

2. FOCUS ON SELECT PLAYERS (Total 77 Featured)

  • Abbott Laboratories
  • Abbott Molecular, Inc.
  • Aidian Oy
  • Beckman Coulter, Inc.
  • Becton Dickinson and Company
  • bioMerieux SA
  • bioMerieux, Inc.
  • Bio-Rad Laboratories, Inc
  • Cellabs Pty Ltd
  • Cepheid Inc.
  • CorisBioconcept SPRL
  • F. Hoffmann-La Roche AG
  • Hologic, Inc.
  • MedMira Inc.
  • Meridian Bioscience, Inc.
  • OraSure Technologies, Inc.
  • Oxoid Limited
  • QIAGEN N.V.
  • Quidel Corporation
  • Rapid Micro Biosystems, Inc.
  • Sekisui Diagnostics, LLC
  • Siemens Healthcare GmbH
  • Thermo Fisher Scientific Inc.

3. MARKET TRENDS & DRIVERS

  • Rapid Diagnostics Bring in a Transformation to Clinical Testing Practices
  • Traditional Rapid Microbiological Tests Make Way for New, Probe Tests
  • Lab Automation Trend Augurs Well for Microbiological Testing Labs
  • Traditional Approaches Give Way to Modern Automated Microbiology Systems
  • Microbiology Laboratories Switch to Automation to Push Yields
  • Growing Incidence of Infectious Diseases to Fuel Demand for Rapid Microbiology Testing
  • Rising Prevalence of Respiratory Infections Drive Market Growth
  • Rise in Prevalence of COPD Augments Demand
  • Influenza Boosts Rapid Test Prospects
  • Rise in Pollution Levels Trigger Increase in Respiratory Diseases, Driving Opportunities for Automated Microbiology Tests
  • Sustained Threat of HIV and Sexually Transmitted Diseases Amplify Need for Rapid Microbiological Testing
  • Rapid HIV Tests: A New Age Diagnostic Weapon against the Killer Disease
  • Home HIV Testing Emerges as a Lucrative Option
  • Advancements in Molecular Diagnostics Drive Market Growth
  • Emerging Technologies in Clinical Microbiology Diagnostics Aim at Faster Diagnosis
  • Automated Blood Culture Systems: The Gold Standard in the Fight against Bacteremia
  • Advancements in Molecular Diagnostics: A Boon for Rapid Microbiological Testing Market
  • Biotechnology: A Crucial Step Ahead in the Growing Popularity of Rapid Microbial Tests
  • Healthcare Needs of the World’s Aging Population: Potential Opportunity in Store
  • Increase in Healthcare Spending in Emerging Markets to Propel Demand for Automated Microbiological Testing
  • Clinical Microbiology Market Benefits from Digitalization and Robotization Trend
  • Integration of Clinical Microbiology with Cloud Computing
  • Artificial Intelligence Holds Positive Implications for Automation of Clinical Microbiology
  • Point-of-Care Rapid Microbiological Testing: Yet to Realize Its Full Potential.
  • Technological Advancements to Drive the Automated Microbiology Testing Market
  • Focus on Safe and High-Quality Foods Propels Rapid Microbiological Testing
  • Foodborne Illness Outbreak Investigations in the US (2019 & 2020)
  • Impact of COVID-19 on Food Safety Testing Industry
  • Stringent Norms Necessitate Food Safety Testing
  • Food Microbiology Testing Market on a Growth Spree
  • Rapid and Automated Tests Emerge as an Attractive Solution
  • Leading Food Processors Exhibit Inclination Towards Rapid Microbiological Testing
  • Automation of Food Microbiology Labs
  • Poultry Industry Embraces Rapid Microbiological Testing Technologies
  • Rapid Microbial Testing in Dairy Industry
  • Real-time PCR/qPCR Technologies Fundamental in Food Safety Testing
  • Technical and Cost Related Hurdles Hamper the Microbiology Testing Market
  • Rapid Microbiological Testing Gains Significance in the Pharmaceutical Industry
  • Key Advantages of Rapid Microbiological Tests for Pharmaceutical Industry
  • Growing Importance of Rapid Microbiological Testing for Pharma Laboratories
  • Key RMM Technologies for Pharmaceutical Industry
  • Adoption of Rapid Methods for QC Microbiology in Biopharmaceuticals
  • Advancements in Rapid Microbiological Testing for Pharmaceutical Industry
  • Rapid Microbial Testing for Regenerative Medicine: An Emerging Space
  • Rapid Microbiological Methods and the Regulatory Environment in Drug Development Industry
  • FDA’s Requirements for Validation of RMM
  • EMA’s Guidance on Use of RMMs for Water Testing
  • Rapid Microbial Testing Emerges as an Important Means for Quality Control of Advanced Therapies
  • Antibiotic Resistant Bacteria Throws the Spotlight on Rapid Microbial Testing Tools
  • Antimicrobial Vulnerability Testing and Identification of Microbial strains
  • Role of Microscopy in Antimicrobial Susceptibility Testing
  • Rising Prominence of NAAT-Driven AST
  • Economic Factors Promise Growth for Rapid AST
  • Rapid Technologies Gain Momentum in Environment Testing Field
  • Deteriorating Quality of Water Throws Emphasis on Water Testing Services
  • Key Issues Confronting the Rapid Microbiological Tests Market

4. GLOBAL MARKET PERSPECTIVE

III. REGIONAL MARKET ANALYSIS

IV. COMPETITION

For more information about this report visit https://www.researchandmarkets.com/r/tppxhp

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

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For E.S.T Office Hours Call 1-917-300-0470

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Global Proteomics Market Trajectory & Analytics Research Report 2021 – ResearchAndMarkets.com

Global Proteomics Market Trajectory & Analytics Research Report 2021 – ResearchAndMarkets.com




Global Proteomics Market Trajectory & Analytics Research Report 2021 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Proteomics – Global Market Trajectory & Analytics” report has been added to ResearchAndMarkets.com’s offering.

Global Proteomics Market to Reach $43.5 Billion by 2026

The proteomics market is anticipated to gain from the pressing need to develop advanced therapeutic and diagnostic options in the wake of COVID-19. The ability of proteomics to help researchers in detecting several proteins in a single analysis is anticipated to make it a suitable weapon in the fight against the COVID-19 virus.

Proteomics represents a highly relevant technique in the battle against COVID-19 owing to the significance to understand the role played by proteins in the infection process as well as disease progression. These insights are critical to support preventative strategies and development of novel therapeutics. The use of mass spectrometry to detect COVID-19 virus` proteins and proteolytic peptides enables a rapid, simple virus detection assay.

On the other hand, targeted proteomics allows detection of peptides of the virus` spike proteins and nucleocapsid with high specificity and sensitivity in clinical and research samples. The approach holds potential to make proteomics an effective option for diagnostic laboratories along with point-of-care testing as a cost-effective alternative to techniques based on nucleic acid.

Proteomics can be potentially used to develop techniques to predict COVID-19 patients who may experience severe symptoms later. Various studies have revealed potential protein-based biomarkers expressed differently among certain COVID-19 patients, which can be used for predicting viral infection during earlier stages. The use of proteomics to understand humoral antibody response against virus` proteins has facilitated the development of specific antibody-based assays intended to support diagnostic or therapeutic objectives.

The U.S. Market is Estimated at $10.2 Billion in 2021, While China is Forecast to Reach $3.9 Billion by 2026

Major driving factors of growth in the market include growing demand for personalized medicine, growing applications of proteomics in drug discovery, rise in demand for early diagnosis and treatment of diseases, technical advancements, rise in birth disorders and genetic disorders and the rapidly growing pharmaceutical and biopharmaceutical markets.

Other factors supporting growth include development of protein targeted treatments and precision molecular medicines for many autoimmune diseases, development of mass spectrometry-based proteomics, and development of molecular targets in malignancies.

Increasing focus of biotechnological and pharmaceutical companies in research and development for identifying new proteomics applications, development of new drugs, and proteomics biomarker discovery in different types of diseases such as cardiovascular diseases and cancer is the major trend in the global proteomics landscape. Proteomics is extensively used in protein expression profiling, targeted protein quantitation, analysis of interactions between proteins, and post-translational modification in different segments of the pharmaceutical industry.

Advanced proteomics solutions are finding extensive application in diagnostic services, drug discovery and other research fields. Proteomics is a promising approach towards personalized medicine to treat several diseases, such as diabetes, obesity, fatty liver, neurological diseases, and cancer.

In addition to the rising incidence of cancer, diabetes, and other potentially fatal diseases, there is a rise in disorders, such as autism and Alzheimer`s, which are highly wanting in terms of research and cure. Use of plasma proteomics method for proteomic biomarker identification is associated with challenges of patients` variation and high dynamic range of plasma proteins.

However, increasing focus on specialty medicines due to technological advancements, sophisticated software, and tools such as IoT, data analytics, big data, and artificial intelligence in the clinical research related to proteomics could create new opportunities for the proteomics market.

Key Topics Covered:

I. METHODOLOGY

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW

  • Impact of COVID-19 on Laboratory Equipment and Supplies Market: A General Review
  • Proteomics Emerges as an Important Research Tool in Battle against COVID-19
  • Pressing Need for COVID-19 Diagnostics & Therapeutics Accentuates Dynamic Role of Proteomics
  • Gaining Insights into COVID-19 & Drug Discovery with Proteomics
  • Proteomics to Enable Potent Antiviral Agents & Better Vaccines against COVID-19
  • Proteomics Labs Explore COVID-19 Therapeutic Options, Dx Development
  • Proteins, Proteome and Proteomics: A Prelude
  • Genesis of Proteomics
  • Important Milestones
  • An Insight into Proteomics Data Type and their Characteristics / Features
  • Proteomics and Genomics: A Comparison
  • Applications of Proteomics
  • Outlook
  • Proteomics at the Fore with Latest Advances
  • Regional Analysis
  • Key Challenges to Address
  • Sparse and Difficult to Measure Data
  • Democratizing Proteomics
  • Absence of High-Profile Projects for Stimulating Interest
  • Creating Novel Experimental Design
  • Lack of Commercialization of High Throughput Impacts
  • Lack of Necessary Technical Skillset
  • Competition
  • Recent Market Activity
  • World Brands

2. FOCUS ON SELECT PLAYERS (Total 178 Featured)

  • ActivX Biosciences, Inc.
  • Agilent Technologies, Inc.
  • Bio-Rad Laboratories, Inc.
  • Bruker Corporation
  • Cytiva
  • Geneva Bioinformatics S.A.
  • Merck KGaA
  • PerkinElmer, Inc.
  • Shimadzu Corporation
  • Millipore Sigma
  • Thermo Fisher Scientific, Inc.
  • Waters Corp.
  • Xencor, Inc.

3. MARKET TRENDS & DRIVERS

  • Proteomics Profiling to Expedite Drug Discovery
  • Other Applications of Proteomics in Drug Discovery
  • New Proteomics Technique to Aid Drug Screening & Biomarker Discovery
  • Growing Interest in Personalized Medicine to Drive Market Growth
  • Oncology: A Key Focus Area for Proteomics
  • Proteomic Approaches Gain Prominence in Cancer Drug Discovery
  • Proteomics Technologies Used in Cancer Drug Discovery and Development
  • Role of Proteomics in Oncology Biomarker Discovery
  • List of FDA-approved Protein Biomarkers for Cancer
  • Advancements in Proteomics Bring Biomarkers into Limelight
  • Different Types of MS-Based Proteomic Discovery Techniques for Biomarkers
  • Affinity-Reagent-Array-Based Techniques
  • Affinity-and-Antibody-Based MS Techniques
  • CE-MS Technology: An Emerging Technology for Discovery of Biomarkers
  • Protein Microarrays: A Novel Tool for the Development of Pharmaceuticals
  • Protein Microarray Formats
  • New Technologies Expand Application of Proteomics
  • DIA Technique for Protein Discovery
  • AI and Machine Learning Address Shortcomings of Traditional Equipment in Effectively Identifying Protein Patterns
  • Bioinformatics Tools along with Proteomics Accelerate the Process of Pathway Prediction
  • Map of COVID-19 and Human Protein Interactions Reveals Drug Targets
  • Single-Cell Proteomics Offers a Better Understanding of Cellular Identity
  • Metalloproteomics: A Rapidly Evolving Field
  • Post-translational Modification of Proteins Increases Functional Diversity of Proteome
  • Pharmacoproteomics Holds Significant Prospects in Precision Medicine
  • Increasing Prominence of Nanoproteomics Widens Opportunities
  • Global Proteomics Sample Preparation Market
  • Challenges Faced
  • Management of Data in Proteomics Research Poses a Big challenge
  • Role of Contract Research Organizations to Increase in Proteomics

4. GLOBAL MARKET PERSPECTIVE

III. REGIONAL MARKET ANALYSIS

IV. COMPETITION

For more information about this report visit https://www.researchandmarkets.com/r/gyyuc5

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Janssen Receives Positive CHMP Opinion for RYBREVANT® (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy

Janssen Receives Positive CHMP Opinion for RYBREVANT® (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy




Janssen Receives Positive CHMP Opinion for RYBREVANT® (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy

If approved by the European Commission, amivantamab will be the first treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for advanced non-small cell lung cancer (NSCLC)1

The Committee for Medicinal Products for Human Use (CHMP) decision is based on results from the Phase 1 CHRYSALIS study evaluating amivantamab as a monotherapy in patients after previous treatment with platinum-based therapy2

BEERSE, Belgium–(BUSINESS WIRE)–FOR EU TRADE AND MEDICAL MEDIA ONLY. NOT TO BE DISTRIBUTED TO UK AND BENELUX BASED MEDIA

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product amivantamab, intended for the treatment of adult patients with advanced NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy.3 If approved, amivantamab will be the first treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for advanced NSCLC.1

“This group of patients often face a poor prognosis as there are currently no targeted therapy options for this specific mutation nor does it typically respond to existing therapies used to treat more common EGFR mutations,” 1,4,5 commented Catherine Taylor, M.D., Vice President, Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Janssen-Cilag AG. “The decision today by the CHMP recognises amivantamab has the potential to provide an urgently required, effective and tolerable new treatment option specifically targeted for patients diagnosed with non-small cell lung cancer who have EGFR exon 20 insertion mutations.”

Amivantamab is a fully-human EGFR and MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistant EGFR and MET mutations and amplifications.6,7,8,9 The European marketing authorisation application (MAA) is based on results from the Phase 1 CHRYSALIS study, a multicentre, open-label, clinical study evaluating amivantamab as a monotherapy in patients after previous treatment with platinum-based therapy, which demonstrated efficacy and a generally well-tolerated safety profile.10 Confirmed complete or partial responses were observed in 32 out of 81 patients, resulting in an overall response rate of 40 percent (95 percent CI, 29% – 51%), with a median duration of response of 11.1 months (95 percent CI, 6.9 – not reached).10 The median progression free survival (time experienced without progression or death) was 8.3 months (95 percent CI, 6.5 – 10.9) and the median overall survival in patients treated with amivantamab was 22.8 months (95 percent CI, 14.6 – not reached).10

The most common adverse events (AEs) were predominantly Grade 1-2 and included infusion-related reactions (66 percent), rash (86 percent) and paronychia (45 percent). Sixteen percent of patients experienced treatment-related Grade ≥3 AEs.10 Treatment-related discontinuations were seen in four percent and treatment-related dose reductions in 13 percent of patients.10 There were no treatment-related deaths.10 Ninety-four percent of infusion related reactions (IRRs) occurred with the first infusions and rarely impacted the ability to continue with subsequent treatments.10 Initial study results from the CHRYSALIS EGFR exon 20 insertion mutation population were presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program11 and updated results were presented at the IASLC World Conference on Lung Cancer (WCLC) 2020.12

“Amivantamab has the potential to address the high unmet need in the treatment of people with EGFR exon 20 insertion mutations in non-small cell lung cancer,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “At Janssen, we are committed to delivering innovative therapies and making a meaningful impact in areas of high unmet need and in the lives of patients. With the development of a novel bispecific antibody like amivantamab, we believe advancing medicines targeting specific pathways can bring the greatest benefits and improve outcomes for patients with tumour alterations, such as EGFR and MET.”

The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, which is expected later this year.13 The U.S. Food and Drug Administration (FDA) approved amivantamab in May 2021 for the treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.14 Additional regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide.

###

About Amivantamab

Amivantamab is a fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications.6,7,8,9 Amivantamab is being studied in multiple clinical trials, including:15

  • the Phase 1/1b, CHRYSALIS-2, (NCT04077463) study assessing the combination of amivantamab and lazertinib in patients who have progressed after treatment with osimertinib and chemotherapy, as well as lazertinib as a monotherapy16
  • as first-line therapy in the Phase 3 MARIPOSA (NCT04487080) study assessing amivantamab in combination with lazertinib,* a novel third-generation EGFR tyrosine kinase inhibitor (TKI), against osimertinib in untreated advanced EGFR-mutated NSCLC17
  • the Phase 3 MARIPOSA-2 (NCT04988295) study assessing the efficacy of lazertinib, amivantamab, carboplatin-pemetrexed vs. with carboplatin-pemetrexed in participants with locally advanced or metastatic EGFR Exon 19del or Exon 21 L858R substitution NSCLC after osimertinib failure18
  • the Phase 3 PAPILLON (NCT04538664)study assessing amivantamabin combination with carboplatin-pemetrexed for patients with advanced or metastatic EGFR-mutated NSCLC with exon 20 insertion mutations19
  • the Phase 1 PALOMA (NCT04606381) study assessing the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for amivantamab SC delivery with the aim to find effective solutions that positively impact patient management.20

About the CHRYSALIS Study

CHRYSALIS (NCT02609776) is an open-label, multicentre, first-in-human Phase 1 study to evaluate the safety, pharmacokinetics and preliminary efficacy of amivantamab as a monotherapy, in combinations with lazertinib and in combination with platinum-based chemotherapy, in patients with advanced NSCLC with various EGFR mutations.2 In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumours Version 1.1* (RECIST v1.1), clinical benefit rate, median duration of response and median progression-free survival, as well as the safety profile of amivantamab.2,21

The study will enrol 460 patients with advanced NSCLC.2 The study consists of two parts: the first consists of amivantamab monotherapy and combination dose escalations, and the second consists of amivantamab monotherapy and combination dose expansions.2

*RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumours, which is a standard way to measure how well solid tumours respond to treatment and is based on whether tumours shrink, stay the same or get bigger.2

About Non-Small Cell Lung Cancer (NSCLC)

In Europe, it is estimated that 477,534 patients were diagnosed with lung cancer in 2020, with around 85 percent diagnosed with NSCLC.22,25 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.24

The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.23 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.24 EGFR mutations are present in 16 to 19 percent of Caucasian patients with NSCLC and present in 37 to 41 percent of Asian patients who have NSCLC adenocarcinoma.25 The five-year survival rate for all people with metastatic NSCLC and EGFR mutations who are treated with EGFR TKIs is less than 20 percent.26 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of 8 percent in the frontline setting, which is worse than patients with EGFR exon 19 deletions or L858R mutations, who have a real-world five-year OS of 19 percent.27

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

Learn more at www.janssen.com/emea/. Follow us at www.twitter.com/JanssenEMEA for our latest news. Janssen Research & Development, LLC; Janssen-Cilag, S.A. and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

# # #

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding amivantamab and lazertinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC any of the other Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

###

References:


1 Remon, J et al. EGFR exon 20 insertions in advanced non-small cell lung cancer: A new history begins. Cancer Treatment Reviews. 90 (2020).

2 ClinicalTrials.gov. Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed October 2021.

3 Committee of Medicinal Products for Human Use (CHMP) meeting highlights. Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rybrevant Accessed 15 October 2021.

4 Crossland V et al. HSR19-082: Epidemiological Findings and Outcomes in Non-Small Cell Lung Cancer Patients with Exon 20 Insertion Mutations: A Meta-Analysis. JNCCN 2019; 17(3.5): HSR19-08.

5 Hirano T et al. In Vitro Modeling to Determine Mutation Specificity of EGFR Tyrosine Kinase Inhibitors Against Clinically Relevant EGFR Mutants in Non-Small-Cell Lung Cancer Oncotarget 2015; 6(36): 38789–38803.

6 Grugan et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells. MAbs. 2017;9(1):114-126.

7 Moores et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13)(suppl 27216193):3942-3953.

8 Yun et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR–MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion–Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209.

9 Vijayaraghavan et al. Amivantamab (JNJ-61186372), an Fc Enhanced EGFR/cMet Bispecific Antibody, Induces Receptor Downmodulation and Antitumor Activity by Monocyte/Macrophage Trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056.

10Sabari, J. et al. Amivantamab in Post-platinum EGFR Exon 20 Insertion Mutant Non-Small Cell Lung Cancer. WCLC Oral Presentation #3031. January 2021 .

11 Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harboring Exon 20 Insertion Mutations. Available at: https://www.businesswire.com/news/home/20200518005380/en/Janssen-Announces-Phase-1-Results-for-Bispecific-Antibody-Amivantamab-in-the-Treatment-of-Patients-with-Advanced-Non-Small-Cell-Lung-Cancer-Harbouring-Exon-20-Insertion-Mutations. Accessed October 2021.

12 Janssen:New Amivantamab Data from CHRYSALIS Study Show Robust Clinical Activity and Durable Responses in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutations. Available at: https://www.businesswire.com/news/home/20210128005929/en/Janssen-New-Amivantamab-Data-from-CHRYSALIS-Study-Show-Robust-Clinical-Activity-and-Durable-Responses-in-Patients-with-Metastatic-or-Unresectable-Non-Small-Cell-Lung-Cancer-and-EGFR-Exon-20-Insertion-Mutations. Accessed October 2021.
13 Janssen Submits European Marketing Authorisation Application for Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. https://www.janssen.com/janssen-submits-european-marketing-authorisation-application-amivantamab-treatment-patients. Accessed October 2021.

14Johnnson and Johnson. RYBREVANT® (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Available at: https://www.jnj.com/rybrevanttm-amivantamab-vmjw-receives-fda-approval-as-the-first-targeted-treatment-for-patients-with-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations. Accessed October 2021.

15 ClinicalTrials.gov. Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed October 2021

16 A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed October 2021

17 ClinicalTrials.gov. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). Available at: https://clinicaltrials.gov/ct2/show/NCT04487080. Accessed October 2021

18 ClinicalTrials.gov. A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure (MARIPOSA-2). Available at https://clinicaltrials.gov/ct2/show/NCT04988295 Accessed October 2021

19 ClinicalTrials.gov. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

(PAPILLON). Available at: https://clinicaltrials.gov/ct2/show/NCT04538664?term=PAPILLON&cond=NSCLC&draw=2&rank=1. Accessed October 2021.

20 ClinicalTrials.gov. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies. Available at: https://clinicaltrials.gov/ct2/show/NCT04606381. Accessed October 2021.

21 Park et al, Amivantamab (JNJ-61186372), an anti-EGFR-MET bispecific antibody, in patients with EGFR exon 20 insertion (exon20ins)-mutated non-small cell lung cancer (NSCLC). Available at https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.9512. Accessed October 2021.

22 Globocan 2020. Estimated number of incident cases deaths in 2020, Europe, both sexes, all ages. Available at: www.gco.iarc.fr. Accessed October 2021.

23 Zappa C et al. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res 2016; 5(3): 288–300.

24 Wee,P, Wang, Z. Epidermal Growth Factor Receptor Cell Proliferation Signaling Pathways. Cancers (Basel). 2017 May; 9(5): 52.

25 Zhang et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget 2016. 7 (48): 78985 – 78993.

26 Lin JJ, Cardarella S, Lydon CA, Dahlberg SE, Jackman DM, Jänne PA, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.

27 Girard N, BazhenovaL, MinchomA, OuSI, GadgeelSM, Trigo J, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.

CP-256815

October 2021

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