An email has been sent to your address with instructions for changing your password.
There is no user registered with this email.
Sign Up
To create a free account, please fill out the form below.
Thank you for signing up!
A confirmation email has been sent to your email address. Please check your email and follow the instructions in the message to complete the registration process. If you do not receive the email, please check your spam folder or contact us for assistance.
Welcome to our platform!
Oops!
Something went wrong while trying to create your new account. Please try again and if the problem persist, Email Us to receive support.
Geron Announces Experienced Commercial Leadership Hired for Planned Commercial Launch of Imetelstat in the U.S.
Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Very Positive)
Tags
Rhea-AI Summary
Geron Corporation (NASDAQ: GERN) announced key additions to its senior commercial leadership team as it prepares for the anticipated launch of imetelstat, a first-in-class telomerase inhibitor, in the U.S. for lower risk myelodysplastic syndromes (MDS) in the first half of 2024, pending regulatory approvals. The company reported positive Phase 3 clinical trial results and plans to submit a New Drug Application (NDA) in mid-2023 and a Marketing Authorization Application (MAA) in the EU in late 2023. This strategic hiring aims to ensure successful market access and commercialization efforts.
Positive
Completion of positive Phase 3 IMerge trial results for imetelstat.
Strategic hiring of experienced professionals in key commercial functions to support upcoming product launch.
Anticipated U.S. launch of imetelstat in lower risk MDS in the first half of 2024, contingent on regulatory approval.
Negative
Dependence on regulatory approvals for commercial launch timelines.
Potential for additional clinical testing requirements that could delay commercialization.
Leadership in place for core commercial functions, including in Market Access, Trade & Channel Relations, Commercial Operations, Analytics, Marketing, Sales and Medical Affairs
Company continues stage-gated commercial readiness efforts for an anticipated commercial launch of imetelstat in lower risk MDS in the first half of 2024 in the U.S. and by the end of 2024 in the EU, assuming regulatory approvals are granted
FOSTER CITY, Calif.--(BUSINESS WIRE)--
Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today highlighted multiple additions to its senior commercial leadership team, as it prepares for the potential commercialization in the U.S. market of imetelstat, a first-in-class telomerase inhibitor. Key additions include seasoned professionals with deep operational and launch experience in Trade & Channel Relations, Market Access, Marketing, Medical Affairs and Sales. The Company recently reported positive top-line results from its IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes (MDS) and is planning a New Drug Application (NDA) submission in the U.S. in mid-2023 and a Marketing Authorization Application (MAA) submission in the EU in the second half of 2023.
Anil Kapur, Geron’s Executive Vice President of Corporate Strategy and Chief Commercial Officer, said, “As we continue to advance development of imetelstat in hematologic malignancies and prepare for potential commercialization, we are gratified by our ability to attract top-level talent to Geron and are excited to have this deeply experienced commercial leadership team in place for our planned commercial launch in lower risk MDS in the U.S. in the first half of 2024, assuming regulatory approval is granted.”
Peter Avalos, M.B.A., M.S., Vice President, Trade and Channel Relations
Peter Avalos joined Geron in December 2022 from Daiichi Sankyo Inc., where he established a field reimbursement model and hub infrastructure to ensure visibility to key data and metrics to execute a successful launch of the antibody drug conjugate, Enhertu, into the U.S. market. Mr. Avalos has over twenty-five years of experience working in the healthcare industry across both the drug and medical device sectors. His deep experience includes building and executing patient engagement models, group purchasing organizations (GPO), trade and patient access, as well as roles across many disciplines, including accounting and finance, sales leadership, pricing and strategy. Previous company experiences include Walgreens Boots Alliance, Inc., Dendreon Pharmaceuticals LLC and Johnson & Johnson. Mr. Avalos holds multiple degrees from Seton Hall University, including a B.S. in Business Administration, an M.S. in International Business and an M.B.A.
As Vice President, Trade and Channel Relations, Mr. Avalos leads the development of imetelstat’s trade distribution, national accounts and GPO strategy, as well as the future hub and field reimbursement model to support potential commercial launch of imetelstat into the U.S. market.
Nishan Sengupta, Ph.D., Vice President, Market Access and Pricing
With over 20 years of experience working in the healthcare industry across both the drug and medical device sectors, Nishan Sengupta was a core brand team member for multiple global and U.S. commercial launches, including Imbruvica, Xarelto and Humira. Prior to joining Geron in August 2021, Dr. Sengupta served as the cross-sector (drug/device) Access Strategy Lead for cancer initiatives at Johnson & Johnson, where he led the access strategies for local drug delivery, robotic bronchoscopy and systemic interception across the enterprise. He also served as the Market Access leader for Janssen’s hematology B-cell portfolios, where he built a global team and was a core member of the clinical development team for the commercial alliance between Janssen and Pharmacyclics, Inc. During this time, he was instrumental in the global launch of Imbruvica by obtaining reimbursement in all key global markets, across multiple indications and expanded access to over 60+ countries. Prior to his roles at Johnson & Johnson, Dr. Sengupta worked in U.S. oncology at F. Hoffmann-La Roche Ltd and led health economics and outcomes research teams for Abbott (now AbbVie Inc) in their immunology franchise. He has also co-authored over 30 research papers in the field of patient reported outcomes (PRO), cost-effectiveness, health policy and is the recipient of multiple awards from scientific organizations including American College of Clinical Pharmacy (ACCP), International Society for Pharmacoeconomics and Outcomes Research (ISPOR), International Society on Thrombosis and Hemostasis (ISTH) and U.S. Pharmacopeia. Dr. Sengupta is a registered pharmacist and earned his Ph.D. in Health Policy and Economics from the University of Southern California.
As Vice President, Market Access and Pricing, Dr. Sengupta leads the development of imetelstat’s strategic market access, pricing and evidence generation strategies to support successful reimbursement and patient access in the U.S. and global markets through demonstration of value to payers, physicians and healthcare systems.
Prior to joining Geron in October 2022, Lorraine Shui was the U.S. brand lead for sickle cell marketing at Novartis Pharmaceuticals Corporation where she set and executed strategy and tactics for account management. During Ms. Shui’s nine-year tenure at Novartis, she held various roles of increasing responsibility in marketing and also served as an oncology area sales leader. Prior to Novartis, Ms. Shui held positions in U.S. and global marketing, market access and market research at Bristol-Myers Squibb Company and Johnson & Johnson. With nearly 20 years of commercial pharmaceutical experience focused on oncology and rare diseases, Ms. Shui has completed numerous launches for many successful drugs, including Kisqali, Tafinlar/Mekinist, Afinitor, Opdivo, Yervoy and Sprycel. Ms. Shui holds a Pharm.D. from St. John’s University and an Executive M.B.A. from Columbia University.
As Vice President, Marketing, Ms. Shui leads the overall commercial launch planning for imetelstat in the U.S. market, including leadership of the internal go-to-market cross-functional U.S. launch readiness team. She is also responsible for building the marketing team, leading the development and execution of brand vision, strategy and supporting tactical plans and directing the cross-company omni-channel and non-personal promotion efforts.
Denise Meyer, B.Pharm., Pharm.D., M.B.A., Vice President, Medical Affairs
Since August 2021, Denise Meyer has served as Geron’s Vice President, Medical Affairs. Prior to joining Geron, Ms. Meyer was U.S. Medical Affairs Lead for Specialty Medicine at Bayer Corporation, where she built the field medical teams for Hematology and Early Pipeline development, expanding their reach and enhancing support for clinical trial enrollment. With over 20 years of experience in the biopharmaceutical industry, Ms. Meyer has in-depth medical and marketplace knowledge of drug, device, biomarker, and diagnostics development and commercialization. Her career in industry has encompassed leading roles in medical affairs, global program management and commercialization. She has held leadership roles at Bristol-Myers Squibb as the Field Medical leader, Myeloid Hematology; at Baxalta as Senior Director, Oncaspar; at Millennium Pharmaceuticals, Inc. as Head of Global New Product Planning; at Amgen Inc. as Executive Director, Global Program Leader for Nplate®; and at Eli Lilly & Co as Director, Global Marketing. At these companies, Ms. Meyer has been part of the development of several MDS and myelofibrosis (MF) therapies, including launches of Onureg, Reblozyl and Inrebic. Ms. Meyer is a registered pharmacist and holds B.Pharm. and Pharm.D. degrees from Wayne State and an Executive M.B.A with a concentration in New Product Development from the Kellogg School of Business at Northwestern University.
As Vice President, Medical Affairs, Ms. Meyer is responsible for building the in-house medical affairs team, including field medical liaisons, and the associated medical Information structure to fully execute the go-to-market U.S. imetelstat launch plan.
Scott Hutson, Vice President, Sales
With over 20 years of experience in commercial organizations across various oncology areas, including hematology, solid tumors and immuno-oncology, Scott Hutson has led and participated in numerous commercial launches in the U.S. for many successful blockbuster drugs, including Procrit, Zytiga, Xtandi, Tagrisso, Imfinizi and Enhertu. Prior to joining Geron in November 2022, Mr. Hutson was the Sr. Commercial (Sales) Director for the lung cancer team at AstraZeneca where he led sales team readiness effort and launch planning for over eight years. Prior to this role, Mr. Hutson was West Area Director of (Sales) in the oncology division at Medivation, Inc., where he built the U.S. sales/commercial launch team. He also spent over 11 years in the oncology unit of Janssen in various sales leadership roles. Mr. Hutson holds a B.S. degree in Business and Political Science from Arizona State University.
As Vice President, Sales, Mr. Hutson is responsible for building and executing the sales operational plan for potential commercial launch of imetelstat in the U.S. market, including the future hiring of the U.S. sales force.
About Imetelstat
Imetelstat is an investigational, novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis stimulating agent, and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.
About Geron
Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Its investigational first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize winning science in a treatment that may alter the underlying course of these diseases. To learn more, visit www.geron.com or follow us on LinkedIn.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) potential commercialization of imetelstat; (ii) that Geron plans a commercial launch of imetelstat in the U.S. for lower risk MDS in the first half of 2024 and by the end of 2024 in the EU; (iii) that imetelstat has potential disease-modifying activity and may alter the underlying course of hematologic malignancies; and (iv) Geron is planning an NDA submission in the U.S. in mid-2023 and an MAA submission in the EU in the second half of 2023. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties include, without limitation, risks and uncertainties related to: (a) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (b) whether regulatory authorities determine that imetelstat in lower risk MDS is sufficiently safe and efficacious and grant regulatory approval; (c) whether regulatory authorities accept for filing Geron’s planned NDA and MAA submissions; (d) whether any past or future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (e) whether imetelstat actually demonstrates disease-modifying activity in patients in clinical trials; (f) whether regulatory authorities require additional clinical testing of imetelstat prior to granting any approval in lower risk MDS even though IMerge Phase 3 met its primary endpoint; (g) whether there are failures in manufacturing or supplying sufficient quantities of imetelstat that delay, or do not permit, the anticipated commercial launches in (i) and (ii) above; and (h) Geron may decide to partner and not to commercialize independently in the U.S. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission (SEC) under the heading “Risk Factors,” including Geron’s Current report on Form 8-K filed with the SEC on January 4, 2023, and any subsequent filings. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
What are the key highlights of the Geron Corporation press release regarding imetelstat?
Geron Corporation announced leadership additions and plans for a potential U.S. launch of imetelstat for lower risk MDS in the first half of 2024, following positive Phase 3 trial results.
When is the planned NDA submission date for Geron's imetelstat?
The planned New Drug Application (NDA) submission for imetelstat is set for mid-2023.
What are the anticipated challenges for Geron Corporation's imetelstat launch?
Challenges include obtaining regulatory approvals and the possibility of additional clinical testing that may delay the commercial launch.
What is the expected timeline for imetelstat's launch in the EU?
The anticipated launch of imetelstat in the EU is by the end of 2024, assuming regulatory approvals are granted.
