Healthcare Industry News: Janssen
News Release - July 22, 2019
Geron Enhances Oncology Expertise to Advance Corporate ObjectivesMENLO PARK, Calif., July 18, 2019 -- (Healthcare Sales & Marketing Network) -- Geron Corporation (Nasdaq: GERN) today announced the appointments of Sharon McBain as Vice President, Global Regulatory Affairs and Lynn Bodarky as Vice President, Business Development. These appointments further enhance the Company’s oncology expertise to advance its current and longer-term corporate objectives.
Vice President, Global Regulatory Affairs – Sharon McBain
As Vice President, Global Regulatory Affairs, Ms. McBain will be responsible for global regulatory strategy development, oversight of regulatory submissions, and interactions with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other ex-U.S. health authorities. She will guide the strategic regulatory direction of the imetelstat development program, including assuming a leadership role in the achievement of the Company’s objective to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020 for relapsed/refractory myelofibrosis (MF).
Ms. McBain is a well-respected industry veteran with more than 35 years of biopharmaceutical drug development experience, including more than 20 years of experience in regulatory affairs. Most recently, she was Senior Director, Global Regulatory Leader, Oncology at Janssen Research and Development, LLC (Janssen) where she led the global regulatory development strategy for hematology-oncology drug candidates, including imetelstat. At Janssen, she was responsible for procuring imetelstat’s orphan drug designation in both lower risk myelodysplastic syndromes (MDS) and relapsed/refractory MF, as well as securing FDA Fast Track designation for imetelstat in lower risk MDS. She also provided global regulatory expertise in order to evaluate a number of other early-stage development assets as well as due diligence for potential in-licensing opportunities. Outside of her project responsibilities at Janssen, Ms. McBain initiated and led an industry alliance working group with representatives from the pharmaceutical industry and various health authorities to identify and define surrogate endpoints for hematologic malignancy clinical trials. She also led multiple advisory boards and has frequently participated in expert panels organized by the FDA and the EMA on this topic.
Prior to Janssen, Ms. McBain established a successful consulting business working for multiple companies, including Janssen, and supported the European approval for DACOGEN during this time. Before that, Ms. McBain was the Head of Development, International Regulatory Affairs at Biogen, where she managed Tysabri through to approval. Ms. McBain began her career in drug development and regulatory affairs with GlaxoSmithKline plc, and held various positions of increasing responsibility throughout her 20-year tenure, including serving as the Head of the Gastrointestinal (GI)/Metabolic Therapy Area, where she led regulatory filings resulting in approvals for multiple new products.
Ms. McBain holds a B.Sc. (Hons) in applied biology from North East London Polytechnic in Stratford, East London, Great Britain.
Vice President, Business Development – Lynn Bodarky
As Vice President, Business Development, Ms. Bodarky will support Geron’s longer-term corporate objectives of partnering the ex-U.S. commercialization rights for imetelstat, as well as building a leading hematology-oncology franchise through the identification and potential acquisition or in-licensing of attractive oncology product candidates.
Ms. Bodarky has more than 25 years of corporate strategy, business development and licensing, marketing and corporate affairs experience within the biopharmaceutical industry. Most recently, she was President of LMB Consulting, LLC where she provided corporate strategy and end-to-end business development advisory services to biopharmaceutical companies. Prior to that, she was Vice President, Business Development for Intrexon Corporation where she was responsible for negotiating and structuring corporate partnerships across therapeutic areas, including oncology. Ms. Bodarky’s previous experience includes senior corporate strategy and business development roles within the following organizations: International Partnership for Microbicides; Pfizer Inc.; Progenics Pharmaceuticals, Inc.; Pharmacia Corporation; and Merck & Co., Inc.
Ms. Bodarky has a B.S. from The Wharton School, University of Pennsylvania and an M.B.A. from Columbia Business School, Columbia University.
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
In connection with the commencement of employment, the Company has granted non-statutory stock options to purchase an aggregate of 1,100,000 shares of Geron common stock to Ms. McBain, Ms. Bodarky and two other new employees. The stock options were granted on July 17, 2019 at an exercise price of $1.24 per share, which is equal to the closing price of Geron common stock on the date of grant. Each stock option granted has a 10-year term and vests over four years, with 12.5% of the shares underlying the option vesting on the six-month anniversary of commencement of employment and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Each stock option was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and is subject to the terms and conditions of a stock option agreement covering the grant and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat consist of a Phase 2/3 trial, called IMerge, in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial, called IMbark, in Intermediate-2 or High-risk myelofibrosis. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for the treatment of patients with transfusion-dependent anemia due to lower risk MDS who are non-del(5q) and refractory or resistant to an erythroid stimulating agent.
Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
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) that Geron’s growing internal expertise will advance its current and longer-term corporate objectives; (ii) that Geron will conduct an End of Phase 2 meeting with the FDA for relapsed/refractory MF by the end of the first quarter of 2020; (iii) that the imetelstat program could potentially be commercialized; (iv) that Geron plans to partner the ex-U.S. commercialization rights for imetelstat; (v) that Geron will build a leading hematology-oncology franchise; (vi) that imetelstat may have disease-modifying activity; and (vii) other statements that are not historical facts, constitute forward-looking statements. These 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: (i) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (ii) whether imetelstat is safe and efficacious, and whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (iii) whether Geron is able to complete the required activities in order to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020; (iv) whether imetelstat is approved by regulatory authorities for commercialization; (v) Geron’s potential inability to successfully retain or recruit key personnel to support its current and future corporate objectives or to otherwise successfully manage its growth; and (vi) whether imetelstat demonstrates disease-modifying activity. 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 under the heading “Risk Factors,” including Geron’s quarterly report on Form 10-Q for the quarter ended March 31, 2019. 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.
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