Healthcare Industry News: U.S. Food and Drug Administration
News Release - September 24, 2018
Tocagen Appoints Mohamed Ladha as Vice President to Establish Commercial OrganizationSAN DIEGO, Sept. 24, 2018 -- (Healthcare Sales & Marketing Network) -- Tocagen Inc. (Nasdaq :TOCA ), a clinical-stage, cancer-selective gene therapy company, today announced the appointment of Mohamed Ladha as vice president, head of commercial. Mr. Ladha will build, oversee and execute the global commercial strategies for Tocagen's oncology products upon regulatory approval in the United States and other key markets.
"Mohamed's extensive experience and successful track record in developing and commercializing oncology products such as Temodar® for brain cancer will be invaluable as we advance towards the potential global commercialization of Toca 511 & Toca FC," said Marty Duvall, chief executive officer of Tocagen.
Mr. Ladha has over 23 years of experience in the fields of oncology and immunology including leading product development and marketing teams at pharmaceutical and biotechnology companies. He has commercialized eight products for a variety of oncology indications, including TEMODAR® (temozolomide, Schering-Plough/Merck) for glioblastoma, OncoTICE® (BCG, Schering Plough/Merck) for bladder cancer, and ALUNBRIG® (brigatinib, ARIAD/Takeda) for lung cancer, as well as medicines for autoimmune diseases. Most recently he led the U.S. lung cancer portfolio at Takeda Oncology where he was responsible for the launch and commercialization of ALUNBRIG and subsequent pipeline products. Prior to this, Mr. Ladha led the U.S. and global lung cancer portfolio at ARIAD Pharmaceuticals, part of Takeda Oncology since early 2017. Previously, Mr. Ladha was the head of global and U.S. biosimilars at Hospira/Pfizer where he oversaw the launch and commercialization of three biosimilars in oncology and autoimmune diseases. He also held roles in oncology field sales and later led oncology marketing and product commercial development at Schering-Plough and then Merck for nine years. Prior to joining industry, Mr. Ladha spent five years as a researcher at Harvard Medical School's Dana-Farber Cancer Institute and co-authored several scientific publications on his cancer research in areas of RAS driven signal transduction pathway and retinoblastoma and cyclin-dependent cell cycle mechanisms. Mr. Ladha received a master's of public administration in healthcare/international development from Harvard University and a master's of business administration in marketing and finance from Northwestern University.
"With a highly differentiated cancer-selective gene therapy platform, provocative clinical data for Toca 511 & Toca FC including six complete and durable responses in patients with recurrent brain cancer, and a fully enrolled pivotal Phase 3 trial, I am eager to join Tocagen's team and build the company's commercial capabilities for the launch and commercialization of Toca 511 & Toca FC, following approval," said Mr. Ladha. "If the Toca 5 trial results are positive, Toca 511 & Toca FC would be the first therapeutic to show a treatment benefit in a randomized trial in patients with recurrent high grade glioma. That's a powerful proposition for patients with brain cancer, especially in a therapeutic area that has lacked any major treatment advances for almost two decades."
About Tocagen Inc.
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. Tocagen's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial for recurrent high grade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of glioma. For more information about Tocagen, visit www.tocagen.com.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our business plans and objectives and expectations regarding the enrollment, timing and success of our clinical trials as well as future regulatory approval of Toca 511 & Toca FC. Risks that contribute to the uncertain nature of the forward-looking statements include: the timing and results of our ongoing and planned clinical trials; our ability to execute on our strategy, including our ability to complete the clinical development and other activities required for regulatory approval of Toca 511 & Toca FC in the U.S. and other jurisdictions; and regulatory developments in the United States and foreign countries. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Tocagen's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Tocagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
In connection with the hiring of Mr. Ladha, the Compensation Committee of the Board of Directors of Tocagen has approved the grant to Mr. Ladha an inducement stock option award to purchase 75,000 shares of Tocagen common stock. The stock option will be granted on September 30, 2018 in accordance with Tocagen's general practice. The stock option will have an exercise price per share equal to the closing price of Tocagen's common stock on September 30, 2018, and it will be a non-qualified stock option and will have a 10-year term. The stock option will vest over four years, with 25% of the shares subject to the option vesting on the one-year anniversary of the commencement of Mr. Ladha's employment with Tocagen and the remainder of the shares vesting in equal monthly installments over the following three years, subject to Mr. Ladha's continued service with Tocagen through the applicable vesting dates. The stock option will be subject to the terms and conditions of Tocagen's 2017 Equity Incentive Plan, as amended, and the award agreement pursuant to which the stock option is granted.
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