According to the United States Attorney's Office, Xanthe Lam, a principal scientist at the Roche Holding AG unit from 1986 until 2017, conspired with her husband and fellow former employee Allen Lam, and John Chan, another former Genentech employee, to steal trade secrets over the course of 5 years related to the biopharmaceutical dornase alfa (Pulmozyme) and some of Roche’s top-selling cancer drugs: rituximab (Rituxan), trastuzumab (Herceptin), and bevacizumab (Avastin).
According to a statement issued October 29 by the United States Attorney’s Office in San Francisco, former Genentech employees were charged with conspiring to steal trade secrets to assist biosimilar developer JHL Biotech.
According to the statement, Xanthe Lam, a principal scientist at the Roche Holding AG unit from 1986 until 2017, conspired with her husband and fellow former employee Allen Lam, and John Chan, another former Genentech employee, to steal trade secrets over the course of 5 years related to the biopharmaceutical dornase alfa (Pulmozyme) and some of Roche’s top-selling cancer drugs: rituximab (Rituxan), trastuzumab (Herceptin), and bevacizumab (Avastin).
JHL is currently in the process of developing biosimilars for all 3 of the branded products. In fact, both of its potential biosimilars for trastuzumab and rituximab are about to enter phase 3 trials, while its potential bevacizumab biosimilar was cleared for a phase 1 trial in February 2018. JHL also indicated in March 2018 that it would commence a phase 1 clinical trial of its dornase alfa biosimilar.
The indictment alleges that Xanthe Lam downloaded, collected, and transferred to Allen Lam and others at JHL “certain confidential Genentech documents relating to the processes by which the company formulated drugs and managed raw materials. Xanthe Lam also allegedly secretly consulted for JHL while still employed at Genentech.”
According to prosecutors, Xanthe Lam also allowed a fourth conspirator, James Quach, employed by JHL, to gain access to Genentech documents in efforts to steal the company’s proprietary manufacturing protocols. Specifically, the indictment alleges that she allowed Quach to gain access to Genentech’s secure document repository from which he subsequently stole the company’s proprietary manufacturing protocols.
“We don’t think the government will be able to sustain the charges,” said Xanthe Lam’s lawyer, William Osterhoudt, Bloomberg reported. “She is a brilliant scientist and has patents in her own name. She has been working hard to develop medicines to help people,” he said.
Separately, Genentech filed a civil suit, making similar allegations, in a San Francisco federal court.
“Dishonest and illegal actions such as these threaten scientific innovation, obstruct fair competition, and undermine the work of our employees and people throughout the industry who act with integrity and in the best interests of patients every day,” a Roche representative told Yahoo Finance on Tuesday.
All 4 defendants were arraigned earlier this week before a federal magistrate judge and pleaded not guilty. If found guilty of trade secret theft, Xanthe Lam, Allen Lam, and Chan face as long as 10 years in prison. Quach could face as many as 5 years. All 4 defendants were released on bond and are due back in court on November 2.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.