Global Pharma Briefs: News from Roche, Lilly, and Dr. Reddy’sBy
A roundup of news from the US (Dr. Reddy’s Laboratories, Roche, Lilly, and Biolojic).
Dr. Reddy’s Issues Recall of Generic Lipitor
Dr. Reddy’s Laboratories has initiated a voluntary recall of atorvastatin calcium tablets, a generic version of Pfizer’s anti-cholesterol drug, Lipitor, due to the detection of certain impurities based on failed impurities/degradation specifications.
The Class III recall applies to atorvastatin calcium tablets, 40 mg, packaged in 90-count bottles and 500-count bottles, 10,440 90-count bottles and 224,710 500-count bottles. A Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. The products were distributed nationwide in the US.
The recall was cited in the Weekly Enforcement Report of March 10, 2021 of the US Food and Drug Administration.
Source: US Food and Drug Administration
Roche Withdraws Bladder Cancer Indication for Tecentriq in US
Roche is voluntarily withdrawing an indication in the US for Tecentriq (atezolizumab) for prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).
Tecentriq was granted accelerated approval in 2016 for the treatment of prior-platinum treated mUC. Continued approval for this indication was contingent upon the results of a post- marketing study for the prior-platinum treated mUC indication. This study did not meet its primary endpoint of overall survival in the PD-L1 high patient population. Subsequently, the US Food and Drug Administration (FDA) designated the study could continue until the final analysis. However, Roche says as the treatment landscape in prior-platinum (second-line) mUC has evolved with the emergence of new treatment options, it is voluntarily withdrawing this indication.
Roche says it will work with the FDA over the coming weeks (as reported on March 8, 2021) to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq. Tecentriq is approved in the US, European Union, and countries globally, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer, small cell lung cancer, certain types of mUC, in PD-L1-positive metastatic triple-negative breast cancer. and for hepatocellular carcinoma.
Tecentriq had 2020 sales of $2.7 billion.
Lilly To Make Leadership Changes in Mfg Organization
Eli Lilly and Company has announced the upcoming retirement of two executive committee members and the naming of its successors in the company’s manufacturing operations and ethics and compliance organizations.
Myles O’Neill, Senior Vice President and President of Lilly’s manufacturing operations, will retire May 2, 2021 after nearly 19 years with the company. Edgardo Hernandez, who currently serves as Senior Vice President, Global Parenteral Drug Product and Device Manufacturing, will succeed O’Neill as Senior Vice President and President of Lilly’s manufacturing operations.
Melissa Barnes, Senior Vice President and Chief Ethics and Compliance Officer, will retire June 27, 2021 after more than 26 years with the company. Alonzo Weems, presently Vice President and Deputy General Counsel, will succeed Barnes as Senior Vice President and Chief Ethics and Compliance Officer.
Mr. Hernandez and Mr. Weems will report to David A. Ricks, Lilly Chairman and Chief Executive Officer, and both will join Lilly’s Executive Committee.
Source: Eli Lilly and Company
Lilly, Biolojic in AI Research Pact for Diabetes Drugs
Eli Lilly and Company and Biolojic Design, a Tel Aviv Israel-based biotechnology company that computationally designs functional antibodies, have entered into a research collaboration and license agreement that will use Biolojic’s artificial intelligence-based multibody platform to discover and develop a potential novel antibody-based therapy for treating diabetes.
Under the agreement, Lilly will pay research fees associated with the collaboration, and additionally, Biolojic is eligible to receive up to a total of $121 million in potential development and commercialization milestones and a promissory note that may be convertible into Biolojic equity at a future date. Biolojic is also eligible to receive tiered royalties in the low- to mid-single digits on product sales should Lilly successfully commercialize a therapy from the collaboration. The specific targets to be studied in the collaboration were not disclosed.
Source: Eli Lilly and Company