Pharmaceutical Technology Editors

AstraZeneca and Daiichi Sankyo announced on Jan. 20, 2021 that their HER2-positive metastatic breast cancer treatment, Enhertu (trastuzumab deruxtecan), has been granted conditional approval from the European Commission as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more previous anti-HER2-based regimens.

The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease, AstraZeneca said in a company press release. The treatment was previously approved for use in the United States under accelerated approval, and in Japan under a conditional early approval system.

“Enhertu is already transforming outcomes for patients with HER2-positive metastatic breast cancer in the US and Japan, and this approval enables us to bring the benefits of this medicine to patients in the [European Union],” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca. “We will continue to explore the potential of Enhertu in this setting, as well as in earlier lines of treatment and stages of disease, with the ambition of improving the lives of patients with HER2-targetable breast cancer.”

“This expedited review underscores the practice-changing potential of Enhertu for patients in the metastatic setting,” added Gilles Gallant, senior vice president, global head, Oncology Development, Oncology R&D, Daiichi Sankyo, in the press release. “Enhertu is the first-ever new medicine to be approved in breast cancer in Europe on the basis of Phase II single-arm data, and one of the fastest accelerated assessment procedures for an application in oncology.”

Articles

The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease.

AstraZenca and Daiichi Sankyo’s Breast Cancer Treatment Approved for Use in Europe

Thermo Fisher Scientific announced on Jan. 19, 2021 that it is acquiring Mesa Biotech, a US-based molecular diagnostic company for $450 million in cash.

Under the terms of the agreement, Thermo Fisher will pay an additional $100 million in cash if certain milestones are reached after the closing of the transaction, which is set for the first quarter of 2021, Thermo Fisher said in a company press release.

Through the acquisition, Thermo Fisher will have access to Mesa’s PCR-based rapid point-of-care testing platform for detecting infectious diseases including SARS-CoV-2, Influenza A and B, respiratory syncytial virus, and Strep A, the press release said.

"Mesa Biotech's innovative platform will enable us to accelerate the availability of reliable and accurate advanced molecular diagnostics at the point of care. Since the start of the pandemic, Thermo Fisher has acted quickly to provide support to the scientists and healthcare professionals at the frontlines of combating COVID-19," said Mark Stevenson, executive vice-president and chief operating officer of Thermo Fisher Scientific, in the press release. "The addition of Mesa Biotech's easy-to-use, rapid PCR-based test is highly complementary to our existing offering and will further help us meet the continuing demand for COVID-related testing while we work to rapidly scale and develop point-of care tests for other infectious diseases in the future."

Through the acquisition, Thermo Fisher will have access to Mesa’s PCR-based rapid point-of-care testing platform for detecting infectious diseases.

Thermo Fisher to Acquire Mesa Biotech for $450 Million

Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company, and Merus, a Netherlands-based clinical-stage oncology company, announced on Jan. 19, 2021 that they are entering into a research collaboration and exclusive license agreement to research and develop up to three CD3-engaging T-cell redirecting bispecific antibody therapies using Merus' proprietary Biclonics platform for up to $1.6 billion.

Through the agreement, Merus will receive an upfront cash payment of $40 million, an equity investment by Lilly of $20 million, and $540 million in potential development and commercialization milestones per product, Eli Lilly said in a company press release. Merus will handle the discovery and early-stage research activities of the products, while Loxo Oncology at Lilly will lead additional research, development, and commercialization activities.

"CD3-engaging bispecific antibodies are rapidly becoming one of the most transformative immune-modulating modalities used to treat cancer. We expect these therapies will become an important component of the Loxo Oncology at Lilly biologics strategy," said Jacob Van Naarden, chief operating officer of Loxo Oncology at Lilly, in the press release. "Merus has built a differentiated platform and one that we believe can enable us to create bispecific antibody therapies with wider therapeutic indexes than those available today. We look forward to working closely with Merus to develop new potential medicines for patients with cancer."

"The collaboration with Loxo Oncology at Lilly and their world class research capabilities opens up exciting possibilities for Merus' Biclonics platform," added Bill Lundberg, MD, president and CEO at Merus, in the press release. "Our CD3 T-cell engager platform includes over 175 novel and diverse anti-CD3 common light chain antibodies across a wide range of affinities and attributes and enables functional screening of large libraries for optimal performance. We look forward to working together with Loxo Oncology at Lilly to define a new generation of medicines to treat cancer."

The companies will develop up to three CD3-engaging T-cell redirecting bispecific antibody therapies using Merus' proprietary Biclonics platform.

Loxo Oncology at Lilly and Merus Enter into Bispecific Antibody Partnership for up to $1.6 Billion

Contec announced on Jan. 19, 2020 that it has introduced ReFIBE sterile cleanroom wipes, sustainable polyester wipes made from recycled post-consumer plastic bottles.

According to a company press release, the plastic bottles are first chopped into flakes and cleaned, then the flakes are melted, filtered, and formed into chips, which are melted and made into yarn. Finally, the yarn is knitted into sterile and non-sterile 9” x 9” and 12” x 12” ReFIBE wipes.

Laser-cut with heat-sealed edges, ReFIBE are cleanroom laundered and made with 100% polyester, Contec said in the press release.

“ReFIBE has been such a fulfilling project to work on,” said Amy Russ, global project manager for the Cleanroom Division at Contec, in the press release. “We consider it our responsibility to offer clean, sustainable alternatives to our customers, and ReFIBE wipes are just the beginning. We are excited to develop more sustainable options for both existing Contec products and new innovations in the months and years to come.”

ReFIBE sterile cleanroom wipes are sustainable polyester wipes made from recycled post-consumer plastic bottles.