Pharmaceutical Technology Editors

Bristol Myers Squibb (BMS) announced their $4.1 billion acquisition of Turning Point Therapeutics, a clinical-stage precision oncology company, on June 3, 2022. The acquisition grants BMS access to the company's oncology pipeline and lead candidate, repotrectinib.

Repotrectinib is a tyrosine kinase inhibitor designed to target proto-oncogene tyrosine-protein kinase ROS (ROS1) and neurotrophic tyrosine receptor kinase, oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumors. According to a BMS press release, the Phase I/II TRIDENT-1 clinical trial found a longer duration of response with repotrectinib versus existing ROS1 agents in first-line NSCLC.

“Today’s news builds upon our long legacy of pioneering next-generation medicines for patients with cancer,” said Samit Hirawat, chief medical officer, global drug development, BMS, in the press release. “With repotrectinib, we have the opportunity to change the standard of care and address a significant unmet medical need for ROS1-positive non-small cell lung cancer patients.”

“Through this transaction, we will be able to harness the full potential of our precision oncology platform to advance the standard of care for cancer patients,” said Athena Countouriotis, president and CEO, Turning Point Therapeutics, in the press release. “With Bristol Myers Squibb’s leadership in oncology, strong commercial capabilities and manufacturing footprint, we will be able to further accelerate the pace at which we can bring our novel medicines to benefit people diagnosed with cancer around the world.”

Repotrectinib has received three breakthrough therapy designations from FDA. According to the release, BMS expects it to be approved in the United States in the second half of 2023.

Articles

The acquisition grants Bristol Myers Squibb access to the company's oncology pipeline and lead candidate, repotrectinib.

Bristol Myers Squibb Acquires Turning Point Therapeutics for $4.1 Billion

Eli Lilly and Company (Lilly) announced a $2.1 billion investment in two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County. According to a company press release, the sites are intended to increase Lilly's manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines.

“More than 146 years after our founding, Lilly remains committed to investing and innovating in Indiana," said David A. Ricks, Lilly's chair and CEO, in the company press release. "These new sites will add capacity in support of our growing pipeline of innovative medicines, while also creating more high-tech jobs for Hoosiers. We are pleased to be a founding investor at the LEAP Lebanon Innovation District."

This move follows Lilly’s 2019 expansion in Indiana, which saw $2.5 billion invested over five years. According to the release, this brought the current number of Lilly manufacturing employees to 3,700, while the current project is slated to add an additional 500 new Lilly roles and four indirect jobs for every Lilly position created.

"Lilly has been an anchor in Indiana's economy for generations, and this announcement means they will continue to be here for generations," said Indiana governor, Eric J. Holcomb, in the press release. "I am incredibly proud Lilly continues to make exciting investments in Indiana that will better the lives and opportunities of Hoosiers for decades to come. And in turn, the very research and pharmaceutical manufacturing spearheaded here in our state will improve lives worldwide."

Eli Lilly and Company plans to build two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.

Lilly to Invest $2.1 Billion in New Indiana Manufacturing Facilities

Pfizer announced on June 6, 2022 that it will invest $120 million in its Kalamazoo, MI facility to support the production of its COVID-19 oral treatment, PAXLOVID. The investment is predicted to create more than 250 additional high-skilled jobs at the company’s Kalamazoo site.

The investment is a step towards the company’s goal to further strengthen its commitment to US manufacturing, increasing its capability to produce and supply treatments and medicines for patients in the United States and around the world. Pfizer has shipped 12 million courses of PAXLOVID across 37 countries, including 5 million courses shipped to the US, and has manufactured almost 17 million treatment courses total, to date.

“Pfizer Global Supply has made the impossible possible, making billions of vaccine doses and now millions of treatment courses to help battle the deadly COVID-19 pandemic,” said Albert Bourla, chairman and CEO of Pfizer, in a press release. “By increasing production at our Michigan facility, we are both helping patients around the world and expanding important manufacturing innovation to the US. This investment builds upon our $5 billion of investments across our manufacturing and distribution portfolio since 2017 to support the ongoing growth of US manufacturing leadership.”

“Pfizer’s Kalamazoo facility has been at the forefront of pharmaceutical manufacturing for more than 135 years through the legacy company Upjohn,” added Mike McDermott, chief global supply officer of Pfizer, in the release. “The Kalamazoo facility uses some of our most innovative manufacturing technology and has been essential in Pfizer’s fight against COVID-19, producing nearly one billion doses of COVID-19 vaccine at the site to date. Through this expansion, we will continue to invest in the next generation of manufacturing and supply chain resilience.”

Pfizer will invest $120 million to produce COVID-19 oral treatment in the US. 

Pfizer to Invest $120 Million in COVID-19 Oral Treatment Production

Sanofi announced on June 2, 2022 that Regeneron will obtain worldwide exclusive license rights to Libtayo, a treatment for non-small cell lung cancer (NSCLC). Prior to Sanofi’s restructure of its immune-oncology collaboration with Regeneron, the companies had split Libtayo’s worldwide operating profits equally and co-commercialized the treatment in the United States, with Sanofi solely responsible for commercialization in the rest of the world.

Under the new license and collaboration agreement, Sanofi will receive an upfront payment of $900 million as well as an 11% royalty on worldwide net sales of Libtayo. Sanofi will also be entitled to a $100 million regulatory milestone payment as well as sales-related milestone payments of up to $100 million over the next two years.

Regeneron will also increase the share of its profits that are paid to Sanofi to reimburse Sanofi-funded development expenses from 10% to 20% until Regeneron’s share of the cumulative development costs incurred under the collaboration has been reached.

“Our diverse oncology portfolio doubled between 2019 and 2022 and now includes 12 compounds in clinical trials, each with a unique mechanism of action,” said Bill Sibold, executive vice president of specialty care & president of North America, Sanofi, in a press release. “Our early steps with Libtayo in immuno-oncology provided a strong foundation for our revitalized oncology efforts. Now, we are focused on leveraging our internal capabilities and advancing a new generation of oncology medicines. We continue to maintain a strong partnership with Regeneron in immunology and will work closely with them on the seamless transition of Libtayo to ensure there is no impact for patients.”

Sanofi will grant Regeneron worldwide exclusive license rights to Libtayo, a treatment for non-small cell lung cancer.

Sanofi Grants Regeneron Worldwide Exclusive License Rights to Libtayo

Astellas Pharma and GO Therapeutics announced that Xyphos Biosciences, a wholly owned subsidiary of Astellas, and GO have entered into a strategic research collaboration and license agreement to develop novel immuno-oncology therapeutics. Xyphos is paying $20.5 million in upfront cash, but milestone and contingency payments could increase the total to as much as $783 million.

According to an Astellas press release from June 1, 2022, the two companies will collaborate exclusively to identify antibodies with high affinity to two different glycoprotein targets for use in a range of therapeutic modalities. GO will work toward discovering high-affinity antibodies against the two targets, while Astellas will be responsible for research activities, clinical development, and commercialization of any derived therapeutics.

“We are excited to collaborate with Astellas to develop a new class of immuno-oncology therapeutics," said Constantine Theodoropulos, co-founder and CEO, GO Therapeutics, in the press release. “The combination of GO’s targets and antibodies and Astellas’ ACCEL [advanced cellular control through engineered ligands] technology promises to create a new generation of cancer treatments that have a greater therapeutic index. This will enable oncologists to increase the efficacy of antibody-based immunotherapies for solid tumors with less damage to healthy tissues.”

"At Astellas, we have positioned immuno-oncology as one of the primary focuses of our R&D strategy,” said Naoki Okamura, chief strategy office, Astellas, in the press release. “We believe that this collaboration will bring synergies between the two companies' cutting-edge research and will ultimately lead to the development of new therapeutics for patients with great unmet medical needs.”

Astellas and GO Therapeutics will work together to develop novel antibodies for immuno-oncology.

Astellas and GO Therapeutics Enter into Immuno-Oncology Research and License Agreement Worth Up to $783 Million

Thermo Fisher Scientific and Qatar Genome Program, a member of the Qatar Foundation, have announced a partnership to use custom genotyping arrays to accelerate genomic research and the clinical applications of predictive genomics in Qatar. The goal of this partnership is to work toward expanding the benefits of precision medicine across global Arab populations.

According to a May 23, 2022 press release, Thermo Fisher and Qatar Genome Program will develop an Axiom custom genotyping array for pan-Arab populations via whole genome sequencing data from 19 Arab countries. The array consists of approximately 800,000 variants and aims to drive research into conditions like diabetes, cardiovascular and metabolic diseases, autism, inherited genetic disorders, and cancer. The array is designed to be a cost-effective alternative to whole genome sequencing for Arab populations.

A partnership between the two entities first began in 2018 when they developed the first microarray specifically designed for the Qatari population, the Q Chip, which detects genetic alterations that increase individuals' risk of various diseases. Per the terms of this agreement, the organizations will continue to refine algorithms and define clinically actionable content to assess polygenic risk scores and clinically relevant variants, including those related to pharmacogenomics.

“Qatar’s national vision is to provide a high standard of living for our people, and that includes providing access to genomics data, technology and insights to improve population health across the country,” said Radja Badji, genome operations manager, Qatar Genome Program, in the press release. “Our collaboration with Thermo Fisher will not only help us advance precision medicine in Qatar but also among people of Arab identity worldwide.”

“Thermo Fisher’s Axiom microarray technology is designed to help accelerate precision medicine, and we are honored to partner with the Qatar Genome Program as they take bold steps to leverage the power of genomics to improve the standard of care for human health,” said Chad Carter, vice-president and general manager of microarray genetic solutions, Thermo Fisher Scientific, in the press release. “Together, we’re creating building blocks for implementing comprehensive precision medicine initiatives at scale for population health.”

Thermo Fisher Scientific and Qatar Genome Program will use custom genotyping arrays to accelerate genomic research in Qatar.