Global Pharma Briefs: News from Pfizer, Moderna, CStone, and Covis

By Miranda Greenberg -

October 8, 2020

A roundup of news from China (Pfizer, CStone Pharmaceuticals), Luxembourg (Covis, AMAG Pharmaceuticals), and the US (Moderna, XtalPi).

China

Pfizer, CStone in $480-M Oncology Drug Pact in China
Pfizer has formed a strategic collaboration, worth up to $480 million, with CStone Pharmaceuticals, a Suzhou, China-based biopharmaceutical company, for the development and commercialization of CStone’s sugemalimab, a PD-L1 antibody, in mainland China, and for a framework for bringing additional oncology assets to the Greater China market.

Under the agreement, Pfizer will make an equity investment in CStone of $200 million for 115,928,803 CStone shares at $1.725 per share. As a result of its equity investment, Pfizer will hold a 9.90% stake in CStone. CStone is also entitled to receive up to $280 million in milestone payments for sugemalimab and additional tiered royalties.

This collaboration provides financing to support CStone’s development of sugemalimab, which is being developed for lung, gastric, and esophageal cancers, and other high-incidence cancers in China. Pfizer will in-license and exclusively lead commercialization of sugemalimab in China. Pfizer obtains exclusive commercialization rights to sugemalimab in mainland China, and CStone retains all development and commercialization rights to sugemalimab outside mainland China. CStone will continue to lead clinical development and regulatory strategy for five selected indications.

In addition, CStone and Pfizer will together select late-stage (post proof-of-concept) oncology assets for co-development in the Greater China market. These assets may come either from Pfizer’s pipeline or through joint in-licensing. CStone and Pfizer may pursue, on a selected basis, joint in-licensing arrangements for additional oncology assets for the Greater China market.

Source: CStone Pharmaceuticals

Luxembourg

Covis To Acquire AMAG Pharmaceuticals in $647-M Deal
Covis Group, a Luxembourg-based specialty pharmaceutical company, has agreed to acquire AMAG Pharmaceuticals, a Waltham, Massachusetts-based pharmaceutical company, in a deal valued at $647 million, inclusive of debt to be assumed or repaid net of cash.

Under the proposed acquisition, Covis will acquire AMAG for $13.75 per share. Following the successful completion of a tender offer, an indirect, wholly owned subsidiary of Covis will merge with AMAG and the outstanding AMAG shares not tendered in the tender offer will be converted into the right to receive the same $13.75 per share in cash paid in the tender offer. The tender offer is expected to begin in October 2020.

The transaction, which has been unanimously approved by the Board of Directors of each company, is expected to close in November 2020, pending Hart-Scott-Rodino approval and the conditions to the tender offer being satisfied.

Following the announced acquisition on October 1, 2020, AMAG reported on October 5, 2020 that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research informed the company that the agency is proposing to withdraw approval of AMAG’s Makena (hydroxyprogesterone caproate injection), a drug for reducing the risk of preterm birth. Makena had 2019 sales of $121 million, accounting for 37% of the company’s 2019 revenues of $327 million.

The FDA in its letter also notified AMAG that the company has the opportunity to request a hearing on the withdrawal. AMAG said it is evaluating potential options. The company has 15 days to respond to the FDA indicating whether AMAG would like to proceed with a hearing. If AMAG does request a hearing, the FDA Commissioner would decide whether to grant AMAG’s request and, if granted, would conduct a hearing and decide whether to withdraw approval following the hearing. AMAG says that this process can take months, and during this time, Makena and the approved generics of Makena will remain on the market, according to the FDA.

Source: Covis Group and AMAG Pharmaceuticals (acquisition) and AMAG Pharmaceuticals (FDA notification)

US

AI Drug Technology Start-up XtalPi Raises $319 M
XtalPi, a Cambridge, Massachusetts-based pharmaceutical technology company using artificial intelligence (AI) and cloud-based computing for drug discovery and development, has raised $318.8 million from global investment companies.

XtalPi was founded in 2014 by a group of quantum physicists at the Massachusetts Institute of Technology. It uses multi-disciplinary expertise in physics, chemistry, pharmaceutical R&D, and algorithm design to evaluate the physiochemical and pharmaceutical properties of small-molecule candidates for drug design, solid-form selection, and other aspects of drug development.

The investment is co-led by SoftBank Vision Fund, a technology-focused venture capital fund, PICC Capital, a Beijing-based investment platform, and Morningside Venture Capital, a Hong Kong-based private investment firm.

Source: XtalPi

Moderna Gets $56 M from US Gov’t for Nucleic Acid Vaccines, Therapies
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has been awarded up to $56 million in an agreement with the Defense Advanced Research Projects Agency (DARPA) to fund development of a mobile manufacturing protype using Moderna’s existing manufacturing technology that is capable of rapidly producing vaccines and therapeutics.

The agreement builds on a previous assistance grant with DARPA established in 2013. The award is part of DARPA’s Nucleic Acids On Demand World-Wide (NOW) initiative to develop a mobile, end-to-end automated manufacturing platform to provide in-field manufacturing of nucleic acid (including mRNA) vaccines and therapeutics intended to deliver protections and treatments to both military personnel and local populations. The company says the design envisions a manufacturing unit capable of producing hundreds of doses of medicines in a matter of days in a 6 foot x 6 foot x 6 foot container in remote locations globally.

DARPA’s financial support of the NOW program is part the agency’s commitment to creating biotechnological approaches to rapidly detect, characterize, and mitigate threats from newly emerging or engineered pathogens.

Source: Moderna