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Shortly after unveiling a revised R&D strategy and organizational restructuring, AstraZeneca made a massive bet on an early-stage platform that suggested the big pharma has taken to heart new CEO Pascal Soriot’s directive to be more willing to embrace risk.
|"Soriot was struck by the technology |
within 10 minutes... "
Heading into Soriot’s strategy review on March 21, AstraZeneca announced an organization-wide R&D restructuring that would consolidate the work in both small and large molecules within three strategic regional centers: Cambridge, U.K., Gaithersburg, Md., and Molndal, Sweden. At a time when some of its top sellers have faced patent expirations, the pharma has struggled to develop successful, innovative high-growth new drugs.
Shortly before his departure, outgoing R&D chief Martin Mackay vetted and introduced Soriot to the Moderna mRNA therapeutics technology and the two companies quickly came together around a significant collaboration, Moderna CEO Stephane Bancel said.
“When Mackay came in, he was very impressed with the data we showed him under a confidentiality agreement,” Bancel said. “In turn, he impressed us by coming back very quickly to see us with his entire R&D executive team. We quickly we got into a discussion about potentially partnering one or two drugs in cardiology.”
When Soriot joined the talks, plans for the deal expanded. “Soriot was struck by the technology within 10 minutes, he got it totally,” Bancel noted. Given AZ's ramp up of business development, we wonder what he's going to buy after a 20 minute browse.
AstraZeneca wanted multi-year exclusivity on Moderna’s entire cardiovascular program, which was fine with Bancel if he could structure a deal to hold back some of his firm’s oncology programs. In December, Bancel outlined a corporate strategy in which Moderna would seek to out-license large-scale therapeutic opportunities while keeping some rare disease opportunities in-house for development and commercialization.
What resulted was a deal under which AstraZeneca will hold options to select up to 40 mRNA drug candidates for preclinical and clinical development and commercialization. Beyond the $240 million upfront payment, Moderna also can earn up to $180 million in “technical milestones,” an arrangement Bancel described as almost a secondary, contingent upfront payment.
Moderna also could earn development, regulatory and commercial milestones for each drug candidate licensed by AstraZeneca, as well as sales royalties ranging from the high single digits to low double digits. Bancel said total remuneration under the deal could go well beyond $1 billion, as each product candidate will carry potential Phase I, Phase II, Phase III, NDA-filing, U.S. approval and ex-U.S. approval earn-outs.
Under the agreement, Moderna will perform discovery work against targets selected by AstraZeneca, but the pharma will be responsible for preclinical and clinical development for any candidate it then opts to license. This will leave Moderna with substantial opportunity to continue advancing its own proprietary programs, focused on niche opportunities within oncology.
Moderna’s selling point is that its mRNA candidates, based on research licensed from Harvard University and Massachusetts Institute of Technology, will enable the human body to restart or increase the production of endogenous therapeutic proteins inside a patient’s cells without triggering an innate immune response. In addition, while other RNA-based technologies such as RNA interference have faced significant drug-delivery obstacles, Moderna believes it can create injectable drugs for intramuscular, subcutaneous or intravenous administration. Evidently, AstraZeneca agrees.