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After years of construction delay, and pandemic-enforced social distancing, employees will finally be able to work together at AstraZeneca's new global HQ in Cambridge, UK.

After an intense 18 months of developing and manufacturing a not-for-profit COVID-19 vaccine for the world, AstraZeneca is entering a new phase as it looks to return to some kind of normality in its commercial and R&D operations.

AstraZeneca is still very much engaged in the field, and head of R&D Sir Mene Pangalos is overseeing the development of a second generation COVID-19 vaccine, but there is a clear sense that the immense pressure of 2020’s race to develop a COVID-19 vaccine has now abated.

That is important for the company, which must maintain its run of R&D success and productivity established under Pangalos in recent years, with non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib) and diabetes/heart disease therapy Forxiga (dapagliflozin) among its novel blockbusters propelling its growth, currently one of the best in the sector. (AstraZenecas Soriot Dismisses Any Pfizer Vaccine Envy Amid Buoyant Q2 Results)

The company has also just finalized its $39bn acquisition of Alexion, which will operate as a semi-autonomous rare disease unit, but which could further boost AZ’s presence in novel immunology-based therapies. (AstraZeneca Clears Final Hurdle To Seal Alexion Takeover)

There is no doubt that developing the COVID-19 vaccine has taken its toll on Pangalos and his colleagues, who have been applauded for bringing the low cost and highly effective vaccine to people around the world, but who have also been criticized for problems with manufacturing and concerns about cases of rare but potentially fatal side-effects.

Sir Mene Pangalos

That means AstraZeneca is still having to defend its achievements on Vaxzevria.

Speaking last week as the company reported its performance in the first half of the year, Pangalos told Scrip that he and his colleagues are proud of what they have achieved – but also "exhausted.”

“It most definitely has not been easy, because the ‘day job’ and everything else has had to carry on at the same time,” said Pangalos.

The company and its manufacturing partner the Serum Institute of India have now delivered 1 billion doses worldwide, which includes being the European Union’s second biggest vaccine supplier and the biggest supplier to the global COVAX initiative, benefitting lower and middle income countries in particular.

“It's been a heavy lift but we are incredibly proud of what we've done,” he said. “Not just in the doses delivered but also where we've delivered them and how we've delivered them. I think we have been true to our word in doing it globally and affordably.”

The company had pledged to deliver up to three billion doses of the vaccine worldwide by the end of 2021, but CEO Pascal Soriot has now revised that figure to more than two billion, largely because of lower-than-expected manufacturing yields.

AstraZeneca and Oxford’s not-for-profit price contrasts with Pfizer/BioNTech and Moderna, who have earned many billions from their mRNA-based vaccines. Pfizer’s COVID-19 vaccine Comirnaty has transformed its business, opening up new potential for the US giant in vaccines, but for AstraZeneca, any business advantage will be much more modest.

AstraZeneca has not yet publicly stated whether it will continue marketing its vaccine into a post-pandemic phase, where it would charge a higher (though still affordable) price, and it appears to be weighing up the benefits and risks of such a decision.

Returning To A New R&D Headquarters

Even while R&D had enjoyed a renaissance, there have been plenty of headwinds.

In March this year, the company was shocked and saddened by the sudden death of its head of oncology R&D Jose Baselga. (Shock As AstraZenecas Oncology RD Head Jos Baselga Dies)

The company’s long-time cancer leader Susan Galbraith has now taken up the post, with a challenge to build on and diversify its oncology portfolio.

Another huge headache has been the construction of the company’s new global headquarters in Cambridge, UK. First started in 2014, timelines have lengthened inexorably and budgets spiralled out of control to over £1bn ($1.3bn).

The building is now finally ready for employees to move in, and after pandemic-enforced social distancing, the company can now bring together lab-based scientists with office-based R&D leaders on one site, which has been specifically designed to foster collaboration and boost research productivity.

Pangalos nevertheless concedes that the half-empty buildings have been somewhat lifeless because of social distancing and working from home measures.

“I think energy levels will go up on the sites, and the collaboration levels will go up. We will be doing less virtual meetings and more in-person meetings. We won’t go back to where we were [pre-pandemic] in terms of traveling and there'll be more [workplace] flexibility, but more face-to -face and less Zoom and Teams will be very welcome.”

Despite all of the obstacles, Pangalos is confident that the company has been able to maintain R&D momentum, even though the pandemic has caused trial recruitment problems across the industry as people stayed home.

He quoted the company’s “20-30% success rate” in candidates moving from first-in-man or pre-clinical to launch is well above the industry average.

Progress in AZ’s late-stage oncology pipeline has been particularly notable over the past twelve months; a year ago there were six projects in Phase III, that has now swollen to 13.

Four of these are combinations of Imfinzi with tremelimumab, where chances of success are not rated highly by external analysts, but other novel candidates look promising. These include AKT inhibitor capivasertib which is in several Phase III studies across breast cancer types and prostate cancer and multi-drug combinations.

Another of its hotly-tipped late-stage candidates is the Daiichi Sankyo-partnered antibody drug conjugate datopotamab deruxtecan, which is in Phase III for NSCLC.(AstraZenecaDaiichi Sankyo ADC Pact Continues Clinical Success In Breast Cancer)

Alexion Crossover And Extending Farxiga Franchise

AstraZeneca’s leadership are remaining tight-lipped for now on what new synergies it will gain by adding Alexion to the group but it is clear that the US biotech’s expertise in the complement immune system could be exploited more fully by the big pharma company.

Pangalos said many aspects of complement biology are potentially relevant to many established AstraZeneca therapy areas beyond rare disease, including diabetes, chronic kidney disease, fibrosis, pulmonary fibrosis and chronic obstructive pulmonary disease

In terms of mid-stage pipeline, he pointed to a number of new combinations involving Farxiga, which could help extend the SGLT2 inhibitior’s market exclusivity for many years to come.

Farxiga’s revenues have been transformed thanks to its new uses beyond diabetes in heart failure and chronic kidney disease, and there could be more to come. In Phase II are combinations with AZD9977, an MCR modulator and with zibotentan, an ETA agonist for use in chronic kidney disease (CKD).

The hope is that these combinations can boost the benefits to CKD patients, but also maintain the franchise and ensure that Farxiga does not drop off a patent cliff in 2025/26.

Returning to the principles of R&D success, Pangalos said that tough choices need to be made, even with a lot of positive early and mid-stage results.

One such dilemma will be whether to develop Vaxzevria has a commercial product post-pandemic. That decision may have a bearing on its COVID-19 vaccine’s legacy, including whether or not it could help create a platform for its Sanofi-partnered respiratory syncytial virus vaccine candidate, nirsevimab, now in Phase III, which has blockbuster potential. (Sanofi Spotlights Nirsevimab In RSV Further Dupixent Development)

“The biggest challenge we have is prioritization and making sure that we don't spread ourselves too thinly," concluded Pangalos. "We need to do some things exceptionally well and that means focus and prioritization, which is difficult.”

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