As the second quarter of 2023 draws to a close, DDW’s Megan Thomas reviews key updates and results from three top pharmaceutical companies.
Business updates
Pfizer reported second quarter 2023 revenues totalling $12.7 billion, a decrease of $15.0 billion, or 54%, compared to the prior year quarter, reflecting an operational decline of $14.7 billion, or 53%, primarily due to a decrease in Paxlovid and Comirnaty revenues globally, as well as an unfavorable impact of foreign exchange of $283 million, or 1%. Excluding contributions from Comirnaty and Paxlovid, company revenues grew $537 million, or 5%, operationally.
AstraZeneca saw total revenue reach $22,295m, up 4% despite a decline of $2,181m from Covid-19 medicines. Excluding Covid-19 medicines, total revenue increased 16% and product sales increased 15%. Total revenue from oncology medicines increased 22%, CVRM 20%, R&I8 10%, and rare disease 12%. Other core operating income and expense included the previously-announced gain resulting from an update to the contractual relationships for Beyfortus (nirsevimab), totalling $712m. Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “Each of our non-Covid-19 therapy areas saw double-digit revenue growth, with eight medicines delivering more than $1bn of revenue in the first half, demonstrating the strength of our business. Several medicines grew rapidly including Ultomiris, Imfinzi/Imjudo and Farxiga, with revenues up 64%, 57% and 40% respectively.”
For Sanofi, second quarter 2023 sales growth of 3.3% at CER and business EPS growth of 8.1% at CER. Specialty care grew 11.8% driven by Dupixent (€2,562 million, +34.2%) and Nexviazyme (€103 million, +146.5%), more than offsetting anticipated impact of Aubagio generic competition in the US. Vaccines were up 9.1% due to strong PPH vaccines sales in rest of world region and Covid vaccine supply in Europe, while general medicines core assets grew 2.4%, non-core assets lower mainly due to Lantus (€353 million, -36.5%).
Key partnerships
In May 2023, Pfizer and Thermo Fisher Scientific announced a collaboration agreement to help increase local access for next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East and Asia, where advanced genomic testing has previously been limited or unavailable. In June 2023, Pfizer also announced it entered into a manufacturing capacity reservation agreement with the European Health and Digital Executive Agency of the EC, which provides the EU access to doses of an mRNA-based vaccine should one be developed to protect against a future pandemic-causing disease.
In June 2023, AstraZeneca entered into an exclusive option and license agreement with Quell Therapeutics to develop multiple engineered T-regulator cell therapies that have the potential to be curative in Type-1 diabetes and inflammatory bowel disease indications. In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America. Moreover, in July 2023, AstraZeneca and Vaxess Technologies commenced a collaboration for the evaluation of a novel RNA-based pandemic influenza prototype vaccine in patch format. Also in July 2023, Alexion, AstraZeneca Rare Disease (Alexion) and Pfizer entered into an agreement for Alexion to purchase and license the assets of Pfizer’s early-stage rare disease gene therapy portfolio for a total consideration of up to $1bn, plus tiered royalties on sales.
In July 2023, Sanofi and Scribe Therapeutics expanded their partnership to progress the development of in vivo genetic therapies to treat sickle cell and other genomic diseases.
Corporate highlights
In July 2023, Pfizer announced changes to its executive leadership team to further advance its aspirations to discover and develop new medicines and vaccines, with an emphasis on oncology. Chris Boshoff, M.D., joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. Mikael Dolsten, MD, Chief Scientific Officer, President, Pfizer Research & Development, expanded his role to lead all discovery, early- and late-stage clinical development for all non-oncology therapeutic areas, including vaccines, inflammation and immunology, internal medicine and infectious diseases as well as non-malignant haematology and rare neuromuscular diseases. As a result of these moves, William Pao, M.D., Chief Development Officer and Executive Vice President, will be leaving Pfizer to pursue new opportunities outside the company.
At AstraZeneca, Sharon Barr, currently Senior Vice President, Head of Research and Product Development of Alexion, will succeed Mene Pangalos as Executive Vice President, BioPharmaceuticals R&D. Barr will report to Chief Executive Officer, Pascal Soriot and became a member of AstraZeneca’s Senior Executive Team as of 1 August.
In August 2023, Houman Ashrafian was appointed as Head of R&D at Sanofi, Madeleine Roach was appointed Head of Business Operations (effective 1 October, 2023), Emmanuel Frenehard was appointed Chief Digital Officer, and Bill Sibold, Head of the Specialty Care GBU, left Sanofi to pursue an external opportunity. Brian Foard will lead the Specialty Care GBU ad interim.
Read about more recent corporate appointments here.
Regulatory developments
There were several noteworthy developments across Pfizer’s pipeline, which were covered by DDW. In May 2023, Pfizer announced the FDA approval Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. Additionally, Abrysvo was approved for use at 32-36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth to six months of age. In August, Arvinas and Pfizer UK were awarded a UK Innovation Passport for vepdegestrant (ARV-471), an investigational PROTAC ER (estrogen receptor) degrader. Moreover, the FDA approved Pfizer’s Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). Keep up to date with more of Pfizer’s updates on DDW.
Key regulatory milestones for AstraZeneca include US approvals for Lynparza in BRCA-mutated prostate cancer (PROpel), Farxiga in HF11 regardless of ejection fraction (DELIVER), and Beyfortus (developed with Sanofi) for the prevention of RSV12. In the EU, approvals include Ultomiris in NMOSD13. In China, there has been approval of Enhertu in HER214 -low metastatic breast cancer, Soliris in gMG15 and Koselugo in neurofibromatosis. Moreover, capivasertib in combination with Faslodex was granted priority review in the US for advanced HR16-positive breast cancer.
Pipeline advancements
A comprehensive update of Pfizer’s development pipeline includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase I and all candidates from Phase II through registration. This includes Aztreonam-avibactam (PF-06947387), Danuglipron (PF-06882961), Elranatamab (PF-06863135), Fidanacogene elaparvovec (Haemophilia B Gene Therapy), GBS6 (PF-06760805, Group B Streptococcus Vaccine), and Marstacimab (PF-06741086).
Key positive read-outs for AstraZeneca include datopotamab deruxtecan in lung cancer (TROPION-Lung01), Tagrisso in NSCLC (FLAURA2), Lynparza + Imfinzi in endometrial cancer (DUO-E), Imfinzi in gastric and gastroesophageal cancers (MATTERHORN).
When it comes to pipeline advancements, Sanofi’s Dupixent BOREAS Phase III COPD results were presented at ATS and published in the New England Journal of Medicine; Itepekimab in COPD passed a recent interim futility analysis of the Phase III AERIFY studies; Amlitelimab positive Phase IIb data support potential for transformational target profile in Atopic Dermatitis; Frexalimab Phase IIb primary endpoint met demonstrating significantly reduced disease activity in MS; and the company’s vaccines pipeline is moving at pace with 12 innovative assets with new data highlighted at a recent investor event.
