Shots:

• The 40th Annual J.P. Morgan Healthcare Conference took place virtually on Jan 10-13, 2022. The premier conference is the most extensive and most informative health care investment symposium in the Healthcare and pharma sector, which connects global leaders, emerging companies, innovative technology creators, and members of the investment community
• Considering the top biopharma companies and their healthcare industry footprints, PharmaShots summarized the presentation of leading companies and derived the critical insights based on the therapeutic areas.
• Pfizer steals the show by announcing four deals; Biogen stays in the limelight with its most controversial drug, Aduhelm. Next, Takeda comes into the picture with the acquisition of Adaptate Biotherapeutics.

The 40th annual J.P. Morgan Healthcare Conference witnessed virtual presentations and Q&A sessions from some of the biggest names in biopharma. PharmaShots chose top biopharma companies and their key therapeutic areas, including oncology, neurology, inflammation, cardiovascular, infectious, and others.

In comparison, the COVID-19 pandemic has dominated and highlighted the industry for the past two years, oncology being at the top grabs more attention of the investors and attendees. Johnson & Johnson (JNJ) plans to spin off its consumer health division into an independent company in 18 to 24 months or by the end of 2023; the remaining JNJ will focus on Pharmaceutical and MedTech with anticipated pharmaceutical revenue of $60B by 2025 with the compounded average growth of 5%.

JNJ continues to focus on organic and inorganic opportunities to move into higher-growth markets and market segments in the MedTech sector. Currently, thirteen marketed drugs across six therapeutic areas (including Darzalex, Erleada, Tremfya, or Imbruvica) will deliver more than $1B each in annual revenues by 2025. JNJ plans to file 36-line expansions for these 13 products through 2025 (expansion includes additional lines of therapy, combination regimens, new formulations) and plans to file 14 new product filings by 2025, which has the potential to earn >$1B.

GSK presented its achievements, including 13 key approvals and a late-stage pipeline (63 vaccines & medicines in pivotal trials). GSK's drug portfolio targets four major therapy areas, i.e, infectious disease, HIV, Oncology, immunology/respiratory.

Moderna plans to invest up to $500M in the manufacturing facility in Africa, pledged to achieve net-zero carbon emissions globally by 2030. In addition, the company is investing in Moderna Science Centre in Cambridge, launched AI Academy in partnership with Ciarnegie Mellon, and reported Moderna Charitable foundation and global fellowship program. With the acquisition of Allergan, AbbVie will achieve a synergy of >$2B and a net leverage ratio of ~2.0x by the end of 2022.

Oncology remains at the top, being the most critical disease to treat among the patients.

• Novartis
  • The company started its presentation by flaunting its strong position in five therapeutic areas and new technology platforms. Oncology is one of the key areas of Novartis. The company expects the launch of Scemblix, which is the first FDA-approved CML treatment that binds to the ABL myristoyl pocket and is the first STAMP inhibitor in 3L CML. The drug can provide the best benefit-risk profile in 1L CML. In addition, the company has submitted the regulatory filing of the 68Ga-PSMA-11 kit for PET imaging to the FDA in mCRPC patients, the 2nd most diagnosed cancer in men. Novartis' mid-stage pipeline also steals the show with the expected entrance of JDQ443 in P-III KRAS G12C mutant NSCLC in H1'22. Novartis' Ociperlimab is currently in P-III study in NSCLC combined with tislelizumab
  • The company discussed its option to license agreement with Beigene for TIGIT inhibitor, ociperlimab, with the potential to treat a wide range of solid tumors. The two P-III trials are underway in NSCLC and additional studies are ongoing with the combination regimen in multiple solid tumor indications
• AbbVie
  • AbbVie's robust pipeline of late-stage oncology products includes Navitoclax, a BCL-2 / BCL-xL inhibitor developed for myelofibrosis with the pivotal trial readouts, regulatory submission and approval anticipated in 2023
  • Another drug, Epcoritamab, a CD3-CD20 bispecific across B cell malignancies including DLBCL and FL where the company is currently conducting P-III study in relapsed/refractory DLBCL and plan to conduct additional P-III studies anticipated to start in 2022, P-II data and regulatory submissions for 3L DLBCL are expected in H2'22
  • ABBV-383, a BCMA-CD3 bispecific whose P-III studies in relapsed/refractory MM are expected to begin in 2022. In addition, Teliso-V, a c-Met ADC whose P-II long-term data are expected in 2023, the data may support a submission for its accelerated approval
  • AbbVie's plan to submit its combination product, Imbruvica + Venclexta for 1L CLL and R/R MCL (data readout due in 2022) with the anticipated approval of 1L CLL in 2022 and R/R MCL in 2023. Venclexta will be due for P-I/II data readout expected to be submitted and get approved for higher-risk MDS in 2022 by accelerated approval and for 3L+ MM w/ t(11;14) data readout due in 2022 and regulatory submission and approval is expected in 2023. Imbruvica is due for R/R FL/MZL P-III data readout and is expected to be approved in 2023
  • The company expected Navitoclax's regulatory submission and approval in 2023 for 1L and R/R MF. In addition, AbbVie will submit the P-II data of Epcoritamab for 3L R/R DLBCL in 2022, which is due for data readout (submission based on AA); the approval is expected in 2023. Early-stage data readout for ABBV-647 in P-I (NSCLC), ABBV-011 (SCLC), ABBV-151 in solid tumors, TTX-030 in P-I (solid tumors) anticipated in 2022, and ABBV-GMAB-3009 (CD37) in P-I heme tumors, ABBV-CLS-579/484 (PTPN2) in P-I solid tumors, ABBV-155 (BCL-xL ADC) in P-I solid tumors, Eftoza (Trail) P-I solid/heme tumors anticipated in 2023
• Roche
  • Roche's vision in 2030 is to decrease the cost and interventions by increasing more targeted efficacious. In the oncology space, Roche estimated that six adjuvants of Tecentriq (SCCHN, RCC, HCC, NSCLC) & Alecensa (ALK+ NSCLC and R/R MM t(11;14)) data readouts are expected in 2022 both in Roche sponsored or in the supported study
  • Roche conducted nine pivotal studies for Tiragolumab and expected 4 data readouts in 2022, including SKYSCRAPER-01 & SKYSCRAPER-01 for lung cancer and SKYSCRAPER-04 & SKYSCRAPER-09 for solid tumors
  • Roche expected the data readout for giredestrant in 2L/3L ER+ mBC in 2022 and plan to file regulatory submission in mosunetuzumab and glofitamab in 2022
• BMS
  • BMS mentioned vital growth drivers for the upcoming decade, including new launches, Abecma, Breyanzi, Inrebic, Onureg, Reblozyl and Zeposia, and three launches anticipated in 2022 (relatimab and nivolumab fixed dose combination, mavacamten, deucravacitinib) & upcoming clinical & regulatory milestones across product pipeline. In addition, the company announced a $5B accelerated share repurchase agreement to be executed during Q1'22
  • BMS provides total revenue 2022 & Non– GAAP EPS guidance to reaffirm long-term financial targets. The company planned to file regulatory submission of relatlimab + nivolumab in the US & EU with anticipated PDUFA on March 19, 2022
• Moderna - showed its presence in oncology presence with strategic collaboration with Carisma. This collaboration will combine Carisma's engineered macrophage technology with Moderna's mRNA and LNP technologies to generate and develop in vivo CAR-M therapeutics.
• JNJ
  • In the oncology space, Johnson & Johnson plans to launch Carvykti, a BCMA CAR-T therapy, in 2022. The company is also developing Carvykti in combination with Darzalex for MM and recently filed with FDA for teclistamab
  • Additionally, Rybrevant, an approved drug for NSCLC, combined with Lazertinib to create a new SOC for EGFR positive NSCLC. Johnson & Johnson anticipated the revenue of >$5B each for Darzalex, Carvykti, Rybrevant in 2025 or beyond
• Bayer - Nubeqa to become a foundational drug across the patient spectrum in prostate cancer and its data will be released in February 2022
• Takeda
  • As part of Takeda's approach to build a robust pipeline in Oncology, the company exercised its option to acquire Adaptate Biotherapeutics following a successful multi-year R&D partnership. The acquisition added a novel antibody-based γδ T-cell engager platform, including pre-clinical candidate and discovery pipeline programs, to Takeda's immuno-oncology portfolio, demonstrating its commitment to delivering life-transforming medicines to patients
  • The company is confident with its global brands, alongside new product launches such as Exkivity (mobocertinib) and Livtencity (maribavir) that contributed to forecasted total company incremental revenue growth of ~$4.5B by FY20251
• Gilead
  • Gilead unveils its oncology portfolio by announcing that the company is currently conducting 30+ clinical studies in multiple cancer indications and is expected to initiate 20+ clinical studies in 2022. The year 2021 was an excellent year for Gilead in the oncology space as it received 4 BTD and four approvals in 2021
  • As per the presentation presented in JPM, Gilead is planning 15+ new clinical trials with its Trodelvy (topoisomerase inhibitor conjugate directed to the Trop-2 receptor), which includes 7+ P-III trials and is collaborating with Merck's Keytruda to target 1L mTNBC and 1L NSCLC. In addition, Gilead is expecting the top readouts of TROPiCS-02 HR+/HER2- in Q1'22
  • Yescarta is another vital drug in Gilead's oncology portfolio, and the company is expecting its sBLA decision in 2L LBCL in H1'22 with anticipated MAA in H2'22 Yescarta entered Gilead's portfolio with Kite's acquisition in 2017 and now expecting its MAA decision in ALL and iNHL in 2022. The company is anticipating oncology space as one of its key areas and contributing at least a third of total revenues in 2030
• Amgen
  • The company highlights its oncology portfolio with its primary focus on Lumakras, which is under evaluation across a range of lung cancer. The therapy is approved in 35+ countries and is currently under review in many geographies. The treatment evaluates over 11 combinations in lung cancer and other tumour types
  • In addition, Amgen provides updates that its therapies are under evaluation in prostate cancer. The company has initiated two P-III studies with Bemarituzumab and a P-III study assessing Lumakras + Vectibix combo colorectal cancer, supporting the P-III study's initiation. In addition, the company showed 9% total volume growth from Kyprolis, Vectibix, Nplate, Blincyto and Xgeva in the oncology space
• Sanofi
  • Sanofi focused on advancing its oncology portfolio by collaborating with best-in-class AI partners. The company collaborated with Exscientia and licensed up to 15 candidates in oncology and immunology
  • In addition, Sanofi expanded the oncology pipeline with AI and federated learning by collaborating with owkin. The collaboration focused on four cancer indications
• Merck
  • The company’s key focus was on Ketryda LOE and plans to be the oncology market leader in 2025. The company will expand its oncology portfolio (Keytruda, Lynparza, Lenvima, Welireg) into new tumors. The company advances innovations including ADCs, KRAS and BTK inhibitors and will enhance patient benefits through subcutaneous delivery and formulation (TIGIT, LAG-3, CTLA-4 and potentially ILT4).
  • Merck reported that Keytruda's adjuvant NSCLC trial, KEYNOTE-091, met one of its two co-primary endpoints
• Regeneron
  • The presentation opened with this brief about its continued progress & development across the oncology pipeline, Libtayo, solid tumor bispecifics, heme-onc specifics
  • The company also announced its potential to extend the benefits of checkpoints inhibitors with initial data in 2022. REGN5093 (METxMET)- data anticipated in H2'22, REGN4018 (MUC16xCD3)- data from dose-escalation monotherapy FIH study foreseen in H1'22, REGN5678 (PSMAxCD28)-dose escalation with Libtayo ongoing -initial data expected in 2022
• Lilly
  • Lilly discussed the limited FDA label for Verzenio in breast cancer and guidelines from influential industry groups like ASCO. For pirtobrutinib, the specificity of their molecule was focused and its use in patients who have failed front-line BTK inhibitors. The initiation of a head-to-head study against market leader ibrutinib was discussed. It is believed that ibrutinib will have a secure spot as a leading agent
  • The company explores options for sequencing treatments by combining BCL-2 inhibitors, like venetoclax. Another rolling submission to the FDA has been made for pirtobrutinib, a Bruton tyrosine kinase inhibitor, seeking accelerated approval in mantle cell lymphoma, which is expected to be completed in 2022

COVID-19 has been dominating the world for the last two years. Almost all the global pharmaceuticals are directly or indirectly putting their efforts in converting the pandemic into endemic.

• Merck
  • Merck showed its presence in COVID space by reporting that its COVID-19 oral pill molnupiravir has a mechanism of action that can work against Omicron
  • The study showed 30% efficacy in reducing the risk of hospitalization and death in November. Dean Y. Li, Merck's president of Research Laboratories, stated that molnupiravir would work on Omicron and other variants that may come up in the future
• Pfizer
  • Pfizer's Chief Executive Officer, Albert Bourla reported that increased vaccination with booster shots would be an essential tool to mitigate severe infection. Bourla acknowledged that the Omicron variant is a more challenging target and the two doses of the vaccine are not enough. However, the third booster dose proves to provide good protection against deaths and decent protection against hospitalization
  • The company reported that it had established a strong manufacturing supply that could provide the necessary doses of the vaccine. Also, the company's manufacturing capabilities will produce out millions of doses of Paxlovid
  • Pfizer has produced >3B doses of Comirnaty in CY† 2021 and has a production capacity of 4B doses in CY† 2022
• Gilead
  • has applied its antiviral expertise to COVID-19 by launching Veklury, the first FDA authorized drug in COVID-19 in hospitalized settings and showed 87% reduction in risk for hospitalization in investigational PINETREE study
  •  In addition, the company has cleared IND for its Oral COVID-19 remdesivir pro-drug with P-I initiation expected in Q1'22
• Novartis
  • Novartis is making its entry into the antiviral market. Novartis and Molecular Partners reported positive P-II results in EMPATHY clinical trial of ensovibep on COVID-19 patients. The companies noted that ensovibep leads to a 78% risk reduction in an earlier-stage population and faster recovery
  • No unexpected safety findings were reported. The lowest dose of 75mg was effective in viral load reduction
• BioNTech
  • BioNTech's presentation opened with a brief overview which includes multi-platform strategies such as mRNA vaccines, next-generation immunomodulators, cell & gene therapies, targeted antibodies, small molecule immunomodulators, ribologicals
  • BioNTech's BNT162b2 poised for continued global impact in 2022, its omicron variant-specific approach could be ready in Mar 2022 and is subjected to regulatory approval. The company is expecting up to 4B doses manufacturing capacity in 2022
• Moderna
  • Moderna proved to be a big player in COVID-19. It showed that 807M doses of its COVID-19 vaccine shipped worldwide in 2021. The company plans to bring to market a pan-respiratory annual booster vaccine, first-in-class vaccines for latent viruses, therapeutics based on mRNA-encoded proteins and gene-editing enzymes
  • Moderna signed advanced purchase agreements (APAs) and options for delivery of Moderna COVID-19 Vaccine/Spikevax in 2022. In addition, the company reported that its COVID-19 variant boosters (Omicron, Delta, and Beta/Delta) are in development. Its pan-respiratory vaccine can be customized with different viruses, demographics, and geography across the season (time)
• GSK
  • GSK presented Xevudy that plays a significant role in COVID 19 treatment & had shown against the omicron variant and other variants of concern, which was designed by targeting highly conserved regions in COVID-19
  • In addition, the company reported the decision of the US government to procure an additional 600 million doses of Xevudy
• Regeneron
  • Regeneron announced that its REGEN-COV addressed treatment needs and the long-term opportunity for COVID-19 prevention. In addition, the company unveiled that REGEN-COV is currently active on Delta and omicron. The company is expecting its next-generation antibodies to enter clinical development in the first quarter of 2022
  • A supplemental NDA for baricitinib has been filed for COVID-19 indication and initiation of an emergency use authorization request for bebtelovimab, Eli Lilly's third COVID-19 neutralizing antibody. In addition, for bamlanivimab and etesevimab, the FDA expansion to the emergency use authorization as post-exposure prophylaxis was granted in certain individuals to prevent SARS-CoV-2 infection

For the full report please email us at connect@pharmashots.com