Sanofi ( SNY Quick Quote SNY - Free Report) & Glaxo ( GSK Quick Quote GSK - Free Report) began a new study on their jointly developed coronavirus vaccine candidate after delaying its development plans last year. Merck ( MRK Quick Quote MRK - Free Report) agreed to acquire autoimmune drug developer, Pandion Therapeutics for $1.85 billion. Pfizer ( PFE Quick Quote PFE - Free Report) and partner BioNTech said they are testing a third dose of their COVID-19 vaccine to understand its immune response against the highly transmissible new variants of the virus. Recap of the Week’s Most Important Stories Merck announced a definitive agreement to acquire Pandion Therapeutics for $60 per share in cash, representing an approximate total equity value of $1.85 billion. The proposed acquisition will add Pandion’s pipeline candidates targeting a broad range of autoimmune diseases. Its lead candidate, PT101, recently completed a phase Ia study in ulcerative colitis and other autoimmune diseases. The study met its primary objective of safety and tolerability Merck to Acquire Pandion Therapeutics: Glaxo and Sanofi announced the start of a new phase II study on their adjuvanted recombinant protein-based COVID-19 vaccine candidate with an improved antigen formula. The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology. Sanofi/Glaxo Begin New COVID-19 Vaccine Study:
In December, the companies had announced a delay in the development plans of the vaccine due to insufficient immune response in older adults in early-stage studies. Data from the phase I/II study showed that in adults aged 18 to 49 years, the candidate showed an immune response comparable to patients who recovered from COVID-19. However, in older adults, the candidate demonstrated a low immune response, which the companies believe may be due to an insufficient concentration of the antigen.
The new phase II study aims to select the most appropriate antigen dosage for adults of all ages for phase III evaluation.
If the data of the phase II study are positive, the companies plan to start a phase III study in the second quarter of 2021 and the vaccine is now expected to be available in the fourth quarter of 2021.
Meanwhile, the FDA granted approval to Sanofi/Regeneron’s Libtayo as a monotherapy for patients with first-line advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression. This approval is for the third indication for Libtayo. It is approved for two other skin cancer indications.
Meanwhile, Sanofi also announced a deal with Johnson & Johnson to provide manufacturing support for the latter’s single-shot COVID-19 vaccine candidate.
Pfizer and BioNTech announced that they will be conducting a small study to test a third dose (30 µg), a booster of their COVID-19 vaccine, BNT162b2 to understand the effect of a booster on immunity against COVID-19 caused by new and emerging variants of the virus. The booster of the current vaccine will be given to phase I participants, 6 to 12 months after receiving their initial two-dose regimen. Meanwhile, the companies are in discussion with regulatory authorities including the FDA about conducting an additional registration-enabling study to evaluate a variant-specific mRNA vaccine to protect specifically against the South African variant (B.1.351 lineage). Earlier this week, the FDA issued guidelines to provide recommendations to COVID-19 vaccine manufacturers to evaluate the impact of the virus variants on the efficacy or performance of their vaccines. Pfizer to Begin New Study to Test COVID-19 Vaccine Booster:
The FDA accepted and granted priority review to Pfizer’s biologics license application (BLA) seeking approval for TICOVAC, its tick-borne encephalitis (TBE) vaccine. TBE is a viral infection of the brain and spine, which has been declared an endemic in parts of Europe and Asia. The FDA’s decision is expected in August 2021.
AstraZeneca Withdraws Bladder Cancer Indication for Imfinzi: AstraZeneca ( AZN Quick Quote AZN - Free Report) voluntarily withdrew the previously treated metastatic bladder cancer indication for its PD-L1 inhibitor, Imfinzi in the United States. Imfinzi was granted accelerated approval in the United States for the above indication in 2017. However, continued approval was based on data from the DANUBE phase III study in the first-line metastatic bladder cancer setting, which did not meet its primary endpoint in 2020.
Imfinzi is also approved to treat unresectable, stage NSCLC in second-line setting and extensive-stage small cell lung cancer (ES-SCLC). The withdrawal of the bladder cancer indication does not affect the other approved indications of Imfinzi.
Bayer’s Mixed Q4 Earnings: Bayer’s ( BAYRY Quick Quote BAYRY - Free Report) fourth-quarter sales declined 7% year over year. However, on a Fx and portfolio adjusted basis, sales rose 2.6%. While sales of its Crop Science segment rose 4.3% on an Fx and portfolio adjusted basis, revenues at the Pharmaceuticals segment rose 0.5%. Consumer Health sales rose 3.1%. Fourth-quarter 2020 core earnings per American Depositary Receipt was 39 cents. The company expects sales to rise about 3% on a Fx and portfolio adjusted basis in 2021. AbbVie’s Rinvoq Meets Goals in 2nd Ulcerative Colitis Study: AbbVie’s ( ABBV Quick Quote ABBV - Free Report) phase III induction study (U-ACCOMPLISH) evaluating Rinvoq (upadacitinib) for moderate-to-severe ulcerative colitis (UC) met the primary endpoint of clinical remission and all ranked secondary endpoints including clinical, endoscopic and histologic outcomes. In the study, 33% of patients given Rinvoq achieved clinical remission at week 8 compared to 4% in the placebo group. This is the second phase III induction study on Rinvoq in the UC indication. Positive top-line results from first induction study, U-ACHIEVE, were announced in December last year. Rinvoq is presently approved to treat moderate-to-severe rheumatoid arthritis (RA) and is under review in the United States and EU for ankylosing spondylitis, psoriatic arthritis and atopic dermatitis indications.
Meanwhile, the FDA granted approval to AbbVie blockbuster medicine, Humira to treat pediatric patients (5 years of age and older) with moderately to severely active UC. Humira is already approved to treat UC in adult patients. The drug is now approved to treat 11 indications in the United States including five approvals in pediatric indications.
AbbVie also submitted a new drug application to the FDA for AGN-190584 (pilocarpine 1.25%), its investigational ophthalmic solution for the treatment of presbyopia.
The NYSE ARCA Pharmaceutical Index declined 1.9% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Last week, Lilly recorded the maximum gain (1.3%) while Roche declined the most (5.3%).
In the past six months, Lilly recorded the maximum gain (38.1%) while Merck declined the most (11.7%).
(See the last pharma stock roundup here:
Coronavirus Vaccine Updates From PFE, AZN & JNJ) What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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