This week, World Health Organization (WHO) authorized
AstraZeneca’s ( AZN Quick Quote AZN - Free Report) COVID-19 vaccine for emergency use. J&J ( JNJ Quick Quote JNJ - Free Report) filed an application seeking conditional approval for its COVID-19 vaccine in Europe while Pfizer ( PFE Quick Quote PFE - Free Report) announced a new supply deal in Europe for Comirnaty, its COVID-19 vaccine. Recap of the Week’s Most Important Stories AstraZeneca’s COVID-19 Vaccine was granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for adults (including adults over 65 years). The EUL allows for two doses of the vaccine to be administered at a four to 12-week interval. The WHO authorization also applies to Covishield manufactured by Serum Institute of India (SII) per a deal with AstraZeneca. With the EUL received, AstraZeneca and SII will begin supplying the vaccines globally through COVAX, targeting to make available 300 million doses of the vaccine to 145 countries including those where different variants of the SARS-CoV-2 virus are prevalent. AstraZeneca’s COVID-19 vaccine has been approved for temporary/conditional use in more than 50 countries including the European Union and United Kingdom. WHO Authorizes AstraZeneca’s COVID-19 Vaccine: J&J filed J&J files CMA for Coronavirus Vaccine in Europe: a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency, seeking approval for its single-dose COVID-19 vaccine candidate. The company had filed an application seeking Emergency Use Authorization (EUA) from the FDA earlier this month. The company has also begun rolling filings in other countries. Pfizer and its Germany-based partner BioNTech won a deal with the European Commission to Pfizer’s New Comirnaty Supply Deal in EU: supply additional 200 million doses of Comirnaty, its COVID-19 vaccine in Europe. With the latest deal, the total number of doses to be delivered to the EU is 500 million, with delivery expected by the end of 2021. Of the new deal for 200 million doses, an estimated 75 million are expected to be supplied in the second quarter.
Pfizer/BioNTech began a global phase II/III study to evaluate its COVID-19 vaccine, BNT162b2 in healthy pregnant women. Meanwhile, the companies expect to start additional studies in children (aged 5 – 11) over the next couple of months and those for kids less than 5 years later this year. A phase III study in subjects 12 to 15 years of age is already ongoing.
Pfizer initiated a pivotal phase II study on elranatamab, its investigational BCMA CD3-targeted bispecific antibody, in relapsed /refractory multiple myeloma.
Lilly’s Tirzepatide Succeeds in Two More Phase III Studies: Lilly ( LLY Quick Quote LLY - Free Report) announced top-line data from two phase III studies (SURPASS-3 and SURPASS-5) on its investigational dual GIP and GLP-1 receptor agonist tirzepatide. Data from the studies showed that the candidate led to superior blood sugar reductions (A1C reduction) and weight loss in type II diabetes patients. Both the studies met all the primary and all key secondary endpoints. Data from the 52-week SURPASS-3 study showed that the highest dose of tirzepatide led to a 2.37% reduction in A1C levels and weight loss of 12.9 kgs compared to titrated insulin degludec. In the SURPASS-5 study, tirzepatide reduced A1C by 2.59% and body weight by 10.9 kg after 40 weeks of treatment compared to placebo.
Lilly also announced a strategic collaboration with Rigel Pharmaceuticals, in-licensing exclusive rights to the latter’s RIPK1 inhibitors, including R552, for all indications including autoimmune and inflammatory diseases. R552 has completed phase I studies and will begin phase II studies in 2021. For the deal, Lilly will make an upfront payment of $125 million to Rigel, while being entitled to pay up to an additional $835 million in future potential milestones payments.
Glaxo Begins RSV Vaccine Study in Older Adults: Glaxo ( GSK Quick Quote GSK - Free Report) began dosing in a phase III study evaluating the immunogenicity, safety, reactogenicity and persistence of its Respiratory Syncytial Virus (RSV) candidate vaccine in older adults. Meanwhile, a separate phase III study will assess the vaccine’s efficacy in this patient population. The candidate has shown promising safety and immunogenicity in a phase I/II study in both young and older adults. Glaxo is already developing maternal and pediatric vaccines against RSV vaccines.
expanded its existing coronavirus collaboration with Vir Biotechnology for developing new monoclonal antibody (mAb) candidates for influenza and other respiratory viruses. Glaxo and Vir Biotech are already developing two monoclonal antibody candidates - VIR-7832 and VIR-7831 as a potential treatment of COVID-19 under their existing coronavirus collaboration agreement. Per the new deal, the companies are looking to develop VIR-2482, an intramuscularly administered mAb for treating influenza A. Glaxo will make an upfront payment of $225 million along with an equity investment worth $120 million in Vir Biotech for the expanded deal. The FDA granted approval to Novartis’ Entresto Gets FDA Nod for Expanded Use: Novartis’ ( NVS Quick Quote NVS - Free Report) Entresto for an expanded indication in chronic heart failure. Entresto can now be prescribed to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure, mainly those adults with left ventricular ejection fraction (LVEF) below normal,
With the approval Entresto has become the first therapy indicated for the treatment of patients with both major types of chronic heart failure — heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF).
The FDA granted Fast Track Designation to Sanofi’s ( Fast Track Tag to Sanofi’s Efanesoctocog alfa: SNY Quick Quote SNY - Free Report) Efanesoctocog alfa, an investigational factor VIII replacement therapy for treating hemophilia A. Sanofi is developing the candidate in a phase III study for severe hemophilia A in partnership with Sobi.
The NYSE ARCA Pharmaceutical Index declined 0.9% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Last week, AstraZeneca recorded the maximum gain (2.9%) while Novartis declined the most (3%).
In the past six months, Lilly recorded the maximum gain (34.1%) while Merck declined the most (10%).
(See the last pharma stock roundup here:
AZN’s Q4 Earnings, FDA Approval for LLY & SNY’s Drugs) What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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