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This week, Pfizer (PFE - Free Report) announced that it has offered to buy Arena Pharmaceuticals in a $6.7 billion deal. Eli Lilly (LLY - Free Report) raised the 2021 profit and sales outlook and provided upbeat financial guidance for 2022. The FDA approved AbbVie (ABBV - Free Report) & Pfizer’s JAK inhibitor drugs, Rinvoq and Xeljanz, respectively for new indications. The regulatory agency placedclinical holds on further studies on Merck’s (MRK - Free Report) HIV candidate, islatravir. The Centers for Disease Control and Prevention’s (CDC) recommended Pfizer and Moderna’s COVID vaccines over J&J’s (JNJ - Free Report) .
Recap of the Week’s Most Important Stories
Pfizer to Acquire Arena Pharma: Pfizer announced a definitive agreement to acquire Arena Pharmaceuticals for $100 per share or $6.7 billion in an all-cash deal. The deal will add Arena’s lead candidate etrasimod, a next-generation and selective sphingosine-1-phosphate (S1P) receptor modulator, to Pfizer’s inflammation and immunology pipeline. Etrasimod is in late-stage development for ulcerative colitis (UC) while also being studied across multiple gastroenterology and dermatology indications. In addition, Arena’s pipeline includes candidates like temanogrel and APD41, which are in mid-stage development for cardiovascular diseases.
Pfizer announced data from the final analysis of the phase II/III study — EPIC-HR — evaluating its oral antiviral candidate for COVID-19, Paxlovid. The final results were consistent with the interim data from the study announced last month, which showed that Paxlovid reduces the risk of hospitalization or death by 89% compared to placebo in patients treated within three days of symptom onset.
However, a secondary endpoint data demonstrated that treatment with Paxlovid within five days of symptom onset reduced the risk of hospitalization or death for any cause by 88% versus placebo
The European Commission (“EC”) approved Pfizer’s investigational once-daily JAK1 inhibitor, abrocitinib, for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. The drug will be marketed with the trade name of Cibinqo. The regulatory filing for abrocitinib is under priority review with the FDA. Cibinqo is already approved in the U.K. and Japan this year.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued an advice for Paxlovid. The advice stated that Paxlovid could be used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. The advice means authorities of European member states can allow supply and use of the oral pill in emergency situations even before EU’s conditional marketing authorization. The EMA is presently conducting a rolling review of the marketing application.
Lilly Ups 2021 Outlook, Guides Better-Than-Expected 2022 View: Eli Lilly raised its previous sales and earnings forecast for 2021 due to additional expected revenues from its COVID-19 antibody medicines. Lilly expects adjusted earnings per share in the range of $8.15 to $8.20 in 2021, up from the prior expectation of $7.95 to $8.05. Revenues in 2021 are expected in the range of $28.0 billion and $28.3 billion, compared with $27.2 billion-$27.6 billion expected previously.
The drug giant also issued its financial guidance for 2022 which exceeded expectations. Lilly expects 2022 revenue to be between $27.8 billion and $28.3 billion while earnings per share are expected to be between $8.50 and $8.65.
Lilly is fast closing in on its goal of launching 20 new medicines over the 10-year period from 2014 to 2023, having already launched 16 new medicines over the last eight years. Lilly plans to launch five more medicines — tirzepatide, donanemab, pirtobrutinib, lebrikizumab and mirikizumab — over the next two years, if they are approved.
Lilly’s phase III maintenance study, LUCENT-2, evaluating mirikizumab for moderately to severely active ulcerative colitis (UC), achieved the primary endpoint of clinical remission. In the study, significantly more patients treated with mirikizumab maintenance dosing achieved the primary endpoint of clinical remission at one year (52 weeks). The study also achieved all key secondary endpoints at year one.
FDA’s Clinical Hold on HIV Studies on Merck’s Islatravir: The FDA has placed clinical holds on further studies evaluating Merck’s once-monthly investigational nucleoside reverse transcriptase translocation inhibitor, oral islatravir (MK-8591) for the treatment and prevention of HIV-1 infection. The decision was taken based on observations of decreases in total lymphocyte and CD4+ T-cell counts in some study participants in previous clinical studies on islatravir. With the FDA’s clinical hold, no new studies can be initiated on islatravir. While several studies on islatravir have been placed on full clinical hold, mostly PrEP studies, several others have been put on partial clinical hold.
The European Commission has approved Merck’s Vaxneuvance, its 15-valent pneumococcal conjugate vaccine for adults 18 years of age and older. The vaccine was approved by the FDA in July. The approval for Vaxneuvance in Europe was based on data from seven clinical studies that evaluated the vaccine candidate in 7,438 individuals in a variety of populations who are at increased risk of pneumococcal disease.
AbbVie & Pfizer JAK Inhibitor Drugs Get FDA Nod for New Indications: The FDA granted approval to Pfizer’s JAK inhibitor drug, Xeljanz, to treat adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor ("TNF") blockers.
The FDA also approved AbbVie’s JAK inhibitor, Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis (PsA) in patients who have had an inadequate response or intolerance to one or more TNF blockers. This marks the second-approved indication for Rinvoq in the United States, the first being moderate-to-severe RA.
These approvals mark the first new approvals for JAK inhibitor drugs by the FDA after the agency issued a Drug Safety Communication (DSC) in September to include warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death to be added to the label of three JAK inhibitor drugs, including Xeljanz, Rinvoq and Lilly/Incyte’s Olumiant (baricitinib).
CHMP Nod to J&J’s COVID Booster Shot: The CHMP gave a positive opinion recommending the use of the booster dose of J&J’s single-shot COVID-19 vaccine at least two months after primary vaccination with its vaccine or with Pfizer or Moderna’s two-shot mRNA COVID-19 vaccine regimen. The opinion will now be reviewed by the European Commission and a final decision related to conditional marketing authorization for the booster dose should be available shortly.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously that Pfizer and Moderna’s two-shot mRNA-based vaccines should be “preferred” over J&J’s viral vector COVID-19 vaccine due to cases of rare blot clotting issues with the latter. The CDC endorsed the recommendations made by ACIP.
The NYSE ARCA Pharmaceutical Index rose 6.5% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: PFE Announces Arena Buyout, LLY Ups 2021 View & More
This week, Pfizer (PFE - Free Report) announced that it has offered to buy Arena Pharmaceuticals in a $6.7 billion deal. Eli Lilly (LLY - Free Report) raised the 2021 profit and sales outlook and provided upbeat financial guidance for 2022. The FDA approved AbbVie (ABBV - Free Report) & Pfizer’s JAK inhibitor drugs, Rinvoq and Xeljanz, respectively for new indications. The regulatory agency placedclinical holds on further studies on Merck’s (MRK - Free Report) HIV candidate, islatravir. The Centers for Disease Control and Prevention’s (CDC) recommended Pfizer and Moderna’s COVID vaccines over J&J’s (JNJ - Free Report) .
Recap of the Week’s Most Important Stories
Pfizer to Acquire Arena Pharma: Pfizer announced a definitive agreement to acquire Arena Pharmaceuticals for $100 per share or $6.7 billion in an all-cash deal. The deal will add Arena’s lead candidate etrasimod, a next-generation and selective sphingosine-1-phosphate (S1P) receptor modulator, to Pfizer’s inflammation and immunology pipeline. Etrasimod is in late-stage development for ulcerative colitis (UC) while also being studied across multiple gastroenterology and dermatology indications. In addition, Arena’s pipeline includes candidates like temanogrel and APD41, which are in mid-stage development for cardiovascular diseases.
Pfizer announced data from the final analysis of the phase II/III study — EPIC-HR — evaluating its oral antiviral candidate for COVID-19, Paxlovid. The final results were consistent with the interim data from the study announced last month, which showed that Paxlovid reduces the risk of hospitalization or death by 89% compared to placebo in patients treated within three days of symptom onset.
However, a secondary endpoint data demonstrated that treatment with Paxlovid within five days of symptom onset reduced the risk of hospitalization or death for any cause by 88% versus placebo
The European Commission (“EC”) approved Pfizer’s investigational once-daily JAK1 inhibitor, abrocitinib, for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. The drug will be marketed with the trade name of Cibinqo. The regulatory filing for abrocitinib is under priority review with the FDA. Cibinqo is already approved in the U.K. and Japan this year.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued an advice for Paxlovid. The advice stated that Paxlovid could be used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. The advice means authorities of European member states can allow supply and use of the oral pill in emergency situations even before EU’s conditional marketing authorization. The EMA is presently conducting a rolling review of the marketing application.
Lilly Ups 2021 Outlook, Guides Better-Than-Expected 2022 View: Eli Lilly raised its previous sales and earnings forecast for 2021 due to additional expected revenues from its COVID-19 antibody medicines. Lilly expects adjusted earnings per share in the range of $8.15 to $8.20 in 2021, up from the prior expectation of $7.95 to $8.05. Revenues in 2021 are expected in the range of $28.0 billion and $28.3 billion, compared with $27.2 billion-$27.6 billion expected previously.
The drug giant also issued its financial guidance for 2022 which exceeded expectations. Lilly expects 2022 revenue to be between $27.8 billion and $28.3 billion while earnings per share are expected to be between $8.50 and $8.65.
Lilly is fast closing in on its goal of launching 20 new medicines over the 10-year period from 2014 to 2023, having already launched 16 new medicines over the last eight years. Lilly plans to launch five more medicines — tirzepatide, donanemab, pirtobrutinib, lebrikizumab and mirikizumab — over the next two years, if they are approved.
Lilly’s phase III maintenance study, LUCENT-2, evaluating mirikizumab for moderately to severely active ulcerative colitis (UC), achieved the primary endpoint of clinical remission. In the study, significantly more patients treated with mirikizumab maintenance dosing achieved the primary endpoint of clinical remission at one year (52 weeks). The study also achieved all key secondary endpoints at year one.
FDA’s Clinical Hold on HIV Studies on Merck’s Islatravir: The FDA has placed clinical holds on further studies evaluating Merck’s once-monthly investigational nucleoside reverse transcriptase translocation inhibitor, oral islatravir (MK-8591) for the treatment and prevention of HIV-1 infection. The decision was taken based on observations of decreases in total lymphocyte and CD4+ T-cell counts in some study participants in previous clinical studies on islatravir. With the FDA’s clinical hold, no new studies can be initiated on islatravir. While several studies on islatravir have been placed on full clinical hold, mostly PrEP studies, several others have been put on partial clinical hold.
The European Commission has approved Merck’s Vaxneuvance, its 15-valent pneumococcal conjugate vaccine for adults 18 years of age and older. The vaccine was approved by the FDA in July. The approval for Vaxneuvance in Europe was based on data from seven clinical studies that evaluated the vaccine candidate in 7,438 individuals in a variety of populations who are at increased risk of pneumococcal disease.
AbbVie & Pfizer JAK Inhibitor Drugs Get FDA Nod for New Indications: The FDA granted approval to Pfizer’s JAK inhibitor drug, Xeljanz, to treat adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor ("TNF") blockers.
The FDA also approved AbbVie’s JAK inhibitor, Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis (PsA) in patients who have had an inadequate response or intolerance to one or more TNF blockers. This marks the second-approved indication for Rinvoq in the United States, the first being moderate-to-severe RA.
These approvals mark the first new approvals for JAK inhibitor drugs by the FDA after the agency issued a Drug Safety Communication (DSC) in September to include warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death to be added to the label of three JAK inhibitor drugs, including Xeljanz, Rinvoq and Lilly/Incyte’s Olumiant (baricitinib).
CHMP Nod to J&J’s COVID Booster Shot: The CHMP gave a positive opinion recommending the use of the booster dose of J&J’s single-shot COVID-19 vaccine at least two months after primary vaccination with its vaccine or with Pfizer or Moderna’s two-shot mRNA COVID-19 vaccine regimen. The opinion will now be reviewed by the European Commission and a final decision related to conditional marketing authorization for the booster dose should be available shortly.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously that Pfizer and Moderna’s two-shot mRNA-based vaccines should be “preferred” over J&J’s viral vector COVID-19 vaccine due to cases of rare blot clotting issues with the latter. The CDC endorsed the recommendations made by ACIP.
The NYSE ARCA Pharmaceutical Index rose 6.5% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, all the stocks were in the green with Pfizer rising the most (17.6%).
In the past six months, Pfizer has recorded the maximum gain (60.7%) while Novartis has declined the most (7.5%)
(See the last pharma stock roundup here: PFE Booster Works on Omicron, AZN COVID Cocktail Gets FDA Nod)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.