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Pharma Stock Roundup: GSK's Consumer Unit Offer Rejection, FDA Updates for AZN, PFE

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This week, Glaxo (GSK - Free Report) rejected a $68 billion buyout offer for its consumer healthcare business from consumer giant, Unilever. The FDA approved Pfizer (PFE - Free Report) & AbbVie’s (ABBV - Free Report) JAK inhibitor drugs to treat eczema and also granted priority review to AstraZeneca (AZN - Free Report) and partner, Daiichi Sankyo’s supplemental biologics license application (sBLA), seeking approval for cancer drug Enhertu for expanded use in breast cancer. Sanofi (SNY - Free Report) announced positive data from the second pivotal prurigo nodularis phase III study on its blockbuster medicine, Dupixent (dupilumab).

Recap of the Week’s Most Important Stories

Glaxo Rejects Unilever’s Offer for Consumer Healthcare Unit: Glaxo issued a statement saying that it received a non-binding and conditional acquisition offer of 50 billion pounds ($68 billion) for its Consumer Healthcare segment from Unilever on Dec 20, 2021. The offer comprised £41.7 billion in cash and £8.3 billion in Unilever shares. Glaxo said it had rejected this offer as well as two previous unsolicited proposals from Unilever as it believes they fundamentally undervalue the CHC unit. Unilever, in a press statement, confirmed that it approached Glaxo about a potential purchase of the CHC unit. Later, Unilever, in a separate press release, mentioned that it will not raise its offer above 50 billion pounds.

Glaxo’s Consumer Healthcare segment is a joint venture between Glaxo and Pfizer in which Glaxo owns a controlling stake of 68%. Glaxo intends to separate its Consumer Healthcare segment into a standalone company in mid-2022. An acquisition offer from Unilever or another company may result in a sale instead of a spin-off.

FDA Approves Pfizer & AbbVie’s JAK inhibitor Drugs for Eczema: The FDA granted approval to Pfizer’s once-daily JAK1 inhibitor, Cibinqo (abrocitinib), for the treatment of moderate-to-severe atopic dermatitis or eczema in adults who are candidates for systemic therapy. Cibinqo is already approved in Europe, U.K. and Japan.

The FDA also approved AbbVie’s JAK inhibitor, Rinvoq (upadacitinib), for treating moderate-to-severe atopic dermatitis in adults and children (12 years and older) in patients who have had an inadequate response to other pills or injections, including biologic medicines. This marks the third-approved indication for Rinvoq in the United States, the others being moderate-to-severe rheumatoid arthritis and active psoriatic arthritis (PsA).

The FDA is now frequently granting approval for new indications to JAK inhibitor 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 Pfizer’s Xeljanz, Rinvoq and Lilly/Incyte’s Olumiant (baricitinib).

FDA’s Priority Tag to AstraZeneca’s Enhertu sBLA: The FDA accepted and granted priority review to AstraZeneca and its Japan-based partner, Daiichi Sankyo’s sBLA seeking approval for cancer drug Enhertu for unresectable and/or metastatic HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen. With the FDA granting priority review to the sBLA, a decision is expected during the second quarter of 2022. The sBLA is based on data from the head-to-head DESTINY-Breast03 phase III study

Enhertu is already approved to treat unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2-based regimens in the metastatic setting based on data from the DESTINY-Breast01 study.

Sanofi’s 2nd Study on Dupixent in Prurigo Nodularis Succeeds: Sanofi and Regeneron’s second pivotal phase III study on Dupixent (dupilumab) for treating adult patients with uncontrolled prurigo nodularis, a chronic inflammatory skin disease, met its primary and all key secondary endpoints. In the PRIME study, Dupixent significantly reduced itch and skin lesions compared to placebo at 24 weeks.

PRIME is Sanofi’s second successful study on Dupixent for the prurigo nodularis indication. Positive top-line data from the first pivotal study were announced in October last year. Data from the studies will be submitted to global regulatory authorities, starting in the first half of 2022.

The NYSE ARCA Pharmaceutical Index declined 1.6% in the last five trading sessions.

Here’s how the eight major stocks performed in the last five trading sessions.

Zacks Investment ResearchImage Source: Zacks Investment Research

In the last five trading sessions, AstraZeneca rose the most (3.6%) while Pfizer declined the most (2.7%).

In the past six months, Pfizer has recorded the maximum gain (32.7%) while Novartis declined the most (3.2%)

(See the last pharma stock roundup here: PFE’s Research Deal With BEAM & Other Updates)

What's Next in the Pharma World?

Watch out for J&J’s Q4 and FY21 results and regular pipeline and regulatory updates next week.