M&A activity in the drug and biotech sectors picked up speed this week as Pfizer (PFE – Free Report) made a huge $43 billion bid for another cancer drug maker, Seagen (SGEN – Free Report) , announced. Sanofi (SNY – Free Report) announced an agreement to acquire Provention Bio, bringing its newly approved type 1 diabetes (T1D) drug, Tzield, to Sanofi’s portfolio. Novo Nordisk (NVO – Free Report) and Sanofi announced plans to reduce the prices of some of their insulins after competitor Eli Lilly made a similar announcement earlier this month. Merck’s Phase III study (MRK – Free Report) of Keytruda in the treatment of metastatic malignant pleural mesothelioma met its primary endpoint.
Summary of the most important stories of the week
Pfizer Offers to Purchase Seagen: Pfizer announced a definitive agreement to purchase cancer drug maker Seagen for $229 per share in cash, representing an enterprise value of approximately $43 billion. The Seagen acquisition is expected to strengthen Pfizer’s cancer drug portfolio by adding a class of antibody-drug conjugates (ADCs). Seagen enjoys a leadership position in ADC technology. Seagen currently markets four cancer drugs — Adcetris, Padcev, Tukysa, and Tivdak. All of these drugs have seen heavy uptake to date. Seagen enjoys a leadership position in ADC technology. The Pfizer/Seagen transaction is expected to close in late 2023 or early 2024, subject to Seagen shareholder and regulatory approvals. Some analysts believe the Seagen-Pfizer merger shouldn’t be subject to in-depth Federal Trade Commission scrutiny because there aren’t any major overlaps between their drugs. The boards of directors of both companies have already approved the transaction.
The FDA has approved Pfizer’s calcitonin gene-related peptide (CGRP) receptor antagonist Zavzpret (Zavegepant) for the acute treatment of migraine. The product is scheduled to hit the market in July. With the approval, Zavzpret is the first intranasal CGRP receptor antagonist indicated for the acute treatment of migraine.
Pfizer and its partner BioNTech announced that the FDA has granted emergency use authorization for its Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a (fourth) booster dose for children aged six months to four years. The bivalent vaccine is already approved for children under five years of age as the third dose in a three-dose primary series.
The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 in favor of Paxlovid’s favorable benefit-risk profile.
Although Paxlovid already has FDA emergency use approval, Pfizer is seeking formal/full approval for the drug to treat mild to moderate COVID-19 in adult patients who are at high risk of progression to serious disease. AMDAC based its vote on the body of scientific and real data on the drug. The FDA’s decision is expected to be made in May 2023.
Sanofi Acquires Provention Bio: Sanofi announced an agreement to purchase Provention Bio for $25.00 per share in cash, representing an equity value of approximately $2.9 billion. The acquisition adds Provention Bio’s Tzield to Sanofi’s portfolio, which is the first therapy to delay the onset of stage 3 type 1 diabetes (T1D) in patients as young as 8 years old who already have stage 2 T1D Suffer. Tzield was approved by the FDA in 2022. Sanofi already has a co-promotion agreement with Provention Bio for Tzield. The therapy is being evaluated in Phase III for the treatment of pediatric and adolescent patients with newly diagnosed clinical T1D.
Novo Nordisk & Sanofi Cut Insulin Prices: Novo Nordisk announced plans to cut the prices of several pre-filled insulin pens and vials in the United States by up to 75%. Products include pre-filled pens and vials of basal (long-acting), bolus (short-acting) and pre-mixed insulins, most notably Levemir, Novolin, NovoLog and NovoLog Mix 70/30. Novo Nordisk announced that it would reduce the list price of its NovoLog insulin by 75% and that of Novolin and Levemir by 65%. It also lowers the prices of some non-branded insulin products.
Sanofi also announced a 78% reduction in the list price of its most popular insulin, Lantus. Sanofi also said it is capping the cost of Lantus for all patients with commercial insurance at $35. Sanofi said it will also lower the list price of its short-acting Apidra insulin.
However, Novo Nordisk and Sanofi do not plan to start doing this before January 2024. The announcement from Novo Nordisk and Sanofi comes nearly two weeks after Eli Lilly said it would slash list prices of some of its popular insulins by 70% in a bid to significantly reduce diabetes patient out-of-pocket costs.
Merck’s Keytruda study in malignant mesothelioma met objective: Merck’s Phase III study evaluating Keytruda plus chemotherapy for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma met its primary endpoint of overall survival (OS). The final analysis of the study showed that Keytruda plus chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival in this patient group compared to chemotherapy alone. Malignant pleural mesothelioma is a cancer that forms in the lining of the lungs.
The NYSE ARCA Pharmaceutical Index is down 2.9% over the past five trading sessions.
Here’s how the eight big stocks have performed over the past five trading sessions.
Over the past five trading sessions, AbbVie is up the most (5.4%) while Roche is down the most (0.3%).
Over the past six months, Merck has risen the most (23.9%) while Roche has fallen the most (16.1%).
(See the latest pharma stock recap here: LLY’s Alzheimer’s trial setback, FDA updates for SNY, MRK)
What’s next in the pharmaceutical world?
Watch for regular pipeline and regulatory updates next week.
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