The long-predicted deal-making boom in Big Pharma started with a bang on Wednesday, as Bristol-Myers Squibb announced it will buy Celgene in a cash and stock transaction worth $74 billion. The deal values Celgene at $102.43 a share—54% higher than its closing price on Wednesday evening.
In a presentation the two companies planned for early Thursday morning, they laid out a combined company that would be the number-one player in oncology, with products including BMS’s checkpoint inhibitor Opdivo and Celgene’s multiple myeloma blockbuster Revlimid. The combined company would also be the top player in the cardiovascular space, with BMS’s blood thinner Eliquis—a fast-growing brand it shares with Pfizer—and it will be in the top five in immunology and inflammation, they contend (PDF).
During a conference call with analysts after the announcement, Giovanni Caforio, M.D., chairman and CEO of BMS, said that by making the acquisition, the company would benefit from a greatly expanded pipeline and the opportunity for six near-term product launches. They include a CAR-T treatment for multiple myeloma, ozanimod to treat multiple sclerosis and luspatercept for beta thalassemia.
Source: Fierce Pharma
Sanofi and Regeneron’s biologic Dupixent has been granted a priority review in the US for use to treat certain adolescent patients with moderate-to-severe atopic dermatitis.
The companies are seeking approval to market the drug for patients aged 12 to 17 years whose disease is inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable.
Dupixent (dupilumab) inhibits interleukin-4 and interleukin-13 (IL-4 and IL-13) signaling, two key drivers of Type 2 inflammation, a systemic response known to play a role in moderate-to-severe atopic dermatitis.
In one clinical trial, 24% of patients who received weight-based dosing of Dupixent every two weeks and 18% of those given a fixed dose every four weeks achieved the primary endpoint of clear or almost-clear skin, versus 2% in the placebo arm.
Also, 41.5% of those who received Dupixent every two weeks and 38 percent of patients who took the drug every four weeks achieved 75% or greater skin improvement (EASI-75) compared to 8% in the control group.
On the safety side, the overall rate of adverse events was comparable between the Dupixent groups and placebo (72% for Dupixent every two weeks, 64% for Dupixent every four weeks and 69% for placebo) over the 16-week treatment period, while there were no serious adverse events or events leading to treatment discontinuation in either drug treatment group.
Dupixent was approved in the US in March last year for the treatment of adults with moderate-to-severe atopic dermatitis, and just days ago won clearance for patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
Its approval for adolescents with moderate-to-severe atopic dermatitis could help address significant unmet medical need for this patient group, who have no approved systemic biologic medications.
A decision by the US Food and Drug Administration is expected by March 11, 2019.
Source: Pharma Times
Tusk Therapeutics Ltd (“Tusk”) was today acquired by Roche. Tusk has developed an antibody with a novel mode of action aimed at depleting regulatory T-cells (Tregs). Tregs suppress immune responses, including those against cancer cells. Preclinical data has shown that depleting Tregs from the tumor microenvironment can enhance and/or restore anti-tumor immunity. Tusk’s antibody has been designed to deplete these harmful Tregs, while not interfering with other immune cells acting against the tumor. Tusk’s program is expected to start clinical trials in cancer patients towards the end of 2019.
Tusk was founded in 2014 by Droia Oncology Ventures, Tusk’s majority shareholder. Under the terms of the agreement, Tusk’s shareholders will receive an upfront cash payment of Euro 70 million, plus additional contingent payments of up to Euro 585 million based on achievements of certain predetermined milestones.
Luc Dochez, Chief Executive Officer of Tusk Therapeutics, said: “We are delighted that Roche will further develop this novel antibody and drive the development ahead. The remaining portfolio of our immune-oncology targets will be further developed by Black Belt Therapeutics, a newly formed company spun out of Tusk Therapeutics.”