Prescribed Reading: Novartis ups the ante in gene therapy, while GSK folds on the space
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
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Mergers & analysis
The M&A bonanza of 2018 continued in earnest this week, with Novartis AG plopping down more than $8 billion for a gene therapy company and Alexion Pharmaceuticals Inc. finally forking over some dough to add to its pipeline.
Novartis is going full force into gene therapies, this time picking up AveXis Inc. for $218 per share, and getting its hands on a spinal muscular atrophy gene therapy. The transaction disappointed Biogen investors who were hoping the big biotech would pick up the potential competitor to its own SMA drug Spinraza (nusinersen).
Elsewhere, Alexion Pharmaceuticals is continuing its turnaround plan by acquiring Wilson Therapeutics AB for its late-stage rare disease drug. About 90% of the company's revenues still come to from its blockbuster rare disease drug Soliris (eculizumab). But the drug is facing a loss of patent protection and Alexion has been scrambling to diversify.
Mylan NV is also working its turnaround story; the company inked three deals this week to license complex copycat drugs. The generics drugmaker is trying to change its story and give investors a different perception of the company — namely, that it can be a leader in hard-to-copy generics and biosimilars.
AstraZeneca plc padded its antisense portfolio, picking up a NASH candidate from Ionis Pharmaceuticals Inc. in a deal worth $330 million. This is the third such deal between the pair.
Another British pharma spent its week offloading rare disease drugs. GlaxoSmithKline plc followed through on its promise to exit rare disease drug development. The big pharma sold the unit to Orchard Therapeutics Ltd, including its gene therapy Strimvelis.
Merck & Co.'s Keytruda (pembrolizumab) continued to wow the oncology world this week with interim results that showed it improved overall survival in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who tested positive for PD-L1 expression over chemotherapy alone. These data come ahead of the American Association of Cancer Research conference this weekend, where other results will show how patients respond to Keytruda when paired with chemo.
Checkpoint inhibitor competitor Roche AG wasn't having the same success; the pharma paused a trial of its PD-L1 inhibitor Tecentriq (atezolizumab) paired with Cotellic (cobimetinib) as a maintenance treatment for colorectal cancer after four patients in the study died. Roche is working on next steps for the trial.
Pfizer Inc. was also handed a miss this week, revealing a data monitoring committee has recommended halting a Phase 3 study of Inlyta (axitinib) as an adjuvant therapy for kidney cancer after a review found the drug did not help extend disease-free survival versus placebo.
The industry was also hit with the latest failure in Alzheimer's disease. The crippling neurodegenerative disease has managed to evade pharma researchers for years now, and a study from vTv Therapeutics Inc. was not the one to break this hard-to-crack nut.
AbbVie's women's health portfolio hit a snag this week when the Food and drug Administration delayed its decision on approval of elagolix for endometriosis-associated pain by three months in order to review safety data related to liver toxicity. A drug that also limits the progesterone hormone from Allergan plc being studied in uterine fibroids was also recently delayed after patients in Europe began showing signs of liver function issues. While analysts believe the AbbVie drug will ultimately gain approval, a safety signal could limit uptake.
Elsewhere, Kadmon Holdings Inc. got the greenlight from the FDA to move forward with a pivotal Phase 2 study of its ROCK2 inhibitor KD025, following receipt of finalized guidance after a Type C meeting in March.
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