The pharmaceutical industry has largely given up on in-house research and development, saying that the R&D timeline is too costly, long and uncertain to fund with shareholders’ money. The industry has gone from bolt-on acquisitions of smaller companies with marketed products to battling it out for clinical-stage drug candidates. What’s surprised some industry observers is that these acquirers are now targeting early-stage and even pre-clinical drug candidates, to boost their own production pipelines, but as a way to stymie the competition, too.
Pharmaceutical mergers and acquisitions hit a peak in 2014, with 188 deals (up 25% year-over-year) and $213.3 billion in spending (up 220% y-o-y). Actavis plc (now Allergan plc), acquired both Allergan (NYSE: AGN) and Forest Labs (NYSE: FRX) for a combined $91 billion, the two largest transactions in the sector that year.
By comparison, in 2014, biotechnology M&A reached 136 deals (up 62%) and $21.0 billion (down 29% y-o-y). Swiss drug maker Roche (SIX: RO) announced the sector’s largest deal, its $8.3 billion takeover of InterMune, Inc. (NASDAQ: ITMN). Regular readers know that we consider deal volume a better measure of investor interest than deal values, since many deals are announced without disclosing financial terms. So both healthcare sectors were showing strength that year.
What’s the deal this year? Through August 31, 2016, the pharmaceutical sector has reported 116 transactions and combined spending of $74.3 billion. With four months to go, including a presidential election that has addressed high drug prices, we don’t expect to see deals on the scale of the Actavis/Allergan hookup ($66 billion) or the failed Pfizer (NYSE: PFE) bid for Allergan in November 2015, at $160 billion.
In the first eight months of this year, the biotech sector recorded 94 deals, with a combined total of $12.0 billion spent so far. The sector’s largest deal announced to date is AbbVie’s (NYSE: ABBV) $5.8 billion acquisition of privately held Stemcentrx, Inc.
Of the 210 combined biotech and pharma deals through August 2016, 111 transactions (53%) targeted clinical candidates or companies with clinical candidates. Acquirers have spent $36.6 billion in upfront payments, before any milestone payments kick in. Some 46 of the targets were privately held companies, and 63 were publicly traded.
Pfizer has made two of the top three largest acquisitions in the first eight months of 2016. The largest, and most recent, was the August 22 announcement that Pfizer agreed to pay approximately $13.5 billion for Medivation (NASDAQ: MDVN), a biopharma focused on developing and commercializing small molecules for oncology. Its portfolio includes XTANDI® (enzalutamide), an androgen receptor inhibitor, the leading novel hormone therapy in the United States.
Medivation and Astellas Pharma, Inc. (TSE: 4503) have collaborated on a robust development program for XTANDI, including two Phase 3 studies in non-metastatic prostate cancer and another Phase 3 study in hormone-sensitive prostate cancer. It is also being further developed in Phase 2 studies for the potential treatment of advanced breast cancer and hepatocellular carcinoma.
In addition, Medivation has a promising, wholly owned, late-stage oncology pipeline, which includes two development-stage oncology assets, talazoparib and pidilizumab. Talazoparib is currently in a Phase 3 study for the treatment of BRCA-mutated breast cancer and possibly other tumors. Pidilizumab is a pre-clinical immuno-oncology (IO) asset being developed for diffuse large B-cell lymphoma and other hematologic malignancies. It has the potential to be combined with IO therapies in Pfizer’s portfolio.
This deal may be the end of months of bidding for Medivation, which began in mid-April with an unsolicited offer from Sanofi SA (NYSE: SNY) for $52.50 per share in cash (approximately $9.3 billion) for all outstanding Medivation common stock. Medivation deemed the offer too low, but that salvo brought other Big Pharma companies, including AstraZeneca (NYSE: AZN). As part of its deal with Pfizer, Medivation has agreed to pay $510 million in the event it accepts a better offer before the transaction closes by the end of 2016.
On the same day that Medivation publicly declined Sanofi’s offer, AbbVie announced its acquisition of Stemcentrx, Inc. for $5.8 billion. Stemcentrx develops therapies that cure and significantly improve survival for cancer patients. Its novel, late-stage Rova-T (rovalpituzumab tesirine) compound for small cell lung cancer is a biomarker-specific antibody drug conjugate. It is currently in registrational trials for small cell lung cancer. The acquisition expands AbbVie’s oncology pipeline with four additional early-stage clinical compounds in solid tumor indications and a significant portfolio of pre-clinical assets.
The third largest deal this year, also from Pfizer, was for Anacor Pharmaceuticals (NASDAQ: ANAC), which focuses on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform, for $5.2 billion. Its flagship asset, crisaborole, is currently under review by the FDA for the treatment of eczema.
We expect this trend of buying other companies’ candidates to continue. In late August, Novartis AG (NYSE: NVS) announced it was disbanding its gene therapy unit, which produced CTL019, a CAR-T therapy in development for leukemia and lymphoma. The drug candidate remains on track for a U.S. regulatory filing in early 2017, but the news brought down shares of Novartis and other players in the CAR-T space. As the Novartis division chief noted, “Things don’t always work out as envisioned.”