Pharma BD Deal Intelligence

Bayer AG / Onyx Pharmaceuticals

2011 · Co-Development · $160M · Complete

Bayer bought its way out of a lawsuit and into full control: $160M cash resolved the 2009 litigation and handed Bayer sole decision-making on regorafenib, which went on to win speedy FDA approval at $9,350/month with $1.25B+ peak-sales expectations — a bargain settlement in hindsight.

Outcome grade pending — assessed 5 years post-close.

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The coverage arc

Oct 11, 2011 Onyx Pharmaceuticals Form 8-K (settlement and regorafenib agreement) Neutral

Under a Settlement Agreement entered into on October 11, 2011, Onyx and Bayer agreed to settle and dismiss all claims related to the complaint filed by Onyx…

Oct 13, 2011 PharmaTimes Neutral

Frames the settlement factually as resolution of the dispute — 'a deal has now been reached, and legal proceedings have been dropped' — without evaluating the…

Sep 27, 2012 FierceBiotech Bullish

FierceBiotech reported the speedy FDA approval of regorafenib at $9,350/month with analyst peak-sales expectations of $1.25B+, validating Bayer's decision to…

Source summaries from our enrichment pipeline; follow links for originals.

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Bayer and Onyx restructured their global oncology collaboration: Bayer gained sole decision-making for regorafenib in exchange for $160M cash settlement and royalty on regorafenib. Bayer also bought out Onyx's Japan Nexavar royalty rights.

Did it work? Outcome assessment

Strategic verdict
Achieved Stated Rationale
Financial impact
Accretive
Stivarga (regorafenib) grew into a meaningful Bayer oncology franchise: sales rose from €275M (2016) to €475M (2020) and €477M (~$521M) in 2021, net of which Bayer pays the contractual 20% royalty on worldwide oncology net sales (held by Amgen after its 2013 Onyx acquisition).
Pipeline outcome
Assets Advanced
Regorafenib won three FDA approvals inside the window: metastatic colorectal cancer (September 2012, under priority review), GIST (February 2013), and second-line hepatocellular carcinoma (April 2017, the first new FDA-approved liver-cancer drug in a decade, based on the Phase III RESORCE trial).

Key facts

Disease & market context

Metastatic Colorectal Cancer (and GIST, HCC, RCC)

$1.3B Peak sales expectation for regorafenib (analyst consensus pre-launch)

Disease Overview

Metastatic colorectal cancer (mCRC) is advanced colon or rectal cancer that has spread beyond the original site, typically to the liver or lungs. Patients who progress through standard chemotherapy backbones (FOLFOX/FOLFIRI) and targeted biologics (bevacizumab, cetuximab, panitumumab) have historically had few effective options and short survival, making third-line therapy a high unmet-need niche.

Competitive Landscape

At the time of the 2011 restructuring, the mCRC armamentarium centered on Roche's Avastin (bevacizumab), Lilly/BMS Erbitux (cetuximab), Amgen's Vectibix (panitumumab), and the FOLFOX/FOLFIRI cytotoxic backbones. Bayer/Onyx's Nexavar (sorafenib) was approved in HCC and RCC but had failed in CRC. Regorafenib — structurally distinguished from sorafenib by a single fluorine atom, which sparked Onyx's 2009 lawsuit — was Bayer's wholly-owned multikinase inhibitor (VEGFR1-3, TIE2, KIT, RET, RAF, PDGFR) being advanced as the first oral salvage option for chemo-refractory mCRC. The CORRECT Phase 3 trial later showed a statistically significant but modest OS improvement (6.4 vs 5.0 months), supporting FDA approval as Stivarga in September 2012 with a list price of ~$9,350/month and analyst peak-sales estimates of $1.25B+. The 2011 restructuring resolved Onyx's litigation, gave Bayer sole decision rights on regorafenib in exchange for $160M cash plus a 20% royalty to Onyx and US co-promotion, and bought out Onyx's Japan Nexavar royalty. The deal cleared the runway for a unified Bayer-led launch and is generally viewed as a value-preserving compromise — Onyx monetized litigation risk while retaining royalty exposure to a likely launch. Source: https://www.biospace.com/onyx-pharmaceuticals-inc-bayer-healthcare-restructure-oncology-agreement-announce-settlement-reached-in-litigation-b-onyx-b-gets-160m-in-sett

Related deals — scored

DealYearValueOutcome
Bayer AG / Onyx Pharmaceuticals (this deal)2011$160M
Bayer AG / Schering AG2006$21.5B79
Bayer AG / BlueRock Therapeutics2002$600M79
Bayer AG / Merck & Co., Inc.2014$14.2B71
Bayer AG / Schering AG (residual squeeze-out)2007$985M69
Bayer AG / Arvinas, Inc.2019$1.0B59
Bayer AG / Merck & Co. Inc.2014$14.2B56

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