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Agreements

Date: 2014-10-01

Type of information: Collaboration agreement

Compound: Adempas™ (riociguat), vericiguat and other sGC modulators presently in earlier stages of R&D

Company: Bayer (Germany) Merck&Co (USA - NJ)

Therapeutic area: Cardiovascular diseases

Type agreement:

collaboration

Action mechanism:

soluble guanylate cyclase (sGC) stimulator

Disease:

Details:

* On May 6, 2014, Bayer and Merck & Co also agreed to enter into a strategic pharma collaboration in the area of cardiovascular diseases with a focus on sGC (soluble guanylate cyclase) modulation. Cardiovascular diseases represent one of the most significant therapeutic areas. Despite previous achievements there remains high medical need, for example, in various diseases such as certain forms of pulmonary hypertension or heart failure. Novel modulators of the sGC pathway may have the potential to address this need. However, major development efforts and clinical programs are required to fully explore the benefits of these novel compounds. This collaboration brings together two leading companies in this field. The collaboration includes Adempas™ (Riociguat), which is already approved for the treatment of pulmonary hypertension and inoperable chronic thromboembolic pulmonary hypertension, as well as vericiguat, an investigational compound that is currently being developed in two Phase IIb studies in worsening chronic heart failure. Furthermore, the parties agreed that sGC modulators presently in earlier stages of research and development may be included in the collaboration.

Financial terms:

Bayer and Merck & Co will equally share costs and profits from the sGC modulators and implement a joint development and commercialization strategy. Bayer will lead the commercialization for Adempas™ in the Americas while Merck & Co will lead the commercialization outside the Americas. For vericiguat and other potential investigational sGC modulators, Bayer will lead the commercialization outside the Americas while Merck & Co will lead the commercialization in the Americas. Both companies will have the option to co-promote Adempas™ and the follow-on sGC modulators in each others\' territories. 
Merck & Co will make payments to Bayer of up to $2.1 billion (€1.5 billion), comprising an up-front payment of $1.0 billion (€0.7 billion), and sales milestone payments of up to $1.1 billion (€0.8 billion) related to future collective sales of certain collaboration compounds including Adempas™.

Latest news:

* On October 1, 2014, Bayer announced the completion of the acquisition of the consumer care business of Merck & Co. The company also announced that the strategic pharma collaboration between Bayer and Merck & Co., Inc. in the field of soluble guanylate cyclase (sGC) modulators comes into effect simultaneously. Bayer plans to strengthen its development options in the cardiology business with the global co-development and co-commercialization agreement, which has already been approved by the relevant antitrust authorities. Merck & Co., Inc. will make payments of up to $ 2.1 billion to Bayer. These include an up-front payment of $ 1 billion, which is to be paid shortly after completion as well as revenue-based milestone payments of up to $ 1.1 billion for future combined sales of certain jointly developed substances, including the pulmonary hypertension treatment Adempas™ (riociguat).

Is general: Yes