Mergers & Acquisitions

DUE DILIGENCE SUPPORT

NDA can help you if you are considering the sale of your pharmaceutical or biotech product to another company. We help position the manufacturing of your asset to best support its successful commercialization.

If you have acquired the rights to a new molecule or marketed product, and want to know how to best support it’s long term manufacture then NDA can help.

In addition we have assisted Pharmaceutical companies during due diligence exercises, both in the collation and establishment of data rooms, and in the review of due diligence data on behalf of prospective purchasers.

We have conducted due diligence audits of manufacturing facilities and processes to identify compliance risks. We then work the client to establish and implement risk mitigating action plans.

INTEGRATION MANAGEMENT

NDA have helped clients integrate operations following major mergers and acquisitions. We work with clients functional experts to review all of the operations within the original companies and establish work streams to ensure the successful integration of operations as quickly as possible.

MERGERS & ACQUISITIONS CASE STUDY –DUE DILIGENCE

ISSUE:

A pharmaceutical company was considering the acquisition of new product in phase IIb clinical trials and wished to understand if anything about the manufacturing and supply of the product would impede the acquisition.

OBJECTIVE:

Review available Due Diligence data and recommend if the acquisition should progress from a manufacturing and supply perspective

DELIVERABLE:

Reviewed the Due Diligence information provided by product owner from manufacturing and supply perspective.

Identified key issues with manufacturing and supply process of the drug substance and drug product that required significant process development, and supply chain development.

Estimated the cost and time required to undertake the process development work and work required to ensure the supply chain is suitable for phase III supply and registration.

Established an outline manufacturing strategy which identified the key activities required to support the supply of the product through phase III, registration, launch, and growth phases.

Estimated cost of goods at launch and at peak sales to allowing the client to calculate the Net Present Value (NPV).

MERGERS & ACQUISITIONS CASE STUDY – INTEGRATION MANAGEMENT

ISSUE:

A major pharmaceutical company acquired a specialist virtual pharmaceutical company for $1.6 billion and wanted to integrate the manufacturing and supply operations as quickly as possible.

OBJECTIVE:

Integrate the manufacturing and supply function of the virtual company into the operations of the major pharma company, allowing the virtual companies operations to be closed down as quickly as possible.

DELIVERABLE:

Established and implemented a plan of work to integrate the manufacturing and supply operations of the virtual companies into the operations of the major pharma company as quickly as possible.

Reviewed the existing supply chains to determine if they were fit for purpose. Identified the work required to improve security of supply and lower cost of goods.

Reviewed the existing manufacturing and supply agreements with contract manufacturers to determine if the agreements should be assigned as written or re-negotiated.

Transitioned the existing sales and operations planning process to that of the major pharma company.

Transition the order fulfillment processes to that of the major company
Identified the existing inventories and transitioned inventory management to the major company.

Agreed termination dates for the virtual company employees and transitioned knowledge from the employees prior to termination.