Complex pharmaceutical problems rarely fit into one box. Neither do I.

Independent qualification of 12 products in a pipeline

Commissioned at board level to establish whether a mid-sized Danish pharmaceutical company could trust the business cases behind its development pipeline. I built one model covering market and price, competition, regulatory pathway, development and supply, then took all twelve products through it. Several turned out to rest on optimistic assumptions; others carried upside nobody had quantified.

Generics development and business development

I led the development and business-development organisation around a clear pipeline strategy: sharper search and qualification of new products, loss-making projects pruned or reprioritised, business-case discipline, and an integrated pipeline process that gave the board monthly visibility on value, risk and timing. We shifted deliberately towards niche products and in-house development rather than competing primarily on price, and built a culture with the confidence to challenge.

Operating income rose from DKK 6.7 million in 2013 to DKK 38.0 million in 2014, a 467% increase on just 6% revenue growth, with the annual report attributing the improvement to organisational restructuring and portfolio and process optimisation. Within three years the business had moved from an existential turnaround to a platform for a strategic acquisition of approximately DKK 450 million.

Clearing a 110-product acquisition, and pricing what came with it

The acquisition of approximately 110 Takeda products, two production sites and around 600 employees, at a purchase price of up to €615 million including earn-outs, triggered Danish merger control. I represented Orifarm before the competition authority alongside external counsel: a notification of more than 300 pages, product-by-product market definition and HHI analysis, and the negotiation of a remedy package. It became the first major pharmaceutical merger cleared in Denmark. I then led the ongoing authority dialogue and the compliance reporting required under the remedies, including challenging how those remedies were interpreted in practice.

From board recommendation to a closed factory

Two years after the Takeda acquisition the group held three production sites and an unanswered strategic question: was this a trading company or a manufacturing company? I was a core member of the project group that analysed the manufacturing footprint – a substantial share of total volume and some 700 people – took the findings to the board, and built the scenarios and payback cases that set the direction. When the decision fell I moved into implementation as advisor to the steering group: thirteen product dossiers transferred in 14–16 months against an industry norm of 24, no failed transfers, no stock-outs, and a GMP-compliant shutdown and closing inspection. It remains the largest project the company has completed entirely in-house.

Seven proceedings, four countries, one commercial thread

Patent litigation was not something I became involved in once a dispute had started. As VP, I led the identification of patent openings where a generic product could create significant value despite an expected injunction, assessed the commercial opportunity against the legal and patent risk with counsel, and decided which cases were worth pursuing.

Over roughly a decade that led to seven proceedings against Novartis, Mundipharma and Neurim in Denmark, Sweden, Finland and Norway. I was the commercial constant throughout: shaping strategy with counsel, building the loss and damages models, supplying market data and evidence to the courts, managing disclosure of highly confidential commercial information under court order, and appearing as the company’s business witness. Patents and utility models were invalidated, injunctions were lifted, and none of the proceedings were decided against us. In Denmark the Maritime and Commercial High Court found Novartis liable without fault for a wrongful injunction and awarded DKK 13.0 million plus interest in 2017, later adjusted on appeal; in Norway the Oslo District Court invalidated all three asserted patents and awarded costs.

Turning grey zones into an approved market

The opportunity was unusual: the patients and the market already existed, but an approvable product did not. Immediate-release melatonin was widely compounded ex tempore as a sleep aid in ADHD patients, with no authorised immediate-release tablet carrying clinical documentation suited to a generic application – the one authorised melatonin product was a prolonged-release tablet with an indication far from that use. Isotretinoin had been supplied in Sweden for decades through named-patient import because its risk-benefit assessment had never been revisited. Ursodeoxycholic acid had never been approved in Denmark at all.

Under my leadership we found and executed a different route for each – in-house development for melatonin, a new regulatory procedure for isotretinoin, external development for UDCA – and then took them through the barrier most companies stop at: securing reimbursement, including QALY-based health-economic cases built without proprietary clinical data. The result was access to established markets rather than the slow creation of new ones. We were first to market with an approved immediate-release melatonin tablet, today one of the company’s largest in-house-developed generics, and in Sweden the entire named-patient isotretinoin market migrated to our product within a month of launch.