M&A In GLP-1 Technology: Practical Recommendations And Best Practices

By Michele M. Simkin, Foley & Lardner

The GLP-1 revolution has rewritten the playbook for metabolic disease, and it’s also reshaping dealmaking. Explosive demand, expanding indications, and rapid innovation in formulations and combination therapies have pushed acquirers to move quickly while staying disciplined. Below is a practical guide for business development, corporate strategy, and diligence teams negotiating mergers, acquisitions, and significant licensing in the GLP-1 arena. The guidance draws on recent market dynamics, practitioner insights, and cautionary case studies from the GLP-1 domain.

1. Anchor Strategy In Patient And Market Reality And Not Just The Hype

You win GLP-1 deals by grounding strategy in the clinical value these drugs create across diabetes, obesity, and broader cardiometabolic risk. The category’s ability to deliver double-digit weight loss alongside cardiovascular and metabolic benefits has shifted GLP-1s from “therapies” to preventive medicine platforms with downstream systemwide savings. Position your investment thesis on those real-world outcomes and the large, growing, and diversifying patient populations.

Best practice: Tie target selection to explicit patient population expansion paths (e.g., cardiovascular (CV) risk reduction, chronic kidney disease, sleep apnea, surgical eligibility via BMI improvement). Assess whether the asset’s trial strategy and key opinion leaders’ network align with those growth vectors.

​2. Prioritize Assets That “Make A Better GLP-1”

A wave of innovations is improving the GLP-1 experience through new modalities and combinations: oral, transdermal, long-acting injectables; dual/triple agonists (GLP-1/GIP/glucagon); and combination regimens pairing GLP-1s with non-incretin agents. These innovations differentiate products, extend life cycles, and open new indications.

Best practice: Map each target to at least one durable differentiation lever:

• Delivery innovation: oral or transdermal approaches, depot technologies, and patient-friendly devices that improve adherence and persistency
• Mechanistic breadth: dual/triple agonists targeting broader metabolic endpoints (weight, lipids, glycemia, hepatic fat, inflammation)
• Combo synergies: rational combinations with cardiometabolic or oncology agents to enhance efficacy or enable new lines of therapy

Back the promise with evidence: target exposure-response analyses, early human pharmacokinetics and pharmacodynamics (PK/PD), tolerability profiles that reflect the real-world dose-titration journey, and plans for head-to-head or “add-on” trials against class leaders.

3. Build Manufacturing And Supply Leadership Into The Deal Thesis

GLP-1 demand has outpaced capacity. CMC (chemistry, manufacturing, and controls) and supply chain are not back-office issues in this category; they determine market share. Deals that secure fill/finish, peptide synthesis scale, and device assembly capacity can be strategically decisive, as seen in acquisition activity aimed at ensuring global supply resilience. Make sure the transaction builds or de-risks your manufacturing moat.

Best practice: In diligence, trace the entire supply chain:

• Peptide synthesis at scale: vendor concentration, long-lead intermediates, and yield profiles
• Formulation and device: stability, device reliability data, and human-factors validation
• Redundancy and tech transfer: dual-sourcing, validated second sites, and documented process knowledge to compress scale-up timelines
• Regulatory inspection history: past observations at CMDOs and remediation track records

Elevate CMC leaders to the deal table early. Make secure capacity a deal deliverable.

4. Stress Test Oral Programs, And Then Price Risk Accordingly

Oral GLP-1 programs attract intense interest for obvious adherence advantages, but they carry distinct risks. Several oral agents have stalled due to safety and liver tolerability concerns, and moving from injectable to oral is not a simple formulation exercise. You need innovative delivery science plus robust nonclinical and clinical packages to earn a premium.

Best practice: During diligence, insist on:

• Mechanistic plausibility for oral absorption: transporter targeting, permeation enhancers, gastric retention, or prodrug strategies, with translational evidence
• Liver and GI safety depth: full histopathology, drug-induced liver injury (DILI) signal characterization (identifies and assesses risk of liver adverse events (AEs)), exposure margins, and clean drug–drug interaction data for likely co-meds
• Food-effect and variability plans: realistic adherence modeling and mitigation strategies (e.g., flexible dosing windows)
• Contingent economics: Use milestones, earn-outs, or option-to-buy structures that match the stepwise de-risking of oral programs.

5. Treat IP And Exclusivity As A Program, Not A Paragraph

In GLP-1, the “IP stack” spans compositions, formulations, devices, methods of treatment (including new patient populations), and combination regimens. Patent expiry timing for first-generation blockbusters underscores why acquirers must pursue life cycle management from day one, especially around next-gen dosage forms and patient population-specific claims.

Best practice: Build a multilayered IP and exclusivity plan:

• Freedom to operate (FTO): Map claims covering peptides, backbones, salts, devices, and excipient systems across key markets.
• Evergreen via innovation: File early and often on formulation improvements, delivery tech, and combination methods supported by new clinical data.
• Regulatory exclusivities: Optimize data exclusivity, orphan designations (if applicable), pediatric incentives, and device clearances.
• Biosimilar/biobetter defense: Monitor emerging peptide biosimilar pathways and anticipate interchangeability policies. Align patent term with launch and label expansion milestones.

6. Valuate With Discipline — Separate Platform Potential From Asset Proof

GLP-1 is hot; early-stage valuations often reflect platform potential more than asset readiness. Counter fear of missing out with transparent risk-adjusted models and explicit “kill switches.” Reference class-wide success rates, supply constraints, and regulatory vectors when you frame scenarios. Account for dose-limiting tolerability and real-world persistence, and not just intermittent total diet weight loss means.

Best practices:

• Scenario modeling: Run base/optimistic/downside cases with realistic time-to-capacity and time-to-access assumptions.
• Research & development (R&D) ops reality: Include operational risks (e.g., enrollment friction, titration algorithms, discontinuation rates) and payer controls.
• Milestone pacing: Make step-ups in consideration contingent on manufacturing readiness, Phase 2 dose-finding success, or head-to-head deltas that matter clinically and commercially.

7. Put Regulatory Strategy On The Critical Path

Regulators will scrutinize safety (especially for oral agents), promotion (given off-label weight loss demand), and manufacturing controls. You must anticipate evolving guidance and public health optics, especially as GLP-1s enter prevention and combination therapy narratives.

Best practices:

• Label-building trials: Design pivotal programs that justify differentiated labels (e.g., CV risk, renal endpoints, sleep apnea metrics).
• Risk management plans: Prepare risk evaluation and mitigation strategies (REMS)-like frameworks where appropriate; strengthen adverse event monitoring and patient education for GI and hepatic risks.
• Promotion governance: Align medical, legal, and regulatory processes to manage pent-up demand and social media spillover responsibly.

​​8. Use Deal Structure To Match Risk With Control

One size does not fit all in GLP-1 dealmaking. You can balance speed and prudence with structures that stage commitment and reward de-risking.

Best practices:

• Options and staged buy-ins: Secure early access and collaboration rights while awaiting key readouts (e.g., oral safety or depot bioequivalence).
• Co-development with capacity commitments: Pair equity/licensing with binding manufacturing investments or guaranteed slots.
• Alliance governance: Define decision rights for indication expansion, device choice, and CMC changes; embed rapid dispute resolution paths.
• Commercial carve-outs: Consider regional partnerships aligned with distribution strengths in Asia/Latin America/Africa to accelerate footprint.

9. Plan For Integration Where It Matters Most: Trials, Tech, And Throughput

In GLP-1, integration success shows up in three places: the clinical plan, the technology stack, and the physical throughput of product to patients.

Best practices:

• Clinical integration: Merge biometrics, titration protocols, and adherence support tools quickly; harmonize endpoints across ongoing trials to enable pooled analyses.
• Technology integration: Stand up a joint device–drug working group on day 1; align digital companions and data pipelines for real-time adherence and adverse event monitoring.
• Throughput integration: Establish sales and operation planning (S&OP) cadences that link demand planning, active pharmaceutical ingredient (API) lots, and device assembly — weekly at first. Put a named executive in charge of “capacity to demand” with authority across sites.

10. Make Digital And Companion Solutions A Core Value Driver

Patients already use wearables and glucose sensors. In GLP-1, companion tech can personalize titration, detect early intolerance, and reduce discontinuation. These tools enhance real-world effectiveness and payer value arguments, and they create new data assets. Consider targets or partnerships that bring those capabilities.

Best practices:

• Companion road map: Define which digital signals (activity, sleep, heart rate variability, continuous glucose) inform dose, switch, or adherence prompts.
• Evidence plan: Run pragmatic studies to show that companions improve persistence, cardiometabolic outcomes, and cost offsets.
• Data rights: Negotiate data ownership/usage rights up front; ensure privacy by design and payer-ready analytics.

11. Execute An “Access Early” Strategy For Payer And Policy Alignment

Even breakthrough GLP-1s must navigate step edits, prior authorizations, and affordability debates. Engage payers and policymakers early with outcomes-based designs and adherence strategies that reduce waste.

Best practices:

• Value dossiers tuned to new indications: Link clinical endpoints to total cost of care models (CV events, renal progression, surgical eligibility).
• Adherence economics: Quantify how delivery innovation or digital companions cut discontinuations and dose waste.
• Contracting pilots: Explore outcomes-based arrangements where real-world weight loss or CV risk reduction unlocks rebates.

12. Create A Transparent Risk Register — And Use It

GLP-1 deals fail when teams gloss over known risk patterns: oral safety, scale-up friction, regulatory optics, and IP cliffs. Write the risks down, assign owners, and review them monthly during and after the transaction.

Best practice:

• Top-quartile risk hygiene:
  • Oral programs: DILI watchlist, exposure margins, and mitigation triggers
  • CMC: yield thresholds, batch failure contingencies, and second site timelines
  • Regulatory: communication guardrails and label expansion dependencies
  • IP: continuation/divisional filing schedule tied to key readouts and device changes

13. Keep An Eye On Adjacency And Ecosystem Fit

Smart acquirers evaluate how a GLP-1 platform plugs into their broader cardiometabolic strategy — hypertension, dyslipidemia, NASH/MASH, and heart failure pathways — as well as their device and digital assets. Recent transactions illustrate the logic of capacity acquisition, dual agonist platforms, and cross-disease combinations to accelerate ecosystem effects.

Best practice: Score targets on “ecosystem synergy”: 1) shared prescriber base, 2) compatible sales channels and prior authorization workflows, 3) overlapping diagnostics/monitoring, and 4) real-world data leverage.

14. What “Good” Looks Like: A GLP-1 M&A Checklist

Use this working list to keep your team focused:

1. Strategic fit
   • Identify a clear patient population expansion path and label-building plan.
   • Develop specific differentiation levers (delivery, dual/triple, combination).
2. Clinical/safety evidence
   • Obtain convincing Phase 2 dose-finding; exposure–response clarity.
   • Identify robust hepatic/GI safety for oral programs; drug-drug interaction (DDI) plan.
3. CMC/supply
   • Document process knowledge, second site strategy, and device reliability.
   • Secure capacity via CAPEX, CDMO slots, and tech transfer packages.
4. Regulatory
   • Implement label differentiating endpoints and risk management planning.
   • Determine promotion governance for high-demand categories.
5. IP/exclusivity
   • Consider layered claims (formulation, device, new populations, combos).
   • Develop a life cycle road map through and beyond early patent expirations.
6. Commercial/access
   • Identify a persistence-focused patient support plan and payer pilots.
   • Consider companion tech to strengthen adherence and value claims.
7. Deal design
   • Establish milestone-based economics aligned to key de-risking events.
   • Develop governance and capacity covenants; regional carve-outs as needed.

Conclusion

GLP-1 is not just a hot category — it’s a complex industrial system spanning peptide chemistry, device engineering, health economic value, and data-driven care. The winners in GLP-1 M&A will combine speed with rigor: they will buy differentiation, secure supply, de-risk oral innovation with eyes wide open, and orchestrate IP, regulatory, and access as one program. Execute that playbook, and you can capture durable value while expanding tangible health benefits for millions of patients.

About The Author:

Michele Simkin is a partner in Foley & Lardner’s Chemical, Biotechnology & Pharmaceutical Practice. She provides strategic business counseling to life sciences, pharmaceutical, and medical device clients relating to all aspects of intellectual property, including patent procurement and portfolio management, licensing agreements, due diligence related to IP acquisitions or sales, as well as validity, non-infringement, and freedom to operate analyses. She previously served as chair of the firm’s Intellectual Property Department, overseeing a team of over 300 IP professionals, and she is currently a member of the firm’s Management Committee.