Tercica, Inc. was a biopharmaceutical company based in California, United States, dedicated to developing and marketing therapies for endocrine and metabolic disorders—especially those related to growth hormone deficiencies. Tercica became widely recognized for its work on Increlex®, an IGF-1 (Insulin-like Growth Factor-1) therapy, offering hope to children suffering from growth failure due to severe primary IGF-1 deficiency (SPIGFD).
Founded in the early 2000s, Tercica stood at the intersection of innovative science and unmet medical needs. The company became a part of the Ipsen Group in 2008 through acquisition, enhancing Ipsen’s global endocrine footprint.
Understanding the Medical Need: Growth Disorders and IGF-1
What is IGF-1 and Why Does It Matter?
IGF-1 (Insulin-like Growth Factor-1) is a hormone similar to insulin in structure and plays a crucial role in childhood growth and anabolic effects in adults. The production of IGF-1 is stimulated by growth hormone (GH) from the pituitary gland.
In some patients—particularly children—deficiency or insensitivity to GH leads to severe short stature, delayed development, and other health complications. When GH therapy fails (due to GH insensitivity or lack of receptor response), IGF-1 becomes a critical alternative treatment pathway.
Conditions Treated by IGF-1 Therapy
Tercica’s primary therapy, Increlex®, was developed to address rare pediatric disorders such as:
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Severe Primary IGF-1 Deficiency (SPIGFD)
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Laron Syndrome (a form of GH insensitivity)
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Certain forms of dwarfism unresponsive to GH
These conditions affect a small number of individuals globally, making them “orphan diseases” and ideal candidates for orphan drug development strategies.
Tercica’s Breakthrough Drug: Increlex®
What is Increlex®?
Increlex® (mecasermin [rDNA origin] injection) is a recombinant human IGF-1 approved by the FDA in 2005. It directly stimulates linear growth in children whose growth failure stems from primary IGF-1 deficiency rather than growth hormone deficiency.
Unlike traditional GH therapy, Increlex bypasses the need for GH receptor function, making it the only approved treatment for SPIGFD at the time of its release.
FDA Approval and Impact
The FDA approval of Increlex was a major milestone for Tercica. It:
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Established a new class of therapeutic agents.
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Addressed a previously untreated patient population.
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Created a niche market for IGF-1 therapies.
Increlex quickly became the gold standard for treating patients with IGF-1-related growth disorders.
Tercica’s Business Model and Strategy
Focus on Orphan Drugs
Tercica followed an orphan drug strategy, which included:
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Focusing on rare diseases with limited competition.
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Applying for orphan drug designation to secure 7 years of market exclusivity.
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Leveraging fast-track approval routes with the FDA and European Medicines Agency (EMA).
This strategy allowed Tercica to optimize its research and development budget while gaining strong pricing power for its innovative therapies.
Partnership with Genentech
To produce and supply mecasermin, Tercica partnered with Genentech, one of the largest biotechnology companies in the U.S. Genentech had pioneered IGF-1 research, and the collaboration gave Tercica access to:
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Proven biologic manufacturing facilities
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Rights to IGF-1 intellectual property
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Early access to clinical data
This collaboration was crucial to the development and launch of Increlex.
Tercica’s Global Reach and Ipsen Acquisition
Why Did Ipsen Acquire Tercica?
In 2008, Ipsen, a French biopharmaceutical company, acquired Tercica in a deal valued at over $600 million. The acquisition served multiple strategic purposes:
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Gave Ipsen immediate entry into the U.S. endocrinology market
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Added Increlex to its growing endocrinology portfolio
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Strengthened its research and commercialization capabilities
Following the acquisition, Tercica was integrated into Ipsen’s U.S. operations, significantly increasing the global availability of Increlex.
Expansion After Acquisition
Under Ipsen’s guidance, Increlex’s market grew to include:
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European Union markets
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Canada and Latin America
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Australia and Asia (selective markets)
Ipsen’s regulatory and commercial infrastructure helped streamline international approvals and expand access to patients worldwide.
Research, Trials, and Scientific Contributions
Clinical Trials and Safety
Increlex underwent extensive clinical evaluation before and after its FDA approval. Some trial outcomes included:
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Significant improvements in height velocity in SPIGFD patients
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Mild to moderate adverse events (e.g., hypoglycemia, tonsillar hypertrophy)
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Better outcomes in younger patients with early intervention
Tercica also initiated post-marketing surveillance to ensure long-term safety and efficacy.
Educational Outreach and Advocacy
Tercica invested heavily in:
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Physician education on diagnosing and managing SPIGFD
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Collaborating with pediatric endocrinology societies
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Partnering with patient advocacy groups to raise awareness
This outreach played a key role in early diagnosis and treatment of IGF-1 deficiency.
Lessons from Tercica’s Journey
Innovation in Niche Markets
Tercica’s focus on an underserved niche highlights the potential of smaller biotech firms to make significant impacts in rare disease treatment. It also showcases how a targeted, orphan-drug model can lead to commercial success even in a limited patient population.
Strategic Collaborations and Exit Planning
By partnering with major players like Genentech and aligning itself with Ipsen, Tercica demonstrated:
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The importance of strategic alignment in biotech
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The role of IP licensing in expanding R&D capabilities
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The value of scaling globally through acquisition
The Legacy of Tercica in Biotech
Even though Tercica no longer exists as a standalone company, its legacy endures. The development of Increlex has:
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Helped thousands of children with rare growth disorders
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Inspired further research into IGF-1 related therapies
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Cemented a place for orphan drugs in modern biotech strategies
Today, Increlex remains a critical component of Ipsen’s endocrine product line, and Tercica’s early risk-taking laid the foundation for continued innovation in rare disease treatment.
Conclusion:
Tercica exemplifies how biotech innovation, strategic partnerships, and a mission-driven approach to rare diseases can lead to breakthroughs that change lives. From its foundation to its acquisition by Ipsen, the company played a key role in pioneering IGF-1 therapy and elevating awareness for growth hormone resistance syndromes.
In a world increasingly focused on personalized medicine and rare disease solutions, the story of Tercica stands as a testament to what’s possible when science meets purpose.
