AbbVie and Gilgamesh Pharmaceuticals Announce Collaboration and Option-to-License Agreement to Develop Next-Generation Therapies for Psychiatric Disorders

Rhea-AI Summary

AbbVie and Gilgamesh Pharmaceuticals have announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. This partnership aims to leverage AbbVie's expertise in psychiatry and Gilgamesh's innovative research platform to discover novel neuroplastogens targeting mechanisms that may provide significant clinical benefits while minimizing challenging side effects seen with first-generation compounds. The agreement includes a significant upfront payment, potential milestone fees, and royalties for Gilgamesh, showcasing AbbVie's commitment to advancing mental health treatment through innovative technologies.

Positive

• Collaboration between AbbVie and Gilgamesh Pharmaceuticals to develop next-generation therapies for psychiatric disorders

• Leveraging AbbVie's psychiatry expertise and Gilgamesh's innovative research platform

• Focus on discovering novel neuroplastogens targeting mechanisms with potential clinical benefits

• Agreement includes upfront payment, potential milestone fees, and royalties for Gilgamesh

• Potential for significant advancements in mental health treatment through innovative technologies

Negative

• Risks associated with developing next-generation therapies for psychiatric disorders

• Potential challenges in minimizing side effects of novel neuroplastogens

• Uncertainty regarding the success of research and development activities

• Dependence on the option exercise by AbbVie for further development and commercialization

• Potential for competition and market saturation in the psychiatric treatments sector

Insights

Pharmaceutical Industry Analyst

The partnership between AbbVie and Gilgamesh Pharmaceuticals centers on developing neuroplastogens, a newer class of therapeutic agents targeting psychiatric disorders. Considering the current treatment landscape, where many patients with psychiatric conditions experience inadequate responses to existing medications, advancements in this area have the potential to fulfill a substantial unmet medical need. Neuroplastogens represent an innovative approach, focusing on neural plasticity to conceivably offer benefits over first-generation psychedelic compounds, including a reduction in psychoactive side effects, which have limited their clinical application. The sizable upfront payment and tiered royalty agreement signal confidence in the potential market value of these therapies and align with industry norms for collaborations of this nature. However, the long-term nature of drug development and the regulatory hurdles ahead suggest that any financial benefits are speculative and would not materialize for several years. The commitment of up to $1.95 billion in option fees and milestones indicates the partnership's scale and strategic importance to AbbVie's psychiatric portfolio. The financial implications for Gilgamesh are transformative, though contingent on clinical and regulatory success, which should be considered by investors.

Biotech Patent Attorney

From a legal and intellectual property perspective, the collaboration between AbbVie and Gilgamesh Pharmaceuticals is a strategic move. The focus on neuroplastogens -- which are next-generation psychedelic compounds -- could result in obtaining patents for novel compounds with unique mechanisms of action. This would give AbbVie a competitive edge in the psychiatric treatment market. Patents not only provide market exclusivity but also enhance the negotiating power in future licensing deals or collaborations. The financial terms of the deal, including the upfront payment and potential milestone payments, reflect the high value placed on innovative treatments in this sector. Furthermore, the tiered royalty structure provides an ongoing incentive for Gilgamesh to continue contributing to the research and development efforts. For investors, patents serve as indicators of the potential for long-term revenue streams, but they should also be aware of the inherent risks in drug development and the time it takes from patent filing to market approval.

Market Research Analyst

The strategic alliance between AbbVie and Gilgamesh Pharmaceuticals taps into the growing mental health market, which has been fueled by increasing awareness and decreasing stigma. The demand for new psychiatric treatments is robust, as traditional antidepressants and anxiolytics leave a considerable portion of patients untreated or partially treated. The market for innovative psychiatric drugs, especially those with a novel mechanism, such as neuroplastogens, is potentially lucrative. This collaboration positions AbbVie favorably in the market, as it seeks to capitalize on Gilgamesh's pioneering research to diversify and strengthen its neuropsychiatric pipeline. However, the actual market entry of these neuroplastogens is subject to clinical trial outcomes and regulatory approvals, with success rates in psychiatric drug development being notoriously unpredictable. Thus, while the market opportunity is significant, the risks associated with the development process must be accounted for by investors.

-   Collaboration to leverage AbbVie's psychiatry expertise and Gilgamesh's innovative research platform to develop next-generation neuroplastogens for the treatment of psychiatric disorders

NORTH CHICAGO, Ill. and NEW YORK, May 13, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Gilgamesh Pharmaceuticals today announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. This collaboration will leverage AbbVie's expertise in psychiatry and Gilgamesh's innovative research platform to discover novel neuroplastogens.

Classic psychedelic compounds provide novel mechanisms to address mental health disorders, and some have shown promising clinical efficacy where other treatments have been ineffective. However, these first-generation compounds may induce profound psychoactive effects, such as hallucinations, necessitating in-office administration and concomitant supportive care.

Next-generation versions known as neuroplastogens target mechanisms that have shown potential to provide significant clinical benefits and are designed to minimize the challenging effects seen with first-generation compounds. These new compounds hold substantial promise for treating a variety of psychiatric conditions, including mood and anxiety disorders. Gilgamesh has leveraged an innovative research platform to successfully identify lead compounds in this novel class of therapeutics.

"Significant unmet need remains for people living with psychiatric disorders and we know that to innovate in this field, we need to pursue novel technologies and approaches," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research at AbbVie. "We look forward to working with Gilgamesh's world-class team to advance the development of novel neuroplastogens and pave the way for additional treatment approaches in psychiatry."

"We are thrilled to partner with AbbVie, a global pharmaceutical company focused on innovation in psychiatric care, to address the pressing challenges in mental health treatment," said Jonathan Sporn, M.D., chief executive officer at Gilgamesh Pharmaceuticals. "Our collaboration will pioneer research of a new generation of therapies that hold great potential for improving patient outcomes."

Under terms of the agreement, AbbVie and Gilgamesh have agreed to research and develop a portfolio of next-generation therapeutics for psychiatric disorders. Upon exercise of the option, AbbVie will lead development and commercialization activities. Gilgamesh will receive an upfront payment of $65 million from AbbVie and is eligible to receive up to $1.95 billion in aggregate option fees and milestones, as well as tiered royalties from mid-single to low-double digits on net sales.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

About Gilgamesh Pharmaceuticals

Gilgamesh Pharmaceuticals is a clinical stage neuroscience biotech developing innovative, best-in-class new chemical entities (NCEs) that target the root causes of psychiatric diseases, moving away from symptom management towards rapid-acting and durable, disease modifying therapies. We do this by designing best-in-class NCEs acting through proven mechanisms, which are optimized for safety, efficacy, and patient access. Gilgamesh is advancing a diverse portfolio of programs, including two lead clinical programs, GM-1020 and GM-2505, which have both commenced Phase 2 studies in Major Depressive Disorder. Learn more about the company's therapeutic pipeline at https://www.gilgameshpharmaceutical.com/.

Forward-Looking Statements 

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

View original content to download multimedia:https://www.prnewswire.com/news-releases/abbvie-and-gilgamesh-pharmaceuticals-announce-collaboration-and-option-to-license-agreement-to-develop-next-generation-therapies-for-psychiatric-disorders-302143485.html

SOURCE AbbVie

FAQ

<p>What is the collaboration between AbbVie and Gilgamesh Pharmaceuticals about?</p>

The collaboration aims to develop next-generation therapies for psychiatric disorders by leveraging AbbVie's expertise in psychiatry and Gilgamesh's innovative research platform.

<p>What are neuroplastogens in the context of psychiatric disorders?</p>

Neuroplastogens are next-generation compounds that target mechanisms with potential clinical benefits while minimizing challenging side effects seen with first-generation compounds.

<p>What financial terms are included in the agreement between AbbVie and Gilgamesh?</p>

The agreement includes an upfront payment of $65 million to Gilgamesh, with potential milestone fees, and royalties from mid-single to low-double digits on net sales.

<p>Who will lead development and commercialization activities upon the exercise of the option?</p>

AbbVie will lead development and commercialization activities once the option is exercised under the agreement.

<p>What potential benefits can the new generation of therapies bring to mental health treatment?</p>

The new therapies hold promise for improving patient outcomes by addressing significant unmet needs in psychiatric care through innovative technologies.