News

Patent Cliff Looms – Can Kv1.3 Take the Baton for the Next Wave of Drug Licensing?

Views: 0     Author: Ken     Publish Time: 2025-07-30      Origin: Site

facebook sharing button
twitter sharing button
line sharing button
wechat sharing button
linkedin sharing button
pinterest sharing button
sharethis sharing button


1. Introduction: The Patent Cliff Is Coming, Leaving Market Voids

"Patent cliff" refers to the sharp revenue drop pharma companies face when blockbuster drug patents expire, opening the door to generic competition. Between 2025 and 2030, nearly 200 branded drugs will lose exclusivity, putting an estimated $230–$400 billion in annual sales at risk. This impending wave of patent expirations – one of the largest in recent history – threatens about $230 billion in U.S. drug sales by 2030 and over $400 billion worldwide. Major companies like Merck, Bristol Myers Squibb (BMS), and Johnson & Johnson (J&J) are bracing for significant revenue erosion as their top sellers go off-patent.


BlockbusterDrugs-Sales

Figure: Estimated sales figures of blockbuster drugs facing patent expiry within 2025–2030


This patent cliff will create substantial market voids in certain therapeutic areas, but also opportunities for innovation. Analysts note that dozens of blockbuster drugs (each >$1B sales) are set to lose exclusivity by 2030. As a result, pharma firms are under pressure to fill pipeline gaps with new therapies – through acquisitions, licensing deals, or partnerships. Unibest's perspective: in this environment, proactively scouting new targets and programs for collaboration is crucial. Identifying the right next-generation target could allow drug developers to seize first-mover advantage in addressing unmet needs left by expiring therapies.


2. Blockbusters Nearing the Cliff and Key Therapeutic Gaps to Watch

Which drugs are approaching the patent cliff? A host of multibillion-dollar blockbusters will lose patent protection in the next few years, potentially leaving treatment gaps in their respective disease areas. Notable examples include:

  • Keytruda (pembrolizumab, Merck) – an immunotherapy for multiple cancers (melanoma, lung, etc.), with 2024 sales ~$25 billion. Its primary U.S. patent expires in 2028. As a cornerstone oncology therapy, Keytruda's loss of exclusivity will impact the oncology space heavily. Indeed, oncology is one key area facing a patent cliff, with Keytruda and other top cancer drugs (e.g. J&J's Darzalex) set to expire by 2029.

  • Eliquis (apixaban, BMS/Pfizer) – an oral anticoagulant for stroke prevention (atrial fibrillation) and clot disorders, with 2024 sales ~$12 billion. Patents expire by 2026–2027. Its patent cliff will leave a gap in the cardiovascular/thrombosis market, especially for patients needing safer blood thinners. BMS, for example, derives a significant share of revenue from Eliquis and will be hit hard when it goes off-patent.

  • Stelara (ustekinumab, J&J) – a biologic for autoimmune diseases like psoriasis, Crohn's disease, and lupus, with 2024 sales ~$10.9 billion. Stelara's U.S. exclusivity ends by 2025 (biosimilar entry) and fully by 2028. This creates a potential void in immunology therapy for conditions like psoriatic disease and inflammatory bowel disease not fully controlled by current drugs.

  • Eylea (aflibercept, Regeneron/Bayer) – an injectable biologic for macular degeneration and diabetic eye disease, ~$9 billion global sales (2019). U.S. and EU patents expired in 2023–2025. Ophthalmology could see patient switches to biosimilars, but also demand for new mechanisms to treat retinal disorders beyond anti-VEGF therapy.


These are just a few of the high-profile drugs on the cliff. In total, 190 drugs (including 69 blockbusters) will lose exclusivity by 2030. Therapeutic areas likely to have the biggest "white space" include oncology, immunology/autoimmune diseases, metabolic diseases, and certain specialty areas like neurology. 


For instance, BMS's immunotherapy Opdivo (nivolumab) for cancer, and AbbVie's Humira (adalimumab) for rheumatoid arthritis (already off-patent in 2023) are leaving behind large patient populations open to new treatments. Many of these patients could benefit from novel targets addressing mechanisms not covered by existing drugs.


From an industry view, only a few big pharmas are positioned to sustain growth through 2030 without new products. Most are turning to external innovation sourcing. This is where Unibest can help. Leveraging our global project monitoring and scouting capabilities, Unibest can identify innovative pipeline assets that align with these patent-cliff gaps. In other words, as top-selling drugs in oncology, immunology, etc. come off-patent, we help partners find the next generation of candidates in those fields. (For example, see our [NewCo Licensing Pipeline] for current innovative drug projects open for collaboration.) By mapping upcoming market voids to promising new targets, companies can proactively fill those gaps rather than cede ground to competitors.


3. Kv1.3: A New Target with High Potential in Autoimmune Disease

Amid the search for post-patent-cliff innovations, Kv1.3 has emerged as a compelling drug target – especially for autoimmune and inflammatory diseases. Kv1.3 is a voltage-gated potassium ion channel expressed on certain immune cells (notably effector memory T cells) that drive autoimmune reactions. Mechanism in autoimmunity: Effector memory TEM cells depend on the Kv1.3 channel for activation; blocking Kv1.3 suppresses their inflammatory activity. In simple terms, Kv1.3 inhibitors can selectively dial down overactive T cells that attack the body's own tissues, while sparing normal immune function. This precision immunomodulation makes Kv1.3 a promising therapeutic approach for diseases like multiple sclerosis (MS), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), psoriasis, type-1 diabetes, and others.


fonc-09-00933-g001

Figure: Schematic of Kv1.3 channel's role in effector memory T‑cell activation via membrane potential modulation


Why Kv1.3 matters now: Several current autoimmune drugs (e.g. biologic antibodies like Stelara, TNF inhibitors, etc.) blunt broad aspects of the immune system. In contrast, Kv1.3 blockers target a specific subset of chronically activated T cells implicated in many autoimmune diseases. Preclinical research and early clinical trials have shown that Kv1.3 blockade can reduce inflammatory pathology in models of MS, RA, lupus, and more, often with fewer side effects on general immunity. This makes Kv1.3 a versatile target to address unmet clinical needs across multiple autoimmune conditions.


Putative-mechanisms-of-the-effect-of-the-Kv1-3-blocker-ADWX-1-on-T-EM-cells-ADWX-1

Figure: ADWX‑1 Kv1.3 blocker selectively inhibits TEM cells by disrupting IL‑2 and NF‑AT/NF‑κB signaling pathways.


Current pipeline and competitors: The Kv1.3 field is heating up, with both biotech and pharma players investing in this mechanism:

  • Peptide blockers: Biotech companies like Kineta (with its ShK-186 peptide, a sea anemone toxin derivative) pioneered Kv1.3 blockers in early trials. Dalazatide (ShK-186) showed ability to reduce TEM cells in psoriasis patients in Phase 1, demonstrating proof-of-concept for Kv1.3 in human disease. Other peptide toxin analogues (e.g. from scorpion venom) are also being optimized for potency and selectivity. These biologic approaches aim for high specificity to Kv1.3.

  • Small-molecule inhibitors: Several companies are advancing oral Kv1.3 blockers. For example, D.E. Shaw Research developed a lead compound DES-7114. In a notable deal, Eli Lilly paid $60 million upfront (with up to $475 million in milestones) to license DES-7114 and related Kv1.3 inhibitors in 2022. This big pharma interest validates Kv1.3's potential. Similarly, Zealand Pharma has a potent Kv1.3 blocker (ZP9830) in its pipeline, and China-based DP Technology recently nominated a preclinical candidate DPT0218 (an "AI-designed" Kv1.3 inhibitor) for autoimmune indications like IBD and atopic dermatitis.

  • Clinical stage projects: At least one Kv1.3 therapeutic has reached Phase 2: YR-001, a topical Kv1.3 blocker ointment from Hangzhou Yirui (China), is in a Phase IIa trial for atopic dermatitis (eczema). This marks the furthest clinical progress so far, indicating safety and early efficacy signals are being evaluated in patients. We anticipate more Kv1.3 drug candidates entering Phase 1 soon, given multiple programs in late preclinical stage (as tracked by DelveInsight's pipeline report).


Overall, the Kv1.3 pipeline spans peptides, small molecules, and even antibodies, with applications in dermatology, neurology, and systemic autoimmune diseases. Several programs are backed by substantial deals (Lilly's >$500M commitment, 4SC/Maruho's €200M+ deal – see next section), underscoring the commercial interest. The competitive landscape is still relatively uncrowded (only a handful of companies), which means a well-positioned entrant could capture significant value.


Unibest's role: Unibest closely monitors emerging targets like Kv1.3 across global pipelines. Our team can quickly identify Kv1.3 opportunities – for example, innovative programs in China or other regions that may be under the radar of big pharma. Through our network and intelligence systems, we track clinical trial registries, company announcements, and scientific reports on Kv1.3. This enables us to alert clients to partnership or license opportunities early. Whether you aim to license-in a Kv1.3 asset or form a joint venture (NewCo), Unibest can help scout the right partner and asset. (See our [NewCo/License service page] for how we facilitate cross-border pipeline collaborations.) By tapping into Unibest's insights, clients stay ahead in the Kv1.3 race, potentially securing the next breakthrough autoimmune therapy.


4. Market Gaps and Unmet Needs: How Kv1.3 Could Fill the Void

The upcoming patent expirations will not only challenge pharma financially, but also leave therapeutic gaps where patients' needs are not fully met by older drugs. Here's how Kv1.3 could "take the baton" in key areas:

  • Autoimmune & Immunology voids: Many immunology blockbusters nearing patent cliff (e.g. Humira, Stelara, Enbrel, Cosentyx) target cytokines or immune pathways, but a significant subset of patients still experience disease flares or inadequate response. For instance, in rheumatoid arthritis and lupus, up to 30–40% of patients have refractory disease despite current biologics. These conditions represent an "enormous unmet clinical need," as noted by experts. Kv1.3 inhibitors offer a novel way to suppress autoreactive T cells in diseases like RA, SLE, multiple sclerosis and psoriasis – potentially helping patients who don't respond to anti-TNF, anti-IL-6, or B-cell therapies. By targeting TEM cells, Kv1.3 blockers could prevent the tissue damage those cells cause in joints, skin, and organs. This targeted approach might also avoid some side effects of broad immunosuppression (since resting T cells and other immune cells are less affected). In short, as older monoclonal antibodies face biosimilars, Kv1.3 drugs could become the next-generation immunomodulators to achieve deeper or more durable remission in autoimmune diseases.

  • Neurology (MS) and beyond: Neurological autoimmune diseases like multiple sclerosis could particularly benefit from Kv1.3 therapies. MS involves pathogenic T cells attacking myelin in the CNS. Existing MS drugs (e.g. interferons, S1P modulators) blunt relapses but don't specifically remove autoreactive Tcells. Kv1.3 blockers have shown efficacy in animal models of MS by selectively inhibiting myelin-reactive T cells. With MS drugs like Tysabri and Tecfidera eventually losing exclusivity, a Kv1.3-based therapy could find a niche, especially in progressive MS where current options are few. Similarly, in type-1 diabetes (T1D), pancreatic islet–reactive T cells express high Kv1.3; blocking them might preserve insulin-producing cells. This could open a new front in diabetes care where few disease-modifying therapies exist.

  • Inflammatory bowel disease (IBD): Patent cliffs for biologics like vedolizumab and ustekinumab in Crohn's and ulcerative colitis will intensify the search for new IBD treatments. Kv1.3 is upregulated on T cells in the gut mucosa of ulcerative colitis patients. Inhibiting Kv1.3 could quell gut inflammation in a targeted way. The potential market is large – globally 8 million people have IBD, and the autoimmune drug market for IBD alone is projected at $28B by 2028. If a Kv1.3 drug can demonstrate mucosal healing or steroid-sparing in IBD, it could capture significant share of this growing market, particularly as patents for anti-integrin and anti-IL12/23 drugs expire.


cancers-15-02716-g001

Figure: Topology of the Kv1.3 channel including phosphorylation sites – highlights possible modulation points for next‑generation inhibitors.


In all these cases, Kv1.3 therapies address patients' unmet needs: those who do not fully respond to current standard of care or who cannot tolerate existing drugs. A new mechanism can offer hope for remission. Furthermore, many autoimmune conditions still lack any curative or highly effective treatment – e.g. no approved drugs specifically target the long-lived T cells that drive disease memory. Kv1.3 would be first-in-class in that regard, potentially differentiating itself in crowded markets.


To quantify the opportunity: autoimmune diseases collectively affect an estimated 5–10% of the population. This includes millions with conditions like RA (4.5M worldwide), lupus (~5M worldwide), MS (~2.8M), and psoriasis (>60M). Even with numerous drugs available, a substantial percentage of patients (~20–40%) have uncontrolled disease activity or progressive disability. The burden is huge, both medically and commercially. As one medical leader noted, autoimmune disorders pose "an enormous unmet clinical need" and strain healthcare systems. A successful Kv1.3 therapy could tap into this broad patient base, offering a new option where others fail.


Unibest's value-add: Unibest combines global epidemiology and market research with on-the-ground insight to pinpoint where a new drug like Kv1.3 could make the biggest impact. We assist clients in market analysis, comparing disease prevalence, current treatment outcomes, and competitor pipelines. For example, our analysts can profile how many moderate-severe lupus patients (and what percentage) are inadequately controlled by current biologics – building the case for a Kv1.3 drug's market entry. We also survey physician and patient needs in these therapeutic areas to guide indication selection for Kv1.3 projects. Using these data, Unibest can recommend which Kv1.3 licensing opportunities have the strongest commercial potential (e.g. a program targeting MS vs. one targeting psoriasis) and help prioritize development focus. Our goal is to ensure that when you pursue a Kv1.3 asset, you do so with a clear alignment to a real market void and large unmet need, maximizing the likelihood of clinical and commercial success.


5. Licensing Models: Opportunities and Pathways to Collaboration

How can companies capitalize on Kv1.3 and other new targets? Often, the fastest route is through strategic licensing or partnership deals. There are a few common collaboration models in the biopharma industry, each with advantages:

  • License Out: A biotech or developer out-licenses its drug candidate to a larger partner, granting rights to develop and commercialize it (usually in certain territories or globally). In return, the licensor (original developer) receives an upfront payment, milestone fees for development achievements, and royalties on sales. Advantage: The smaller company secures funding and the expertise/resources of the larger partner to bring the drug to market. For example, Germany's 4SC licensed out its preclinical Kv1.3 inhibitor program to Japan's Maruho. The 2017 deal included up to €105 million in upfront and milestones (and additional sales milestones/royalties). Maruho, a dermatology-focused pharma, took on development of the Kv1.3 compounds for autoimmune skin diseases, validating 4SC's science while providing significant non-dilutive capital. (Notably, 4SC's compounds were designed to act on chronically activated T cells and spare normal ones – a unique selling point that helped secure the deal.)

  • License In: Conversely, a pharma company licenses in an asset – essentially the mirror of license out. Here the larger company acquires rights to an external candidate to fill its pipeline. Advantage: The licensee (big pharma) gains a promising drug without starting from scratch, accelerating its pipeline to address gaps (like those from patent cliffs). For instance, Lilly's deal with D.E. Shaw for a Kv1.3 blocker (mentioned above) is a license-in: Lilly paid $60M upfront for rights to DES-7114 and will pay up to $475M based on development and commercial milestones. This gave Lilly a ready-made entry into the Kv1.3 space to bolster its immunology franchise.

  • NewCo Joint Venture: In some cases, two parties create a new company (NewCo) to jointly develop a drug or a portfolio. This often happens when a regional company has a promising compound and an investor/partner forms a NewCo to develop it globally, sharing equity and risk. Advantage: Both parties are aligned in the venture's success, combining strengths (e.g. one provides the science, the other provides capital, clinical expertise, or market access). NewCo deals can be attractive for early-stage assets in need of focused development. For example, one could envision a NewCo where a biotech with Kv1.3 IP partners with an Asian pharma to develop it for global markets, each holding equity. The NewCo model can also facilitate dedicated funding (e.g. raising venture capital separately).


Each model has nuances in structure, but all generally involve a mix of upfront payments, milestone payments at key R&D stages (IND filing, Phase II completion, NDA approval, etc.), and royalties or profit-share on eventual sales. Recent Kv1.3 deals illustrate the scale: aside from Lilly's half-billion dollar commitment, the 4SC–Maruho license featured €103M in R&D milestones plus up to €105M in sales milestones and single-digit royalties. Another example: Debiopharm, a Swiss pharma known for licensing in early oncology drugs, often structures deals with moderate upfronts and hefty success-based payouts (though not directly in Kv1.3, it exemplifies creative deal-making like co-development support and option-based milestones).


Opportunity for Kv1.3 deals: Given the strong interest in autoimmune therapies, a preclinical Kv1.3 asset today could command an upfront in the tens of millions (USD), with total deal value well into the hundreds of millions if it progresses. Pharma companies facing the patent cliff in immunology (e.g. those losing Humira, Stelara, etc.) are actively scouting for novel targets – making Kv1.3 a prime candidate for out-licensing or partnering. For smaller biotechs or research institutes with Kv1.3 programs, now is the time to seek a licensee or NewCo formation, before the field gets crowded or large competitors develop their own in-house programs.


Unibest's end-to-end support: Executing a successful licensing deal requires rigorous due diligence and savvy negotiation. This is where Unibest excels. Our services span the entire licensing lifecycle:

  • Due Diligence: We assist in thoroughly evaluating the science and IP of the asset. For a Kv1.3 program, that means reviewing efficacy data, selectivity, safety signals, CMC (chemistry, manufacturing, controls) readiness, and patent status. Unibest's experts (scientists, clinicians, IP attorneys) perform a deep dive to ensure the asset is sound and aligns with the client's strategic goals.

  • Valuation & Deal Structuring: Unibest provides commercial valuation modeling, forecasting the asset's future market potential and risk-adjusted NPV. We benchmark comparable licensing deals (for instance, comparing a Kv1.3 deal to recent autoimmune drug licenses) to guide what upfront and milestones are fair. Our team then helps design a deal structure – how much upfront vs. milestones, royalty rates, co-development options, etc. – to create a win-win for both licensor and licensee. We might recommend including regulatory and sales milestones that match the product's trajectory (e.g. a bonus if a Kv1.3 drug gets approval in multiple indications).

  • Negotiation and Contracting: Drawing on experience, Unibest can negotiate on behalf of our client or support behind the scenes. We pay attention to key terms: territorial rights, sublicense conditions, IP ownership, milestone definitions, termination clauses, and so on. Our goal is to protect our client's interests while expediting agreement. Complex issues (like handling manufacturing rights, or defining what constitutes a "competitive product") are areas we provide counsel on.

  • Project Management and Post-deal Integration: After signing, the real work begins – transferring the asset and moving it through development. Unibest helps manage the tech transfer (e.g. of Kv1.3 assay systems or peptide synthesis know-how), ensures communication flow between teams, and sets up governance (joint steering committees, etc.). We also assist with regulatory strategy – for example, advising on IND/CTA filings in different regions (see our [DS/DP registration service] for our capabilities in drug substance & product regulatory compliance). Our quality assurance specialists coordinate CMC and quality control checks (leveraging Unibest's in-house quality systems) so that the program meets all standards as it progresses. We remain involved to monitor milestones and help troubleshoot any scientific or logistical hurdles, thus de-risking the project for our clients.


In summary, Unibest provides a one-stop solution for licensing deals – from finding the right partner, through negotiating a favorable contract, to supporting development all the way to the clinic. By entrusting us with these aspects, clients can confidently pursue licensing opportunities like Kv1.3 knowing that no detail – scientific, financial, or legal – will be overlooked.


6. How Unibest Empowers Clients to Seize the Kv1.3 Licensing Opportunity

Unibest has a 20-year track record of bridging pharmaceutical partnerships, and we stand ready to help clients capture the window of opportunity around Kv1.3. Here's how our key strengths translate into success for your licensing endeavors:

  • Extensive Resource Network: Over two decades, Unibest has built deep relationships with pharmaceutical innovators and manufacturers across China and globally. This means we know who has that promising Kv1.3 compound in a Chinese biotech pipeline, or which API producers can scale up a Kv1.3 small-molecule inhibitor efficiently. Our network of research institutions, drug discovery startups, CROs, and suppliers is at your disposal. For example, if a client is interested in a Kv1.3 candidate from a university lab, Unibest likely has contacts to facilitate discussion and evaluate the project. Moreover, our strong ties with intermediate and API manufacturers (see our [Intermediates Catalog] and [API Catalog]) give us an edge in assessing the compound's synthetic feasibility and cost structure early on. This resource advantage ensures that once you license a project, we can help source high-quality materials and potentially reduce CMC costs through our vetted suppliers. In short, Unibest's network accelerates every step from partner identification to product development, saving you time and money.

  • Global Pipeline Monitoring & Intelligence: We maintain a continuous watch on emerging drug pipelines worldwide using proprietary intelligence tools and databases. Our team tracks not only well-publicized Western pipelines but also innovative targets being explored in China, India, Eastern Europe, etc. This monitoring capability is crucial for finding "hidden gems" like a novel Kv1.3 analog that might be in early development in a smaller company. We also subscribe to industry reports (GlobalData, BioPharma Dive, GreyB analyses, etc.) to stay updated on competitive movements. With this knowledge, Unibest can alert clients in real-time about new Kv1.3 data or available projects. We can rapidly perform landscaping: How many Kv1.3 programs exist? What stage are they in? Which companies might be looking to license out? By having this intelligence at our fingertips, Unibest positions our clients ahead of the curve in pursuing high-potential assets before others catch on.

  • Comprehensive Service Capability: Unibest is not just a matchmaker – we are a full-service partner through the entire collaboration process. Our services span market analysis, due diligence, deal-making (as detailed in Section 5), and crucially all the technical and regulatory support needed to actualize a deal. For instance, once a Kv1.3 license is signed, we assist with quality and compliance assessments (leveraging our [Quality Control] expertise), ensuring the asset meets global standards. We provide support in scaling up synthesis or biologic production, with a keen eye on cost control (through process optimization and our cost benchmarking, see [Cost Control] for our approach). If the project involves bringing a compound to China or exporting from China, our regulatory affairs experts handle IND/CTA filings, GMP audits, and documentation, smoothing the path to clinical trials in the target region. We also manage project timelines and risk monitoring: setting milestone goals, tracking progress, and proactively identifying any risks (scientific or operational) to mitigate them. Essentially, Unibest becomes an extension of your team, project-managing the license from signature to Phase I and beyond. This one-stop support frees our clients to focus on strategic decisions while we handle execution details.


Let's illustrate Unibest's impact with a typical collaboration scenario: A mid-sized U.S. pharma is interested in acquiring an innovative autoimmune drug to fill its pipeline gap as its own product faces a patent cliff. Unibest identifies a Chinese biotech with a preclinical Kv1.3 candidate showing strong efficacy in lupus models. We facilitate initial discussions and scientific evaluations. Once interest is confirmed, Unibest conducts thorough due diligence – confirming the reproducibility of the Chinese data, assessing IP (e.g. checking patent filings in U.S./EU), and evaluating any formulation challenges. We then help the U.S. client craft a licensing deal: perhaps an exclusive license for worldwide rights (excluding Greater China, which the Chinese partner retains), with an upfront payment and milestones for clinical success. Unibest negotiates terms acceptable to both sides, leveraging our understanding of cross-cultural business norms and deal benchmarks. After signing, our team helps the U.S. company set up local R&D collaboration to transfer assays and know-how from the Chinese labs. We coordinate the tech transfer of the Kv1.3 manufacturing process to a GMP CRO, and guide the IND application writing using both Chinese preclinical data and new studies per FDA requirements. Within months, the U.S. sponsor is able to start a Phase I trial of the Kv1.3 inhibitor – a timeline accelerated greatly by Unibest's orchestration. Throughout, we monitor the project's progress, handle communication between the companies (overcoming any language or time-zone barriers), and keep an eye on any competitive intel (ensuring our client stays ahead in the Kv1.3 field).


The outcome: the client successfully moves a licensed Kv1.3 drug into clinical development, seizing a first-in-class position, while the original developer gains a strong partner and financial resources. Unibest's orchestration not only made this deal possible but also derisked it at every step, exemplifying our motto – "Collaborate with confidence." Over the years, Unibest has facilitated numerous such win-win partnerships, honing a playbook that we are ready to apply to the Kv1.3 opportunity.


7. Conclusion and Call to Action: Seizing the Window of Opportunity

The looming patent cliff of 2025–2030 is a double-edged sword. On one side, it poses a significant threat to pharma companies – up to $400 billion in revenue is at stake as blockbuster drugs lose exclusivity. But on the other side, it creates a once-in-a-decade opening for new players and new therapies to rise. The market void left by aging blockbusters is an invitation for innovative solutions. Companies that move quickly to introduce next-generation treatments can capture market share and address patients' unmet needs, turning the patent cliff from a challenge into an opportunity.


Kv1.3, as discussed, embodies the kind of high-potential innovation that can "take the baton" in the post-patent-cliff era. Its unique mechanism in autoimmune disease could make it the basis of multiple future therapies – therapies that patients are waiting for, and that could become the next licensing success stories. However, the window to act is limited. Competitors are already exploring Kv1.3, and early partnerships are being snapped up (Lilly's deal, etc.). To stake a claim in this next wave of innovation, interested companies – whether large pharmas seeking to license in or biotechs aiming to license out – should begin evaluations and dialogues now.


Unibest is here to help you act decisively. With our proven expertise in licensing and our comprehensive support platform, we stand ready to be your partner in capturing the Kv1.3 opportunity (and others like it). We encourage global and domestic pharmaceutical firms, biotech ventures, and investors to reach out to Unibest for a strategic consultation. Concretely, we invite you to:

  • Initiate a Project Screening Discussion: We can start with an informal discussion of what types of Kv1.3 or other innovative pipeline projects you are looking for (or have available). Our team will then present a curated list of candidates from our pipeline database that match your criteria, such as stage, indication, or region. (See our updated [NewCo Licensing Pipeline] for some available projects.)

  • Leverage Our Due Diligence Service: If you already have a Kv1.3 collaboration in mind, engage Unibest to conduct an impartial due diligence audit. We will provide a detailed report on the asset's strengths, weaknesses, market outlook, and a recommendation on how to proceed – giving you confidence before you commit.

  • Use Unibest as your Deal Facilitator: For companies ready to negotiate, our business development experts and legal team can step in to drive the process forward efficiently and fairly. We aim to shorten negotiation timelines and avoid common pitfalls, so you can sign the deal and start development sooner.

  • Plan for Success with Unibest's Support: Once a deal is in hand, let us assist with integration – from arranging kick-off meetings between technical teams to setting up regulatory filings (our [DS/DP Registration] service can take on the complex documentation work). Engaging us early in the post-deal phase ensures momentum is maintained and milestones are met.


Time is of the essence. The patent cliff clock is ticking, and those gaps in the market will be filled – if not by you, then by a competitor. Unibest's message is clear: don't wait on the sidelines. Whether you are a pharma giant looking to in-license a pipeline-saving drug, or a biotech entrepreneur seeking a partner to advance your discovery, now is the moment to act. Let Kv1.3 be your success story in the next wave of drug licensing deals.


Contact Unibest today to explore collaborative opportunities and receive a personalized strategic roadmap. Together, we can transform the patent cliff challenge into a launchpad for your next blockbuster – securing patient benefit and your business growth for years to come.



Sources:

  • Stat News – Patent cliff of 2025–2033 threatens over $400B in revenues.

  • PharmaLive/GlobalData – Nearly 200 drugs lose exclusivity 2025–2030, ~$230B US sales at risk.

  • LinkedIn (Dr. Rupal Rana) – 2025–2030 patent cliff: ~200 blockbusters, $236B global revenue at risk.

  • BioPharma Dive – Top drugs facing patent expiry this decade (Keytruda, Stelara, Opdivo, Eylea, etc.).

  • 4SC AG – Press release on Kv1.3 inhibitors license to Maruho (up to €208M deal).

  • Labiotech.eu – Commentary on 4SC–Maruho Kv1.3 deal and mechanism (T cell activation role).

  • Caldwell Law – Definition of "patent cliff" and revenue impact (steep drop, 80% market loss in year1).

  • Aurora Biomed – Presentation on Kv1.3 as autoimmune target (TEM cell dependence on Kv1.3).

  • DP Technology (BioSpace) – Kv1.3 inhibitor DPT0218 announced; Lilly's $60M+$475M deal for DES-7114.

  • Hangzhou Yirui (Patsnap) – YR-001 Kv1.3 blocker in Phase II for atopic dermatitis.

  • University of Glasgow (Lancet study) – Autoimmune disorders affect ~10% of population; "enormous unmet need" quote.

  • Morgan Stanley via FiercePharma – $183.5B sales of products losing exclusivity by 2030.

  • Esko Pharma blog – ~190 drugs (69 blockbusters) off-patent by 2030; ~$300B revenue at risk.

  • BioPharma Asia (Kineta data) – Kv1.3 peptide inhibitor (dalazatide/ShK-186) in autoimmune trials.

  • Caldwell Law – Generics often capture >80% market share in first year after LOE.