Titan Pharmaceuticals, Inc.

For all of 2023, Hetlioz generated slightly more than $100 million in sales, representing a steep 37% decline from the $159.7 million it brought home in 2022. The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. Supreme Court shot down the company’s attempt to challenge an appeals court decision invalidating several of the drug’s patents in 2023.  The High Court has rebuffed (PDF) Vanda’s bid to contest the May 2023 ruling from the U.S. Court of Appeals for the Federal Circuit roughly four months after the company appealed to the Supreme Court to review the decision, according to a SCOTUS order list published Monday. Vanda first sued Israeli-American pharma Teva and Canada-based Apotex in Delaware back in 2018, alleging the generic drug makers had tread on certain Hetlioz patents after applying to make copycats of the med, which was first approved by the FDA in 2014 to treat non-24-hour sleep-wake disorder. In December 2022, the Delaware federal court both rejected Vanda’s infringement claims and took things a step further by ruling that four of Vanda’s patents were invalid. An appeals court upheld the decision in 2023, prompting Vanda to seek the Supreme Court’s aid in January, Reuters reports. "We are disappointed that the Supreme Court has decided not to hear our case and clarify the lower court standard for obviousness in patent law," Mihael H. Polymeropoulos, president, CEO and chairman of Vanda's board said in a statement. "However, we are pleased that our case has drawn attention to an area of law that has broad and significant implications in life sciences innovation." The failure of Vanda’s legal Hail Mary will likely take a heavy toll on the company and the future success of its decade-old drug. For all of 2023, Hetlioz generated slightly more than $100 million in sales, representing a steep 37% decline from the $159.7 million it brought home in 2022. In its most recent earnings report, Vanda blamed (PDF) the sales falloff on the Hetlioz generic launches in the U.S. Aside from Hetlioz, Vanda also markets the schizophrenia and bipolar disorder drug Fanapt as well as the multiple sclerosis drug Ponvory. Vanda shelled out $100 million in December to pick up U.S. and Canadian rights to Ponvory from Johnson & Johnson’s Actelion subsidiary. Vanda’s total 2023 revenues clocked in at $192.6 million, of which Hetlioz sales accounted for slightly more than 50%. Vanda’s Monday share price was down about 4.3% on news of the Supreme Court rejection. Meanwhile, this marks the second major setback for Hetlioz this year. In early March, the FDA denied Vanda’s request for a hearing over the regulator’s 2019 rejection of Hetlioz in jet lag disorder. Separately, Vanda revealed around the same time that the FDA had also swatted down its expansion bid for Hetlioz in insomnia. That second rejection came after the FDA in February alerted Vanda it had identified shortcomings in the drug’s insomnia application that “precluded discussion of labeling and postmarketing requirements/commitments,” Vanda said in a release at the time. Still, it hasn’t all been bad for Vanda this year. Earlier this month, the FDA signed off on the company’s Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder. Fanapt, also known as iloperidone, started its development journey in the mid-1990s, ping-ponging between Novartis and Titan Pharmaceuticals before Vanda acquired the drug in 2004. The FDA rejected the drug in 2008 but ultimately approved iloperidone in schizophrenia in 2009 under the Fanapt moniker. Elsewhere, Vanda last week parried a hostile takeover bid by Future Pak to acquire the Washington, D.C.-based company at what Vanda claimed was a discount to its “intrinsic value.” Vanda managed to ward off the takeover attempt through what’s known as a “poison pill”—an approach that works by imposing a significant penalty on any person or group that acquires ownership of 10% or more of its shares of common stock without prior approval of the company’s board. Editor's note: This story has been updated with comments from Vanda. 

Vanda's Fanapt was originally approved by the FDA in 2009 as a treatment for schizophrenia. Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder. Those with manic or mixed episodes are a subset of the 10 million in the U.S. with bipolar I, which is characterized by mood swings from euphoria to depression. The approval “significantly increases the commercial opportunity for Fanapt," Vanda said in a release. Investors agreed as Vanda’s share price increased by 40% on Wednesday morning. The boost is much needed for the Washington, D.C.-based company which has seen revenue fall from a record high of $269 million in 2021 to $193 million last year. Iloperidone has a long history dating to the mid-1990s, with Novartis and Titan Pharmaceuticals taking turns developing it before Vanda acquired it in 2004. After rejecting iloperidone in 2008 because of a lack of clinical data, the FDA approved it in 2009. Upon its launch, Jefferies analysts estimated sales would reach $300 million by 2013. But Fanapt never met those expectations. Over the next decade, sales increased slowly, peaking at $95 million in 2021. Last year, Fanapt generated $90 million in revenue. Vanda’s revenue slide over the last two years is attributed largely to declining sales of its other major product Hetlioz (tasimelteon), a treatment for the circadian rhythm disorder Non-24. Generic competition in the U.S. has caused Hetlioz sales to tumble from $160 million in 2022 to $100 million last year. Over the years, Vanda has been unsuccessful in its bid to gain approvals for Hetlioz to treat insomnia and jet lag disorder. The company is hoping to fill the revenue void by spending $100 million to secure rights in the U.S. and Canada to Johnson & Johnson's multiple sclerosis treatment Ponvory. Vanda made the deal in December of last year. The FDA based its latest approval of Fanapt on results from a phase 3 trial of 400 patients. Those on Fanapt showed improvements on the Young Mania Rating Scale over four weeks compared to those on placebo. Evidence of improvement was seen as early as two weeks of being on the medication. Fanapt comes with a boxed warning about an increased risk of death for elderly patients with dementia-related psychosis who are treated with antipsychotic drugs. Vanda is also investigating Fanapt as a treatment for post-traumatic stress disorder (PTSD).

DUBLIN, March 7, 2024 /PRNewswire/ -- The "Co-promotion and Co-marketing in Pharmaceuticals and Biotechnology 2016-2024" report has been added to ResearchAndMarkets.com's offering. Co-promotion and Co-marketing Deals in Pharmaceuticals and Biotechnology provides a detailed understanding and analysis of how and why companies enter co-promotion and co-marketing deals. Fully revised and updated, the report provides details of co-promotion and co-marketing deals from 2016 to 2024, the report provides access to co-promotion and co-marketing deal payment terms as announced between the parties. This data provides useful insight into the payment and other deal terms. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered and rights transferred - contract documents provide this insight where press releases and databases do not. This report contains a comprehensive listing of co-promotion and co-marketing deals announced since 2016 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual co-promotion and co-marketing contract documents as submitted to the Securities Exchange Commission by companies and their partners. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview and analysis of the trends in co-promotion and co-marketing as well as a discussion on the merits of the type of deal. Chapter 3 provides an overview of the structure of co-promotion and co-marketing deals. Chapter 4 provides a review of the leading co-promotion and co-marketing deals since 2016. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database. Chapter 5 provides a comprehensive listing of the top 25 most active co-promotion and co-marketing dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand. Chapter 6 provides a comprehensive and detailed review of co-promotion and co-marketing deals organized by company A-Z, therapy, technology and industry type signed and announced since 2016 where a contract document is available. Contract documents provide an indepth insight into the actual deal terms agreed between the parties with respect to the co-promotion and co-marketing deal. The deal directory includes a comprehensive listing of all co-promotion and co-marketing deals announced since 2016. Each listing is organized as a deal directory by company A-Z, therapeutic area and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document. The report also includes numerous table and figures that illustrate the trends and activities in co-promotion and co-marketing dealmaking since 2016. In conclusion, this report provides everything a prospective dealmaker needs to know about co-promotion and co-marketing alliances. Co-promotion and Co-marketing Deals in Pharmaceuticals and Biotechnology provides the reader with the following key benefits: Understand deal trends since 2016 Browse co-promotion and co-marketing deals Benchmark analysis - identify market value of transactions Financials terms Directory of deals by company A-Z, therapy focus and technology type Leading deals by value Most active dealmakers Identify assets and deal terms for each transaction Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Co-promotion and Co-marketing Deals in Pharmaceuticals and Biotechnology includes: Trends in co-promotion and co-marketing dealmaking in the biopharma industry Overview of co-promotion and co-marketing deal structure Directory of co-promotion and co-marketing deal records covering pharmaceutical and biotechnology The leading co-promotion and co-marketing deals by value Most active co-promotion and co-marketing dealmakers The leading co-promotion and co-marketing partnering resources Analyzing contract agreements allows due diligence of: What are the rights granted or optioned? What rights are granted by the agreement? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are intellectual property rights handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in co-promotion and co-marketing dealmaking 2.1. Introduction 2.2. Definition of co-promotion and co-marketing deals 2.3. Trends in co-promotion and co-marketing deals since 2016 2.3.1. Co-promotion and co-marketing dealmaking by year, 2016-2024 2.3.2. Co-promotion and co-marketing dealmaking by phase of development, 2016-2024 2.3.3. Co-promotion and co-marketing dealmaking by industry sector, 2016-2024 2.3.4. Co-promotion and co-marketing dealmaking by therapy area, 2016-2024 2.3.5. Co-promotion and co-marketing dealmaking by technology type, 2016-2024 2.3.6. Co-promotion and co-marketing dealmaking by most active company, 2016-2024 2.4. Reasons for entering into co-promotion and co-marketing partnering deals 2.5. The future of co-promotion and co-marketing deals Chapter 3 - Overview of co-promotion and co-marketing deal structure 3.1. Introduction 3.2. Co-promotion and co-marketing agreement structure Chapter 4 - Leading co-promotion and co-marketing deals 4.1. Introduction 4.2. Top co-promotion and co-marketing deals by value Chapter 5 - Top 25 most active co-promotion and co-marketing dealmakers 5.1. Introduction 5.2. Top 25 most active co-promotion and co-marketing dealmakers Chapter 6 - Co-promotion and co-marketing deals including contracts directory 6.1. Introduction 6.2. Co-promotion and co-marketing deals with contracts 2016-2024 Deal directory Deal directory - Co-promotion and co-marketing dealmaking by companies A-Z Deal directory - Co-promotion and co-marketing dealmaking by therapy area Deal directory - Co-promotion and co-marketing dealmaking by technology type Some of the companies featured 3D Medicines 4D Molecular Therapeutics Abbvie AbCellera Biologics ALK-Abello Allegis Pharmaceuticals Allergan Bausch & Lomb Baxalta Bayer Beam Therapeutics BeiGene Beijing Minhai Biotechnology Belharra Therapeutics Belintra Berlin Chemie BioAge Labs Biogen Biognosys Biological Industries BioNano Genomics BioNTech Cipher Pharmaceuticals Concordia Pharmaceuticals CRISPR Therapeutics CrossLink Bioscience CSL Dova Pharmaceuticals Dovetail Genomics DualityBio Eagle Genomics Eagle Pharmaceuticals EA Pharma Eli Lilly Empatica Enterome Bioscience Epizyme Eton Pharmaceuticals Exact Sciences Fabric Genomics Gilead Sciences Glenmark Pharmaceuticals Goldfinch Bio GSK GT Research H3 Biomedicine Halyard Health Hanmi Pharmaceutical Harbin Pharmaceutical Group HD Biosciences Iconic Therapeutics Idorsia IGM Biosciences Illumina Immatics Biotechnologies Immunicon ImmunityBio Ionis Pharmaceuticals Ironwood Pharmaceuticals iTeos Therapeutics Janssen Biotech Janssen Pharmaceuticals Jiangsu Alphamab Konica Minolta Kowa Pharmaceuticals America KSQ Therapeutics Kyorin Pharmaceutical Kyowa Hakko Kirin Kyverna Therapeutics Luqa Pharmaceuticals Luxcel Biosciences Lygos Macrogenics Manchester BIOGEL MannKind Biopharmaceuticals Medicines360 MedImmune Medovate MEI Pharma Menarini Merck and Co Merck KGaA Mersana Therapeutics Mesoblast Metagenomi Metavant Microsoft Nkarta Therapeutics Novartis Novo Nordisk nRichDX Numab Otonomy Otsuka Oxford BioMedica Pacira Biosciences Paragon Bioservices Pfizer Phil Prothena Provention Bio PSI (Population Services International) Purdue Pharma Pure Pharmaceuticals QED Therapeutics Qiagen Quanta Radius Health Rainbow Scientific Rakuten Medical Recludix Pharma RedHill Biopharma RefleXion Medical Regeneron Pharmaceuticals Regenxbio Relay Therapeutics Repare Therapeutics Resonant Specific Technologies Revolution Medicines Rigel Pharmaceuticals Roche Sanofi Seren Pharmaceuticals Seres Therapeutics Shimadzu Shionogi Silicon Biosystems Simcere Pharmaceuticals Sirtex Medical SK Biopharmaceuticals Solid Biosciences Sonoma BioTherapeutics Sosei SparingVision Stealth BioTherapeutics Stoke Therapeutics StrideBio Tango Therapeutics Teijin Telix Pharmaceuticals Terumo Blood and Cell Technologies Tetraphase Pharmaceuticals Teva Pharmaceutical Industries Theravance Thermo Fisher Scientific Tilak Healthcare Tilray Titan Pharmaceuticals Tolmar Urovant Sciences US WorldMeds Verity Pharmaceuticals Vertex Pharmaceuticals Vertice Pharma Vifor Pharma Voyager Therapeutics WAVE Life Sciences Xellia Pharmaceuticals Xencor ZAI Laboratory Zymeworks For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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