Company profile for Catalent Pharma Solutions

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About

We are a global leader in providing integrated services, superior drug delivery technologies & manufacturing solutions to help life science innovators develop & launch successful pharmaceuticals, biologics and consumer health products, enabling a better customer journey from product development to patient. With over 85 years of experience in the industry, Catalent supports partners in introducing 200 new products and manufactu...
We are a global leader in providing integrated services, superior drug delivery technologies & manufacturing solutions to help life science innovators develop & launch successful pharmaceuticals, biologics and consumer health products, enabling a better customer journey from product development to patient. With over 85 years of experience in the industry, Catalent supports partners in introducing 200 new products and manufacturing over 70 billion doses/year. We have grown to become a vibrant community of approximately 15,000 employees, including around 2,400 scientists and technicians, supporting over 7,000 products for over 1,000 customers.

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CONTACT DETAILS

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U.S.A
Address
Address
14 Schoolhouse Road, Somerset, NJ 08873
Telephone
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+1 877-587-1835
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INTERVIEW #SpeakPharma

[Sponsored by another company]
“Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”
This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

Impressions: 4916

https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

Radio Compass
16 Dec 2024

VLOG #PharmaReel

[Sponsored by another company]

DATA COMPILATION #PharmaFlow

[Sponsored by another company]
BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch
Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities.  North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.  Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.  

Impressions: 4560

https://www.pharmacompass.com/radio-compass-blog/bms-j-j-bayer-lead-25-000-pharma-layoffs-in-2024-amylyx-fibrogen-kronos-bio-hit-by-trial-failures-cash-crunch

#PharmaFlow by PHARMACOMPASS
16 Jan 2025

NEWS #PharmaBuzz

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https://www.businesswire.com/news/home/20241218507326/en

BUSINESSWIRE
18 Dec 2024

https://www.catalent.com/catalent-news/catalent-and-novo-holdings-fulfill-all-regulatory-closing-conditions-for-pending-transaction/

PRESS RELEASE
16 Dec 2024

https://www.catalent.com/catalent-news/catalent-and-novo-holdings-fulfill-all-regulatory-closing-conditions-for-pending-transaction/

PRESS RELEASE
14 Dec 2024

https://www.catalent.com/catalent-news/catalent-and-novo-holdings-receive-european-commission-unconditional-approval-for-pending-transaction/

PRESS RELEASE
09 Dec 2024

https://www.reuters.com/markets/deals/eu-antitrust-regulators-set-okay-165-bln-novo-holdings-catalent-deal-source-says-2024-11-22/

REUTERS
23 Nov 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulators-quiz-novo-nordisk-catalent-rivals-165-bln-deal-2024-11-13/

REUTERS
13 Nov 2024

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Drugs in Development

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Details:

The partnership aims to support the development and manufacturing of Siren Biotechnology’s AAV immuno-gene therapies, being developed for the treatment of cancer.


Lead Product(s): AAV-based Therapy

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: PreclinicalProduct Type: Cell and Gene therapy

Sponsor: Siren Biotechnology

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership May 08, 2024

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BIO Partnering at JPM
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BIO Partnering at JPM
Not Confirmed

Details : The partnership aims to support the development and manufacturing of Siren Biotechnology’s AAV immuno-gene therapies, being developed for the treatment of cancer.

Brand Name : Undisclosed

Molecule Type : Cell and Gene therapy

Upfront Cash : Undisclosed

May 08, 2024

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Details:

Under the agreement, Melt Pharmaceuticals will utilize Catalent’s proprietary Zydis® orally disintegrating tablet fast-dissolve technology with MELT-300 (midazolam), a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery.


Lead Product(s): Midazolam,Ketamine Hydrochloride

Therapeutic Area: Neurology Brand Name: Melt-300

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Melt Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement September 26, 2023

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BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : Under the agreement, Melt Pharmaceuticals will utilize Catalent’s proprietary Zydis® orally disintegrating tablet fast-dissolve technology with MELT-300 (midazolam), a sublingual, needle- and opioid-free patented formulation for procedural sedation du...

Brand Name : Melt-300

Molecule Type : Small molecule

Upfront Cash : Undisclosed

September 26, 2023

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Details:

Under the agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead candidate MM-120 (lysergide D-tartrate), which is currently in Phase 2 for generalized anxiety disorder.


Lead Product(s): Lysergide D-tartrate

Therapeutic Area: Psychiatry/Psychology Brand Name: MM-120

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Mind Medicine

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement August 03, 2023

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BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : Under the agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead candidate MM-120 (lysergide D-tartrate), which is currently in Phase 2 for generalized anxiety disorder.

Brand Name : MM-120

Molecule Type : Small molecule

Upfront Cash : Undisclosed

August 03, 2023

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Details:

Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive™, for the emergency treatment of known or suspected opioid overdose.


Lead Product(s): Naloxone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Rivive

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Harm Reduction Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement March 23, 2023

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BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : Under the agreement, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive™, for the emergency treatment of known or suspected opioid overdose.

Brand Name : Rivive

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 23, 2023

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Details:

The collaboration leads to the successful reformulation of an investigational, orally dosed small molecule in Grünenthal’s pipeline to improve its bioavailability. Phase 1 studies of the molecule will be supported by using the Catalent Xpress Pharmaceutics™ platform.


Lead Product(s): Undisclosed

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: PreclinicalProduct Type: Small molecule

Sponsor: Grunenthal

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration March 15, 2023

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BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : The collaboration leads to the successful reformulation of an investigational, orally dosed small molecule in Grünenthal’s pipeline to improve its bioavailability. Phase 1 studies of the molecule will be supported by using the Catalent Xpress Pharmace...

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 15, 2023

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Details:

PSI-GAD (psilocybin) reacts agonistically with serotonin (5-hydroxytryptamine) type 2A (5-HT2A) receptors to produce a “mystical-like” hallucinatory effect due to induced frontal hyper-frontality, which in turn mediates its anti-depressant and anti-anxiety effects.


Lead Product(s): Psilocybine

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Incannex Healthcare

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 06, 2023

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BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : PSI-GAD (psilocybin) reacts agonistically with serotonin (5-hydroxytryptamine) type 2A (5-HT2A) receptors to produce a “mystical-like” hallucinatory effect due to induced frontal hyper-frontality, which in turn mediates its anti-depressant and anti-a...

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 06, 2023

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Details:

Under the terms of the license agreement, Catalent and Ethicann will develop Ethicann’s clinical drug pipeline using Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology including EPI-002 (cannabinoid) candidate to treat MS spasticity.


Lead Product(s): Cannabinoid

Therapeutic Area: Musculoskeletal Brand Name: EPI-002

Study Phase: PreclinicalProduct Type: Small molecule

Sponsor: Ethicann Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 12, 2023

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BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Lead Product(s) : Cannabinoid

Therapeutic Area : Musculoskeletal

Highest Development Status : Preclinical

Partner/Sponsor/Collaborator : Ethicann Pharmaceuticals

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Details : Under the terms of the license agreement, Catalent and Ethicann will develop Ethicann’s clinical drug pipeline using Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology including EPI-002 (cannabinoid) candidate to treat MS sp...

Brand Name : EPI-002

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 12, 2023

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Details:

INBRIJA® (levodopa) is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa. INBRIJA utilizes ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation.


Lead Product(s): Etilevodopa

Therapeutic Area: Neurology Brand Name: Inbrija

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Acorda Therapeutics

Deal Size: $10.0 million Upfront Cash: Undisclosed

Deal Type: Agreement January 05, 2023

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BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : INBRIJA® (levodopa) is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa. INBRIJA utilizes ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inha...

Brand Name : Inbrija

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 05, 2023

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Details:

SRP-9001 (delandistrogene moxeparvovec) is an investigational gene transfer therapy intended to deliver SRP-9001 to muscle tissue for the targeted production of essential components of dystrophin.


Lead Product(s): Delandistrogene Moxeparvovec

Therapeutic Area: Genetic Disease Brand Name: SRP-9001

Study Phase: Phase IIIProduct Type: Cell and Gene therapy

Sponsor: Sarepta Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement January 05, 2023

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BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : SRP-9001 (delandistrogene moxeparvovec) is an investigational gene transfer therapy intended to deliver SRP-9001 to muscle tissue for the targeted production of essential components of dystrophin.

Brand Name : SRP-9001

Molecule Type : Cell and Gene therapy

Upfront Cash : Undisclosed

January 05, 2023

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Details:

Exelixis will fund the development work conducted by Catalent until development candidate selection is complete, after which Exelixis will assume responsibility for conducting preclinical, clinical, and commercial activities.


Lead Product(s): Antibody-drug Conjugate

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: DiscoveryProduct Type: Large molecule

Sponsor: Exelixis

Deal Size: Undisclosed Upfront Cash: $30.0 million

Deal Type: Licensing Agreement November 03, 2022

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BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Lead Product(s) : Antibody-drug Conjugate

Therapeutic Area : Oncology

Highest Development Status : Discovery

Partner/Sponsor/Collaborator : Exelixis

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Details : Exelixis will fund the development work conducted by Catalent until development candidate selection is complete, after which Exelixis will assume responsibility for conducting preclinical, clinical, and commercial activities.

Brand Name : Undisclosed

Molecule Type : Large molecule

Upfront Cash : $30.0 million

November 03, 2022

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