Lonza Extends Partnership with Pharmacyclics to Support Manufacturing of Recently Approved Oncology Therapeutic, IMBRUVICA
Lonza, a leading supplier in Chemical Development and Manufacturing, has established an agreement with Pharmacyclics, Inc. to support the commercial and clinical production of its first-in-class oral oncology drug, IMBRUVICA (Ibrutinib).
This agreement follows a successful multi-year partnership, including the development and clinical manufacturing, which was utilised for Pharmacyclics’ NDA submission and now first FDA approval of their lead product for oncology treatment. Under the long term agreement, Lonza will continue to support the production of commercial and clinical material.
Pharmacyclics received final FDA approval of IMBRUVICA on 13 November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
IMBRUVICA is a first-in-class, oral therapy and is a new agent that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to grow and divide uncontrollably. IMBRUVICA has been granted three Breakthrough Therapy Designations by FDA, a first for an oncology drug. These designations are intended to expedite the development and review of drugs for serious or life-threatening conditions. To date, nine Phase III clinical trials have been initiated with IMBRUVICA and 38 clinical trials are currently registered on www.clinicaltrials.gov.
“We are proud to support Pharmacyclics through both clinical and commercial supply of their breakthrough oncology drug,” said Dr Stephan Kutzer, COO Lonza Pharma & Biotech “This extended partnership is an example of Lonza’s commitment to our client’s complete product life cycle and our dedication to the advancement of potentially life-saving treatments like IMBRUVICA.”
“Our multi-year partnership with Lonza helped us rapidly move IMBRUVICA from clinical development to our first FDA filing,” said Heow Tan, Chief of Quality and Technical Operations at Pharmacyclics. “Based on this successful collaboration, we are pleased to announce the partnership with Lonza, in support of both our clinical and commercial supply.”
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance