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Product › Details

BTK inhibitor

Products Next higher product group cancer drug
Period Status 2013-11-13 registration start
Organisation Organisation Pharmacyclics Inc.
  Group AbbVie (Group)
     

Lonza Group Ltd.. (1/13/14). "Press Release: Lonza Extends Partnership with Pharmacyclics to Support Manfacturing a Recently Approved Oncology Therapeutic, Imbruvica". Basel.

Lonza, a leading supplier in Chemical Development and Manufacturing, announced today it 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 utilized 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 the 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."


About Imbruvica™

IMBRUVICA is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. For more information about IMBRUVICA, including the full prescribing information, please visit www.IMBRUVICA.com. 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. It is one of the first medicines to file for FDA approval via the new Breakthrough Therapy Designation pathway, enabling Pharmacyclics to rapidly bring this medicine to patients in need.


About Lonza

Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers' needs from research to final product manufacture. It is the global leader in the production and support of chemical and biological active pharmaceutical ingredients. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is also the world leader in microbial control providing innovative, chemistry-based and related solutions to destroy or to selectively inhibit the growth of harmful microorganisms. Its activities encompass the areas of water treatment, personal care, health and hygiene, industrial preservation, materials protection, and wood treatment. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition and agro markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange and secondary listed on the Singapore Exchange Securities Trading Limited ("SGX-ST"). In 2012, the company had sales of CHF 3.925 billion. Further information can be found at www.lonza.com. be found at www.lonza.com.

Lonza Contact Information

Lonza Group Ltd
Investor Relations
Dirk Oehlers
Tel +41 61 316 8540
dirk.oehlers@lonza.com

Lonza Group Ltd
Corporate Communications
Dominik Werner
Tel +41 61 316 8798
dominik.werner@lonza.com

Lonza Group Ltd
Corporate Communications
Melanie Disa
Tel +1 201 316 9413
melanie.disa@lonza.com

   
Record changed: 2018-05-09

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