AbbVie and Mylan Lead Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AbbVie and Mylan.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday November 2, 2016 to Tuesday November 8, 2016.
AbbVie’s Lung-Cancer Drug Gets Orphan Drug Status
AbbVie has received orphan drug status from the US Food and Drug Administration (FDA) for veliparib, an oral poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor, being investigated in combination with chemotherapies, such as carboplatin and paclitaxel, or radiation for treating advanced squamous non-small cell lung cancer (NSCLC). Researchers are investigating whether veliparib in combination with DNA-damaging therapies, such as chemotherapy or radiation may lessen the repair of DNA damage in cancer cells. Veliparib is not currently approved to treat any form of NSCLC, according to AbbVie.
Veliparib is currently being studied in more than a dozen cancers, including in Phase III studies in advanced squamous and non-squamous NSCLC, ovarian cancer, and breast cancer. Veliparib’s efficacy and safety have not been established by the FDA or any other health authority, according to AbbVie.
Mylan Starts Clinical Study of Biosimilar of BMS Arthritis Drug
Mylan and partner, Momenta Pharmaceuticals, a Cambridge, Massachusetts-based pharmaceutical company, have begun a Phase I study for a proposed biosimilar to Orencia (abatacept), Bristol-Myers Squibb’s anti-arthritis drug. Under the Momenta-Mylan collaboration agreement, Momenta has achieved the milestone necessary to earn a $25 million payment from Mylan.
The proposed biosimilar, designated M834, is developed in collaboration by Mylan and Momenta Pharmaceuticals. BMS’ Orencia is approved in the US, European Union (EU), and Japan for treating rheumatoid arthritis and approves in the US and EU for treating juvenile idiopathic arthritis. Orencia is a top-selling drug for BMS with 2015 worldwide sales of $1.9 billion. For the nine months ended on September 30, 2016, worldwide Orencia sales totaled $1.6 billion.