This week, there were the usual regulatory and pipeline updates in the biotech sector. Biosimilars are taking center-stage with quite a few companies in the news this week related to their progress in this area.
Meanwhile, Zafgen ZFGN, a company focused on obesity and complex metabolic disorders, has decided to suspend the development of its lead pipeline candidate. In other news, immuno-oncology continues to attract deals with Celgene CELG agreeing to shell out up to $2.561 billion under a collaboration agreement.
Recap of the Week’s Most Important Stories
1. The obesity market continues to pose challenges with yet another company deciding to change its priorities. Zafgen said that it has decided to suspend the development of its lead pipeline candidate, beloranib, and to refocus its resources on the development of a second-generation MetAP2 inhibitor, ZGN-1061, in severe and complicated obesity.
Beloranib was placed on full clinical hold in Dec 2015 by the FDA. Following discussions with the agency, Zafgen decided that the obstacles, costs and development timelines for beloranib did not justify additional investment in the program. Zafgen also announced a workforce reduction.
A few weeks back, Arena, which has a marketed obesity drug in its portfolio, had announced a cut in its workforce and said that it would be shifting its priorities to its proprietary clinical stage pipeline. Though Arena did get some good news this week -- the FDA granted approval for a new once-daily formulation of the company’s obesity drug, Belviq.
2. Amgen AMGN, which is facing the prospect of biosimilar competition for many of its core drugs, got a bit of a breather recently with the FDA issuing a complete response letter (CRL) for Sandoz’s biosimilar version of Amgen’s Neulasta (pegfilgrastim). Amgen is already facing biosimilar competition from Zarxio – Sandoz’s biosimilar version of Neupogen while an FDA advisory panel recently voted in favor of approving Sandoz’s biosimilar version of Enbrel.
Amgen itself is working on bringing biosimilars to market and recently got a favorable vote from an FDA advisory panel for its biosimilar version of AbbVie’s ABBV top-selling drug, Humira. Last week, Amgen signed up with Japanese company, Daiichi Sankyo, to commercialize nine biosimilars in Japan including the biosimilar version of Humira (Read more: Amgen and Daiichi Sankyo Team Up for Biosimilars in Japan).
3. Biogen BIIB is also progressing with the development of biosimilars. Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, said that its regulatory application for SB5, a biosimilar version of Humira, has been accepted for review.
4. Celgene has entered into a strategic worldwide collaboration with immuno-oncology focused company Jounce. Celgene could end up paying up to $2.561 billion for the deal which provides Celgene with the option to jointly develop and commercialize Jounce’s lead candidate, JTX-2011, and additional innovative immunotherapies targeting B cells, T regulatory cells and tumor-associated macrophages. This deal once again outlines the growing importance of immuno-oncology.
Meanwhile, Celgene gained EU approval for the use of its blockbuster cancer drug, Revlimid in adult patients with relapsed or refractory mantle cell lymphoma, a rare sub-type of aggressive non-Hodgkin's lymphoma (Read more: Celgene's Revlimid Gains EU Nod for Mantle Cell Lymphoma).
5. Juno JUNO, in the news recently related to its lead pipeline candidate being in and out of a clinical hold in the U.S., acquired a privately held company last week. With the acquisition of RedoxTherapies, Juno has gained an exclusive license to vipadenant, a small molecule adenosine A2a (A2a) receptor antagonist that has the potential to disrupt important immunosuppressive pathways in the tumor microenvironment in certain cancers. Juno plans to evaluate vipadenant in combination with engineered T cells.
MEDICAL-BIOMED/GENETICS Industry Price Index
MEDICAL-BIOMED/GENETICS Industry Price Index
The NASDAQ Biotechnology Index was down 1% over the last five trading days. While Biogen gained 2.6% over the last five trading days, Vertex declined 2.5% during this period. Over the last six months, Amgen was up 7.4% while Alexion lost 20.8% (See the last biotech stock roundup here: Juno In and Out of Clinical Hold, Amgen Biosimilar Gets Panel Backing).
What's Next in the Biotech World?
Quite a few major biotech companies will be reporting second quarter results over the next few days including Biogen, Gilead GILD, Vertex and Amgen.
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