This week was a relatively quiet one for the pharma sector ahead of earnings. In key developments, AbbVie (ABBV - Free Report) signed its fourth licensing deal to protect revenues from its blockbuster drug Humira; J&J (JNJ - Free Report) gained FDA approval for label expansion of its blood thinner, Xarelto and Bristol Myers Squibb (BMY - Free Report) signed a new oncology collaboration with Compugen to study a combination of their cancer drugs for advanced solid tumors.
Recap of the Week’s Most Important Stories
AbbVie’s Fourth Licensing Deal for Humira Biosimilar: AbbVie signed its fourth licensing deal to protect revenues from its blockbuster arthritis drug, Humira. This time the settlement is with Sandoz, the generic arm of Novartis (NVS - Free Report) , per which the latter will have a non-exclusive license to launch Humira in the United States on Sep 30, 2023. In Europe, Sandoz can launch Humira biosimilar from Oct 16. AbbVie has similar licensing deals with Amgen, Mylan and Samsung Bioepis/Biogen. Amgen, Mylan and Samsung Bioepis’ biosimilar versions are expected to be launched in the United States in January, June and July 2023, respectively while in the EU, Amgen and Biogen’s biosimilars are expected to be launched this month.
Bristol Myers’ Cancer Collaboration With Compugen: Bristol-Myers and Israel-based small cancer drugmaker, Compugen Ltd. (CGEN - Free Report) announced a new collaboration to study a combination of cancer drugs, Compugen’s anti-PVRIG antibody, COM701 and Bristol Myers’ PD-1 inhibitor Opdivo in patients with advanced solid tumors. Bristol-Myers will also buy an equity stake worth $12 million in Compugen. Bristol-Myers agreed to buy about 2.4 million shares of Compugen at $4.95 a share.
J&J’s Blood Thinner Gets FDA Nod for New Patient Population: The FDA granted approval to a supplemental new drug application (sNDA) seeking label expansion of its blood thinner, Xarelto (2.5 mg tablets twice daily) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease and/or peripheral artery disease (CAD/PAD). With approval for the new vascular indication, Xarelto will be the only Factor Xa inhibitor indicated for these patient groups. J&J gained approval for a similar label update in the EU in August
J&J also presented data from a pivotal phase III study, which showed that its drug Stelara induces clinical remission and response in ulcerative colitis patients who had failed prior therapy. Stelara is not yet marketed for the UC indication. Stelara is presently marketed for the treatment of moderate-to-severe plaque psoriasis, active psoriatic arthritis and Crohn's disease. (Read more: J&J’s Stelara Succeeds in Phase III Ulcerative Colitis Study).
Novartis’ Multiple Sclerosis Candidates in Focus: Novartis announced that both the FDA and the European Medicines Agency (EMA) have accepted its regulatory application seeking approval of siponimod for the treatment of secondary progressive multiple sclerosis (SPMS) in adults. Novartis used a priority review voucher to expedite the review of siponimod in the United States. A decision is expected in March 2019 in the United States and late 2019 in Europe. (Read more: Novartis' Applications for MS Drug Accepted by FDA & EMA).
Novartis also announced top-line data from a phase IIIb head-to-head study, ASSESS, evaluating its marketed multiple sclerosis drug, Gilenya versus Teva’s Copaxone in patients with relapsing remitting multiple sclerosis. Data from the study showed that the patients on Gilenya 0.5mg tablets once-daily experienced significantly fewer relapses than patients taking once daily subcutaneous injection of Copaxone 20mg. Treatment with Gilenya 0.5mg led to a 40.7% relative reduction in the rate of relapses over a period of one year versus Copaxone. Meanwhile, though a numerical risk reduction in relapses was achieved in patients taking Gilenya 0.25mg, the result did not reach statistical significance.
The NYSE ARCA Pharmaceutical Index declined 4.3 in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
All stocks have recorded a decline of more than 4% this week. Bristol-Myers declined the most (7.8%) in the last five trading sessions.
In the past six months, Lilly (LLY - Free Report) has been the biggest gainer (35.4%) while Glaxo (GSK - Free Report) declined the most (5.2%).
(See the last pharma stock roundup here: PFE to Get New CEO, LLY Presents Impressive Diabetes Data)
What's Next in the Pharma World?
Watch out for J&J and Novartis’ third-quarter earnings, and several pipeline and regulatory updates next week.
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