According to the statement, the New Drug Application (NDA) is supported by pivotal data from the Phase 3 COLUMBA (MMY3012) study. This randomized open label study revealed that daratumumab SC showed non-inferiority to daratumumab IV while boasting a lower rate of infusion-related reactions.
Halozyme (HALO) co-formulated the drug, using its Enhanze drug delivery technology which has been shown to remove traditional limitations on the volume of biologics that can be delivered just under the skin.
“We are pleased to see this New Drug Application submission in Japan, which builds on Janssen’s prior regulatory submissions in the U.S. and EU that are currently under review,” said Dr. Helen Torley, president and CEO of Halozyme.
“We are excited that patients with multiple myeloma in Japan may soon have a new therapeutic option that can be administered with a shorter infusion time when compared with a multi-hour intravenous infusion” she added.
Overall analysts are cautiously optimistic on the outlook for JNJ, with the stock scoring recent upgrades from both Merrill Lynch and Wells Fargo. Merrill Lynch analyst Bob Hopkins put the upgrade down to “our belief that in the current unprecedented environment the most defensive names will continue to outperform.” So far JNJ is trading up 6% year-to-date. (See JNJ stock analysis on TipRanks).
Meanwhile Halozyme has a bullish Strong Buy Street consensus, with an average analyst price target of $24 (2% upside potential).
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