Lotus Pharmaceutical Co (美時化學製藥) has received approval from Japan’s Pharmaceuticals and Medical Devices Agency for its generic version of blood cancer drug Revlimid (lenalidomide), boosting its shares by as much as 3.54 percent in early Taipei trading yesterday.
The approval was for 2.5mg and 5mg capsules of lenalidomide, which it jointly developed with Japan’s Fuji Pharma Corp, Lotus Pharmaceutical said in a regulatory filing on Tuesday.
Lotus Pharmaceutical was responsible for developing the lenalidomide formula — the company’s first high-value generic product in Japan, while Fuji Pharma ran local bioequivalence studies of the drug.
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With the approval, Lotus Pharmaceutical is to supply the finished product to Fuji Pharma for commercialization in Japan. The companies expect to launch the product in Japan this year.
Sales of Revlimid in Japan totaled about US$282 million last year, Lotus Pharmaceutical said, citing data from life sciences researcher Iqvia Institute.
As of the second quarter, only Osaka, Japan-based Sawai Pharmaceutical Co had obtained agency approval for lenalidomide, but its generic product has not yet been marketed in the Japanese market, Lotus Pharmaceutical said.
“Lotus and Fuji are among the first to market their product in Japan and gain a good market share there,” Capital Investment Management Corp (群益投顧) said in a note yesterday. “Lotus received 16 approvals for its generic products worldwide in the second quarter, which is a remarkable achievement and will gradually contribute to its revenue and royalty income in the future.”
Lotus Pharmaceutical shares surged in early morning trading yesterday before retreating to close up 1.71 percent at NT$268.
Capital Investment gave Lotus Pharmaceutical a “buy” rating with a 12-month target price of NT$295.
Lotus Pharma’s net profit more than tripled to NT$1.27 billion (US$39.82 million) in the second quarter, up 286 percent from NT$327.67 million in the same period last year, the company said on Tuesday.
That translated into earnings per share (EPS) of NT$4.85, the best second-quarter performance in its history.
In the first half of the year, EPS totaled NT$9.43, up 217 percent year-on-year, it said.
Lotus Pharma’s cumulative revenue in the first seven months totaled NT$11.25 billion, up 58.16 percent from the same period last year, company data showed.
With better business prospects, the company projected annual revenue growth of 13 to 15 percent for this year, higher than its previous estimate of 7 to 10 percent, while gross margin is expected to reach 55 percent, compared with 50 percent in its earlier forecast.
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