In the new drug development, pursuing the marketing of the first product of its variety is always the highest goal of pharmaceutical enterprises, as the first drug marketed can enjoy a period of market exclusivity, thus to rapidly occupy the market, and furthermore, the first marketed in the new technology and new field will be long under the spotlight and be favored by more capital, however, being first does not necessarily mean the market recognition, the pioneering new products always face many unknown challenges and would easily turn from a "pioneer" to a "martyr", and the latecomers have more opportunities to achieve higher success by stepping on the "bodies" of "martyrs". The strategy to pursue the First-to-Market or me-better product becomes more important in the drug development process.
1. "Pioneer" turning into "martyr", latecomers surpassing
When applying new technology in the market, the first products that reach the finish will be much favored but also confronted with many unknown traps. ADCs and bispecific antibodies have experienced highs, lows, and regaining popularity in the antibody therapy field, and such experience is also the process of: successful marketing of the first products that represent the new technology, poor market performance thereof after marketing, and latecomers regaining recognition.
1.1 ADC field
Pfizer’s ADC Mylotarg that targets CD33 was approved by FDA in 2000 for treating AML (acute myeloid leukemia), to become the first marketed product in the history of ADCs, however, Mylotarg did not achieve the expected success as a pioneer, with the average annual sales of USD 33 million during 2006-2010, barely growing. In addition to the unsatisfactory market performance was the gradually exposed safety problem in the clinical trial. The drug was eventually removed from the market in June 2010, to sadly turn from a pioneer to a "martyr".
In 2011, one year after Mylotarg was removed from the market, Adcetris (targeting CD30) of Takeda and Seattle Genetics was successfully marketed, and in 2013, Roche’s new-generation HER2-targeting ADC Kadcyla developed based on own Herceptin was successfully marketed. Sales of the two grew year by year after marketing (Fig. 1), marking ADCs’ gradual maturing. Pfizer reset the technical scheme after analyzing the early-stage clinical data to bring Mylotarg to the market again in 2017.
1.2 Bispecific antibody field
In the bispecific antibody field, Removab was approved for marketing in 2009, to become the first to test the water. Unfortunately, its market performance was unsatisfactory after its marketing, with sales in 2010-2012 separately of USD 3.32 million, 4.43 million, and 4.54 million. Thereafter, it was hard to find the drug on the market. The drug was quietly removed from the market in 2017. Removab is a hybrid of two maternal antibodies from mice and rats and achieves double-targeting, however, fully mouse antibodies have no longer been the mainstream in the antibody field.
Blincyto is a key product based on BiTE technology that was obtained by Amgen after acquiring Micromet Company for USD 1.2 billion in 2012, and was approved by FDA in 2014 as a second-line therapy for Ph chromosome-negative pre-B cell acute lymphoblastic leukemia (ALL). Despite the much controversial expensive expenses of USD 178,000 for two cycles of therapy, its performance was not disappointing after the marketing, with total sales in 2015 and 2016 separately reaching USD 77 million and 115 million, which achieved the forecast of the analyst at the beginning of marketing: the goal of annual sales reaching at least USD 100 million. The performance of Blincyto seemed to be average, however, it was much better than that of Removab that became a "martyr". More importantly, Ph chromosome-negative pre-B cell ALL is an extremely rare disease that attacks about 6,000 people in the U.S. every year. Currently, what people expect the most is the third member of the bispecific antibody family—emicizumab that was approved to treat hemophilia A in 2017.
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