Bispecific antibody is known as bsAb for short. The branch of technology in antibody drugs and bispecific antibody drugs over the past few years have been absolutely the hot spot. Anyone who makes drugs feels like it's hard to say not knowing this technology. Pharmaceutical companies feel like they might be inferior if they don't have a layout in this direction, and they're likely to miss out on big opportunities in the future. Is that the technology really important? Since the technical analysis is very professional, let me talk about it from the market.
The two bispecific antibodies which is currently available are Removab and Blincyto. Let's take a look at two stories about them.
Do you know First-in-Class is with complicated background and awkward status?
Removab, the first therapeutic antibody drug in the field of bispecific antibodies who was approved by the European Union on April 20, 2009, is certain to be First-in-Class consisting by antibody-peptide. Its original patent was granted in 1998 by Ascension GmbH, a smaller German biotechnology company. Shortly, after the deal was completed, TRION entered into an alliance with Fessenius, an established German company, and decided to jointly develop the later approved listing Removab. Ascension GmbH later sold all of its TRION holdings to Fessenius, a biotech subsidiary focused on developing biopharmaceuticals, which was later sold to Fesenius by Ascension GmbH, a subsidiary that specialized in the development of biological drugs. In 2011, Swedish Orphan Biovitum (Sobi) struck a marketing deal with Fresenius Biotech on which Removab was successfully approved for listing. Removab was approved for sale by EMA in June 2013. Also, in this month, Fessenius announced the sale of Fresenius Biotech would become as a whole to the Further family, the owner of Neopharm (the amount of the deal was not disclosed by the parties to the agreement). Fresenius Biotech GmbH was logically renamed Neovii Biotech GmbH.
The indication for Removab approved in 2009 in the European Union is malignant ascites. If there is also a therapeutic effect on primary tumors, the market is worth imagining. But the market reaction was completely different. In 2009, the product was sold at $1.66 million, and in 2010-2012 it was 3.32 / 4.43 / 4.54 million dollars, respectively. The annual sales of the product have not been found in mainstream medical databases since 2013, followed by ovarian cancer, stomach cancer, non-small cell lung cancer, breast cancer, and other indications. In the II phase, dismal sales figures offer no hope for these new indications.
But Removab, has never been born. Its biological parents, Ascension GmnH, had no attachment to it from the start. Its two stepfathers, TRION and Fresenius, were just passing by in the process of his growth. And Neovii turned a blind eye to him in the end.
How is the market condition of Blincyto?
Let's take a look at the Blincyto of Amgen approved by FDA and EMA in December 2014, which is a double-specific antibody to CD3 on one end of CD19 that binds to the surface of white blood cell B cells, and on the other end of the surface of T cells. The basic idea is consistent with that of another popular cellular immunotherapy now. Its first indication is the second-line treatment of acute lymphoblastic leukemia.
Blincyto has another American biology company, Micromet Inc. At the time, it was named MT103. In June 2003, Micromet signed an agreement with MedImmune to develop MT103. As everyone knows, in March 2009, after AstraZeneca acquired MedImmune2 in June 2007, Micromet bought back an interest in the original MedImmune agreement from AstraZeneca, so Micromet regained ownership. In January 2012, Amgen became Amgen's AMG103 by buying Micromet’s MT103 in full cash for $11 a share. Later, in May 2013, Amgen licensed the Japanese interest in the product to Astellas. In August 2013, it licensed its Indian interest to Dr. Reddy's in India.
Blincyto's U.S. sales were about $50 million in 2015, compared with $85 million in 2016. At the same time, Amgen is also carrying out clinical research on new indications such as diffuse large B-cell lymphoma and mantle cell lymphoma, which is expected to be further expanded. Some analysts believe the drug could reach annual sales of $178 million in 2017.
Amgen spent $1.16 billion in 2012 and certainly there would not spend small amount money on research and drug developing after the acquisition. Amgen's global sales figures for 2016 were $225 billion to $228 billion. However, Amgen will no doubt be a bit disappointed by the result of Blincyto alone in 2016.
Why the prospect of a variety on the market is not bright?
As for the next bispecific antibody drug most likely show in the market, Roche's ACE-910 (RG6013 Emicizumab) is considered to have no bright future. The drug is originally developed by Japanese and foreign pharmaceutical companies and they reached a global cooperative development agreement with Roche in August 2014.
Although severe adverse events with thromboembolism / thrombotic microvascular disease (Thrombotic microangiopathy, TMA) were reported in four participants in November 2016, the possibility that ACE-910 would eventually be approved for listing is high.
The indication for ACE910 is type A hemophilia with VIII inhibitors. We all know that hemophilia is a rare disease and the global market for hemophilia is estimated to be around $10 billion. But this huge market has been crowded into a number of heavyweights, including Shire,Baxalta, Northrop, Bayer, Baijian and CSL, of which Type A hemophilic drugs (such as Feiba,Advate,Adynovate) sold $2.84 billion in 2015. We can see that this market is large.
ACE-910 expects to hit the market around the end of 2019, which means we don't see a double antibody drug with annual sales of more than $500m over the next five years.
Bispecifics, how many people are obsessed with you? How many people are manic for you? However, to me, it is really hard to say I love you.