AstraZeneca’s research and development line was mixed last year. The Clinical Phase III trial result of Olaparib used for the treatment of BRCA mutations related advanced ovarian cancer after chemotherapy treatment was satisfactory. If everything goes smoothly, this drug will take up a large field.
Osimertinib Mesylate, an innovative drug that targets EGFRT790M-positive lung cancer, was eventually approved by the FDA at the end of 2016 after more than two years of clinical studies. Clinical data showed that this drug significantly had better effects than its competitor Clovis.
Qtern is a combined product (a fixed dose combination of saxagliptin and daglitaxel) that was listed on March 9 of 2017 after experiencing many setbacks. It may be able to restore AstraZeneca’s declining diabetes sector.
In the field of tumor research, anti-CTLA-4 monoclonal antibody Tremelimumab and PD-L1 inhibitor Durvalumab are highly anticipated. While, following Avelumab of Pfizer/Merck’s entering the market as the fourth one, AstraZeneca can only be the fifth to enter the market of immune checkpoint cancer drugs at most, ranking after Merck, Bristol-Myers Squibb, Roche, Pfizer and Merck.
Recently, increasing voices are questioning the toxicity of anti-CTLA-4 monoclonal antibody Tremelimumab in drug combination. As the problem gradually exposes its true appearance, AstraZeneca may take measures to deal with this crisis.
Last December, AstraZeneca spent $ 4 billion in the acquisition of AcertaPharma. This acquisition helped AstraZeneca gain Acalabrutinib. Acalabrutinib has an identified orphan drug status from CLL/SLL, MCL and lymphoplasmic lymphoma, and is of great market value.
Although Selumetinib has previously been identified as an orphan drug, repeated Clinical Phase III trial failure not only reduced people’s expectation on it, but may also lead to the termination of this project.
Taking into account the serious central side effects of the psoriasis drug IL17 antibody Brodalumab, the project partner Amgen withdrew from cooperation with AstraZeneca in 2015. However, it was eventually listed in February this year as other systemic treatment program without responding to adult moderate to severe plaques psoriasis.
ZS-9 is AstraZeneca’s nightmare. Hyperkalemia drug was purchased by AstraZeneca with $ 2.7 billion in 2015. During the acquisition, FDA refused its application because of its manufacturing factory. In March this year, FDA again refused its listing application with the same reason.
Faced with such operational pressure, AstraZeneca announced to cut $ 1 billion from its R&D expense. Small department like neuroscience was directly dissolved.
Sanofi’s local R&D department in recent years had nearly no contribution, and almost all of the R&D tasks were passed on to Regeneron and other partners. It is no wonder that CEO Elias Zerhouni emphasized the importance of coopertaion repeasdly. The first targeted biotherapy Dupixent (Dupilumab) for the treatment of moderate to severe atopic dermatitis (AD) was co-developed by Sanofi and Regeneron. It has been favored by the outside world, and is expected to change the market structure of this field. It is still in clinical trials of indications for nasal polyposis.
Another type of co-development rheumatoid arthritis drug sarilumab was rejected by FDA beacause of production line problem. It should have been surpassed by its rival Baricitinib (Eli Lilly, Incyte), but Baricitinib didn’t make it to the end. Currently, sarilumab is completing relevant data. Eli Lilly and Incyte are believed to have been far lagged behind.
Diabetes drug sotagliflozin is an SGLT-1/2 inhibitor, which is a product developed by Sanofi with a huge sum of money with Lexicon. While, no news are disclosed recently.
Anti-CD38 Isatuximab is a therapeutic agent for multiple myeloma and will compete with Johnson & Johnson’s first CD38 targeted drug Darzalex for the market. However, Johnson & Johnson has embarked on clinical work to expand the indications with the intention of reducing the loss caused by the competition.
8. Eli Lilly
Psoriasis drug Taltz’s successful approval last year was a good thing for Eli Lilly. The share of the market for biosimilar erosion over the years seemed to have improved by raising the price of medicine rather than introducing more new products.
Solanezumab‘s third clinical trial failed. This drug seems to have no help in improving the condition of Alzheimer’s patients. JAK1/2 inhibitor Baricitinib was regarded as a groundbreaking drug of 2017, but was rejected because of security problem.
At the beginning of the year, Eli Lilly’s CEO stood down and handed over the power to the new CEO David Ricks, who began to cut spending and layoffs at the beginning of his term of office. Of course, this reduction in spending behavior in the industry is a common phenomenon, but Eli Lilly is always reluctant to completely reorganize their R&D line. Compared to its peers, Eli Lilly does spend a lot in R&D, and this situation will have to continue or it can‘t repair this tattered R&D line.
In 2016, Gilead was eager to squeeze into the R&D giant. It spent a total of $ 5.1 billion on research and development, but the investors were not satisfied with result brought by the huge amount of money.
The high efficiency showed in the clinical research data of the publication of the HIV drug Bictegravir may bring Gilead back to the glory of Hepatitis c cocktail era. Last year, the anti-alcoholic steatohepatitis drug acquired by Gilead with $ 600 million performed well in the recent data of Clinical Phase I trial.
In addition, Gilead’s position in the field of hepatitis C drugs is being threatened by factors such as drug price restrictions, imitation competition, and declining market capacity. Therefore, Gilead has had to shift the focus further to HIV.
In November 2016, Gilead spent $ 510 million to buy Momelotinib. It had a poor performance in the Clinical Phase III study of the treatment of myelofibrosis. The original research NASH drug GS-4997 has also been questioned. In addition, Gilead still had to terminate the clinical study of the repeatedly failed pancreatic cancer monoclonal drug simtuzumab and ulcerative colitis drug GS-5745.
Moreover, Gilead lost the lawsuit in the dispute with Merk. The court said that Sovaldi and Harvoni infringed upon the patent right of Merk, and asked Gilead to pay $ 2.54 billion of infringement fee.
Bristol-Myers Squibb used to be a leader in the field of immune checkpoint inhibitors. Due to clinical frustration, it had to give the priority in this field to Merck’s Keyrruda.
Although Bristol-Myers Squibb did not do its best in market operation, but based on the company’s experience in the field of cancer immunization research, it continues to use the advantages and focus on this area in the future, emphasizing on researching the applications of LAG-3, GITR, CFS1R, IDO and other targets in the field of tumor. In addition to the field of cancer, CD28, TYK2 and BTK are also optimistic for the company’s research direction.
It seems that what Bristol-Myers Squibb need is time. This company has excellent research and development strength and is respected by the industry. While, accumulation is mostly needed for it, and of course, it also needs good business operation.