The year 2018 has proven excellent for the pharmaceutical and biotechnology sector with respect to FDA approvals. The regulatory agency has agreed to 59 new drugs, well above the 46 approved in 2017. Immuno-oncology has once again been the focus of concern in 2018, which it's Acts of scientific conferences, collaborations of clinical trials, acquisitions or approvals of the FDA.
The recently announced $ 74 billion mega-merger of two cancer giants, Bristol-Myers (BMY – Free Report) and Celgene (CELG – Free Report), and Glaxo (GSK – Free Report) and Lilly (LLY – Free Report) , proposed TESARO and Loxo Oncology, two small cancer biotechs, clearly reflect the growing interest in this category.
While 2018 was a year focused on immuno-oncology, we are looking at four therapeutic areas that we believe will be of great interest in 2019. These areas are marked by extensive research, innovative technologies and the promise to transform the path diseases are treated.
The basic concept of cancer immunotherapy or immuno-oncology is to use parts of the immune system to fight the disease. This can be done by stimulating the immune system to attack cancer cells or by introducing components of the immune system into the body. Although some immuno – oncology treatments have the potential to be effective as monotherapy, others may be more effective when they are combined with other treatments.
The different types of immunotherapies include monoclonal antibodies / mAbs (synthetic versions of immune system proteins that may be designed to attack a very specific part of a cancer cell), immune checkpoint inhibitors (recognize and attack cancer cells ), vaccines (help prevent or protect cancer cells). treat cancer) and others stimulating the entire immune system.
Some encouraging results, demonstrating partial and complete responses in patients with advanced cancer, and the FDA's approval of two CAR-T treatments in 2017, Kymriah of Novartis and Yescarta of Gilead, prompted hope for cancer patients and increased interest in this segment. The possibilities of immunotherapy develop especially with the use of several treatments in combination. It aims to develop targeted therapies or precision drugs.
Because immuno-oncology is changing the paradigm of cancer treatment, this field represents a huge commercial potential.
Almost all major drug companies have formed collaborations with smaller biotechnologies with innovative immuno-oncology candidates in 2018 and this trend is expected to continue in 2019.
Alzheimer's disease is an area in which many companies have tried their luck but with minimal success. In recent years, major players such as Merck (MRK – Free Report), Lilly, Pfizer (PFE – Free Report) and J & J (JNJ – Free Report) have faced failures in their quest for treatment of Alzheimer's disease.
Among the companies currently working on Alzheimer's disease treatments are actors such as Biogen, Lilly, Novartis, Eisai and Amgen.
Biogen's aducanumab is one of the most important candidates in the company's portfolio and is currently the subject of several studies in the final phase. Biogen is also working on elenbecestat (E2609), a BACE inhibitor in a phase III program, and BAN2401, a humanized beta-amyloid antibody in development. The three candidates are developed in collaboration with Eisai. Earlier this month, Biogen announced agreements with C4 Therapeutics and Skyhawk Therapeutics to develop potential therapies for AD, Parkinson's and other neurological conditions.
Lilly has flortaucipir in his pipeline, which is under development for AD. Last month, he announced the signing of a collaboration agreement with Swiss Biotech, AC Immune, to jointly develop inhibitors of the aggregation of morphomer tau, potentially capable of treating Alzheimer's disease (AD) and dementia. other neurodegenerative diseases. Meanwhile, Novartis and Amgen are collaborating on the BACE1 inhibitor CNP520, which has accelerated status in the United States. Roche also collaborates with AC Immune for the development of treatments for Alzheimer's disease.
Although Alzheimer's disease has always been a very complex therapeutic area and few companies have tried to find a cure, the market is extremely lucrative. As a result, many companies continue to invest heavily in the development of Alzheimer's disease treatments. Indeed, more than five million Americans live with Alzheimer's disease and this number is expected to triple by 2050 (Data: Alzheimer's Association). The market has immense commercial potential and companies offering new treatments could generate billions of dollars in sales.
Marijuana for medical purposes is another segment of the pharmaceutical and biotechnology industry that will remain in the limelight this year. Canada became the first major economy to legalize the recreational pot, with a number of US states giving the green light to cannabis last year.
The industry sparked strong investor interest in 2018 with the FDA approving the first plant-derived cannabinoids drug, GW Pharma's epidiolex, in June.
The sector is expected to grow rapidly, with legislators allowing or considering allowing more legal uses of marijuana and related products, particularly in the life sciences and medicine sectors.
In addition to GW Pharma, the main players in this field are INSYS Therapeutics, Corbus Pharmaceuticals Holdings and Zynerba Pharmaceuticals. Tilray was the first cannabis company to go public in a major US exchange in 2018.
Epidiolex oral solution is approved for the treatment of rare and serious epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex represents the potential of blockbuster. GW Pharma has developed several new CBD formulations, including improved liquid formulations, a solid dosage form and an intravenous formulation.
The specialized pharmaceutical company INSYS uses its spraying technology and its exclusive capabilities for the development of pharmaceutical cannabinoids for a wide range of indications, including the treatment of opioid overdose, anaphylaxis, Epilepsy, infantile spasms, anorexia in cancer patients and other areas of the disease with a significant unmet need. GW Pharma and INSYS are both tier 3 Zacks (pending). You can see You will find here the complete list of Zacks actions # 1 of the current rank (strong purchase).
The market for alcohol-free steatohepatitis or NASH has potential. Chronic liver disease, NASH is caused by an excessive accumulation of fat in the liver, which in turn is called steatosis. NASH is known to affect up to 15 million people in the United States and could lead to inflammation, hepatocellular damage, progressive fibrosis and cirrhosis. By 2025, the global market for NASH treatments is expected to reach $ 35 billion.
Despite its large population of patients and its potentially fatal effects, there is currently no FDA-approved drug to treat NASH. Given the market outlook for NASH, a number of companies are developing candidates for the same product and an FDA-approved drug is expected to enter the market by 2020.
The main players on the NASH market are Intercept Pharmaceuticals, Gilead, Allergan and Genfit SA. In fact, combination treatments are also under study to treat NASH. Gilead is studying the inhibitor selonsertib ASK-1 in combination with its other active NASH, GS-0976 and GS-9674. In October, Pfizer signed a collaboration agreement with Novartis for the research of combination therapies including their early-stage experimental candidates for NASH.
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