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                                                      7 Blockbuster Drugs to Go to Market in 2016

                                                      TIME:2016/7/26 10:55:22 SOURSE:

                                                      7 drugs among the new drugs to go to market in 2016 are expected to become blockbuster drugs in 2020, all with the annual sales peak to exceed USD 2 billion in the future.

                                                      NO.1 Obeticholic acid

                                                      Company: Intercept Pharmaceuticals / Sumitomo Dainippon Pharma

                                                      Indication: Chronic liver diseases such as non-alcoholic steatohepatitis (NASH) and primary biliary cirrhosis

                                                      2020 sales forecast: USD2.62 billion

                                                      Obeticholic acid has been proved effective in treating NASH which has a huge number of patients: about 2% to 3% of the global population, and this proportion will further expand with the increase of the patients with obesity and insulin resistance. There is still no drug for treating NASH approved, thus the market space is huge.

                                                      NO.2 Emtricitabine and tenofovir alafenamide (F/TAF)

                                                      Company: Gilead/ Japan Tobacco

                                                      Indication: HIV-1 infection

                                                      2020 sales forecast: USD2 billion

                                                      Gilead’s two HIV-1 infection drugs under development are both expected to be big money-makers of the company. Tenofovir alafenamide (TAF) has been proved to be a safer antiretroviral drug. Gilead itself is hoping that the new daily single-dosage anti-HIV-1 infection drug which is developed based on TAF will be able to replace its existing drugs, including Truvada (emtricitabine/tenofovir disoproxil fumarate).

                                                      NO.3 Tenofovir alafenamide and emtricitabine and rilpivirine (R/F/TAF)

                                                      Company: Gilead/ Janssen

                                                      Indication: HIV-1 infection

                                                      2020 sales forecast: USD1.57 billion

                                                      Like F/TAF, R/F/TAF developed by Gilead in partnership with Janssen also has the advantages of improving renal and reducing bone loss compared with existing HIV drugs, allows more HIV-1 patients to receive antiretroviral drug treatment and prolongs their life, equivalently further expanding the market of TAF therapy.

                                                      NO.4 MK-5172 Grazoprevir

                                                      Company: Merck & Co.

                                                      Indication: HCV infection

                                                      2020 sales forecast: USD1.54 billion

                                                      FDA once withdrew the breakthrough drug designation of Merck & Co.’s HVC drug, however, MK-5172, a HCV infection therapy with a high cure rate, is still an option worthy of consideration for specific population. Approved on January 28, MK-5172 will go up against Gilead’s Harvoni and AbbVie’s Viekira Pak by virtue of a more aggressive price after going to market.

                                                      NO.5 Venetoclax

                                                      Company: AbbVie

                                                      Indication: Chronic lymphocytic leukemia

                                                      2020 sales forecast: USD1.48 billion

                                                      As one of the star drugs in the 2015 annual meeting of the American Society of Hematology (ASH2015), AbbVie’s Ventoclax left a deep impression on everyone with the overall response rate of 79.4% in patients with relapsed chronic lymphocytic leukemia. Ventoclax is also developed to treat other hematological cancers like non-Hodgkin’s lymphoma, as well as in combination with tamoxifen in patients with metastatic breast cancer. As announced on January 12, FDA has accepted NDA and granted Priority Review for Venetoclax for the treatment of people with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, including those with 17p deletion. Venetoclax is expected to be the first BCL-2 inhibitor in the market.

                                                      NO.6 Nuplazid

                                                      Company: Acadia Pharmaceuticals

                                                      Indication: Parkinson’s disease psychosis

                                                      2020 sales forecast: USD1.41 billion

                                                      About 40% of Parkinson’s patients are accompanied with Parkinson’s disease psychosis, and Nuplazid is expected to become the first drug for treating such disease. Clinical studies have shown that Nuplazid does not worsen patients’ motor symptoms and can improve patients’ night-time sleep, daytime wakefulness, and caregiver burden. Nuplazid may be developed to treat schizophrenia in the future.

                                                      NO.7 Uptravi (Selexipag)

                                                      Company: Nippon Shinyaku/Actelion

                                                      Indication: Pulmonary arterial hypertension (PAH)

                                                      2020 sales forecast: USD1.27 billion

                                                      Uptravi is able to both delay the progression of PAH, and reduce the risk of hospitalization. A clinical research showed that Uptravi reduced the risk of death by 39% versus placebo. Approved on December 22, 2015, Uptravi is being promoted as an additional therapy once the baseline treatment of patients with PAH has been started, and is expected to bring in USD189 million sales revenue in its first year in the market.


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