Rome, 18 December - New drugs against HIV and diabetes, but above all anticancer therapies and for rare diseases: according to the estimates of the analysts of the market intelligence company EvaluatePharma, the ten drugs that will arrive in 2018 belong to these categories likely to generate annual sales in excess of $1 billion.
The sales forecasts, projected for the peak in 2022, concern these ten specialties:
1) Bictegravir/FTC/TAF of Gilead, an anti-HIV drug whose peak sales are expected to be 5.05 billion dollars/year. It is a fixed-dose combination of bictegravir (Bic) and emtricitabine/tenofovir alafenamide (FTC/TAF) indicated for the treatment of HIV-1 infection in treatment-naïve adults. Received the priority review of the FDA.
2) Semaglutide by Novo Nordisk, antidiabetic, with a peak sales forecast of 2.7 billion dollars/year. The drug, which received the green light from the FDA in recent days, is a new once-weekly subcutaneous GLP-1 analog intended for the treatment of adult patients with type 2 diabetes. superior result to Eli Lilly's Trulicity (dulaglutide). It will be marketed under the name Ozempic and poses a serious threat to a number of drugs currently on the market.
3) Epacadostat by Incyte, anticancer. – Peak sales forecast: $1.94 billion/year. It is an oral inhibitor of IDO1 (indoleamine 2,3-dioxygenase 1), a key immunosuppressive enzyme that facilitates tumor growth because it allows cancer cells to avoid immunological surveillance. Epacadostat it is extremely potent and selective, capable of regulating the tumor immune microenvironment, thus restoring effective antitumor immune responses.
4) Rova-T by AbbVie, anticancer. Peak sales forecast of $1.44 billion/year dollars in cash and up to an additional $4 billion upon meeting goals). The drug has demonstrated encouraging antitumor activity combined with a manageable safety profile in a recent Phase 1 study. It works by releasing a cytotoxic "bomb" directly on DLL3 proteins, normally expressed by cancer cells in the 80% of patients with this type of tumor, and absent in healthy cells.
5) Ozanimod of Celgeneagainst multiple sclerosis. Peak sales forecast: $1.27 billion/year. It is a novel orally active, selective sphingosine 1-phosphate 1 (S1PR1) and 5-phosphate (S1PR5) receptor modulator in development for immuno-inflammatory indications, including relapsing multiple sclerosis, ulcerative colitis, and Crohn's. It belongs to the same class of fingolimod, but characterized by improved security.
6) Apalutamide by Johnson & Johnson, anticancer, peak sales forecast: $1.24 billion/year. It is a next-generation oral androgen receptor blocker for non-metastatic castration-resistant prostate cancer (CRPC), for which Janssen filed an FDA approval application in October. The first drug for this clinical setting, it works by inhibiting the action of testosterone in cancer cells and preventing androgens from binding to the specific receptor. Prostate cancer is the most common cancer among American men, along with skin cancer. More than 161,000 cases of prostate cancer are expected to be diagnosed in 2017. It has been estimated that 10-20% of patients diagnosed with prostate cancer may develop CRPC within 5 years. The global market for prostate cancer drugs is estimated to reach US$12 billion by 2025.
7) Elagolix by AbbVie, against pain associated with endometriosis. Peak sales forecast: $1.21 billion/year. It is an oral gonadotropin-releasing hormone (GnRH) antagonist and is being developed for the treatment of moderate to severe endometriosis pain, a condition that affects one in ten women of reproductive age and is associated with painful symptoms that can be debilitating.
The application for approval was filed with the FDA last September and, if accepted, will Elagolix the first treatment option for the treatment of pain associated with endometriosis in over a decade.
8) AVXS-101 by Avexis, drug for the treatment of spinal muscular atrophy (MSA, a rare disease), with peak sales forecast of $1.14 billion. Got the
designation of breakthrough therapyy, as well as the designation fast trackfor the treatment of Type 1 AMS, one of the most serious genetic neurological disorders.
Spinal muscular atrophy is a serious neuromuscular disease caused by a genetic defect in the SMN1 gene, leading to the loss of motor neurons and causing progressive muscle weakness and paralysis. AVXS-101 will compete directly with the new drug Spinraza by Biogen which, at a price of 750,000 dollars for the first year of treatment, is one of the 10 most expensive therapies in the world.
9) Lanadelumab of Shire, a monoclonal antibody targeting plasma kallikrein, involved in the etiopathogenesis of hereditary angioedema (HAE) or Quincke's angioedema, a rare disease characterized by recurrent swelling of the skin, mucous membranes and internal organs which can sometimes be fatal. Peak sales forecast: $1.12 billion/year
There are only very few drugs to treat HAE attacks and its symptoms and Shire has most of them, having Cynryze (human C1-inhibitor), Firazyr (icatibant) e kalbitor (ecallantis).
Lanadelumab it is the result of the purchase by Shire (for 5.9 billion dollars) of Dyax, which had developed the drug, of particular interest due to the mechanism of action which differs from that of already available drugs.
10 Epidiolex by GW Pharma, a non-psychoactive cannabinoid, developed for the treatment of seizures in two specific types of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. The peak sales forecast is $960 million. It is a liquid formulation of purified cannabidiol of plant origin, whose dossier was filed with the FDA for approval on October 30, accompanied by clinical data on 1,500 patients, 400 of whom had more than a year of drug exposure.
GW Pharma expects "significant demand" from the Lennox-Gastaut and Dravet patient populations, which total approximately 35,000 and 8,000 patients, respectively. There are currently no licensed treatments in the United States for Dravet syndrome.
The positive results of the recent phase 3 study on Epidiolex represent the only well-controlled clinical evaluation of a cannabinoid drug for this devastating, drug-resistant condition.
