Blockbusters and promising R&D novelties of 2015

Looking into the future

Svetlana Shelepko, Weekly Pharmacy www.apteka.ua according to the materials
http://www.evaluategroup.com, http://www.deloitte.com, http://www.fda.gov,
http://www.gilead.com, http://www.gsk.com, http://www.vrtx.com, http://www.sanofi.usIt is expected that 2015 will be quite a favorable period for pharmaceutical companies.

This will be facilitated by a large number of R&D novelties that can reach the status of blockbusters by 2020, among them candidates for drugs for the treatment of cardiovascular and respiratory diseases, oncopathology, drugs for the treatment of diabetes and mental illness. Another positive aspect for manufacturers of original medicines is the fact that 2015, according to forecasts, will be relatively calm for them: the number of key original drugs whose patents expire this year will be smaller compared to previous years, as a result of which only a few of them will be subjected to pressure from generics. It will be possible to learn from this publication which drugs will become the best—selling and therapeutic areas the most promising, as well as which R&D novelties, the launch of which is planned in the USA for 2015, may become blockbusters in the future.

The best of the best: Market leaders 2015First of all, it is worth noting that, according to the analytical company "Evaluate Pharma", in 2015, the volume of sales in monetary terms of each of the top 10 best-selling medicines in the United States is expected to amount to more than $ 5 billion.

At the same time, the total sales volume of these drugs will be about $ 82 billion.

Have the R&D novelties of recent years been included in this rating? They're leading it! The first line of the rating is occupied by drugs intended for the treatment of hepatitis C by Gilead Sciences: Sovaldi (sofosbuvir) and Harvoni (sofosbuvir + ledipasvir), with a combined projected sales volume in the United States in 2015 of about $ 15.3 billion. (Table 1).

Table.1 Top-10 drugs by projected sales volume in monetary terms in the USA in 2015 and the forecast of this indicator for 2020.№

Harvoni (sofosbuvir + ledipasvir) was approved by the U.S. Food and Drug Administration (FDA) in October 2014 and became the third drug approved by the FDA for the treatment of chronic viral hepatitis C genotype 1. Earlier, in November 2013, the drug Olysio (simeprevir) was approved for the treatment of this pathology Johnson & Johnson, and in December 2013 — Sovaldi drug (sofosbuvir).

The peculiarity of the Harvoni drug is that it is the first combined drug produced in the form of tablets for the treatment of chronic viral hepatitis genotype 1, and for the first time a treatment regimen for this pathology was approved, in which interferon or ribavirin is not required.

According to the forecasts of Evaluate Pharma, the volume of sales in the USA of Sovaldi and Harvoni drugs will reach its peak in 2016, in turn, the volume of sales in the USA of a drug for the treatment of rheumatoid arthritis — Humira (adalimumab) by AbbVie, which is expected to take the 2nd line of the top-The 10 best-selling drugs in 2015, will reach its peak in 2017, 14 years after the launch, and will regain the primacy in the ranking of the best-selling drugs in the United States in 2020.

In general, most representatives of the top 10 best-selling drugs in the United States in 2015. they are widely known to consumers as medicines for the treatment of rheumatoid arthritis, diabetes mellitus, oncopathology and other diseases, the launch of which took place about 10 or more years ago.

Who will lose patent protection?It is worth noting that in 2015, patent protection for several key original medicines will expire in the United States.

So, in April 2015, Abilify (aripiprazole) will lose patent protection the company "Otsuka", which is used to treat schizophrenia and other mental disorders. It is expected that the volume of sales of this drug in the United States in 2015 will amount to $ 1.79 billion, but in 2016 this figure is projected to decrease to $ 0.33 billion.

In November 2015, patent protection expires for the drug Avodart (dutasteride) of GlaxoSmithKline, intended for the treatment of benign prostatic hyperplasia, and Tracleer (bosentan) of Actelion, intended for the treatment of pulmonary hypertension.

In May 2015, the antibiotic Zyvox (linezolid) of Pfizer will lose patent protection. It is expected that the volume of sales of this tool in the United States in 2015 will amount to $ 0.36 billion, in turn, in 2016 this figure will decrease to $ 0.11 billion.

The most promising therapeutic areasDespite the fact that, according to the forecasts of Evaluate Pharma, among antidiabetic medicines, only one drug will enter the top 10 best-selling medicines in 2015, in particular Lantus (insulin glargine) of Sanofi, it is expected that type II diabetes mellitus will be the most promising therapeutic area in 2015. with a projected volume of sales in the United States of drugs for the treatment of this pathology in the amount of about $ 41.43 billion.

(Table 2). This will be greatly facilitated by the presence on the market of other drugs for the treatment of type II diabetes mellitus, for example, drugs from the group of dipeptidyl peptidase-4 inhibitors, as well as glucagon-like peptide antagonists 1. If we add to this the increase in the incidence of type II diabetes worldwide, it becomes clear why this particular therapeutic area will be the most attractive for drug manufacturers both in 2015 and in the future. Thus, it is expected that the volume of sales of antidiabetic drugs on the world market in 2020 will amount to 59.17 billion dollars.

Table.2 Top 10 Therapeutic Areas by projected Sales volume
medicines on the world market in 2015№

Among the therapeutic areas, melanoma is expected to become the fastest growing on the world market for the period 2015-2020, with more than a three-digit increase in drug sales over this period from $2.7 billion in 2015 to $8.8 billion in 2020. In part, this will be achieved by increasing sales of Opdivo (nivolumab) by Bristol-Myers Squibb, intended for the treatment of unresectable or metastatic melanoma resistant to other drugs.

In turn, the increase in revenue from sales of Imbruvica (ibrutinib) of Pharmacyclics, according to forecasts of Evaluate Pharma, will cause a three-digit growth rate in sales of medicines for the treatment of chronic lymphocytic leukemia for the period 2015-2020 from 2.6 to 8.5 billion dollars. accordingly. It is expected that a double-digit increase in sales of medicines for stroke prevention on the world market during this period (from $6.2 billion in 2015 to $ 11.9 billion in 2020) will be due to an increase in sales of oral anticoagulants, such as Xarelto (rivaroxaban) companies "Bayer", Pradaxa (dabigatran etexilate) companies "Boehringer Ingelheim" and Eliquis (apixaban) Pfizer and Bristol-Myers Squibb.

The most anticipated R&D noveltiesAmong the most promising candidates for drugs in the pharmaceutical field, the launch of which is planned for 2015, according to the company "Evaluate Pharma", it should be noted the combination of VX-809 and ivacaftor of Vertex Pharmaceuticals, intended for the treatment of cystic fibrosis (Table 3). It is expected that the volume of its sales in the United States in 2020.

it will reach $4.74 billion.

Table.3 Top-5 most promising candidates for drugs, the launch of which is planned for 2015.,
according to the projected sales volume in the USA in 2020№

The first step towards creating this combination was obtaining FDA approval for the drug Kalydeco (ivacaftor) in January 2012. The drug improves lung function in patients with cystic fibrosis and is indicated for a specific G551D mutation, which is observed in only 4% of such patients. At the same time, the majority of patients with cystic fibrosis worldwide have a mutation of F508del in a heterozygous and homozygous state. A promising product that allows correcting the defect caused by F508del mutations is the VX-809 molecule.

Thus, it should be expected that in the near future a significant breakthrough can be made in changing approaches to the treatment of cystic fibrosis and increasing its effectiveness after receiving FDA approval for the use of a combination of VX-809 and ivacaftor.

Another promising product in phase III clinical trials is the Novartis drug candidate LCZ696, intended for the treatment of heart failure, with projected sales in the United States in 2020 in the amount of about $ 3.88 billion. This drug is a combination of an angiotensin II receptor antagonist (valsartan) and a non-lysine inhibitor (sacubitril).

Pfizer's palbociclib drug candidate, intended for the treatment of ER⁺, HER ^2– locally advanced breast cancer in combination with letrozole, closes the top three. It is expected that the volume of sales of this tool in the United States in 2020 will amount to $ 3.08 billion.

Among the R&D innovations in the biotechnological field, products for reducing the level of low-density lipoproteins in the blood were in the top three in terms of projected sales in the United States in 2020: alirocumab from Sanofi and evolocumab from Amgen and Astellas, with marks of $ 2.18 and 1.95 billion. accordingly (Table 4). These products are experimental monoclonal antibodies to the enzyme PCSK9 (proprotein convertase subtilisin/kexin type 9), which reduces the ability of the liver to remove low-density lipoproteins.

Table.4 Top-5 candidates for biologics, the launch of which is planned for 2015, according to the projected sales volume in the USA in 2020.№

The candidate for Toujeo (insulin glargine) from Sanofi, also known as U300, intended for the treatment of diabetes mellitus, closes the top three of this rating. The difference between this product and the Lantus drug (insulin glargine) presented on the market by this company is in its concentration — 300 IU / ml. According to forecasts, Toujeo sales in the United States in 2020 will amount to about $ 1.69 billion. This product is expected to receive FDA approval in the first half of 2015.

In conclusionSo, 2015 can be very successful for the pharmaceutical industry.

An important role in this will be played by the R&D activities of pharmaceutical and biotechnology companies: the development and introduction of innovative medicines to the market. Thus, it is expected that 2015 will be able to boast of the number of R&D novelties brought to the US market, which a few years after the launch will reach the status of blockbusters, breaking the mark of annual sales of $ 1 billion. But, as you know, blockbusters are one of the main drivers of growth in the pharmaceutical market and an important indicator of industry productivity. The main therapeutic areas that are attractive for the R&D segment of the pharmaceutical and biotechnological markets in 2015, according to research by the analytical companies EvaluatePharma and Deloitte, will be diabetes mellitus and oncopathology. The results of clinical trials of products in these areas are very promising.