Author/Song Yining

List of heavy new drugs with strong sales volume

Some new drugs on the market are welcomed by the market as soon as they are listed, and even rewrite the competition pattern, while others have a bad start and are "dumb" in the increasingly fierce market competition.

According to McKinsey & Company's 20 14 analysis of new drugs listed in 2003-2009, about two-thirds of new drugs failed to meet the sales expectations in the first year after listing. Discovering new safety problems, difficulties in manufacturing and supply, doctors' reluctance to try new choices, competitors' first-Mover advantage, inefficient marketing, chaotic management caused by company turmoil, or just bad timing of listing may lead to the initial battle of new drugs, which will further dim their market prospects.

According to the sales of the first four quarters after being approved for listing, FiercePharma summarized the top ten "fierce" new drugs that started with the strongest start since 20 17.

It should be noted that a higher initial speed does not guarantee the longest range. For example, Gilead's hepatitis C (HCV) drug Epclusa, as the first antiviral drug to treat six major forms of HCV, was approved for marketing in June 2065.438+06, and its sales amounted to 65.438+75 billion US dollars. However, with the shrinking of the whole HCV market, Epclusa became the first antiviral drug to treat six main forms of HCV.

Similarly, drugs with average performance in the first four quarters after listing may have a strong "stamina" with the development of the market and changes in industry cognition. For example, Entresto, Novartis's heart failure drug, was suspected as soon as it went on the market, and doctors were reluctant to prescribe it. Therefore, although the sales of this drug is expected to be as high as several billion dollars, it only earned 65.438+0.7 billion dollars in the first year after listing (2065.438+06). But by 20 19, its sales reached 173 billion US dollars, up over 70% year-on-year.

0 1、Mavyret:

Catch the last bus of high growth of hepatitis C market.

The whole course of treatment of Mavyret only takes 8 weeks, while other similar drugs for hepatitis C need 12 weeks. In order to further highlight the competitive advantage, AbbVie priced Mavyret at $26,400, which was significantly lower than its competitors' $70,000-$80,000.

This made Mavyret's initial sales growth very smooth. In the first quarter of 20 18 alone, Mavyret generated sales of $894 million, 60% higher than expected. At that time, the CEO of AbbVie thought that the growth momentum would last for a long time, which would help it fill the gap caused by the decline in sales in adalimumab.

However, things did not go as expected. Mavyret caught the last bus of rapid growth in the field of hepatitis C. With the rapid recovery of existing patients, the pharmaceutical field reached its peak in 20 15, with global sales of about $23 billion, and has been declining since then. In the last three quarters of 20 18, the sales volume of Mavyret also declined. In 20 19, the global sales of Mavyret was $2.89 billion, a year-on-year decrease of 16%.

At the same time, in 20 19, Gilead launched an authorized generic version of its hepatitis C drug with a price of 24,000 US dollars, which directly targeted Mavyret and regained some market share. In May last year, Mavyret was approved in China, and 65.438+million hepatitis C patients entered the blue ocean market, which may bring new growth opportunities.

Biktawi:

The most successful new anti-AIDS drug

Gilead's new three-in-one compound anti-HIV drug Biktarvy quickly became the leader in the field of anti-HIV treatment in the United States in the second full quarter after its listing. Judging from the sales situation in the first four full quarters, Biktarvy is the most successful new anti-AIDS drug, with sales reaching $6,543.8+$94 million.

Gilead adopted a breakthrough small package, which made the total weight of the drug only 275 mg, greatly reducing the psychological burden of patients taking the drug. By contrast, Triumeq, a competitor of GlaxoSmithKline, takes 950 mg per tablet. Moreover, Biktarvy showed a high drug resistance barrier, almost no drug interaction signal, and showed a lower incidence of side effects than Triumeq in clinical trials.

However, Biktarvy's real competitor is not the traditional combination of three drugs or four drugs. At the end of 20 17, the FDA approved the first two-drug HIV mixture Juluca (dotiravir/ribavirin) of GSK, and then in April of 20 19, another two-drug mixture Dovato (dulutavir/lamivudine) of GSK for newly diagnosed patients was approved for marketing. GlaxoSmithKline believes that the two drug therapies can reduce the potential drug interactions and side effects caused by patients' long-term exposure to various pharmaceutical ingredients, and maintain a high virus inhibition for a long time.

At present, there is still a lack of long-term large-scale clinical evidence to support the advantages of "two drugs" and "three drugs". From the perspective of market performance, the total sales of Juluca and Dovato in 20 19 was 526 million US dollars, while Biktarvy reached 4.74 billion US dollars, and it is still growing rapidly.

03、Ocrevus:

Strong growth will meet strong enemies.

Aurelizumab (Ocrevus), a drug for the treatment of multiple sclerosis (MS), is considered to be the most successful drug in Roche's history, and gained a place in this field in the first year of marketing. This is the first drug for primary multiple sclerosis that is difficult to treat. In the head-to-head test of recurrent MS, we beat Rebif of MSD, and the price was 25% lower than the latter.

Roche's low price strategy has paid off. Ocrevus gained 7% market share in the first 12 months after listing, of which about 70% came from patients who used other drugs.

In 20 19, although new competitors entered the market, such as Siponimod of Novartis and Cladribin of Merck, the growth momentum of Roche's Ocrevus remained strong. Its annual sales increased by 57% compared with 20 18, reaching 3,765.438 million Swiss francs.

In the future, Ocrevus will soon face the competition from Novartis's ofatumumab, which is superior to Sanofi's Aubagio in reducing the recurrence rate and slowing down the disease recurrence and disability, and oral administration is convenient for patients to manage themselves, which may have some advantages over injectable Ocrevus.

04. Singerix:

Too popular to generate enough capacity.

Before 20 17, Zostavax of Merck was dominant in the prevention of herpes zoster, and Shingrix of GlaxoSmithKline broke the original market structure as soon as it went on the market. Listing/kloc-almost crossed the "blockbuster" threshold within 0/2 months, and has maintained the growth momentum since then.

In mid-March, 20 18, that is, only five months after listing, Shingrix has occupied more than 90% of the herpes zoster vaccine market in the United States. According to GSK data, by the end of 20 18, its market share has reached 98%.

Shingrix's huge market demand not only surprised the industry, but even GSK was caught off guard. In the middle of 20 18, the supply of Shingrix began to fall short of demand, and GSK had to restrict orders and suspend advertising. Sales of Shinglix 2019 in the fourth quarter more than doubled year-on-year to 532 million pounds, despite the serious delay in production capacity.

GSK is currently building a new production base. The company revealed that there is limited room for further sales growth of Shingrix in 2020 before the new production capacity is put into the market.

05、Spinraza:

Competing with gene therapy for SMA market

Spinraza is used to treat spinal muscular atrophy (SMA). Although the price of each injection is as high as $654.38+0.25 million, patients need to inject the first and second injections every 65,438+0.4 days and 30 days at the beginning, and then every four months, so the expensive pricing has caused controversy. However, in the second quarter of 20 17, the sales of the drug reached 203 million US dollars, almost three times the industry forecast.

However, as the patients who participated in the treatment gradually entered the dose maintenance stage, the fever of Spinraza obviously subsided, and the sales of 20 17 in the third quarter decreased slightly to1980,000 USD. Subsequently, the drug was squeezed out by Novartis gene therapy Zolgensma, which was more expensive, but once administered, it could be cured for life.

06、Skyrizi:

Is about to become a "blockbuster"

Although Abway's psoriasis drug Skyrizi is not the first IL-23 inhibitor to enter the market, it has great influence on Johnson &: Johnson & Johnson's IL- 12/23 double antibody Tremfya and Novartis's IL- 17A inhibitor can be "Cosentyx". The rapid growth of Skyrizi in the market is undoubtedly of great significance for AbbVie to fill the gap caused by the decline in sales of Humira.

One of Skyrizi's competitive advantages in the market is its low-frequency administration. It only needs to be injected once every other month at the initial stage of treatment, and then twice every 12 weeks. Its clinical data is also very convincing. In the third phase clinical study, 90% of 80% patients' diseased skin can return to normal within one year, and 60% patients will return to health. In the long-term follow-up study, it was found that 72% patients' diseased skin would return to normal within two years.

In the first quarter of 2020, Skyrizi's sales reached 300 million US dollars, and this year's annual sales may easily exceed 654.38 billion US dollars, becoming a "blockbuster". Abbey is now committed to expanding the indication label of Skyrizi and continuing to open the market.

07. Zogensma:

"high-priced medicine" for innovative payment methods

Zolgensma, a single dose of $2 million from Novartis, is the most expensive drug at present. After the drug went on the market, it was also accused of data manipulation. Novartis's delay in publishing the internal investigation results, coupled with the resignation of relevant executives, made the whole incident confusing. Therefore, FDA delayed the approval of some clinical trials of Zolgensma.

Although there are many twists and turns, many patients have confirmed that Zolgensma is an extremely effective treatment, and it can significantly improve its motor ability with only one injection. Novartis also provides drug payers with an agreement based on treatment results. If and only if the drug is effective, the payer needs to pay all the treatment expenses within 5 years. At present, the agreement has covered 90% of commercial medical insurance patients. Zolgensma's sales were also higher than analysts' expectations, and the total revenue in the six months from 20 19 reached 3 10/00000 USD.

08、Ozempic:

Want to rewrite GLP- 1 drug market structure

For Novo Nordisk, a well-established diabetes drug manufacturer, ozan Peak is a "link between the past and the future" product, which undertakes the task of regaining the market share lost by Novo Nordisk, an old GLP- 1 agonist, and striving for the market for the newly listed oral somatropin Rybelsus. Before Ozempic went public, the GLP- 1 agonist market was dominated by Trulicity injected once a week by Lilly.

Clinical data show that Ozempic can not only lower blood sugar level, but also help patients lose weight, which is more effective than Januvia, DPP-4 inhibitor of Merck, and GLP- 1 agonist Bydureon of AstraZeneca. The data also show that Ozempic can reduce the risk of stroke by 39% and the overall risk of cardiovascular events by 26%, which is expected to become a new generation of treatment standards.

In the third quarter of 20 18, Ozempic took the leading position in the field of prescription drugs for type 2 diabetes in the United States, and by the end of 20 18, its sales volume officially surpassed Novozymes. By 20 19, Ozempic's market share in the United States reached 37%. At present, Novo Nordisk is focusing on the first oral GLP- 1 agonist Rybelsus.

09, Trovia:

Excellent data helps sales.

Johnson & Johnson has its own TNF antibody drug Remicade and IL- 12/23 inhibitor Stelara, but despite this, Tremfya has played a huge economic benefit in the field of skin anti-inflammation, which shows that the space in this field is still huge.

Relevant data show that Tremfya has a significant effect on moderate and severe plaque psoriasis. By 16 weeks, at least 7 patients who were treated with 10 got at least 90% healthy skin, and the effect was better than that of Humira in AbbVie. And defeated Novartis psoriasis drug Cosentyx in a head-to-head test. Thanks to these good data, Tremfya earned $465,438+06 million in one year.

However, in a clinical trial of Lilly Company in the treatment of moderate and severe plaque psoriasis, the psoriasis drug Taltz beat Tremfya, and achieved good systemic treatment effect within 12 weeks, reaching its main research focus, or was approved by FDA and EMA to expand the indications this year.

10、Dupixent:

"Conscience price" rapidly develops patient groups

Dupixent is a fully humanized monoclonal antibody, which can inhibit the signal transduction of IL-4 and IL- 13, and it is also the only biological agent approved for children with moderate and severe atopic dermatitis aged 6 ~1/kloc-0. The drug is priced at $37,000, which is lower than the cost-benefit threshold calculated by the Institute of Pharmacoeconomics and is well received by the outside world. In just five weeks after the listing of Dupixent, 3,500 clinical patients were obtained, much faster than other successful dermatological drugs. In the second quarter of 20 17, that is, the first full quarter after listing, Dupixent received bills from 8,500 patients, with sales exceeding1.1.80 billion euros.

By the end of 20 19, Dupixent's sales increased by 15 1% year-on-year, reaching 2.07 billion euros (US$ 2.32 billion). According to EvaluatePharma, its sales may reach $3.4 billion in 2020.