On December 20th, the research and development staff of biopharmaceutical companies will talk about their undeveloped needs in the medical field when they review their post-development projects. However, the market is harsh, and potential hopes will inspire investors' interest, and some innovations may also be cold. Evaluate, a well-known market research firm, has announced a top-of-the-range top 10 drug listed in 2018.
Some mature companies are making great efforts to launch new heavy drugs in 2018. New progress has been made in AIDS and diabetes, with 6 of the 10 expected heavy drugs being new cancer treatments or rare disease treatments.
NO.1 Bictegravir/F/TAF
Enterprise: Gilead
Peak sales: $ 5.05 billion
Category: HIV infection
This is Gilead's largest "star" project, combining the experimental integrase chain transfer inhibitor Bictegravir (50mg) (BIC) with emtricitabine/tenofovir formamide (FTC/TAF) in a fixed dose. Treatment for AIDS patients. Gilead has submitted a new drug approval application to the US FDA on June 12 this year, and plans to submit a listing application in Europe quickly. The combination of new drugs can simplify the treatment of AIDS and bring convenience to patients.
The product has been highly anticipated. In January 2017, EvaluatePharma predicted its sales in 2022 would reach $2.502 billion. Now, Gilead is awaiting the approval of February 12, 2018 (PDUFA, the date of the FDA's new drug approval) and preparing for the drug's listing. The drug will show Gilead's position in the AIDS treatment market, and many analysts highly value it, and its expectations have increased significantly.
Gilead has been the protagonist of the anti-HIV drug market for many years, and has no intention of handing over the market to the two drug combinations Juluca (Dolutegravir-Rilpivirine) that GlaxoSmithKline just approved (November 21). GlaxoSmithKline's product is also a landmark achievement in this field, and cocktail therapy compliance is better than ever; Gilead's strength lies in its greater understanding of the AIDS market. By then, Gilead Science and GlaxoSmithKline will compete directly in the market.
NO.2 Semaglutide
Enterprise: Novo Nordisk
Peak sales: $ 2.7 billion
Category: Diabetes
On December 5, the US FDA gave a green light to Novo Nordisk's semaglutide, a weekly GLP-1 (glucagon-like peptide-1) diabetes. drug. It will be marketed under the trade name Ozempic, administered intramuscularly, in the same mechanism as Eli Lilly's Truecity (Dulaglutide), and defeated Trulicity in a direct comparative study. Semaglutide reduced HbA1c (glycated hemoglobin) and body weight more significantly than the same weekly Tranlicity. This will put considerable pressure on the courtesy.
As a heavy-weight drug that is expected to sell for as much as $2 billion, Novo Nordisk has also launched a large-scale obesity trial to see if patients can get rid of the weight problems that cause diabetes. This makes the drug a clear threat to all related drugs on the market, and other drugs have no obvious effect in this regard.
NO.3 Epacadostat
Enterprise: Incyte company
Peak sales: $ 1.94 billion
Category: Tumor
Epacadostat is a small molecule indoleamine 2,3-dioxygenase (IDO) inhibitor developed by Incyte. Clinical trials have shown that the combination of IDO inhibitors and programmed death receptor 1 (PD-1) monoclonal antibodies is superior in some respects to PD-1 monoclonal antibody alone.
Incyte has reached a cooperation agreement with the two giants of PD-1 monoclonal antibody, Merck and Bristol-Myers Squibb, respectively, to conduct a joint clinical trial of Epacadostat and their PD-1 monoclonal antibody pembrolizumab (Keytruda) and nivolumab (Opdivo). . The Epacadostat and Keytruda combination phase I/II studies reported at this year's annual meeting of the American Society of Clinical Oncology produced up to 47% response rates in patients with advanced renal cell carcinoma (RCC).
NO.4 Rova-T (Rovalpituzumab Tesirine)
Enterprise: Aberdeen
Peak sales: $ 1.44 billion
Category: Tumor
Abbott spent $5.8 billion in cash for the drug and promised to pay an additional $4 billion in phased expenses to acquire the little-known biotech "unicorn" Stemcentryx.
The greater the price paid, the higher the expectations. In combination with Bristol-Myers Squibb's human-killing receptor-1 (PD-1) inhibitors Opdivo (Nivolumab) and Yervoy (Ipilimumab), Abbott hopes to be a winner in the treatment of small cell lung cancer (SCLC). This drug acts as a cytotoxic bomb on cancer cells that express DLL3, which is common in SCLC.
NO.5 Ozanimod (Ozamod)
Enterprise: New Base
Peak sales: $ 1.27 billion
Category: Multiple Sclerosis
In a phase III clinical trial for the treatment of relapsing multiple sclerosis, Ozanimod significantly reduced the annual recurrence rate to the primary clinical endpoint. New base executives are not ashamed to promote the sales potential of the experimental drug.
Their initial goal was $4 billion to $6 billion. However, this number has been declining. At the end of October, Geoffrey Porges, an analyst at Sanford C. Bernstein, a US market research organization, still believes that its sales can reach $2.9 billion. Therefore, there is clearly room for the peak sales of $1.27 billion.
NO.6 Apalutamide
Enterprise: Johnson & Johnson
Peak sales: $ 1.24 billion
Category: Tumor
Apalutamide (aparumamine, ARN-509) has been receiving attention for many years. Johnson & Johnson acquired the project when it acquired Aragon for $650 million. It is the only breed of Johnson & Johnson to be included in this list. Apalutamide is a research-based new generation of oral androgen receptor inhibitors for the treatment of non-metastatic castration-resistant prostate cancer (CRPC).
On October 11, Johnson & Johnson submitted a new drug application to the FDA requesting approval for its use in treating male patients with non-metastatic trends against CRPC. A data from a Phase III study called SPARTAN supports this application. The study showed that Apalutamide treatment showed statistically significant prolonged non-metastatic survival compared with placebo.
Apalutamide is a new generation of oral androgen receptor inhibitors that block testosterone in prostate cancer cells and prevent androgen from binding to receptors. Currently, there are no FDA approved therapeutics for patients with non-metastatic CRPC.
Prostate cancer is the most common cancer in the United States except for skin cancer. According to the American Cancer Society, more than 161,000 men were diagnosed with prostate cancer in 2017. Patients with non-metastatic prostate cancer who receive ADT will eventually develop resistance to ADT and develop into CRPC. Data estimate that 10% to 20% of patients diagnosed with prostate cancer may develop CRPC in approximately 5 years.
NO.7 Elagolix
Enterprise: Aberdeen
Peak sales: $ 1.21 billion
Category: Gynecology (endometriosis and uterine leiomyoma)
This is the second drug from Abbott to Top10, which is expected to reach $900 million in annual sales in 2020.
Two phase III clinical trials of this oral gonadotropin-releasing hormone receptor antagonist (each with 800 women) tracked the clinical response to dysmenorrhea - acute and potentially disabling menstrual pain, and menopause Pelvic pain.
Elagolix is ​​a short-acting, non-peptide antagonist of the highly potent, selective, orally effective gonadotropin-releasing hormone receptor (GnRHR). Due to its non-peptide nature and its oral bioavailability, it belongs to a new class called the first (second drug candidate) of the second generation GnRHR inhibitor. Its half-life is relatively short, and the action of gonadotropin-releasing hormone (GnRH) is not completely blocked all day, and the degree of inhibition can be adjusted as needed. In addition, if you stop using Elagolix, its effect is reversible. Because Elagolix inhibits incomplete estrogen, it has minimal effect on bone mineral density, in contrast to first-generation GnRH inhibitors. In addition, the incidence and severity of menopausal side effects such as hot flashes are also reduced compared to the first generation GnRH inhibitors.
Abbott plans to make it a heavyweight drug, although it is not a “gold mine†like Humira (Adalimumab, Adalimum/Simeret), but it is also an important part of the company's product portfolio.
NO.8 AVXS-101
Enterprise: Avexis company
Peak sales: $ 1.14 billion
Category: Rare disease (spinal muscular atrophy)
AVXS-101 is a gene therapy for SMA1 spinal muscular atrophy that addresses SMA single gene problems and prevents further muscle degradation in response to SMN gene defects and/or loss. The drug can target the motor neurons and cross the blood-brain barrier to work quickly. No adverse reactions were found in the test.
A few weeks ago, an optimistic data on a small study of 15 patients with spinal muscular atrophy using this gene therapy was revealed. The FDA is eagerly awaiting the early launch of products that will save patients facing deadly diseases. The therapy poses a direct threat to the new franchise of Spinraza (Nusinersen), which Biogen also uses to treat this condition. The latter's first year of treatment costs $750,000, making it one of the top ten most expensive therapies in the world.
NO.9 Lanadelumab
Enterprise: Shire (Shire)
Peak sales: $ 1.12 billion
Category: rare disease (hereditary angioedema)
Shire paid Dyax for nearly $6 billion to receive this new generation of hereditary angioedema (HAE). On May 18 this year, Charles Pharmaceuticals announced positive data on the phase III clinical trial of Lanadelumab in the treatment of advanced HAE, which means that a new rare disease treatment that may cost up to six digits (hundreds of thousands of dollars) is about to be approved. Listing. Charles Pharmaceuticals plans to submit a Lanadelumab Biopharmaceutical Licensing Application (BLA) to the US FDA by the end of 2017 or early 2018.
The drug has been approved by the FDA for breakthrough therapy, as well as the FDA and the European Medicines Agency for the identification of rare drugs. If the clinical data is reviewed by a regulatory agency, a return on investment may be obtained in 2018. Charles will play the role of a global rare drug.
NO.10 Epidiolex
Enterprise : GW Pharmaceutical
Peak sales: $ 960 million
Category: Rare disease (rare epilepsy)
The expected sales peak of $960 million is close to $1 billion, so Epidiolex (Cannabidiol, cannabinol) is eligible to enter the ranks of heavy drugs.
GW Pharmaceuticals UK is a global leader in the research and development of plant-derived cannabinoid therapeutic products. In March of this year, they obtained a series of optimistic data on the drug – key data for Dravet syndrome, a rare form of severe epilepsy. A few months later, he was given key trial results for Lennox-Gastaut syndrome, a severe and rare refractory childhood epilepsy.
Epidiolex treatment of LGS and Dravet syndrome was given a rare drug status by the European Medicines Agency; the US FDA gave Epidiolex treatment for LGS, Dravet syndrome, tuberous sclerosis, and infant snoring.
Not all analysts are so conservative about Epidiolex's peak sales expectations, and some analysts have estimated that it has exceeded $2 billion. The biotech company is ready for the year of transformation.
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