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FiercePharma Announces Top 10 Most Anticipated New Drugs to Launch in 2020

Release time:

2020-02-14 15:16

The year 2020 has come to February, which means that a new round of new drugs is coming soon. This year, there are still a variety of new drugs waiting to be marketed, from antibody-drug conjugates to controversial homeopathic remedies that are trying to change the food allergy market. FiercePharma compiled a list of the top 10 most anticipated new drug launches in 2020 based on the EvaluatePharma team's estimated global sales for 2024.
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1. 药物：Enhertu（fam-trastuzumab deruxtecan-nxki）
Company: AstraZeneca, No.
Indications: HER2-positive breast cancer
Estimated 2024 sales: $2.4 billion
The FDA approved the antibody-drug conjugate-Enhertu treatment in late 2019 for patients with inoperable or metastatic HER2-positive breast cancer who have failed at least two other treatments in the metastatic setting. Enhertu will carry a boxed warning label warning of interstitial lung disease and embryo-fetal toxicity. AstraZeneca and Daiichi Sankyo will jointly develop and market the drug outside Japan, where Daiichi Sankyo has exclusive rights.
The Enhertu consists of Herceptin (an antibody that targets HER2) and a topoisomerase I inhibitor payload and is currently being tested in gastric cancer as well as non-small cell lung cancer and colorectal cancer.
The FDA's approval was based on a Phase 2 Destiny study, in which Enhertu shrank tumors in 61 percent of patients and completely eliminated tumors in 6 percent of patients, Dichi said. The 97 percent disease control rate included patients who saw tumor shrinkage but were not large enough to be considered responders. Almost all Destiny patients (99%) had side effects, including nausea, vomiting and low white blood cell counts. Fifteen percent stopped treatment because of side effects, the company said.
2. Drug: ozanimod
Company: Brithtime Myers Squibb
Indications: Multiple sclerosis
Estimated 2024 sales: $1.598 billion
Ozanimod is a key component of Bristol-Myers Squibb's $74 billion acquisition of Celgene. It is an S1P receptor modulator designed to suppress inflammatory activity by preventing immune cells from entering the central nervous system from the lymph nodes. Multiple existing and future powerful adversaries are targeting the same mechanism.
To break through the hurdles once and for all, it must compete with several FDA-approved drugs as well as promising experimental ones. That includes Novartis's $3.3 billion-a-year Gilenya, which is locked in a patent battle and could face a generic challenge sooner than originally planned. Celgene touted ozanimod's safety profile as superior to older Novartis drugs, particularly with regard to liver toxicity and cardiac side effects. However, there are other newer treatments for MS that are worth worrying about.
In addition to MS, Bristol-Myers also called for ozanimod for inflammatory bowel disease, which has entered Phase 3 testing.
3. 药物：inclisiran
Company: Novartis
Indication: High LDL cholesterol
Estimated 2024 sales: $1.529 billion
Praluent-year sales of the existing PCSK9 drug, Amjin's Repatha, and Sanofi and Regeneration totaled just $1 billion. Novartis thinks its new drug inclisiran will behave differently, inclisiran is at the heart of the widely discussed $9.7 billion acquisition of The Medicines Company.
Inclisiran have provided comparable data on their ability to lower bad cholesterol. The new drug differs from the two antibodies in that it uses small interfering RNA to target PCSK9. Inclisiran can be given twice a year after the two lead-in doses, compared to biweekly or monthly for both FDA-approved drugs.
In the United States, MedCo (now Novartis) submitted its inclisiran New Drug Application to the FDA in December 2019.
4. Drug: Evrenzo (roxadustat)
Company: Abojin, AstraZeneca, Astellas
Indications: Nephropathy-related anemia
Estimated 2024 sales: $1.488 billion
AstraZeneca shares the rights to the anemia drug Evrenzo (roxadustat) in the United States and China, where China has approved and covers patients with non-dialysis-dependent and dialysis-dependent chronic kidney disease anemia, and AstraZeneca applied for the drug in the United States in December 2019 for both indications. In Japan, its partner Astellas won the green light for dialysis patients.
Roxadustat is the first drug in the class of hypoxia-inducible factor prolyl hydroxylase inhibitors to be approved anywhere. Unlike Amgen and Johnson & Johnson's standard-of-care injection, Epogen/Procrit, oral roxadustat compensates for anemia by mimicking the response to reduced oxygen levels.
Roxazus he will soon face some strong competition. These include the daprodustat of GlaxoSmithKline, which partnered with Kyowa Kirin to apply for approval in Japan. Akebia Therapeutics and local partner Mitsubishi applied for their rival vadadustat in Japan in July 2019. In the United States, Akebia works with Japanese pharmaceutical company Otsuka for anemia treatment.
5. 药物：sacituzumab govitecan
公司：Immunomedics
Indication: Triple-negative breast cancer
Estimated 2024 sales: $1.44 billion
Triple-negative breast cancer (TNBC) therapy, sacituzumab govitecan as a third-line treatment for advanced metastatic TNBC, did not successfully pass the FDA: a complete response letter (CRL) in early 2019 almost dispelled hopes of approval. But Immunomedics companies resubmitted their applications for the drug in early December, and the FDA has set a decision date of June.
Sacituzumab govitecan is an antibody-drug conjugate comprising an active ingredient in a chemotherapeutic Onivyde. The chemotherapy is tasked with fighting the Tecentriq of Roche's I-O therapy, which was approved in March to treat TNBC.
Cantor analyst Dr. Varun Kumar hypothesized that sacituzumab could be a strong candidate for a merger if it receives FDA approval as a third-line or later treatment. Kumar estimated the potential acquisition value of the drug at $7.1 billion.
6. Drug: Female
Company: Gilead Science
Indications: Rheumatoid arthritis
Estimated 2024 sales: $1.28 billion
Under the rapid review of the FDA filing, the rheumatoid arthritis drug candidate, felotinib, may greatly help Gilead Sciences enter the anti-inflammatory drug market.
Fongotinib has already applied for approval in Europe and Japan, but the US market is the source of large funds, which is an important milestone for Gilead. Recent data show that the drug is superior to methotrexate alone, and that it has an advantage over AbbVie's old rheumatoid arthritis drug Humira.
The safety of felotinib is a particular source of continuing uncertainty. Gilead and Galapagos believe that non-gotinib will not be plagued by the safety issues affecting Pfizer Xeljanz and Lilly Olumiant, as well as other members of the JAK family. However, AbbVie's RInvoq, which is specific for JAK1 like felotinib, received a boxed warning when it received FDA approval earlier this year.
7. Drug: Palfortia (AR101)
Company: Aimmune
Indication: Peanut allergy
Estimated 2024 sales: $1.28 billion
On January 31, the FDA approved Aimmune Palforzia for the treatment of peanut allergies. Palforzia will set a major precedent in the area of food allergies where avoidance is the norm. While some market watchers are skeptical, FDA approval could make the Palforzia a sensation for years to come.
Palforzia, as a peanut allergy immunotherapy, the patient is desensitized by administering increasing doses of peanut protein.
"Given the need for frequent outpatient visits and gastrointestinal side effects during dosing, we believe that many investors will have questions about the commercial opportunities of this product." Credit Suisse analyst Vamil Divan wrote, "But we found that physicians and patients/parents have great interest in the product, side effects seem to be easy to manage, and commercial opportunities can be resolved by targeted sales personnel."
8. 药物：valoctocogene roxaparvovec
Company: BioMarin Pharmaceutical Company
Indications: Hemophilia A
Estimated 2024 sales: $1.212 billion
BioMarin submitted its application for a gene therapy valoctocogene roxaparvovec for hemophilia A (valrox) to the FDA at the end of 2019, following an application to the EMA. And its rival Roche/Spark is still in the middle of an introduction study that tests traditional factor VIII replacement therapy SPK-8011 the next 3 phases.
BioMarin has increased its production capacity for gene therapy to 10,000 doses per year to allow valrox to hit the market in 2020, meaning the company could treat all existing patients with severe hemophilia A in the United States within two years, ahead of a possible SPK-8011 approval.
Once approved, valrox will first compete with Roche's antibody drug Hemlibra for non-inhibitor patients, who have quickly grabbed their share from factor VIII therapy and contributed US $0.95 billion to Roche's revenue in the first nine months of 2019, because a recent Citi survey of 60 American hematologists shows that they expect 29% of Hemlibra patients and 34% of factor VIII patients to switch to gene therapy within one year.
9. 药物：rimegepant
Company: Biohaven Pharmaceutical Company
Indications: Migraine
Estimated 2024 sales: $0.897 billion
Although Biohaven lost out to Allergan in the competition for the first marketed oral CGRP, whose Ubrelvy(ubrogepant) was approved by the FDA at the end of 2019, industry observers believe that the rimegepant will be more successful, probably based on the fact that although acute treatment may be the first indication for rimegepant, Biohaven is also looking to expand into a larger prevention market.
Three commercially available CGRP drugs, Aimovig of Amjin and Novartis, Ajovy of Teva Pharmaceuticals and Emgality of Eli Lilly, are approved injections for migraine prevention; Biohaven surprisingly bring oral options. Lilly also has a new oral drug, Reyvow, the first in the serotonin (5-HT)1F receptor agonist category. But the treatment's side effects, including dizziness and drowsiness, could limit its peak sales to less than $0.5 billion.
With the oral CGRP migraine drug rimegepant as its first commercial product, Biohaven is confident of challenging all of these large pharmaceutical companies.
10. Drug: risdiplam
Company: Roche
Indication: Spinal muscular atrophy
Estimated 2024 sales: $0.803 billion
Roche's risdiplam will enter the spinal muscular atrophy market after Novartis's Zolgensma and Bojian's Spinraza, provided the FDA approves it by a May decision deadline.
Risdiplam, a survival motor neuron gene 2 splice modifier, is an oral liquid that patients can take at home. Bijian Spinraza Injection is administered in multiple loading doses over the first two and a half months, with maintenance doses every four months thereafter. Novartis's gene therapy Zolgensma is a one-time treatment for patients under 2 years of age.
Cantor analyst Alethia Young pointed out in a recent report that if the oral drug is approved, it could be a "game changer" for SMA ".

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