API SUPPLIERS

API Suppliers

27

US DMFs Filed

9

CEP/COS Certifications

0

JDMFs Filed

0

Other Certificates

4

Other Suppliers

21

API REF. PRICE (USD / KG)

6,398

API Market Place

8

INTERMEDIATES

22

DOSSIERS // FDF

USA (Orange Book)

1

Europe

0

Canada

1

Australia

0

South Africa

2

Uploaded Dossiers

0

GLOBAL SALES (USD Million)

U.S. Medicaid

58.00

Annual Reports

147.00

FDF Market Place

0

EXCIPIENTS

9

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

8

USFDA Exclusivities

1

DIGITAL CONTENT

Blog #PharmaFlow

2

News

9

REF STANDARD

EDQM

0

USP

0

JP

0

Other Listed Suppliers

0

SERVICES

0

Blog

Full Screen View

New Drug Approvals by FDA & EMA (Mid-2020 Recap)

In case you thought Covid-19 had slowed down US Food and Drug Administration’s New Drug Approvals, you’re in for a pleasant surprise — the FDA appears to be more active than ever before. By the end of June, the FDA had already approved 33 new drugs which put the approval activities within the ballpark of the past two years — 62 novel drugs were approved in 2018, while 54 were approved in 2019. FDA’s Center for Drug Evaluation and Research (CDER) approved 25 new molecular entities and new therapeutic biological products, of which almost half — 12 out of 25 — were oncology drugs, while the rest of the novel therapies were approved by the Center for Biologics Evaluation and Research. The European Medical Agency (EMA) was also busy as the regulator issued a positive opinion for 41 drugs, of which 27 were classified as novel treatments. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Conditional Approval for Gilead’s Remdesivir Gilead’s Remdesivir has certainly been one of the most talked about drugs this year. While it is still under clinical evaluation, the FDA, EMA and the Japanese Ministry of Health, Labour and Welfare (MHLW) found ways of providing market access to this drug as a treatment against Covid-19. On May 1, 2020, based on the totality of scientific evidence available to the FDA, the agency issued an Emergency Use Authorization (EUA), as it believed that remdesivir may be effective in treating Covid-19 and that the known and potential benefits of remdesivir, when used to treat Covid-19, outweigh the known and potential risks of such products. On June 25, 2020, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of conditional marketing authorization for Veklury (remdesivir). The demand for remdesivir is such that the US bought more than 500,000 doses, which is all of Gilead’s production for July and 90 percent of production for August and September, leaving almost no stock of remdesivir for the UK and Europe. In 127 poor or middle-income countries, Gilead is allowing generic drugmakers to supply remdesivir. It has signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to further expand the supply of the antiviral drug. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Vertex’s Kaftrio bags EMA approval Earlier this year, PharmaCompass published its compilation of the sales forecasts for the new drugs approved by the FDA in 2019. The list was led by Vertex’s cystic fibrosis treatment — Trikafta — which is expected to have sales of US$ 3.935 billion by 2024. Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor and its stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date. In June 2020, EMA’s CHMP adopted a positive opinion, recommending the granting of a marketing authorization for Vertex’s combination which will be marketed as Kaftrio. EMA also adopted positive opinions on other drugs which were previously approved by the FDA in 2019, such as Novartis’ Zolgensma and Piqray, Pfizer’s Staquis and Daurismo among many others. Immunomedic’s antibody-drug conjugate (ADC) — Trodelvy (sacituzumab govitecan-hziy) — was approved by the FDA for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. Trodelvy follows remdesivir in our list of FDA approved drugs in 2020 with the highest sales potential. The current forecast for Trodelvy sales is US$ 2.151 billion by 2026. FDA’s approval of Lundbeck’s Vyepti (eptinezumab) and Biohaven’s Nurtec ODT (rimegepant) for migraine headaches brought additional CGRP-targeted products to the market. It will be interesting to see how Nurtec ODT is accepted given it is a small molecule drug, which makes administration easier. It was recently promoted on social media by Khloe Kardashian. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Covid-19 impacts drug launches The pandemic has, however, started taking a toll on drug launches. One of the most anticipated drug approvals of the year, Bristol-Myers Squibb’s multiple sclerosis (MS) treatment — Zeposia (ozanimod) — was approved in both the US and Europe. However, the launch of the drug would be delayed due to the coronavirus outbreak. The drug was added to BMS’s portfolio through its US$ 74 billion acquisition of Celgene last year. Its approval was one of the three conditions set for a potentially higher payout for Celgene investors. Analysts have high hopes from ozanimod. Its average peak sales for 2024 have been predicted to be at US$ 1.62 billion by Cortellis, though the Covid-19 pandemic may weigh in there as well. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) First non-statin cholesterol drug bags FDA approval This year also witnessed the first non-statin treatment to be cleared for sale in the US in nearly 20 years. The drug, bempedoic acid, is made by Esperion Therapeutics Inc. This cholesterol-lowering drug is aimed at helping millions of people who can’t tolerate or don’t get enough help from widely used statin pills like Lipitor and Crestor. This new drug is to be used as an add-on treatment with statins. It lowers bad cholesterol or low-density lipoprotein (LDL) by inhibiting its synthesis in the liver. It targets patients with high cardiovascular risk. Esperion also won approval of bempedoic acid in combination with ezetimibe, another cholesterol-lowering drug. In January last year, Daiichi Sankyo Europe had entered into an exclusive licensing agreement with Esperion Therapeutics for Daiichi Sankyo Europe to market bempedoic acid and bempedoic acid/ezetimibe combination tablet in the European Economic Area and Switzerland. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Approvals not granted to almost 20 drugs There were setbacks too, and not everything rolled smoothly. This year, almost 20 drug approvals were not granted. Among the major setbacks were Bristol Myers Squibb and bluebird bio, Inc announcing that they have received a Refusal to File letter from the FDA regarding the Biologics License Application (BLA) for their CAR-T therapy, idecabtagene vicleucel (ide-cel), for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. Two years after Intarcia Therapeutics received a CRL for its matchstick-sized, long-term drug implant for type 2 diabetes, the FDA issued a second CRL to the company for its ITCA-650 implant. The implant is designed to be a small, osmotic pump which can be slipped under the skin and deliver a continuous, six-month dose of the GLP-1 agonist exenatide. The FDA also did not approve Intercept Pharmaceuticals’ obeticholic acid to treat NASH (or nonalcoholic steatohepatitis, a liver condition in which the buildup of fat progressively scars the organ), as it wasn’t convinced that its benefits outweighed the potential risks. After acquiring Allergan for US$ 63 billion, one of the first drugs which AbbVie was expecting approval for was Abicipar pegol, their experimental DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD). However, FDA’s review indicated the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of wet AMD. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Our view While everyone’s attention is on the Covid-19 pandemic, the industry is certainly busy working towards getting new drugs to market. At the halfway mark, the FDA and EMA seem to be on track to set approval records this year, since the number of drugs approved by June are almost twice the number that were approved at the same time last year. However, it remains to be seen how companies adapt their sales and marketing strategies in a world where mobility is likely to get restricted and interpersonal contact is set to reduce dramatically. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available)

Impressions: 69881

Subscribe

Excel Download

#PharmaFlow by PHARMACOMPASS

23 Jul 2020

Share

Top drugs and pharmaceutical companies of 2019 by revenues

Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues. Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively. Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention. GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion). US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic. Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)

Impressions: 54754

Subscribe

Excel Download

#PharmaFlow by PHARMACOMPASS

29 Apr 2020

Share

Find PharmaFlow Article for Crisaborole

Crisaborole

Crisaborole

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

27 API Suppliers

9 USDMF

4 EU WC

12 NDC API

21 Listed Suppliers

DEVELOPMENTS

2 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

INTERMEDIATES

22 Suppliers

DOSSIERs // Finished Dosage Formulations

4 Dossiers

1 FDA Orange Book

1 Canada

2 South Africa

RELATED EXCIPIENT COMPANIES

Suppliers

5 Kerry

2 BASF

1 Nanjing Well Pharmaceutical

1 Finar

EXCIPIENTS BY APPLICATIONS

5 Co-Processed Excipients

3 Topical

2 Solubilizers

2 Film Formers & Plasticizers

1 Thickeners and Stabilizers

1 Fillers, Diluents & Binders

1 Parenteral

1 Coating Systems & Additives

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions

MARKET PLACE

8 APIs

PATENTS

8 US Patents

1 US Exclusivities

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow

9 News

API SUPPLIERS

API REF. PRICE (USD / KG)

INTERMEDIATES

DOSSIERS // FDF

GLOBAL SALES (USD Million)

EXCIPIENTS

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

REF STANDARD

SERVICES

New Drug Approvals by FDA & EMA (Mid-2020 Recap)

Top drugs and pharmaceutical companies of 2019 by revenues

What are you looking for?