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DMF submissions in 2020: Industry sustains its filing momentum

In case you thought Covid-19 had slowed down the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA), you are in for a pleasant surprise. During the first half of this year, the industry maintained its momentum of filing DMFs with the FDA. In the first six months of this year, FDA received 283 DMF submissions (against 616 for the full year of 2019). Expectedly, India continued to lead with 155 DMF filings. Submissions from India were more than double the amount of those made by Chinese (45) and American firms (30) combined. This trend has been witnessed for some time now. In 2019, out of the 616 active DMF submissions to the FDA, Indian companies had submitted more than half (331), though the submissions from India were a little less than double of those made by Chinese and American firms. Drug master files (DMFs) are submissions made to the FDA by manufacturers who provide the agency with confidential, detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing of human drug products.View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available) India’s MSN Labs leads total count of DMF filings As in the past, India’s MSN Laboratories continued to lead the DMF filings by a single company with 40 submissions, followed by Dr Reddy’s (8) and Metrochem API (7). MSN has always been a pioneer in being the first to file a DMF for new products. This year was no different. The firm submitted the first DMF for 11 products — Abaloparatide, Abemaciclib, Amifampridine Phosphate, Betrixaban Maleate, Fenfluramine Hydrochloride, Lofexidine Hydrochloride, Neratinib Maleate, Ozenoxacin, Rolapitant Hydrochloride, Tafamidis, Valbenazine Tosylate. There were also first DMF filings by AMRI (Brexanolone), Formosa Laboratories (Elagolix Sodium), Glenmark Life Sciences (Solriamfetol Hydrochloride) and Hikal (Ertugliflozin L-Pyroglutamic Acid). The API DMF is part of the final generic drug product submission to the FDA. Therefore, the owner of a DMF incurs a one-time fee, the first time the generic drug submission references that DMF. DMF holders may also pay the fee in advance in order to have their DMF subjected to an initial completeness assessment by the FDA. This would allow their DMF to be included on a publicly available list of DMFs that have paid their fee and have not failed the initial completeness assessment. View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available) Assessment review of only 62 DMFs completed by the FDA While 283 DMFs were submitted to the FDA, only 22 percent of them — or 62 DMFs — have had their assessment review completed by the FDA so far. The GDUFA fee associated with a DMF assessment review for the current fiscal year is US$ 57,795. It has been revised upward to US$ 69,921 (an increase of US$ 12,126) for the upcoming fiscal year, which starts in October. Although MSN led in the number of DMF filings, it had no assessments completed for its DMF submissions in the first half of the year. Three Indian companies, Aurobindo, Honour Lab and Intas, and one Chinese company, Jiangsu Hengrui, led in the maximum (three each) number of assessments completed by the FDA. The products with the most commonly filed DMFs were Brivaracetam, Cetrorelix, Edaravone and Lifitegrast, with four submissions each. DMF filings also help provide insights into some of the new drug approvals that can be expected in the future. In the first half of the year, we witnessed submissions for Dapoxetine Hydrochloride (MSN), Fasoracetam (MSN), Indoximod (MSN), Resiniferatoxin (Indena), Omidenepag Isopropyl (UBE Industries), Treosulphan (Fermion), Roxadustat (Dr Reddy’s), Bexagliflozin (Piramal), Antazoline Phosphate (Metrochem) and Dyphylline (Shanghai Wonder) which are all products that have currently not been approved by the FDA and could potentially be approved in the future.View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available) Our view The Covid crisis and the surging demand for APIs like hydroxychloroquine, favipiravir and dexamethasone has revealed the global dependence on India and China for APIs. India, a prominent API manufacturer, admitted to its extreme dependence on China for APIs and intermediates when it shared a list of products which included antibiotics, vitamins, hormones and even commonly used medicines like aspirin and paracetamol. In July this year, India announced the guidelines for its schemes for the development of bulk drugs and medical device parks across the country. These schemes are part of India’s self-reliance campaign. Similar reshoring initiatives have been announced by the United States, France and Japan, and many other countries also want to reduce their reliance on China. While shifting supply chains is certainly a long drawn out process, the wheels have definitely started to turn. It remains to be seen what impact these initiatives will have on the DMF filings with the FDA in the next few quarters. View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available)

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03 Sep 2020

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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)

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29 Apr 2020

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Does the FDA promote European manufacturers over others? The ice-bucket challenge winner!

This week, Phispers brings you a short analysis on how FDA might be promoting European drugmakers over others. There is also news on how India plans to set up a drug audit office in China to check quality of APIs coming from there. Besides, there is news on lawsuits against J&J, a report on drug spends in the US and updates on new drug trials and approvals. Does the FDA promote European manufacturers over others? Does the US regulator have more faith on European manufacturers over those based in India and China? Recent news reports seem to suggest it does. Thomas Cosgrove, the Director of the Office of Manufacturing Quality (OMQ) within US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) spoke at the Food and Drug Law Institute's annual conference last week. Cosgrove directs CDER’s compliance activities with respect to current good manufacturing practice (cGMP) and product quality. In the coverage provided by RAPS, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers. “If any firm in the supply chain falls down, the supply chain itself can fall down. This is a very real risk," Cosgrove said, noting that the agency can reject applications for drugs over good manufacturing practice (GMP) issues. He further said: “You're pretty confident that those European companies you're dealing with have a strong culture of quality and can perform pretty consistently," But, like in other parts of the world, these companies might not have a deep experience with how the US regulations work or even how to deal with the FDA, and may not have been inspected by the agency before, he added. Cosgrove’s comments come at a time when a compilation by Barbara Unger on FDAZilla.com highlighted that the warning letters issued due to data-integrity concerns to firms in US and Europe (13 total) were more than those issued to firms in India (9) and almost equivalent to firms in China (14). There have also been other examples where inspection data highlights a difference in inspection outcomes for the same facilities. PharmaCompass had recently covered the US and EU’s efforts to utilize each other’s GMP inspections, and how such a dependence maybe problematic. While FDA has stepped up its inspections of foreign drug manufacturers in recent years, there are more than 1,000 foreign drug facilities the agency has never inspected. India to restart inspection of Chinese API manufacturers India is cracking the whip on quality and will restart inspecting drug manufacturing facilities in China soon, in order to ensure only quality active pharmaceutical ingredients (API) are imported from countries like China. “In the light of the fact that India has faced repeated scrutiny of its manufacturing facilities in the name of quality medicines, the commerce ministry along with other concerned ministries are serious to set up a permanent audit office in China to conduct inspections on a regular basis in China,” G N Singh, Drug Controller General of India, said. The plan to set up a drug audit office in China for inspecting manufacturing units there is not new. It has been in the pipeline for the past three years, as the project is awaiting approval from several ministries in both India and China. India’s health ministry is also in the final stages to release a draft guideline towards enhancement of GMP to align India-specific standards with global regulations for better product quality of pharmaceutical products. The ice-bucket challenge winner! First new treatment approved by the FDA for ALS in 22 years Last week, the US FDA approved Radicava (edaravone) — a drug to treat patients with the rare amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease. ALS is a progressive disease that attacks and kills the nerve cells that control voluntary muscles. Eventually, the brain’s ability to start and control voluntary movement is lost, and the patient succumbs to the disease — usually after three to five years from the onset of the symptoms. Around 12,000-15,000 Americans are said to have ALS. Most people with ALS die from respiratory failure. British physicist Stephen Hawking is suffering from ALS. An “ice bucket challenge” conducted in 2014 drew global attention back to ALS. The challenge involved people pouring ice-cold water over each other’s heads, and posting a video on social media, seeking funds for research on the condition. Edaravone is an intravenous drug. The drug is being sold in Japan and South Korea by Mitsubishi Tanabe Pharma Corp. The company is selling the drug at US$ 145,000 per year. In the US, the last drug approved to treat this disease was Riluzole in 1995. However, the drug isn’t a cure for ALS, it only delayed the need for a breathing tube. Six months of treatment with edaravone reportedly reduced the rate of functional decline in patients by about a third. Another bad week for Teva — its new MS drug fails to meet primary endpoint Teva’s bad days don’t seem to relent. Last week, it’s late-stage trial for laquinimod — considered a successor to the aging flagship multiple sclerosis therapy Copaxone — failed the test on the relapsing-remitting form of the disease. The drug did not meet the primary endpoint, trying to significantly improve the time to disability progression compared to placebo after three months. Teva’s laquinimod was heralded as its brightest pipeline prospect. Investigators are still testing this drug for primary progressive MS and Huntington’s disease. But due to this failure, it’s unlikely that analysts will ascribe much potential value to the drug. Early last year, Teva (which had partnered with Active Biotech) was forced to suspend use of the highest dose of laquinimod due to cardio side effects. Despite this setback, Teva was hopeful of a win with the lower doses and was preparing for a launch after completing studies this year. Trump administration gets FDA to switch TVs from CNN to Fox News The Trump administration is ensuring researchers at FDA view the media of its choice. This week, CBS News confirmed an email was sent to researchers at the FDA's Center for Biologics Evaluation and Research to change the channel on internal television screens from CNN to Fox News. CNN and Donald Trump have been feuding for several months now. On May 2, CNN had refused to air an advertisement issued on 100 days of Trump administration, that called mainstream media “fake news” — a term frequently used by the president. The email from “[White Oak] Digital Display” sent on Wednesday, May 3, was sent to inform the researchers of the “reason for the change from CNN to Fox". White Oak is the name of the FDA’s campus. The email informs employees that the decision came from the Trump administration. “The reason for the change is that a decision from the current administration, administrative officials has requested that all monitors, under our control, on the White Oak Campus, display FOX news,” the email reads. People are paying less for drugs, says IMS Quintiles report While there is widespread outrage in the US over soaring drug prices, a new study by QuintilesIMS Institute shows people are, on an average, actually paying less for their medications than they did a few years ago. QuintilesIMS Institute is a research organization that specializes in healthcare analysis. The report is independent, and did not receive industry funding. While drug prices are on the rise with net prices rising 3.5 percent last year, patients’ out-of-pocket costs for medicines have declined — from US$ 32 per name-brand prescription in 2013 to US$ 28 today, the study said. “The outlook for medicine spending through 2020 is for mid-single digit growth driven by further clusters of innovative treatments, offset by a rising impact from brands facing generic or biosimilar competition,” says a QuintilesIMS report titled ‘Medicines Use and Spending in the U.S. – A Review of 2015 and Outlook to 2020’. However, this isn’t the only report that shows this counterintuitive pattern of declining out-of-pocket costs. A Peterson-Kaiser Health System Tracker report last year found a slight decline in patients' personal spending on prescriptions, even as the overall costs increased. Mixed week for J&J, as it loses talc verdict and wins Xarelto case Last week was a mixed week for Johnson & Johnson (J&J). On the one hand, the St. Louis jury ordered Johnson & Johnson to pay US$ 110 million to Lois Slemp, a lady who claimed several decades of using talc products caused her ovarian cancer that later spread to her liver. On the other hand, J&J won a bellwether case last week over the alleged risks of its blockbuster drug, Xarelto. The Slemp trial lasted several weeks and had Slemp’s attorneys call upon scientists to testify studies documenting a link between ovarian cancer and talc use. Slemp’s attorneys also presented documents showing that J&J knew about the risks. J&J, however, said it will appeal against the verdict. A company spokesperson said a previous victory (for J&J) in St. Louis and two in New Jersey “highlight the lack of credible scientific evidence behind plaintiffs’ allegations." In the other case, a US court (the federal jury in New Orleans) cleared Bayer AG and J&J of liability in the first trial emanating from thousands of lawsuits that blamed injuries on the blood thinner Xarelto. “The jury's verdict affirms both the safety and efficacy of Xarelto, and that its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine,” Bayer said in a statement. Rivaroxaban's total 2016 sales were $ 5.392 billion.

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11 May 2017

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Find PharmaFlow Article for AM20060748

AM20060748

AM20060748

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

29 API Suppliers

10 USDMF

6 JDMF

5 EU WC

1 KDMF

11 NDC API

19 Listed Suppliers

DEVELOPMENTS

23 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

DOSSIERs // Finished Dosage Formulations

13 Dossiers

5 FDA Orange Book

2 Canada

6 Listed Dossiers

RELATED EXCIPIENT COMPANIES

Suppliers

2 Actylis

1 DKSH

EXCIPIENTS BY APPLICATIONS

3 Parenteral

1 Topical

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions

MARKET PLACE

12 APIs

1 DOSSIERS // FDF

PATENTS

4 US Patents

3 US Exclusivities

ANALYTICAL SOLUTION(s)

7 Other Ref. Standards

DIGITAL CONTENT

3 Data Compilations & Company Tracker #PharmaFlow

55 News

API SUPPLIERS

API REF. PRICE (USD / KG)

INTERMEDIATES

DOSSIERS // FDF

GLOBAL SALES (USD Million)

EXCIPIENTS

PATENTS & EXCLUSIVITIES

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DMF submissions in 2020: Industry sustains its filing momentum

Top drugs and pharmaceutical companies of 2019 by revenues

Does the FDA promote European manufacturers over others? The ice-bucket challenge winner!

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