Altaxa

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

50 API Suppliers, 26 USDMF, 15 CEP/COS, 4 JDMF, 13 EU WC, 6 KDMF, 20 NDC API, 27 Listed Suppliers

DEVELOPMENTS

5 Drug(s) in Development

5 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

INTERMEDIATES

5 Suppliers

5 Suppliers

DOSSIERs // Finished Dosage Formulations

333 Dossiers, 96 FDA Orange Book, 164 Europe, 26 Canada, 13 Australia, 19 South Africa, 15 Listed Dossiers

DRUG PRODUCT COMPOSITION

INJECTABLE;SUBCUTANEOUS - EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML), INJECTABLE;SUBCUTANEOUS - EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML), TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE, SYSTEM;IONTOPHORESIS - EQ 6.5MG BASE/4HR, POWDER;NASAL - EQ 11MG BASE, SPRAY;NASAL - 20MG/SPRAY, SPRAY;NASAL - 5MG/SPRAY, TABLET;ORAL - 500MG;EQ 85MG BASE, TABLET;ORAL - 60MG;EQ 10MG BASE, INJECTABLE;SUBCUTANEOUS - EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML), INJECTABLE;SUBCUTANEOUS - EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

INJECTABLE;SUBCUTANEOUS - EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
INJECTABLE;SUBCUTANEOUS - EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
TABLET;ORAL - EQ 100MG BASE
TABLET;ORAL - EQ 25MG BASE
TABLET;ORAL - EQ 50MG BASE
SYSTEM;IONTOPHORESIS - EQ 6.5MG BASE/4HR
POWDER;NASAL - EQ 11MG BASE
SPRAY;NASAL - 20MG/SPRAY
SPRAY;NASAL - 5MG/SPRAY
TABLET;ORAL - 500MG;EQ 85MG BASE
TABLET;ORAL - 60MG;EQ 10MG BASE
INJECTABLE;SUBCUTANEOUS - EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
INJECTABLE;SUBCUTANEOUS - EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

RELATED EXCIPIENT COMPANIES

Suppliers, 1 Actylis, 1 Finar

EXCIPIENTS BY APPLICATIONS

1 Parenteral, 1 Topical

GLOBAL SALES INFORMATION

47 US Medicaid Prescriptions, 130 Finished Drug Prices

MARKET PLACE

11 APIs, 1 DOSSIERS // FDF

PATENTS

49 US Patents, 10 Health Canada Patents

ANALYTICAL SOLUTION(s)

3 EDQM Standards, 3 USP Standards, 5 Other Ref. Standards

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow, 30 News

Blog

Full Screen View

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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#PharmaFlow by PHARMACOMPASS

29 Apr 2020

FDA’s 2016 Approvals of New Drugs, Formulations, Strengths & More

After 2 years of sky-high approval numbers, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research approved 22 novel drugs in 2016, down from the 19-year high of 45 in 2015. The FDA also approved many new dose forms, formulations, combination products and vaccines. This week, PharmaCompass, shares its analysis of the new drug approvals by the FDA in 2016. Reasons behind the low approvals in 2016 Of the 22 novel drugs approved by the FDA, the FDA approved 9 products with orphan designation, in line with the industry’s recent focus on rare diseases. However, as the industry shifts its focus towards biotechnology, only 7 of the novel products approved were biologic applications. The 9 orphan designees approved (41% of all new drug approvals) were significantly lower than the 21 (47%) orphan designees approved in 2015 and 17 (41%) in 2014. FDA’s approval of 4 (18%) oncology drugs in 2016, was also down from the 14 (31%) approvals in 2015, 9 (22%) in 2014 and 9 (33%) in 2013. The reasons for the low 2016 approval count, have been attributed to the agency approving five drugs in 2015 that actually had approval action dates in 2016 and an increase in the number of drugs that the agency rejected. A key reason for the rejections was the sponsors’ failure to comply with good manufacturing practice regulations. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! Gilead’s Epclusa, the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with chronic hepatitis C virus (HCV) infection, is expected to become the most profitable approval of 2016 with expected sales of $ 8.4 billion by 2022. 2016 also saw the FDA’s contentious approval of Exondys 51™ (eteplirsen) under its accelerated approval process. Exondys 51™ treats Duchenne muscular dystrophy (DMD), a rare genetic disease which causes progressive muscle wasting that affects around 20,000 boys and young men in the United States. Approvals of three biosimilars which target $ 33 billion in brand drug sales In a giant leap for the generic pharmaceutical industry, three biosimilar applications were approved in 2016 that target brand drugs which generated more than $ 33 billion in sales last year. All the three biosimilars approved were tumor-necrosis factor alpha (TNF α) inhibitors used to manage inflammatory conditions. Pfizer and Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade® (2016 sales - $ 8.8 billion), was the first to get approval for all Remicade-approved indications, except pediatric ulcerative colitis. Inflectra was launched at risk in November 2016. After Inflectra’s approval, the FDA approved Sandoz’s Erelzi, a biosimilar to Enbrel® (etanercept – Amgen, 2016 sales - $ 9.1 billion). On Sept. 23, 2016, Amgen’s Amjevita™ (adalimumab – atto), a biosimilar of the world’s best-selling drug by revenue, AbbVie’s Humira®(2016 sales - $ 16.4 billion), was also approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! Kim Kardashian’s pregnancy drug is now available in a new strength Diclegis, a combination of an antihistamine (doxylamine succinate) and a form of vitamin B6 (pyridoxine HCl), made headlines when the FDA issued a warning letter for the social media promotion of the drug by Kim Kardashain, star of the reality show ‘Keeping Up With The Kardashians’ Duchesnay, the company which produces Diclegis, got approval for Bonjesta which combines twice the amount of doxylamine and pyridoxine when compared with Diclegis which contains 10mg of each ingredient. Indian generic companies get approvals for differentiated products As the generic industry in the U.S. continues to face severe pricing pressure, Indian generic companies are attempting to overcome these challenges by trying to move up the value chain by supplying differentiated generic products. Consistent with this strategy, the applications of Sun Pharmaceuticals for a new ophthalmic version of Bromfenac (Bromsite) and Dr. Reddy’s Laboratory for an injectable version of Sumatriptan (Zembrace™ SymTouch) to treat migraines were also approved. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! Pfizer launches an opioid treatment with abuse-deterrent properties The abuse of opioids, including prescription painkillers and drugs like heroin, is something the United States has struggled with since before the 1900s. Last year, the FDA announced that immediate-release opioid painkillers such as oxycodone and fentanyl will have to carry a "black box" warning about the risk of abuse, addiction, overdose and death. Pfizer got approval last year for Troxyca ER a combination containing oxycodone and naltrexone. Troxyca ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. In it, the oxycodone releases slowly over several hours. If the capsules are crushed, the encased naltrexone mixes with oxycodone, essentially cancelling any euphoric effects. Pfizer also received approval for an extended release form of Tofacitinib (Xeljanz® XR) to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! A dietary supplement gets approved along with new forms of commonly used drugs In 2016, Endoceutics got Intarosa, a once-daily vaginal insert, approved which is the first FDA approved product to contain prasterone, also known as dehydroepiandrosterone (DHEA). Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease. Lisinopril, the most commonly used drug by U.S. Medicare patients, was approved as an Oral Solution for the first time. Diabetes treatments, one of the most commonly prescribed drug categories in the U.S., saw the addition of Sanofi and Novo Nordisk’s fixed-dose, long-acting insulin and glucagon-like peptide 1 (GLP-1) agonist combinations to the list of options available to treat adult type-2 diabetes. Our View The approval of new drugs ensures that the world has access to improved healthcare solutions and breakthrough medical therapies. With Donald Trump “focused on accelerating the FDA” and an on-going argument that drugs should not have to be proven effective before getting approved, this year looks like the one where the new drug approval scenario will be shaken up for time to come. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!

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#PharmaFlow by PHARMACOMPASS

09 Feb 2017

Find PharmaFlow Article for Altaxa

Altaxa

Altaxa

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

50 API Suppliers

26 USDMF

15 CEP/COS

4 JDMF

13 EU WC

6 KDMF

20 NDC API

27 Listed Suppliers

DEVELOPMENTS

5 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

5 Suppliers

DOSSIERs // Finished Dosage Formulations

333 Dossiers

96 FDA Orange Book

164 Europe

26 Canada

13 Australia

19 South Africa

15 Listed Dossiers

DRUG PRODUCT COMPOSITION

INJECTABLE;SUBCUTANEOUS - EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

INJECTABLE;SUBCUTANEOUS - EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

TABLET;ORAL - EQ 100MG BASE

TABLET;ORAL - EQ 25MG BASE

TABLET;ORAL - EQ 50MG BASE

SYSTEM;IONTOPHORESIS - EQ 6.5MG BASE/4HR

POWDER;NASAL - EQ 11MG BASE

SPRAY;NASAL - 20MG/SPRAY

SPRAY;NASAL - 5MG/SPRAY

TABLET;ORAL - 500MG;EQ 85MG BASE

TABLET;ORAL - 60MG;EQ 10MG BASE

INJECTABLE;SUBCUTANEOUS - EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

INJECTABLE;SUBCUTANEOUS - EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

RELATED EXCIPIENT COMPANIES

Suppliers

1 Actylis

1 Finar

EXCIPIENTS BY APPLICATIONS

1 Parenteral

1 Topical

GLOBAL SALES INFORMATION

47 US Medicaid Prescriptions

130 Finished Drug Prices

MARKET PLACE

11 APIs

1 DOSSIERS // FDF

PATENTS

49 US Patents

10 Health Canada Patents

ANALYTICAL SOLUTION(s)

3 EDQM Standards

3 USP Standards

5 Other Ref. Standards

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow

30 News

API SUPPLIERS

API REF. PRICE (USD / KG)

INTERMEDIATES

DOSSIERS // FDF

GLOBAL SALES (USD Million)

EXCIPIENTS

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

REF STANDARD

SERVICES

Top drugs and pharmaceutical companies of 2019 by revenues