Cabazitaxel
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: 54808

https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

#PharmaFlow by PHARMACOMPASS
29 Apr 2020
Dr. Reddy’s expansion plans for API production
Unrelated to the inspection of the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment, Forests & Climate Change to expand their drug and intermediate manufacturing at three locations. All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were   Existing Capacity Planned Capacity Anticipated Investment CTO I 14.7 TPM 45.5 TPM Rs 30 crores CTO II 21.9 TPM 68.9 TPM Rs 45 crores CTO - III 4.45 TPM 28.1 TPM Rs 12 crores  *$1 million is approximately about Rs 6.2 crores & TPM is tons per month In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below). Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.   Table Dr. Reddys production plans at various facilities Product Name Planned Capacity (TPM) Facility Location Alendronate Sodium Trihydrate 6.67 CTO - III Alfuzosin 2.33 CTO - I Altretamine 0.03 CTO - I Amlodipine Besylate 33.33 CTO - II Amlodipine Besylate 133.33 CTO - III Amlodipine Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2) 100 CTO - II Amlodipine Maleate 30 CTO - III Amsacrine 0.07 CTO - I Anastrazole 0.83 CTO - II Aprepitant 3.33 CTO - III Aripiprazole 0.33 CTO - II Atomoxetine 1.67 CTO - III Atorvastatin  375.83 CTO - II Azacitidine 0.67 CTO - I Bicalutamide 0.03 CTO - II Bivalirudin 0.03 CTO - II Bivalirudin Trifluoro Acetate 0.03 CTO - I Bortezomib 0.03 CTO - I Cabazitaxel 0.02 CTO - I Candesartan cilexetil 6.67 CTO - II Cetirizine Hydrochloride 66.67 CTO - I  Cetirizine 16.67 CTO - II Ciprofloxacin 176.67 CTO - II Ciprofloxacin HCl  533.33 CTO - II Ciprofloxacin Lactate 33.33 CTO - II Clopidogrel Bisulfate 500 CTO - I Clopidogrel Premix 166.67 CTO - II Diluted Everolimus 5% (Everolimus) 0.33 CTO - II Disodium Pamidronate 0.33 CTO - III Docetaxel 1.9 CTO - I Dutasteride 3.33 CTO - II Esomeprazole magnesium 66.67 CTO - III Ezetimibe 3.33 CTO - II Fexofenadine Hydrochloride  500 CTO - I Finasteride 10 CTO - II Fluoxetine 110 CTO - I Fondaparinux Sodium 0.33 CTO - II Galantamine 0.03 CTO - II Gemcitabine 13.33 CTO - I Glimepiride 13.33 CTO - II Imatinib 0.17 CTO - I Irinotecan 0.33 CTO - I Ketorolac 66.67 CTO - II Lacidipine 5 CTO - III Lamotrigine 33.33 CTO - I Lansoprozole 8.33 CTO - III Letrozole 0.03 CTO - II Levocetrizine Di HCl 10 CTO - III Levofloxacin 200 CTO - II Lomustine 1.33 CTO - I Losartan Postassium 150 CTO - I Meloxicam 0.03 CTO - I Memantine HCl 3.33 CTO - II Mesalamine 0.03 CTO - II Metoprolol Succinate 266.67 CTO - II Moxifloxacin 116.67 CTO - II Norfloxacin  0.03 CTO - I Omeprazole 133.33 CTO - III Omeprazole Magnesium 50 CTO - III Omeprazole Sodium 10 CTO - III Omerprazole Form B 33.33 CTO - III Paclitaxel 0.33 CTO - I Pantoprazole Sodium 100 CTO - III paroxetine HCl 0.03 CTO - II Pemetrexed 0.67 CTO - I Rabeprazole Sodium 83.33 CTO - III Raloxifene 33.33 CTO - II Ramipril 100 CTO - III Repaglinide 6.67 CTO - II Rivastigmine 6.67 CTO - II Risperidone 13.33 CTO - I Rivastigmine 6.667 CTO - I Rizatriptan Benzoate 1.33 CTO - II Rocuronium Bromide 0.03 CTO - II Ropinrole HCl 1.83 CTO - III Rosiglitazone 3.33 CTO - II Sparfloxacin 3.33 CTO - I Tacrolimus 5 CTO - II Tadalafil 3.33 CTO - II Telmisartan 100 CTO - II Temozolamide 0.03 CTO - I Terbinafine HCl 133.33 CTO - III Tizanidine HCl 16.67 CTO - III Topotecan 0.07 CTO - I valganciclovir 0.03 CTO - I Vardenafil 3.33 CTO - II Voriconazole 8.33 CTO - III Ziprasidone Hydrochloride 100 CTO - I Zoledronic acid 0.33 CTO - III Zolmitriptan 0.83 CTO - I Zonisamide 0.03 CTO - II

Impressions: 3098

https://www.pharmacompass.com/radio-compass-blog/dr-reddy-s-expansion-plans-for-api-production

#PharmaFlow by PHARMACOMPASS
03 Apr 2015
Cabazitaxel –The Market Overcrowding Begins
Many companies have been actively developing Cabazitaxel (Jevtana Kit®), a prostate cancer drug that belongs to the same class of molecules as off-patent blockbusters Paclitaxel (Taxol®) and Docetaxel (Taxotere®). Sanofi, the originator, has been struggling with sales of this molecule, as it has never lived up to its blockbuster expectations, with lackluster global sales of 273 million euros in 2014. The major part of the sales, 142 million euros, have been in Europe, where sales showed an increase of 28.2% over the previous year. Sales last year in the United States, on the other hand, grew only 5.8% and were 91 million euros.  Lately, Sanofi received notice when Breckenridge Pharmaceutical, Inc., announced Paragraph IV ANDA litigation (1st generic filing) for Cabazitaxel. The first generic challenge followed the National Health Services’ (NHS) decision in the UK to remove the drug from the Cancer Drugs Fund approved list of medicines, because of its poor cost-effectiveness. Cabazitaxel, most often used after Docetaxel treatment (against cancers) has failed, has been priced at about $5,500 per treatment cycle, which is almost twice the cost of Docetaxel.  With almost 9 companies having filed USDMFs for the different polymorphs of Cabazitaxel and significant development activity on this product in India, as shown by the import-export trade data, it remains to be seen if the investment will provide the anticipated returns, since Sanofi definitely does not seem to be having the same experience.  

Impressions: 6099

https://www.pharmacompass.com/radio-compass-blog/cabazitaxel-the-market-overcrowding-begins

#PharmaFlow by PHARMACOMPASS
11 Mar 2015