Seqens Seqens

X
menu

    Market Place

    Market Place

    Post Enquiry

    Post Enquiry
    menu

    Find PharmaFlow Article for Ezetimibe

    Client Email Product

    Ezetimibe

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    DOSSIERs // Finished Dosage Formulations

    DRUG PRODUCT COMPOSITION

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS

    ANALYTICAL SOLUTION(s)

    DIGITAL CONTENT

    PharmaCompass
    Related ProductsRelated Products
    API SUPPLIERS
    API Suppliers

    API Suppliers

    75
    US DMFs Filed

    US DMFs Filed

    28
    CEP/COS Certifications

    CEP/COS Certifications

    0

    JDMFs Filed

    JDMFs Filed

    10
    Other Certificates

    Other Certificates

    15
    Other Suppliers

    Other Suppliers

    51
    API REF. PRICE (USD / KG)
    1,374

    API Market Place

    16
    INTERMEDIATES
    26
    DOSSIERS // FDF
    USA (Orange Book)

    USA (Orange Book)

    61
    Europe

    Europe

    76
    Canada

    Canada

    20
    Australia

    Australia

    45
    South Africa

    South Africa

    30
    Uploaded Dossiers

    Uploaded Dossiers

    98
    GLOBAL SALES (USD Million)

    U.S. Medicaid

    7,353.00

    Annual Reports

    2,115.00

    FDF Market Place

    5
    EXCIPIENTS
    219
    PATENTS & EXCLUSIVITIES

    USFDA Orange Book Patents

    16

    USFDA Exclusivities

    1
    DIGITAL CONTENT

    Blog #PharmaFlow

    8

    News

    106
    REF STANDARD

    EDQM

    0

    USP

    2

    JP

    0

    Other Listed Suppliers

    2
    SERVICES
    6
    left grey arrow
    right gray arrow
    • TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - 10MG
    • TABLET;ORAL - 10MG;10MG
    • TABLET;ORAL - 10MG;20MG
    • TABLET;ORAL - 10MG;40MG
    • TABLET;ORAL - 10MG;80MG
    BlogBlog
    Full View ScreenFull Screen View
    Top drugs and pharmaceutical companies of 2019 by revenues

    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: 54752

    subscribeSubscribe
    ExcelExcel Download

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

    #PharmaFlow by PHARMACOMPASS
    29 Apr 2020
    Share Share
    Top drugs by sales in 2017: Who sold the blockbuster drugs?

    Top drugs by sales in 2017: Who sold the blockbuster drugs?

    The year 2017 was a landmark year for pharmaceutical industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies. The US Food and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency (EMA) approved 35 drugs with a new active substance, up from 27 in 2016. Sales for most major pharmaceutical companies continued to grow in 2017. Earnings forecasts for 2018 have been raised due to the recent US tax reform that has generated investor hopes for accelerated dividend growth and share buyback plans. This week, PharmaCompass brings you a compilation of the top drugs of 2017 by sales revenue. Click here to Access All the 2017 Data (Excel version available) for FREE! Top-sellers: Humira races ahead, despite launch of biosimilars; Enbrel a distant second   There wasn’t any upheaval at the top of the pharma drug sales charts. AbbVie’s anti-TNF (tumor necrosis factor) giant Humira (adalimumab), which is approved to treat psoriasis and rheumatoid arthritis, added almost another US $3 billion to its 2016 sales and posted nearly US $19 billion in revenues. Last year, AbbVie’s raised expectations for Humira’s earnings to reach US $21 billion in global sales by 2020. The company believes this drug will continue to be a significant cash contributor until 2025 and the US $21 billion sales forecast by 2020 is about US $3 billion higher than its expectation two years ago. In 2016, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita (adalimumab-atto) — a biosimilar of Humira. And in 2017, another Humira biosimilar — Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) — received approval from the FDA and European authorities.  Click here to Access All the 2017 Data (Excel version available) for FREE! Enbrel (etanercept), the longest-used biologic medicine for the treatment of rheumatism around the world, was the second best-selling drug with US $8.262 billion in 2017 sales. The sales of the drug were down from US $9.366 billion in 2016 owing to lower selling prices and increased competition, which in turn hurt demand.  Since it was first approved in the United States in 1998, Enbrel has been approved in over 100 countries and the drug is promoted by Amgen, Pfizer and Takeda in different geographies. Novartis’ biosimilar copy of Enbrel, which got approved by the FDA in August 2016 for the treatment of patients with rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS) and other diseases is still not on the market because of a patent-protection challenge from Amgen. Amgen is arguing in the US federal court that its drug has patent protection until 2029. Click here to Access All the 2017 Data (Excel version available) for FREE! Fast-growing drugs: Eylea and Revlimid bring fortunes for Regeneron and Celgene   Regeneron’s flagship eye treatment, Eylea (aflibercept) which is marketed by Bayer outside the United States, added another US $1 billion in annual sales last year to record US $8.260 billion in total sales. Eylea net sales grew 11 percent year-on-year in the US and 19 percent year-over-year outside the US. The company believes much of the recent growth in the US was driven by demographic trends with an aging population as well as an overall increase in the prevalence of diabetes. These demographic trends are expected to continue in the coming years, providing an opportunity for continued growth. Eylea sales alone contribute 63 percent to Regeneron’s total sales.  Click here to Access All the 2017 Data (Excel version available) for FREE! Celgene’s Revlimid (lenalidomide) — a thalidomide derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in an additional US $1.2 billion in 2017 sales and had total revenues of US $8.187 billion.  Revlimid continues to contribute more than 60 percent to the company’s total sales of US $13 billion. Celgene received a setback this month as the USFDA refused to consider Celgene’s application for ozanimod, an experimental treatment for relapsing multiple sclerosis. The treatment was being seen as a key to the company’s fortunes as Celgene had said ozanimod is worth US $4 billion to US $6 billion a year in peak sales. Click here to Access All the 2017 Data (Excel version available) for FREE! Gilead’s Hepatitis C franchise enters free fall   Gilead Sciences’ blockbuster hepatitis C drugs franchise that includes Sovaldi and Harvoni continue to feel the competitive heat as they registered US $9.137 billion in 2017 sales, down from US $14.834 billion the previous year. While reporting 2017 results, Gilead provided guidance for 2018 and said its sales of Hepatitis C drugs could fall further to US $3.5 billion - US $4 billion. At their peak in 2015, Gilead’s Sovaldi and Harvoni had together generated US $19.1 billion in sales. One of the major reasons for this drop is AbbVie’s launch of its new treatment Mavyret at a deep price discount to the competition. AbbVie also claims to have the shortest treatment course at eight weeks, compared with 12 weeks or longer for other treatments.  AbbVie reported US $1.274 billion in Hepatitis C drug sales in 2017, down from US $1.522 billion in 2016. Click here to Access All the 2017 Data (Excel version available) for FREE! Novartis’ Gleevec, Merck’s cardiovascular drugs, GSK’s Advair face generic heat   Novartis’ Gleevec (imatinib), which had at one point become the best-selling drug for Novartis and had brought in US $3.323 billion for the company in 2016, started facing generic competition last year and the anti-cancer drug lost US $1.380 billion in sales to bring in ‘only’ US $1.943 billion last year.  The US patents of  Merck’s cardiovascular drugs — Zetia (Ezetimibe) and Vytorin (Ezetimibe and Simvastatin) — expired in April 2017. In May 2010, Merck and Glenmark Pharmaceuticals entered into an agreement that allowed Glenmark to launch a generic version of Zetia in late 2016. The drugs that had combined sales of US $3.701 billion in 2016 felt the generic heat in 2017 and the sales were US $1.606 billion lower at US $2.095 billion. Click here to Access All the 2017 Data (Excel version available) for FREE! GSK’s Advair, which was expected to encounter generic competition in 2017, continued to breathe easy as the FDA found deficiencies in the applications of Hikma, Mylan and Sandoz. All three failed to get the FDA nod for their generic versions of Advair, a drug used in the management of asthma and chronic obstructive pulmonary disease that generated sales worth US $4.431 billion (£3.130 billion) in 2017.  Top 15 drugs by sales   Here is PharmaCompass’ compilation of the best-selling drugs of 2017. This is based on information extracted from annual reports and US Securities and Exchange Commission (SEC) filings of major pharmaceutical companies. If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version. Click here to access all the 2017 data (Excel version available) for FREE! S. No. Company / Companies Product Name Active Ingredient Main Therapeutic Indication 2017 Revenue in Millions (USD) 1 AbbVie Inc., Eisai Humira® Adalimumab Immunology (Organ Transplant, Arthritis etc.) 18,946 2 Amgen, Pfizer Inc., Takeda Enbrel® Etanercept Immunology (Organ Transplant, Arthritis etc.) 8,262 3 Regeneron, Bayer Eylea Aflibercept Ophthalmology 8,260 4 Celgene Revlimid Lenalidomide Oncology 8,187 5 Roche MabThera®/Rituxan® Rituximab   Oncology 7,831 6 Johnson & Johnson, Merck, Mitsubishi Tanabe Remicade®  Infliximab Autoimmune Disorders 7,784 7 Roche Herceptin® Trastuzumab Oncology 7,435 8 Bristol-Myers Squibb, Pfizer Inc. Eliquis®  Apixaban Cardiovascular Diseases 7,395 9 Roche Avastin®  Bevacizumab Oncology 7,089 10 Bayer, Johnson & Johnson XareltoTM Rivaroxaban Cardiovascular Diseases 6,590 11 Bristol Myers Squibb, Ono Pharmaceutical Opdivo Nivolumab Oncology 5,815 12 Sanofi Lantus Insulin Glargine Diabetes 5,731 13 Pfizer Inc. Prevnar 13/Prevenar 13 Pneumococcal 7-Valent Conjugate Anti-bacterial 5,601 14 Pfizer Inc., Eisai Lyrica Pregabalin Neurological/Mental Disorders 5,318 15 Amgen, Kyowa Hakko Kirin Neulasta® Pegfilgrastim Blood Disorders 4,553 Sign up, stay ahead In order to stay informed, and receive industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to Access All the 2017 Data (Excel version available) for FREE!  

    Impressions: 58407

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2017-who-sold-the-blockbuster-drugs

    #PharmaFlow by PHARMACOMPASS
    29 Mar 2018
    Share Share
    Teva to sell assets to reduce debt, lay-off 7,000 workers; Shkreli awaits sentence

    Teva to sell assets to reduce debt, lay-off 7,000 workers; Shkreli awaits sentence

    This week in Phispers, we look at the growing troubles at Teva. The company plans to divest non-core assets to reduce debt and lay-off 7,000 workers. The FDA approved AbbVie’s Mavyret, a drug that poses considerable challenge to Gilead’s Harvoni and Sovaldi. Meanwhile, Martin Shkreli was found guilty in three out of eight charges; diabetes drug exenatide showed benefit to Parkinson’s disease patients in a study; and in the US, the Senate passed key FDA funding bill.   Teva in dire straits: To lay off 7,000 workers, to sell non-core assets to repay debt   Teva has been in trouble for quite sometime now. It’s a classic case of a company taking on more debt to spur growth. But it’s fallen into hard times, as three CEOs changed guard this decade. Last week, the world’s largest manufacturer of generic medicines said it would divest non-core assets to shed a part of its US$ 35 billion debt load. While debt may be historically cheap, it still has to be repaid. And if revenues don’t keep up with payments, the downfall can be rapid for Teva.  Teva had taken on the debt in order to dominate all facets of generic drugs, including a US$ 40.5 billion acquisition of Allergan’s generics business last year. The Allergan deal added more pressure on drug prices and margins. Teva also slashed its earnings goals for the second time this year. It warned investors it may have to renegotiate some debt agreements if cash flow worsens. Teva reduced its dividend by 75 percent. The company also mentioned that it is in the process of laying off 7,000 workers. Greater competition in the generic drug business due to increased approvals (of generic drugs) by the US Food and Drug Administration (USFDA) has led to poor results, the company said. The continued deterioration of its business environment in Venezuela has made matters worse. The plight of Teva has been worsened due to the leadership crisis — the company has been without a CEO and a CFO for months. Activist shareholder Benny Landa blamed acting CEO Yitzhak Peterburg and the board of directors for leading Teva to disaster. Landa said what is happening in the company is no less than a catastrophe. “I've been saying this for three or four years: the company board of directors is incapable of making big decisions and getting the company back on track,” he said. Price-gouging Shkreli awaits sentence; found guilty on three out of eight charges    Martin Shkreli — the co-founder of Elea Capital, MSMB Capital, Retrophin and the former CEO of Turing Pharmaceuticals who is more famous for price gouging and for defrauding investors — could spend years in prison due to last week’s investor fraud conviction if the judge focuses on the intended impact of his crime and on his antics on the social media, say legal experts. Back in 2015, Shkreli had raised the price of an infection treatment by 5,000 percent to avoid prison due to an unusual twist to his case — defrauded investors suffered no loss from his crime. That could work in Shkreli’s favor, because investor harm is the main factor in determining a sentence for securities fraud in the US. However, a report quotes a law enforcement source as saying that prosecutors will challenge Shkreli's underlying assumption of how to calculate the losses of investors. While Shkreli was convicted on three securities fraud and conspiracy counts, he was acquitted of other charges, including the charge that he conspired to steal US$ 11 million in assets from Retrophin. What’s caught the public eye though is Shkreli’s social media antics. Hours after his conviction, Shkreli declared the mixed verdict by the federal jury on YouTube as an “astounding victory.”  Without showing any sign of remorse, 34-year old Shkreli said: “I’m one of the richest New Yorkers there is, and after today's outcome it's going to stay that way.” According to lawyers, such a conduct on social media could backfire at the time of sentencing. “He lacked any remorse, and the judge may avoid appearing lenient when she sentences him,” James Cox, a law professor at Duke University, said. Diabetes drug exenatide could stop the progress of Parkinson’s disease      In future, clinicians may be able to stop the progress of Parkinson’s disease with a drug normally used in type 2 diabetes. At present, the drugs used to treat Parkinson’s disease only help in managing the symptoms. They do not prevent brain cells from dying. In Parkinson’s, the brain is progressively damaged and the cells that produce the hormone dopamine are lost. Legendary boxer Muhammad Ali had died last year at the age of 74 after battling for years with Parkinson’s disease. In the trial, half the patients were given the diabetes drug exenatide and the rest were given a placebo (dummy treatment). All the patients stayed on their usual medication. Those on just their usual medication declined over 48 weeks of treatment. But those given exenatide were stable. And three months after the experimental treatment stopped, those who had been taking exenatide were still better off. Exenatide, derived from the saliva of Gila monster, is a glucagon-like peptide-1 (GLP-1) agonist. It treats type 2 diabetes by mimicking the hormone GLP-1, which triggers insulin secretion. According to University College London (UCL) researchers, Parkinson’s patients treated with exenatide did better on movement tests than patients who received a placebo. If they can prove the drug changes the disease itself, it could transform the way we treat Parkinson’s. Though the UCL team is “excited”, it has urged caution as any long-term benefit is uncertain and the drug needs more testing. FDA approves AbbVie’s Mavyret — a drug that cures Hepatitis C in eight weeks    Last week, the USFDA approved the first-ever drug that can treat all six major strains of hepatitis C (or HCV) in just eight weeks — AbbVie’s Mavyret. For competitors like Gilead, Mavyret spells bad news. Mavyret is also being considered a ‘steal’ in the world of HCV drugs, with a price tag of US$ 26,400 for an eight-week treatment course. In comparison, Gilead’s Harvoni costs about US$ 63,000 for eight weeks, though the discounts bring the net price down to US$ 30,000. Gilead also has its own ‘pan-genotype’ hepatitis C medicine, Epclusa, in addition to its blockbuster HCV drugs Sovaldi and Harvoni, that have been at the centre of a controversy around their steep prices.  With a combination of two new direct-acting antivirals — glecaprevir and pibrentasvir — Mavyret treats adult Hepatitis C patients with genotype 1 through 6 who don’t have cirrhosis or with mild cirrhosis, or those who are on dialysis. According to the FDA, it’s the first pan-genotypic HCV drug with an eight-week treatment duration. Other options cure the disease in 12 weeks or longer. J&J’s Invokana is CVS Caremark’s preferred diabetes drug   Close on the heels of Express Scripts’ 2018 formulary release, rival pharmacy benefit management (PBM) giant CVS Caremark has published its own list of drugs that are in, and those that are out. Express Scripts Holding is the largest PBM organization in the US. In the SGLT2 class of drugs to treat diabetes, CVS removed Eli Lilly and Boehringer Ingelheim’s Jardiance and added Johnson & Johnson’s Invokana as a preferred option. This, despite the fact that Invokana came with an increased risk for amputations in a cardiovascular outcomes study finished earlier this year. A Boehringer Ingelheim spokesperson said the company is “very disappointed” with the formulary move “and the potential treatment disruption” and the impact this could have on patients. This decision restricts treatment options for patients who could benefit from Jardiance’s life-saving cardiovascular benefit, the spokesperson added. CVS removed 17 drugs in 10 classes, with Merck’s Zetia, Daiichi Sankyo’s Benicar and Teva’s Nuvigil among them. Despite the removals, the company expects 99.76 percent of members will be able to keep using their current treatments. US Senate overwhelmingly passes reauthorization of FDA’s user fees   In the US last week, Senators voted overwhelmingly to pass a key Food and Drug Administration (FDA) funding bill. The bill is now with President Trump, for his approval. The Senate passed a five-year reauthorization of the FDA’s user fees in a 94-1 vote, with only Senator Bernie Sanders voting against the measure. The move is in major contrast to the recent rancor surrounding the Senate’s efforts to repeal ObamaCare. The funding reauthorizations are based on recommendations from industry groups. This bill renews FDA’s authority to collect fees from the prescription drug and medical device industries. Together, they account for 25 percent of all FDA funding; and should amount to around US$ 8-9 billion over the next five years. The fee helps speed up the approval of new drugs and devices. This funding reauthorization of FDA’s user fee comes about a month before the current user fee agreement expires. The White House hasn’t said if it will sign the user fee bill. In a statement of administrative policy issued in July after the bill passed the House, the White House expressed concern with some minor provisions, though it did not threaten a veto.    

    Impressions: 2374

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/teva-to-sell-assets-to-reduce-debt-lay-off-7-000-workers-shkreli-awaits-sentence

    #Phispers by PHARMACOMPASS
    10 Aug 2017
    Share Share
    Venture capitalist likely to head USFDA; Layoffs at Sanofi, Lilly, Mylan, AstraZeneca and Endo

    Venture capitalist likely to head USFDA; Layoffs at Sanofi, Lilly, Mylan, AstraZeneca and Endo

    This week, Phispers brings you news on the probable new head of the US FDA. Meanwhile, pharma biggies like Mylan, Endo, Eli Lilly, AstraZeneca and Sanofi have announced restructuring and layoffs, Switzerland’s Lonza has announced plans to buy Capsugel and Perrigo plans to offload its API plant in India to Strides Shasun. And there is more, read on. Trump likely to pick venture capitalist Scott Gottlieb to head FDA America’s President-elect Donald Trump is considering Scott Gottlieb, a partner at one of the world's largest venture capital funds and a former deputy commissioner at the US Food and Drug Administration (FDA), to run the government healthcare agency. News comes days after Jim O’Neill — managing director at Mithril Capital Management, a venture capital firm run by Peter Thiel (the billionaire Trump donor and transition team advisor) — was said to be considered for the FDA top-job. According to Michael Gaba, federal policy leader of law firm Holland & Knight’s national healthcare and life sciences team, Gottlieb is a more “palatable” choice, as opposed to O’Neill, who believes that drugs should be allowed on the market before their efficacy has been established, as long as they are safe.  Because if O’Neill heads the FDA, neither the doctor nor the drug maker would have a clue whether the medicine will actually work or not, because the government never required it to be tested. Gaba is of the view that the drug industry too is likely to oppose O’Neill’s stance, since companies want to be able to make credible claims about their products, and that they are indeed effective in treating the ailments they claim to treat.  Layoffs at Sanofi, Lilly, Mylan, AstraZeneca and Endo Over the last week, five pharmaceutical biggies that together account for a market cap of US $ 228 billion in the US bourses — Mylan, Endo Pharmaceuticals, Eli Lilly, AstraZeneca and Sanofi — have announced major restructuring and layoffs.  The decisions of these companies are driven by a number of factors ranging from failures in clinical trials to feeling the need to squeeze off dead weight in the face of wilting sales. There was some good news for Endo — its Par Pharmaceutical unit launched the first copycat of Merck’s cholestrol-fighting drug Zetia. Endo’s Zetia is the only copycat for six months under FDA exclusivity rules. Though Merck’s Zetia sales (pegged at US $ 2.5 billion in 2015) is likely to suffer from this copycat drug, the company will face the biggest declines in Zetia sales after that 180-day monopoly ends next year. That’s when multiple generics players are likely to jump in the fray. For Endo, the Zetia generic presents an opportunity to recoup sales as it struggles to redefine itself. Endo’s generic launch comes just after it cut 375 staffers and pulled the plug on a pain med project. Endo bought Par Pharmaceutical last year for US $ 8 billion. Par will share profits for the generic with its licensing partner — India-based Glenmark Pharmaceuticals. Eli Lilly also had some good news — in the coming weeks, two leading US medical societies are poised to issue new diabetes treatment guidelines reflecting the lifesaving cardiovascular effects of Eli Lilly's Jardiance. This is likely to push up Jardiance sales.  Swiss drugmaker Lonza in talks to buy Capsugel for around US $ 5 billion In a statement, Lonza Group AG, the Swiss pharmaceutical manufacturer, said it is in advanced talks with private equity firm KKR & Co LP to acquire Capsugel, an American manufacturer of capsule products and other drug delivery systems. The potential transaction, according to sources quoted in a Reuters news report, is likely to be valued at more than US $ 5 billion.  Capsugel “would fit perfectly with Lonza’s ... strategy and strengthen its position as leading supplier to a number of important healthcare markets,” Lonza said in a statement. “A successful acquisition would be value adding and be within Lonza's stated acquisition criteria,” it added.  Under pressure to shore up finances, Perrigo offloads API plant to Strides Perrigo is offloading the FDA-approved API plant in Ambernath, Maharashtra, for a consideration of US $ 14.8 million (INR 1,000 million) to India’s Strides Shasun. Perrigo has been under pressure from investors to shore up its finances. On its part, Strides has been shoring up its API business, following its merger with Shasun Pharmaceutical Ltd in 2014. After the acquisition, Strides will continue to produce some of Perrigo’s products at the plant under a long-term agreement. The deal is expected to close by the end of the year. With this acquisition, Strides will get a plant that had sales of about US $ 10.9 million for the fiscal year ended March 31, 2016. It went through its last FDA inspection without a Form 483. Strides intends to use the facility for captive consumption APIs and will move all of its integrated drug master files (DMFs) for captive consumption to the Perrigo plant, which has a potential capacity of 600 tons per year. Now, Sweden too wants to host London-based EMA post Brexit vote After other European Union (EU) members — such as Spain, France and Poland — have shown keenness to become the future location of the London-based European Medicines Agency (EMA), the Swedish government last week launched a campaign to become the new host of the drug agency after Britain’s vote to leave the EU.  The tussle to host the 900-strong EMA is likely to form a part of complex political horse-trading around Brexit. Italy, Denmark and Ireland have also put themselves forward as hosts. “With one of Europe’s top national medicines agencies, an excellent climate for research and life science as well as good conditions for an efficient relocation, Sweden is a good future home for the EMA,” Sweden’s healthcare minister Gabriel Wikstrom said in a statement.   Diabetes drug Pioglitazone may pose risk of bladder cancer, confirms FDA The US FDA has said it still believes that pioglitazone (sold as Actos and other brands) — the type 2 diabetes drug — may pose an increased risk for bladder cancer after updating its review of published research. Research on pioglitazone has gone back and forth on this issue. Back in 2011, the FDA had added a warning about the increased risk for bladder cancer to the drug’s label based on interim results of a 10-year epidemiological study of patients with diabetes in the database of Kaiser Permanente (KP) of Northern California. The data suggested that bladder cancer risk rose as the dose and treatment duration increased. The revised label advises clinicians not to prescribe pioglitazone for patients with active bladder cancer and to exercise caution while using it in patients with a history of the cancer. Subsequent studies (one in 2014, another in 2015) rebutted the causal link between pioglitazone and bladder cancer. The 2015 study, published in the Journal of the American Medical Association, looked at the full 10 years of data drawn from the KP database but could no longer find the cancer signal detected in the interim results. However, a retrospective cohort study published earlier this year reported a 63 percent higher risk for bladder cancer for pioglitazone, with longer duration and larger doses increasing the risk.  

    Impressions: 2500

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/venture-capitalist-likely-to-head-usfda-layoffs-at-sanofi-lilly-mylan-astrazeneca-and-endo

    #Phispers by PHARMACOMPASS
    15 Dec 2016
    Share Share
    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics.   GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field.  Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs.  FDA continues to race ahead with generic approvals  The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark  In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements.  Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million..  The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement. 

    Impressions: 2757

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/gsk-google-form-first-bioelectronics-firm-11-generic-companies-benefit-from-the-teva-allergan-deal

    #Phispers by PHARMACOMPASS
    04 Aug 2016
    Share Share
    Merck vs Merck: A ‘Mercky’ tale

    Merck vs Merck: A ‘Mercky’ tale

    It doesn’t help that the company, which calls itself Merck in the United States isn’t allowed to do so in other parts of the world, because the other Merck is called Merck. Confused? Well you wouldn’t be the only one! Merck is the world’s oldest pharmaceutical and chemical company, which has done business for almost 350 years. Since almost everybody in a chemistry lab has used a Merck product at some point of time, and now that Sigma Aldrich also belongs to Merck, we thought it would be worthwhile to create a simple comparison chart to better understand the two companies:   Merck & Co., Inc. Merck KGaA Website www.merck.com www.merckgroup.com  Logo      Headquarter Kenilworth, New Jersey, United States Darmstadt, Germany Founded 1891, by George Merck, as an American subsidiary of German Merck 1668, by Friedrich Jacob Merck The Split Owing to World War I, Merck & Co. was expropriated by the U.S. government in 1917 Name in the US and Canada Merck EMD Millipore (Emanuel Merck Darmstadt) Name in the rest of the World MSD, Merck Sharp & Dohme or  MSD Sharp & Dohme Merck Total Sales (2014) $42 Billion €11.5 Billion Employees 70,000 39,000 Merger & Acquisitions Sharp & Dohme, Inc. Schering-Plough Idenix Pharmaceuticals Cubist Pharmaceuticals OncoEthix Medco Containment Services Inc. Millipore Corporation Serono SA Sigma-Aldrich AZ Electronic Materials SA Major Products Januvia®, Janumet®, Zetia®, Vytorin®, Gardasil®, Remicade® Rebif®, Erbitux®, Gonal-f®, Concor®, Glucophage®, Euthyrox® Recent facts of Confusion: 2011 German Merck KGaA used to have Facebook page:http://www.facebook.com/merck, but one day found U.S. Merck & Co. there instead. As Merck KGaA had an agreement with Facebook, the matter reached the courts . Eventually Facebook admitted their mistake and let the German Merck resume its place at www.facebook.com/merck. U.S. Merck & Co. now sits at http://www.facebook.com/MerckBeWell. 2014 Protestors from the group STOPAIDS (a network working on how to secure an effective global response to HIV and AIDS) reached the offices of Merck KGaA in London, when protesting Merck’s “campaign to delay South Africa’s proposal to allow low-cost copies of patented drugs.” The only problem: the protestors were targeting U.S. based Merck & Co instead of German Merck… 2014 Bloomberg headline “Bayer to Buy Merck Consumer-Health Unit for $14.2 Billion” resulted in Merck KGaA issuing a same day clarification “Merck to Keep Consumer Health Business” since the Bloomberg article was referring to the U.S. Merck & Co! 2015 Even Merck KGaA CEO Karl-Ludwig Kley admits that his company bears some fault in allowing the situation to get to this point: “over many decades we underinvested in our brand,” he told the Financial Times: “we need to make people more aware of the fact there are two Mercks.”   RadioCompass just thought it was worth helping Mr Kley out with this complilation! 

    Impressions: 9771

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/merck-vs-merck-a-mercky-tale

    #Phispers by PHARMACOMPASS
    13 May 2015
    Share Share
    The Next Generic Attack: Brilinta® (Ticagrelor), Xarelto® (Rivaroxaban), Tradjenta® (Linagliptin) and…

    The Next Generic Attack: Brilinta® (Ticagrelor), Xarelto® (Rivaroxaban), Tradjenta® (Linagliptin) and…

    With almost 30,000 Drug Master Files (DMFs) submitted to the FDA, reviewing the filings of only the first quarter of 2015, provides an indicator on the current areas of focus of generic pharmaceutical companies. A detailed evaluation of the 241 filings for active pharmaceutical ingredients only, made us find some interesting trends worth sharing. European Blockbuster battle! Of the 241 DMFs, 21 APIs had more than one DMF filing and accounted for 25% of the total filings. Interestingly, 20 DMFs  were for only three APIs: AstraZeneca’s blood thinner Brilinta® (Ticagrelor), with 2014 sales of $476 million, already had DMF filings from Dr. Reddy’s, Mylan, Polpharma and Zhejiang Hisun at the end of last year. With a maximum of 9 new filings from players like Teva, Alembic, Lek and others, AstraZeneca should brace itself for some serious generic onslaught.  While the 9 filings for Ticagrelor were the most for any single compound, not far behind is Bayer’s own blood thinner: Xarelto® (Rivaroxaban). With 7 submissions, the focus of the generic companies is understandable as Rivaroxaban had sales in excess of $3 billion and year-on-year growth in excess of 70%. However, patents currently protect the product till 2020, so patience is needed before generics can access this golden opportunity. Interestingly, 4 filings for Linagliptin (Boehringer’s antidiabetic Tradjenta®) make it yet another European pharma giant lead the list of products being subjected to generic competition, and make us wonder why European blockbusters are preferred over others? Exclusive but not patented There are products, which have no patent protection, but the market is protected by FDA granted exclusivities (learn more on patents and exclusivities from the FDA website). An opportunity for generic companies to gain significant market share of a multi-hundred million dollar market, without any litigation risk or cost is something companies dream about.  As the time of exclusivity expiry nears, Clobazam, Tetrabenazine, Hydroxyprogesterone Caproate, Deferiprone and Trypan Blue will all see increased generic activity as their Drug Master Files have been submitted. Fragmented Activity More than 80% of the DMF submissions were made by companies who filed only a single product. While the products varied from simple compounds like Sodium Chloride to biologics like Plasmid DNA, over 140 companies filed DMFs in the first quarter with almost 30 submitting a DMF for the first time. An expanding list of suppliers who support DMFs increases options for sourcing managers.  However, a fragmented supplier base limits the industrial scale companies can achieve and raises concerns regarding how many can successfully sustain compliance standards under increased regulatory scrutiny? The Next Generic Wave Blood thinners are an opportunity few generic companies wish to pass on. Boehringer’s (Dabigatran Etexilate), Bristol-Myers Squibb’s (Apixaban) and Bayer’s (Rivaroxaban) are novel compounds in this category which had combined sales in excess of $5 billion last year.  While Dagibatran saw a flurry of activity over the last two years with almost 15 DMF filings, there were no additional filings this year. On the other hand, Apixaban, which generated $774 million for Bristol-Myers Squibb in 2014, has only one DMF filing at the moment and that too was done over a year ago. The export data out of India, reviewed on PharmaCompass, for Apixaban, indicates that product development is already complete so it is just a matter of time before the filings begin.   Conclusion: Product and supplier selection is a critical component of every generic company’s strategy. The PharmaCompass database is designed to assist professionals in business development, marketing and sourcing to take more informed decisions. If you would like us to share our shortlist of 241 DMFs, we will be happy to send it to you by email (click here). You can also access our compilation of the 2014 annual reports of major pharmaceutical companies to review the various products along with their revenues (click here): Table: Products with more than one DMF filing in Q1 2015 PRODUCT NAME DMF FILINGS TICAGRELOR 9 RIVAROXABAN 7 LINAGLIPTIN 4 APREPITANT 3 CINACALCET HYDROCHLORIDE 3 ATAZANAVIR SULFATE 2 ATORVASTATIN CALCIUM TRIHYDRATE 2 CLOBAZAM 2 CLOFARABINE 2 DEFERASIROX 2 DIMETHYL FUMARATE 2 EZETIMIBE 2 ICATIBANT ACETATE 2 LURASIDONE HYDROCHLORIDE 2 MELPHALAN HYDROCHLORIDE 2 OLANZAPINE 2 OLMESARTAN MEDOXOMIL USP 2 PRASUGREL HYDROCHLORIDE 2 RIVASTIGMINE USP 2 ROSUVASTATIN CALCIUM 2 SOLIFENACINE SUCCINATE 2

    Impressions: 8782

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/the-next-generic-attack-brilinta-ticagrelor-xarelto-rivaroxaban-tradjenta-linagliptin-and

    #PharmaFlow by PHARMACOMPASS
    13 May 2015
    Share Share
    Dr. Reddy’s expansion plans for API production

    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: 3086

    subscribeSubscribe
    ExcelExcel Download

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

    #Phispers by PHARMACOMPASS
    03 Apr 2015
    Share Share
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty
    veranova-m-2024-04-22

    Access Virtual Booth

    Contact Supplier

    View Presentation

    Shandong Boyuan Pharmaceutical Ezetimibe RMB

    Access Virtual Booth

    Contact Supplier

    View Presentation

    Post Enquiry
    POST ENQUIRY

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search