Tag Archives: Roche

Top Pharma News and Developments that Made Headlines in April

These are last month’s pharma news and developments brought to you by Congress Bookers, a reliable accommodation partner for lead pharma companies worldwide.

 

FDA approved Brineura for a specific form of Batten disease

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The U.S. Food and Drug Administration approved Brineura as a treatment for a specific form of Batten disease. Being an enzyme replacement therapy, Brineura’s active ingredient (cerliponase alfa) is a recombinant form of human TPP1, the enzyme deficient in patients with CLN2 disease.

Brineura is set to slow loss of walking ability in pediatric patients aged 3 and older suffering from late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency.

The FDA granted approval of Brineura to BioMarin Pharmaceutical Inc.

 

Novartis entered clinical trial agreement with Allergan

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Novartis entered into a clinical trial agreement with Allergan to use its FXR agonist and Allergan’s cenicriviroc (CVC) for the treatment of non-alcoholic steatohepatitis (NASH) as part of a Phase IIb study.

NASH is known to be one of the biggest triggers of liver diseases leading to liver transplants worldwide. At the moment, there aren’t any approved treatments for NASH.

As part of the agreement, Novartis and Allergan will conduct a Phase IIb clinical trial to assess the safety, efficacy and tolerability of their combines therapies for NASH.

 

Bristol-Myers Squibb enters into separate agreements with Biogen & Roche

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Bristol-Myers Squibb entered into two separate agreements with Biogen and Roche to License anti-eTau and anti-myostatin compounds.

Under the agreements, Bristol- Myers Squibb plans to license BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy (PSP), to Biogen, and BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy, to Roche.

 

Roche’s Tecentriq won FDA OK

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Genentech, a unit of Swiss drugmaker Roche Holding AG, got approval from the FDA for its already approved immunotherapy drug, Tecentriq, to treat advanced bladder cancer. The FDA granted Tecentriq an accelerated approval as an initial treatment for patients with advanced bladder cancer who are not eligible for standard cisplatin chemotherapy.

Tecentriq belongs to PD-1 inhibitors drug class. The latter helps the immune system fight cancer by blocking a mechanism used by tumors to escape attack.

 

GlaxoSmithKline’s malaria vaccine Mosquirix to undergo pilot studies in Ghana, Kenya and Malawi

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GlaxoSmithKline’s Mosquirix is set to undergo real-world pilot studies in Ghana, Kenya and Malawi, 3 African countries selected by the World Health Organization, starting next year.

The pilots will enroll babies aged between 5 to 17 months. Besides testing the vaccine’s efficacy, the study will also focus upon whether it’s possible or not to deliver 4 doses in the sub-Saharan areas.

World Health Organization selected the three African countries because of their high malaria rates despite broad use of insecticidal bed nets and well-functioning immunization programs.

 

Takeda partners Harrington Discovery Institute for rare disease therapeutics development

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Pharma company Takeda has partnered with Harrington Discovery Institute at University Hospitals in Cleveland, Ohio, to advance breakthrough therapeutic discoveries in rare diseases.

Under the agreement, Takeda will leverage Harrington Discovery Institute’s established operating model to set up a new programme to advance the development of medicines for rare diseases.

The Harrington programme will assist US MD and PhD researchers to carry out disruptive and transformative research, that may lead to the development of new treatments.
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Top Pharma News & Developments that Made Headlines in March

These are last month’s pharma news and developments brought to you by Congress Bookers, a reliable accommodation partner for lead pharma companies worldwide.

 

FDA approved Roche’s OCREVUS

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The US Food and Drug Administration (FDA) approved Roche’s OCREVUS (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis (MS).

OCREVUS reduced relapses per year by half during the two RMS Phase III studies. Furthermore, in a separate PPMS Phase III study, OCREVUS was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain compared with placebo with a median follow-up of three years.

The European Medicines Agency (EMA) has validated OCREVUS’ Marketing Authorisation Application (MAA) which is currently under review.

 

AstraZeneca Partnered with Circassia

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AstraZeneca entered a strategic collaboration with respiratory biopharmaceutical company Circassia Pharmaceuticals plc. The agreement was signed for the development and commercialisation of inhaled respiratory medicines Tudorza and Duaklir in the US.

Tudorza and Duaklir are used for the treatment of chronic obstructive pulmonary disease (COPD). While Tudorza was launched in the US in 2012, Duaklir will be submitted for US regulatory review in 2018.

Under the agreement, AstraZeneca will receive a minority equity stake in Circassia while the latter will lead the promotion of Tudorza and was granted the rights to Duaklir in the US. AstraZeneca will complete ongoing development activities and continue to manufacture and supply both medicines.

 

MedImmune Formed Alliance with Sanofi Pasteur for MEDI8897

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MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, have formed an alliance to develop and commercialise potential next-generation respiratory syncytial virus antibody MEDI8897.

The two companies will jointly develop and commercialise MEDI8897, a monoclonal antibody (mAb) for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV).

MedImmune and Sanofi Pasteur will equally share all costs and profits.

 

Mylan in Global Settlement & License Agreements with Genentech and Roche on Herceptin

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In March, Mylan has agreed to the terms of a global settlement with Genentech and Roche in what concerns patents for Herceptin (trastuzumab). This enables Mylan to have global licenses for its trastuzumab product.

Under the agreement, Mylan will be able to commercialize its trastuzumab product in markets worldwide. The licenses pertain to all countries except Japan, Brazil and Mexico.

As part of the settlement, Mylan agreed to withdraw its pending Inter Partes Review (IPR) challenges against two US Genentech patents (patent numbers 6,407,213 and 6,331,415).

 

Boehringer Ingelheim Expanded Its Collaboration with Vanderbilt University

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Boehringer Ingelheim has entered a collaboration with Vanderbilt University. This adds to an already existing collaboration by focusing on the research and development of small molecule compounds targeting the protein SOS. This molecule activates KRAS and triggers a molecular switch that plays a key role when tackling some of the deadliest types of cancer.

This collaboration has led to discoveries that might set the scene for the development of novel cancer treatment options based on molecules that are able to block this critical cancer driver.

 

Merck’s Keytruda Got FDA Nod for Treating Blood Cancer

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Merck got a first approval from the U.S. Food and Drug Administration (FDA) under the accelerated approval program for its immunotherapy drug Keytruda as a treatment for a type of blood cancer. Keytruda is already approved for treating lung, head and neck cancers.

FDA’s accelerated approval program allows for quicker approval of drugs that fill an unmet medical need.

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February’s Top Pharma News & Developments

These are last month’s pharma news and developments brought to you by Congress Bookers, a reliable accommodation partner for lead pharma companies worldwide.

 

AstraZeneca entered agreement with TerSera Therapeutics for Zoladex

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AstraZeneca entered an agreement with TerSera Therapeutics LLC for the commercial rights to Zoladex in the US and Canada. Zoladex is used to treat prostate cancer, breast cancer and several benign gynaecological disorders.

Under the agreement, TerSera is set to pay AstraZeneca USD 250 million upfront, plus USD 70 million in sales-related milestones and a quarterly share of sales in the “mid-teen percentage” range. AstraZeneca will also develop and supply Zoladex to TerSera.

 

Novo Nordisk filed for regulatory approval of semaglutide for the treatment of type 2 diabetes in Japan

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Novo Nordisk has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for semaglutide, a new glucagon-like peptide-1 analogue for the treatment of adults with type 2 diabetes.

This move follows the recent once-weekly semaglutide regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada and SwissMedic.

 

Allergan Launched See America

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Allergan launched a new initiative dubbed See America, through which it aims to make vision health a priority for all US residents. Increasing awareness of the diseases that can cause blindness and enhancing access to vision care for those who need it most are the initiative’s main focus.

The launch followed the release of a report published by the National Academies of Sciences, Engineering, and Medicine (NASEM), which stressed upon the overwhelming number of Americans affected by blindness from preventable causes.

 

Amgen’s Parsabiv got FDA approval

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The US Food and Drug Administration (FDA) approved Amgen’s Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.

Parsabiv is the first therapy approved for this condition in 12 years. It is also the only calcimimetic that can be administered intravenously three times a week after the hemodialysis session.

 

Roche to start second late-stage study of Alzheimer’s disease drug

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Roche’s partner AC Immune revealed that Roche is set to launch a second Phase III study of the experimental Alzheimer’s disease therapy crenezumab. The latter was discovered by AC Immune and out-licensed to Roche’s Genentech unit in 2006. The CREAD2 trial will enrol 750 patients with prodromal or mild Alzheimer’s disease.

 

Boehringer Ingelheim’s Giotrif got approved for lung cancer in China

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Global pharmaceutical company Boehringer Ingelheim announced that their afatinib (Giotrif), an irreversible second-generation ErbB family blocker, was approved for lung cancer in China.

Afatinib has received Imported Drugs License (IDL) status by the China Food and Drug Administration (CFDA) for locally advanced or metastatic EGFR mutation-positive lung cancer patients who have not received any prior therapy with tyrosine kinase inhibitors, as well as for patients with locally advanced or metastatic squamous cell carcinoma of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy.

Afatinib is the first and only second-generation ErbB family blocker approved in China.

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Congress Bookers provides a whole range of services needed to organize a group for a medical congress. On our website, you will find a full list of hotel allotments for the most important medical congresses in 2017, regardless of their location. The biggest congresses next year are:

  • EHA 2017 – 445 rooms in fourteen 4-star hotels
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  • EURETINA 2017 – 160 rooms in five 4-star hotels
  • EASD 2017 – 423 rooms in thirteen 4-star hotels
  • EAACI 2017 – 688 rooms in fourteen 4-star hotels

A Closer Look at the Top 5 Largest Pharma Companies in the World

If you google “pharma news” you’ll find an impressive number of websites dedicated to the latest news in the pharma industry, covering an impressive number of players, some new, others well-established. But who are the leaders, the companies that set new directions while changing people’s lives during the process?

Here are some interesting pieces of information on 5 of the largest pharma companies in the world.

 

Johnson & Johnson (J&J)

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Revenue: 70.07 billion USD (2015)

 

Johnson & Johnson is the largest pharma company in the world. It was founded in the US in 1886 by the three Johnson brothers Robert, James, and Edward who initially only focused upon producing antiseptics in order to prevent illness and death. Consequently, Johnson & Johnson was the first company to produce first aid kits, as well as sanitary products for women, dental floss, and commercial dressings for small wounds.

Today, Johnson & Johnson has more than 127,000 employees in over 57 countries. The company’s focus in now upon 3 major areas: pharmaceuticals, diagnostics, and consumer products. J&J has manufactured innovative products Band-Aid, Tylenol, Rogaine, Johnson’s baby products, and Neutrogena skin care.

 

Novartis

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Revenue: 49.41 billion USD (2015)

 

Novartis, the second largest pharmaceutical company in the world, was founded in Switzerland in 1996 following the merger of Ciba-Geigy and Sandoz, two Swiss companies founded over 250 years ago. Novartis is known to be one of the biggest pharma spenders on research, investing over $9.9 billion in R&D.

The company has over 118.000 employees and is currently divided into 3 operating divisions:

Pharmaceuticals, Alcon (eye care) and Sandoz (generics). While its generics business is the second largest in the world, Novartis is number one when it comes to its Its eye care division. Novartis’s best-selling drug is Gleevec which generated sales of USD 4.7 billion in 2015 alone.

 

Pfizer

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Revenue: 48.85 billion USD (2015)

 

Pfizer was founded in the US in 1849, which makes it one of the oldest pharma companies in the world. The company started very small. It was founded by cousins Charles Pfizer, a chemist, and Charles Erhart, a confectioner, with money borrowed from Pfizer’s father. The two soon developed their first product, an antiparasitic dubbed santonin, that was used to treat intestinal worms. The drug turned out to be a real success.

Pfizer developed many well-known pharmaceutical drugs such as antidepressant Zoloft, lowering blood cholesterol drug Lipitor, and Viagra, a drug used to treat erectile dysfunction. The company has over 78.000 employees and a profit margin that makes it the most profitable pharma company in the world.

 

Roche

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Revenue: 50.856 billion USD (2015)

 

The company was founded by Fritz Hoffman-La Roche in Basel, Switzerland in 1896 during the European industrial revolution. During its first years, it successfully produced the first in a series of thyroid medications, as well as a non-prescription cough syrup dubbed Sirolin. After the World Wars, Roche became the first company to mass-produce synthetic vitamin C.

With over 88.000 employees, the company operates two segments – pharmaceuticals and diagnostics – and sells its products in over 190 countries. Roche’s prescription drugs include cancer therapies MabThera/Rituxan and Avastin, Perjeta and Kadcyla for HER2-positive breast cancer, hepatitis drug Pegasys, idiopathic pulmonary fibrosis drug Esbriet, macular degeneration therapy Lucentis, and Tamiflu, which is used to prevent and treat influenza (including pandemic strains).

 

Bayer

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Revenue: 46.32 billion EUR

 

Bayer was founded in Germany in 1863 and it became renowned through its iconic product Aspirin which was developed in 1897. A year later, the company started the commercialization of heroin as a cough suppressant and a substitute for morphine.

Bayer’s lost its assets and trademarks during WW II as part of America’s campaign against Germany. It was only in 1978 that the company brought back its business in the US.

Nowadays, Bayer has over 116,000 employees and its key products include analgesics such as Bayer Aspirin and Aleve, food supplements Redoxon and Berocca, and skincare products Bepanthen and Bepanthol.

These are the top 5 pharma companies that probably everyone has heard of. They are closely followed by Merck, Sanofi, GlaxoSmithKline, AstraZeneca and Gilead Sciences.

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Congress Bookers provides a whole range of services needed to organize a group for a medical congress. On our website, you will find a full list of hotel allotments for the most important medical congresses in 2017, regardless of their location. The biggest congresses next year are:

 

From 60 Pharma companies to 10 Big Pharma companies in 20 Years

We’ve all heard about Novartis, Pfizer, Sanofi and Roche. They’re some of the big guys in the pharma landscape, enjoying increased popularity, splitting the high budgets and revolutionizing the healthcare and pharma industry but what’s the road they took to get here? In order to answer that question, we’re going to analyze the 10 biggest pharma companies nowadays which used to be around 60 distinct companies 20 years ago. Here’s what they did to stand the test of time and grow.

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Novartis

It all dates back to 1970 when Ciba-Geigy was formed by the merger of J. R. Geigy Ltd and CIBA. In 1996, from the merger of Ciba-Geigy and Sandoz Laboratories, Novartis was born. In 2005, Novartis acquired Hexal and Eon Labs, thus growing its generic division Sandoz. A year later, in 2006, Novartis acquired full control of Chiron Corp. for USD 5.1 billion. In 2010, Novartis acquired the world’s largest eye-care company Alcon for USD 39.3 billion. Three years later, in 2012, the company bought Fougera Pharmaceuticals for USD 1.5 billion. In 2016, Novartis acquired Selexys Pharmaceuticals Corporation and SelG1 antibody for reduction of pain crises in sickle cell disease (SCD).

AstraZeneca (AZ)

AstraZeneca  was created in 1999 following the merger of Astra and Zeneca Group. In 2004, AZ completed its first big acquisition of Cambridge Antibody Technology. Later on, in 2007, it acquired MedImmune for about USD 15.2 billion. In 2012, AstraZeneca acquired Ardea Biosciences for USD 1.3 billion. One year later, it acquired Amylin from BMS for USD 4.3 billion and in 2015 acquired ZS Pharma for USD 2.7 billion. In 2015, AstraZeneca bought 55% majority stake in Acerta for USD 4 billion.

Pfizer

In 2000, Pfizer acquired American pharmaceutical company Warner–Lambert for USD 111.8 billion to bring its drug, Lipitor, to market. In 2002, Pfizer aimed to acquire full rights to Pharmacia’s product Celebrex and thus agreed to buy Pharmacia for stock valued at USD 60.0 billion. In 2009, Pfizer bought pharmaceutical company Wyeth for USD 68.0 billion. In 2015, Pfizer acquired Hospira for USD 15.2 billion and announced the merger with Allergan. The latter is considered to be one of the biggest mergers in pharma history. In 2016, Pfizer announced the successful completion of its acquisition of Medivation.

Sanofi

Sanofi resulted from the merger between Sanofi-Synthélabo and Aventis in 2004. The former was created in 1999 when Sanofi merged with Synthélabo. Aventis was formed in 1999 following the merger of Rhône-Poulenc S.A. with Hoechst Marion Roussel (HMR). The latter itself was formed in 1995 from the merger of Hoechst AG with Cassella, Roussel Uclaf and Marion Merrell Dow.

In 2011, Sanofi-Aventis acquired Genzyme and changed its name to Sanofi.

Johnson & Johnson

J&J was founded in 1886 as a medical devices, pharmaceutical and consumer packaged goods company. The pharmaceutical division is made up of Janssen & Cilag. In 2006, Janssen acquired the consumer healthcare business of Pfizer for USD 16.6 billion in what is considered to be the company’s largest M&A deals. In 2013, the company acquired Aragon Pharma and in 2014 it bought Alios BioPharma, Inc. for USD 1.75 billion.

Merck & Co.

Merck was founded in 1668 and is the world’s oldest operating chemical and pharmaceutical company. Merck & Co. was established as a subsidiary of Merck in 1891, but became an independent company in 1917. It is known as MSD (Merck Sharp and Dohme) outside of North America. In 1993, Merck purchased Medco Containment Services Inc. for USD 6 billion. In 2009, Merck merged with Schering-Plough. The latter had acquired Organon from Akzo Nobel in 2007 while Organon resulted from a merger between Diosynth and Organon in 2004. Ten years later, Merck bought Cubist Pharmaceuticals for USD 8.4 billion.

Roche

Roche’s first acquisition took place in 1994 when the company bought Syntex Corporation for USD 5.3 billion. In 2002, Roche’s Japanese subsidiary Nippon Roche merged with Chugai. Following the deal, Roche got a majority stake in the Japanese company. In 2008, Roche acquired Ventana Medical Systems for USD 3.4 billion and in 2009, the company bought Genentech for USD 46.8 billion.

Teva

Teva resulted from the merger between Assia, Zori and Teva in 1976. In 2006, Teva completed its first big acquisition of IVAX Corporation for USD 7.4 billion. In 2011, it acquired Cephalon for USD 6.8 billion. After acquiring Auspex Pharma for USD 3.5 billion in 2015, Teva completed its acquisition of Allergan’s generics business (“Actavis Generics”) in 2016.

Gilead Sciences

Gilead Sciences was founded in June 1987. Over the past 16 years, the company has made several acquisitions. The biggest ones include: CV Therapeutics for USD 1.4 billion in 2009 and USD 10.4 billion acquisition of Pharmasset in 2011.

GlaxoSmithKline (GSK)

GSK was founded in 2000 following the merger of Glaxo Wellcome and SmithKline Beecham. In 2001, GSK acquired Block Drug for USD 1.2 billion. In 2009, GSK acquired Stiefel Laboratories for USD 3.6 bn. 4 years later, in 2013, GSK acquired Human Genome Sciences (HGS) for USD 3 billion. In 2015, GSK completed the acquisition of vaccine business of Novartis and sale of its oncology business to the Swiss drug major in a global deal. Under the agreement, GSK Pharma expanded its vaccine portfolio and took over 120 employees from Novartis to boost its sales in India.

There’s so much pharma history behind all of the big names out there and the evolution is far from reaching an end. We’re looking forward to seeing what these pharma giants have in store during the next couple of years and who’s going to lead the way in the M&A sector.

Congress Bookers provides a whole range of services needed to organize a group for a medical congress. On our website, you will find a full list of hotel allotments for the most important medical congresses in 2017, regardless of their location. The biggest congresses next year are: