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Top Pharma & Biotech Deals, Investments, M&As in August 2018
In August, the biotech boom of 2018 continued unabated and the Wall Street Journal reported that investment banks have lured top biotech analysts with guaranteed pay packages of US$ 3 million or more. At this time of the year, equity analysts who assess companies and write reports that help investors gauge prospects and interpret news will certainly have their hands full as investments into pharma and biotech companies continue to grow at a rapid pace. Leading the pack in August was US-based Emergent BioSolutions which made two acquisitions to stay on track of its growth plan to achieve US$ 1 billion in revenue by 2020.  While European businesses have had a long-established practice of taking off during the months of July or August, last month two German startups — Affimed NV and Mologen AG — announced big ticket deals which could result in multi-billion dollar payouts. And Hong Kong continued its efforts to lure overseas-listed firms to conduct secondary share offerings in the financial hub. Click here to view the major deals in August 2018 (FREE Excel version available) Emergent BioSolutions’ billion-dollar shopping spree   In a deal valued up to US$ 735 million, consisting of an upfront payment of US$ 635 million and up to US$ 100 million in cash for potential sales-based milestones, Emergent Biosolutions acquired Adapt Pharma to access its flagship product Narcan (naloxone Hydrochlroride) Nasal Spray — the first and only US Food and Drug Administration (FDA) approved nasal form of naloxone for the emergency treatment of a known or suspected opioid overdose. The acquisition is designed to help Emergent expand its presence within the public health threats market to respond to the opioid crisis, which has been declared a public health emergency by the US government. Click here to view the major deals in August 2018 (FREE Excel version available) Narcan is often carried by police officers and medical teams and was approved in 2015. Earlier this year, the US Surgeon General released a public health advisory urging more Americans to carry naloxone. The purchase of Adapt Pharma is expected to generate revenues of US$ 200 million to US$ 220 million and to be accretive to adjusted net income and EBITDA in 2019. Just weeks earlier, Emergent announced an all-cash US$ 270 million acquisition of specialty vaccines company PaxVax. The acquisition will add two revenue-generating FDA-licensed vaccines that protect against cholera and typhoid fever to Emergent’s vaccine portfolio. These vaccines are expected to generate revenues of US$ 70 million to US$ 90 million in 2019. Click here to view the major deals in August 2018 (FREE Excel version available) Novo bags new diabetes technology by acquiring Bristol univ spinout — Ziylo   Novo Nordisk acquired full rights to Ziylo’s early-stage glucose binding molecules in a staged acquisition with a potential deal value that could exceed US$ 800 million. The acquisition will give Novo Nordisk full rights to Ziylo’s glucose binding molecule platform to develop glucose responsive insulin molecules. Ziylo is a University of Bristol spin-out company based out of the Unit DX science incubator in Bristol, UK. Ziylo has been pioneering the use of its platform technology — synthetic glucose binding molecules — for therapeutic and diagnostic applications.  Click here to view the major deals in August 2018 (FREE Excel version available) Ziylo’s glucose binding molecules are synthetic molecules that exhibit an unprecedented selectivity to glucose in complex environments such as blood. The development of glucose responsive insulin molecules is a key strategic area for Novo Nordisk, as it wants to develop this safer and more effective (next generation of insulin) therapy. A glucose responsive insulin would help eliminate the risk of hypoglycaemia (deficiency of glucose in the blood stream), which is the main risk associated with insulin therapy and one of the main barriers to achieving optimal glucose control. Such an insulin molecule could also lead to better metabolic control. Just before selling itself to Novo, Ziylo spun out a new company dubbed Carbometrics to develop the diagnostics and glucose monitoring applications of its technology. Carbometrics is now the new home for all Ziylo researchers. Through a research collaboration with Novo Nordisk, Carbometrics will assist with ongoing optimization of glucose binding molecules for use in glucose responsive insulin molecules. Click here to view the major deals in August 2018 (FREE Excel version available) Novo Nordisk has a strong presence in the diabetes care market with a global value market share of 27 percent. In the total insulin market, Novo’s global value market share is 46 percent; and in the modern and new-generation insulin market, it is 45 percent. The European discovery outfit at Evotec also announced a tie up with Novo Nordisk to build early-stage pipeline drugs for diabetes, obesity drugs, and also diseases like NASH (non-alcoholic fatty liver disease), cardiovascular diseases and diabetic kidney disease. The scientists at Evotec will build a preclinical pipeline of small molecules primarily concentrating on diabetes and obesity. While the financial details of the alliance are not known, it is clear that Evotec is adding a major partnership on top of a string of deals with companies like Celgene, Bayer and Sanofi, as well as a number of smaller biotech firms. Click here to view the major deals in August 2018 (FREE Excel version available) German cancer startups announce big ticket deals   Last month, Genentech, a member of the Roche group, announced it will pay German clinical stage biopharmaceutical company — Affimed — US$ 96 million upfront. It also committed to funding, thereby making Affimed eligible for up to an additional US$ 5.0 billion in revenues which includes milestone payments, and royalties on sales. The German start up is focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK and T cells). Affimed will apply its proprietary Redirected Optimized Cell Killing (ROCK®) platform, which enables the generation of both NK cell and T cell-engaging antibodies, to discover and advance innate immune cell engager-based immunotherapeutics of interest to Genentech. Click here to view the major deals in August 2018 (FREE Excel version available) In June, at the European Hematology Association, Affimed shared data of its lead candidate AFM13 in combination with Keytruda (Pembrolizumab) in patients with Relapsed/Refractory Hodgkin Lymphoma. Assessment of 18 patients treated at the highest AFM13 dose showed best overall response rate (ORR) of 89 percent (16/18 patients). Another German company Mologen AG announced a deal with Oncologie which could generate payouts of over US$ 1.16 billion (€1 billion) towards the development of its lead compound — lefitolimod. In the near-term, Mologen would receive US$ 26.63 million (€23 million) to conduct the phase III Impala trial and build on the promising data from a phase II trial as a maintenance therapy after first-line induction chemotherapy in patients with metastatic colorectal cancer. Impala is a randomized phase III study in patients with metastatic colorectal carcinoma. In the field of active immunotherapies, great hopes are riding on substances that bind to very specific receptors, known as toll-like receptors (TLR). These receptors are part of the innate defense system. Through activation of the immune system, they are able to facilitate the recognition of tumor-associated antigens. Click here to view the major deals in August 2018 (FREE Excel version available) Many years of research work have shown that toll-like receptor 9 (TLR9) plays a particularly important role in the fight against cancer. Substances that activate TLR9 are referred to as TLR9 agonists and form the main focus of global research and development activities. Lefitolimod is regarded as the best-in-class TLR9 agonist. Under new listing rules, Hong Kong stages second biotech IPO   Chinese cancer drug developer BeiGene, which debuted to a US$ 158 million public offering on the Nasdaq back in 2016, had its secondary IPO on the Hong Kong stock exchange last month. As part of an effort to attract secondary listings, Hong Kong is implementing new and more lenient rules for drugmakers that are still in the earliest stages of the clinical trial process without any products on the market. BeiGene is only the second to launch an IPO under the new regime and the US$ 903 million raised during the dual listing improves its exposure to investors in Asia while being close to the mainland China market. Click here to view the major deals in August 2018 (FREE Excel version available) BeiGene intends to use net proceeds from the offering for clinical trials, preparation for registration filings, and for the launch and commercialization of its core product candidates — zanubrutinib, tislelizumab, and pamiparib. Under the revised rules, Ascletis Pharma was the first early-stage biotechnology company to be listed on the Hong Kong Stock Exchange (HKEX) in July 2018. After the new rules were put in place in Hong Kong, more than 10 biotech companies, mostly Chinese, announced plans to list in Hong Kong. Some have also dropped plans to launch IPOs in the US in favor of the Hong Kong exchange. Click here to view the major deals in August 2018 (FREE Excel version available) The overall IPO range sought by BeiGene was reportedly between US$ 908 million and US$ 1.07 billion and one of the reasons given for the biotech falling short of its target was the vaccine scandal in China which has been making headlines and may have hurt investor confidence. Currently New York-based Nasdaq is the biggest center for biotech listings, with US$ 2.4 billion worth of such shares sold last year, according to the data provided by Thomson Reuters. Click here to view the major deals in August 2018 (FREE Excel version available) Our view   The first half of 2018 witnessed a spate of M&A activity in the pharmaceutical and biotech space with the industry witnessing some of the biggest deals from companies like Takeda, Celgene and Sanofi. In addition, healthcare startup funding from venture capital firms reached US$ 15 billion, which is 70 percent higher than the corresponding figure for last year. Click here to view the major deals in August 2018 (FREE Excel version available) While July and August were comparatively slow months for activity, we expect a significant ramp up of deal-making in the coming months. Keep track of all that is happening with PharmaCompass’ compilation of Top Pharma & Biotech Deals — PharmaFlow. Click here to view the major deals in August 2018 (FREE Excel version available)  

Impressions: 2507

https://www.pharmacompass.com/radio-compass-blog/top-pharma-biotech-deals-investments-m-as-in-august-2018

#PharmaFlow by PHARMACOMPASS
13 Sep 2018
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: 2749

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
The secret drug pricing formula
Why do “Americans pay, by far, the highest prices in the world for prescription drugs”? This concern has reached an unprecedented level where government and non-government lawmakers are taking a very serious view of this problem. Hilary Clinton has already made it “a campaign priority” for her 2016 presidential election bid. * Valeant pharmaceuticals buys two heart drugs in February and increased their list prices by 525% and 212%. The reason, company was doing “our duty is to our shareholders and to maximize the value”   * Study published in the journal Neurology on the cost of multiple sclerosis treatments, found drugs originally costing $8,000 to $11,000, now cost about $60,000 per year. The cost of increase is at rates 5 to 7 times higher than prescription drug inflation. Drug costs in the United States currently are 2 to 3 times higher than Canada, the U.K. and Australia. * The Wall Street Journal wrote about “lawmakers in a handful of states stretching from California to Massachusetts, have introduced bills in a bid to force the pharmaceutical industry” to disclose their costs. * In response to pressure by Senators Bernie Sanders and Elijah Cummings, the inspector general of Health & Human Services (HHS) will investigate how recent increases in generic drug prices, have impacted the Medicaid rebate program (for better understanding of the program and the reason why IMS data is different to company sales data, read this Forbes article . * Massachusetts Attorney General, Maura Healey demands why prices of naloxone, which is used to reverse heroin overdoses, has “skyrocketed ” since a public health emergency was declared a year ago. * The JAMA Oncology Study found that price of cancer drugs is independent of novelty and yet cancer drug prices have risen faster than prices in other sectors of health care.   The pharmaceutical defense: * The historical response, of the pharmaceutical industry, for the reason behind high cost of drugs is that funds are needed to continuously research and develop novel medicines. * “The price charged for an individual drug is not a reflection of development costs,” says Ken Kaitin, director of the Tufts Center for the Study of Drug Development. * The Generic Pharmaceutical Association also states that “since 2008, the price of brand drugs has almost doubled, but the price of generic drugs has been cut roughly in half.”    The counter argument: In an interview , Dr. Steve Miller CMO at Express Scripts said, “The industry is still innovating, but on a financial model of drug development that has little to do with science. The acquisition of Pharmasset by Gilead Sciences solely to obtain the rights to the HCV blockbuster Sovaldi is a good example. The drug was already through Phase III trials and Pharmasset had determined $36,000 per treatment was the right price; then Gilead bought the company, for $11 billion, and promptly added $50,000 to the asking price for Sovaldi. That’s not what is meant in recognizing an “innovative step.” Pharmaceutical giant Actavis CEO, Brenton Saunders “growth pharma” model, which believes “the idea that to play in the big leagues you have to do drug discovery is really a fallacy” will not help win public sympathy. When assessing the price increase of generic drugs, the United State Senators mentioned that the prices of “certain dosages or dose forms of a product have increased rapidly while prices for other doses remained flat or declined”. An example given is Fluconazole 100mg tablet having experienced a price increase of 954%, while the 150mg actually had a price decline of 8%.   The reality: Consistent with the conclusion in the JAMA Oncology study “that current pricing models are not rational, but simply reflect what the market will bear".   Expected action: HHS conducted an investigation on generic drug price increases in 2007 and recommended that generic drug makers pay rebates to state Medicaid programs. The practice is currently standard for branded pharmaceuticals. Although lawmakers are pushing this course of action, the inaction since 2007 and study on multiple sclerosis drugs shows limited benefit if generic drugs are made to pay rebates.   A far more likely outcome will be a European model, where federal health care programs like Medicare and Medicaid negotiate directly with drug makers to get lower prices. This provision was added in the recent budget of President Obama, but currently there is no progress. While regulators create their legislation, the pharmaceutical industry is in serious consolidation mode. If the Teva, Mylan deal comes through, and they combine, the options of negotiating with generic companies are going to seriously reduce.  

Impressions: 2659

https://www.pharmacompass.com/radio-compass-blog/the-secret-drug-pricing-formula

#Phispers by PHARMACOMPASS
29 Apr 2015
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