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    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)   

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    #PharmaFlow by PHARMACOMPASS
    29 Apr 2020
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    Data-integrity concerns at Baxter’s US$ 625 million buy in India; Did pharma bribes fund terrorism in Iraq?

    Data-integrity concerns at Baxter’s US$ 625 million buy in India; Did pharma bribes fund terrorism in Iraq?

    This week, Phispers has details on the Amneal-Impax merger and an update on Allergan’s alleged ‘Mohawk tribe’ ploy to delay the launch of generics for its blockbuster eye drug Restasis. While data-integrity concerns emerged at Claris in India, which was acquired by Baxter for US$ 625 million in December last year; veterans and relatives of soldiers in the US sued five pharma companies over an allegation of bribery that funded terrorism in Iraq. Meanwhile, USFDA cleared the second CAR T-cell cancer therapy; and Reckitt Benckiser made changes to its consumer health unit, while continuing to eye Pfizer’s OTC range.   Allergan’s Mohawk tribe deal receives a blow; is it likely to breakup soon? Last month, PharmaCompass had reported how Allergan had agreed to transfer the patents on its blockbuster eye drug Restasis to the Saint Regis Mohawk Tribe in the United States. This was seen as Allergan’s ploy to prolong the launch of Restasis generics. As part of the agreement, the tribe received a one-time payment of US$ 13.75 million and possible annual royalties of about US$ 15 million. Last week, Allergan received a major blow when a US district court pronounced four of its patents covering Restasis as invalid. The court also raised questions on Allergan’s decision to transfer the patents to the native American tribe. “Sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities,” US Circuit Judge William Bryson wrote in the order on the agreement between Allergan and the Mohawk tribe. Mylan had termed the move by Allergan “a sham” and said that it was merely an attempt to evade generic competition for a longer period of time.  On transferring the Restasis patents to New York state’s Mohawk tribe, Allergan had claimed that the group’s status as a sovereign nation meant the patents could not be reviewed by the US patent office. Meanwhile, an Endpoints News report quotes Ronny Gal, an analyst with Sanford C. Bernstein & Company, as saying that “if 2018 does not go well, splitting the company will become a real option” for Allergan CEO Brent Saunders. Gal apparently chatted with Saunders on the matter, who in turn said the discussion is premature. But Gal is of the view that Saunders has “given it some thought”.  Meanwhile, the Mohawk tribe filed lawsuits against Microsoft and Amazon claiming patent infringement. The tribe is a co-plaintiff with a small tech firm called SRC Labs, which claims that Microsoft and Amazon have been infringing its patents on data processing technologies for years. SRC Labs and the tribe are seeking damages and royalties. SRC transferred the patents to the tribe in early August, a month before the Mohawk tribe’s partnership with Allergan made headlines.    After being acquired by Gilead, Kite’s CAR T-cell therapy gets FDA nod After approving Novartis’ Kymriah — the highly personalized cancer treatment known as CAR T-cell therapy (CAR is short for chimeric antigen receptor) last month — the US Food and Drug Administration (USFDA) approved yet another revolutionary cancer treatment last week. This second CAR T-cell therapy, known as Yescarta, treats a type of blood cancer called aggressive B-cell non-Hodgkin lymphoma. The one-time infusion CAR T-cell therapy is made by California-based Kite Pharma, which was acquired by Gilead Sciences for US$ 11.9 billion in August this year. Yescarta will be priced at US$ 373,000, while Novartis’ Kymriah costs US$ 475,000. The Yescarta treatment is for adults with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment, such as chemotherapy and bone-marrow transplants. This therapy removes a person’s cells, reengineers them and then puts them back in their body to attack cancer cells. In late August, the FDA had cleared Kymriah — the first CAR T-cell therapy, which is designed for children and young adults whose leukemia doesn’t respond to standard treatments. About 600 patients in the US fall into that category every year.   Lawsuit alleges pharma bribes funded terrorism in Iraq In the US, several veterans and relatives of soldiers killed or wounded in Iraq between 2005 and 2009 sued five drug and medical equipment makers last week and accused them of funding an Iraqi terrorist militia that killed hundreds of American soldiers following the 2003 US-led invasion. The lawsuit names parent companies and subsidiaries of AstraZeneca, General Electric, Johnson & Johnson, Pfizer and Roche Holding.  The civil lawsuit was filed in federal court in Washington and accuses the multinationals of routinely bribing Iraqi Ministry of Health officials to win drug contracts when the office was controlled by the anti-American Mahdi Army. The 203-page suit, filed on behalf of 108 plaintiffs, seeks to hold the drug companies responsible for the deaths and injuries of US service members. According to the lawsuit, these drug giants were not only filling purchasing orders but offering substantial kickbacks and free medication, even as they were aware that they were in business with a group of terrorists engaged in violence against US interests and Americans. According to the lawsuit, such payments were in violation of the Anti-Terrorism Act.   Amneal, Impax merge to create fifth largest generic drugmaker in US Last week, Amneal Pharmaceuticals merged with Impax Laboratories in an all-stock deal. The merger comes at a time when speedy approvals of generic drugs by the US FDA has increased competition in the sector, mounting pressure on smaller generic drug makers such as Impax. The deal would make Amneal the fifth-largest generics player in the US. Through this merger, Impax shareholders will get 25 percent of the new company—which will take Amneal’s name and have an expected value of US$ 6.4 billion. Amneal’s owners will control the rest. Expectedly, the Impax shareholders weren’t too thrilled with the news — the stock plummeted 12 percent after the deal was announced. Besides, there’s reason to be concerned. The last big deal in the generics industry — Teva’s US$ 40.5 billion buyout of Allergan’s generics unit—has landed the Israeli generic giant in a mess. Debt-ridden Teva has since reported an earnings miss, a reduced guidance, layoffs, cost-cutting measures and divestments. The Amneal-Impax deal will create a more diversified company with “one of the industry's leading high-value generic product pipelines and a growing specialty business,” Impax CEO Paul Bisaro said in a statement. Bisaro, who was formerly an executive at Allergan Plc, would be the CEO of the new publicly-listed entity. The combined company will have a diverse pipeline with more than 300 products either filed with the FDA or in active stages of development, analysts said. The deal is expected to generate double-digit revenue and earnings growth in the next three years.   Reckitt makes changes to its consumer health unit; eyes Pfizer’s OTC range Since December 2015, there have been talks about Reckitt Benckiser eyeing Pfizer’s over the counter (OTC) unit. And if news reports are to be believed, it is preparing a bid for the unit, if it comes up for divestment. Moreover, the British household goods company is making some big changes to its consumer health operations. Reckitt Benckiser is splitting its business into two units, one of which will be dubbed RB Health. The other one will comprise the recently acquired Mead Johnson nutrition business, and will have its own management team, under CEO Rakesh Kapoor (who will serve as its president). During the company’s third-quarter earnings calls, Kapoor said the new consumer unit (RB Health), with revenues of around US$ 7.5 billion (amounting to 60 percent of the group’s top-line), “will be a global leader in consumer health and the only one really focused on the broader consumer health market” beyond just OTC medicines. However, he clarified that this doesn’t mean he’s not interested in adding more OTC medications into the fold. Recently, the Sunday Times reported that Reckitt Benckiser is preparing to bid for Pfizer’s OTC unit if it comes up for auction. However, shareholders are skeptical about such a big purchase, in the wake of the US$ 17.4 billion (£13.2 billion) buyout of Mead Johnson. Since the deal, Reckitt Benckiser has suffered a sales slowdown, a cyberattack and four executive-committee exits. And investors are wary of Reckitt Benckiser adding on more debt. However, Kapoor is upbeat on its consumer health operations — aging populations in the developed markets are spending more on health and well-being. And in emerging markets, he expects to see higher spending in those fields as the middle class grows.   Data-integrity concerns emerge at Baxter’s US$ 625 million buy of Claris in India Global medical products company Baxter International Inc's expansion plans seem to have hit a hurdle. In December last year, Baxter had announced the acquisition of Claris Injectables Limited (Claris) in India for US$ 625 million. The acquisition of Claris will provide Baxter with a portfolio of molecules in anesthesia and analgesics, renal, anti-infectives and critical care. However, a recent FDA inspection has highlighted data integrity concerns at Claris. The Form 483 shared by the FDA of the inspection at the site in Ahmedabad raises concerns about “electronic records” that do not match the corresponding environmental monitoring documents. The inspection was held from July 27, 2017 to August 4, 2017. The investigators also found a mismatch between electronic attendance records and the paper records maintained at the facility. The investigators also observed operators backdating documents, false media fill records and “official, original documentation” lying in “the ‘scrap’ area”. The FDA also found that Claris’ investigations into customer complaints and out-of-specification investigations to be deficient. After Daiichi’s failed Ranbaxy acquisition and Mylan’s troubles at Agila the data-integrity concerns at Claris adds to an increasing list of acquisitions in India that have run into problems.       

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    #Phispers by PHARMACOMPASS
    23 Oct 2017
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    Lundbeck’s CEO to head Teva; Pfizer gets FDA warning letter for supplying faulty EpiPens

    Lundbeck’s CEO to head Teva; Pfizer gets FDA warning letter for supplying faulty EpiPens

    This week, Phispers brings you news about Teva, which finally found a CEO in Kare Schultz. Allergan transferred the patent of its best-selling eye drug Restasis to the Mohawk tribe in order to protect it from patent dispute. There was more news on EpiPen, as Pfizer received an FDA warning letter for Mylan’s flagship product. And, a leaked audio revealed how Insys lied to a patient who didn’t have cancer to sell a prescription opioid. Teva nabs Lundbeck’s CEO to revive its fortunes; to pay over US$ 44 million    After months of bad news, this week there was finally some good news from the much-troubled Teva. The Israeli generic drug giant finally managed to get a new chief executive officer for itself, after Erez Vigodman’s resignation in February this year. Teva poached Lundbeck’s Kare Schultz as its new CEO. Schultz, 56, will move to Israel and be based at Teva’s headquarters in Petach Tikva. In an SEC filing, Teva said Schultz is starting with a base pay of US$ 2 million. Along with several bonuses (including a signing bonus of US$ 20 million), his initial package adds up to over US $44 million. Schultz has 30 years of experience in global pharma business. After the acquisition of Allergan’s generic business — Actavis — last year, Teva has been saddled with huge debts. And the key question before the new CEO is whether he will maintain Teva as both a generics and specialty drugmaker, or split it in two or get out of the highly competitive generics business. During the last quarter (April to June), Teva posted revenues of US$ 5.7 billion, out of which US$ 3.1 billion came from generics and US$ 2.1 billion from its own branded drugs. About half the sales of its own medicines come from a blockbuster multiple sclerosis drug which is now facing competition from generics. Pfizer gets FDA warning letter for supplying faulty EpiPens to Mylan   The US Food and Drug Administration (FDA) has told Meridian Medical Technologies, a division of Pfizer that makes the EpiPen injector device (sold by Mylan NV), that serious component and product failures have been associated with patient deaths. In a warning letter issued on September 5, the FDA said the Pfizer unit failed to adequately investigate problems at its manufacturing facility in Brentwood, Missouri. It also did not take appropriate corrective actions before an FDA inspection earlier this year. Throughout last year, Meridian received hundreds of complaints that the EpiPen device, which is used to combat serious allergic reactions, failed to operate during life-threatening emergencies. In March this year, tens of thousands of EpiPens were recalled worldwide after two reports of the shot failing to work in emergencies. In a note to Stat News, Pfizer said: “Between 2015 and now, we have shipped more than 30 million EpiPen Auto-Injectors globally. It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals.”  “We currently have no information to indicate that there was any causal connection between these product complaints and any patient deaths,” it added. In a statement, Mylan said it is confident of the safety and efficacy of EpiPen products being produced at the Brentwood site. According to the FDA warning letter, in April 2016, a customer complained that an EpiPen failed to activate. Though Meridian confirmed the problem, in June 2016 it decided the defect was infrequent. Moreover, between 2014 and 2017, Meridian received 171 devices from patients who complained their devices failed to activate even when they followed the instructions. But Meridian only examined some of the devices and told the FDA inspectors they could not examine the rest without “approval by management”. The warning letter highlights that Meridian “failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness. You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA's inspection.” Allergan tries to protect eye drug by selling its patent rights to Mohawk tribe   Allergan played an unusual gambit last week to protect its best-selling eye drug — Restasis — from a patent dispute. It did that by transferring the patent of the drug to the Saint Regis Mohawk Tribe, a Mohawk Indian reservation in Franklin County, New York, United States. Under the deal, Allergan will pay the tribe US$ 13.75 million. In exchange, the tribe will claim sovereign immunity as grounds to dismiss a patent challenge through a unit of the United States Patent and Trademark Office. The tribe will lease the patents back to Allergan, and will receive US$ 15 million in annual royalties as long as the patents remain valid. For the Mohawk tribe, the deal could generate a new revenue stream. Bob Bailey, Allergan’s chief legal officer told FiercePharma: “I have spent time with the chiefs and their primary motivation for doing this… is to diversify the stream of incomes that this tribe enjoys away from casinos and cigarettes, into longer term, more viable streams…”  If successful, the move will represent a new way for drug companies to circumvent the inter partes review, a procedure for challenging the validity of a United States patent before the United States Patent and Trademark Office. The move sent ripples across the pharmaceutical industry. Surely, if this strategy pays off, there will be other drug companies following suit. Many observers ridiculed the company on social media by calling the deal unscrupulous and sure to bring more criticism to the industry. The tribe has reportedly also taken ownership of patents owned by a technology company. Interestingly, last year, Allergan CEO Brent Saunders had won accolades for condemning predatory drug pricing by the likes of Martin Shkreli and emphasized the company’s commitment to research and development.  This week, in a Federal District Court in Marshall, Texas, Mylan challenged Allergan’s move. Netherland headquartered Mylan, in its court filing stated that Ireland headquartered Allergan is “attempting to misuse Native American sovereignty to shield invalid patents from cancellation.” Biocon’s Malaysia facility gets EU nod; Dr Reddy’s gets six major observations   Biocon, India’s leading biopharmaceutical company, had some good news to share, after its recent setbacks related to its biosimilar program. Its insulin facility in Malaysia — Biocon Sdn Bhd — received an EU GMP compliance certificate from the HPRA (Ireland), the representative European inspection authority. Biocon Malaysia is “one of Asia’s largest state-of-the-art integrated insulins manufacturing facilities, set up with an investment of about US$ 275 million, at the BioXcell Biotech Park in Johor, Malaysia,” Biocon said in a statement. Dr Reddy’s Vizag plant: Indian pharma major Dr Reddy’s said its plant in Vishakapatnam (India) has been issued six major observations related to good manufacturing practices (GMP) by the regulatory authority of Germany — Regierung von Oberbayern. In a statement issued to the Bombay Stock Exchange last week, the company said: “This is to inform you that on 7th September, 2017, the Regulatory Authority of Germany, concluded an audit for our formulations manufacturing facility in Duvvada, Vishakapatnam, with zero critical and six major observations.” Products manufactured at this facility are not currently exported to the EU. The company will be submitting a Corrective and Preventive Action plan (CAPA) to the authorities, the company added. The Duvvada facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by November 2018 for continuation of its EU-GMP certification, the statement added. Meanwhile, Cadila Healthcare received zero observations from the USFDA for its Moraiya plant, situated in Gujarat (India). The FDA has issued zero observations for the unit after its re-inspection this year. Opioid crisis: Leaked audio reveals how Insys lied to a patient who didn’t have cancer   In the United States, an explosive audio revealed how opioids were being given by a drug company to a patient who didn’t have cancer. The audio was released by Senator Claire McCaskill’s office last week. It explains how many in America had been victims of the opioid crisis. According to Business Insider, the audio is a phone call between an employee from Insys, the Arizona-based maker of Subsys (an opioid pain medication given to cancer patients), and a pharmacy benefit manager (PBM).  In the US, PBMs are supposed to ensure that everyone who gets Subsys has cancer. But the patient in question, Sarah Fuller, didn't have cancer. An Insys employee tried to convince Fuller she had cancer, and succeeded. Fuller eventually died of a Subsys overdose on March 25, 2016. The audio accompanies a report from McCaskill’s office on the marketing and business practices of Insys. Since December 2016, several Insys executives, including a former CEO, have been arrested over the opioid issue. German Merck hires JP Morgan to divest its consumer health business   Germany’s Merck KGaA has hired JP Morgan to sell its consumer health business, which includes brands such as Seven Seas vitamins, the company said last week. The annual sales of Merck’s over-the-counter medicines and vitamin supplements are around US$ 1 billion. The divestment would help fund research into higher-margin prescription drugs, Merck said. The business could be worth around US$ 4.5 billion. According to news reports, Merck has already sounded out prospective buyers including Swiss food giant Nestle. Merck had held preliminary talks with Nestle in summer this year. Nestle reportedly favored a joint venture deal and no agreement could be reached.  According to Euromonitor International, the global market for consumer health products is worth around US$ 233 billion. Merck ranks 32nd in this sector, with a 0.4 percent share. J&J dumps hepatitis C drug development; Roche suffers R&D setback   Janssen Sciences Ireland UC, a unit of Johnson & Johnson, said it would discontinue further development of its hepatitis C research, citing increased availability of a number of effective hepatitis C therapies. Its investigational hepatitis C treatment regimen — JNJ-4178 — is a combination of three direct acting antivirals. “The ongoing phase II studies with JNJ-4178 will be completed as planned, with no additional development thereafter,” Janssen said in a statement. Roche drug fails endpoints: Roche said its drug for geographic atrophy — lampalizumab — failed in first of two late-stage studies. Lampalizumab was once considered a potential mega-blockbuster that could bring in US$ 6 billion a year. Lampalizumab did not reduce mean change in geographic atrophy lesion area compared to a placebo at one year (48 weeks). Given the lack of efficacy, “further dosing in patients will be interrupted until the results from the second Phase III study are evaluated,” Roche said.

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    14 Sep 2017
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    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. 

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    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
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