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    Teva to market cannabis inhaler; FDA makes quality metrics voluntary

    Teva to market cannabis inhaler; FDA makes quality metrics voluntary

    This week, Phispers brings you news on J&J’s plans to acquire Actelion and Teva’s new medical cannabis inhaler due for launch in Israel. There are pharma deals from across the globe, such as Roche’s decision to sell its South Carolina plant and Catalent’s acquisition of Accucaps.M&A Compass: Roche sells API plant; Catalent laps up Accucaps; Teva announces layoffsSwiss drug maker Roche is selling its active pharmaceutical ingredients (API) plant in South Carolina (US) to Patheon NV, a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharma sectors. The deal will save 200 jobs in South Carolina. Patheon has also entered into a multi-year supply arrangement with Roche. Meanwhile, Catalent, Inc has acquired Accucaps Industries Limited, a Canada-based developer and manufacturer of over-the-counter (OTC), high potency and conventional pharmaceutical softgels. The acquisition is subject to approval by the Canadian government. It will substantially complement Catalent’s global OTC and prescription pharmaceutical softgel capabilities and capacity.While Patheon and Catalent are making acquisitions, Teva announced layoffs, and Pfizer cancelled its expansion plans in Ireland. Two ministers of Malta announced that Teva Pharmaceutical Industries will be laying off over 200 workers before the end of 2017. Earlier this year, Teva had acquired Actavis Generics and recently informed the government of its decision to start “consolidating production” around its 30 plants in Europe and that it would also lay off workers in Malta.Meanwhile, Pfizer has cancelled a planned US $ 425 million expansion of its Grange Castle plant in Dublin, a development which would have led to permanent employment for 350 people and 1,250 jobs during construction.Pfizer is one of Ireland’s largest private sector employers. It had sought permission earlier this year for a major extension to the plant. However, the plans have been shelved due to failure of a high-profile, late-stage pipeline drug to lower cholesterol.Teva to market medical cannabis inhaler in Israel For the first time, the medical cannabis sector managed to comply with the pharmaceutical standards for inhalation. Israel’s Teva Pharmaceuticals has partnered with Tel Aviv-based Syqe Medical to market medical cannabis in Israel for pain management. The dose is administered with the help of an inhaler — the most efficient means of administering cannabis.Teva will be the exclusive marketer and distributor of the inhaler in Israel. The inhaler, which is pending approval from Israel’s ministry of health, will be available for home use.J&J approaches Actelion for acquisition; Actelion says no guarantee of the deal Last week, Switzerland’s leading biopharmaceutical company — Actelion Ltd — confirmed that it has been approached by the US healthcare titan Johnson & Johnson for a possible takeover. Actelion is focused on the discovery, development and commercialization of innovative drugs, and is a leader in the field of pulmonary arterial hypertension (PAH).However, Actelion said there is no guarantee of the deal. Actelion chief executive Jean-Paul Clozel desires to keep the company independent after building it from scratch. And news reports say J&J will have to pay a steep premium if a takeover is to succeed.Actelion's rare-disease focus makes it an attractive target, since its drugs face less price pressure than other more widely used medicines. There are other reasons why the takeover looks improbable. First, Actelion’s market capitalization far outstrips its net present value. Second, President-elect Donald Trump’s proposed repatriation holiday may come in the way of J&J making the acquisition.Drugs in India fail quality standards; Vietnam bans major Indian manufacturersThis was a bad week for Indian pharma. Drug regulators of seven Indian states alleged that 27 medicines — sold by 18 major drug companies — are of “substandard” quality. These were cited with false labelling, wrong quantity of ingredients, discoloration, moisture formation, failing dissolution test and failing disintegration test.The tests on the 27 medicines were done by drug regulators of Maharashtra, Karnataka, West Bengal, Goa, Gujarat, Kerala and Andhra Pradesh. The drug makers include Abbott India, GSK India, Sun Pharma, Cipla and Glenmark Pharma, Alkem Labs, Cadila Healthcare, Emcure Pharma, Hetero Labs, Morepen Labs, Macleods Pharma, Wockhardt Pharma and Zydus Healthcare.The drug brands alleged to be substandard are: antipsychotic drug Stemetil and antibiotic drug Pentids from Abbott India, anti-bacterial medicine Althrocin by Alembic Pharma, migraine medication Vasograin by Cadila Pharma, cough syrup Ascoril by Glenmark Pharma, worm infection drug Zentel by GSK India, arthritis medication Hydroxychloroquine (HCQS) by Ipca Labs, anti-inflammatory medication Myoril by Sanofi Synthelabo, and Torrent Pharma’s hypertension drug Dilzem.In Parliament, the minister of state for health said that drugs, which are banned in other countries, have been allowed to be sold in India subject to certain provisions. The drugs which have been allowed in India are nimesulide, analgin and pioglitazone. What was worse, Vietnam blacklisted 39 Indian drug companies, including Aurobindo Pharma, Cadila and Macleods Pharmaceuticals for quality standard violations. The Vietnamese drug regulator has also banned companies in Bangladesh and South Korea. The regulator has listed the names of blacklisted companies on its website.FDA’s quality metrics programme to be voluntary till 2018Last week, the US Food and Drug Administration (FDA) released a revised version of its proposal to collect quality metrics data from drug manufacturers in response to protests from the industry.As per the revised draft, the program will begin with a voluntary phase that will run into 2018, after which the FDA intends to make the program mandatory.The revised draft guidance also narrows the scope of the program by cutting the number of metrics the agency plans to ask for. It also grants more flexibility with quality metrics to drug companies that are reporting by both product and site."The revised draft guidance includes the following changes from the earlier draft guidance: Adoption of a phased-in (voluntary) approach, reduction in the number of data elements requested (i.e., reduction in reporting burden), support for both product reports and site reports, modifications to the quality metrics data definitions, addition of clarifying examples for the definitions, addition of comment fields, and clarification of special considerations for non-application and OTC (over-the-counter) product reporting," the FDA said.EMA publishes results of two more clinical studiesThe European Medicines Agency (EMA) has published clinical data for two more medicines — Armisarte and Caspofungin — on its clinical data website. The clinical data website was launched on October 20, 2016, when the EMA had added clinical data for Kyprolis and Zurampic. The website is in line with the EMA’s policy on the publication of clinical data.Armisarte, a hybrid product (a product that is similar to its reference product but is available in a different pharmaceutical form), is indicated for the treatment of malignant pleural mesothelioma lung cancer and advanced non-small-cell lung cancer.Caspofungin Accord, a generic product, is indicated for the treatment of invasive candidiasis, invasive aspergillosis and other fungal infections when the patient is febrile and neutropenic.Pharmaceuticals most counterfeited category, says reportA new report cites pharmaceuticals as the most targeted category for counterfeiting. Globalization and the booming use of the internet is giving a boost to counterfeiting.The report has been launched by online brand protection firm, NetNames. Titled The Risks of the Online Counterfeit Community, the report looks at online counterfeiting. It warns that no brand can afford to underestimate the sophistication of fraudsters in the digital world.The size of the counterfeit market for pharmaceuticals is estimated at US $ 200 billion, followed by electronics (US $ 169 billion) and food (US $ 49 billion). According to NetNames, one in six products bought online is fake. And one-third of all counterfeit seizures in the EU are linked to internet distribution channels.According to NetNames, there are up to 50,000 internet pharmacies in operation. Around 95 per cent of these do not comply with laws and industry standards. Meanwhile, 90 per cent of drugs purchased online come from a different country than what the website claims. According to the report, the internet provides counterfeiters with anonymity, virtually no barriers to entry, low overheads, easier distribution with more frequent, smaller consignments sent by mail, and fewer risks of being caught. And the desire by consumers to seek out big brands online at discount prices, is providing counterfeiters with a ready target audience and the opportunity to further the fraudsters' reach and potential profitability.Trump announces Tom Price as health secretaryThis week, America’s President-elect Donald Trump announced Republican US Representative Tom Price as his Health and Human Services Secretary. Price is an orthopedic surgeon from Georgia.Seema Verma, the founder of a health policy consulting company, will lead the Centres for Medicare and Medicaid Services, which is part of Health and Human Services (HHS).Meanwhile, Trump is expected to name Steven Mnuchin, a former Goldman Sachs partner and Hollywood financier, as his nominee for the post of Treasury Secretary. Mnuchin, who spent 17 years at Goldman Sachs before leaving in 2002 to launch a hedge fund, served as Trump's campaign finance chairman. Billionaire investor Wilbur Ross, known for his investments in distressed industries, is expected to be named Commerce Secretary.   

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    01 Dec 2016
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    FDA chief named in payments controversy; fake vaccine scandal impacts Indonesian children

    FDA chief named in payments controversy; fake vaccine scandal impacts Indonesian children

    This week Phispers brings you scandals such as that of fake vaccines in Indonesia, studies and analyses on drug prices and VC investments in biotech firms, scrutiny on clinical trials done in India, new initiatives such the one undertaken by the FDA on cancer, regulatory action, court cases and other interesting pharma industry news from across the world.   Did the FDA commissioner receive payments from GSK and AstraZeneca?A database of pharmaceutical company payments to physicians updated by the US Centers for Medicare & Medicaid Services (CMS), includes the name of the current US Food and Drug Administration (FDA) Commissioner Robert Califf. “The database says Califf received five payments from GlaxoSmithKline for travel, lodging, food and beverages, as well as a more than US $ 5,000 consulting fee from AstraZeneca in 2015. In 2014, when he was not working for the FDA, Califf received almost US $ 32,000 from companies and in 2013, he received more than US $ 28,000.” An FDA spokesperson said Commissioner Califf has filed a dispute with CMS in regard to the reported data.  The news comes at a time when awareness on pharma companies and their dealings with doctors is on the rise. In the UK, the NHS has warned that drugs firms should stop paying doctors and health service officials who refuse to be named in a new transparency register. In Ireland, doctors and other healthcare professionals were paid €6.8 million by pharmaceutical companies last year. J&J to pay US $ 70 million to family of boy who developed breastsLast week, a jury in America awarded US $ 70 million to the family of a boy who developed breasts after taking Johnson & Johnson (J&J) unit Janssen Pharmaceuticals' antipsychotic drug Risperdal. The jury found that the company failed to warn the boy's healthcare providers about the risk of gynecomastia, which is breast growth in men or boys caused by a hormonal imbalance. According to a copy of the verdict, the company intentionally falsified, destroyed or concealed evidence in the case. Johnson & Johnson and Janssen are facing more than 12,000 claims over Risperdal, according to J&J's most recent quarterly report. Warning letters for Chinese factories; two Indian firms on import alert It was a busy week for the US FDA as it issued warning letters to three facilities in China – Shanghai Desano Pharmaceutical, Chongqing Lummy Pharmaceutical and Guangzhou Haishi Biological Technology. The laboratory personnel at Desano were found conducting “unofficial” testing to an order that the FDA inspectors concluded that “the volume of data in these auxiliary ‘test folders’ suggests that performing unofficial analyses is a common practice at your facility.” Chongqing Lummy which had been placed on the FDA’s import alert list earlier this year had investigators finding analysts manipulating results for multiple batches of API distributed to the US. Guangzhou Haishi, which unlike Desano and Lummy, produces finished formulations for the United States had investigators unveiling that the company released finished batches of drug products without complete testing. And despite the violations uncovered, Haishi’s quality unit released multiple batches of drug products for distribution.While warning letters were being issued to companies based in China, two Indian companies – Harika Drugs and Silverline Chemicals – which refused FDA inspections were placed on the import alert list.  As all the news of compliance troubles was accumulating, Strides Shasun successfully passed an FDA inspection in India; while regulators in the United States and Europe discussed ways on increasing collaboration to reduce the inspection load.  VCs continue to invest in American biotech startupsWhile 2015 proved to be the biggest year on record for venture investing in American biotech firms, this year could be equally big. In 2015, a total of US $ 7.7 billion flowed into a range of startups. These were largely clustered in Boston/Cambridge and San Francisco. This year, the IPO window for drug developers has dropped considerably, but the VC money seems to be flowing into the biotech space at the same pace as last year. Millions of Indonesian children to be revaccinated due to fake vaccine scandal Fake vaccines, that have been distributed across Indonesia since 2003, will have the Indonesian government reinoculate children aged 10 and under. While it is not clear how many children will receive their jabs again, it is estimated that the number runs in millions. The Indonesian police have arrested 15 suspects and seized hundreds of bogus vaccines, including substances that passed off as vaccines for polio and hepatitis B. The fake-vaccine manufacturing and distribution rackets uncovered in Indonesia follows a similar public-health outcry that occurred in China a few months back.  Scrutiny on clinical trials performed in India continues Last week, two regulators -- Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) – took action pertaining to clinical trials conducted in India. The MHRA suspended marketing approval for a widely used antibiotic – erythromycin – that had won clearance based on clinical trials conducted by India's Quest Life Sciences, due to concerns over the integrity of trial data. The MHRA's decision bars the sale of a generic version of erythromycin that is being sold in the UK by Dawa Ltd, a Kenyan drug maker. The EMA, on the other hand, has recommended the suspension of drug Riluzole Alkem, for which studies were conducted at the Alkem Laboratories site in Taloja (Maharashtra).  Advertising Standards Authority bans Reckitt Benckiser’s painkiller ad There are strict rules that govern the advertising for pharmaceuticals and Reckitt Benckiser recently found out that there can be a blowback if you astray from the rules.  The company was selling targeted painkillers for different ailments: period pain, migraines and headaches. The Advertising Standards Authority (ASA) banned an advertisement for Nurofen Joint and Back because, despite appearances, the pills in the range have no specific targeting powers.  AstraZeneca and Genzyme were recently shamed in advertisements for separate breaches of the Association of the British Pharmaceutical Industry's (ABPI) Code of Practice. AstraZeneca apparently breached three clauses of the Code by producing a leave piece which provided misleading instructions on how to use the EMIS Web clinical system – which allows healthcare professionals to record, share and use vital information.Similarly, Genzyme breached the Code when it made a presentation about Fabrazyme (agalsidase beta) to an expert advisory group, that the PMCPA (Prescriptions Medicines Code of Practice Authority) says was “misleading, inconsistent with the Fabrazyme SPC and disparaging of a competitor product.” New age antibiotics, a golden opportunity for Big PharmaAfter decades of ignoring the antibiotics business due to scant rewards, Big Pharma is back to developing new antibiotics. Research incentives from governments are spurring drug makers to renew efforts to fight antimicrobial resistance and replenish the arsenal of infection-fighting drugs. Giants such as Roche Holding and Merck are stepping up their efforts. Several startups are seeking partners to help market new products.“Some large pharmaceutical companies are re-entering the space, and new companies focused on antibacterial development are emerging as industry darlings,” said Ankit Mahadevia, chief executive officer of Spero Therapeutics LLC, a biopharmaceutical company in Massachusetts that’s developing novel treatments for bacterial infections. An analysis that decodes drug price hikes, discounts and inflationA Bloomberg analysis of 39 medicines sold in the US with global sales of more than US $ 1 billion per annum revealed that 30 of them logged price increases of more than double the rate of inflation from 2009 to 2015, even after estimated discounts were factored in. Only six drugs had price increases in line with or below inflation. The analysis is based on discount estimates from SSR Health, an investment research firm that compared estimates of gross sales for each drug, based on prescription data, to company-reported US net sales. According to the analysis, discounts vary according to the disease type and competition. For instance, the price increases in Humalog, the popular, short-acting insulin made by Eli Lilly were wiped out by even-bigger discounts. Gilead, Massachusetts find middle ground on Hepatitis C drugAfter threatening Gilead Sciences over the cost of its hepatitis C treatments, the commonwealth of Massachusetts has reached a deal with the drug maker for rebates for some of its residents who are infected with the chronic disease. The cost of hepatitis C drugs for about 2,800 people covered by MassHealth, which is the commonwealth’s Medicaid programme, has so far totaled about US $ 318 million from late 2014 through early 2016. The deal is expected to save the state a significant amount of money. Meanwhile, Gilead Sciences recently raised prices on a pair of older HIV medications that face patent expiration. This is part of the company’s strategy to encourage patients to switch to newer HIV treatments. However, this sort of pricing strategy is triggering criticism by AIDS activists. FDA strengthens its cancer initiative Richard Pazdur – who has been with the Food and Drug Administration for 20 years – was recently elevated to a new role. He will be running a new Oncology Center of Excellence that will coordinate all of the FDA’s clinical efforts in cancer. This oncology centre is part of the American Vice President Joseph Biden’s US $ 1 billion National Cancer Moonshort effort. At the FDA, Pazdur was evaluating new cancer drugs.Cancer medicines now account for 40 percent of the drugs under development. According to the FDA commissioner, Robert Califf, a few years ago, pharma companies were worried that their drug pipelines had run dry. Now, they are filing drug applications at a dizzying pace. Add to that, he says, new technologies like DNA sequencing and 3D printing, and there is an “avalanche” of new products coming. “We have to be prepared for this,” Califf says. 

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    #Phispers by PHARMACOMPASS
    07 Jul 2016
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    Phispers: Pfizer-Allergan end megamerger, GSK wants to make copying its drugs easier & more

    Phispers: Pfizer-Allergan end megamerger, GSK wants to make copying its drugs easier & more

    This week, the biggest news in the world of pharmaceuticals was the termination of the Pfizer-Allergan mega-merger due to new measures taken by the US government. Post that, Allergan signed a US $ 3 billion licensing deal with UK’s Heptares for a portfolio of neurological drugs. But a lot more happened last week – for instance, Pfizer and Celltrion won approval for a biosimilar of J&J’s Remicade, GSK said it wants to make it easier for manufacturers in least-developed countries to make its drugs and Valeant terminated the salesforce for its female libido pill. Pharmaceutical Whispers (Phispers) brings you the latest news from across the world. Pfizer-Allergan terminate merger; Allergan signs licensing deal with HeptaresOn Monday, the US Treasury announced new measures to curb tax-inversion deals. The measures seemed to specifically target the Pfizer-Allergan US $ 160 billion mega deal. And, by Wednesday, the US government had achieved its desired objective – Pfizer and Allergan announced their decision to mutually terminate the deal.  Allergan, which is run from New Jersey but has a legal domicile in Dublin, last year agreed to merge with Pfizer. This mega-merger would have moved the Pfizer headquarters from New York to Dublin, saving the pharma behemoth billions of dollars in taxes. As per news reports, Pfizer will need to pay a US $ 400 million fee to Allergan for expenses relating to the deal. Though the US Treasury decision and the termination of the Pfizer-Allergan deal represents a victory for President Barack Obama, whose administration proposed tougher rules aimed at curbing tax inversions, Allergan is not wasting time. Just hours after Allergan backed away from the US $ 160 billion-merger with Pfizer, the company bounced back with a US $ 3.3 billion licensing deal for global rights to a portfolio of drugs for neurological disorders from the UK's Heptares. The deal sends a clear signal that Allergan CEO Brent Saunders plans to barrel ahead with new pacts to bolster the company's pipeline.  Pfizer, Celltrion win approval for biosimilar of J&J’s RemicadeNot all news this week was negative for Pfizer as the FDA approved Celltrion’s biosimilar application of Johnson & Johnson’s Remicade. The product will be co-marketed by Pfizer in the United States, a relationship Pfizer accessed through its acquisition of Hospira last year. Celltrion’s application is only the second biosimilar approved by the FDA. However, unlike generic medicines, biosimilars which have been currently approved are not interchangeable with the reference drug. The European Medicines Agency also issued a positive opinion to the Bioepis copy of Remicade. Samsung Bioepis, a joint venture between a unit of the Samsung group and Biogen, has become a force in the biosimilar drugs industry. In fact, South Korea too is emerging as a hub for biosimilar production. Last week, Bioepis filed a lawsuit against AbbVie Inc., makers of the world’s best-selling rheumatoid arthritis drug – Humira – which generated sales of US $ 14 billion last year. In 2015, Johnson & Johnson’s Remicade sales were US $ 6.5 billion.  Glaxo not to patent drugs in poorer countriesIn an unusual step, GlaxoSmithKline said it wants to make it easier for manufacturers in the world's 48 least-developed countries to copy its medicines. The company said it would not file patents in these countries in the hope that by removing the fear of patent litigation and by allowing independent companies to make and sell versions of its drugs in those areas, it would widen public access to these drugs. In countries classified as lower middle income countries by GSK, it will continue to file patents, but will grant licenses to generic manufacturers in exchange for a “small royalty”. Gilead has adopted a similar model, of granting generic licensing agreements in developing countries, for its blockbuster Hepatitis C treatment, Sovaldi. The end of the female Viagra?Valeant Pharmaceutical, still reeling from all its accounting and price-gouging problems, has terminated the sales force for the female libido pill that it acquired last year for US $ 1 billion. The drug – Addyi  (flibanserin) – failed to gain traction in its first six months on the market. Valeant’s stock has plunged 90 percent since its peak in August last year. Valeant plans to relaunch its sales effort for Addyi with an internal team it will build in the coming months, says a Bloomberg news report. In the meantime, the drug will still be available. Along with the 140 contract workers that make up the Addyi sales force, Valeant is firing about 140 employees across its dermatology, gastrointestinal and women’s health divisions, with dermatology taking the biggest hit. Valeant has about 22,000 employees. Alkem, Rusan and Anuh Pharma – data-integrity issues raise its ugly head yet again in India Inspection at Alkem: In July 2015, the European Union banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences. And this year, another laboratory is under the lens of EU regulators.A routine inspection by the European Medicines Agency in March 2015 of the Department of Bioequivalence of Alkem Laboratories, a major generic drugs manufacturer in India, raised concerns regarding study data used to support the marketing authorization applications of some drugs in the EU.  Rusan Pharma back in news: In an inspection conducted in 2010 at Rusan Pharma’s facility in Gandhidham (India), the UK’s Medicines and Healthcare Regulatory Agency (MHRA) uncovered “evidence of fraudulent presentation of data” and determined that the site did not comply with Good Manufacturing Practices (GMPs). The same year, another unit of Rusan, located in Ankleshwar (India), did not meet GMP compliance standards during an inspection conducted by Romania’s National Agency for Medicines and Medical Devices. This week, Rusan was back in news. In January 2016, re-inspection by UK’s MHRA of the Gandhidham site found the Pharmaceutical Quality System “not operating in an adequate manner”. In addition, the inspection report mentions “there was not adequate evidence that the root causes of critical data integrity issues raised at the last inspection had been addressed.”  Non-compliant sourcing of drugs by Anuh Pharma: The French Health Agency’s inspection at Anuh Pharma’s facility in Boisar (India) revealed the firm was sourcing commonly used Azithromycin from a non-EU GMP compliant source (Hebei Dongfeng Pharmaceutical Company Limited, China), micronizing the product and then directly exporting it to Europe under the manufacturer name, Anuh Pharma. In addition, several documents were found within a pile of rubble which included an original batch repacking record. A large number of active substances were manufactured at the site, such as chloramphenicol, chloramphenicol palmitate, erythromycin, erythromycin ethylsuccinate, roxithromycin, ciprofloxacin HCl etc.    Catalent’s compliance problems delay OPKO’s new drug launchWith more than 40 manufacturing facilities around the world, Catalent is a preferred manufacturing partner for several major pharmaceutical companies across the world. OPKO Health, Inc., one of Catalent’s customers submitted its application for RAYALDEE® (calcifediol) to the FDA. In the complete response letter (CRL) issued to the company, the FDA indicated observations of deficiencies at Catalent’s St. Petersberg, Florida, facility as a result of an FDA field inspection initiated on March 14, 2016, and had held up the new drug approval. According to a news report, OPKO revealed the deficiencies occurred at Catalent’s primary softgel development and manufacturing at St Petersburg, Florida, which was hit with a Form 483 being issued on March 25. Meanwhile, Catalent began production of essential drugs at its French plant, which had been suspended by France’s health regulator in November last year due to occurrence of out-of-place capsules in several product batches. Safety warnings for new age diabetes drugs -- saxagliptin and alogliptin Last year, the FDA had issued safety warnings on new age diabetes drugs called SLGT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) and PharmaCompass had asked the question, “Diabetes: Which new drug is the safest?”. At the time Merck succeeded in demonstrating the cardiovascular safety of Januvia®, which was not the case for other products in the same categrory such as AstraZeneca’s Onglyza® (saxagliptin) and Takeda’s Nesina® (alogliptin). This week the FDA issued a safety warning on Onglyza® (saxagliptin) and Nesina® (alogliptin) as the evaluation of two clinical trials determined that more patients who received saxagliptin or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo. Blockbuster drug approval expected soon for non-alcoholic fatty liver The FDA reviewed the application of Intercept Pharmaceuticals Inc's liver drug, Obeticholic Acid (OCA) and did not raise any major red flags indicating a high likelihood that it will get approved. While the drug is being reviewed for use in patients with primary biliary cirrhosis, a rare liver disease, late-stage studies are underway on the same drug to treat non-alcoholic steatohepatitis (NASH), which has no approved treatment. Obeticholic acid (OCA) is listed as one of the top 10 possible blockbuster drugs by FierceBiotech with an expected sales in 2020 of US $ 1.6 billion. Gilead is also actively building its liver disease pipeline and this week, the company paid US $ 400 million upfront to acquire an early-stage pipeline of liver disease drugs from privately held Nimbus Therapeutics. Heart-disease science turns over its headScience is supposed to be simple – for instance, LDL is bad cholesterol and HDL is good cholesterol. If a drug lowers the bad cholesterol and increases the good one, the risk of heart disease should reduce significantly. Specialists were stunned by the results of a study of 12,000 patients, announced on Sunday at the American College of Cardiology’s annual meeting: “There was no benefit from taking the drug, Evacetrapib.” The drug’s maker, Eli Lilly, stopped the study in October, citing futility, but it was not until Sunday’s meeting that cardiologists first saw the data behind that decision. As per the study, participants taking the drug saw their LDL levels fall to an average of 55 milligrams per deciliter from 84. Their HDL levels rose to an average of 104 mg per deciliter from 46. Yet 256 participants had heart attacks, compared with 255 patients in the group who were taking a placebo. Ninety-two patients taking the drug had a stroke, compared with 95 in the placebo group. And 434 people taking the drug died from cardiovascular disease, such as a heart attack or a stroke, compared with 444 participants who were taking a placebo.   

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    #Phispers by PHARMACOMPASS
    07 Apr 2016
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