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    Pharma Deals, Investments and M&As in March 2018

    Pharma Deals, Investments and M&As in March 2018

    If the first two months of 2018 saw pharma and biotech firms receive more money than what all biotech companies raised throughout 2013, March witnessed the biggest takeover transaction of the year so far — health insurer Cigna Corporation acquired pharmacy benefit manager (PBM) Express Scripts Holding for around US$ 67 billion. Healthcare shakeout in the United States continues   As part of a shakeout in healthcare that has indeed gathered momentum in the United States, primarily in response to the growing frustration over drug pricing, health insurer Cigna Corporation has agreed to buy pharmacy benefit manager (PBM) Express Scripts Holding for around US$ 67 billion. Click here to view the major deals in March 2018 (FREE Excel version available) As of 2017, Express Scripts is the largest of the remaining independent PBMs. The deal would give the two companies substantial bargaining power over drug prices in the US. Healthcare spending has been rising rapidly, accounting for an estimated 18 percent of the US economy in 2017. PBMs, such as Express Scripts, negotiate drug benefits for insurance plans and employers. The medical supply chain has become cumbersome. Insurers, PBMs, drug distributors, pharmacies, and large medical groups — all get a cut of the profits from caring for patients. Bringing these businesses under one roof could streamline costs and improve care. The deal could help Cigna compete with players like CVS Health Corp and UnitedHealth Group Inc. The former recently acquired Aetna Inc. for around US$ 69 billion, linking its pharmacies and drug-benefit plans with the insurer’s coverage. There are lots happening in the PBM space. In March, Andrew Witty, former CEO of GlaxoSmithKline who retired from the British drug major a year back, announced he was taking a leadership role in managing drug benefits in one of the largest, fastest growing outfits in the US. Click here to view the major deals in March 2018 (FREE Excel version available) Witty has been named the new CEO of UnitedHealth’s Optum division, a PBM group and healthcare analytics company. Optum has 140,000 staffers around the world. It earns roughly half of UnitedHealth’s revenue (which was US$ 201 billion in 2017) from its three key subsidiaries — OptumHealth and OptumInsight as well as OptumRx. Merck continues its cancer drug deal making   Japan’s Eisai Co and US-based Merck & Co announced a potential multibillion-dollar deal to develop and sell Eisai’s cancer drug Lenvima, which is already approved in dozens of countries as treatment for thyroid cancer and advanced kidney cancer (when used along with another medicine). As per the deal, the Japanese drugmaker could potentially receive up to US$ 5.76 billion if it proves a success. This includes an upfront payment of US$ 750 million. The remaining US$ 5.01 billion will be paid by Merck for development achievements and sales milestones, a joint statement said. Merck will be entitled to half of all global Lenvima sales revenue, even for its already approved uses for thyroid cancer and advanced kidney cancer. The deal is similar to a multibillion-dollar oncology collaboration Merck struck with AstraZeneca Plc for its cancer drug Lynparza last year. Click here to view the major deals in March 2018 (FREE Excel version available) Ionis buys back into company it spun-off less than a year ago   Akcea Therapeutics, a biotech company focused on rare diseases caused by lipid disorders, was founded in 2015 as a subsidiary of Ionis Pharmaceuticals. Its drug pipeline of four drug candidates were developed using Ionis’ technology and its most advanced drug was volanesorsen, a drug developed to treat familial partial lipodystrophy, or FPL. A year ago, Akcea was spun out of its parent as it filed an initial public stock offering (IPO) to drive forward the FDA approval for its lead drug which is expected by mid-2018. Last month, Ionis announced that it has signed an exclusive, worldwide licensing deal with Akcea related to two of its other drugs - inotersen and AKCEA-TTR-LRx, formerly IONIS-TTR-LRx. The total milestone payments associated with this deal are $1.3 billion while the transaction could make Ionis eligible for up to $1.7 billion, plus profit-sharing payments. Click here to view the major deals in March 2018 (FREE Excel version available) Interim Lundbeck CEO’s billion-dollar buy   Denmark-based H. Lundbeck announced it was acquiring Prexton Therapeutics for US$ 123 million. Lundbeck is also committing an additional US$ 1 billion in milestones — with more than half of that tied to sales goals.  Prexton Therapeutics was formed as a spin-off from Merck in 2012. The acquisition has a mid-stage Parkinson’s drug— foliglurax — at its core. The drug is in Phase II testing for the symptomatic treatment of Parkinson’s disease and dyskinesia, including Levodopa Induced Dyskinesia (LID). First data from the ongoing clinical Phase II program is expected to be available in the first half of 2019, the company said. Click here to view the major deals in March 2018 (FREE Excel version available) Anders Götzsche, the interim CEO of Lundbeck, said the acquisition will provide Lundbeck full control of the future of foliglurax. “Foliglurax addresses high unmet needs with its potential indication in Parkinson’s fitting perfectly within Lundbeck’s core areas and this treatment option also appears to be highly interesting for patients, physicians and payers,” Götzsche said.  Click here to view the major deals in March 2018 (FREE Excel version available) The Phase II trial, which began in 2017, will add foliglurax to standard care of treatment for Parkinson’s disease, which includes drugs like levodopa. The primary goal of the Phase II trial is to assess efficacy, safety and tolerability of foliglurax in reducing motor complications of levodopa therapy in patients experiencing end-of-dose wearing-off and LID. GlaxoSmithKline doubles down on OTC   Over the past few months, there has been a lot of speculation around who will acquire Pfizer’s consumer health division auction has been the subject of a lot of speculation over the past few months. Last month Reckitt Benckiser pulled out of the race and British drug major GlaxoSmithKline was considered the leader in the race for the division. However, GSK too withdrew from the deal talks. While there was news  that Glaxo had made a final bid valuing Pfizer’s over-the-counter (OTC) treatments at about US$ 15 billion to US$ 20 billion, GSK announced it had reached an agreement with Novartis to acquire full ownership of its consumer healthcare business. GSK will buy out Novartis’ 36.5 percent stake in a joint venture worth US$ 13 billion (£9.2 billion). Click here to view the major deals in March 2018 (FREE Excel version available) With this acquisition, GSK is in full control of a joint venture that owns successful OTC products like Sensodyne toothpaste, Panadol headache tablets and Nicotinell patches. In 2017, the business reported sales of US$ 11 billion (£7.8 billion). Japan’s Fujifilm bets on the market for cell culture media   Irvine Scientific Sales Company (ISUS) and IS Japan (ISJ), two companies specializing in cell culture media were acquired last month for $800 million by Japan’s Fujifilm. In recent years, culture media has received increased interests as it contains the nutrients required for the growth and proliferation of cells essential for cell culturing in the R&D and manufacturing of biopharmaceuticals and regenerative medicine products. Most importantly, the quality of the culture medium can influence the quality and efficiency of cell culturing. Click here to view the major deals in March 2018 (FREE Excel version available) “The market for cell culture media is expanding following the dramatic growth in the demand for biopharmaceuticals centered around antibody drugs and the increasing need for treatments using cells, and its annual growth is expected to be approximately 10% going forward,” the company said in its official announcement. Click here to view the major deals in March 2018 (FREE Excel version available) Our View   The first quarter of 2018 has shown a relentless rise in dealmaking as an outcome of increased liquidity in the financial markets, new technological breakthroughs, dwindling new drug pipelines of major pharmaceutical companies, an aging population along with rising health consciousness among consumers is expected to further propel dealmaking in the world of pharmaceuticals. With Pfizer always on the lookout, the upcoming quarter may just eclipse the records we’ve seen set in the first three months of the year.  Click here to view the major deals in March 2018 (FREE Excel version available)  

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    https://www.pharmacompass.com/radio-compass-blog/pharma-deals-investments-and-m-as-in-march-2018

    #PharmaFlow by PHARMACOMPASS
    19 Apr 2018
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    India-China border tension may impact billion dollar pharma deal; AZ’s investors worry as key cancer drug fails trial

    India-China border tension may impact billion dollar pharma deal; AZ’s investors worry as key cancer drug fails trial

    This week in Phispers, we analyze the situation at AstraZeneca, where its much anticipated lung cancer drug failed in clinical trials. In the US, there are reports that various generic players are looking to enter into M&A deals in order to safeguard themselves against regulatory crackdown on prices. The tension along the India-China border may lead to cancellation of the Fosun-Gland deal by the Indian government and in the US, the FDA is looking to cut nicotine in cigarettes to ensure they are non-addictive. AstraZeneca’s key lung cancer drug fails in first stage trial; gets investors worried   The year 2017 was supposed to be a pivotal year for AstraZeneca. The firm was supposed to display new marvels from its laboratories and march towards annual revenues of US$ 45 billion by 2023. This target was set when Pfizer’s takeover offer was rejected in 2014. But so far, the year has turned out horribly for AstraZeneca. Its key lung cancer drug — Imfinzi — flopped in clinical trials. Known as the ‘Mystic’ study, this was the most anticipated clinical experiment in the pharmaceutical industry this year. The study was key to proving the value of the group’s new drug pipeline, after it rejected a US$ 118 billion takeover bid by Pfizer in 2014.The news crashed the share price of AstraZeneca by 15 percent. Imfinzi, an immuno-oncology drug, was said to be a potential replacement for chemotherapy. However, all is not lost yet. The first stage of the trial merely measured the drug’s ability to prevent a cancer from becoming worse. The second stage, which looks at survival rates, is said to be more important. But for Pascal Soriot, AstraZeneca’s CEO, this came as an embarrassment. He faced a barrage of questions from analysts about future payouts of the company. He was forced to defend the company’s dividend strategies at post-result meets last week. Fears for AstraZeneca’s dividend were driven by the failure of the lung cancer. But there is hope for Astra in the future — another lung cancer pill, Tagrisso, has produced good data. And AstraZeneca is partnering with Merck on another immuno-oncology drug, Lynparza. Another downside for Astra in 2017 has been the uncertainties faced by the company regarding its top executives. It began in January this year, when Luke Miels, the head of AstraZeneca’s European operations, announced he is quitting the company to join GlaxoSmithKline. Recently, there were speculations regarding Soriot considering an offer to join Israeli drugmaker Teva as its head. He is learnt to have turned down the offer. Bleak US generics market forecast has drug makers scrambling for deals   In the US, generic drug makers are turning to M&As in order to safeguard themselves against a concerted effort by regulators to crack down on the steep prices of drugs. According to a Reuters report, Impax Laboratories, Perrigo and Alvogen have been talking to advisers about various strategic options for their generics businesses. These options range from acquisitions, as well as outright sale. Earlier, Reuters had reported that Mallinckrodt, one of the largest producers of the generic opioid painkiller oxycodone, has been exploring a sale of its specialty generics unit. In May, the CEO of Impax, which makes a generic version of the EpiPen allergy injection, said it was looking at deals. The US generics market is getting increasingly competitive. Last month, Novartis reported that sales at its Sandoz generics unit were down 4 percent. Generic drugs are cheaper versions of brand-name drugs. In the US, the government is targeting generics to cut the cost of prescription drugs. According to a 2016 report by the Journal of the American Medical Association, US consumers spend more than twice as much on drugs per capita compared to other industrialized nations. In order to bring down the prices of drugs, the US Food and Drug Administration (US FDA) has committed to eliminating the backlog of drug applications awaiting its approval. This could mean nearly 4,000 new drugs will come onto the market over the next few years, based on FDA estimates. Even today, small and mid-sized drug makers are under pressure as consolidation among generic drug distributors has made it less profitable for them to sell their drugs. India-China border skirmish may impact Fosun-Gland deal   The heightened tensions along the India-China border are likely to impact business. In the pharmaceutical industry, the Cabinet Committee on Economic Affairs (CCEA) in India is likely to reject Shanghai Fosun Pharmaceutical Group’s US$ 1.3 billion acquisition of Hyderabad-based Gland Pharma Ltd, says a Bloomberg report. However, a report in The Economic Times says the proposal was listed for CCEA’s consideration two weeks back. But the CCEA is yet to take a call on the Gland Pharma-Fosun deal. “It is wrong to say that the deal has been rejected,” the official said. The Gland Pharma-Fosun deal had been approved by the now-abolished Foreign Investment Promotion Board (FIPB) in March this year. And Fosun was to acquire 86 per cent stake in the injectable drugmaker.  According to IndiaSpend, China is today the 17th largest foreign direct investor in India, an improvement on the 36th rank it held in 2010. CRO Consolidation: LabCorp buys Chiltern, Evotec acquires Aptuit   Consolidation in the CRO industry continued unabated last week. LabCorp bought Chiltern for US$ 1.2 billion last week. Two years back, LabCorp had bought Covance for US$ 6.1 billion. The acquisition of Chiltern will add another 4,500 clinical outsourcing workers around the globe to its employee roster. Another CRO that made an acquisition last week was Germany’s Evotec. It bought out its rival Aptuit for US$ 300 million in cash. And the deal will add hundreds of scientists to its organization along with facilities in Basel, Oxford and Verona. Evotec has earned a large number of clients on both sides of the Atlantic. Evotec says most of Aptuit’s 750 employees are scientists. Last year, Aptuit reportedly handled 1,000 projects for some 400 companies. The CRO business has been consolidating for years, with private equity groups leading the way to build up these global organizations. Leading the pack is Thermo Fisher, which had made acquisitions worth US$ 22 billion in the last five years. Three months back, Thermo Fisher Scientific acquired Patheon NV for US$ 5.2 billion while INC Research Holdings merged with private-equity owned CRO — inVentiv Health. FDA to cut nicotine in cigarettes to non-addictive levels   Last week, the US government proposed cutting nicotine in cigarettes to “non-addictive” levels in order to move smokers towards potentially less harmful e-cigarettes. The FDA Commissioner Scott Gottlieb said the agency will study regulating nicotine levels with a view towards the “FDA’s potential to render cigarettes minimally addictive or non-addictive.” “Nicotine itself is not responsible for the cancer, the lung disease and heart disease that kill hundreds of thousands of Americans each year,” Gottlieb said. “It's the other chemical compounds in tobacco and in the smoke created by setting tobacco on fire that directly cause illness and death,” he added.  The FDA cannot reduce nicotine levels to zero, nor can it ban cigarettes. However, after this announcement by Gottlieb, shares of major tobacco firms in the US and UK slumped. Analysts said they expect regulators in Europe to study similar actions on nicotine products. This action shakes up a public health debate on whether e-cigarettes represent a health risk or a potential benefit. NotPetya cyber attack hits Merck’s profits   Merck is the latest in a string of companies that have disclosed that their operations were significantly disrupted by the NotPetya attack, which devastated businesses and government agencies in Ukraine in June and has gradually spread around the globe. According to a Reuters report, Merck said it had been a victim of an international cyber attack in June 2017, due to which the company had to halt production of drugs. As a result, its profits for the rest of the year have been hit. The company, however, said it is yet to know the magnitude of the impact as it is in the process of restoring manufacturing operations. Merck had disclosed the attack last month, but did not disclose the manufacturing shutdown at the time. The company said it was confident that it will be able to maintain a continuous supply of its top-selling and life-saving drugs, such as cancer drug Keytruda, diabetes drug Januvia and hepatitis C drug Zepatier. However, there maybe temporary delays in delivering some other products, which the company did not identify. “Full recovery from the cyber-attack will take some time, but we are making steady progress,” CEO Ken Frazier said. At least four other major US and European firms have also experienced massive outages due to NotPetya.  

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    https://www.pharmacompass.com/radio-compass-blog/india-china-border-tension-may-impact-billion-dollar-pharma-deal-az-s-investors-worry-as-key-cancer-drug-fails-trial

    #Phispers by PHARMACOMPASS
    03 Aug 2017
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    GSK’s NiQuitin (nicotine film strips) effectiveness questioned in whistleblower lawsuit

    GSK’s NiQuitin (nicotine film strips) effectiveness questioned in whistleblower lawsuit

    GlaxoSmithKline (GSK) rang in the New Year with yet another whistleblower lawsuit in the US market. The whistleblower – Alexandre Selmani – has accused the drug maker of firing him for pointing out statistical shortcomings in its study data, used to market the effectiveness of GSK’s smoking cessation product.Selmani, a former GSK biostatistics manager, had worked with the company for almost a decade. He alleges his supervisors repeatedly ignored his efforts to alert them to statistical mistakes made in clinical trials for NiQuitin Strips (called “NiQuintin” in the lawsuit!). The lawsuit was filed in a New Jersey state court. Selmani claims the company has engaged in an “illegal, deceptive marketing programme” to promote the product “without justification” as a “significant advance” in nicotine treatment. The lawsuit also alleges GSK maintained its product was superior to existing nicotine treatments. The 2014 study and Selmani’s protestsIn 2012, Selmani discovered that there were numerous mistakes made in the ‘Smokers Health Project’ being conducted by Michelle Kotler, Director of Biostatistics and Selmani's direct supervisor.Selmani began complaining about the data in mid-2012, but met resistance from his seniors. He then sent an email to Glaxo’s COO at the time, now CEO, Andrew Witty. In the email, he warned Witty that the mistakes had “the capacity to cause negative consequences and potential health and safety issues for the general public,” says the lawsuit. Despite Selmani’s protests, the company submitted the data for publication. The study in question, made public by GSK in April 2014 in Psychopharmacology, concluded that the nicotine film (NiQuitin) could be useful in providing quick craving relief for low-dependence smokers. The study compared the efficacy of the 2.5 mg nicotine oral soluble film to 2 mg nicotine lozenge for acute relief of smoking cue-provoked craving. According to Selmani, the film and lozenge could not be considered bioequivalent because they didn't have the same dose. In addition, he stated that the statistical criteria used to draw the conclusions of “the study was deficient”.  In his lawsuit, Selmani alleges that his supervisors gave him low performance ratings and reduced raises. They retaliated against him, and ultimately fired him in October 2015. His lawsuit cites the New Jersey Conscientious Employee Protection Act, which addresses retaliation by employers. GSK firmly behind its studyAccording to the study, “a randomized, open label, active comparator controlled, parallel group study was conducted with 322 smokers enrolled. After four hours of abstinence from smoking, eligible subjects were exposed to smoking cues as provocation.” The 322 smokers then took a randomized single dose of either the 2.5 mg nicotine film or the 2 mg nicotine lozenge. Craving assessments were completed at 50 seconds, three, five, seven, 15, 20, 25 and 30 minutes after the drug was administered.“Both treatments reduced cue-induced craving and had similar maximum effects on craving relief. However, the 2.5 mg nicotine film relieved cue-induced craving to a greater degree than the 2 mg nicotine lozenge at 50 seconds,” the study said.Meanwhile, a Glaxo spokeswoman told StatNews that the company had not been served and it stands “fully behind Nicoderm as a safe and effective form of smoking cessation which continues to help people to quit smoking. GSK goes to great lengths to promote ethics and compliance in the workplace… We also continually educate our employees about how they can report complaints so they can be appropriately investigated.”However, what is unclear in the GSK response is that Nicoderm, sold in the United States, is a patch while the NiQuitin brand in Europe has strips, patches, gums and lozenges. GSK’s previous troubles with whistleblowersThis isn’t the first time GSK has run into trouble with whistleblowers. Back in October 2010, Cheryl Eckard – the whistleblower who exposed serious contamination problems at GSK’s drug manufacturing operations in Puerto Rico – had been awarded US $ 96 million, after she won a lawsuit. At that time, Cheryl Eckard's payment was said to be the biggest ever handed to a US whistleblower. It was awarded after an eight-year fight, post which GSK agreed to pay the US government US $ 750 million to settle civil and criminal charges that it manufactured and sold adulterated drug products. Eckard had lost her job nine month after she made the complaints to the GSK management.Similarly, in August 2012, four former GSK employees – Greg Thorpe, Blair Hamrick, Thomas Gerahty and Matthew Burke – together made a gain of US $ 250 million after the evidence they provided helped US authorities secure a record settlement with GSK for mispromoting drugs Paxil and Wellbutrin to the US consumers between 1998 and 2003. The total fine paid by GSK was US $ 3 billion. The payout made to the four ex-employees was in line with a US law that allows whistleblowers to receive a portion of money the government recovers while prosecuting fraud. The four men, who had sales and marketing jobs with GSK in the US, fought the company for 10 years.  Our viewThe results of the GSK study are in the public domain. And so are the allegations made by Selmani in his lawsuit. After going through both the documents, we wonder if NiQuitin is a “significant advance” in nicotine treatment, as claimed by GSK.Given GSK’s previous track record of treating its whistleblowers, we feel this is one territory the drug maker needs to tread carefully. 

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    https://www.pharmacompass.com/radio-compass-blog/gsk-s-niquitin-nicotine-film-strips-effectiveness-questioned-in-whistleblower-lawsuit

    #Phispers by PHARMACOMPASS
    13 Jan 2016
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