Bristol, TN, United States

King Pharmaceuticals
Bristol, TN, United States

King Pharmaceuticals, is a wholly owned subsidiary of Pfizer based in Bristol, Tennessee. Before being acquired by Pfizer, it was the world's 39th largest pharmaceutical company. On October 12, 2010, King was acquired by Pfizer for $14.25 per share. King produced a wide range of pharmaceuticals, including Altace for heart attack prevention, Levoxyl for hypothyroidism, Sonata, a sleeping aid, and Skelaxin, a muscle relaxant. King Pharmaceuticals operated manufacturing facilities in Bristol, Tennessee; Rochester, Michigan; St. Louis, Missouri; St. Petersburg, Florida; and Middleton, Wisconsin. They employed approximately 2,700 people including a sales force of over 1,000 individuals. King Pharmaceuticals, Inc. was incorporated in the State of Tennessee in 1993. According to the King Pharmaceutcals, Inc. Form 10-K for the year ended December 31, 2007 filed with the U.S. Securities and Exchange Commission, the wholly owned subsidiaries of King Pharmaceuticals, Inc. are Monarch Pharmaceuticals, Inc.; King Pharmaceuticals Research and Development, Inc.; Meridian Medical Technologies, Inc.; Parkedale Pharmaceuticals, Inc.; King Pharmaceuticals Canada Inc.; and Monarch Pharmaceuticals Ireland Limited. Wikipedia.

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Setnik B.,King Pharmaceuticals | Roland C.L.,King Pharmaceuticals | Cleveland J.M.,King Pharmaceuticals | Webster L.,Lifetree Clinical Research and Pain Clinic
Pain Medicine | Year: 2011

Objectives. Remoxy® is a water-insoluble, highly viscous oral formulation of oxycodone extended release (ER) currently in development. The primary objective was to determine the abuse potential of Remoxy under fed conditions relative to oxycodone ER and immediate release (IR) under fasted conditions and compared with placebo (treatment group X). A secondary objective was to evaluate abuse potential under reversed fed/fasted conditions (treatment group Y). Design. Phase I randomized double-blind triple-dummy placebo- and active-controlled 6-way crossover study. Setting. A single US site. Patients. Healthy men and women aged 18-50 years who were nondependent, recreational opioid users. Interventions. Remoxy 40mg whole and chewed, oxycodone ER 40mg whole and crushed, oxycodone IR 40mg crushed, and placebo. Outcome Measures. The primary endpoint was the drug liking subscale of the drug effects questionnaire assessed by various pharmacodynamic parameters. Secondary endpoints included additional pharmacodynamic measures, chewing duration, and safety measures. Results. In treatment group X, Remoxy whole (fed) and chewed (fed) had a significantly lower abuse potential compared with oxycodone ER (crushed, fasted) and IR (fasted) based on the majority of pharmacodynamic parameters of interest for the primary endpoint (drug liking subscale) as well as secondary endpoints. Treatment group Y showed generally similar results. Conclusions. The abuse potential of Remoxy when taken whole or chewed was significantly lower than two comparators with known abuse potential, including oxycodone IR and crushed oxycodone ER, under the fed/fasted conditions tested. Remoxy may be associated with a reduced risk potential for abuse. © 2011 Wiley Periodicals, Inc.

King Pharmaceuticals | Date: 2012-07-11

The present invention provides novel crystalline polymorphic forms of 2-cyclohexylmethylidenehydrazino adenosine, also known as binodenoson, methods of making the same, and methods for the manufacture of a pharmaceutical composition by employing such crystal forms, in particular, for the use of binodenoson in a subject, in need thereof, as a pharmacological stress agent to produce coronary vasodilation.

News Article | March 18, 2010

After three tries, Somaxon Pharmaceuticals has won FDA approval for its insomnia drug. The San Diego-based biotech company said today it has gotten clearance to start selling doxepin (Silenor) in the U.S. for patients with short term and chronic insomnia. The news sent shares of the company (NASDAQ: SOMX) up by 60 percent to $6.20 at 1:20 pm Eastern time. This is the first FDA-approved product for Somaxon, which was founded in 2003. Somaxon persisted after its application was turned down by the FDA in February and December 2009. The approval means that Somaxon, or whoever it might form a partnership with, will seek to differentiate the new drug from competitors like Sanofi-Aventis’ zolpidem (Ambien and Ambien CR), King Pharmaceuticals’ zaleplon (Sonata), Dainippon Sumitomo’s eszopiclone (Lunesta). Somaxon’s drug has a different way of working than others, as I described in this feature story earlier in the week. The Somaxon product is designed to block histamine, a neurotransmitter in the brain that’s believed to help keep people awake. Clinical trials have shown that the drug can help people get a full night’s sleep including sleep into the 7th and 8th hour, the company says. Somaxon says its market research suggests that patients often decide not to use other drugs because of the potential for abuse and dependence. Somaxon hopes to take advantage of that market desire, pointing out that there were no indications of dependence in its clinical trials that enrolled more than 1,000 patients. The company didn’t say how much the drug will cost in its statement. The company hopes to introduce the product to the U.S. market in the second half of 2010, CEO Richard Pascoe said in a statement.

ZymoGenetics, Citing Two Patient Deaths, Builds Up Ammunition for Case Against Rival Before it asked the FDA to yank a drug made by its chief competitor, King Pharmaceuticals, off the U.S. market, ZymoGenetics learned that physicians had attributed the deaths of two patients to bad reactions to the drug, says ZymoGenetics CEO Doug Williams. I spoke with Williams this morning shortly after the Seattle biotech issued a statement saying that it has filed a formal citizen petition with the FDA, asking the agency to force Bristol, TN-based King to withdraw a rival treatment for surgical bleeding from the U.S. market. ZymoGenetics (NASDAQ: ZGEN) contends that King’s Thrombin-JMI product poses a risk of immune-system reactions that can lead to severe bleeding episodes, and even death. ZymoGenetics has been trying to grab away King’s market share, primarily by arguing its drug is safer. The King product, which has been around for years, is the dominant drug used to control bleeding in an estimated 1 million surgeries a year in the U.S. It generated $255 million in U.S. revenues last year. But ZymoGenetics has sensed an opportunity to supplant King’s drug, because it is derived from cow’s blood, and therefore recognized as foreign by the immune system, which it says can lead to complications with repeated use. ZymoGenetics won FDA approval for its recombinant version of human thrombin, called Recothrom, in January 2008. Just as with insulin for diabetes, animal-derived products eventually lose in the marketplace when safer, genetically engineered human products come along to replace them, the company contends. Yet ZymoGenetics it has struggled to capture much of the market for surgical bleeding drugs. It generated just $8.8 million in first-year sales—partly because physicians were unaware of the risks associated with the animal-derived product they had been using for many years, Williams says. Now the company hopes to change that, by asking the FDA to take a closer look at how to handle that risk from the cow-derived clotting agent. “There are physicians using Thrombin-JMI without a clear understanding of its risks,” Williams says. “There are at least three better alternatives in the marketplace now, that don’t have the same risk profile.” When reached by phone this morning, King Pharma’s vice president of investor relations, Jack Howarth, said the company has no comment. The 31-page citizen petition, which I reviewed this morning, highlights 25 cases published by researchers that drew a link between cow-derived blood control treatments and bad immune-system reactions that led to severe complications, or death. One report by a physician to the FDA last October attributed a death to usage of Thrombin-JMI, and just this month, ZymoGenetics said it learned of a second case. The prescribing information for Thrombin-JMI has carried the FDA’s strictest warning, called a “Black Box,” since 1996. It warns physicians of potentially dangerous immune reactions. But ZymoGenetics said few physicians seem aware of the risk, and keep using King’s product anyway. Now that ZymoGenetics’ genetically engineered version is on the market, along with two other products that use clotting proteins derived from human blood—Johnson & Johnson’s Evithrom and Baxter Healthcare’s Gelfoam Plus—there’s no longer any reason … Next Page »

News Article | May 5, 2009

ZymoGenetics is still struggling to generate sales from its lone commercial product. The Seattle biotech company said today it had $4.5 million in sales of recombinant thrombin (Recothrom) for surgical bleeding in the first quarter, which is down slightly from $4.7 million in the previous quarter. The trend can’t be encouraging, although ZymoGenetics (NASDAQ: ZGEN) suggested the raw numbers may be a bit misleading. That’s because the previous quarter’s product sales were inflated by about $800,000 worth of extra wholesale stockpiling that wasn’t actually sold to hospitals until the first quarter. When factoring out the inventory buildup, sales would have increased 36 percent in the quarter, the company said. ZymoGenetics won FDA approval to market recombinant thrombin in January 2008, so it has now had more than a year of experience in the marketplace to encourage doctors and hospitals to start buying it. The drug, a genetically engineered copy of a human protein that helps with the normal blood clotting process, is made to compete against a rival from King Pharmaceuticals derived from cow blood, called Thrombin-JMI. The ZymoGenetics product is supposed to be superior, although doctors haven’t started switching en masse. The ZymoGenetics drug generated just $8.8 million in sales last year, and the company has predicted it will generate $25 million to $35 million this year. Thrombin-JMI had $255 million in sales a year ago. With the first quarter off to a slow start, ZymoGenetics will have to boost sales significantly later this year to reach its goal. ZymoGenetics’ new president, Stephen Zaruby, formerly of Bayer, said everything about the drug—people who sell it, how it’s positioned in the marketplace, and how it’s priced, are subject to change. Still, the round of 161 job cuts announced last week—one-third of ZymoGenetics’ staff—was designed to cut R&D and other departments, while maintaining the company’s ability to market the drug. “We recognized from the beginning that this was a process of medical education, and that it would take time,” said ZymoGenetics CEO Doug Williams, on a conference call with analysts. “We are beginning to make progress, and it will take continuing efforts to bear fruit.” Specifically, Zaruby said he remains confident in the product, because of increasing hospital orders in the first quarter, and larger and more frequent orders from existing hospital customers. Pricing, however, is down, he said, as more customers are taking advantage of bulk-buying discounts the company implemented in October to become more competitive with Thrombin-JMI. By the second half of 2010, the product should generate positive cash flow that can be plowed into the rest of the business, Williams said. As recombinant thrombin has struggled, ZymoGenetics has acted to boost revenues in other ways, while also reducing costs. The company signed a partnership in January with Bristol-Myers Squibb that has brought in $105 million in cash so far this year, and is expected to produce another $95 million for ZymoGenetics this year. That helped the company raise its cash reserves from $89.9 million heading into this year, to more than $152 million at the end of the first quarter, March 31. The company has shown it wants to make that cash last longer than it would have in the past. ZymoGenetics says its recent job cuts, along with reduced spending on R&D programs, will save $30 million a year.

News Article | December 10, 2010

Two companies in the business of distributing video had a good day on Thursday: Netflix beat out the New York Times for a spot on the S&P 500, and Cablevision also joined the index, thanks to King Pharmaceuticals merging with Pfizer. The S&P 500 switchup is good news for the companies, both of which occupy potentially tenuous positions within their respective industries. Cablevision, for example, spent a good portion of October in a messy fight with News Corp over retransmission rights for Fox programming, eventually caving in right before Game 3 of the World Series). Congress may start intervening in such disputes, since cable providers are dependent on companies like Fox for their content. But every retrans battle in recent memory seems to end with customers losing out on content they want, like G4 or the Hallmark Channel, or the content provider getting what they want. Meanwhile, the Hollywood studios that fuel Netflx’s catalog of movies and TV shows are growing increasingly uneasy with Netflix’s rising success. While Netflix is making plenty of deals to add new content, several execs were quoted recently as saying that they saw Netflix as a shark out to steal their content — more than a hint that the company may struggle in the coming months to secure the titles it needs to stay relevant. It’s easy to see why Hollywood might feel threatened — Netflix’s stock is up over 230 percent from last year. But today’s reindexing means a boost in stock prices for both companies and potentially greater stability in the marketplace. It’s no guarantee of success, but these days, there’s really no such thing.

News Article | October 13, 2010

Pfizer has announced its intention to acquire pain drug maker King Pharmaceuticals for $3.6 billion. Pfizer and King Pharma have entered into a definitive merger agreement whereby Pfizer will acquire King Pharma for $14.25 per share. The offer price represents a 40 per cent premium on King Pharma’s closing price as at Oct 11, 2010. The Boards of both companies have approved the deal, which is expected to boost Pfizer’s 2011 and 2012 earnings by 2 cents annually. The company expects 2013 – 2015 earnings to be boosted by 3_4 cents annually. Pfizer also expects to achieve cost savings of at least $200 million by late 2013. With several of King Pharma’s products facing slowing prescription trends mainly due to generic competition, analysts believe that Pfizer’s main attraction is towards King Pharma’s pain management portfolio. “With this acquisition, Pfizer is looking to strengthen its position in the pain management market, which represents a significant commercial opportunity. The addition of King Pharma’s pain products will diversify Pfizer’s product portfolio and bring in additional sources of revenue.” In the deal Pfizer gains products including the pain drug Avinza and EpiPen, a pre_filled injection designed to quickly treat serious allergic reactions.The deal is Pfizer’s largest since it bought rival Wyeth for $68 billion in 2009. That deal closed last October.

NOT FOR DISTRIBUTION IN THE UNITED STATES OR TO U.S. NEWSWIRE SERVICES Comstock Metals Ltd. (TSX VENTURE: CSL)("Comstock" or the "Company") is pleased to announce that at its Annual General Meeting of Shareholders held on Monday February 27, 2017, incumbent directors David Terry, Doug Turnbull, Steven Goldman and Rasool Mohammad were re-elected to the Board of Directors of the Company, and Ken Kuchling and Jeffrey Gregory were elected as new directors. At the Meeting, Shareholders also approved the number of directors, approved and ratified the Company's stock option plan, and re-appointed Dale Matheson Carr-Hilton LaBonte LLP, Chartered Accountants, as auditor of the Company. The Company is also pleased to announce that it has closed its previously announced non-brokered private of units ("Units") and flow-through units ("FT Units"). Pursuant to the offering the Company issued a total of 13,344,157 Units and 3,563,900 FT Units raising aggregate gross proceeds of $2,643,125.65. President and CEO David Terry stated ""I am very pleased to have Ken Kuchling and Jefferson Gregory join the board of directors of Comstock. Their vast experience and knowledge will be instrumental in assisting the Company as it moves forward." Mr. Kuchling brings with him over 35 years' experience in mine engineering, mining operations and consulting across a variety of commodities including precious metals, base metals, bauxite, iron ore, tungsten, molybdenum as well as diamonds and potash. Throughout his consulting career he has had direct involvement in scoping and feasibility studies, project management, 43-101 technical reports, economic modelling, mine design, and environmental permitting. Mr Kuchling has project experience working in various regions in Canada, Alaska, Mexico, Panama, Argentina, Suriname, Russia, South Korea, Italy, Spain, and Senegal. He was involved in the design stage and environmental permitting of the Diavik Diamond Project in the Northwest Territories and has experience with tropical to Arctic mining conditions. Mr. Kuchling is a mining engineering graduate from McGill University and holds a Masters of Mine Engineering from University of British Columbia. He is also a member of Professional Engineers Ontario (PEO) and currently lives in Toronto Ontario. Mr. Gregory is a businessman and investor specializing in the pharmaceutical sector. Throughout his career he has been involved in founding and operating a number successful companies, including NYSE-listed King Pharmaceuticals, Inc. between 1993 and 2004 and Graceway Pharmaceuticals LLC from 2006-2011. Mr. Gregory is the listed inventor on numerous awarded USPTO patents and he serves, or has served, as a member of the Board of Directors of multiple pharmaceutical, academic and charity organizations. Mr. Gregory or his transactions in the pharmaceutical industry have won numerous business awards and have been featured on multiple occasions in, among others, The Wall Street Journal, Forbes Magazine, Smart Money Magazine, Business Week, and CNBC. His strategies and methods have been taught as case studies at The Wharton School at The University of Pennsylvania. Mr. Gregory graduated from the University of Maryland in 1979 with a BS degree in Pharmacy and from the University of Maryland in 1985 with a Juris Doctorate Degree. He also holds an honorary Doctor of Laws degree conferred upon him by King University, TN. Each Unit was issued at a price $0.15 and consists of one common share in the capital of the Company (a "Share") and one common share purchase warrant (a "Warrant"). Each Warrant entitles the holder thereof to purchase one additional common share of the Company (a " Share") at an exercise price of $0.20 per Share for a period of 24 months from the Closing Date. Each FT Unit was issued at a price $0.18 and consists of one flow-through common share in the capital of the Company (a "FT Share") and one-half of one common share purchase warrant (each whole warrant a "FT Warrant"). Each FT Warrant entitles the holder thereof to purchase one additional non flow-through common share of the Company (a "Share") at an exercise price of $0.20 per Share for a period of 24 months from the Closing Date. The Warrants and FT Warrants include an acceleration clause, whereby, if the weighted average trading price of the Company's common shares on the TSX Venture Exchange (or such other exchange on which the common shares may trade) is at a price equal to or greater than $0.40 for a period of 20 consecutive trading days, the Company will have the right to accelerate the expiry date of the Warrants and FT Warrants. If the Company exercises such right, it will give written notice to the holders of the Warrants and FT Warrants that such warrants will expire 30 days from the date of notice to the warrant holders. Such notice by the Company to the holders of the Warrants and FT Warrants may not be given until 4 months and one day after the Closing Date. In connection with the closing of the financing, the Company paid finders an aggregate commission of $58,318.81 and issued an aggregate of 352,898 compensation options. Each compensation option entitles the holder thereof to acquire one Unit at a price of $0.15 per Unit for a period of 24 months from the Closing Date. The Company will use the gross proceeds of the offering of FT Units for eligible exploration expenditures, which will constitute "Canadian Exploration Expenses" ("CEE") that are "Flow-Through mining expenditures", as defined in the Income Tax Act (Canada) which can be renounced to purchasers of the FT Units for the 2017 taxation year in the aggregate amount of not less than the total amount of the gross proceeds raised from the flow-through offering. The CEE shall be incurred no later than December 31, 2018. The proceeds from the offering of Units will be used to fund exploration on the Company's mineral properties and for general working capital. The securities issued under the offerings have not been, and will not be, registered under the U.S. Securities Act or any U.S. state securities laws, and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons absent registration or any applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. The securities issued in this financing are subject to a hold period that expires on June 28, 2017. Comstock Metals Ltd. is a Canadian-focussed mineral exploration company with two 100% owned resource-stage gold projects. Additional Assets: Comstock also owns the early stage Old Cabin gold project in Ontario and uranium claims in the Patterson Lake area of Saskatchewan and has optioned out its Corona property in Mexico (see Comstock's news release dated January 28, 2016). David A. Terry, Ph.D., P.Geo., a Qualified Person as defined by National Instrument 43-101, has reviewed and approved the scientific and technical disclosure in this news release. This news release includes forward-looking information and statements, which may include, but are not limited to, information and statements regarding or inferring the future business, operations, financial performance, prospects, and other plans, intentions, expectations, estimates, and beliefs of the Company. Such statements include statements regarding the use of proceeds resulting from the financing. Forward-looking information and statements involve and are subject to assumptions and known and unknown risks, uncertainties, and other factors which may cause actual events, results, performance, or achievements of the Company to be materially different from future events, results, performance, and achievements expressed or implied by forward-looking information and statements herein. The assumptions on which the forward looking statements contained herein rely include the ability to complete the proposed financing. Although the Company believes that any forward-looking information and statements herein are reasonable, in light of the use of assumptions and the significant risks and uncertainties inherent in such information and statements, there can be no assurance that any such forward-looking information and statements will prove to be accurate, and accordingly readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance upon such forward-looking information and statements. Any forward-looking information and statements herein are made as of the date hereof, and except as required by applicable laws, the Company assumes no obligation and disclaims any intention to update or revise any forward-looking information and statements herein or to update the reasons that actual events or results could or do differ from those projected in any forward looking information and statements herein, whether as a result of new information, future events or results, or otherwise, except as required by applicable laws. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this Release.

News Article | August 29, 2016

The R&D Index: Market Watch for the week ending Aug. 26, 2016 closed at 1,540.31 for the 25 companies in the R&D Index. The Index was down -0.65 percent (or 10.2 basis points) over the week ending Aug. 19, 2016. Only seven companies gained value from 0.06 percent (Intel) to 2.72 percent (Cisco), while 18 companies lost value from -0.14 percent (Oracle) to -3.02 percent (Roche). Following a protracted bidding war with Sanofi R&D Index member Pfizer announced last week that it would purchase biotech Medivation and its prostate cancer drug Xtandi for $14 billion—more than double the $6 billion that Medivation was valued at earlier this year. Pfizer is well known for purchasing other biopharms over the past 10 years to fill its pipeline with blockbuster drugs. The other firms that Pfizer has acquired include Warner-Lambert in 2000 for $112 billion, Pharmacia in 2002 for $60 billion, Wyeth in 2009 for $68 billion and King Pharmaceuticals for $3.6 billion in 2010. Pfizer agreed to acquire Allergen in 2015 for $150 billion, which fell through after the Obama Administration targeted the deal with new M&A rules. Pfizer is considering breaking its organization into two companies—one for fast-growing brand-name drugs and another for drugs that have lost patent protection. Last week's news concerning the Fed's decision on whether or not to increase short-term interest rates turned in favor increasing rates following comments by Fed Chair Janet Yellen at a meeting on Friday. Yellen cited continued solid performance in the labor market, inflation, and economic activity over the past three months as justification for a rate increase at the Fed's next policy meeting on Sept. 20-21. Yellen clarified her recommendation would depend on the Labor Department's September 2 jobs report for August. Employers have added an average of 190,000 jobs/month in May, June and July. According to the CME Group, there is a 36 percent probability of a rate increase, which is significantly lower than it was earlier this Spring. A report by China General Administration of Customs (imports) noted last week that oil production in China may have peaked and that its imports have continued to grow and will accelerate in the years to come. China is the fourth-largest oil producer and this news implies that oil prices in the future could rise as China steps up imports to meet its domestic demands. China's current oil fields are aging and new discoveries at home have not matched its increases in demand. PetroChina, the country's largest oil producer announced last week that production fell 4 percent in the first half of 2016, double the pace of decline in 2015. China Petroleum & Chemical also noted that its crude production fell over 12 percent in the same period. China recently announced its first foreign military outpost in Djibouti, Africa, which was established in part to safeguard oil fields on which it relies. R&D Index is a weekly stock market summary of the top international companies involved in research and development. The top 25 industrial spenders of R&D in 2014 were selected based on the latest listings from Schonfeld & Associates' June 2015 R&D Ratios & Budgets. These 25 companies include pharmaceutical (11 companies), automotive (5), ICT  (7) and conglomerate (2) organizations who invested a cumulative total of more than $170 billion in R&D in 2014, or approximately 10.8% of all the R&D spent in the world by government, industries and academia combined, according to R&D Magazine's 2014 Global R&D Funding Forecast. The stock prices used in the R&D Index are tabulated from NASDAQ, NYSE, XETRA and OTC common stock prices (in U.S. dollars) for the companies selected at the close of stock trading business on the Friday preceding the publication of the R&D Index in R&D Magazine's R&D Daily eNewsletter. The companies used in the R&D Index include Microsoft, Intel, Roche Holdings, Novartis, Johnson & Johnson, Pfizer, Toyota Motor, General Motors, Merck & Co., Ford Motor, Cisco, Apple Computer, Sanofi SA, Qualcomm, IBM, Astra Zeneca plc, Honda Motor, Daimler, Oracle, GlaxoSmithKline, Siemens, Eli Lilly Co., Ericsson, Bristol-Myers Squibb and Bayer AG. Stock prices are based on those stocks traded on the U.S. exchanges. R&D Index trends (in the stock prices) are just one indicator of the amount of capital available to these high-technology companies to invest in R&D and should not be implied to indicate the absolute value of R&D investments made by these organizations. The companies chosen for the R&D Index have very large sophisticated internal and global R&D organizations with each company investing between $4.3 and $11.7 billion annually on their R&D efforts.

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