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Apr-16-2008Pozen-GSK migraine drug wins FDA approval(topic overview)
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Shares added $1.01 to $60.95 in early action. Shares of drug maker Pozen Inc. soared in premarket trading Wednesday following regulatory approval of its long-delayed migraine drug Treximet. The Food and Drug Administration on Tuesday approved the drug, a combination of an anti-inflammatory drug and GlaxoSmithKline PLC's Imitrex, which is expected to begin competing against generics later this year. [1] Drug makers GlaxoSmithKline PLC and Pozen Inc. are expected to hear Tuesday whether federal regulators will approve their long-delayed migraine drug. Treximet is a combination of an anti-inflammatory drug and Glaxo's Imitrex, which is expected to begin competing against generics later this year. The Food and Drug Administration has twice asked the companies for more data on Treximet since they first submitted it for approval in 2005. Wachovia Securities analyst Michael Tong said he is "optimistic on the chance of FDA approval," in a note to investors Monday. Other analysts cautioned that a recently issued warning letter to Glaxo could potentially stall approval. The letter, posted online last week, cited Glaxo for failing to update the agency on safety studies of its blockbuster diabetes pill Avandia.[2]
The drugmakers said the FDA approved Treximet for the acute treatment of migraine attacks with or without aura in adults. Treximet is a combination of an anti-inflammatory drug and Glaxos Imitrex, which is expected to begin competing against generics this year. The FDA had twice asked the companies for more data on Treximet since they first submitted it for approval in 2005.[3]
Yang forecast annual peak Treximet sales of $200 million and peak annual royalty revenue of $34 million for Pozen. Analyst enthusiasm was somewhat tempered by the potential impact of competition from generic Imitrex later this year, as well as concerns over how successfully the companies will be able to switch patients over from Imitrex. They said the Treximet approval could signal an improved regulatory profile for Pozen's next pain drug, which is in late stages of clinical testing. Treximet's U.S. approval met with several delays despite its being a combination of two older approved medicines.[4] Genotoxicity refers to the potential of damaging cellular DNA that can lead to mutations and cancer. Regulatory approval would enable Pozen to bring its first product to market, an accomplishment that has eluded the company with two other drugs. It would also benefit GlaxoSmithKline, which is struggling with slowing sales and increasing competition. The company plans to market the pill as a replacement for its migraine treatment Imitrex, which generated $1.37 billion in sales last year. Treximet is expected to begin competing against cheaper generics later this year.[5] Today, the Chapel Hill drug development company and its partner, British pharmaceutical giant GlaxoSmithKline, expect to learn whether additional safety information answered all of the FDA's questions. Regulatory approval would allow Pozen to bring its first product to market, an accomplishment that has eluded the company and its co-founder and chief executive, John Plachetka, with two other drugs. It would also benefit GSK, which is struggling with slowing sales and increasing competition.[6]
Treximet, which Pozen is developing with partner GlaxoSmithKline, has come up short of regulatory approval twice in the past two years after the FDA raised concerns about the drug's possible side effects. This copyrighted material may not be published, broadcast or redistributed in any manner.[7]
Analysts project Treximet sales to exceed $1 billion per year by 2011. The drug could be on pharmacy shelves by this summer. The FDA approval cheered investors, who had seen Pozen's stock lose 32 percent of its value in the past year.[8] The Food and Drug Administration's decision will have a bigger effect on Pozen, one of dozens of small drug developers based in the Triangle. Winning permission to sell Treximet, which analysts project could reach $1 billion a year in sales by 2011, will likely boost Pozen's stock immediately, offering some relief to investors that have seen the value of their shares fall 32 percent in the past year.[6] The approval by the U.S. Food and Drug Administration triggers a $20 million milestone payment to Pozen, which will also receive royalties from Glaxo on sales. Lazard Capital Markets forecast Treximet sales of $58 million this year, with annual sales reaching a peak of $320 million. Jefferies & Co analyst Eun Yang said the approval news was far better than his "anticipation of a further delay in final approval."[4] Chapel Hill, N.C. -- After years of trying and multiple submissions to regulators, Pozen Pharmaceuticals and GlaxoSmithKline received U.S. Food and Drug Administration approval for the migraine drug Treximet on Tuesday.[9] Pozen has won approval from the U.S. Food and Drug Administration for the Treximet migraine drug it developed with GlaxoSmithKline, the company said late Tuesday.[10] Shares of Pozen Inc. (Nasdaq: POZN ) are rocketing this morning after the small cap pharmaceutical company said that it, along with GlaxoSmithKline (NYSE: GSK ), has received approval from the Food and Drug Administration for Treximet, a tablet that treats migraine attacks with or without aura in adults.[11] After navigating what has to be one of the most frustrating paths to Food and Drug Administration approval of a new drug, the small biopharma company Pozen and its big pharma partner GlaxoSmithKline have finally emerged victorious. Last night the companies issued a press release announcing the agency has given the green light to their migraine treatment Treximet.[12]
NEW YORK -- Shares of drug maker Pozen are surging in premarket trading after the Food and Drug Administration approved the migraine drug Treximet.[13]
Pozen shares closed up 6.4 percent at $10.53 Tuesday based on Wall Street expectations that Treximet would be approved. "Migraine patients want their medicine to work early, and to continue to provide relief," said Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University and an investigator who participated in clinical trials, in a statement distributed by GSK. "The FDA approval of Treximet is good news for migraine patients because clinical trials showed that Treximet produced sustained migraine pain relief for a significant number of patients."[9] "The FDA approval of Treximet is good news for migraine patients because clinical trials showed that Treximet produced sustained migraine pain relief for a significant number of patients." Silberstein said, significantly fewer patients on Treximet required the use of a rescue medication to treat their migraine attack than those taking sumatriptan 85 mg.[14] The approval of Treximet was based on data from two identical double-blind, randomized, placebo-controlled, parallel-group, multicenter studies of more than 2,900 migraine sufferers. Findings from these pivotal studies demonstrated that Treximet provided more patients migraine pain relief at two and four hours compared to sumatriptan 85 mg, naproxen sodium 500 mg or placebo alone. Importantly, in these studies Treximet was effective at relieving the pain of a migraine attack and maintaining that relief from two to 24 hours.[14] Treximet provided patients sustained migraine pain relief from two to 24 hours compared to the individual components. Silberstein added that significantly fewer patients on Treximet required the use of a rescue medication to treat their migraine attack compared to those who took sumatriptan 85 mg.[5]
GlaxoSmithKline noted that in clinical trials, Treximet provided a significantly greater percentage of patients migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone.[5]
Treximet provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components. "Migraine patients want their medicine to work early, and to continue to provide relief," said Dr. Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University and an investigator who participated in clinical trials.[14]
"The FDA approval of Treximet is good news for migraine patients because clinical trials showed that Treximet produced sustained migraine pain relief for a significant number of patients," said Dr. Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University.[8]
In the past, migraine was believed to be a vascular condition induced by blood vessel dilation alone. New insight suggests that migraine is much more complex, involving a chain of events that are both neurovascular and inflammatory. The FDA has twice asked GlaxoSmithKline and Pozen for more data on Treximet since they first submitted it for approval in 2005. In January this year, Chapel Hill, North Carolina-based Pozen announced that it has submitted the findings from the short-term human volunteer study of the genotoxic potential of Treximet to the FDA. The results of this study, the design of which was agreed upon with the FDA prior to its conduct, indicated that no chromosomal aberrations were induced in peripheral blood lymphocytes when Treximet was administered to volunteers for seven days. The submission of this study report is in addition to the response made to the FDA in October 2007 which provided clarifying information on the Chinese Hamster Ovary, or CHO assay.[5] Since 2005, the FDA has requested additional data for Treximet. In October last year, Pozen submitted a complete response to the second approvable letter for its migraine drug Trexima. At that time, the company had said that in order to clarify FDA's concern on the genotoxic potential of Trexima, the company would clarify non-clinical information in addition to a routine clinical safety update.[5]
GlaxoSmithKline (LSE: GSK) (NYSE: GSK) and POZEN Inc. (Nasdaq: POZN) announced today that the FDA has approved Treximet for the acute treatment of migraine attacks with or without aura in adults.[14] LONDON, Apr. 16, 2008 (Thomson Financial delivered by Newstex) -- GlaxoSmithKline (NYSE:GSK) Plc. and Pozen Inc. (NASDAQ:POZN) said the FDA has approved the Treximet migraine treatment for adults with acute migraine attacks.[15] GlaxoSmithKline (GSK) and Pozen announced that FDA has approved Treximet for acute treatment of migraine attacks with or without aura in adults.[16]
GlaxoSmithKline has received notification that the U.S. Food and Drug Administration had approved its pipeline migraine pill, Treximet, a version of an existing treatment.[17] GlaxoSmithKline PLC Wednesday said the U.S. Food and Drug Administration has approved migraine pill Treximet, a modified version of a current blockbuster, which will allow the British company to compensate for sales lost to competition from cheap generics.[18] LONDON (SHARECAST) - The U.S. Food and Drug Administration has approved a combination migraine drug developed by GlaxoSmithKline and US-listed Pozen.[19]
The Food and Drug Administration late Tuesday cleared Treximet, the migraine pill developed by Pozen and GlaxoSmithKline.[8]
The wait is over for Pozen Pharmaceuticals POZN investors, as the Food and Drug Administration has approved the biotech company's previously delayed Treximet.[20] The Food and Drug Administration had told Pozen to expect a ruling by Tuesday on the safety information for Treximet that the company submitted in October and January.[7]
Chapel Hill, N.C. -based Pozen and GSK expect to launch Treximet in mid-May. It is the first drug on the market for Pozen. Treximet uses Pozen's technology to combine 85 milligrams of sumatriptan, the active ingredient in GSK's painkiller Imitrex, with 500 milligrams of naproxen sodium, the active ingredient in painkillers such as Aleve. Patent protections on sumatriptan begin to run out late next year, and it's widely expected that some doctors will simply prescribe a generic form of the drug along with naproxen to help patients with migranes. Any further delay on Treximet's approval would have cut into its head start on those generic sales, likely lowering the drug's peak revenue. [10] Now, however, GSK and Pozen can roll out Treximet as the successor drug to Imitrex -- a current blockbuster with more than $1 billion in sales. Analysts are mixed on whether Treximet will achieve such sales levels, but many think so, with some predicting sales of more than $1.5 billion worldwide by 2011. GlaxoSmithKline is based in London and has its U.S. headquarters in Philadelphia.[10] Jefferies analyst Eun Yang says the drug will be on sale by mid-May. Glaxo will pay Pozen $20 million at that time, she says, and the company will also get a 6 percent royalty on Treximet sales. She says the drug could reach $200 million in peak sales, with Pozen getting as much as $34 million in annual revenue.[13]
Shares were trading as high as $17.45 the day before that August approvable letter slashed the stock by 45% to $9.93. Earlier in April, Pozen shares hiccupped on news that Glaxo received a warning letter from the FDA regarding study data it had omitted in submissions to the agency on a different venture, its diabetes drug Avandia.[20] Investors swarmed to Pozen (Nasdaq: POZN ) stock in after-hours trading Tuesday night, driving the share price up 37 percent, or $3.97, to $13.50. It is Pozen's first drug approval.[9] The day GSK's problems with regulators became public last week, Pozen's stock lost about 8 percent. In the four trading days since then, its shares dropped another 7.5 percent, closing at $9.90 Monday, down 10 cents.[6]
In premarket trading, shares of Chapel Hill, N.C. -based Pozen Inc. are up $4.37, or 41.5 percent, to $14.90.[13]
Shares of Pozen popped up more than 40 percent this morning after the Chapel Hill company won regulatory approval for a new medicine for migraine sufferers.[8] NEW YORK, April 16 (Reuters) - Shares of Pozen Inc (POZN.O: Quote, Profile, Research ) soared more than 40 percent on Wednesday after U.S. health regulators finally approved the combination migraine treatment it developed with GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research ).[4]
For Pozen, royalties and payments on sales milestones are at stake. GSK plans to market the pill as a replacement for its migraine treatment Imitrex, which generated $1.37 billion in sales last year.[6] The pill is slated to replace Imitrex, GSK's blockbuster migraine pill that generated about $1.37 billion in sales last year.[8]
Nearly 30 million Americans are estimated to get migraines. They cost business about $15 billion a year on lost worker productivity. Glaxo needs this follow-on product to replace Imitrex which is facing generic competition in the not-too-distant future. A migraine expert says the fusing of the two drugs into one caplet makes them work better than taking the two drugs separately.[12] Treximet is a follow-on product for Glaxo's migraine drug Imitrex, which ranks sixth in terms.[18]
The drug, Treximet, which combines the common pain drug naproxen with Glaxo's older, widely used migraine treatment Imitrex, is expected to be available in the United States by mid-May, the companies said Tuesday night.[4] Treximet is a migraine treatment that combines partner GlaxoSmithKline's GSK Imitrex with an anti-inflammatory pain reliever.[20]
According to GlaxoSmithKline, Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GlaxoSmithKline, and an anti-inflammatory pain reliever in a single tablet.[5]
About POZEN (Nasdaq: POZN) POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. Since its inception, POZEN has focused its efforts primarily on the development of pharmaceutical products for the treatment of acute and chronic pain, migraine and other pain related conditions.[21] Treximet will be Pozen's first product on the market, an accomplishment that has eluded the small Chapel Hill drug development company and its co-founder and chief executive, John Plachetka, with two other drugs. It's a milestone that few of the Triangle's small drug companies have met, and it will trigger payments to Pozen and bonuses for its executives. GSK, which makes the pill at its plant in Zebulon, will market Treximet.[8] The FDA had earlier expressed concerns about cardiovascular side effects of the drug, but Pozen said the FDA did not express that concern in that August letter. He vowed to fight on, insisting that GSK was also committed to getting the drug approved. "We have a good product here," he said, vowing that Pozen would "move forward in this difficult regulatory environment."[22] Now, Pozen can cash in on an FDA approval milestone. GSK should benefit, too, with its Imitrex drug as part of the Treximet drug combo.[22] Pozen spokeswoman Fran Barsky said GSK's spat with the FDA should not have an effect on Treximet's chances for approval.[6]
The climb came after the company received FDA approval for Treximet tablets for acute treatment of migraines.[16] The companies say Treximet should be available in about a month. Patients who get a few dozen shots around their head, neck and shoulders once every few months have reported being headache-free. POZN shares, which have been on a rollercoaster over the past several months, rallied yesterday in anticipation of the FDA approval, but they're really taking off on heavy volume today.[12]
The FDA approved the drug after a review of data that showed Treximet had "a significantly greater percentage of patients migraine relieve at two hours" compared to being treated by the drugs in Treximet separately.[9] June 9, 2006: Treximet falls short of regulatory approval, with the FDA wanting more safety data.[6] Timing of the regulatory approval would be crucial for future Treximet sales, analysts said.[6] A further delay in regulatory approval would position Treximet face-to-face with a generic version of Imitrex. "It would be difficult for Treximet to break into a heavily generic market," Hazlett wrote in his note.[6] Aug. 8, 2005: The company announces that it has filed for regulatory approval of Treximet.[6]
Concerns about possible side effects caused the drug to come short of regulatory approval twice in the past two years.[5] Glaxo is also seeking regulatory approval for modified versions of another two products that, like Imitrex, are facing the loss of patent protection Lamictal for epilepsy and Requip for Parkinsons disease and restless-leg syndrome.[3]
Pozen's name is on Treximet's regulatory paperwork, but GSK's problems could put Treximet's application for approval at risk, Hazlett wrote in a research note.[6] CHAPEL HILL - Pozen was left guessing Tuesday night about the future of its migraine treatment Treximet, which was up for regulatory review for a third time.[7] Aug. 5, 2005: Pozen pulls the plug on MT100, a migraine treatment that also ran into regulatory problems, after investing years of research and $39 million.[6]
Competition is also looming from a new, possibly more effective migraine treatment that Merck is hoping to bring to market as early as next year.[6]
Studies published in the Journal of the American Medical Association last year found that Treximet, combining 85 milligrams of Imitrex and 500 milligrams of naproxen, relieved migraines more effectively than either ingredient alone, Bloomberg News reported.[8] Pozen has a commercialisation and development deal with GSK to develop migraine therapies. The product combines elements of GSK's marketed triptan product sumatriptan with naproxen sodium and is said by the companies to work better than its individual components. jh1/lht Copyright Thomson Financial News Limited 2008.[15] The FDA expressed concerns about genotoxicity, or damage to DNA, that was "seen for the combination of naproxen sodium and sumatriptan," Pozen said in a letter in August. Those are the ingredients Pozen has combined in one pill.[9]
Last August, for example, Pozen shares plunged 46 percent, or $7.59 a share, to $9.36 after an FDA rejection. "It appears the FDA is concerned about this one test," Pozen Chairman and Chief Executive Officer John Plachetka said in a conference call at the time. He said Pozen believed the genotoxicity issue had been addressed and that the three other "genetox" tests were negative.[22] Investors went on a buying spree after the news broke late last night, driving up Pozen (Nasdaq: POZN ) shares more than 37 percent, or nearly $4 a share, to nearly $14.[22] POZN closed Tuesday's regular trading session on the Nasdaq at $10.53, up $0.63 or 6.36% on a volume of 1.56 million shares.[5] On the NYSE, GSK closed Tuesday's regular trading session at $42.21, down $0.13 or 0.31% on a volume of 0.80 million shares.[5]
Pozen announced the approval after the market close Tuesday, sending shares soaring by more than 40% in off-hours trading to open Wednesday up $4.07, or 38.7%, at $14.60.[20]
Pozen had failed to win approval for other pain relievers MT100 and MT300. After those setbacks and repeated delays in the Treximet approval process, Pozen's shares tool repeated poundings.[22]
GSK had partnered with Pozen to produce the drug, which utilizes proprietary technology from Pozen to combine a pain reliever based on triptans and an anti-inflammatory pain reliever.[9] June 12, 2003: Pozen announces a partnership with GSK to develop MT400, a migraine drug now known as Treximet.[6] GSK gives Pozen what are called milestone payments (i.e. when the drug's approved, when it goes to market, when it hits a certain revenue goal, etc.) and a six percent royalty on sales.[12] Now with a new drug GSK backers can afford a smile. Perhaps this victory will help GSK recover from the hammering it has taken in both publicity and sales about its diabetes drug Avandia.[22]
GSK angered regulators by failing to disclose some safety studies that it conducted for a controversial diabetes drug. Last week, the FDA warned that approval of all GSK drugs might be delayed until the drug maker addresses regulators' concerns about its reporting compliance.[6] If the FDA delays approval or rejects the drug, Pozen's stock will fall sharply as fed-up investors head for the exit.[6] Oct. 20, 2003: The FDA declines to grant marketing approval for MT300, Pozen's injectable treatment for severe migraines.[6]
In the letter, FDA said it could deny approval of new drugs until the company corrects the problems.[2] Last year, the FDA asked the drug makers for more information on results of a study that linked the product with cancer. They submitted the additional data in October.[8] You can read about the most recent regulatory "hamster hurdle" in a few of my blogposts from last year (At the time the drug was called Trexima, but the FDA apparently wanted the name changed slightly.)[12]
Worry that Glaxo's FDA issues might carry over proved to no avail. The approval is timely for Glaxo, which faces generic-drug pressure this year for Imitrex.[20]
Treximet combines an anti-inflammatory drug with Glaxo's Imitrex to treat acute migraines.[13] Treximet was studied in a one-year open-label tolerability and safety study of 565 patients who treated nearly 24,500 migraine attacks with the active drug.[5] Patients completing the one-year study treated an average of five migraine attacks per month with Treximet.[21]
The company also stated that Treximet was effective at relieving pain of migraine attack and maintaining that relief from two to 24 hours.[16] Prescription Treximet is indicated for the acute treatment of migraine attacks, with or without aura, in adults.[21] Treximet is well studied, with more than 3,700 migraine sufferers treating nearly 30,000 migraine attacks in clinical studies.[14]
Treximet contains sumatriptan that mediates vasoconstriction, which correlates with the relief of migraine headache. It also contains naproxen, an anti-inflammatory agent. Therefore, sumatriptan and naproxen sodium contribute to the relief of migraine through pharmacologically different mechanisms of action.[21] Treximet contains 85 mg sumatriptan formulated with RT Technology, and 500 mg naproxen sodium.[5]
Treximet is contraindicated in patients with hypersensitivity to sumatriptan, naproxen, or any other component of the product.[21] Treximet is contraindicated in patients who have had allergic reactions to products containing naproxen. It is also contraindicated in patients in whom aspirin or other NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps. Both types of reactions have the potential of being fatal.[21]
Treximet also includes GSK's Imitrex, a billion-dollar-selling drug that faces generic competition. [9] GSK already has paid Pozen more than $35 million to develop Treximet and bring it to market.[22] GSK (NYSE: GSK ) has paid Pozen more than $35 million to develop the compound.[9]
Not only did Pozen win Food and Drug Administration approval, it also now will pull in additional money from development partner GlaxoSmithKline. [22] Fall 1996: Pozen is formed by John Plachetka, Peter J. Wise and Joseph J. Ruvane Jr., former executives with the drug maker now known as GlaxoSmithKline.[6]
August 1, 2007: The FDA informs Pozen that it is worried about an early laboratory test that raised questions about the drug's safety.[6] January 2008: Pozen meets a deadline to submit additional information to the FDA about safety concerns, a move that locks in April 15 as the date by which the FDA must issue a decision on Treximet.[6] BMO Capital Market's Robert Hazlett advised investors that a delay by FDA would lower Treximet's value to Chapel Hill, N.C. -based Pozen.[2]
The FDA had declined to approve the drug twice, asking the companies for more information about Treximet's safety.[10] GSK "has run some of the Treximet studies and is manufacturing Treximet," the note reads. "If the FDA has any concerns in this area, the agency might delay the application until. addresses the problems fully."[6] Pozen recently submitted data to address FDA concerns about genotoxic "aberrations" in human volunteers.[9] Pozen submitted additional safety information to address the FDA's concerns.[8]
In an earlier review of the drug, the FDA expressed concern about cardiovascular side effects.[9]
The companies requested FDA approval in 2005, but the agency twice asked for more data.[13] The approval of Treximet was based on data from two identical double-blind, randomized, placebo-controlled, parallel-group, multicenter studies of more than 2,900 migraine sufferers.[5] The drug's approval could also be good news for the more than 29 million Americans who suffered from migraines.[9] Aquarius said it would fund the purchase with reserves, debt and by placing $400 million worth of new shares to institutional investors through an accelerated book building process.[5] Shares added 73 cents to $42.85. The world's largest beverage company, The Coca-Cola Co., said acquisitions, growth in its key carbonated beverage brands and success overseas helped boost its first-quarter profit by 19 percent on a 21 percent increase in sales, beating expectations.[1] The new acquisitions are expected to generate approximately 390,000 in annual hog production for AgFeed. The Company anticipates that this additional production will add approximately 250,000 hog sales to its 2008 revenues. AgFeed previously provided guidance indicating that it would achieve approximately 120,000 hog sales in 2008 from its currently existing hog farm operations.[16]
The drug is a line extension of Glaxo's Imitrex, which ranks sixth in terms of annual sales.[17] U.S. sales have the potential to reach more than $1bn (£500m) a year.[17]
The drug, Treximet, is expected to be available in U.S. pharmacies by the middle of May, the companies said.[23] Analysts expect another delay could cause the stock to drop by as much as 30 percent. Might work this time Analyst Ken Trbovich with RBC Capital Markets expects that Treximet will make the cut this time.[6] Glaxo shares were up 0.6 percent at 1,077 pence (US$21.28; 13.44) in midday trade on the London Stock Exchange.[3] Warning: Do remember, particularly if you are new to stock market investment that the prices of shares and other investments can fall sharply.[17] U.S. stocks crept higher on Monday with energy shares buoyed by record oil prices and moods lifted by better-t.[3]
Stock quotes are delayed at least 15 minutes for Nasdaq, at least 20 minutes for NYSE/AMEX. U.S. indexes are delayed at least 15 minutes with the exception of Nasdaq, Dow Jones Industrial Average and S&P; 500 which are 2 minutes delayed.[11] The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: http://www.pozen.com.[21]
All times are ET. : Time reflects local markets trading time. - Intraday data delayed 15 minutes for Nasdaq, and 20 minutes for other exchanges. Disclaimer[21] At 1,074p, Glaxo's shares continue to be good value, yielding about 5 per cent and trading on a one-year forward price earnings multiple of close to 11 times.[17]
A six-month delay, according to Hazlett, would lower the drug's value from $4.60 per share to $2.70, while a one-year delay would lower the drug's value to $1.55 per share.[2]
The third try is supposed to be the charm for Pozen's migraine pill Treximet. [6] Pozen focuses on products for the treatment of migraines using compounds already on the market.[6] The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with Treximet, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). NSAID-containing products, including Treximet, should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding.[21]
Treximet, formerly known as Trexima, is being developed by Pozen under an alliance with GlaxoSmithKline. [5] Treximet is made at GSK's plant in Zebulon, which has been hit with layoffs as part of the company's broader cost cuts.[6] Pozen CEO Plachetka is a former GSK executive who helped develop Imitrex for the U.S. market.[6] Sumatriptan is the active ingredient in Imitrex tablets, available in strengths of 25 mg, 50 mg and 100 mg. It mediates vasoconstriction, which correlates with the relief of migraine headache.[5]
In August, the agency put off approval, asking for more clinical data, which Pozen provided last fall. [20] The most common treatment-related adverse events reported within 24 hours of taking Treximet were dizziness; nausea; somnolence; chest discomfort and chest pain; neck, throat and jaw pain, tightness and pressure; numbness/tingling; upset stomach; and dry mouth.[21]
SOURCES
1. Premarket Movers: Intel, Dow stocks lead gainers - Forbes.com
2. Ahead of the Bell: Migraine drug
3. Glaxo and Pozen receive FDA approval for migraine drug - International Herald Tribune
4. Pozen shares jump after migraine drug approval | News | Hot Shares | Reuters
5. RTTNews - Breaking News, financial breaking News, Positive EPS Surprises, Stock research .
6. newsobserver.com | Pozen, GSK hope FDA will approve pill
7. newsobserver.com | Pozen still waiting on FDA
8. Charlotte Observer | 04/16/2008 | Pozen shares surge on FDA approval
9. Oh, What a Relief for Pozen, GSK ''' FDA Approves Migraine Drug; Pozen Shares Surge :: WRAL.com
10. Pozen-GSK migraine drug wins FDA approval - Philadelphia Business Journal:
11. Pozen and Glaxo score FDA approval for migraine treatment drug
12. Glaxo, Pozen Become "Headache Free" On Migraine Drug - Pharmas Market with Mike Huckman - MSNBC.com
13. Ahead of the Bell: Pozen climbs on migraine drug approval | Chron.com - Houston Chronicle
14. SunHerald.com : Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine
15. GlaxoSmithKline and Pozens Treximet approved for adults by FDA
16. RTTNews - Global financial news, Hot Stocks, Stock Splits, Long Term Stocks.
17. GSK's pipeline pushes on - Investors Chronicle
18. Free Preview - WSJ.com
19. ShareCast - News you can use
20. Pozen Secures FDA OK for Migraine Drug | Biotech | GSK POZN - TheStreet.com
21. Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine
22. Congratulations to Pozen, GSK for Persevering in Migraine Drug Battle :: WRAL.com
23. U.S. FDA approves migraine drug from Glaxo, Pozen | News | Hot Shares | Reuters
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