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Approved! And a sweet After Hours close @ 5.10
GLTA!
SNTS looks great... Lets see if we can close over $5 tomorrow!
GLTA!
Santarus Announces FDA Approval of Schering-Plough HealthCare Products' ZEGERID OTC
Santarus earns $20 million milestone
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ: SNTS - News), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Schering-Plough HealthCare Products, Inc.’s, New Drug Application (NDA) for ZEGERID OTC™ Capsules (omeprazole/sodium bicarbonate) with a dosage strength of 20 mg of omeprazole for over-the-counter (OTC) treatment of frequent heartburn. Schering-Plough and Merck & Co., Inc. merged on November 3, 2009. The OTC heartburn market in the U.S. is estimated at $1.7 billion based on data from Information Resources, Inc., a market research firm, and company estimates.
The NDA was submitted by Schering-Plough under the terms of a license agreement for OTC proton pump inhibitor (PPI) products using Santarus’ proprietary technology. Upon approval of ZEGERID OTC, Santarus earned a $20 million milestone and may be entitled to receive up to an additional $37.5 million in sales milestones. Santarus will also be entitled to a low double-digit royalty, subject to adjustment in certain circumstances, on net sales of any ZEGERID OTC products sold by Schering-Plough HealthCare Products under the license agreement. In turn, Santarus will be obligated to pay royalties to the University of Missouri on net sales of any such OTC products.
“We are pleased that Schering-Plough HealthCare Products has achieved this significant regulatory milestone for ZEGERID OTC and we look forward to seeing the product on retail store shelves across the United States in the first half of 2010,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We believe the consumer advertising and publicity associated with the launch of ZEGERID OTC will increase awareness of the ZEGERID® brand.”
“The introduction of ZEGERID OTC also allows Santarus to further leverage its proprietary technology through participation in the consumer market for PPIs in addition to the prescription market,” he added.
Santarus is continuing to manufacture, promote and sell its ZEGERID (omeprazole/sodium bicarbonate) prescription products in both 20 mg and 40 mg dosage strengths of omeprazole in the U.S. prescription market for PPI products. Approximately 96% of ZEGERID Capsules prescriptions are written for the 40 mg dosage strength. Prescription strength ZEGERID is indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), for the short-term treatment of erosive esophagitis diagnosed by endoscopy, for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months), and for short-term treatment of active benign gastric ulcers and active duodenal ulcers.
Important Safety Information about Prescription Strength ZEGERID Capsules and Powder for Oral Suspension
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In 178 critically ill patients treated with ZEGERID Powder for Oral Suspension, adverse events generally reflected the serious, underlying medical condition of the patients, but some adverse events occurred with more frequency in patients treated with ZEGERID Powder for Oral Suspension than in those treated with the comparator (acid-controlling) drug. For more information about these and other events, please see Table 13 of the full Prescribing Information at www.Zegerid.com. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
ZEGERID Capsules contain 304 mg of sodium per dose. ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose. This should be taken into consideration for patients on a sodium-restricted diet.
Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.
Since both 20 mg and 40 mg ZEGERID contain the same amount of sodium bicarbonate (1100 mg in capsules, 1680 mg in packets of powder for oral suspension), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/ sodium bicarbonate), which is a prescription drug indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage lower GI product candidates, budesonide MMX® and rifamycin SV MMX®, for the U.S. market. Budesonide MMX is being investigated in two multicenter Phase III clinical trials for the induction of remission of mild or moderate active ulcerative colitis. Rifamycin SV MMX has been investigated in a Phase II clinical program in travelers’ diarrhea. More information about Santarus is available on the company’s Web site at www.santarus.com.
Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding anticipated launch timing for ZEGERID OTC. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: the timing for launch of ZEGERID OTC; whether Schering-Plough is able to generate market demand and acceptance for ZEGERID OTC and, in turn, generate sales milestones and royalty payments for Santarus; whether the introduction of ZEGERID OTC increases awareness of the ZEGERID brand; Schering-Plough’s level of commitment, the potential for termination of the licensing arrangement and other risks related to the licensing arrangement; the scope and validity of patent protection for ZEGERID products, including the timing and outcome of the patent infringement lawsuit against Par Pharmaceutical, Inc., and Santarus’ and its strategic partners’ ability to commercialize products without infringing the patent rights of others; and other risks detailed in Santarus’ prior press releases as well as in public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus® and ZEGERID® are registered trademarks of Santarus, Inc. GLUMETZA® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. MMX® is a registered trademark of Cosmo Technologies Limited.
$4.73 AH...
GLTA!
EDIT: Nevermind, blew past that... $4.85 now! Weeeeeeee
EDIT 2: $5 HIGH!!!
Awesome! That chart looks great, imo.
GLTY!
Yeah, and don't forget that they have another decision coming up on Wednesday!
GLTA!
Setting up for a nice EOD close...
GLTA!
iBox Updated!
GLTA!
I finally got filled @ 3.63...
GLTA!
I'm holding as well.
Silenor has a lot going for it, IMO. I read somewhere on the YMB that the management expects it to bring in 500M/yr. Could be much bigger than anyone thinks, IMO.
GLTY.
Let's close above .05 today..
GLTA!
Two HUGE blocks just purchased...
09:13 $ .115 192,000
09:12 $ .115 3,500
09:12 $ .115 500
09:12 $ .115 22,500
09:12 $ .1152 1,000
09:12 $ .115 249,000
GLTA!
Good morning incans!
$4.10 pre-market.
GLTA!
231k volume pre-market... Last trade .11
GLTA!
HUGE news today, in my opinion. Shows that 514 works.
JMO.
GLTA!
ADVENTRX Pharmaceuticals Reports Additional Pre-Clinical Data for ANX-514
South Korean Partner Demonstrates Bioequivalence and Similar Toxicity Profile to Taxotere
SAN DIEGO, Dec. 1 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that a new, recently completed preclinical study has affirmed the bioequivalence and comparable toxicity of ANX-514 and Taxotere® (docetaxel). Shin Poong Pharmaceuticals, ADVENTRX's partner for ANX-514 in South Korea, independently conducted the study and data analysis.
"Our independent confirmation of the bioequivalence and comparable overall safety of ANX-514 and Taxotere affirm our belief in both the emulsion platform technology underlying several ADVENTRX product candidates and its application to docetaxel," stated Mr. Byung Yong Kim, Executive Managing Director of Shin Poong Pharmaceuticals. "We intend next to conduct a separate clinical bioequivalence study of ANX-514 in South Korea and look forward to continuing to work with ADVENTRX toward the possible commercialization of ANX-514 in both the U.S. and South Korea."
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel emulsion formulation of the chemotherapy drug docetaxel, a formulation of which is marketed under the brand name Taxotere. ANX-514 is formulated without polysorbate 80 or other detergents and is intended to reduce the severity and/or incidence of the hypersensitivity reactions often associated with Taxotere.
In May 2009, ADVENTRX announced the results of a clinical bioequivalence study of ANX-514. ANX-514 was determined to have comparable overall safety as Taxotere, with no differences between treatment groups in severe toxicities. However, pharmacokinetic equivalence, the primary endpoint of the study, was not demonstrated based on benchmark regulatory standards. The study data revealed higher blood-levels of docetaxel during and immediately following infusion of the study drug (i.e., during the first hour of treatment) in patients receiving ANX-514 relative to those receiving Taxotere, but, at 10 minutes after the completion of infusion, docetaxel blood-levels were comparable and remained so through the end of the observation period. ADVENTRX is analyzing these short-term increased levels, which were the reason ANX-514 was outside benchmark regulatory standards for determining bioequivalence.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are designed to improve the performance of existing cancer treatments by addressing limitations associated principally with their safety and use. More information can be found on the Company's web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that preclinical results are not predictive of the success of subsequent clinical trials and that products will not perform as preclinical data suggests or as otherwise anticipated; the robustness of the preclinical study conducted by Shin Poong Pharmaceuticals and the validity of any conclusions drawn therefrom, including the risk that ADVENTRX did not independently verify the data or conclusions provided by Shin Poong Pharmaceuticals; the risk the FDA will determine that ANX-514 and Taxotere are not bioequivalent, including as a result of determining that increased docetaxel blood-levels during and immediately following infusion are clinically relevant; the risk that future studies of ANX-514, including those performed by Shin Poong Pharmaceuticals, will not demonstrate the bioequivalence of ANX-514 and Taxotere; the potential for regulatory authorities to require additional preclinical work and/or clinical activities to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-514, which activities may increase the cost and timeline to NDA submission or approval and negatively impact ADVENTRX's ability to raise additional capital; the risk that ADVENTRX will be unable to raise sufficient additional capital to continue the development of ANX-514; the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to continue as a going concern; the risk that the performance of third parties on whom Shin Poong Pharmaceuticals relied to conduct its preclinical studies or evaluate the data, including contract laboratories and contract research organizations, may have been substandard, or they may have failed to perform as expected; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date on which it was made.
FCSC needs some media coverage... Seems like no one knows about them.
GLTA!
Picked up a few shares today... Looks good.
GLTA!
SOMX looks great today, hopefully it'll continue into the week!
GLTA!
Probably daytraders entering in in anticipation of the volatility SOMX will experience going into the PDUFA date...
JMO.
GLTA!
WOW! Nice move today!!
GLTA.
When it was @ .065 I put my bid in @ .069 and thankfully got filled at .0655!
GLTA!
Me too!! Just think about what will happen when BioMedReports issues the full report Tuesday to all readers!
GLTA!
I like your optimism... However, I doubt we break .021 until either the EOY or early 2010. Which, IMO, makes for an excellent buying opportunity now!
JMO.
GLTA!
IMO, SOMX will see $9+ IF they get approval. Of course, that's just my opinion, and I could easily be wrong. Just depends on how the market takes the news (whatever it is).
GLTA!
Looks good, in my opinion.
Thanks for the chart!
I'm buying more as well, IDGI is really at a low price now.
GLTA!
Wow. I may have to add a few more shares... :)
Yeah. Nice break through .10.
GLTA!
Wow. That does sound huge, imo.
GLTA!
LIZ hasn't been this low since early September, I believe.
GLTA.
And if we get news, PDMI is gonna get crazy!
JMO.
GLTA!
100% agree... In several months, .01 will be looked upon as a steal, IMO.
GLTA!
So, who thinks we go up tomorrow?
GLTA!
LJPC looks like it has some potential to make some money here, imo. Does anyone think they could possibly file INDs for their SSAO Inhibitors for different diseases??
GLTA.
Happy Thanksgiving!