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6:34PM Santarus confirms District Court ruling in Par litigation (SNTS) 5.36 : Co confirmed that the U.S. District Court for the District of Delaware has ruled that five patents covering Santarus' ZEGERID (omeprazole/sodium bicarbonate) prescription products are invalid due to obviousness. These patents were the subject of lawsuits brought by Santarus against Par Pharmaceutical (PRX). The case was heard in a five-day bench trial that concluded on July 17, 2009. Santarus plans to appeal the Court's ruling to the U.S. Court of Appeals for the Federal Circuit Court
Santarus Announces Launch of ZEGERID OTC by Schering-Plough Consumer HealthCare
ZEGERID OTC Now Available on Retail Store Shelves in the U.S.
Press Release Source: Santarus, Inc. On Thursday April 1, 2010, 9:15 am
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ:SNTS - News), a specialty biopharmaceutical company, today announced that Schering-Plough HealthCare Products, Inc., the consumer healthcare subsidiary of Merck & Co., Inc., has commenced promotion of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its licensing agreement with Santarus for the over-the-counter (OTC) market in North America. The OTC heartburn market in the U.S. is estimated at approximately $1.8 billion based on data from market research firm Information Resources, Inc. and Santarus estimates.
Under the terms of the ZEGERID OTC license agreement, Santarus is entitled to a low double-digit royalty, subject to adjustment in certain circumstances, on net sales of any ZEGERID OTC products sold in North America. In turn, Santarus will be obligated to pay royalties to the University of Missouri on net sales of any such OTC products. Santarus also may be entitled to receive up to an additional $37.5 million in sales milestones.
ZEGERID OTC is the only OTC proton pump inhibitor (PPI) product with two active ingredients, omeprazole, a PPI, and sodium bicarbonate. The sodium bicarbonate acts as a buffer to raise the gastric pH and protect the omeprazole from acid degradation in the stomach and allows it to be absorbed. ZEGERID OTC is a 14-day course of treatment taken once daily as directed to treat frequent heartburn, defined as heartburn that occurs two or more days a week. For more information about ZEGERID OTC, visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.ZegeridOTC.com&esheet=6234511&lan=en_US&anchor=www.ZegeridOTC.com&index=1&md5=61734171cbc3bd73f31ff05f455fb9b9.
“The commercialization of ZEGERID OTC is in keeping with our strategy to maximize our patented PPI technology,” said Gerald T. Proehl, president & chief executive officer of Santarus. “With its dual-ingredient formula, ZEGERID OTC offers an attractive alternative to the currently marketed OTC PPI products and positions us to receive royalty revenues without further investment from Santarus. Schering-Plough Consumer HealthCare began shipping ZEGERID OTC in late March, and we expect to report royalty revenue from these shipments in our first quarter financial results.”
He added, “We expect the consumer advertising and publicity campaign associated with the launch of ZEGERID OTC to increase consumer and physician awareness of the ZEGERID brand. Santarus is working to capitalize on this anticipated increased awareness through a significant promotional campaign for our prescription products focused on approximately 45,000 physicians who prescribe PPI products but are not called on by our sales force. The new Santarus campaign includes journal advertising, teledetailing, direct mail and e-mail promotion, Internet outreach and the availability of product samples.”
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 97% 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 (4-8 weeks) 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 (4-8 weeks) of active benign gastric ulcers and active duodenal ulcers, and for reduction of risk of upper gastrointestinal bleeding in critically ill patients (only powder for oral suspension 40 mg; use beyond 14 days has not been evaluated).
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 http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.Zegerid.com&esheet=6234511&lan=en_US&anchor=www.Zegerid.com&index=2&md5=156c569f5b4ace3a9d5879fa4a2848a6. 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.
For more information about prescription strength ZEGERID, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.Zegerid.com&esheet=6234511&lan=en_US&anchor=www.Zegerid.com&index=3&md5=cd9307e8f1ad474be040fcb407cdfe17
4:14PM Santarus reports Q4 results; issues FY10 revenue guidance (SNTS) 4.40 -0.04 : Santarus reports Q4 earnings of $0.40 vs $0.21 First Call consensus; revs increased 66% year/year to $62.4 mln vs $51.02 mln First Call consensus. Co issues guidance for FY10, sees total revenues of $170 mln to $175 mln vs $163.5 mln First Call consensus. Co also expects net income of $11 mln to $13 mln for the full year, which may include a net loss in the first quarter due to seasonality of prescription demand and timing of research and development expenses, vs $12.81 mln First Call consensus
Form 8-K for SANTARUS INC
2-Feb-2010
Item 8.01. Other Events.
Santarus, Inc. ("Santarus" or the "Company") participated in a telephone conference on February 1, 2010 with Chief Judge Gregory M. Sleet of the United States District Court for the District of Delaware and other parties. The telephone conference was held to address Santarus' motion for preliminary injunction, which was filed in mid-January 2010 and requested that the Court enjoin Par Pharmaceutical, Inc. ("Par") from launching a generic version of Santarus' Zegerid® Capsules in the event that the Court's final ruling in the related pending patent infringement litigation has not been issued on or before expiration of the applicable 30-month stay of U.S. Food and Drug Administration ("FDA") approval of Par's generic product. The 30-month stay for Zegerid® Capsules is scheduled to expire on or about February 3, 2010.
During the telephone conference, counsel for Par indicated that Par would be willing to agree not to launch its proposed generic version of Zegerid® Capsules pending the Court's final ruling if Santarus agreed to post a bond that could be charged in the event the Court's final ruling is in favor of Par. In such event, Par would also be required to establish that it suffered damages as a result of any delay in its launch. Alternatively, if the Court's final ruling is in favor of Santarus, the bond would be discharged. There was no agreement on the amount or terms of a bond or whether a bond in any amount would be appropriate at this time, and the Court directed the parties to negotiate further in an attempt to reach agreement on such matters and to notify the Court of their progress.
Santarus and the University of Missouri filed two lawsuits which were consolidated into the pending patent infringement litigation against Par in response to the Abbreviated New Drug Applications ("ANDAs") submitted by Par with the FDA regarding Par's intent to market generic versions of Santarus' Zegerid® brand prescription products. The patents asserted in the litigation are U.S. Patent Nos. 6,645,988; 6,489,346; 6,699,885; 6,780,882; and 7,399,772. A bench trial for the litigation was held in July 2009. During the trial, the court ruled in favor of Santarus and the University of Missouri on the issue of infringement. Post-trial briefs were submitted
in August 2009, and the Court has not yet ruled on Par's defenses of invalidity and inequitable conduct.
Santarus and the University of Missouri filed each of the original lawsuits against Par within the time period necessary to automatically stay, or bar, the FDA from approving Par's ANDAs for 30 months or until a district court decision that is adverse to the patents, whichever is earlier. The 30-month stay applicable to Zegerid® Capsules expires on or about February 3, 2010, and the 30-month stay applicable to Zegerid® Powder for Oral Suspension expires in May/June 2010.
Santarus is not able to predict whether it will be able to reach agreement with Par on the matters discussed in the telephone conference or the timing or resolution of the overall litigation.
Santarus Receives Previously Announced $20 Million Milestone for FDA Approval of ZEGERID OTC
Press Release Source: Santarus, Inc. On Tuesday December 22, 2009, 4:00 am EST
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ:SNTS - News), a specialty biopharmaceutical company, today announced that it has received the $20 million milestone payment previously announced on December 1, 2009 relating to the approval of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its over-the-counter (OTC) licensing agreement with Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co., Inc. Schering-Plough and Merck merged on November 3, 2009.
The U.S. Food and Drug Administration (FDA) approved Schering-Plough HealthCare Products’ New Drug Application (NDA) for ZEGERID OTC for OTC treatment of frequent heartburn on December 1, 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. ZEGERID OTC capsules are expected to be available on retail store shelves in the first half of 2010.
The NDA was submitted by Schering-Plough HealthCare Products under the terms of a license agreement for OTC proton pump inhibitor (PPI) products using Santarus’ proprietary technology. Santarus 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.
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.
Why is the share pricing going down? any idea when the lawsuit comes out
Budesonide European Trial Enrolled
By Zacks Equity Research
On 9:32 am EST, Thursday December 10, 2009
Santarus Inc. (NasdaqGM: SNTS - News) recently announced that it has finished enrolling patients for a phase III study that is being conducted in Europe with pipeline candidate, budesonide MMX. Santarus is developing the candidate in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA.
Budesonide MMX is being evaluated for the treatment of ulcerative colitis. The partners are conducting another phase III study with the candidate in the US, which is approximately 60% enrolled. The primary endpoint of the trials is the percentage of patients who achieve clinical remission in each of the budesonide MMX treatment groups compared to placebo as measured by the ulcerative colitis disease activity index (UCDAI) after eight weeks of treatment. A total of 1,000 patients will be studied in the phase III clinical program.
The phase III program is being carried out under the US Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process. We expect to see preliminary top line results from the European phase III study in the first half of 2010.
In addition to in-licensing budesonide MMX from Cosmo in December 2008, Santarus in-licensed another late stage pipeline candidate from Cosmo - rifamycin SV MMX. We believe both products fit well with the company’s focus on the gastrointestinal (GI) market. While budesonide will target mild-to-moderate ulcerative colitis, rifamycin is being investigated for the treatment of traveler’s diarrhea.
If developed successfully, the company should be in position to file a new drug application (NDA) for budesonide MMX in the second half of 2011. Meanwhile, the NDA filing for rifamycin SV MMX should come in 2012. Annual peak sales of budesonide MMX and rifamycin SV MMX could be in the range of $150 million - $250 million and $50 million - $150 million, respectively. We currently have a Neutral recommendation on Santarus.
2:00AM Santarus receives FDA approval for immediate-release omeprazole tablet with dual buffers (SNTS) 4.98 : Co announces the FDA has approved the New Drug Application for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole. Santarus submitted the NDA for this tablet product in January 2009.
SNTS news - FDA approval - moving in AH NOW...lol...Santarus Receives FDA Approval for Immediate-Release Omeprazole Tablet with Dual Buffers
Tablet Form is a New Prescription Product for the Treatment of GERD NDA Supplement Submitted for Trade Name
* Press Release
* Source: Santarus, Inc.
* On 7:08 pm EST, Friday December 4, 2009
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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 the company’s New Drug Application (NDA) for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole. Santarus submitted the NDA for this tablet product in January 2009.
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The NDA for the new prescription tablet product was approved for all indications the company was seeking, including for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, or GERD; however, the FDA has not yet approved a trade name for the new product. Santarus has submitted an NDA supplement requesting approval of a proposed trade name that includes the “ZEGERID®” brand name and anticipates that the FDA will complete its review of this NDA supplement within 180 days.
“We are pleased to receive FDA approval for our new immediate-release prescription tablet product and our current plans are to launch in 2010 following approval of our NDA supplement,” said Gerald T. Proehl, president and chief executive officer. “With its dual buffering system and convenient tablet dosage form, we believe this new immediate-release omeprazole product will be an attractive addition to our ZEGERID family of prescription products for the treatment of GERD and certain other upper GI conditions.”
The new dual buffer tablet product is an immediate-release proton pump inhibitor (PPI) that combines omeprazole with the antacids sodium bicarbonate and magnesium hydroxide. The antacids protect the omeprazole from acid degradation and facilitate its rapid absorption. Santarus also promotes ZEGERID® (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension to gastroenterologists and other selected physicians. Santarus reported net product sales for ZEGERID of $87 million for the nine months ended September 30, 2009.
Omeprazole/sodium bicarbonate/magnesium hydroxide tablets are indicated for the treatment of heartburn and other symptoms associated with 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 ulcer and active duodenal ulcer.
Important Safety Information
The most frequently reported adverse events with omeprazole/sodium bicarbonate/magnesium hydroxide tablets are headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. For more information about these and other events, please see Section 6 of the full Prescribing Information. 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.
Omeprazole/sodium bicarbonate/magnesium hydroxide tablets contain 750 mg (9 mEq) of sodium bicarbonate (equivalent to 209 mg of Na+) and 343 mg (12 mEq) of magnesium hydroxide (equivalent to 143 mg of Mg2+).
The sodium content of this product should be taken into consideration when administering to patients on a sodium-restricted diet or at risk of developing congestive heart failure (CHF).
Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. Increased sodium intake can cause swelling and weight gain.
Magnesium content increases risk of hypermagnesemia and magnesium toxicity in the elderly and in patients with renal impairment or renal disease.
Omeprazole/sodium bicarbonate/magnesium hydroxide tablets are contraindicated in patients with known hypersensitivity to any component of the formulation.
Since both 20 mg and 40 mg omeprazole/sodium bicarbonate/magnesium hydroxide tablets contain the same amount of sodium bicarbonate and magnesium hydroxide, two 20 mg tablets are not equivalent to, and should not be substituted for, one 40 mg tablet. This would result in taking twice the amount of sodium bicarbonate and magnesium hydroxide.
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 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 the timing for the FDA’s review of the NDA supplement and for the anticipated launch of the immediate-release omeprazole tablet product, and whether the new tablet product will be an attractive addition to the ZEGERID family of products.
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 and outcome of the FDA’s review of the NDA supplement requesting approval of a proposed trade name for the new immediate-release omeprazole tablet product; timing for commercial availability of the new tablet product; whether Santarus is able to generate market demand and acceptance for the new tablet product; the scope and validity of patent protection for the new tablet product and Santarus’ other ZEGERID products, including the outcome and duration of the pending patent infringement lawsuit against Par Pharmaceutical, Inc., and Santarus’ ability to commercialize the new tablet product and its other ZEGERID products without infringing the patent rights of others; other difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products; 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.
Contact:
Company Contact:
Santarus, Inc.
Martha L. Hough, 858-314-5824
VP Finance & Investor Relations
Debra P. Crawford, 310-691-7100
Chief Financial Officer
or
Investor Contact:
Lippert/Heilshorn & Associates, Inc.
Jody Cain (jcain@lhai.com), 858-314-5708
Bruce Voss (bvoss@lhai.com), 858-314-5708
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Yeah! Looking forward to the PDUFA date on Friday.
GLTA!
Looking good so far!
GLTA
SNTS looks great... Lets see if we can close over $5 tomorrow!
GLTA!
hey, making a couple of grand for sleeping tonight ain't bad :)
OMG I contacted my broker (he already thinks I'm a nut so wth!!)
darn! wish I bought more than 1000 shares!
bet we go over $6 tomorrow!
BOOYAH!! Nice call.
edit > 5.87 in AH, still going
weeeeeeeeeeeeeeeeeeeeee
up AH!!!
5.72 x 5.74
SAN FRANCISCO (MarketWatch) -- Santarus Inc. /quotes/comstock/15*!snts/quotes/nls/snts (SNTS 5.77, +1.48, +34.50%) said Tuesday that the Food and Drug Administration approved over-the-counter heartburn medication Zegerid that uses its technology, triggering a $20 million milestone payment to the biotech company. Shares of Santarus rose 23% to $5.29 a share in after-hours activity. Drug maker Schering-Plough, which was recently acquired by Merck & Co. /quotes/comstock/13*!mrk/quotes/nls/mrk (MRK 37.16, +0.28, +0.76%) , will make milestone and royalty payments to Santarus as a result of the FDA approval.
can you explain or link me the 2nd approval you mentioned? thank you
5:20PM Santarus announces FDA approval of Schering-Plough HealthCare Products' ZEGERID OTC (SNTS) 4.29 +0.30 : Co announced that the U.S. Food and Drug Administration (FDA) has approved Schering-Plough HealthCare Products, Inc.'s, New Drug Application for ZEGERID OTC Capsules (omeprazole/sodium bicarbonate) with a dosage strength of 20 mg of omeprazole for over-the-counter treatment of frequent heartburn. Schering-Plough and Merck & Co. merged on November 3, 2009.
just saw!!! gets the 20million milestone payment too! tomorrow should be nice.
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.
how about $5.30AH!!! LOL
$4.73 AH...
GLTA!
EDIT: Nevermind, blew past that... $4.85 now! Weeeeeeee
EDIT 2: $5 HIGH!!!
Yeah, and don't forget that they have another decision coming up on Wednesday!
GLTA!
looking forward to hear fda approval friday. i have my fingers crossed! its up .30 after hours!!!
Setting up for a nice EOD close...
GLTA!
Picked up a few shares today... Looks good.
GLTA!
Santarus' Zegrid Facing Back-to-Back FDA Approval Dates
Santarus’ (SNTS) main drug, Zegerid, is coming up on back-to-back FDA approval dates in early December. Zegerid is a proprietary immediate-release formulation that combines the proton pump inhibitor omeprazole with the antacid sodium bicarbonate indicated for upper gastrointestinal diseases and disorders, including gastrointestinal reflux disease (GERD). It is the first and only immediate release proton pump inhibitor on the market.
The first of these FDA approval dates is December 4th, for a 505(b)(2) application of a tablet form of Zegerid to be marketed by Santarus by prescription. The tablet formulation would add to Santarus’ current capsule and powder form of the drug. The 505(b)(2) pathway is an abbreviated application used for approval of a different format of currently approved drugs, and historically these applications have a high rate of approval with the FDA.
The second FDA date is of higher importance to the company; it is following on December 9th. This is the PDUFA date for Santarus’ partner Schering Plough (Merck (MRK)) and is for the first over-the-counter (OTC) version of Zegerid branded omeprazole with sodium bicarbonate in a 20mg omeprazole dose strength. This PDUFA date is the second time around for Schering Plough; a response to a January complete response letter, and should therefore have a good chance of approval this time.
An approval of the OTC version of Zegerid will trigger a $20 million milestone payment to Santarus, and Santarus will receive low double-digit royalties on net sales of OTC Zegerid.
The OTC version of Zegerid through the partnership will make Zegerid a household name, just like Prilosec and other current drugs for the indication. Schering Plough’s marketing will include direct-to-patient advertising through regular media outlets, and the impact of this should be very positive for the prescription Zegerid products currently marketed and sold by Santarus. When a patient asks the physician about a drug by name, the physician has a strong tendency to prescribe it rather than spending valuable time explaining why another drug should be used – this is the bottom line of direct-to-patient advertising.
As Santarus is currently a profitable company without these events, the impact of both to the already stellar performance of this company will have analysts make drastic changes to upcoming quarterly estimates. We are already seeing adjustments in estimates after the surprisingly good third quarter without accounting for these upcoming catalysts. With annual revenue of $150 million, Santarus is currently undervalued with a market capitalization of just $225 million.
Author's Disclosure: Long SNTS
Picked up a few shares today
Looks like a winner here
4:50AM Santarus and Norgine enter license for ZEGERID immediate-release omeprazole products in Europe (SNTS) 3.66 : Co and Norgine B.V., a European specialty pharmaceutical co, announce that they have entered into a licensing agreement granting exclusive rights to Norgine to develop, manufacture and commercialize prescription immediate-release ZEGERID products incorporating the proton pump inhibitor omeprazole in combination with one or more buffering agents in specified markets in Western, Central and Eastern Europe. Under the license agreement, Norgine will pay Santarus a $2.5 mln upfront fee. Santarus will also be entitled to receive up to an additional $10 mln in milestone payments upon the achievement of certain regulatory events, subject to reductions based on Norgine's actual out-of pocket costs directly related to its clinical, regulatory and reimbursement efforts for a "major" country as defined under the license agreement. Norgine will also pay Santarus tiered royalties ranging from the mid- to high-teens, subject to reduction in certain limited circumstances, on net sales of any products sold under the license agreement.
Santarus to Present at September Investment Conferences
Press Release
Source: Santarus, Inc.
On Wednesday September 2, 2009, 4:00 am EDT
Companies:Santarus Inc.
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ: SNTS - News), a specialty biopharmaceutical company, today announced that Gerald T. Proehl, president and chief executive officer, will make presentations at the following investment conferences:
Thomas Weisel Partners Annual Healthcare Conference on Wednesday, September 9, 2009, at 8:35 a.m. Eastern time (5:35 a.m. Pacific time) at the Four Seasons Hotel in Boston, and
UBS Global Life Sciences Conference on Tuesday, September 22, 2009, at 3:30 p.m. Eastern time (12:30 p.m. Pacific time) at the Grand Hyatt Hotel in New York City.
Webcasts of theses presentations will be available during the event at www.santarus.com and will be archived and available on the Web site for 14 days.
Santarus to Present at BMO Capital Markets Focus on Healthcare Conference
Press Release
Source: Santarus, Inc.
On Wednesday July 29, 2009, 4:00 am EDT
Companies:Santarus Inc.
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ: SNTS - News), a specialty biopharmaceutical company, today announced that Gerald T. Proehl, president and chief executive officer, will make a presentation at the BMO Capital Markets 9th Annual Focus on Healthcare Conference on Wednesday, August 5, 2009 at 11:15 a.m. Eastern time (8:15 a.m. Pacific time) at the Millennium Broadway Hotel in New York City.
A webcast of the presentation will be available during the event at www.santarus.com and will be archived and available on the Web site for 14 days.
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 targeted physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension, which are indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which are 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 traveler’s 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. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans 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: difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products; 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.
Santarus Announces December 2009 Action Date for Schering-Plough's OTC ZEGERID New Drug Application
Press Release
Source: Santarus, Inc.
On Tuesday June 23, 2009, 4:00 am EDT
Companies:Santarus inc.
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ: SNTS - News), a specialty biopharmaceutical company, today announced that Schering-Plough HealthCare Products, Inc. has received notification from the U.S. Food and Drug Administration (FDA) of a December 2009 action date for an over-the-counter (OTC) ZEGERID® branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole.
Schering-Plough submitted a New Drug Application (NDA) in March 2008 seeking approval to sell ZEGERID in the U.S. OTC heartburn market. OTC ZEGERID is being developed under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’ patented technology. Schering-Plough received a complete response letter for its OTC ZEGERID NDA in January 2009 and submitted a response to the FDA in early June 2009.
Under the license agreement with Schering-Plough, Santarus is entitled to receive a $20-million milestone upon FDA approval of OTC ZEGERID, a low double-digit royalty on net sales of any OTC ZEGERID product, and may receive up to an additional $37.5 million in sales milestones.
Santarus Announces Schering-Plough Response Submission to FDA for OTC ZEGERID
On Tuesday June 9, 2009, 4:00 am EDT
Santarus Inc.
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ:SNTS - News), a specialty biopharmaceutical company, today announced that Schering-Plough HealthCare Products, Inc. has submitted its response to the U.S. Food and Drug Administration (FDA) complete response letter for an over-the-counter (OTC) ZEGERID® branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole. Schering-Plough received the complete response letter in January 2009 for its New Drug Application (NDA) seeking approval to sell ZEGERID in the U.S. OTC heartburn market.
The NDA for OTC ZEGERID was submitted by Schering-Plough in March 2008 under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’ proprietary technology.
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 targeted physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension, which are indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which are 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, Increase, Q2 2008 Earnings Call Transcript
http://seekingalpha.com/article/89029-santarus-increase-q2-2008-earnings-call-transcript?source=yahoo
Santarus and Depomed Announce U.S. Promotion Agreement for GLUMETZA Prescription Products
Tuesday July 22, 7:00 am ET
Santarus to sponsor conference call at 10:00 a.m. Eastern time today
SAN DIEGO & MENLO PARK, Calif.--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ: SNTS - News) and Depomed, Inc. (NASDAQ: DEPO - News) today announced that they have entered into a promotion agreement granting Santarus exclusive rights to promote Depomed’s GLUMETZA® (metformin hydrochloride extended release tablets) prescription products in the U.S. GLUMETZA is a once-daily, extended-release formulation of metformin that incorporates patented drug delivery technology and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Santarus expects to train its field sales representatives in the third quarter and to begin promotion of GLUMETZA brand products in the fourth quarter of 2008. Depomed reported GLUMETZA net sales of $5.2 million in the first quarter of 2008.
Metformin is widely used for the treatment of type 2 diabetes, but many patients do not achieve optimal dosing levels due to gastrointestinal (GI) side effects. The advantage of GLUMETZA’s delivery system is that it allows physicians to rapidly titrate dosing up to 2000 mg a day, which results in a more optimal level of glycemic control without significantly increasing GI side effects compared to a daily dose of 1500 mg of immediate-release metformin.
“We view GLUMETZA as an important addition to our product portfolio as it addresses a large and growing market in type 2 diabetes,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We believe that GLUMETZA is an excellent product to leverage our sales organization, with good overlap in our called-on physicians in the primary care market and with growth potential. Based on our current launch plans, we expect increased promotional expenses for GLUMETZA commencing in the third quarter of 2008; however, we believe that the net impact of GLUMETZA will be neutral in the fourth quarter of this year and accretive in 2009 and beyond.”
Under the terms of the promotion agreement, Santarus paid Depomed a $12 million upfront fee, and based on the achievement of specified levels of annual GLUMETZA net product sales, Santarus may pay Depomed one-time sales milestones totaling up to $16 million. Depomed will continue to record revenue from the sales of GLUMETZA and will pay Santarus a fee ranging from 75% to 80% of the gross margin associated with net sales of GLUMETZA, defined as net sales less cost of goods and product-related fees paid to Biovail Laboratories. Santarus will be responsible for all costs associated with its sales force and for all other marketing expenses associated with its promotion of GLUMETZA. A joint commercialization committee has been formed to oversee and guide the strategic direction of the GLUMETZA promotion efforts in the U.S. Depomed will be responsible for overseeing product manufacturing and supply, and retains the option to co-promote GLUMETZA in the future to obstetricians and gynecologists (Ob/Gyn).
“We are pleased to work with a highly motivated and committed partner like Santarus to focus on driving new prescriptions, launching our new 1000 mg dosage strength and increasing sales of GLUMETZA,” said Carl Pelzel, president and chief executive officer of Depomed. “Santarus has a field-based commercial organization of over 300 sales representatives to promote GLUMETZA to their targeted physicians. This organization has demonstrated good results in its promotion of ZEGERID in the highly competitive proton pump inhibitor market, and we look forward to strong results with GLUMETZA.”
Conference Call
Santarus has scheduled an investor conference call regarding this announcement at 10:00 a.m. Eastern time (7:00 a.m. Pacific time) today, July 22, 2008. Individuals interested in participating in the call may do so by dialing 888-803-8275 for domestic callers, or 706-643-7736 for international callers. A telephone replay will be available for 48 hours following conclusion of the call by dialing 800-642-1687 for domestic callers, or 706-645-9291 for international callers, and entering reservation code 56790888. The live conference call also will be available via the Internet by visiting the Investor Relations section of the company’s Web site at www.santarus.com, and a recording of the call will be available on the company’s Web site for 14 days following the completion of the call.
Santarus Increases Revolving Line of Credit to $25 Million and Extends Maturity to July 2011
Monday July 14, 4:00 am ET
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ: SNTS - News), a specialty pharmaceutical company, today announced that it has reached agreement with Comerica Bank to increase its revolving line of credit to $25 million and to extend the maturity date to July 11, 2011. Santarus entered into its first line of credit with Comerica in July 2006 with an original maturity date of July 28, 2009. Santarus will make interest-only payments on any draws from the line of credit, and all principal drawn during the term of the loan facility is due and payable at the maturity date. Interest on outstanding indebtedness under the credit facility is at either Comerica’s prime rate plus one-half percent (0.5%), or the LIBOR rate plus three percent (3.00%), at Santarus’ option.
The line of credit, which is anticipated to be used for working capital needs and other corporate purposes, is secured by the Company’s assets, excluding intellectual property, and contains affirmative and negative covenants, including financial covenants requiring Santarus to maintain certain levels of cash and investments and liquidity. Santarus has not drawn on the line of credit to date.
“We are pleased to expand and extend our commercial line of credit with Comerica, which provides us with increased flexibility in managing our financial resources,” said Debra P. Crawford, senior vice president and chief financial officer of Santarus. “We believe that this source of additional non-dilutive capital will help to support our corporate objectives to diversify our product portfolio and leverage our commercial organization.”
About Santarus
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists or primary care physicians. The company’s current marketing efforts are primarily focused on ZEGERID® Capsules and Powder for Oral Suspension. These products are immediate-release formulations of omeprazole, a widely prescribed proton pump inhibitor. 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. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans 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 potential for any debt that Santarus incurs under the line of credit to impair its ability to obtain additional financing in the future; Santarus’ ability to satisfy the conditions to borrowing under the line of credit; Santarus’ ability to comply with the covenants under the line of credit; the potential for an event of default under the line of credit, and the corresponding risk of acceleration of repayment and potential foreclosure on the assets pledged to secure the line of credit; Santarus’ ability to further diversify its product portfolio, including leveraging its commercial organization; difficulties or delays in development, testing, manufacturing and marketing of, and maintaining regulatory approvals for, Santarus’ products; 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 trademarks of Santarus, Inc.
surf's up......crikey
Santarus Announces Issuance Date of Additional U.S. Patent Covering Zegerid Products
Tuesday July 8, 4:00 am ET
Notice of Allowance previously announced in April 2008
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ:SNTS - News), a specialty pharmaceutical company, today announced that its licensor, the University of Missouri, has received an Issue Notification from the U.S. Patent and Trademark Office (USPTO) indicating that U.S. patent application number 10/641,732 will issue on July 15, 2008 as U.S. patent number 7,399,772. The new patent has claims covering methods for treating acid-caused gastrointestinal disorders by administering a solid pharmaceutical composition comprising non-enteric coated omeprazole and certain antacids. A Notice of Allowance was sent by the USPTO in April 2008. The new patent will have a July 2016 expiration date.
“We are pleased to receive notice of the issuance date for this new patent, which we believe further enhances the intellectual property coverage for our immediate-release ZEGERID® (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension products,” said Gerald T. Proehl, president and chief executive officer of Santarus.
Santarus has licensed rights to the 10/641,732 patent application, as well as other patents and pending patent applications, under an exclusive, worldwide license agreement with the University of Missouri relating to specific formulations of proton pump inhibitors (PPIs) with antacids and other buffering agents and methods of using these formulations. With the issuance of this new patent, there will be a total of six issued U.S. patents covering ZEGERID products and several U.S. patent applications are pending. In addition to the U.S. patent coverage, several international patents have been issued, including in Australia, Canada, India, Mexico, New Zealand, Russia, Singapore, South Africa and South Korea, as well as in countries within the European Patent Organization, and several international patent applications are pending.
Target $3 on Hold-Rated Santarus
Tuesday June 17, 4:16 pm ET
By Jason Napodano, CFA
Although we are pleased to see that Santarus, Inc. (NasdaqGM: SNTS - News) is working on strengthening its presence in the gastroesophageal reflux disease (GERD) market, we remain concerned about the intense competition in this market. We believe that investor focus will remain on prescription trends for heartburn drug Zegerid over the next few quarters. We recommend waiting on the sidelines until visibility improves, and maintain a Hold rating on the shares.
Santarus recently announced that it intends to terminate its co-promotion agreement with Otsuka America Pharmaceutical Inc. for Zegerid. Given the reduced sales force promotional efforts by other companies in the proton pump inhibitor market, Santarus should be able to maintain its share in its target audience despite the termination.
Moreover, the elimination of royalty payment obligations to Otsuka should bring Santarus a step closer to profitability. Based on our revised model, we see the company posting positive EPS in 2009.
Santarus shares have been on a roller-coaster ride over the past few quarters.
Going forward, we believe that the Zegerid patent infringement lawsuit against Par Pharmaceutical Inc (NYSE: PRX - News) will remain an overhang on the shares.
In our opinion, the company needs to reduce its dependence on the Zegerid line of products and should try to boost growth through the in-licensing or acquisition of suitable candidates. Our $3 target price is based on a P/S ratio of 1.3x our 2008 revenues.
Santarus Achieves $2.5 Million Regulatory Milestone under OTC License Agreement with Schering-Plough
Tuesday May 27, 4:00 am ET
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ:SNTS - News), a specialty pharmaceutical company, today announced that it has achieved a $2.5 million regulatory milestone under its over-the-counter (OTC) license agreement with Schering-Plough Healthcare Products, Inc. Santarus expects to receive the $2.5 million payment within the next two weeks. Schering-Plough is seeking U.S. Food and Drug Administration (FDA) approval to sell a ZEGERID® branded omeprazole/sodium bicarbonate OTC product. The OTC heartburn market in 2007 was estimated at $1.6 billion in the U.S. based on data from external market research sources and Santarus estimates.
Under the agreement, Schering-Plough is responsible for the development, manufacturing and commercialization of ZEGERID branded OTC products with the dosage strength of 20 mg of omeprazole for heartburn-related indications in the U.S. and Canada. 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 proton pump inhibitor (PPI) products.
Product Description
ZEGERID (omeprazole/sodium bicarbonate) contains omeprazole, a PPI, and sodium bicarbonate, which raises the gastric pH and thus protects omeprazole from acid degradation.
Important Safety Information about ZEGERID Branded OTC Products
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. 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 contains sodium bicarbonate. This should be taken into consideration for patients on a sodium-restricted diet.
ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.
Positive Clinical Data with Santarus' ZEGERID Capsules in Controlling 24-Hour Gastric Acidity Presented in DDW Abstract
Monday May 19, 4:00 am ET
Morning Dosing of ZEGERID Produced Rapid and Sustained Control of Gastric Acidity in Patients
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ:SNTS - News), a specialty pharmaceutical company, today announced the presentation of an abstract at the Digestive Disease Week (DDW) annual meeting of positive pharmacodynamic study results indicating that, after seven days of pre-breakfast dosing, ZEGERID® (omeprazole/sodium bicarbonate) Capsules 40 mg/1100 mg produced significantly greater and significantly faster control of gastric acidity in patients with gastroesophageal reflux disease (GERD) than two comparator drugs. The clinical study evaluated the effect of morning dosing of immediate-release ZEGERID Capsules, Protonix® (pantoprazole sodium) Delayed-Release Tablets 40 mg and Prevacid® (lansoprazole) Delayed-Release Capsules 30 mg on 24-hour gastric acid control. The clinical data were presented by Colin W. Howden, M.D., Division of Gastroenterology, Northwestern University Feinberg School of Medicine, in a poster session on May 18, 2008.
All three drugs are proton pump inhibitors (PPIs) used to treat GERD by reducing the production of gastric acid. A typical measure of gastric acid control is the ability of a therapy to maintain gastric pH at a level greater than 4. Clinical data from a total of 51 patients were analyzed in the open-label, randomized, crossover study. The primary endpoint of the study was to evaluate the effects of pre-breakfast dosing of ZEGERID Capsules, Protonix tablets and Prevacid capsules on 24-hour gastric acid control by measuring the percent time gastric pH was greater than 4 on the seventh day of once-daily, pre-breakfast dosing.
The study results indicated that the percent time gastric pH was greater than 4 with ZEGERID was approximately 43% longer than with Protonix (p<0.001) and approximately 22% longer than with Prevacid (p=0.005). In addition ZEGERID was associated with more rapid control of gastric acidity. ZEGERID achieved a pH greater than 4 within 20 minutes, compared with 70 minutes for Protonix and 65 minutes for Prevacid (p<0.001 for both comparisons). There were no clinically meaningful differences in the number or nature of adverse events reported in this study among the three drugs. Santarus had previously reported top-line results from this clinical trial in January 2008.
“We are very pleased to present these favorable clinical results at the DDW meeting, which is the largest meeting for gastroenterologists during the year,” said Gerald T. Proehl, president and chief executive officer of Santarus. “These study results reinforce our message that ZEGERID is the only oral PPI that offers immediate-release for rapid and sustained control of gastric acidity in GERD patients whether dosed in the morning or at night.”
Santarus Weighted to One Product
Friday May 9, 3:50 pm ET
By Jason Napodano, CFA
Santarus, Inc. (NasdaqGM: SNTS - News) is a specialty pharmaceutical company engaged in the acquisition, development, and commercialization of proprietary products and therapies that have the potential to treat gastrointestinal diseases and disorders, including gastroesophageal reflux disease (GERD). The company's lead product, Zegerid, is a combination of a proton pump inhibitor and one or more antacids.
Although we are pleased to see that Santarus is working on strengthening its presence in the GERD market, we remain concerned about the intense competition in this market. We believe that investor focus will remain on Zegerid prescription trends over the next few quarters. We recommend waiting on the sidelines until visibility improves.
Zegerid presents a distinctive pharmacological profile compared to other proton pump inhibitors. Although Zegerid's performance was a major disappointment during the initial launch period, sales started picking up with the launch of the capsule formulation in March 2006. We are pleased to see that the company is working on strengthening its commercial presence in the highly competitive GERD market which is dominated by big names like AstraZeneca (NYSE: AZN - News), Wyeth (NYSE: WYE - News), TAP and Johnson & Johnson (NYSE: JNJ - News).
The company intends to drive sales for Zegerid through additional promotional efforts, further managed care wins and a price increase taken in April 2008. We were also pleased to hear about Santarus agreements with GlaxoSmithKline (NYSE: GSK - News) which provide the company with a source for future revenue. Going forward, we believe that the Zegerid patent infringement lawsuit against Par Pharma (NYSE: PRX - News) will remain an overhang on the shares.
In our opinion, the company needs to reduce its dependence on the Zegerid line of products and should try to boost growth through the in-licensing or acquisition of suitable candidates. We maintain a Hold rating with a target price of $3. Our $3 target price is based on a P/S ratio of 1.3x our 2008 revenues.
Arpita Dutt, CA, contributed to this report.
Zacks.com
Wait & Watch on Santarus
Monday April 21, 3:28 pm ET
By Jason Napodano, CFA
Santarus, Inc. (NasdaqGM: SNTS - News) is a specialty pharmaceutical company engaged in the acquisition, development, and commercialization of proprietary products and therapies that have the potential to treat gastrointestinal diseases and disorders, including gastro-esophageal reflux disease (GERD). The company's lead product, Zegerid, is a combination of a proton pump inhibitor and one or more antacids.
Although we are pleased to see that Santarus is working on strengthening its presence in the GERD market, we remain concerned about the intense competition in this market. We believe that investor focus will remain on Zegerid prescription trends over the next few quarters. We recommend waiting on the sidelines until visibility improves.
Meanwhile, Santarus recently announced that it intends to terminate its co-promotion agreement with Otsuka Pharmaceutical Co. Ltd. for Zegerid. Zegerid is currently being promoted by 520 sales reps, including 170 reps provided by Otsuka. Following the termination of the agreement, Zegerid will be promoted by 350 reps.
Given the reduced sales force promotional efforts by other companies in the PPI market, Santarus should be able to maintain its share among its target audience despite the termination of the co-promotion agreement. Moreover, the elimination of royalty payment obligations to Otsuka should bring the company a step closer to profitability. Based on our revised model, we see the company posting positive EPS in 2009 ($0.05 per diluted share).
At this point, we adopt a wait and watch attitude and would like to see how the company's efforts to maintain and drive sales pay off. Going forward, we believe that the Zegerid patent infringement lawsuit against Par Pharma (NYSE: PRX - News) will remain an overhang on the shares.
In our opinion, the company needs to reduce its dependence on the Zegerid line of products and should try to boost growth through the in-licensing or acquisition of suitable candidates. We maintain a Hold rating with a target price of $3.50. Our $3.50 target price is based on a P/S ratio of 1.4x our 2008 revenues.
Santarus Provides Termination Notice to Otsuka America Pharmaceutical for ZEGERID Co-Promotion Agreement
Tuesday April 15, 4:05 pm ET
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ: SNTS - News), a specialty pharmaceutical company, today announced that it has provided notice to Otsuka America Pharmaceutical, Inc. of its intent to terminate their co-promotion agreement effective August 13, 2008, or earlier as the parties may mutually agree. Under the co-promotion agreement, Otsuka America has provided promotional support in the U.S. related to Santarus’ ZEGERID® (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension products. Santarus will continue to promote its ZEGERID prescription products in the U.S. with its field sales organization and inVentiv contract field sales representatives.
“We remain committed to growing ZEGERID prescription product sales. We believe that actions recently taken by other companies to reduce sales force promotion on their branded proton pump inhibitor (PPI) prescription products has created an opportunity for us to reduce our cost structure, while maintaining our share of voice with our targeted physicians,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We sincerely appreciate the collaborative efforts of Otsuka America in working together with our commercial team to launch and promote our ZEGERID products.”
Santarus and Otsuka America entered into the agreement in October 2004 to co-promote ZEGERID products in the U.S. through December 31, 2009, unless terminated earlier under amended terms agreed to in January 2006. Following the effective date of termination of the co-promotion agreement there will be no continuing financial commitments for either company, and Santarus will no longer be obligated to pay a high single-digit royalty on ZEGERID net sales to Otsuka America. In addition, Santarus anticipates that it will accelerate the timeframe over which it amortizes the remaining balance of the $15 million up-front payment previously received from Otsuka America in October 2004. The remaining deferred revenue balance related to the up-front payment was approximately $5 million as of March 31, 2008.
SNTS shorts still burning in the continuing parabolic move over the last few days.
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http://www.santarus.com/
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Santarus, Inc., a specialty pharmaceutical company, engages in the acqusition, development, and commercialization of proprietary products and therapies that treat gastrointestinal diseases and disorders, including gastroesophageal reflux disease (GERD) in the United States. It offers Zegerid family of products, which are proprietary immediate-release formulations that combine omeprazole, a proton pump inhibitor (PPI), and one or more antacids. The company's products are prescribed for the treatment of upper gastrointestinal diseases and disorders, including heartburn and other symptoms associated with GERD, erosive esophagitis, upper gastrointestinal bleeding, and gastric and duodenal ulcers. Santarus offers products in capsule, powder for oral suspension, and chewable tablet dosage forms. It sells its approved products to pharmaceutical wholesalers, who in turn distribute the products to retail pharmacies, mail order pharmacies, hospitals, and other institutional customers. Santarus has a strategic alliance with Schering-Plough Healthcare Products, Inc. to develop, manufacture, and sell over the counter products with the lower dosage strength of 20 mg of omeprazole in the United States and Canada; and a license agreement with the University of Missouri for its patents and pending patent applications relating to specific formulations of PPIs with antacids and other buffering agents. The company was founded in 1996 and is headquartered in San Diego, California.
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