Santarus Inc. (SNTS) 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 ...

Santarus, Inc. (NASDAQ:SNTS) expects the FDA to decide by December 4, 2009 regarding its NDA for ZEGERID tablet product. A NDA (New Drug Application) for DM-1796 is also expected to be filed with the FDA the first quarter of 2010.

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

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Yesterday, Schering-Plough Corp. (SGP) and Johnson & Johnson (JNJ) announced the approval of their drug Simponi (golimumab) in the European Union for the treatment of rheumatoid arthritis and other immune system disorders. The drug was approved by the U.S. Food and Drug Administration (FDA) in April 2009.   As a reminder, Schering acquired co-development rights to Simponi in the third quarter of 2005 from Johnson & Johnson’s biotech arm, Centocor Inc., which had developed and discovered the drug. Johnson & Johnson enjoys exclusive marketing rights of Simponi in the U.S., while Schering-Plough holds marketing rights outside the U.S.  excluding Japan, Indonesia and Taiwan where the drug will be co-marketed with other vendors subsequent to regulatory approvals.   Simponi, a next-generation, fully human, anti-tumor necrosis factor (TNF), received European approval as a once-a-month treatment for rheumatoid arthritis (RA), psoriatic arthritis (PA) and ankylosing spondylitis (AS), which is a ...

We are pleased with UK-based Shire Plc’s (SHPGY) research collaboration with Denmark’s Santaris Pharma for the development of new drugs for rare diseases. Shire will make an upfront payment of $6.5 million and an additional $13.5 million on completion of certain initial studies.

Santaris Pharma also has the potential to get another $72 million in the form of development, regulatory and sales-related milestone payments for each of its five pipeline candidates along with royalties on sales once these products are commercialized. The initial term of the collaboration is two years and Shire may extend it by another two-year term.

With this deal, Shire will be able to utilize Santaris' proprietary locked nucleic acid (LNA) technology platform to develop treatments for several life threatening conditions that cannot be cured by enzyme replacement therapy (ERT), a platform where Shire has a strong presence. We believe the alliance will be beneficial

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In a Schedule 14A proxy statement filed on May 20, 2009 Merck & Co. (MRK) disclosed that it had received notification from Johnson & Johnson's (JNJ) Centocor subsidiary of its intention to terminate, through arbitration, the distribution agreement with Schering-Plough Corp (SGP) for Remicade and golimumab (Simponi). As we detailed in prior reports and blogs, we had expected some sort of challenge from J&J, so the recent news comes as no surprise.In March 2009 Merck and Co. and Schering-Plough announced a merger agreement whereby the companies would combine in a deal currently valued at approximately $48.8 billion. The deal was structured as a "reverse-merger" with Schering-Plough being the surviving entity. Merck believes that the "reverse-merger" structure will avoid triggering a change-of-control provision in Schering-Plough's agreement with J&J relative to rights to Remicade and golimumab.J&J discovered both compounds and licensed ex-U.S. marketing rights ...

The recent volatility from the Healthcare sector has left many investors weary about where to place their money. General market swings aside, M&A activity and legislative developments have intensified the uncertainty in the sector, but have also lead to many investment opportunities.

M&A has been very exciting and has ramped up heavily in the last few months.  Pfizer[PFE: 14.04, 0.00 (0.00%)] and Wyeth, Roche and Genentech [DNA: 0.00, N/A (N/A)], Merck [MRK: 27.16, 0.00 (0.00%)] and Schering-Plough, Gilead [GILD: 44.37, 0.00 (0.00%)] and CV Therapeutics have all hit the headlines.  Obama’s Healthcare Budget Plan has stirred up heavy trading in recent weeks, putting downward pressure on the Managed Care and Pharmaceuticals sectors, while giving a boost to the Generic Drugmakers. The market has rallied in the past week.  Is your portfolio ready

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Sometime during the middle of the year, Genentech (DNA) shareholders are going to get $95 in cash for each share of Genentech stock they own. In total, nearly $47 billion in funds are expected to be returned to biotechnology investors.We've come up with an effective "basket approach" to re-deploy those funds back into the biotech sector -- in search of the next Genentech.Antisense Makes a Lot of SenseFor a little over $13, investors can pick up one share of Isis Pharmaceuticals (ISIS). Isis is the market leader in antisense technology.We've made it no secret in the past -- we are big fans of antisense. We view the drug discovery engine fueled by Isis' antisense technology very similar to the power of Genentech's recombinant DNA and monoclonal antibody technology breakthroughs of the 1980's. Antisense drugs are still in their infancy, ...