Archive for September, 2011
Contrave Is Given New Life as FDA Reverses its Position on Design of Cardiovacular Outcomes Trial (OREX, $2.45)
Investment Opinion Orexigen’s (OREX) anti-obesity drug Contrave has been given new life as the FDA reversed a previous position that would have required a cardiovascular outcomes trial involving 60,000 to 100,000 patients and which might have taken four to six years to complete in order to gain US approval for Contrave. In a press release […]
An In-Depth Look at Santarus as it Develops a Promising Pipeline to Offset Patent Challenges to Existing Products (SNTS, $3.14)
Investment Overview Santarus was founded to commercialize Zegerid for the treatment of gastrointestinal reflux disease (GERD) and ulcers. It competed in the proton pump inhibitor class of drugs, which includes Nexium, Prilosec, Prevacid, Protonix and Aciphex. Despite being up against the sales forces of much larger companies like Astra-Zeneca (AZN), Abbott (ABT), Wyeth and Johnson […]
Transcept to Resubmit Intermezzo NDA; Hopes for a Class I Review
Resubmission of Intermezzo NDA Transcept Pharmaceuticals in a press release today (September 15) said that it plans to resubmit its NDA on Intermezzo following a meeting with the FDA. The key parts of the resubmission are: Transcept proposes to reduce the recommended Intermezzo dose for women from 3.5 mg to 1.75 mg, and to keep […]
Transcept to Resubmit Intermezzo NDA; Hopes for a Class I Review (TSPT, $6.63)
Resubmission of Intermezzo NDA Transcept Pharmaceuticals in a press release today (September 15) said that it plans to resubmit its NDA on Intermezzo following a meeting with the FDA. The key parts of the resubmission are: Transcept proposes to reduce the recommended Intermezzo dose for women from 3.5 mg to 1.75 mg, and to […]
Check with Adolor Management on Entereg Marketing Transition and Progress of Partnering Discussions on ADL 5945 (ADLR, $2.05)
Investment Thesis I upgraded Adolor to a BUY after the company announced that it had reacquired all rights to Entereg from Glaxo. I did this even though binary phase II data on ADL 5945, their new drug for opioid induced constipation, was due at any time. I felt that the stock was attractive on the […]
Budesonide MMX’s Potential in Ulcerative Colitis (SNTS, $3.18)
Investment Thesis This report focuses on the ulcerative colitis market and particularly on budesonide MMX, an important new drug being developed by Santarus for this disease. It uses a novel drug delivery technology in combination with the now generic, non-systemic corticosteroid budesonide. Santarus currently markets three drugs. Its first marketed drug Zegerid has been impacted […]
FDA Cardiovascular and Renal Advisory Committee Goes Against FDA View and Recommends Approval of Xarelto
The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time). The reviewer did […]
FDA Advisory Committee Recommendation for Approval of Xarelto Bodes Well for Approval of Eliquis (apixaban)
The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time). The reviewer did […]
FDA Advisory Committee Goes Against FDA and Recommends Approval of Xarelto
The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time). The reviewer did […]
Rhucin in the Hereditary Angioedema Market Can Be A Meaningful New Product for Santarus (SNTS, $3.14)
Investment Thesis This report is intended to highlight the potential for four current products and one in development for the treatment of hereditary angioedema (HAE), a rapidly growing market. The HAE market is in an early and dynamic period of growth that should last for the next several years. I project that the US market […]