Expert Financial Analysis and Reporting

Overview of Five Briefing Questions Posed by FDA on Dapagliflozin On Friday, July 15, 2011 the FDA published on its website the questions that it has asked the Endocrinologic and Metabolics Drug Advisory Committee to address in its July 19, 2011 meeting on dapagliflozin. My impression on the initial reading of the questions is that […]

Overview and Investment Thesis The strong Bristol-Myers pipeline story is key to the investment thesis and is driven by three potential blockbusters: Yervoy, which was just approved; apixiban which has reported very encouraging phase III data and is likely to be approved in 2012; and dapagliflozin. Of the three, the outlook for dapagliflozin is the […]

Investment Thesis Transcept’s new drug for insomnia, Intermezzo, received a Complete Response Letter on October 26, 2009 in which the FDA acknowledged that it was effective. However, the agency failed to approve the drug because of concerns about dosing and potential next day residual effects. Transcept addressed and in my opinion has successfully answered these […]

Investment Opinion I believe that the Ofirmev approval is a game changer that can propel Cadence into a successful, medium tier, earnings driven bio-pharmaceutical company. While I am recommending purchase of Cadence, I think that it important for investors to understand the risks and uncertainties of the investment outlook. This note discusses the patent challenge […]

CMS Approval Removes Investor Concern CMS issued its final national coverage decision on Provenge yesterday and confirmed the preliminary decision that specifically states that treatment with Provenge is reasonable and necessary. This assures provider reimbursement for Medicare beneficiaries when Provenge is used on-label to treat asymptomatic and minimally symptomatic castrate resistant prostate cancer patients. This […]

Investment Overview I have previously written about Bristol-Myers Squibb (BMY) as having possibly the best pipeline among the major pharmaceutical firms. Despite the new product outlook, I estimate that the loss of sales from products coming off patent will cause overall sales to decrease from $20.4 billion in 2011 to $16.6 billion in 2013. The […]

The investment thesis for Anadys is almost totally based on the prospects for its lead drug, ANA 598, which is being developed for treating hepatitis C. This drug has shown itself to be safe and phase I data supports the belief that it is an effective agent. It is now in a phase II trial […]

Investment Thesis Adolor has gained back Glaxo’s rights to Entereg (alvimopan) in a transaction that I regard as a highly positive, company changing event. Entereg has the critical sales mass to enable Adolor to be a self-sufficient, cash flow positive company. I believe that the Entereg sales run rate entering 2012 could be on the […]

Stock Opinion The FDA has shown great reluctance to approve three anti-obesity agents under development: Orexigen’s ($2.11, OREX) Contrave, Vivus’ ($8.17, VVUS) Qnexa and Arena’s ($1.38, ARNA) Lorques. All three drugs received complete response letters following their NDA submissions and the companies are in the process of addressing the FDA’s concerns before refilling their NDAs. […]

Stock Opinion The FDA has shown great reluctance to approve three anti-obesity agents under development: Orexigen’s ($2.11, OREX) Contrave, Vivus’ ($8.17, VVUS) Qnexa and Arena’s ($1.38, ARNA) Lorques. All three drugs received complete response letters following their NDA submissions and the companies are in the process of addressing the FDA’s concerns before refilling their NDAs. […]