DEPO – Reaffirming Buy Yesterday, Depomed reported better-than-expected earnings for the first quarter. Gralise revenue was $1.75 million, Glumetza revenue was $9.2 million, Janumet XR was $0.2 million. We are reaffirming our BUY recommendation for this company. We feel that increases in total sales for Glumetza, price increases, and an increase in the percentage revenue […]
DEPO – Quick Update – Paragraph IV – DM1992 Phase 2
Depomed released a statement that Actavis Group, a generic drug manufacturer filed a paragraph IV challenge against Gralise, Depomed’s once-daily gabapentin formulation. NEUTRAL on Paragraph IV We view this event as having no net impact. Patent challenges are not unexpected in this pharmaceutical environment, especially in the drug delivery space. The current generic drug legislation rewards early […]
PFE & BMY – The anticoagulant market & the Apixaban Catalyst
Background: The market for anti-thrombosis agents is set for dramatic changes. A thrombus is an aggregation of platelets which plays a key part in several life-threatening diseases, such as myocardial infarction, stroke, deep-vein thrombosis, pulmonary embolism, stent thrombosis, as well as other medical conditions. The market for therapies against thrombosis can be broken down simply […]
DEPO, XNPT, PFE – Managed-care to stunt Lyrica, Horizant and Gralise with step-edits
The Neurology and Pain sectors have been very interesting for biotech investors focused over the past year. Xenoport (NASDAQ:XNPT), Depomed (NASDAQ:DEPO), GlaxoSmithKline (NYSE:GSK) and Pfizer (NYSE:PFE) have all had regulatory successes over the past several months. The problem is the regulatory successes haven’t necessarily resulted in financial success for companies and their shareholders. At a […]
GSK: What To Do With ViiV
Great story came out May 6 from Reuters, reporting that Morgan Stanley analysts recently told investors a ViiV IPO or spinoff could be beneficial for GSK and the Pfizer/GSK joint venture. ViiV was formed in 2009 to wrap together GSK and Pfizer’s HIV drug assets under the premise that a separate entity would allow for […]
Xenoport Drug Horizant approved
Today, the FDA approved Xenoport’s (NASDAQ:XNPT) and GlaxoSmithKline’s (NYSE:GSK) Horizant (gabapentin enacarbil) for the treatment of Restless Leg Syndrome (‘RLS’). EfficacyThe efficacy of Horizant in the treatment of patients with moderate-to-severe primary RLS was demonstrated in two 12-week clinical trials in adults. Recommended DoseThe recommended dosage of Horizant is 600 mg once daily taken with food at about […]
Strategies and Outlook for Xenoport’s Upcoming FDA PDUFA Date
Within a week, Xenoport (NASDAQ:XNPT) and partner GlaxoSmithKline (NYSE:GSK) should receive feedback from the FDA regarding the NDA for Horizant, a gabapentin pro-drug for the treatment of Restless Leg Syndrome (‘RLS’). With several recent clinical trial failures, approval is paramount for Xenoport. Earlier this month, Xenoport announced that its ‘GERD’ product candidate, arbaclofen placarbil, was […]
GSK Pursues Fabry Disease Drug as Orphan Indications Are All The Rage
Amicus has just signed a deal with GSK giving the large pharma worldwide rights to their Fabry disease drug, Amigal, in return for $60 million in upfront payments and $170 million in milestones. Patients are currently enrolling in a Phase III trial of Amigal, with preliminary results expected by the end of this year. This is fantastic […]
