Summary of our recent coverage/positions: October 26, 2011: We reiterated a BUY, see report April 21, 2012: We reiterated a BUY, see report October 17, 2012: We reiterated a BUY, see report January 31, 2012: I tweeted that I sold my shares, see tweet Respective Outcomes: Gains from coverage initiation in October 2011: +52% Gains from […]
DEPO – Quick Update on Depomed
With Depomed’s recent PPS drop to below $5, many long-term investors have found themselves questioning their investment thesis. Although this past quarter has seen some interesting news releases, none have been able to move the stock price. Furthermore, the endless staring and tracking of weekly Gralise data has left investors, who lack patience, without a […]
VVUS – PDUFA approaching, company revving Branding & Marketing
Vivus’s (VVUS), a specialty pharmaceutical company, had faced many setbacks with it’s drug candidate, Qnexa, an investigational treatment for obesity, obstructive sleep apnea and diabetes. In October 2010, Vivus received a Complete Response Letter from the FDA. In March of 2011, several studies were published demonstrating teratogenicity with one of Qnexa’s main ingredients, topiramate. Despite […]
VVUS – Understanding the Upcoming PDUFA
Vivus’s July 17th PDUFA date is quickly approaching. After the FDA Advisory Committee voted strongly in favor of approving Qnexa, for the treatment of obesity, mostly all pundits and analyst have all but claimed victory for Vivus’s upcoming PDUFA date. We feel that overall, Qnexa has received significantly more positive commentary secondary to a meaningful […]
ARNA – Quick Update on Arena’s upcoming PDUFA date
Arena’s June 27th PDUFA date is quickly approaching. After the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity, mostly all pundits and analyst have all but claimed victory for Arena’s upcoming PDUFA date. We feel that despite modest efficacy, Lorcaserin has a high degree of likelihood for approval. […]
ARNA, VVUS & OREX – Update after Lorcaserin AdCOM
Yesterday, the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity. Previously, our group felt that ARNA’s Lorcaserin along with OREX’s Contrave would eventually gain regulatory approval, but that there would be some delay. In the case of ARNA, we were impressed at how eager the Advisory Committee was […]
DEPO, SNTS, XNPT, PFE – Update on Q1 Earnings
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 […]
ARNA – Quick take on FDA Adcom
Our coverage of the anti-obesity sector continues. Yesterday, the FDA released the briefing documents regarding Arena’s application for Lorcaserin. Lorcaserin, or Lorqess, is a novel therapeutic candidate for treatment of obesity. Brief History: In 2010, Arena submitted the NDA for Lorcaserin, a subsequent AdCom voted against the application, five on the roster voted for the […]
DEPO – Quick Update on Depomed’s plan to file NDA for Serada
On Tuesday, Depomed announced that they intend to file an NDA for Serada. At one point, in after hours trading the stock peaked up almost 7%, at which point we cautioned investors, here, to consider selling into this strength. Since then, it seems that the stock price had settled back down pre-news levels until […]
VVUS, OREX, ARNA – Understanding the Advisory Committee
Playing VVUS, OREX, ARNA through FDA Adcomm and Qnexa PDUFA Over the past several months, these three companies, with their respective late-stage anti-obesity drug candidates, have experienced a considerable increase in volatility and share price, due in part to new regulatory revelations regarding clinical pathways to regulatory approval. We believe there will continued volatility leading […]
VVUS – Vivus & the FDA; Understanding the Advisory Committee
Our Previous Coverage: Initial Report – 12/16/11 Quick Update 1 – 01/09/12 Last week, the FDA released the briefing documents for an upcoming Advisory Committee meeting set to discuss Vivus’s Qnexa, an investigational compound for the treatment of obesity. Our team combed through over 400 pages of material, in an effort to synthesize this data […]
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 […]
VVUS – Quick Update – Vivus alters NDA for Qnexa, changes REMS
Vivus Pharmaceuticals (NASDAQ:VVUS) reached an agreement today with the FDA, to alter both it’s REMS and Label for obesity drug candidate, Qnexa. Previous Proposed Label Management took a very conservative approach when filing the initial NDA. Given questions about teratogencity of topiramate, one of the active ingredients in Qnexa, Vivus’s management proposed a label that […]
VVUS – Vivus Pharmaceuticals – Initiating Covereage – Neutral
Vivus (VVUS), is a specialty pharmaceutical company with two lead product candidates that are facing a regulatory decision within the next 6 months. Besides two PDUFA dates, VVUS also has an FDA Advisory Committee Meeting and results from a key study, dubbed FORTRESS, due out in the coming days. The most anticipated drug candidate […]
PFE & BMY – Quick Update on Pfizer’s and Bristol’s Apixaban
In the past week Bristol Myers Squibb (NYSE:BMY) and Pfizer (NYSE:PFE) have had two notably regulatory events for Apixiban, or ELIQUIS. On November 25th, the National Institute for Health and Clinical Excellence (NICE) made an unusually rapid decision to adopt and cover Apixaban for use by the state health service in the UK. This […]
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 […]
SNTS – Initiating Coverage on Santarus
On November 8th, Santarus (NADSAQ:SNTS) reported third quarter earnings of $0.01 per share, which was in-line with estimates. Interesting to note, SNTS management has guided higher on Glumetza sales, and has indicated that they are hiring 40 more sales reps to detail the drug. Management further indicated that they anticipate at least $25 million in […]
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 […]
DEPO – Buying Opportunity after Serada failure
Earlier in October, Depomed (DEPO), announced results from it’s Phase 3 trial, called BREEZE 3, testing Serada, an extended release gabapentin formulation for the use in post menopausal hot flashes. The trial failed to meet 1 of 4 primary endpoints, and failed to meet its key secondary endpoints. Below is an excerpt from Depomed’s press […]
DEPO – Initiating Coverage on Depomed & Examining BREEZE-3
Initiating Coverage: Depomed is a commercial-stage specialty pharmaceutical company with three FDA approved products; ProQuin for infection, Glumetza for Adult Onset Diabetes Mellitus & Gralise for Post Herpetic Neuralgia. Within the next several weeks Depomed will launch Gralise in the USA with a detailing focus to high prescribing neurologists and pain specialists. Also, within the […]
