DEPO – Action Ahead Of The AdCom

DepoMed Inc. (DEPO) -Nasdaq Serada is an investigational formulation of gabapentin, an FDA-approved immediate release pharmaceutical for the treatment of partial epilepsy and management of postherpetic neuralgia (PHN). Recently published studies suggest the potential application of gabapentin for the treatment of menopausal hot flashes. Based on these findings, Depomed has secured exclusive rights to develop […]

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 […]

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 […]

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 – Trading BREEZE-3 Results

Overview In the next several weeks Depomed (DEPO) is expected to announce top-line results from it’s large Phase 3 clinical trial for Serada, an investigational non-hormonal treatment for post-menopausal hot flashes. Our analysis suggests a 35-40% probability of positive outcome for all endpoints with an expected share price move from $1.00 to $3.00(1) from current […]

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 […]

Neurogesx and Depomed seek to persuade pain specialists

I attended a recent medical conference where pain specialists outlined the history and direction of the pain industry, covering both nociceptive and neuropathic pain.   After the conference, I had a chance to talk one-on-one with several pain specialists.  I asked for their input on the industry and several products that I found particularly promising. […]

Despite Abbott Parting With Gralise, Depomed’s Future Looks Bright

During the past week, Depomed (DEPO) announced two significant business development updates. On March 15th, Depomed granted non-exclusive rights for its proprietary extended-release metformin patents, this time, to Boehringer Ingelheim. On March 16th, Depomed announced that they and Abbott (ABT) have reached an agreement over Gralise. Moving Forward From Abbott The details of the agreement […]

Depomed: Attractive and Under-Appreciated Potential

It almost seems counterintuitive that majority shareholders of Depomed (DEPO) have been adding shares after the FDA approval of Gralise, a once-daily treatment for post-herpetic neuralgia. One might expect that large funds would look to the high volume created with an FDA decision as an opportune exit strategy. Yet that hasn’t happened, several funds have […]

Sales Potential and Chances of FDA Approval for DepoMed’s DM-1796

Many biotech investors have been closely watching the upcoming PDUFA date for DM-1796, DepoMed’s (DEPO) investigational extended-release gabapentin formulation. Depomed’s story has been marred with ups and downs, panicking those investors with a faint heart and forcing weak hands to exit, while the major funds continue to accumulate shares. To understand DM-1796’s approvability and its […]

Finding Opportunity in Abbott – Depomed Dispute

Tuesday, Depomed (DEPO) announced that Abbott (ABT) is disputing elements of their contract regarding DM-1796, an investigational extended-release gabapentin formulation. According to the conference call and press release, CEO Carl Pelzel is “perplexed” by Abbott’s last minute maneuvers and expressed haste in beginning the mediation process and, if needed, binding arbitration. Issues with the contract The issues are […]

Investment Opportunities in Women’s Health

The next several months will be an exciting time for the women’s health space, with several important events that may represent an opportunity for investors. Most notably, Pfizer (PFE) has completed data collection for it’s 2186-patient study of Pristiq for the treatment of vasomotor symptoms, more commonly known as hot flashes. Wyeth, now part of […]