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 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 […]
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 – 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 – 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 […]
Platform and Specialty Pharmaceutical Companies can bolster Big Pharma
The pharmaceutical industry is in a weak state, with an impending “patent cliff” that is forcing Big Pharma to reorganize and refocus. In 2011, roughly $20 billion in branded US sales dollars are “at risk” to patent expiry and generic competition. The pinnacle will be reached in 2013 and will subside after 2015. Fiscal Year […]
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. […]
Depomed’s research posters and presentations from recent medical conferences
Depomed, Inc. (NASDAQ:DEPO) presented two analyses of phase 3 clinical data of Gralise™, a once-daily formulation of gabapentin for management of postherpetic neuralgia, at the 63rd Annual Meeting of the American Academy of Neurology (AAN). Below is a poster, presented at AAN, that concludes that there was no effect of previous treatment with gabapentin and […]
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 […]
Depomed’s Stock Price Is a Gift Following FDA Approval of Pain Drug
Now that Depomed’s (DEPO) GRALISE has been approved by the FDA, making a bull case for Depomed becomes easy. GRALISE is an extended release gabapentin formulation, formerly DM-1796, that is prescribed once-daily for the treatment of post-herpetic-neuralgia (“PHN”), which is pain associated with shingles. Approval of GRALISE triggers a milestone payment of $48 million from […]
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 […]
News Stories Miss the Point as Depomed Approaches FDA Target Date
Depomed (NASDAQ:DEPO), a specialty pharmaceutical company, has seen a healthy gain in its stock price due in part to its upcoming PDUFA date for DM-1796, a once-a-day treatment for Post Herpetic Neuralgia. Depomed is a unique company, not only because it has compelling product candidates in its pipeline, but also because its platform technology can […]
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 […]
Serada Half Price Sale: DepoMed’s Stock Price Poised to Climb
Several weeks ago, DepoMed (NASDAQ:DEPO), a specialty pharmaceutical company, announced positive phase 3 trial results for the treatment of Post Herpetic Neuralgia (‘PHN’) with DM1796. But DepoMed’s news of success was soon eclipsed. Only one week later, the company announced that Serada didn’t meet its primary endpoints in two pivotal Phase 3 clinical trials for […]
