Vivus (NASDAQ:VVUS), a specialty pharmaceutical company, has faced some setbacks with its 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, outlining a path to approval, which left investors who expected approval dissappointed. In January 2011, the company met […]
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 […]
Gilead Continues Move Into Oncology With Calistoga Acquisition
What a change a decade makes. Back in 2001, Gilead was a high-flying biotech, in the early legs of its growth projectory. Management at the time was laser focused on the company’s HIV franchise, deciding to sell its oncology assets to a little company called OSI Pharmaceuticals for $200 million. Since then, Gilead has grown […]
Genzyme Sold, Who’s Next?
Now that Genzyme has been acquired by Sanofi-Aventis, money managers have begun asking- where did all that money go? A Dow Jones Newswire article by Steven Russolillo reasoned that arbitrage players who held much of Genzyme shares have been quickly dividing that money between big and small name players for months now. Still, $20 billion […]
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 […]
Eli Lilly: Plenty Of Talk, Now Time For Results
Eli Lilly CEO, John Lechleiter, Ph.D., has been making the rounds lately promoting innovation in pharmaceutical research. Most recently, he delivered the keynote speech at The Economist’s 2011 Pharma Summit: Reinventing Pharma for a New Generation this past February 10, in London. In his remarks, Lechleiter highlighted some of the problems facing the innovative drug […]
Alexion Goes From Acquisition Target To Acquirer
Alexion Pharmaceuticals reported revenues and major developments in its 2010 4th quarter report yesterday. Revenue continued climbing at a rapid clip, 2010 net product sales increased 40 percent to $541.0 million, compared to $386.8 million in 2009 and is projected to grow to between $715-$735 million in 2011. 2010 non-GAAP net income increased 54 percent […]
Idenix: Two Steps Forward and One Step Back
It has happened before- just when things were beginning to look up, Idenix has taken another beating. This time, the experimental AIDS drug it had licensed to ViiV Healthcare, an affiliate of GSK, had been placed on clinical hold by the FDA. The compound, IDX899, a non-nucleoside reverse-transcriptase inhibitor (NNRTI) had only begun Phase IIb […]
Ziopharm and Intrexon: Odd Couples
In January, Ziopharm announced a strategic deal with billionaire RJ Kirk’s synthetic biology company, Intrexon. In return for an $11,628,202 million investment in Ziopharm stock, Intrexon was issued 7.5% of Ziopharm stock and will receive an additional 7.5% once their lead candidate DC-IL-12 begins Phase II trials. From time to time, Kirk will also participate […]
Celgene: Is It Time To Buy?
Celgene has been hit again with issues of secondary malignancies arising from prolonged treatment with its key drug, Revlimid. Shares have crumbled in the past month from $60/sh early this year to as low as $49 on February 4. It has now bounced back above $50. News of secondary malignancies has bedeviled the company since […]
Of Billionaires and Biotechs
The biotech industry does not crank out billionaires. The long timelines to an improbable success combined with inevitable dilution of the founder’s stake makes it all but impossible. Consider that the collective market cap of all biotech companies is only about $360 billion, compared to about $320 billion for Apple alone. But a few men […]
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 […]
Celldex: Can Anything Halt It’s Slide?
Three Phase II trials and still waiting. It’s been a lot of bad news lately for this little biotech. Trial data has been scrutinized, a Phase II/III was downgraded to a Phase II, and big Pharma partner, Pfizer, has left it at the alter. Not surprisingly, the stock has been spiraling downwards since the middle […]
Roche Scores Big With Plexxikon and Immunogen Deals
Roche took a hit in December 2010 when the FDA revoked the breast cancer indication from Avastin, its top selling oncology drug for lack of benefit. Businessweek had estimated this could result in an annual loss of about a billion dollars in sales to the firm. Avastin, while a targeted therapy that shuts down new […]
Big Pharma Is The New Big Biotech
Biotechnology companies used to be distinguished by their ability to produce complex drugs requiring the culture of living organisms- drugs often based on the manipulation of DNA. Genentech and Amgen were pioneers of this field, producing recombinant human proteins and antibody therapeutics. Their success led to the development of the biotechnology industry. Today, the biotech […]
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 […]
Ardea Keeps On Rolling
Ardea’s stock has appreciated about 36% since mid-December, a couple weeks prior to its release of successful Phase IIb gout data. Gout hasn’t been the most exciting area of research. Until 2009, 40 years went by without a new approved treatment for the arthritic disorder. That year, febuxoxtat, marketed by Takeda in the US became […]
Halozyme: It’s All In The Delivery
According to Datamonitor, market share among pharmaceutical products is shifting from oral therapeutics to injectibles due to such factors as therapeutic focus, molecule type and lifecycle stage. Drug delivery platforms have always played an important role in drug development. With this shift, Halozyme’s technology becomes of special interest for its ability to improve the performance […]
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 […]
