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 […]
Achillion Pharma Breaks 52-week High, What’s Next?
Achillion stock has been flat all year, underperforming the biotech indices as well as its peers in the Hepatitis C drug development community. The stock began to leap a couple days after the company announced that data from ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the […]
Enzon Pharmaceuticals – A Two-Platform Company
Enzon is a developmental stage company with a product in Phase II and two in Phase I. The biotech’s pipeline is powerd by two platform technologies- PEGylation, and Locked Nucleic Acid (LNA) antisense. I had a chance to speak with the company’s Chief Scientific Officer, Dr. Ivan Horak last week to discuss their drug pipeline. […]
Biovista – a Dedicated Approach to Drug Repositioning
Following up my previous piece on drug repositioning by Orexigen with its diet pill, Contrave, I spoke with Dr. Aris Persidis, President and co-founder of Biovista- a leading company in the drug repositioning business. Drug repositioning is the discovery and development of novel indications for approved drugs. As Dr. Persidis told me in a phone […]
Oncogenex Has Novel Products and Financial Flexibility
Perhaps unprecedented in the realm of biotech companies, Oncogenex Pharmaceuticals has an astonishing four years of cash. It will end this year with approximately $83-85 million, enough to see it through the completion of three Phase III trials of lead candidate OGX-011 (custirsen) and two Phase II trials of the promising OGX-427. Oncogenex is a […]
Orexigen’s Contrave- Making Waves Beyond Obesity Drugs
The success of Orexigen’s weight loss drug, Contrave, with the FDA advisory panel highlights an important area in drug development- repositioning. Orexigen accomplished this by combining the off-patent drugs bupropion and naltrexone in a novel single pill fixed dose formulation. Bupropion is an antidepressant and smoking cessation drug while naltrexone is used to treat alcoholism […]
Orexigen’s Contrave Receives Panel Backing- Great News For Vivus
In a shock to watchers of recent developments in the area of weight loss drugs, the FDA panel of expert advisors voted 13 to 7 recommending the approval of Contrave from Orexigen. They also voted 11 to 8 with one member abstaining, that a long-term cardiovascular study should be conducted after approval of the drug. […]
Revival of the One Trick Pony
The In Vivo Blog had a very nice piece on the recent turnaround in Exelixis’ strategy- downsizing its broad portfolio to focus on its most advanced compound, XL184. This announcement came after promising results were reported for the compound in castration-resistant prostate cancer patients. Also being downsized is the company; following on the heels of […]
