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 […]

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 […]

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 […]

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 […]

Celgene Plunges on Revlimid Data

Celgene shares lost over 8% in regular trading to close at $55.64 Monday after the company released clinical data for its multiple myeloma drug, Revlimid, at the American Society of Hematology (ASH) over the weekend. The stock lost another 3% after hours. Revlimid is by far Celgene’s biggest selling product as well as major growth […]

MagForce- Revolutionizing Cancer Treatment With Nanotechnology

MagForce is a Frankfurt listed company developing nanotechnology based therapies for solid tumors. Its patented technology is based on the superparamagnetism of iron oxide nanoparticles, which can be manipulated in a magnetic field. The company’s main product, NanoTherm, was approved in the EU in June 2010 for the treatment of glioblastoma. Iron oxide nanoparticles is […]

Are Analysts Underestimating Sales For Avanir’s Nuedexta?

After first receiving a “complete response” letter from the FDA for its Pseudobulbar affect (PBA) treatment, Nuedexta, Avanir has finally won approval with a modified drug formulation and new clinical trial. Nuedexta, also known as AVP-923, is a combination of two approved medicines, dextromethorphan, and quinidine. Dextromethorphan is unclear, but may act through antagonism of […]