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 […]
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 […]
Biosimilar Antibodies- Another Win For Teva Pharmaceuticals
Already the undisputed leader in generics for small molecule drugs, Teva stands to benefit enormously as biosimilars begin to gain momentum. Laws passed in recent years have paved the way for the approval of follow-on versions of biologic medicines. The EU is leading the way with 13 biosimilars approved compared to just one in the […]
Pharma Emulating Biotech to Boost R&D Productivity
Faced with multiple challenges of patent expirations, generic competition, increased government regulation, and most of all- low R&D productivity, many large pharmaceutical companies have decided a solution to their problem is to reorganize their research organizations to more resemble that of smaller biotech companies. The idea is to cultivate a spirit of entrepreneurship and sense […]
Eli Lilly and the Cyclical Business of Drug Development
What people seem not to have noticed with Lilly’s acquisition of Avid Radiopharmaceuticals is the significance of the company’s diversification into the diagnostics business. Until now, Lilly had been purely involved in drug discovery. True, it has collaborations with Dx developers, in particular GE for molecular diagnostics, and Almac for a companion diagonostic to its […]
Pharmasset Riding High on Nucs
Pharmasset is a biotech company focused on the development of HCV therapeutics. It has multiple drugs in development, all based on its core strength in RNA nucleoside analog chemistry. The current standard of care for HCV is a combination of pegylated alpha interferon (IFN-α) and ribavirin taken for 48 weeks depending on patient response. Unfortunately, […]
Are Generics Killing Drug Innovation?
The pharmaceutical industry has created highly innovative medicines, and in years past, was one of the most profitable industries in the world. It has lost that status as the costs of developing a drug have grown, with the FDA demanding ever-higher standards for approval. Fewer than one in ten compounds entering the clinic are approved […]
Big Pharma Embraces Branded Generics
It seems not a day goes by without talk of an innovation crisis in the pharmaceutical industry. On, October 25, the German consultancy, Roland Berger, released an article titled “Fight of Flight” stating 65% of companies surveyed believe that the pharmaceutical industry is facing a strategic crisis. As the patent cliff nears, it appears the […]
Keryx Rallies, But Remains Undervalued
Keryx Biopharmaceuticals is a developmental stage company with two drugs in the final stages of clinical development- quite an accomplishment for a company its size. With Zerenex, its drug for renal disease and Perifosine, its oncology drug, it appears to have good odds of passing FDA muster. Keryx is developing the phosphate binder, Zerenex, for […]
Alexion Pharmaceuticals: Room to Grow
Since the launch of its drug, Soliris, in 2007, Alexion has achieved sales of over $386 million in 2009 and has upped guidance for total 2010 net product sales to between $536-$538 million, a 39% increase over the previous year. Soliris is indicated solely for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), an ultra rare disease […]
The Rx to OTC Switch: Growth Opportunities for Brand Name Drugs
Jason Chew In the US, patent holders are granted a 20-year term of exclusivity on their inventions. In the pharmaceutical industry, long drug development timelines combined with the Hatch-Waxman act have whittled the effective patent life of new drugs to less than 12 years on average. When this period ends, generic drugs enter the market […]
Incyte’s Topical JAK Inhibitor: Throw it Over the Counter
Jason Chew Incyte’s topical formulation of its JAK inhibitor, INCB18424, doesn’t seem to get much respect from analysts. Even after showing robust activity and safety in a placebo-controlled multi-dose Phase IIb trial in mild to moderate psoriasis patients, most believe it has limited market potential. Management hasn’t given any guidance on revenues for topical 424, […]
Bringing Innovation Back to Bioscience Research
Jason Chew Innovation is the lifeblood of the economy. Exceptional basic research is crucial to private industry’s success in driving economic growth. This has been true in industries ranging from aeronautics to the internet. In both cases, much of the enabling technologies were developed in government-sponsored labs. This has been especially true in the life […]
Incyte Pharmaceuticals’ JAK: Just Another Kinase?
Jason Chew With a nearly $2 billion market cap, Incyte is currently the most valuable biotech stock with no marketed product. Is it justified? Practically all of the company’s value is wrapped up in two related Janus Kinase (JAK) inhibitors, both of which are partnered. INCB18424 for oncology is partnered with Novartis and the related […]
Seattle Genetics and Immunogen: Fabless Biotechs?
Jason Chew The results are in and it appears Seattle Genetics’ Antibody Drug Conjugate (ADC) technology does indeed work after all- not that it should be a surprise to anyone following the company. Results released early Monday morning showed 75% of relapsed or refractory Hodgkin’s Lymphoma (HL) patients taking the drug Brentuximab Vendotin, or as […]
The Rise of China as a Bioscience Leader
Jason Chew The US is far and away the leader in the bioscience industry for now, but under-investment by government and hesitation by the Venture Capital industry may allow other countries to take the lead over the long term. In terms of statistics, America stands heads and shoulders above the competition: Receives one-third of new […]
