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 […]
Is Pharma Over Invested in Antibody Therapeutics?
Jason Chew There is no doubt that antibody therapeutics have revolutionized medicine in the last decades. Sales of antibody drugs are estimated to be $30 billion in 2009 and expected to grow at a 14% rate through 2012- this is more than double the rate of growth for all drug sales. Biotech companies have produced […]
Biotech Startups: Begin With an Exit Plan
Jason Chew According to a 2007 study by the Ewing Marion Kauffman Foundation, a nonprofit devoted to entrepreneurship, 40% of youths between the ages of eight and 21 say they would someday like to start their own business. In our highly entrepreneurial society, risk-takers and innovators propel our continued economic growth. Garage and dorm-room start-ups […]
Crossing the Valley of Death: From Innovation to Cure
The term “Valley of Death” has come to describe the period of transition when a developing technology is deemed promising, but too new to validate its commercial potential and thereby attract the capital necessary for its continued development[1]. During this transition, there is often a funding gap due to the weariness of risk-adverse investors. This […]
Big Pharma: In-licensing is Not the Cure
Jason Chew(Featured in TheBigRedBiotechBlog, digitalpathologyinsights) Historically, the Big Pharma business model has been that of a fully integrated pharmaceutical company, complete with basic research and development, clinical trials, sales and marketing, focused on the development of blockbuster drugs. This model has recently been roundly criticized. A research article issued in January from Morgan Stanley titled […]
First in Class vs. Best in Class- The Economics of Drug Discovery
The genomics and proteomics revolution has produced thousands of new targets for drug discovery. Designing molecules with novel mechanisms is sexy and can be very rewarding but is risky and time consuming- though some would say this novelty and pursuit of innovation is the embodiment of the biotech industry. But the pursuit of innovation requires […]
The Virtualization of Drug Development
Virtual Drug Development has been around since the 1990s with little fanfare. In this model, only the key personnel to manage the core operations of a project are retained, while all other functions are outsourced. Roche was an early adopter of virtual drug development, forming a subsidiary called Protodigm in 1996 consisting of only nine […]
