Sandoz Aims to Launch Biosimilar Version of Enbrel

Sandoz, a generic subsidiary of Novartis and an industry leader in the development of follow-on biologics, is launching a Phase III clinical trial of a biosimilar version of Enbrel (etanercept) – one of Amgen’s biggest sellers.  Enbrel fights autoimmune diseases by acting as a tumor necrosis factor (TNF) inhibitor to treat inflammatory conditions like rheumatoid arthritis and psoriasis.  Generic production of biologics is tricky because biologics are proteins derived from cells of living organisms and cannot be perfectly duplicated.  Instead, Sandoz hopes to demonstrate the biosimilarity of its product to Enbrel. The new clinical trial will investigate the ability of the molecule to elicit the same immune response in patients with moderate to severe plaque-type psoriasis.  Safety and efficacy will also be determined. Continue reading

New Product Planning Teams Ramp Up Staff and Budgets for Successful Development

By Jacob Presson,
Research Analyst

New product planning teams are an important part of the product development cycle and portfolio management.  Assisting in the transition from an investigational product to a fully marketed one is vital for the success of a potential drug. One of the most important aspects of working with a new product group is getting them involved as early as possible and then scaling up involvement appropriately as the product progresses through clinical trials. Continue reading

Pfizer-Sun Settlement: Bad Omen for Aggressive Generics Launches

Once upon a time, a generics pharmaceutical company launched a generic version of another company’s branded product before patent expiration. Many years passed, with both companies in court fighting over the patent’s validity, until one summer day they finally reached a settlement. The generics company was dismayed at the amount it would have to pay the branded company, but it agreed anyway for fear that a full court decision would demand even more money. From that day forward, generics companies were on notice that they must be cautious in attempting aggressive generics launches. Continue reading

New Product Planning Teams: A Tale of Three Companies

It’s tempting to steer clear of considering a compound’s commercial potential early in a drug’s development.  After all, market and regulatory forces could all change drastically in the years required to bring a product from pre-clinical testing to launch.  However, avoiding the hard work that comes with commercial planning early in development is not the best approach. To achieve the best results from early commercial work for a product, the right group needs to be doing the work.  Often, the group for the job is new product planning.  But companies often include new product planning teams at different times or involve a different team earlier in the process.  Figure 1 shows examples of companies’ different approaches to involving new product planning in clinical development. Continue reading

Counter-Generics Start Early: Less is Not More

We have a running joke among the researchers at Cutting Edge Information.  Many of the key findings from our research can be boiled down to one phrase: Start Early.  Our usual advice for pharmaceutical companies is to start planning as early as possible for all tasks.  Planning for patent expiration and generic market entry is no exception.  Counter generics start early: companies should plan as early as possible — even as far out as 7 to 10 years prior to loss of exclusivity — to successfully counter the threat of generics.  Yet teams in charge of counter-generic strategy consistently wait until only two years before patent expiry to start planning.  Waiting this long, however, means that many companies won’t have time to implement some of the best tactics before generics hit the market.  Continue reading

Pharma New Product Planning Challenges

No longer can companies wait until Phase 3, or even Phase 2, to begin commercializing their developing brands.  Today, the pharma industry sees increasingly competitive markets and payers who require more convincing before reimbursing products.  Companies must begin shaping their brands very early in their development for the greatest chance of success.  For most companies, the group charged with commercializing developing brands is new product planning. Continue reading

The Appeal of Authorized Generics

To combat the era of patent cliffs, pharmaceutical companies have long been planning strategies to extend the lives of their blockbuster drugs.  Some companies look to preserve their spot in the market by introducing new indications and new formulations.  Others opt to conduct pediatric testing to gain an extension, however short, of the product’s market exclusivity.  Still others would rather create a generic version of their own drug and prevent competition from pulling the rug out from under their sales.  By creating its own authorized generic, the company’s looming patent cliff may not look so precipitous. Continue reading

Portfolio Management an Important Part of Pipeline Planning

The recent news that bapineuzumab, a treatment for Alzheimer’s disease, failed to meet two primary endpoints in a recent Phase III study isn’t great for development partners Pfizer and Johnson & Johnson. The new results show the drug fails to produce clinical significance in treating carriers of the APoE4 genotype. The drug had not performed up to expectations for this patient population in Phase 2 either. Bapineuzumab will continue through trials in other patients who are more likely to show a strong response to the drug, according to pharmaceutical industry expert Ed Silverman in a recent Forbes piece. Continue reading

Driving Counter-Generics Strategies

With patents expiring right and left, pharmaceutical companies are looking for every possible tool to slow revenue losses. Counter-generic strategies are one method to maintain market share, however temporary. Even a period of six months when no generic versions can enter the market, as pediatric exclusivity grants, can mean a difference of millions or even billions of dollars. Continue reading

Alliance Management Communication, Relationships are Key Factors

Eric Bolesh, commercialization and alliance management expert
By Eric Bolesh,
Senior Director

In collaborations among pharmaceutical and biotech companies, conflicts inevitably arise — and they can spring from a host of different factors. Here are several of the most common issues that we hear about in our research:

  • Unrealistic clinical/commercial goals
  • Limiting market factors
  • Lack of staff buy-in
  • Clashing corporate cultures
  • Science that does not meet endpoints
  • Poor patent protections
  • Unclear deal structure
  • Limited communication and coordination
  • Lack of leadership involvement

Some of these problems might be addressed through — or even prevented by — effective alliance management. Continue reading