Waiting to exhale

Nycomed’s PDE4 inhibitor Daxas has been licenced by Forest Labs for the US. This comes just a few weeks after Nycomed approached the US FDA for approval to market the COPD or Smoker’s Lung drug. Forest will pay a $100mn upfront fee. Nycomed also stands to make an additional $5oomn based on regulatory approvals and commercial milestones from Forest.

What does this imply for Glenmark Pharmaceuticals, the Mumbai-based company that licenced oglemilast  a similar PDE4 inhibitor to Forest some years ago? Well Forest says the drug “remains in active development for both COPD and asthma and represents a potentially complementary opportunity.”

Before getting into the possible reasons for Forest’s move – when was the last time a company licenced two drugs from the same class that were so close in the development cycle – some facts :

-Daxas, if approved, will be the first PDE4 inhibitor in the market. PDE4s are a completely new class of drugs which work by regulating an enzyme implicated in airway inflammation. They seem to have the potential to not just offer symptomatic relief like existing therapies but also reverse the disease though this will be conclusively proven when a drug actually hits the market and is taken by enough people

-Daxas will also be the first oral, once-a-day therapy for COPD on the market. Standard treament is usually inhaled bronchodilators, among other things.

-All PDE4s have hit a wall on gastrointestinal side-effects;  it has been tough to find a dose – or doses – effective in the long term and yet without the undesirable side-effects like nausea.  This is the second time Daxas has sought marketing approval in a developed country. Pfizer, an earlier development partner, walked out on Altana  (the company that Nycomed bought) in  2005 ollowing which the company had withdrawn a marketing application with European drug regulators.

-The COPD market is currently worth $24bn but expected to touch $34bn by 2012

Now, for why Forest may have done this.  Its blockbuster Lexapro loses patent protection next year and it needs to make up for lost sales.  Also, Daxas apparently loses patent protection in 2015  – that’s about six years of effective patent life.  But oglemilast has protection until 2024. Assuming that Forest is committed to the drug, and that it gets approved by 2013 Forest gets an early start in the COPD market with Daxas -assuming that it too is approved next year –  and then gets to migrate doctors to oglemilast well in time for the former’s patent expiry. Oglemilast is believed to have found a bigger window to balance safety and efficacy than Daxas – which means multiple doses and therefore more options for doctors.

Or at least that is one way of looking at it. The other – more bleaker – view would be that Forest is hedging its bets as it has toned down expectations from oglemilast. Well, data from phase 2 trials of this molecule will be out soon. That should hold some answers.


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