A Biotechnology Firm Making Its First Step Towards Profitability?
However, it has more than one string to its bow
While Genzyme is the primary contributor to ISIS Pharmaceutical coffers, the company has engaged in a number of new projects with Biogen Idec. The first was announced in January with the goal to commercialize ISIS-SMN RX for the treatment of spinal muscular atrophy (SMA). This project came with a $29 million starter kitty. A second collaboration was announced in June to create a drug for the treatment of myotonic dystrophy type 1 (DM1). This project was funded with an initial payment of $12 million. Together, these payments are just part of a larger $875 million sum paid by Biogen Idec to ISIS Pharmaceuticals over the last five years. So while Genzyme may be the flavor of the month, ISIS Pharmaceuticals has strong, and long standing relationships with other research partners to help fund its research.
What's in it for the Research Partners?
ISIS Pharmaceuticals is heavily dependent on its Partners to fund its research. The Genzyme relationship has almost come to fruition, but the Biogen relationship appears more tenuous given the sums involved. However, Biogen has negotiated itself a bargain. Rival Roche has a licensing deal with PTC Therapeutics for a SMA program which could cost the company close to $0.5 billion, this is compared to the $225 million Biogen has committed to give ISIS Pharmaceuticals for a commercial ISIS-SMN. Biogen also gains the benefit of fast track status for ISIS-SMN, so not only is it paying less it's also likely to get to market first with its drug. The DM1 project is in an earlier phase, but there is no specific treatment for individuals with this genetic disorder. Initial clinical trials haven't offered a management solution and there is little in the way of public research available on the subject.
Fresh opportunities are developing
ISIS Pharmaceuticals is also engaged in new areas of RNA research. It has a joint venture with Alnylam Pharmaceuticals to treat diseases using formerly 'junk status' microRNA. The joint-venture company, Regulus Therapeutics, is looking to IPO soon and this will offer new opportunities for ISIS Pharmaceuticals to explore.
Exciting times at year end?
The kicker for this year is whether the FDA will complete its review and approve KYNAMRO for the commercial market in the next few weeks. Not only is this important from a revenue perspective, but also a demonstration of the company's capability to deliver a commercially viable drug. It is hoped KYNAMRO will become the company's first 'fully fledged' drug to cross the line. What goes for KYNAMRO will not only have a bearing on immediate revenue, but also reflect on its ability to deliver to its clients and perhaps attract new clients in the process. KYNAMRO approval will go a long way towards pushing ISIS Pharmaceuticals into profitability and crack the long standing $19 ceiling along the way.