No real discussion yet on this topic but if I were the management team they shpould be looking at potential partnership opportunities for Arikace. This new mgmt team has the background and experience to structure the proper deal going forward as they prepare for potential commercialization. My feeling is that these discussions will ultimately happen during JPM Conf come January. When I worked for large Pharma we usually entertained these conversations w Biotechs then. Lets see what happens...=)
With regard to the US and Europe Insmed is gearing up to go it alone.
Lewis made the point today that the infrastructure for the ongoing clinical trials would form the basis of the Company's commercialisation strategy.
For those who haven't bothered to do so, I recommend taking the time to visit the transcript I pointed out from the workshop the FDA arranged earlier this year. One of the things which particularly stood out for me is that the experts who participated tend to look at these diseases primarily from the point of view of the bacteria involved.
It was suggested that a good marker for disease states which warrant prompt intervention with antibiotics is the presence of Pseudomonas, NTMs or MRSA.
If the "thought leaders" in the US and the various EU countries believe that Arikace offers a new level of efficacy in the treatment of Pseudomonas infection they are likely to recommend it both in the treatment of patients with Cystic Fibrosis and in the treatment of patients with Non-CF bronchiectasis - in those cases where Pseudomonas has been isolated.
The same rationale will apply if Arikace demonstrates a new level of efficacy in the treatment of Mycobacterial infection, whether the disease is Cystic Fibrosis, Non-CF bronchiectasis, or Tuberculosis.
If the data from the Arikace studies is that good, the recommendation of the leading pulmonologists is the only advertising Insmed will need. All the Company will need to do is to establish distribution points.
But places like China will doubtless present a different challenge, and I wouldn't be at all surprised to see Insmed form a commercialisation partnership.
It's worth pointing out here the instances where Merck has implied that it has an ongoing relationship with Insmed. Merck is far and away the most likely guess for the manufacturer Premacure and PCUT named in their applications earlier this year for Orphan designations for the use of iPlex.
I'd be willing to bet my house that Merck knows all about Arikace, and would be interested in adding Arikace and iPlex to the list of drugs it sells in China - particularly given the funding likely to be available for the treatment of serious unmet medical needs such as MDR-TB and the complications of premature birth.
CEO Lewis clearly stated the INSM belief that the patented liposome could deliver lots of small molecules and biologicals to the lung. They just need to establish a liposome masterfile (general preclinical safety file and manufacturing procedure) and start partnering from there. They can put any type of pharmaceutical preparation inside the liposome (it has to be aquesous based) and they should be able to get a homogenous product for testing. The only limitation with liposomes is the aqueous content cannot break down the liposome (making the preparation an emulsion) and the combination does not oxidize and lose stability. Other than that, there are hundreds of praparations that can be put inside a liposome. But you have to remember that the cost of the product gets split two ways with a partner. The liposome becomes the carrier for the active ingredient, unless INSM provides the active ingredient themselves. This is the precise case for liposome cisplatin, which is currently outlicensed to Eliason (spelling?). The problem there is that cisplatin is the first generation of the platinum containing chemotherapeutic agents and has been replaced for certain indications by carboplatin and oxaliplatin, with others in clinical trial. Medicine does not stand still and competition is everywhere.