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Tuesday, September 6, 2011

Biosante Pharmaceuticals Analysis

BPAX is one of my top recommendations. Biosante is a pharmaceutical company whose principal product is a gel, which is being tested to improve the sexual desire of women who have HSDD. This gel is currently in Phase III studies, with the efficacy end of study results due out before year end. The safety study seems to be going well as the data monitoring committee has allowed for the study to continue. I believe that results from the safety study are expected sometime in the early half of 2012 with an NDA being filed shortly after and the product ultimately hitting the market in 2013. This drug could be huge for the company, Pfizer and other pharmaceutical giants have tried to get to this market.... and failed.

Along with libigel the company has many other near term revenue generating prospects. The main one being that the Bio-T Gel which is being licensed from BPAX to Teva has an upcoming PDUFA date of November 14th. Why is this important? This is important for two reasons, as pursuant to the agreement I believe that BPAX will receive a milestone if the gel is indeed approved, and could receive royalties on any revenues from the product. With a pharmaceutical company like Teva marketing the gel, BPAX could get some nice and solid near term revenues.

Another noteworthy point is the fact that Biosante has already had one product approved, so they should theoretically know the process that they will have to face in order to get this product approved by the FDA. The product that has already been cleared by the FDA is Elestrin, which was licensed by the company to Azur pharmaceuticals. The company amended the agreement and recieved I believe around 3.16 million dollars for the product. They could recieve over 140 million dollars more if different sales milestones are met, however according to the CEO of Biosante this is unfortunately unlikely.

Another product in the Biosante Pharmaceuticals pipeline is the pill-plus, which is currently licensed to Pantahari Biosciences. The pill plus is in various Phase II/III tests around the world. This is significant because again if the product is approved it could allow for Biosante Pharmaceuticals to have a solid revenue stream. The Pill-Plus has already passed a Phase II clinical trial.

One of the more promising drugs in the Biosante pipeline is the melanoma drug, which Biosante Pharmaceuticals licensed to the Hussman foundation. This deal is great for Biosante, because despite the small upfront payment, Biosante has significantly derisked the program. Biosante is eligible for up to 39 million dollars in milestones, and would recieve royalties on any commercial sales of the product.

Finally, the last product which I am going to focus on is the Pancreatic Cancer vaccine which is currently licensed to Aduro Biotechnology. This vaccine is headed for Phase II trials in the end of 2011 and in my opinion has so far been rather promising.

In conclusion, I believe that Biosante Pharmaceuticals is a fantastic investment opportunity and should not be overlooked, I myself own BPAX stock and am looking forward to the future of the company. This is a company that has a very robust and promising pipeline, and the money to get through the Libigel Phase III and to the NDA according to the CEO, which helps to significantly reduce the risk of further dilution of the shares. BPAX should experience a run up into the Elestrin PDUFA date, and should also experience a pop on the news of the Libigel Phase III trials. These trials should be positive, given how positive the other Phase II trial for Libigel was, which surpassed any expectations that I had for this company. In conclusion, BPAX is a great company with a robust pipeline, and a most own for any biotech investor!


  1. Nice article. One piece of (hopefully) constructive criticism is that the mention of the "Pancreatic Cancer vaccine" does not include a name and seems like an afterthought as you don't give any reason as to why you believe it to be "very promising". All-in-all it's a nice piece of work. Cheers!

  2. Hmm, I never considered I didn't even notice that I did that in the article. I do believe this to be a very promising vaccine. As you know, it was recently licensed, and is now going into Phase II trials. The Phase I results, although early were rather positive. I just believe that this is very promising because BPAX does not have to give anymore money into this vaccine and if its approved they get some of the commercial sales, which could be huge for the company. In summary, so far the results have been rather impressive. Thank you so much for your comment, and if you have any more thoughts please don't hesitate to comment :)