BioSante Pharmaceuticals, Inc. (BPAX)

[nutsyprofessor]

Decided to come back during this critical junction of BPAX/ANI merger. Thanks to the IHub Admin for the speedy re-reinstatement.

Pete, I heard about your tragic accident and I am happy to hear that you and your wife are doing well. I hope you have a speedy recovery.

Now back to BPAX: as I've said many times here and on Yahoo, the merger (and timing) with ANI Pharmaceuticals is absolutely the right strategy for Biosante given the current status of their multiple hormone products. However, the issue is with the merger valuation. The merger valuation favors ANI, their stockholders and of course Simes himself because of the Golden Parachute. They will have to rework this deal by doing the following: 1) getting rid of the CVR's that are basically worthless and instead issue common shares to the Biosante shareholders of record, 2) change the ownership split to no less than 49.9% ownership for Biosante, 3) Simes himself needs to show confidence in this merger by sharing in the same benefits being offered to the Biosante shareholders themselves i.e. additional common shares for Simes' as well and NOT a Golden Parachute, and 4) make a true public statement of valuation for the various hormone products, including: Elestrin, BioTgel, The Pill Plus, and Libigel...a $2 million for BioTgel and $0 value for the female products just doesn't cut it! By the way, the right voting strategy at this point is to ABSTAIN i.e. do not vote at all. Simes and ANI will not let this deal die; they will go back and do whatever it takes to get it done. They know that manufacturing/selling the Libigel product is too important to pass up.

Anyway, I want to post this link to an old interview with Mr. Simes:

http://www.twst.com/interview/24862

Given the history of ANI's purchase of the manufacturing (hormone) facilities in Baudette, MN, from Solvay Pharmaceuticals in 2007 and the timing of Libigel's PH3 trial starting in December 2006, and some of Sime's comments and of course his own past with Solvay Pharmaceuticals, I have to believe that the relationship between Simes and ANI probably go way back to 2007 or earlier. Here are some of the more important comments from that Simes' 2007 interview:
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The Wall Street Transcript – September 2007

“Mr. Simes: BioSante is a pharmaceutical company, and today we specialize in hormone therapy products for men and women. Those are our near-term products. When I say near term, I mean one already is FDA approved and in the marketplace, that's our Elestrin for menopausal women. And now in Phase III clinical development is our LibiGel for the treatment of female sexual dysfunction. Our longer-term products are in the areas of vaccines and protein delivery.”

“Number two on the events schedule was also in December 2006. We initiated Phase III clinical development of our LibiGel for the treatment of female sexual dysfunction. As you may know, Phase III is the last phase before submission to the FDA for approval. We are very excited about taking our LibiGel into the final stages of development.”

“Also in the next 12 to 24 months, we will continue the Phase III clinical development of our LibiGel for female sexual dysfunction. This is a very exciting area because today in the United States there is no pharmaceutical product approved for the treatment of female sexual dysfunction, whereas there are three products approved for erectile dysfunction in men. We feel a responsibility to develop this product for women, and we think from a market point of view this is a very exciting area, which is estimated to be between $2 billion and $4 billion in terms of potential.”

“Mr. Simes: As I have mentioned, our Elestrin was introduced in the United States in June by Bradley Pharmaceuticals. We are looking forward to the success of that introduction. It will take about six or nine months until we can really tell how the launch is going, but we are very, very excited and looking forward to sales results. We get a royalty, in addition to which we can get sales-based milestones that can total up to about $40 million.”

“Similarly, with LibiGel at this time we are managing the clinical trials in-house and we can do this very efficiently. In terms of the partnerships, I think the Elestrin deal with Bradley is the best example. We had to make a decision as to whether BioSante would launch the product, put in place a sales force and a marketing department, and launch the product, or find a very excellent licensee who could do that for us on a royalty and a milestone basis, and obviously we chose that path. It has been financially lucrative. We did not need to raise the funds necessary to launch the products ourselves, which would have caused dilution for our stockholders.”

“Mr. Simes: I've been CEO of BioSante since 1998. I have an extensive career in the pharmaceutical business having started with Searle back in 1974. BioSante is the third company where I've been CEO. The previous two companies where I was CEO have been sold to bigger players with good reward for our stockholders. Second here is Phil Donenberg, our CFO. Phil and I have worked together since 1990 at both of these companies that I mentioned. Phil is of course well schooled in public filings as well as new Sarbanes-Oxley regulations.”

“Mr. Simes: Only the investors can answer that one. We hope we make the story as clear as possible. We are actually a very simple story to understand; that is, we are concentrated in the near term in female healthcare products. We have one product approved, our Elestrin, which we believe has shown the investing public that in fact this team knows how to develop a product and move it through to an FDA approval.”