Replies to post #19194 on Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[haysaw]

That is not the bottom line. The financials of the company could crater the shares, even if the supplement is useful in pharmacology. Furthermore, it doesn't have to 'significantly' lower inflammation to be a good development, does it? And do we 'know' it is safe and well tolerated? Up to this point, maybe, but how about 10, 20 years from now? Also, the FDA thought Vioxx was safe enough to approve and market, until serious cardiovascular issues began surfacing years later. Of course, Merck actually withheld damning safety risk data in order to get it approved. Do you think "doctors" were involved in that cover-up? Doctors do make mistakes, have big egos which can cloud their judgement, etc.

Your reasoning leaves a lot to be desired, fwiw.

Ps. The money Mullen is able to raise will be directly at our expense, not his, whether you think he has it figured out or not.

[NukeJohn]

IMHO, the discovery of Anatabine will go down as one of the biggest medical discoveries of the decade.

Quote:
________________________________________
Dr. Mullan after significant research, with his vast knowledge, firmly concluded that the FDA study can fully be done and will be successful. In fact he and Dr.Chapman and others are choosing which disease to target first based on speed, cost and likelihood of success. On 3/20 Dr. Mullan constantly spoke in the plural. He spoke of applications, INDs, diseases. Now, he is either right or wrong. Time will tell. Regardless of the ultimate outcome he believes he is right or he would not be at Star.
________________________________________


He would not have taken the job as CEO if he didn't know the efficacy of Anatabine. The biggest issue they have now is financing...Dr. Mullan already knows anatabine works. IMHO, they are pursuing multiple IND's, including whatever they are doing in the EU via the UK. One issue they are dealing with is that anatabine works on so many diseases related to chronic inflammation, they are having trouble deciding which diseases/conditions to target first. But they did say in the 10-Q that the IND with the FDA would be filed by the end of Q2 which is only about 5 weeks away, and they did say that the UK trial would be announced in Q2 as well. IMHO, there is news on the short term horizon. In addition, all the big pharmas are on the prowl for acquisitions.

IMHO, the March 20th presentation by Dr. Mullan told the big pharma companies what anatabine can do and how it it works. At some point they will pursue teaming arrangements (or an acquisition) with Rock Creek Pharmaceuticals. For example, a couple of years ago, Abbott paid $400 Million to Reata Pharmaceuticals to partner in the joint development of bardoxolone methyl (another compound thought to inhibit transcription of NF-kB). In that deal, Abbott agreed to share in the profits of the drug going forward, and they didn't even get the rights to market the drug in the US.

http://www.genengnews.com/gen-news-highlights/abbott-pays-reata-400m-in-expanded-antioxidant-inflammation-modulator-deal/81246056/

excerpts from the 2011 Abbott press release…

Abbott is paying Reata Pharmaceuticals $400 million up front as part of a worldwide collaboration to jointly develop and commercialize the latter’s second-generation oral antioxidant inflammation modulator (AIM) portfolio. The deal expands the firms’ existing agreement, signed in September 2010, under which Abbott has exclusive rights to develop and commercialize Reata’s lead AIM compound, bardoxolone methyl (RTA 402), globally, excluding the U.S. and certain Asian markets. Bardoxolone methyl is currently undergoing a Phase III clinical study in patients with stage 4 chronic kidney disease and type 2 diabetes.

Under terms of the new deal Abbott and Reata will equally share costs and profits for all new AIMs in the majority of licensed indications, including pulmonary and central nervous system disorders, as well as immunology. Abbott will be responsible for 70% of the costs and retain 70% of the profits for AIM candidates developed for indications in rheumatoid arthritis and other selected autoimmune diseases. Clinical trials with the first compound are expected to start during 2012.

AIMs are transcription factor Nrf2 activators, designed to trigger the expression of a range of antioxidant, detoxification, and anti-inflammatory genes. Nrf2 activation also inhibits NF-KB, which regulates pro-inflammatory genes. Reata claims that Nrf2 suppression and NF-KB activation have been associated with a range of chronic diseases including multiple sclerosis, rheumatoid arthritis, chronic kidney disease, neurodegenerative disease, and COPD.
---------------------------------

That was over two years ago…so what happened with the Phase 3 trials of Bardoxolone Methyl that Abbott paid $400 Million just for the rights to partner and share in the profits? It appears the Phase 3 drug test was halted in October 2012 due to adverse effects of a higher cardiovascular mortality rate.

http://en.wikipedia.org/wiki/Bardoxolone_methyl

excerpts…

A multinational, double-blind, placebo-controlled Phase 3 outcomes study (BEACON) was started in June 2011, testing bardoxolone methyl’s impact on progression to ESRD or cardiovascular death in 1600 patients with Stage 4 CKD (eGFR 15 – 30 ml/min/1.73m²) and type 2 diabetes. This phase 3 trial was halted in October 2012 because of adverse effects (namely a higher cardiovascular mortality in the treatment arm).

---------------------------

So Abbott spent $400 Million for the rights to partner and still offered to share in the profits…but they got nothing for their investment when the phase 3 drug testing failed the safety profile.

It makes one wonder how much they would be willing to pay for an Rx version of Anatabine, especially considering the fact that a nutraceutical version of Anatabine has already been used by over 300,000 people and has an excellent safety profile?

When Rock Creek Pharmaceutical starts teaming with big Pharma, I hope they team with various Big Pharma’s for different families of disease conditions (ie., skin diseases, GI inflammatory Diseases, Endocrinology related diseases, circulatory related diseases, neuro related diseases, etc. etc.)

There was this recent article...

http://www.fiercepharma.com/story/look-ma-scramble-2014-pharma-chasing-deals-ever-higher-prices/2014-01-13

excerpts...

Big Pharma has more money in its pocket for deals. And Big Pharma still needs more M&A for post-patent-cliff rebuilding. But Big Pharma's buyout targets want more money.

So concludes Ernst & Young, which released its annual analysis of the pharma M&A landscape. The upshot is that drugmakers have plenty of cash--and they may want to spend it ASAP, because prices are only going up.

So the need for deals remains strong. JPMorgan agrees that prices are likely to be higher this year--and that deals will be made regardless. "We see M&A in the healthcare sector being up materially in 2014 at all size levels and across all subsectors," JPMorgan investment banking chief Jeff Stute told Bloomberg. "Buyers and sellers will get comfortable with the new reality of where assets are priced."

JMHO,

NJ