CEO says multiple deals, FDA approvals and more filings are in the works Print E-mail
By M.E.Garza   
Thursday, 21 April 2011 01:02
As we first told our premium subscribers on Tuesday, the management team at Intellipharmaceutics (Nasdaq:IPCI )(TSX:I) is clearly excited about the progress they've been making. The pharmaceutical company specializies in the reformulation and manufacturing of novel and generic controlled-release and targeted-release oral solid dosage drugs and they are finally on the verge of going commercial in a big way. With multiple pending FDA approvals, we first profiled IPCI in detail in late January. The company caught our attention for several reasons. Among them is the fact that the reported sales for branded and generic versions of their pending approval products stands at close to $9 billion.

IPCI develops both ANDA (Abbreviated New Drug Application) product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway. Their CEO, Dr. Isa Odidi, is easily considered one of the sector's top drug delivery innovators. When Odidi was at Biovail- which merged with Valeant Pharmaceuticals International (NYSE: VRX)(TSX:VRX) in 2010, he was performing drug alchemy with formulations that mimicked several hard-to-manufacture generic versions of expensive drugs- among them, Pfizer’s (NYSE: PFE ) Procardia XL, Bayer’s OTC: (BAYRY.PK )  Adalat CC, and Novartis’ (NYSE: NVS ) Voltaren XR.

While serving as Biovail’s Vice President of Research of Drug Development and New Technologies he helped grow Biovail into a multi-billion dollar company. Now he’s doing it all over again, this time with his own emerging biotech-- and many see it as extremely undervalued, given the events which are set to transpire there. That sentiment is underscored by the fact that the company is close to FDA approval and plans immediate commercialization of those drug candidates.

One key clue as to the company’s intentions took place on On February 7, 2011, when IPCI announced that it had retained the services of Doll Consulting, LLC and its principal, David S. Doll, to assist with the commercialization of products. Mr. Doll has over 26 years of solid pharmaceutical industry experience in commercial operations, including a stint as Executive Vice President of Commercial Operations at Impax Laboratories from 2006 to 2008. Most notably, Doll successfully negotiated long-term agreements between Impax and several major pharmaceutical companies. Rumors that Mr. Doll has been working his rolodex to bring those same types of partnerships to IPCI led us to an eye-opening interview with Dr. Odidi himself:

CEO, Dr. Isa Odidi: 
We have 5 ANDA’s under review by the FDA at the moment, the last one was just announced a few weeks ago  [On April 4, 2011 the Company announced the filing of an ANDA with the FDA for a generic of Seroquel XR(R) (quetiapine fumarate extended-release tablets)], Seroquel XR is an oral psychotropic agent indicated for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. According to Wolters Kluwer Health, sales of Seroquel XR(R) in the U.S. were approximately $800 million in 2010.]

We continue to work very hard to try to meet our milestones. Part of the Seroquel filling is one attempt in that direction to meet our milestones for this year. We were looking to file two products this year, we just filled the one and the year is still early, so part of that point is that we are performing so far we hope that is the case. We continue to work on many generic products where a few we are first to file in the midst of this. We are hoping that the year is very good. Work is progressing in regards to the NDA front, we have the first NDA, which we made public, Oxydocone XR is our Rexista(tm) technology, which is progressing well.  We are also looking at 2 other products in that same direction, but we have not named them yet.

We are also looking at a once a day solution for a drug that is currently taken multiple times a day. That has not been named publicly either.  

BioMedReports: Dr. Odidi, we’ve been hearing rumors that your company is very close to announcing partnership or licensing deals for some of those drugs. Can you discuss that at all?

CEO, Dr. Isa Odidi:
  We expect some licensing deals to be announced as well. The licensing deals might be two pronged, 1st to license one or more of the products we have currently in front of the FDA to be marketing to the US and rest of the world and secondly to piggyback on that-  a co- development program with one big pharmaceutical player. That is what is happening. Obviously we are also gearing up to manufacture these products cause we expect these products to get into to market after approval- at least the Focalin XR,  so we’re gearing up and we are preparing space and equipment to make sure the products can be manufactured when the approvals come. Quite a lot is happening.

BiomedReports: Can you tell us about the one big player. You said it would be a two pronged approach?

CEO, Dr. Isa Odidi: 
Yes, we should see some licensing deals announced this year. It will be a two pronged approach. First approach is licensing of one or more of the products we have currently in front of the FDA for Approval in the US market and the rest of the world. The second prong is to piggyback on one of these licensing deals where we would  co-develop a product with one of the key players in the world.

BioMedReports: So you would be developing a product for them?

CEO, Dr. Isa Odidi: For them as well as well as pure licensing and marketing of these products.

BioMedReports: When do you think we might start seeing some of those licensing or partnership deals announced?

CEO, Dr. Isa Odidi:
While I can't put a date and time to it, I can tell you that we are working as aggressively as we can and are hopping this is going to happen in the very near term.

BioMedReports: The other thing investors want to know is: When do you think we might actually start hearing something back from the FDA on some of these pending drug approvals?

CEO, Dr. Isa Odidi:
  The approvals for the ANDA's is an ongoing affair. We are corresponding with the FDA on a regular basis we have 5 products filed with them,  so things are going back and forth between the agency and ourselves. It is typical of the process towards getting an approval done, so we are talking to the FDA on a regular basis I cannot tell you when we will get the approval letter, but I can tell you we are working aggressively to make sure that it happens and one point is the fact that we are already gearing up for manufacturing- so that tells you that things are happening.  That’s the best that I can say at this point.

BioMedReports: Does the FDA get involved with things like manufacturing details- since the ANDA is a different process than the one facing new Biotech's filing new NDA's?

CEO, Dr. Isa Odidi: 
They don't get involved with telling you where the site of manufacturing should be, but they do come and inspect your facility. They have a pre-approval inspection of your facility that has to be done. We had the FDA here last December, so we are working with the FDA to make sure everything is in place for an approval to take place . In anticipation of that approval it makes sense to gear up and prepare for production and that is what we are doing as well.

BioMedReports: Yes we have been hearing rumors about that that you have been traveling and gearing up for production and scouting various facilities. I’m sure investors will be excited to hear that, but for those who are not as familiar with the company, could you tell us in your words, Dr. Odidi, why IPCI may be a good investment right now, especially at these prices? What is the value here?

CEO, Dr. Isa Odidi:
I think our strength lies in our drug delivery technology we are also very strong in our ability as formulators and businessmen. We know how to get a business deal done. When you look at our partnership deal with Par Pharmaceutical (NYSE: PRX ) and the way we went about trying to raise money and all those things you’ll see evidence of that.

Secondly, we are able to make sure that whatever we are doing eventually meets its goals. That puts things out there for our investors to help see value. Having said that, I think that the fact that we have a small float is important to consider as well when one looks at us in terms of value for money.

The approach we have used is two- fold, the first part is to have a series of products that are first to file. This way we have exclusivity, and therefore big bang for the money.

The second approach is a fail-safe approach, where we are looking at presenting a basket of products sometime at the end of next year into the market. So when you’re looking at maybe 7, 10, 15 products in a basket set for FDA approval and to be marketed; even if we were to only make $10 or $20 million dollars in sales per product, it adds up to anywhere from $ 100- $200 million in sales. Now when you are looking at our small float, I think it presents very good upside for investors for the share price where we are trading right now.

In addition, we are not a one trick pony.  We certainly feel that in terms of risk, people are not going to get in trouble in terms of expecting good return on their money- especially for this kind of company. Where else can you find a company out there that exists with this kind of operation, with a small float, with strong technology, with products that have already been filled with the FDA? Not many. We feel we are another Impax (Nasdaq: IPXL) in the making.

BioMedReports: Can you give us any idea about how you pick the drugs to go after?

CEO, Dr. Isa Odidi:
  I have to try my best to not provide competitive information, but I will try my best to answer you.

Obviously first to file opportunities are the first drugs we look out for. These drugs are moving targets. We have chosen them, as well as the competition, but a lot depends on who gets there first. We are also looking at blockbusters, products that have very good sales. In addition, we also look at products that are difficult to make (formulate), so there will not be as many competitors in the field. I think that is,  basically, what we do.  As far as targeting those difficult to make products, we have an advantage in that we have a strong technology platform which we can use to do just about anything. We can take any small molecule and give you any profile you want, that is not a problem for us.

So at the end of the day we are not limited by the science of doing the work. We are looking for something that will limit others from the standpoint of time. It is very difficult to make the products that what we want to go after.  Last, we are working on the Rexista program, the abuse resistance technology. We, like many others, are concerned that people abuse narcotics, so for us it is a win-win situation. On the one hand, if we successfully make the product we make money for the company and the shareholders. On the other side, we are also helping solve a big social problem. So as a company, that makes us feel very proud.

BioMedReports:  How are you feeling about the prospects to be able to meet your milestones? You have talked about, in the past, what you want to do; how many drugs you want to file per year, etc. Looking at your record, personally, when you were doing this with a previous company, you seem to have an ability to work at a very brisk pace. Do you think this is going to continue?

CEO, Dr. Isa Odidi:
I think that it should continue, of course the regulatory steps and amounts of money you have to burn come into play.  At the previous company you alluded to, we had hundreds of millions of dollars to spend.  Here we have a very little in comparison, but people are surprised that with the few resources we do have, we are doing what we are doing. [On February 1, 2011 Intellipharmaceutics completed a sale of 4,800,000 units for gross proceed of $12,000,000.]

We just had some twelve million after the raise.  That is not a lot for companies to even develop one product, but we are committed to filing at least two this year, and we have already filed one.  So we think we are on track to do even more.  Last year we did a lot given our limited resources.  Last year the record we set was the same as the previous company you were talking about- Biovail.  We were doing at least four controlled release products a year there.  We should be able to do at least four here as well.  It is not easy but we are working hard and have the science to bear and to do a lot of work.

BiomedReports:  What are your biggest challenges that you see for IPCI?

CEO, Dr. Isa Odidi: I don’t see challenges,  I look at it as a puzzle that you have to solve. It’s an issue of managing the change.  We are growing rapidly and we have to be able to manage the change carefully. Given the resources we have and the fact that we think we can get to profitability next year, when we start selling Focalin XR.  We have to manage change.  We are at the point where we are ready to expand manufacturing given that we have 5 products (filed) with the FDA and many more to come. Also, we’re looking to expand the areas of Marketing and Commercialization.  So far we have been able to manage all of that.

Disclosure: I am long IPCI and plan on holding my shares for some time to come

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