SOURCE: BioMedReports


February 24, 2012 10:39 ET

President of PROLOR Biotech Discusses the Firm's Unique Position and Upcoming Catalysts

LOS ANGELES, CA--(Marketwire - Feb 24, 2012) - As larger pharmaceutical firms have shown an appetite for platform technology companies, shares for companies like PROLOR Biotech (NYSE Amex: PBTH), which possess access to platform technologies with broad-based applicability across a range of product types have been getting more attention from investors and watching their valuations increase.

Analysts like Morgan Joseph's Raghuram Selvaraju, Ph.D., watch trends in the sector for institutional and smart-money clients. He believes that firms such as AstraZeneca, GlaxoSmithKline, Merck & Co., Pfizer and Teva Pharmaceutical Industries are currently searching for new assets to shore up their declining product portfolios and enable them to leverage their substantial expertise in marketing drugs aimed at large patient populations. In addition, Selvaraju believes that unlike other speculative investments in emerging biotech, PROLOR represents a substantially more risk-mitigated opportunity because of the fact that the company is simply seeking to improve existing drugs as opposed to "reinventing the wheel."

Mr. Shai Novik M.B.A., the Pres, Director and Member of Governance Committee for Israel based PROLOR Biotech knows a thing or two about these subjects first hand. Rumors persist that his firm has substantial attention from Big Pharma, especially since PROLOR's protein longevity approach to create improved versions of existing drugs is so appealing. In addition, analysts point out that the the risk associated with developing follow-on biologic agents is substantially lower and have significant implications for physician and patient benefit as well as the potential for an improved outlook on the reimbursement front.

PROLOR's largest individual shareholder -- Dr. Phillip Frost -- owns roughly 21% of the company and also happens to be the Executive Chairman of Teva Pharmaceutical Industries, one of the world's largest pharmaceutical firms. There is little doubt, following recently published reports, that Teva may have significant interest in PROLOR's technology and could be seeking to deploy PROLOR's platform in the development of biobetter drugs.

BioMedReports had the opportunity to sit down with Novik for a candid back and forth about some of the topics on the minds of investors who feel his company may be one of the next big winners in biotech.

Question: Can you please explain why your science has attracted so much attention lately? What makes it so exciting, etc.

Novik: I don't think it is the science that suddenly got attention. The science has been well accepted for quite a while. We announced its plans to submit a Phase III application to the regulatory authorities in 2012 for its lead compound, long-acting growth hormone. We believe this product will be first to market of long-acting growth hormones, and could potentially capture a large portion of this $3 billion market quite rapidly. We announced very positive results from a pilot study in which we injected patients only twice-a-month instead of 30 daily injections. We are in quite a unique position.

Question: Do you think there is interest from Big Pharma for a technology like yours?

Novik: Most of the large companies know us quite well. The technology and the products could potentially fill some gaps for some of the companies. However, we are not commenting on any specific discussions.

Question: Which products in your pipeline are you/your team most excited about and why?

Novik: Each garners a different kind of excitement. The long-acting growth hormone product has terrific clinical data to date and we believe it will be first to market in the long-acting segment. That combination in a $3 billion market makes it a highly-valuable asset in our opinion. The hemophilia long-acting drugs have data that looks better than anything else we've seen out there, and the clinical trial path is not that complex. Lastly, the diabetes/obesity drug has truly remarkable preclinical data in our opinion, and could potentially be the big winner in a very large market. Because all we do is create improved version of existing drugs or drugs with well-know biological mechanisms, we believe our pipeline of drugs offer greater potential return at lower degrees of risk compared to many other projects we are familiar with.

Question: What are the challenges for PBTH at this point? Is there anything that keeps you up at night?

Novik: We need to make sure that if/when we sign partnerships with large companies for the various indications we do so while ensuring the right financial and structural terms. We need to make sure that all relevant institutional investors get to know the company as it is progressing towards a planned Phase III clinical trial, as at that stage the company may be suitable for inclusion into many of the leading life sciences portfolios in the country.

Question: Can you summarize upcoming catalysts for PBTH?

Novik: Regarding clinical development, we are planning to initiate 2 clinical studies in 2012 with our long-acting growth hormone, Phase III in adults and Phase II in children. We would consider approval of the regulatory authorities to initiate the studies major catalysts.

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