SOURCE: Spencer Pharmaceutical, Inc.

June 22, 2011 09:59 ET

Spencer Pharmaceutical Inc. Announces Corporate Update

BOSTON, MA--(Marketwire - Jun 22, 2011) - Spencer Pharmaceutical Inc. (PINKSHEETS: SPPH) provides a Corporate update to its shareholders in response to questions from shareholders.

Back on November 9, 2010 the Company provided a corporate update in the form of a supplemental information report via the newswire. At that time a similar backlog of questions from shareholders were addressed in an open forum. The Company believes this is an effective way of communicating to all shareholders at the same time.

Technologies developed by Spencer and Animal Study Results
All the new platforms developed by Spencer Pharmaceutical are based on monolithic matrices with excipients which possess, for certain drugs, unique profiles for controlled release of active pharmaceutical ingredients (API). These dissolution profiles are advantageous, improving compliance and possibly preventing undesirable secondary effects.

The simplicity and versatility of the or "Highly Soluble Drug Extended Release" technology or HSDER and "Two Release Rates" monolithic excipient technologies 2RR make these novel matrices compatible with various drugs and we believe as being highly competitive in the field of drug delivery systems.

These technologies are based on existing biomaterials used as excipients to:

  • Produce monolithic matrices;
  • Control the release of active pharmaceutical ingredients;
  • Decrease the size of existing pills by Increase the drug loading of tablets
  • Possibly reducing or eliminate side effects caused by multiple-doses during a longer period;
  • Enhance safety and improve efficacy profile of the active molecule offered by our controlled release technologies;
  • Increase patient compliance by taking a single dose;

Advantages:

  • Inexpensive raw material;
  • High drug loading;
  • Simply to manufacture (by direct compression of mixture of dried powders);
  • Compatible with a large range of active pharmaceutical ingredients (API).

During the last few months we have developed the following technologies:

  • 2RR or "Two Release Rates" monolithic excipient technology for the ;
  • HSDER or "Highly Soluble Drug Extended Release" technology;
  • MBP TECHNOLOGY (Matrix for Bioactive Peptide/Protein)

The results of pharmacokinetics studies performed on Beagle dogs have confirmed that the 2RR "Two Release Rates" of Ibuprofen in studies suggest for newly formulated 2RR monolithic tablet of an anti-inflammatory drug (Ibuprofen 400 mg). Our results indicate that our proprietary formulated Ibuprofen is responsible for a first rapid release equivalent to commercial immediate release tablets , but is also capable of a longer sustained release in the therapeutic windows for a bioequivalence approximately equal to three (3) commercial tablets (Ibuprofen 200 mg x 3 tablets). The company is excited about the potential commercial possibilities offered by the results of this new delivery system that has proven its efficacy in a standard animal model.

The HSDER technology (Highly Soluble Drug Extended Release Technology) is particularly adequate for highly soluble Active Pharmaceutical Ingredient (API) for which the Controlled release is advantageous. These drugs, due to their high hydrophilicity, are difficult to be formulated, such as metformin. This drug is an oral anti-diabetic used for the treatment of type-II diabetes, particularly in overweight and obese people. However, metformin may present adverse gastrointestinal associated events such as anorexia, nausea, vomiting and diarrhea, etc. These discomforts are often distressing and represent an important barrier to successful treatment with this agent and it is well recognized that side effects of metformin can be minimized by using a controlled release system. The results of pharmacokinetics studies performed on Beagle dogs have confirmed that Spencer Pharmaceutical proprietary monolithic tablets (Metformin 500 mg) present a kinetic profile similar to that of commercial tablets (Metformin 500 mg) but our formulations are obtained at a much lower production costs by using inexpensive and generally recognized as safe excipients, that allow a high drug loading capacity with simplified production steps.

During the last semester (Quarter) we have also obtained an in-licensed option for an innovative gene-delivery technology and we will keep our shareholders informed about the developments in this field.

Negotiations with Al-Dorra Holdings Inc./Hail First Pharma Inc.
The discussions for a cash buyout to Spencer shareholders shares by Al-Dorra Holdings Inc. and Hail First Pharma Inc. have been revised by Hail First Pharma Inc. In the alternative, Hail First Pharma Inc. has presented an offer to purchase the assets of Spencer in a share and royalty transaction. Negotiations are ongoing and there can be no assurances that such transaction will be completed. To date, Spencer has not received the $1.2mm signed with the extension agreement of March 16th, 2011

Financials/ Financing
The Company recently filed its audited 2010 year end. With Q1 to be filed shortly.

Old business
The Company, as previously announced, will not be partnering with National Pharmaceutical as management felt that we will pursue other opportunities in developing therapeutics related to the Central Nervous System diseases treatment.

Spencer Pharmaceutical Inc. is a US-based Pharmaceutical Research and Development Corporation, which is developing innovative drug release and absorption systems for the treatment of metabolic diseases such as diabetes and metabolic syndrome.

Important Information

About Forward-Looking Statements: In this press release may be "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "believe," "estimate," "expect," "intend" and similar expressions, as they relate to the company or its management, identify forward-looking statements. These statements are based on current expectations, estimates and projections about the company's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and probably will, differ materially from what is expressed or forecasted in such forward-looking statements due to numerous factors, including those described above. In addition, such statements could be affected by risks and uncertainties related to the exploration for and development of mineralized material, product demand, market and customer acceptance, competition, pricing and development difficulties, as well as general industry and market conditions and growth rates and general economic conditions. Any forward-looking statements speak only as of the date on which they are made, and the company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of this release. Information on the Company's website does not constitute a part of this release. Although there is an offer currently coming from a third party, the Company can provide no assurances that the offer will be made, the timelines achieved, or the minimum offer will be realized.

Contact Information

  • Contact:

    Ian Morrice
    Executive Vice President and Director
    Spencer Pharmaceutical Inc.
    1+(617) 973-5017