Unigene's Oral PTH Phase 2 Proof-of-Concept Data to be Presented at Upcoming Scientific Conferences

Data from Phase 2 Study Highlighted Among Presentations at the 5th International MolPharm Workshop and the GIOSEG 5th Meeting Skeletal Endocrinology

 

 

 

BOONTON, N.J., June 28, 2012 /PRNewswire/ -- Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that data from the Company's oral parathyroid hormone (PTH) analog Phase 2 proof-of-concept trial results will be part of two presentations by Dr. Lorraine Fitzpatrick, Medicine Development Leader for GlaxoSmithKline (GSK), at prestigious scientific conferences.

5th International Workshop on Advances in the Molecular Pharmacology and Therapeutics of Bone Disease

"(Mis)Adventures In Drug Discovery"

Date & Time: Thursday, June 28, 2012 at 11:30 a.m. GMT
Location: St. Catherine's College, Oxford, UK
Focus: Examination of PTH secretory dynamics via the comparison of PK data from ronacaleret, oral PTH, and PTH 1-34 and 1-84

GIOSEG 5th Meeting Skeletal Endocrinology

SESSION 4 - Anabolic Therapies for Osteoporosis – "New PTHs: Modalities, Duration, Combinations"

Date & Time: Friday, September 21, 2012 from 2:30 - 4:00 p.m. BST
Location: University of Brescia, Main Hall School of Medicine, Brescia, Italy
Focus: Examination of PTH secretory dynamics via the comparison of PK data from ronacaleret, oral PTH, and PTH 1-34 and 1-84
"We are extremely pleased Dr. Fitzpatrick has chosen to present the data from our oral PTH Phase 2 proof-of-concept trial at two highly prestigious scientific conferences," stated Nozer Mehta, Ph.D., Vice President of Research and Development for Unigene. "Both presentations will serve to highlight data that strongly validate Unigene's proprietary Peptelligence™ technology and, importantly, that the oral delivery of PTH is technically feasible."

The Phase 2 proof-of-concept oral PTH study was conducted by Unigene under a now terminated, amended and restated exclusive worldwide license agreement and related development services and clinical supply agreement with GSK pertaining to an oral formulation of a recombinantly produced PTH analog for the treatment of osteoporosis in postmenopausal women.

On November 9, 2011, Unigene announced positive top-line results of its Phase 2 clinical study evaluating an experimental oral PTH analog for the treatment of osteoporosis in 97 postmenopausal women. The study achieved its primary endpoint with statistical significance.

Unigene has the exclusive worldwide rights to its oral PTH program and is actively seeking a development and commercialization partner.

Unigene will publish the full data set of the Phase 2 results in a peer reviewed scientific journal and appropriate scientific conferences in the second half of 2012.

About Unigene Laboratories, Inc.:

Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture and development of peptide-based therapeutics. The Company is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence™ platform. Peptelligence™ encompasses extensive intellectual property covering drug delivery and manufacturing technologies, unsurpassed research and development expertise, and proprietary know-how representing a genuine distinctive competence. Core Peptelligence™ assets include proprietary oral and nasal peptide drug delivery technologies, and proprietary, high-yield, scalable and reproducible E. coli-based manufacturing technologies.

Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, including statements relating to whether the Company will: continue as a going concern based on its current financial resources; default on the note for its primary debt, including the related covenants; cash flow will be sufficient to fund operations through the end of 2012; the Company will execute solidly on its corporate goals in 2012; address its balance sheet and find solutions to retire its debt; publish detailed results of oral PTH positive Phase 2 proof-of-concept trial in peer review journal and/or prestigious scientific congress; the Company will effectively partner oral PTH; the Company will continue to build a portfolio of feasibility programs with various pharmaceutical companies evaluating Unigene's Peptelligence™ platform; the Company will convert at least one Peptelligence™ feasibility study into a definitive license agreement associated with upfront and milestones and royalties; the Company will file an IND and begin Phase 1 clinical testing of UGP281; select a lead molecule for Type 2 diabetes indication under the joint development vehicle (JDV) with Nordic Bioscience;. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors. These known and unknown risk factors include, but are not limited to: the delay in obtaining or the failure to obtain regulatory approvals for our products and the products of our licensees that may generate royalty and milestone payments to us, our ability to achieve product sales and royalties, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies and our ability to enter into favorable new agreements with such companies, our ability to cut expenses and maintain efficiencies, our ability to enter into new financing arrangements, the ability of our products to gain market acceptance and increase market share, the uncertainty of results of animal and human testing, the risk of product liability and liability for human clinical trials, our dependence on patents and other proprietary rights and the risks associated with patent litigation, dependence on key management officials, the availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, general economic and business conditions, our history of losses and ability to achieve profitability, litigation and other risk factors discussed in our Securities and Exchange Commission ("SEC") filings, including our annual report on Form 10-K and our quarterly reports on Form 10-Q. Words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "potential," "continue," and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward-looking statements, but are not the exclusive means of identifying forward-looking statements. In addition, any statements that refer to expectations, projections, contingencies, goals, targets or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements and are not statements of historical fact. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements after the date of this release.

Investor Contact:
Unigene Laboratories, Inc.
Jenene Thomas
VP, Investor Relations and Business Administration
973-265-1107
jthomas@unigene.com

Media Contact:
Tiberend Strategic Advisors, Inc.
Jason Rando / Andrew Mielach
212-827-0020
jrando@tiberend.com / amielach@tiberend.com

SOURCE Unigene Laboratories, Inc.

 

Posted: June 2012

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