Peptimmune Grants Major Pharmaceutical Company Exclusive Option to License PI-2301 for Multiple Sclerosis

Cambridge, Mass., January 15, 2009 — Peptimmune, Inc. (“Peptimmune”), a privately held biotechnology company, announced today that it has granted Novartis (NYSE: NVS) an exclusive option to obtain exclusive worldwide rights to develop and commercialize PI-2301, Peptimmune’s multiple sclerosis drug candidate. In a separate but related agreement, the MPM Bio IV NVS Strategic Fund L.P. made an equity investment in Peptimmune.In the event that Novartis exercises the option to PI-2301, Novartis would assume the global clinical development, manufacturing, and marketing of PI-2301 and all associated costs. Peptimmune would receive payments upon the option exercise and upon successful completion of certain development, regulatory, and commercial milestones. These payments together could total more than $500 million. In addition, Peptimmune shall be eligible to receive royalties on product sales. Additional terms were not disclosed.“We believe that Novartis represents an outstanding future partner for Peptimmune and the global development of PI-2301. This option agreement provides Peptimmune with access to both Novartis’ world class development expertise and the necessary capital to invest in this proprietary product,” said Thomas P. Mathers, President and CEO of Peptimmune.Todd Foley, Managing Director at MPM Capital commented, “Peptimmune and its world-leading expertise in peptide copolymers represent an attractive investment opportunity.”

About PI-2301PI-2301 is a peptide copolymer developed using Peptimmune’s novel platform peptide chemistry. PI-2301 is designed to enhance the regulatory response of the immune system, thereby controlling the pathogenic autoimmune response in certain diseases. PI-2301 is currently in Phase 1b development by Peptimmune.

About Peptimmune

Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of peptide therapies to improve the management of chronic autoimmune and inflammatory disorders. The Company is in clinical development with second-generation therapeutics that are expected to result in safer and more effective products for multiple sclerosis and pemphigus vulgaris. Current investors include New Enterprise Associates, MPM Capital, Hunt Ventures, Boston Medical Investors, Silicon Valley Bank Capital, and Genzyme Corporation. For additional information, please contact us.

Peptimmune Initiates Phase Ib Study of PI-2301 in Multiple Sclerosis Patients and Presentation at BIO 2008

Peptimmune announces first patient dosed in a phase Ib study of PI-2301 in multiple sclerosis patients in one of the most comprehensive studies of the pharmacologic effects of an immunomodulatory compound in autoimmune disease.


CAMBRIDGE, Mass. – June 17, 2008. Peptimmune, Inc. a privately held biotechnology company, announced that physicians have treated the first participant in a clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with Secondary Progressive Multiple Sclerosis (SP-MS). PI-2301 is a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

The Phase Ib multiple-ascending dose, double-blind, placebo-controlled randomized study will involve up to fifty-three subjects with SP-MS who will receive the drug once weekly in four escalating-dose cohorts. Following establishment of safety at potentially therapeutic doses and proof of pharmacologic mechanism, the Company plans to initiate its Phase II study in multiple sclerosis patients in early 2009. "While the primary goal of this study is to demonstrate safety of PI-2301 in multiple sclerosis patients, we believe that this clinical trial is one of the most comprehensive looks at the pharmacologic effects of any immunomodulator in patients suffering from autoimmune diseases," stated Thomas P. Mathers, President and CEO of Peptimmune. Mr. Mathers will be presenting an overview of the PI-2301 clinical program at the BIO 2008 Business Forum, Wednesday, June 18th, at 9:00 a.m. PST at the San Diego Convention Center, Room 2.

PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone® (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in some diseases. In a Phase I single ascending dose, double blind placebo controlled randomized study, all doses of PI-2301 were safe and well tolerated, and no serious adverse events were observed. Pharmacodynamic assays demonstrated evidence of immune exposure consistent with the pharmacologic mechanism of action for PI-2301, and dose-dependent pharmacokinetics was observed. PI-2301 has been optimized using Peptimmune’s novel platform peptide chemistry and, in preclinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in preclinical models of autoimmune diseases where immune modulation may be effective, such as Crohn’s disease, rheumatoid arthritis, and autoimmune uveitis. Peptimmune has put in place high-quality synthesis and analytical methods that provide a superior level of batch-to-batch reproducibility in the manufacturing of PI-2301.

Over 400,000 Americans have multiple sclerosis (MS), and MS may affect over 2.5 million individuals worldwide. MS is an autoimmune disease in which the individuals’ immune system responds against multiple components of nerve-insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.


About Peptimmune

Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of peptide therapies to improve the management of chronic autoimmune and inflammatory disorders. The Company is in clinical development with second-generation therapeutics that are expected to result in safer and more effective products for multiple sclerosis and pemphigus vulgaris. Current investors include New Enterprise Associates, MPM Capital, Hunt Ventures, Boston Medical Investors, Silicon Valley Bank Capital, and Genzyme Corporation. For additional information, please contact us.

Peptimmune Initiates Phase I Study With a Novel Peptide Copolymer for the Treatment of Multiple Sclerosis

CAMBRIDGE, Mass., Oct. 3 /PRNewswire/ -- Peptimmune, Inc. a privately held biotechnology company, announced that physicians have treated the first participant in a clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PI-2301, a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

The Phase I single ascending dose, double blind placebo controlled randomized study will involve 56 healthy male volunteers who will receive the drug in eight escalating dose cohorts. Following establishment of safety at potentially therapeutic doses, the Company will initiate its first repeat dose study in multiple sclerosis patients in early 2008.

PI-2301 is a second generation peptide copolymer from a similar compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system to control the pathogenic autoimmune response in certain diseases. PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and in pre- clinical studies, has shown to be more potent and effective than Copaxone(R) in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in pre-clinical models of autoimmune diseases where
immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has also introduced highly reproducible manufacturing methods that allow very strict control and characterization of PI-2301 and should provide a superior level of batch to batch consistency.

"The commencement of this clinical trial is an important milestone for the development of PI-2301 and for the Company," stated Thomas Mathers, President and CEO of Peptimmune. "The goal for PI-2301 is to enhance the therapeutic benefit of a proven compound class in multiple sclerosis and give neurologists a new weapon as a primary treatment for patients with
this debilitating disease."

Over 400,000 Americans have multiple sclerosis (MS), and worldwide MS may affect over 2.5 million individuals. MS is an autoimmune disease in which the individuals' immune system responds against multiple components of nerve- insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.

About Peptimmune

Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of peptide therapies to improve the management of chronic autoimmune and inflammatory disorders. The Company is in clinical development with second-generation therapeutics that are expected to result in safer and more effective products for multiple sclerosis and pemphigus vulgaris. Current investors include New Enterprise Associates, MPM Capital, Prism Venture Partners, Vanguard Ventures, Hunt Ventures, Boston Medical Investors, Silicon Valley Bank Capital, Itochu Corporation, and Genzyme Corporation. For additional information, access our website at http://www.peptimmune.com .


SOURCE Peptimmune, Inc.