Merck Serono And Lpath Form Alliance For ASONEP, A Phase I Monoclonal Antibody, Across All Indications

Main Category: Cancer / Oncology
Also Included In: Pharma Industry / Biotech Industry
Article Date: 29 Oct 2008 - 8:00 PDT

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Merck Serono, a division of Merck KGaA, announced today that it has entered a worldwide alliance with Lpath, Inc. (OTCBB:LTPN) of the United States to develop and commercialize ASONEP, a Phase I monoclonal antibody currently being evaluated for the treatment of various cancer types.

ASONEP is a humanized monoclonal antibody that neutralizes S1P, a bioactive lipid that stimulates tumor cell migration, invasion and survival and also promotes angiogenesis, i.e. growth of new blood vessels. S1P has been highly correlated with the development of drug resistance in various cancer types.

Under the terms of the agreement, Merck Serono will provide Lpath up to $23 million of upfront payments and R&D funding to support Lpath's completion of the Phase I clinical trial. If Merck Serono accepts the responsibility to develop ASONEP beyond Phase I, it will pay Lpath an additional $28 million and will fund all continuing development activities. Further payments will be made on achievement of development, regulatory, and sales milestones that could total up to $422 million should ASONEP be approved in multiple indications.

As part of the alliance, Merck Serono now has exclusive, worldwide rights to develop and commercialize ASONEP across all indications and Lpath will receive royalties on commercial sales of the product.

"This alliance is a promising strategic fit for Merck Serono's business model and culture, benefiting from our broad expertise in developing monoclonal antibodies," said Vincent Aurentz, Executive Vice President Portfolio Development and Member of the Merck Serono Executive Board. "ASONEP is an innovative drug candidate and the first monoclonal antibody targeting a bioactive lipid to be tested in clinical trials. We believe that S1P, the bioactive-lipid target of ASONEP, plays an important role in cancer."

Scott Pancoast, President and Chief Executive Officer of Lpath, commented: "Merck Serono, which has distinguished itself as an outstanding developer and marketer of innovative drugs in key therapeutic areas, is an ideal partner for ASONEP and for Lpath. We expect this alliance to further validate the importance of bioactive-lipid-targeted therapeutics and extend Lpath's leadership position in this exciting new field."

About ASONEP™

ASONEP is a unique humanized antibody that binds to and inhibits S1P, a bioactive lipid that has multiple effects on cells including cell proliferation, migration and survival. S1P, which is up-regulated in tumor cells, also promotes tumor and endothelial-cell growth, angiogenesis and inflammation, and, importantly, it prevents apoptosis (cell death). S1P is associated with several pathologies, including cancer, ocular disorders, autoimmune disease, and inflammatory- and fibrosis-related disorders. Further, S1P has been highly correlated with drug resistance across a wide array of tumor types, as well as with increased mortality of patients with many different types of cancer.

By inhibiting S1P activity, ASONEP may be able to increase survival in cancer patients, not only via its anti-angiogenic and anti-tumorigenic effects, but also via its ability to help patients overcome drug resistance.

ASONEP is the systemic version of sonepcizumab, which is the humanized version of Sphingomab™.

About Lpath

Lpath, Inc., headquartered in San Diego, California, is the category leader in bioactive-lipid-targeted therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases. For more information, visit http://www.Lpath.com

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).

With an annual R&D investment of around € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

For more information, please visit http://www.merckserono.net or http://www.merck.de

About Merck KGaA

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.subscribe.merck.de to register online, change your selection or discontinue this service.

Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 32,458 employees in 59 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

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Sarah Herrmann
Chandler Chicco Companies
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