MNTA Momenta Pharmaceuticals Inc

--Momenta to receive $50 million upfront license fee and up to $550 million in potential milestone payments from CSL--

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) and CSL Limited (ASX:CSL) (USOTC:CSLLY) today announced that they have entered into an exclusive research collaboration and worldwide license agreement to develop and commercialize Fc multimer proteins, including Momenta’s M230, a selective immunomodulator of Fc receptors, which is expected to enter the clinic in 2017. Momenta will receive a $50 million upfront license fee from CSL and is eligible to receive future milestone and royalty payments for M230. In addition to advancing M230, CSL and Momenta intend to enter into a research collaboration to develop additional Fc multimer proteins that may originate from Momenta’s or CSL’s research.

“This collaboration and license agreement with CSL validates our belief that M230 is an exciting recombinant product candidate for potential use in autoimmune indications. It was developed using our proprietary Fc biology platform and understanding of how intravenous immunoglobulin (IVIg) works in autoimmune diseases,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “As the global leader in immunoglobulin (Ig) therapy, CSL is the ideal development and commercialization partner for us in the area of Fc biology given their expertise in developing plasma-derived medicines and focus on creating disruptive recombinant products in the autoimmune space.” 

 “We are delighted to announce this collaboration with Momenta, who are leaders in the Fc biology space,” said Paul Perreault, CEO and Managing Director, CSL.  “M230 is a very exciting prospect and offers CSL the potential to further grow and expand our long-term global leadership in helping those patients with autoimmune diseases that are treated with immunoglobulins.”

Under the terms of the agreement, Momenta will grant CSL an exclusive, worldwide license to Momenta’s intellectual property relating to M230. Momenta will receive a $50 million upfront license fee payment from CSL and will also be eligible for up to $550 million in contingent clinical, regulatory and commercialization milestone payments. Momenta has the option to elect a cost and profit sharing arrangement, for which Momenta would fund a proportion of global development and commercialization costs in exchange for a share of U.S. profits, and milestones and royalties outside the United States. Momenta has the option to enter into an agreement to co-promote M230 and any other collaboration product in the U.S.

The companies expect to close the transaction in the first quarter of 2017, subject to customary closing conditions including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Conference Call Information

Momenta will host a conference call for investors today at 4:30 pm ET to discuss this important collaboration with CSL. The conference call will be webcast live and a link to the webcast may be accessed on the “Investors” section of the company’s website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 48172572. A replay of the call will be available approximately two hours after the conclusion of the call.  To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 48172572.

About M230, Selective Immunomodulator of Fc Receptors (SIF3)

Antigen-autoantibody immune complexes (ICs) are a common pathogenic hallmark of many autoimmune diseases. The multiple Fc domains of ICs aggregate Fcγ receptors (FcγRs), triggering cellular activation processes that play critical roles in inflammation and tissue damage. The rational engineering of therapeutics that broadly antagonize FcγRs has been hampered by a limited understanding of the molecular determinants directing FcγR activation. Through the engineering and characterization of oligomeric Fc structures, Momenta has been able to derive novel insights into FcγR modulation and has generated a unique recombinant Fc multimer therapeutic candidate, referred to as M230, with excellent physiochemical and biological properties. Preclinical studies in animal models of autoimmune disease have shown that M230 matched potency and efficacy of intravenous immunoglobulin at significantly lower doses. M230 is currently in preclinical development and is expected to enter the clinic in 2017. 

About Momenta

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications.

To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.

Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

About CSL CSL (ASX:CSL) is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovations, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses CSL Behring and Seqirus – conducts business in more than 60 countries with more than 17,000 employees. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For additional information about CSL, please visit www.CSL.com.au.

Forward Looking Statement For Momenta PharmaceuticalsStatements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements concerning the collaboration and license agreement between CSL and Momenta Pharmaceuticals, Inc., including anticipated payments, as well as future development, manufacture, and commercialization of novel drugs under the agreement; and our and CSL’s ability to successfully develop and commercialize M230.   Forward-looking statements may be identified by words such as "anticipate," "believe," “continue,” "could," "hope," "target," "project," "goal," “objective,” “guidance,” “plan,” "potential," "predict," "might," "estimate," "expect," "intend," "may," “seek”, "should," "will," "would," "look forward" and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, including receiving clearance under the Hart-Scott-Rodino Antitrust Improvements Act and those referred to under the section “Risk Factors” in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, or the risks and factors noted below by CSL, the  Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Forward Looking Statement for CSL The information in this press release speaks only as of the date of this press release, and includes forward looking statements about CSL business prospects and products in research, all of which involve substantial risks and uncertainties, many of which are outside the control of, and are unknown to, CSL. You can identify these forward looking statements by the fact that they use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “may,” “assume,” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Factors that could cause actual results to differ materially include: the success of research and development activities, decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement or access; litigation or government investigations, and CSL’s ability to protect its patents and other intellectual property. The statements being made in this presentation do not constitute an offer to sell, or solicitation of an offer to buy, any securities of CSL.

No representation, warranty or assurance (express or implied) is given or made in relation to any forward looking statement by any person (including CSL). In particular, no representation, warranty or assurance (express or implied) is given in relation to any underlying assumption or that any forward looking statement will be achieved. Actual future events may vary materially from the forward looking statements and the assumptions on which the forward looking statements are based.

Subject to any continuing obligations under applicable law or any relevant listing rules of the Australian Securities Exchange, CSL disclaims any obligation or undertaking to disseminate any updates or revisions to any forward looking statements in this press release to reflect any change in expectations in relation to any forward looking statements or any change in events, conditions or circumstances on which any such statement is based. Nothing in this press release shall under any circumstances create an implication that there has been no change in the affairs of CSL since the date of this press release.

MOMENTA INVESTOR CONTACT:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com

MOMENTA MEDIA CONTACT:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com

CSL INVESTOR CONTACT:
Mark Dehring
CSL
+61 3 9389 3407
Mark.Dehring@CSL.com.au

CSL MEDIA CONTACT:
Natalie de Vane
CSL
1-610-878-4468
Natalie.deVane@CSLBehring.com