Mylan Announces Worldwide Collaboration with Momenta to Jointly Develop and Commercialize Six Biosimilar Products

HERTFORDSHIRE, England and PITTSBURGH, Jan. 8, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that it has entered into an exclusive global collaboration agreement with Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) to develop, manufacture and commercialize six of Momenta's current biosimilar candidates, including Momenta's biosimilar candidate, ORENCIA® (abatacept).

Mylan CEO Heather Bresch commented, "Mylan's long-stated strategy has been to strategically invest in the long-term drivers of our future growth, both through our strong internal focus on R&D and through external collaboration with industry-leading partners. Biosimilars have long been one of these areas of important future growth, both for our company and our industry, given the rapidly growing market for biologic products, the undeniable patient need for more affordable versions of these life-saving medicines, and the attractive competitive landscape for the companies that are able to successfully bring these complex products at scale to the global market. This collaboration with Momenta, which is highly complementary to our partnership with Biocon, will position us as a definitive world leader in biosimilars, with a broad portfolio of 15 biosimilar/insulin analog generic products in development and the scale required to maximize investment in this area. Looking forward, Mylan will continue to expand and diversify its portfolio into such complex products, further differentiating us from other leading generics companies and establishing us at the forefront of the biologics space, while also ensuring we maintain one of the broadest, highest quality portfolios in our industry."

"This exciting collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan, leveraging Momenta's unique technology capabilities and Mylan's strong science, biosimilar-development experience, operational excellence and expansive global commercial footprint. Importantly, this collaboration builds upon Mylan's existing successful biologics and insulins collaboration with Biocon, which is focused on more near-term biosimilar opportunities. Through these partnerships, as well as the strong internal capabilities we have cultivated, Mylan is further expanding what is already one of the industry's most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world," continued Ms. Bresch.

Craig A. Wheeler, president and chief executive officer of Momenta Pharmaceuticals, said, "We are thrilled to welcome Mylan as our new collaboration partner for biosimilars. Our two companies have a common focus on building an industry-leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them. By combining Momenta's proven capabilities in complex-product development and Mylan's world-class global R&D, supply chain and commercial infrastructure, we are well positioned to become a strong competitor in this developing field. Our joint vision is to bring high quality, cost-effective biosimilar products to markets worldwide, and we believe our success will deliver a strong return to our companies' stakeholders." 

Under the agreement with Momenta, Mylan will make an up-front cash payment of $45 million and up to $200 million in contingent milestone-related payments to Momenta, with each company sharing equally in the costs and profits with respect to the products. The companies will be jointly responsible for product development, and Mylan will lead worldwide commercialization efforts. All other financial terms and product details remain confidential.

Mylan's collaboration with Momenta builds upon Mylan's existing biologics and insulin analog partnership with Biocon. The Biocon partnership includes six biosimilar programs (trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept and filgrastim) and three insulin analogs (glargine, lispro and aspart). Five of these biosimilar programs have successfully completed Phase I clinical trials, and four of the programs are in active Phase III testing. Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the U.S. and Europe in 2016. Mylan already has successfully launched its trastuzumab biosimilar product in India and other emerging markets.

Mylan President Rajiv Malik commented, "Mylan has been fully engaged in the development of biosimilars with our partner Biocon for the last six years. During that time, Mylan has cultivated strong experience and expertise in the development of biosimilar products, and is executing on our programs with the scientific and analytical rigor required to fulfill health-authority expectations. Based upon our proactive and informative interactions with global health authorities on our nine active programs, we are extremely optimistic about the strength of our current development programs with Biocon, and we look forward to deploying our expertise in our collaboration with Momenta."

Momenta also is providing information regarding the collaboration on its website.

Forward Looking Statement for Mylan

This press release includes statements that constitute "forward-looking statements," including with regard to statements that biosimilars has long been an area of important future growth, both for Mylan and its industry, given the rapidly growing market for biologic products, the undeniable patient need for more affordable versions of these medicines, and the attractive competitive landscape for the companies that are able to successfully bring these complex products at scale to the global market; that the collaboration with Momenta, which is highly complementary to Mylan's partnership with Biocon, will position Mylan as a definitive world leader in biosimilars with a broad portfolio of 15 biosimilar/insulin analog generic products in development and the scale required to maximize investment in this area; that Mylan will continue to expand and diversify its portfolio into such complex products, further differentiating it from other leading generics companies and establishing us at the forefront of the biologics space, while also ensuring it maintains one of the broadest, highest quality portfolios in its industry; that the collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan, leveraging Momenta's unique technology capabilities and Mylan's strong science, biosimilar development experience, operational excellence and expansive global commercial footprint; that through Mylan's partnerships, as well as the strong internal capabilities it has cultivated, Mylan is further expanding what is already one of the industry's most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world; that Mylan and Momenta have a common focus on building an industry leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them; that Mylan and Momenta's joint vision is to bring high quality, cost effective biosimilar products to markets worldwide and they believe their success will deliver a strong return to their respective stakeholders; that Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the U.S. and Europe in 2016; that Mylan is executing on its programs with the scientific and analytical rigor required to fulfill health authority expectations; and that Mylan is extremely optimistic about the strength of its current development programs with Biocon and looks forward to deploying its expertise in our collaboration with Momenta.  These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any changes in or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize biosimilar candidates; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring biosimilar candidates to market; Mylan's and its partners' ability to protect intellectual property and preserve intellectual property rights, including with respect to biosimilar candidates; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; risks associated with international operations; clearance under the Hart-Scott-Rodino Antitrust Improvements Act; other uncertainties and matters beyond the control of management; and the other risks detailed in Mylan's filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.

Forward Looking Statement for Momenta Pharmaceuticals

Statements 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 about our and Mylan's ability to successfully develop and commercialize high quality, cost-effective biosimilar products; compete successfully in biosimilars; and increase shareholder value.  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 Momenta's Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 filed with the Securities and Exchange Commission, as well as other documents that may be filed by Momenta 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 above by Mylan, Momenta's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing information in this press release as of this date and assumes no obligations to update the information or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which nearly 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 30,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

SOURCE Mylan N.V.

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