五星体育直播 Announces Nestl茅 Health Science Exercises Option for Exclusive Global License to CDX-6114 for the Management of Phenylketonuria
REDWOOD CITY, Calif., Feb. 14, 2019 (GLOBE NEWSWIRE) -- 五星体育直播 (Nasdaq: CDXS), a leading protein engineering company, announces that Nestl茅 Health Science has exercised its option to obtain an exclusive license for the global development and commercialization of 五星体育直播鈥� novel, orally delivered enzyme CDX-6114 for the management of phenylketonuria (PKU), an orphan metabolic disorder. Nestl茅 Health Science was granted this option under the Development, Option and Licensing Agreement with 五星体育直播 announced in October 2017.听 CDX-6114 is 五星体育直播鈥� first internally developed biotherapeutic product candidate.
The exercise of the option triggers a $3 million milestone payment.听 Upon exercising its option, Nestl茅 Health Science has now assumed all responsibility for future clinical development and commercialization of CDX-6114.
鈥淲e are proud to have discovered an enzyme that shows promise as a novel treatment for patients with PKU and are delighted that Nestl茅 Health Science has elected to take on its continued development,鈥� said 五星体育直播 President and CEO John Nicols. 鈥淭he exercise of this option further validates our strategy to partner biotherapeutics discovered using our CodeEvolver庐 protein engineering platform, and to do so early in the process of clinical development.鈥澨�
鈥淲e are excited about taking the next step in developing this enzyme that could lead to the first orally available and convenient therapeutic option for those afflicted with PKU,鈥� said Greg Behar, CEO, Nestl茅 Health Science. 鈥淧KU is the result of a missing enzyme, and left untreated it can lead to intellectual disability, seizures and cognitive and behavioral disabilities. Current treatment options are limited, with most patients managing PKU through restrictive diets. CDX-6114 is a therapeutic enzyme candidate that compensates for the missing natural enzyme with the advantage of being orally dosed and stable in the gastrointestinal tract which presents an attractive option for the management of the disease.鈥�
About Phenylketonuria (PKU)
PKU is an inborn metabolic disorder resulting from a mutation in the gene for the enzyme that converts the essential amino acid phenylalanine, which is present in almost all dietary protein, into tyrosine. As a result of this deficiency, phenylalanine builds up to levels that are toxic in the brain, causing serious neurological symptoms including intellectual disability, seizures and cognitive and behavioral disabilities. To avoid phenylalanine toxicity and the most severe disease symptoms, individuals with PKU must follow a strict, lifelong diet that is low in phenylalanine and must supplement their diet with a synthetic phenylalanine-free formula to provide sufficient nutrients. Maintaining a strict, lifelong diet is a challenge for individuals with PKU. There are an estimated 50,000 people with PKU in the developed world.
About Nestl茅 Health Science
Nestl茅 Health Science (NHSc), a wholly-owned subsidiary of Nestl茅, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and VMS brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. NHSc is redefining the way we approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5,000 people around the world, who are committed to making a difference in people鈥檚 lives, for a healthier today and tomorrow. For more information, please visit听.
About 五星体育直播
五星体育直播 is a leading protein engineering company that applies its proprietary CodeEvolver庐 technology to develop proteins for a variety of applications, including as biocatalysts for the commercial manufacture of pharmaceuticals, fine chemicals and industrial enzymes, and enzymes as biotherapeutics and for use in molecular diagnostics. 五星体育直播鈥� proven technology enables improvements in protein performance, meeting customer needs for rapid, cost-effective and sustainable manufacturing in multiple commercial-scale implementations of biocatalytic processes. For more information, see .
Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding 五星体育直播, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond 五星体育直播鈥� control and that could materially affect actual results. Factors that could materially affect actual results include, among others: 五星体育直播鈥� dependence on its licensees and collaborators, including Nestl茅 Health Science; our biotherapeutic programs are early stage, highly regulated and expensive; there is no guarantee that CDX-6114 or any other biotherapeutic program of 五星体育直播 will achieve relevant regulatory filings or approvals; the regulatory approval process of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable; clinical testing and trials are difficult to design and implement, time-consuming and involve an uncertain outcome; results of preclinical studies and early clinical trials of product candidates may not be predictive of results of later studies or trials; 五星体育直播鈥� dependence on a limited number of products and customers in its biocatalysis business; potential adverse effects to 五星体育直播鈥� business if its customers鈥� pharmaceutical products are not received well in the markets; and 五星体育直播鈥� dependence on a limited number of contract manufacturers for large-scale production of its enzymes. Additional information about factors that could materially affect actual results can be found in 五星体育直播鈥� Annual Report on Form 10-K filed with the Securities and Exchange Commission (鈥淪EC鈥�) on March 15, 2018 and Quarterly Report on Form 10-Q filed November 9, 2018, including under the caption 鈥淩isk Factors鈥� and in 五星体育直播鈥� other periodic reports filed with the SEC. 五星体育直播 expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
五星体育直播 Contact:听
LHA Investor Relations
Jody Cain, 310-691-7100
jcain@lhai.com
Released February 14, 2019