Basel, Switzerland, October 3, 2018 – Novartis announced today that it has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug candidates that are part of the Novartis Infectious Diseases portfolio, which have the potential to address the need for new agents to treat antibiotic resistant Gram-negative infections.
Antibiotic resistance is widely recognized as a major public health threat and innovative candidates to combat drug resistant bacteria remain a critical unmet need. Both the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) have identified CRE and drug resistant Pseudomonads as serious threats that pose significant risk to human health.
“The need for new antibiotics that address drug resistant bacteria is clear and we are pleased to find a partner in Boston Pharmaceuticals who will dedicate the appropriate expertise and resources for the further development and commercialization of these programs,” said Jay Bradner, M.D., President of the Novartis Institutes for BioMedical Research. “Drug discovery and development is a team sport and this agreement is part of our strategy to partner with like -minded innovators outside of our walls to further develop new innovative medicines focused on addressing global health challenges.”
Under the terms of the agreement, Boston Pharmaceuticals acquired worldwide rights to two complementary candidates targeting carbapenem-resistant enterobacteriaceae (CRE) and one candidate targeting Pseudomonas infections. Novartis will receive an upfront payment and is entitled to royalties and milestone payments for successfully commercialized medicines. In addition, Novartis will receive an equity stake in two new companies formed together with Boston Pharmaceuticals to further develop and commercialize these programs. Financial terms of the agreement were not disclosed.
The programs included in this agreement include:
LYS228 is a potential best-in-class monobactam which has entered clinical development and which has demonstrated activity against CRE with resistance caused by serine beta-lactamases (SBLs) and/or metallo beta-lactamases (MBLs);
IID572 is a novel beta-lactamase inhibitor that may be used in combination with LYS228 or other beta-lactam antibiotics to expand their use against difficult-to-treat infections caused by a broader spectrum of CRE; and
MAK181 is an oral, first-in-class LpxC inhibitor for Pseudomonas infections.
“The acquisition of these three novel anti-infective candidates further demonstrates our commitment to addressing unmet medical needs in order to benefit patients,” said Robert Armstrong, Ph.D., C.E.O. of Boston Pharmaceuticals. “Novartis has done a tremendous job advancing new solutions to infections caused by drug resistant Gram-negative pathogens and developing these innovative candidates with best-in-class or first-in-class potential. We look forward to building on this quality research as we advance these candidates.”
Novartis continues to discover and develop new medicines to treat tropical diseases through research at the Novartis Institute for Tropical Diseases (NITD). In addition, earlier this year the company announced a five-year $100 million commitment to advance the Novartis malaria pipeline through 2023 and to complete a comprehensive global clinical trial program for two novel antimalarial drug candidates KAF156 and KAE609.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” “strategy,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products or the licensing and equity agreement with Boston Pharmaceuticals. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that the licensing and equity agreement with Boston Pharmaceuticals will achieve any or all of its intended goals and objectives, or be commercially successful. Nor can there be any guarantee that the investigational or approved products described in this press release will be commercially successful in the future. In particular, our expectations regarding such products and the licensing and equity agreement with Boston Pharmaceuticals could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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