- Designation provides seven years market exclusivity upon approval
BRISBANE, Calif., July 11, 2017 (GLOBE NEWSWIRE) -- KaloBios Pharmaceuticals, Inc. (OTCQB:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to benznidazole for the treatment of Chagas disease, a neglected tropical disease.
“Chagas disease is a serious, life-threatening and underserved disease in the U.S., and patients suffering from this disease are still without an FDA-approved treatment option,” said Cameron Durrant, MD, chairman and CEO of KaloBios. “This orphan designation highlights another example of our continued execution to swiftly advance the benznidazole program to potentially bring a safe and effective treatment for Chagas disease in the U.S.”
Under the U.S. Orphan Drug Act, FDA’s Office of Orphan Products Development grants orphan drug designation to drugs and biologics defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and provides several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
KaloBios expects to submit a New Drug Application (NDA) submission for benznidazole in the first quarter of 2018. The company received clearance from the FDA in June for its Investigational New Drug (IND) application. Earlier this year, it also received positive guidance from the FDA supporting the company’s proposed 505(b)(2) regulatory pathway for benznidazole, enabling the company to use data obtained from previously conducted studies to demonstrate safety and efficacy in the treatment of Chagas disease within the U.S.
About Benznidazole
Benznidazole is an oral anti-parasitic medication used in the treatment of Chagas disease, caused by a protozoan parasite Trypanosoma cruzi carried and transmitted by triatomine insects (often called “kissing bugs”). An estimated 350,000 people in the United States are infected with Chagas disease, which, if left untreated, can lead to serious and potentially life-threatening cardiovascular, gastro-intestinal and neurological complications. According to a May 2017 PLOS Neglected Tropical Diseases paper, those infected have an almost 18 times average higher risk of death from Chagas-related cardiac issues than those not infected. Benznidazole is the current preferred treatment for Chagas disease in other parts of the world but is not currently approved by the FDA in the U.S.
About KaloBios Pharmaceuticals, Inc.
KaloBios Pharmaceuticals, Inc. (OTCQB:KBIO) is an emerging biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases through innovative and responsible business models. Lead compounds in the KaloBios portfolio are benznidazole for the potential treatment of Chagas disease in the U.S., and the proprietary monoclonal antibodies, lenzilumab and ifabotuzumab. Lenzilumab has potential for treatment of various rare diseases, including hematologic cancers such as chronic myelomonocytic leukemia (CMML) and potentially juvenile myelomonocytic leukemia (JMML). For more information, visit www.kalobios.com.
Forward-Looking Statements
This release contains forward-looking statements that are intended to be subject to protection afforded by the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations as to the timing for submission of our NDA for benznidazole and those regarding the expected availability of the 505(b)(2) regulatory pathway. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, our lack of profitability and the need for additional capital to operate our business as a going concern; the uncertainties inherent in the development and launch of any new pharmaceutical product; the acceptability to FDA of a 505(b)(2) development pathway for approval of benznidazole using data drawn from previously conducted studies and the various risks and uncertainties described in the “Risk Factors” and elsewhere in the Company’s periodic and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.
CONTACT: Investors: Mike Cole O: 949-259-4988 C: 949-444-1341 mike.cole@mzgroup.us Media: Lisa Guiterman O: 301-217-9353 C: 202-330-3431 media@kalobios.com
