Le Lézard
Classified in: Health
Subject: LICENSING AGREEMENTS

Starton Therapeutics and Haisco Pharmaceutical Announce an Exclusive Licensing Agreement to Develop and Commercialize STAR-OLZ for Nausea and Vomiting in China


PARAMUS, N.J. and CHENGDU, China, March 01, 2021 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (Starton), a US-based privately held clinical-stage biopharmaceutical company, and Haisco Pharmaceutical Group Co., Ltd. (Haisco), a leading China-based pharmaceutical company, announced today that they have entered into an exclusive licensing agreement for the development and commercialization of STAR-OLZ, a once-weekly transdermal olanzapine delivery system in development for Nausea and Vomiting, in Mainland China.

Starton and Haisco are preparing to launch clinical studies in chemotherapy induced nausea and vomiting (CINV), followed by additional nausea and vomiting indications. Starton has completed a human bioavailability study with STAR-OLZ, which successfully delivered therapeutic blood levels and displayed acceptable tolerability.

Pedro Lichtinger, CEO of Starton Therapeutics, commented, "Haisco is an ideal partner for our STAR-OLZ product. In addition to being a respected pharmaceutical company in China, Haisco leads in antiemetic sales in China and has several antiemetics products in the market and in development. Their knowledge and commercial presence in the most price sensitive market will maximize the potential value that STAR-OLZ brings to patients."

Junmin Wang, Chairman of Haisco Board, commented, "Haisco has built a strong profile in tumor antiemetic area. Our Dolasteron injectable shares a great portion in the antiemetic market in China. In-licensing STAR-OLZ to China brings a more effective and convenient treatment option to Chinese cancer patients and adds on a novel means to differentiate our present antiemetic offerings. We look forward to closely collaborating with Starton to efficiently develop this product to benefit patients as soon as possible."

Under the terms of the agreement, Starton will receive an undisclosed upfront cash payment and is eligible to receive additional development and regulatory milestone payments, plus double-digit royalties on annual net sales of STAR-OLZ in the territory. Haisco will be responsible for developing and commercializing STAR-OLZ in China.

YAFO Capital (Shanghai) and LifeSci Partners acted as transaction advisors on this transaction.

About STAR-OLZ (olanzapine transdermal delivery system):

STAR-OLZ is a once-weekly transdermal delivery system (TDS) in development for chemotherapy induced nausea and vomiting (CINV) and PARP inhibitor induced nausea and vomiting (PIINV).

STAR-OLZ has completed a human bioavailability study in 36 healthy volunteers. In this study, it was found that STAR-OLZ delivers target therapeutic levels of olanzapine over 7 days, is well-tolerated to the skin, adheres to the skin over the dosing interval with easy removal, and has lower overall sedation side effect intensity when compared to ZYPREXA oral. All endpoints and objectives of the study were met.

Multiple randomized controlled studies have shown olanzapine is superior in control of nausea and non-inferior in control of vomiting versus the standard of care NK1 receptor antagonist in CINV prophylaxis. NCCN guidelines recommend olanzapine for CINV, but the current OLZ label has no nausea and vomiting (NV) indications.

PARP inhibitors are a long-term cancer therapeutic which cause nausea in over 70% of patients. There is no antiemetic approved for use in PIINV. STAR-OLZ is in development to be the first product approved for PIINV.

About Starton Therapeutics

A clinical-stage biotechnology company focused on transforming standard of care therapeutics. Starton uses proven continuous delivery technology with proprietary drivers to obtain new indications or develop on-label superiority for patients with hematological malignancies. To learn more, visit www.startontx.com.

About Haisco Pharmaceutical Group

Haisco Pharmaceutical Group is a China-based pharmaceutical company dedicated to providing the best medical products in specialized area to patients and our community. With extensive experience, Haisco is capable of developing, manufacturing and commercializing Innovative drug products as well as generic drug products with high technical barrier in our focused areas.

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the Company's business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the Company's control and involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the Company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the Company. Neither the Company nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, the Company's business, financial condition, liquidity, results of operations, plans and objectives may vary materially from those expressed in the aforementioned forward-looking statements.

Starton Contact:
[email protected]
+1 551 287 6456

Haisco Contact:
[email protected]
028-67250551



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