Allecra Therapeutics and Shanghai Haini Pharmaceutical Announce Exclusive Licensing Agreement for Cefepime/enmetazobactam for Greater China

• Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties
  
• Shanghai Haini gains exclusive manufacturing, development and commercial rights for the licensed territory

SAINT-LOUIS, France and WEIL AM RHEIN, Germany and SHANGHAI, China, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Shanghai Haini Pharmaceutical Co., Ltd. (Shanghai Haini), the subsidiary of Yangtze River Pharmaceutical Group (YRPG), and Allecra Therapeutics (Allecra) today announced that the companies have signed an exclusive licensing agreement under which Shanghai Haini will manufacture, develop and commercialize cefepime/enmetazobactam within Greater China, including Mainland China with Hong Kong and Macau, and Taiwan.

Under the terms of the agreement, Shanghai Haini will be responsible for manufacturing, development and commercialization of cefepime/enmetazobactam, including commercial manufacturing, and all associated costs, within the licensed territory. Subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, Allecra is to receive an upfront cash payment at signing and is eligible to receive further development and sales milestones for cefepime/enmetazobactam with an overall deal value of $78 million, as well as tiered royalties on sales within the licensed territory.

The consummation of the licensing transaction is subject to regulatory approval and other customary conditions precedent.

Mr. Iain Buchanan, on behalf of the Allecra Therapeutics board, said: “We are very pleased to sign this agreement with Shanghai Haini. They are one of the top pharmaceutical firms in China and are considered a market leader in the antibiotics space. With their extensive experience and outstanding development and commercialization capabilities, Shanghai Haini is the ideal partner to maximize the opportunity for cefepime/enmetazobactam for this large and important market region.”

Mr. Tan Pengfei, the General Manager of Shanghai Haini, commented: “We are pleased to in-license cefepime/enmetazobactam and advance its development for Greater China. There is an urgent need in China, and indeed, globally, to bring new antibiotics to the market that can address critical resistance issues. Cefepime/enmetazobactam will be a welcome addition to the tools that doctors have to help their patients, and we look forward to introducing this antibiotic to hospitals and achieving a win-win collaboration.”

A cross-border team of Baker McKenzie life sciences lawyers led by Julia Braun advised Allecra Therapeutics on the legal aspects of the licensing. Staatz Business Development & Strategy acted as corporate finance and transaction adviser on the deal. JunHe LLP provided PRC legal service in connection with the licensing.

Delos Capital, an existing investor of Allecra and a global life sciences fund based in Hong Kong, was instrumental with its representatives serving on Allecra's board in working with both parties in completing the transaction.

About cefepime/enmetazobactam  
Cefepime/enmetazobactam is a combination of enmetazobactam, a novel extended-spectrum β-lactamase inhibitor belonging to the penicillanic acid sulfone class, with the 4^th generation cephalosporin cefepime. Cefepime/enmetazobactam has shown superiority over standard of care in patients with complicated urinary tract infections (cUTIs) in a randomized, controlled, double-blind, global Phase 3 trial. Based on these results, Allecra plans to submit, during the second half of 2021, this ß-lactam/ß-lactamase inhibitor combination for marketing approval in the U.S. and EU. Cefepime/enmetazobactam has been granted Qualified Infectious Disease Product and Fast Track designation by the U.S. Food and Drug Administration (FDA), which will provide five years additional market exclusivity and priority FDA review. The European Medicines Agency (EMA) has indicated that, due to the combination of enmetazobactam with the already-approved cefepime and in light of results obtained in an epithelial lining fluid penetration study with cefepime/enmetazobactam, Allecra Therapeutics is allowed to seek approval of cefepime/enmetazobactam for use in pneumonia, including hospital-acquired/ventilator-associated pneumonia (HAP/VAP), without conducting a Phase 3 study in this indication.

About Allecra Therapeutics
Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms. Lead product candidate, cefepime/enmetazobactam, has shown superiority over standard of care in patients with complicated urinary tract infections (cUTIs) in a randomized, controlled, double-blind, global Phase 3 trial, and the Company is preparing submissions for marketing approval in the U.S. and EU based on these results. The Company has significant patent protection covering proprietary enmetazobactam in major territories. Allecra’s investors are: Forbion, Andera Partners, Delos Capital, Xeraya Capital, EMBL Ventures, and BioMedPartners. Allecra’s wholly owned French subsidiary is a beneficiary of financial support from Bpifrance and the Région Alsace. Please visit www.allecra.com for further information and follow us on LinkedIn.

About YRPG
Yangtze River Pharmaceutical Group (YRPG) was founded in 1971, which is headquartered in Taizhou, China. It is a large-scale Chinese pharmaceutical company that integrates research, production and distribution. As a leading company in the pharmaceutical industry in China, Yangtze River Pharmaceutical Group has extensive marketing network, and adheres to the core values of "High quality, Benefits the people, Innovation, and Perfection". It dedicates in the pharmaceutical industry and also implements the traditional Chinese medicine, chemical medicine, and biological medicine, which is known as the "Three Drives" strategy in order to provide the society with most effective medicines and health services, and to become one of the most respected pharmaceutical companies in the world. For more information, please visit our website, www.yangzijiang.com.

About Shanghai Haini
Shanghai Haini Pharmaceutical Co., Ltd. (Shanghai Haini) was founded in 2001. It is located in Pudong District, Shanghai, at Shanghai Zhangjiang Bio-pharmaceutical Industrial Park. Shanghai Haini is the first wholly-owned subsidiary established by YRPG outside Taizhou headquarter. After 20 years of development, it has become a leading company in the pharmaceutical industry in Shanghai and a rising star in the life and health industry in the "Yangtze River Delta" area.