Hebei Changshan Biochem Pharma & Albumedix Enter Development Agreement

Albumedix and Hebei Changshan Biochem Pharma Co. recently announced they have entered into a supply agreement for the development of a novel type II diabetes treatment that enables once-weekly dosing. The agreement will see Albumedix’s recombinant albumin-based half-life extension platform used for the development and later commercialization of a modified glucagon-like-peptide albumin conjugate (Albenatide) for the treatment of patients living with the condition in China.

According to the International Diabetes Federation, the Chinese diabetes population amounts to a staggering 114 million, representing a third of all people who have the condition worldwide. With a diabetes prevalence of 11.6% for adults, China officially has the world’s largest diabetes epidemic. By combining Albumedix’s albumin-based drug delivery technology with Changshan’s clinical development expertise, Albenatide has the potential to extend the dosing frequency required by diabetics from daily to weekly, thereby significantly improving patient quality of life and treatment adherence as well as overall treatment cost.

Changshan operates through a joint venture with Los Angeles-based ConjuChem, LLC for the development of long-acting diabetic treatments.

“The collaboration between ConjuChem and Changshan is focused on the development of diabetes therapies for the Chinese market, and we are currently in a Phase I clinical trial with Albenatide, with the aim of moving into Phase II later this year,” said Dr. Patrick Soon-Shiong, Chairman and CEO, ConjuChem, LLC and NantWorks, LLC. “ConjuChem created the Drug Affinity Complex (DAC), which uses recombinant human albumin to improve a drug’s therapeutic index. We are confident that working with Albumedix and its exciting albumin-based platform will enable us to reach our goal of developing a patient friendly, once-weekly diabetes treatment.”

“China currently has the largest diabetes population in the world. Through the collaborations with ConjuChem and Albumedix, we are confident that we will be able to develop a more efficacious, safer, and easier-to-use anti-diabetes medicine, which will be a significant benefit to Chinese patients,” added Mr. Shuhua Gao, Chairman and General Manager of Changshan Biochem Pharma.

Albumedix’s albumin-based drug delivery platform, known as VELTIS, is a platform of native and engineered recombinant human albumins. When combined with a drug candidate, it offers the potential for adaptive control of therapeutic half-life. The platform can significantly improve the treatment options available to diabetes patients by maintaining the therapeutic activity for prolonged periods, opening the door towards extended dosing intervals and improved quality of life.

“The adoption of Albumedix recombinant albumin products by Changshan is yet another example of how our albumin-based solutions can help alleviate some of the many complications faced daily by patients living with chronic diseases such as diabetes,” said Peter Rosholm, CEO, Albumedix.

This agreement comes only a few months after the US market authorization of CSL Behring’s Idelvion, a once-every-14-day hemophilia B treatment, which also utilizes Albumedix’s albumin-based technology.

This agreement will not impact the 2016 financial forecast for Albumedix’s parent company, Novozymes.

Albumedix improves patient outcome with a range of albumin-based products and technologies that facilitate the development of superior biotherapeutics. Albumedix develops albumin-based products and technologies for advanced drug and vaccine formulation, extended drug half-life and improved drug delivery. Our products and technologies are used in clinical and marketed drugs and out-licensed to pharmaceutical and biotech companies worldwide. With over 25 years’ experience in the biopharmaceutical industry, we have the scientific, technical and regulatory expertise needed to support companies in moving faster to market with superior biotherapeutics. We also use this expertise to strengthen our own drug pipeline. Albumedix is a global company and fully owned subsidiary of Novozymes. For more information, visit www.albumedix.com.

Hebei Changshan Biochem Pharma Co. Ltd. Is a Chinese public company (SZ300255), headquartered in Zhengding, Shijiazhuang, China. It is a leading producer specializing in developing, manufacturing and marketing heparin sodium, low molecular weight heparin (Enoxaparin, Dalteparin, Nadroparin). In 2013, Changshan through a joint venture partners with ConjuChem LLC to co-develop potential long-acting anti diabetes medicines for Chinese diabetes patients.

ConjuChem, LLC is a privately biotechnology company with a corporate office located in Los Angeles, California. ConjuChem is owned by NantWorks, LLC. ConjuChem creates novel, next-generation medicines using unique, long-acting therapeutic peptides. Underlying all ConjuChem compounds are bioconjugation platforms called Drug Affinity Complex (DAC) and Preformed Conjugate-Drug Affinity Complex (PC-DAC). When applied to a given peptide, DAC and PC- DAC can create new drugs with similar therapeutic activities but with significantly longer durations of activity and improved safety profiles.