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CANbridge: A bridge to China

CANbridge: A bridge to China
By Erin McCallister
Senior Editor

To view the entire article click here.

Many small biotechs in the U.S. and Europe do not have the resources to develop their programs in China in parallel with Western territories, leading to a five- to eight-year lag before a Chinese launch.

CANbridge Life Sciences Ltd. plans to in-license candidates from these companies for China and elsewhere in East Asia as part of a global development strategy for its biotech partners.
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CANbridge wants to get the programs to patients in China faster and believes its executive team can help small biotechs develop their programs in China in parallel with an in-house Western development program.

Two of CANbridge’s executives have experience taking programs through the clinic and to market in China from time spent working at Genzyme China, a division of Genzyme Corp., which was acquired by Sanofi in 2011.

CEO James Xue was the founding general manager of Genzyme China. Crystal Xu, head of clinical development, was Genzyme China’s director of medical and
regulatory affairs.

To view the entire article click here.

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CANbridge to take western cancer drugs to China

World News | September 26, 2013

http://www.pharmatimes.com/Article/13-09-26/CANbridge_to_take_western_cancer_drugs_to_China.aspx

Kevin Grogan

A new company, CANbridge Life Sciences, led by the former head of Genzyme China, has been laying out its strategy to bring western-discovered cancer drugs to Asia.

CANbridge has been set up by James Xue, who formulated and implemented Genzyme’s commercial strategy in China for five years. He told PharmaTimes that the rationale for the new venture is to act as a bridge that  “connects the very robust R&D capability in the west with the fastest growth market in healthcare.”

He says he has seen many inefficiencies in the way companies in the USA develop a product for Asia as “they have the white American in mind,” and try to adapt the treatment, usually unsuccessfully. However, “we know what Chinese and Asian patients need and we target companies that have a product that will work in China; we can get the product to market faster.”

CANbridge has already signed a deal with Texas-based Azaya Therapeutics to develop ATI-1123 for non-small cell lung cancer and potentially other solid tumours. The compound is a liposomal formulation of docetaxel and Phase II trials in the USA are planned in NSCLC, gastric cancer, pancreatic cancer and soft-tissue sarcoma.

Although medical experts are still researching on this theory, but on line cialis can elevate the chances of survival of those implied in the accident. Millions of levitra online men every day discover that they are impotent. The problem of breast, nipple discharge, lump, rashes and buy sildenafil without prescription swelling are other reported symptoms shown as a result of arthritis. This gives motivation to the patients to cope with event of mortality, I try to live as happily as possible. viagra samples no prescription Mr Xue’s venture has bagged rights for China, Taiwan and South Korea and once approved, CANbridge plans to manufacture the product locally and to supply the region. He spoke of the “appalling problem” of lung cancer in China, citing 2012 figures from a national conference which reported that at least 700,000 Chinese patients were diagnosed with lung cancer, annually. Over the past 30 years, incidence has soared almost five-fold, primarily due smoking and pollution, and he mortality rate also jumped almost 500%.

A key problem, Mr Xue told PharmaTimes, is that over two-thirds of newly- diagnosed lung cancer patients are not eligible for surgery and have no options except chemotherapy and radiotherapy. Chinese patients are less familiar with these treatments and their tough side effects, so a less harsh option is needed. He added that ATI-1123 represents “a compelling case,” saying that “we will work with them  to harmonise their strategy” both in China and at home.

Potential partner for big pharma

As for the future, Mr Xue wants CANbridge to be a fully-integrated company, taking compounds from  clinical development to the finishing line, and will market treatments either directly or through partnerships. “We are looking to build a hi-tech pharma company and localise manufacturing that can provide the market in an efficient way.”

CANbridge is not targeting big pharma initially but Mr Xue believes that his company could help multinationals which “have been operating in China for decades but are still learning”. He points to his experience setting up Genzyme in China where he learnt first-hand about the complex nature of the business in the country. Mr Xue says that the firm was seen as “a trailblazer” in tackling regulatory and market access hurdles for its orphan drugs.

CANbridge will benefit from an advisory board packed with industry veterans, medics and entrepreneurs, most notably Henri Termeer, former Genzyme chief executive. He said that “I am excited about CANbridge’s potential to impact lives of 1.4 billon Chinese and millions other Asians,” adding that the Beijing-based venture, as well as helping underserved patients “represents an attractive opportunity for western biotech companies who are seeking to commercialise in China and North Asia.”

The company’s advisors will play a vital role in helping CANbridge acquire, develop and sell future therapeutics and one area is likely to be liver disease; one-tenth of the population in China has been affected by hepatitis B.

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Canbridge, Azaya Ink Deal to Develop ATI-1123 for NSCLC

BioWorld International

BioWorld – The Daily Biopharmaceutical News Source from Thomson Reuters

 

Canbridge, Azaya Ink Deal to Develop ATI-1123 for NSCLC

 

By Shannon Ellis
Staff Writer

Tuesday, September 24, 2013

SHANGHAI – Beijing newcomer Canbridge Life Sciences Ltd. has partnered with emerging nanotech specialist Azaya Therapeutics Inc., of San Antonio, to develop non-small-cell lung cancer (NSCLC) treatment ATI-1123 in China and North Asia.

ATI-1123 is a liposomal formulation of docetaxel that has successfully completed U.S. FDA-approved Phase I trials for multiple solid tumor cancers. Lung cancer is the most prevalent solid tumor cancer in China.

The in-licensing deal for ATI-1123 marks Canbridge’s unofficial launch. Small in size, the 10-person team comes with a strong pedigree. Founder and CEO James Xue was the founding general manager of Genzyme China and is an early returnee who came back to China with an MBA and PhD from the U.S. Crystal Xu heads up clinical development and is the former director of medical and regulatory affairs at Genzyme.

“We are focusing on diseases that most affect the quality of life of Chinese and East Asians and on patients that are also the most underserved,” Xue noted. “Over time, we will build a robust pipeline of drugs and devices in late-stage clinical development that originated at other biopharmaceutical companies outside our region and develop and launch them for China, Taiwan and South Korea. We will not be doing any discovery research. We are focusing on development.”

Licensing a treatment for lung cancer promises to be a good start in a country where smoking and air pollution are rampant. China is the largest producer and consumer of cigarettes in the world. Lung cancer has been found to be two to three times more prevalent in heavily polluted cities.

cheapest viagra uk Even better, majority of these drugs are considered safe because the key components are derived from natural sources. Insufficient blood supply leads the cialis in india man to erectile dysfunction. This can damage endothelial cells and increase the length of the male organ by on line levitra few inches. If vardenafil sale any negligence happens during consumption then this may develop various threatening like headaches, stomach pain, tiredness, dizziness, cough, sinus, swelling, anxieties, depression, behavior change or muscle weakness. A 2012 report from the National Central Cancer Registry pointed out that six people are diagnosed with lung cancer every minute on average, which adds up to about 700,000 diagnosed cases each year. The incidence of lung cancer has increased fivefold in the past 30 years, and the mortality rate has jumped 500 percent without an effective cure.

“In China, over two-thirds of the newly diagnosed lung cancer patients are not eligible for surgery,” Xue said. “Their only options are chemotherapy and radiation. We are racing against time to develop and deliver a more effective treatment to Chinese and Asian lung cancer patients. We see ATI-1123 as a promising potential new treatment in this underserved Asian market.”

ATI-1123 passed Phase I trials in the U.S. with 88 percent of 29 patients using the drug to stabilize the disease.

Under terms of the agreement with Azaya, Canbridge will finance the development and commercialization of ATI-1123 for China, South Korea and Taiwan and will make undisclosed royalty and milestone payments. Phase II trials are planned by Azaya in the U.S. for the use of the drug in NSCLC, gastric cancer, pancreatic cancer and soft-tissue sarcoma.

“Our commercialization strategy for ATI-1123 is to seek approval in the U.S. and the European Union, primarily. However, the Canbridge opportunity was presented, and we felt it was too good to pass up,” said Mike Dwyer, president and CEO of Azaya Therapeutics. “The people who comprise the Canbridge team were responsible for Chinese regulatory approval of several leading Genzyme products. We know them personally and know they only take on drugs they believe will suit their market.”

Azaya’s proprietary technology “improved” docetaxel with a liposomal formulation that, according to Azaya’s licensing proposal, “provides longer exposure to the drug at the site of the tumor while reducing systemic toxicities.” The most common treatment for breast and prostate cancer is docetaxel (Taxotere, Sanofi-Aventis), but the drug can be highly toxic with serious side effects.

Xue said that the nanotechnology developed by Azaya is what makes the drug promising.

ATI-1123 encapsulates the highly toxic cancer agent in a liposomal coating with a diameter of 90 nm, which is smaller than a blood cell.

“Liposome encapsulation works because cancer tumors have leaky vasculature and nano-sized particles can be absorbed and retained,” said Xue. “In turn, the active ingredient is released more slowly and at a higher concentration, resulting potentially in higher levels of efficacy with a much lower side-effect profile.”

Azaya is private biotech firm set up in 2003. The company uses a targeted nanotechnology platform called Protein Stabilized Liposomes to deal with problems created by water insoluble active pharmaceutical ingredients. Also in Azaya’s pipeline is ATI-0918 (generic Doxil/Caelyx), which has been approved as an investigational new drug and is undergoing bioequivalency tests in ovarian cancer.

 

 

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Azaya CEO Mike Dwyer is looking to expand opportunity with licensing agreement

SAN ANTONIO BUSINESS JOURNAL

Sep 20, 2013, 5:00am CDT

Azaya CEO Mike Dwyer is looking to expand opportunity with licensing agreement

http://www.bizjournals.com/sanantonio/print-edition/2013/09/20/azaya-ceo-mike-dwyer-is-looking-to.html?s=image_gallery

Mike Dwyer, the CEO of Azaya Therapeutics Inc., discusses his company’s exclusive licensing agreement with CANbridge Life Sciences.

Azaya Therapeutics Inc., a clinical-stage oncology company, has entered into an exclusive licensing agreement with CANbridge Life Sciences, which will develop and commercialize the San Antonio-based company’s lead compound, ATI-1123, for non-small-cell lung cancer in China, South Korea and Taiwan.

As part of the agreement, CANbridge, which is based in Beijing, China, will fund clinical development in that country, as well as in North Asia, collaborating with Azaya on clinical trial design. Financial terms of the deal have not been disclosed, but Azaya President Mike Dwyer says the partnership creates greater international opportunities for the San Antonio-based bioscience company. We asked Dwyer about the deal and its potential impact

Q: Why did Azaya decide to enter into a licensing
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A: Our commercialization strategy for ATI-1123 is to seek approval in the United States and European Union, primarily. However, the CANbridge opportunity was presented and we felt it was too good to pass up. We know (the CANbridge team) personally and know they only take on drugs they believe will suit their market. We have a high degree of trust in their ability to get the job done.

Q: Does Azaya have any concerns about protecting its intellectual property in China?

A: One of the big concerns people have with China is what happens to the intellectual property. The trust factor of who you do business with and how they are going to deal with you really gets highlighted. (CANbridge) is as familiar with this problem as we are. CANbridge and Azaya are going to share the rewards of this effort. So it is in their best interest to keep those rewards as high as they can so we have more to share.

Q: What impact could this relationship have on treatment outside the U.S.?

A: It could be phenomenal. One of the issues we have with chemotherapy products is their toxicity. In the United States, all of our oncologists have learned how to deal with that toxicity. In countries outside of the United States, the usage of our chemotherapy is not as high because of that toxicity factor. So in China, and in other countries outside the U.S., the type of product we are developing makes a lot more sense and could have a much higher use.

Q: What level of economic impact could this relationship with CANbridge have on Azaya?

A: Potentially in China, we could develop sales of $400 million to $500 million annually. That would be an enormous impact on our long-term sales and our profitability.