Health Canada approved a phase I trial for Alteogen’s ALT02, a biosimilar version of trastuzumab
A green light to launch clinical trials in Canada for one of its leading biosimilar products will give South Korean company Alteogen Inc. and its Brazilian partner a boost on the global market.
Health Canada approved a phase I trial for Alteogen’s ALT02, a biosimilar version of trastuzumab – marketed by Roche AG unit Genentech Inc. as Herceptin, a monoclonal antibody used as a targeted treatment for breast cancer that has a large amount of HER2 protein.
Alteogen’s ALT02 will undergo a randomized, double-blind, parallel, phase I pharmacokinetic trial to compare it to the reference product. “We researched and developed this biosimilar for five years, and this is our first clinical trial for biosimilars,” Alex Park, director of strategic planning at Alteogen, told BioWorld Today. “This time we registered for [Canada], a well-developed country, so it means that [the quality of] our biosimilar data is high enough to get approved by Health Canada. We think this is meaningful for us. After finishing phase I clinical trials, we can move onto phase III.”
That approval marks the first global clinical trial for a biosimilar for the Daejeon-based company, as well as for its partner, Cristalia Produtos Quimicos Farmaceuticos Ltda., of Brazil. Alteogen has been developing biosimilar versions of trastuzumab, etanercept (Enbrel, Amgen Inc.) and adalimumab (Humira, Abbvie Inc.) with Cristalia, a firm founded in 1972 to research, develop, manufacture, sale and export pharmaceutical products.
The partners have plans to launch phase III trials of ALT02 in early 2017.
With clinical trials in progress in Canada, Alteogen is now looking to the Brazilian market in partnership with Cristalia. The two companies have been working together under the Productive Development Partnerships (PDP) of the Brazilian Ministry of Health (MoH) since 2014.
PDPs are exclusive five-year supply deals under which the Brazilian MoH agrees to only buy a particular drug from a single contracted supplier for a set price of 10 percent below the reference price.
“It’s a unique policy in Brazil, and the Brazilian government is importing a lot of original antibody drugs. They requested domestic companies develop antibody similars. If we succeed in antibody similars, the government will purchase the biosimilar. Then, our marketing partner can sell and supply it to the Brazilian government. The most important aspect lies in development, not marketing,” Park explained.
The idea behind the Brazilian plan is to control public health care spending and build local manufacturing. When the deal is terminated, contracted firms must transfer production knowhow to government-funded labs.
Breast cancer is one of the main challenges that the Brazilian government faces. Global statistics suggest that 60 percent of the deaths related to breast cancer occur in developing countries such as Brazil, and over the last few decades, breast cancer has emerged as the leading cause of cancer-related death among Brazilian women.
“We are targeting the Brazilian market first. We will launch the product there. After finishing the phase I, if some other pharma companies want to sell our product, then they will have to do the phase III clinical trial in their home country,” said Park. “We will do the clinical trial only in Canada.
“Canadian regulations are well developed,” he added. “After Canada, we can get approval from the Korea [regulators] and any other countries.”
Founded in 2008, Alteogen is a pharmaceutical research company focused on developing long-acting biobetters, including monoclonal antibody biobetters with antibody-drug conjugate technology. Apart from the deal with Cristalia, Alteogen has made strides elsewhere, inked a joint research agreement with Japan’s Kissei Pharmaceuticals Co. Ltd. in 2014 to develop biosimilars and signed a deal with U.S.-based
Biocure Pharma LLC the same year.
In October, Alteogen signed an exclusive patent license agreement with 3SBio Inc., a leading China-based biopharma company, for ALT-P7, an antibody-drug conjugate targeting the HER2 pathway for cancer, in Mainland China, Hong Kong and Macau. The deal included undisclosed up-front, milestone and royalty payments.
Alteogen listed on South Korea’s KOSDAQ in December 2014 through a public offering of 900,000 shares at SKW26,000 (US$21). The stock is now trading at SKW33,350.
BIOWORLD TODAY, By Haky Moon, Staff Writer