Kalvilla Pharmaceuticals, the company behind the blockbuster Astrazeneca drug, could be facing financial challenges because the government granted a special exemption from a $5-billion-a-year drug-making licence.
The federal government approved the Astrazenec drugs, including the new AstraZeneca blockbuster Kalvita, in January.
In a statement issued Tuesday, the government said the exemption will help prevent Astrazenech from facing “unexpected, unnecessary and potentially adverse effects on the market.”
“The exemptions in the AstraMed approval allow the company to continue producing and marketing AstraZeno and AstraKali,” the statement said.
“While the government’s decision does not require the company or its senior management to seek any further government approval, it will help avoid unnecessary costs.”
“There are many issues with this Astra Zeno application, including some that may require additional regulatory action, but it is important that Kalvistas senior management be aware of any potential risks that may arise as a result of the application,” the government statement said, adding that it will “continue to monitor the application closely and provide advice to the company.”
Astrazeneca said in a statement that the Astrazanac drugs are “an important step toward the safe and effective development of new, safer and more effective medications.”
The Astrazancaps are being produced by a British company and are sold in Canada under a number of brand names including Astra Zeneca, Astra Nova, Astrazenac and Astrazenax.
The government said Astra, which is a brand name, has been approved by Canada’s Food and Drug Administration (FDA).
The Astrazenes are manufactured in China.
The Astra group’s shares were up 1.4 per cent at $30.25 in early trading.
In February, the Astana group announced that it had secured a U.S. approval for the Asta-based Astra-Zeneca drug.
In May, Astana and Astraza agreed to enter into a joint venture that will allow them to combine their operations and the Astrava group will provide a financial support to Astrazinac, the statement added.
The announcement of the deal followed a report in the Financial Post on April 11 that indicated Astrazenac is facing “potential market disruption” because the drug is being sold under different names in Canada and China.
In an interview with CBC News, an Astra company representative said that the company has received a “very clear and positive response” from the FDA.
“We are very confident that we are in the best position to address the immediate risks that could arise,” the company said in the statement.
Astrazas chief executive officer said in March that the combination of Astrazac and Kalvacia will allow the Astaxas company to increase production of Astra.
“This combination of products and manufacturing will allow us to continue to innovate, expand our product range and enhance the safety and efficacy of our product,” he said.
Kalvasa said in April that the combined Astra and Asta group would invest $200 million to create “a world-class pharmaceutical company that can be a leader in developing new and innovative pharmaceutical products that are safer and less toxic than our existing products.”
In April, Kalvas president, David W. Hwang, told the Financial Times that he was “absolutely convinced” that Astrazarac would be approved in Canada.
Kalva said in its statement that it is “committed to continuing to innovate in the areas of pharmaceutical development and the pharma industry and to deliver a world-leading brand.”