The company to be acquired has a portfolio of 25 sterile injectable products, three in-licensed ophthalmic products and a pipeline of seven additional products, four of which are approved by Health Canada.

Riad Mishlawi, president of Hikma Injectables, commented: “This acquisition further expands our portfolio of essential sterile injectable medicines and gives Hikma an entry into the highly attractive Canadian injectables market. The combination of our sales and marketing expertise and this portfolio of exciting products will enable us to expand our North American business and develop a solid position in this important market.”

Teligent’s filing was initially prompted by a warning letter from the US Food and Drug Administration in relation to several violations of GMP regulations at its plant in Buena, New Jersey. The company stopped production of certain products and this, together with the onset of the Covid-19 pandemic, negatively affected its cash flow. Teligent was said to be nearly $130 million in debt when it filed for Chapter 11 protection in a Wilmington, Delaware court.

New sterile compounding business

In separate news, Hikma announced earlier this month that it had launched a new outsourced sterile compounding business called Hikma 503B, which is focused on providing high quality, ready-to-administer injectable medications customized to the specific needs of patients in the US.

The new business will operate principally from a purpose-built facility in Dayton, New Jersey, that Hikma acquired in 2020. Hikma 503B is registering for state licenses across the US and expects to be operating nationwide by the end of 2022.

“Hikma 503B is a natural extension of our injectables business, building on our strong relationships with US hospitals and excellent quality manufacturing protocols to provide urgently needed product offerings to patients and health care providers in the US,” Mishlawi said. “There is substantial demand for outsourced sterile compounded medicines among the thousands of hospitals we currently serve, representing a large opportunity to meet a growing and not fully met need within the US health care system.”

The US market for outsourced compounded sterile injectable medicines is estimated to exceed $2 billion annually, as Hikma underlines. 

Author: Elaine Burridge, Freelance Journalist