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“protein medicinal chemistry.” Elanco says that the process for making pegbovigrastim adds a water-soluble polymer to a specific site of the protein, which increases its half-life from hours to days. That means that the protein remains biologically active and can support bacteria-fighting neutrophils for a longer period of time, Elanco explains. In studies to evaluate the drug’s efficacy, Elanco says pegbovigrastim reduced the incidence of clinical mastitis in cows and heifers by 28 percent, compared against a control group.
Ambrx has used its protein technology to develop and commercialize its own drugs, but it has also landed deals with several large partners, including Merck (NYSE:MRK), which signed on as an Ambrx partner in 2012, and Astellas Pharma, which partnered with the biotech in 2012 in pursuit of new cancer drugs. Ambrx’s relationship with Lilly dates to 2007, when the two companies entered into a licensing and research collaboration to develop a portfolio of Ambrx compounds in animal health.
In 2011, Ambrx and Lilly amended their agreement; Lilly paid Ambrx $8 million and received an exclusive worldwide license to commercialize animal health products from the collaboration. Pegbovigrastim, which has already received approval in 43 countries, including Brazil, New Zealand, Mexico, and the European Union, was the first product to emerge from the partnership. In regulatory documents Ambrx filed in 2014 before it withdrew plans for an initial public offering, the company said its partnership with Lilly includes additional projects addressing metabolic, infectious, and inflammatory diseases in livestock and companion animals.
Under Ambrx’s amended agreement with Lilly, the California biotech is eligible for royalties on pegbovigrastim sales. No U.S. launch date has been set yet for the product, which will be available only by veterinary prescription. Elanco says it will supply pegbovigrastim in pre-filled, single-dose syringes. The drug is administered with two injections, the first about a week before expected calving and the second within 24 hours after giving birth.
Besides becoming the first biological drug approved to treat mastitis, the Elanco drug set another regulatory first. In winning the FDA’s nod, pegbovigrastim also received the regulatory go ahead in Canada—the FDA says it’s the first time that an animal drug was simultaneously reviewed and approved in both countries for a food-producing animal. This review was done under the Regulatory Cooperation Council Initiative, an effort that aims to align the regulatory process for products seeking approval in Canada and the U.S.. While the initiative offers companies the opportunity for simultaneous submissions and collaborative reviews, each country retains the right to make the final approval decision for its market.
Photo courtesy of Flickr user Oregon State University via a Creative Commons license.