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A helping hand in India
HUDDINGE, Sweden—Karo Bio AB has entered into a collaboration and license agreement regarding eprotirome, currently in late-stage clinical testing for dyslipidemia, with Mumbai, India-based Alkem Laboratories Ltd.
Under the agreement, Alkem gains exclusive rights to commercialize eprotirome in India and certain other markets in the Asia-Pacific region and Africa, while Karo Bio is entitled to royalties on Alkem's future sales of eprotirome. In addition, Alkem will participate in Karo Bio's Phase III program for eprotirome by conducting a pivotal clinical study on eprotirome in India, which will include as many as 500 patients with primary hyperlipidemia who possess a high risk for cardiovascular disease, mainly patients with previous cardiovascular events.
Data from the Indian study will be included in Karo Bio's application for marketing approval of eprotirome for the treatment of high-risk patients with heterozygous familial hypercholesterolemia (HeFH) in the European Union. All told, Alkem's relationship with Karo Bio is expected to reduce costs of the Phase III program for HeFH to the Swedish company by around 25 percent.
"The benefits with the collaboration are several. Firstly, it represents a substantial financial value, since our investment in eprotirome's Phase III program will decrease from about SEK 400 million to SEK 300 million as a consequence of Alkem conducting one of the studies," says Fredrik Lindgren, president and CEO of Karo Bio. "Secondly, we secure distribution in the Indian market, as well as in a number of emerging markets. Finally, we facilitate a broadening of the indication scope of eprotirome by conducting the study in India in patients representing a larger patient population. "
For Alkem, currently the seventh-largest pharma in India, this deal represents another step in its mission to be among the top three pharma companies of India in the coming few years, a goal its leader says it will achieve "through organic growth, a sizable portion of which should accrue from international associations and partnerships."
So far, three Phase II trials have indicated that eprotirome can produce a "profound and clinically meaningful" lowering of several important risk factors for the development of cardiovascular disease in patients with high blood lipid levels, both when administered alone and when used as an adjunct to ongoing statin and ezetimibe treatments.
Through the Phase III program focused on high- risk patients with HeFH, Karo Bio expects that successful results could also "facilitate the future development of eprotirome for a broad primary care indication."
Looking even longer-term for the drug's potential for his company, Lindgren notes that Karo Bio expects eprotirome to have "adequate patent protection, at least until 2026."
Karo Bio describes eprotirome as a novel, liver-selective thyroid hormone receptor agonist for the treatment of dyslipidemia, noting that the thyroid hormone is one of the body's ways of regulating lipids in the blood, with that effect exercised in the liver. Eprotirome's profile is unique, the company says, in that with a single compound, powerful reductions of several independent risk factors for the development of atherosclerotic cardiovascular diseases are achieved.
The company describes trial results thus far as "very encouraging, since many patients do not reach their treatment goals with current drugs."
At a seminar held in August, John J.P. Kastelein, a professor of medicine and chairman of the Department of Vascular Medicine at Academic Medical Center in Amsterdam, the Netherlands, provided support for Karo Bio's decision to use HeFH in its strategic approach to developing and ultimately marketing eprotirome, noting that HeFH is the most common hereditary metabolic disorder and should not be regarded as a small indication. In fact, Kastelein said he believes current assumptions about its prevalence to be underestimated.
Patients with HeFH suffer from dyslipidemia at an early age and in his studies of HeFH patients, Kastelein has observed an average age of death at 38 years in male patients who have not started treatment in early adulthood. Kastelein says he sees ample room for drugs that lower LDL cholesterol in HeFH patients—because nearly 80 percent of patients do not reach treatment goals with currently available treatments—and sees eprotirome as an opportunity that can bring new and efficient treatment a step further.
At the same seminar, Steven E. Nissen, a professor of medicine and chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic in Ohio, discussed the regulatory landscape for dyslipidemia drugs and highlighted the clinical need for a new drug for HeFH patients, echoing Kastelein on the point that there are great benefits in bringing down the levels of LDL cholesterol in HeFH patients as early as possible.