HUDDINGE, Sweden—Karo Bio AB has entered into acollaboration and license agreement regarding eprotirome, currently inlate-stage clinical testing for dyslipidemia, with Mumbai, India-based AlkemLaboratories Ltd.
Under the agreement, Alkem gains exclusive rights tocommercialize eprotirome in India and certain other markets in the Asia-Pacificregion and Africa, while Karo Bio is entitled to royalties on Alkem's futuresales of eprotirome. In addition, Alkem will participate in Karo Bio's PhaseIII program for eprotirome by conducting a pivotal clinical study on eprotiromein India, which will include as many as 500 patients with primaryhyperlipidemia who possess a high risk for cardiovascular disease, mainlypatients with previous cardiovascular events.
Data from the Indian study will be included in Karo Bio'sapplication for marketing approval of eprotirome for the treatment of high-riskpatients with heterozygous familial hypercholesterolemia (HeFH) in the EuropeanUnion. All told, Alkem's relationship with Karo Bio is expected to reduce costsof 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 ineprotirome's Phase III program will decrease from about SEK 400 million to SEK300 million as a consequence of Alkem conducting one of the studies," saysFredrik Lindgren, president and CEO of Karo Bio. "Secondly, we securedistribution in the Indian market, as well as in a number of emerging markets.Finally, we facilitate a broadening of the indication scope of eprotirome byconducting the study in India in patients representing a larger patientpopulation."
For Alkem, currently the seventh-largest pharma in India,this deal represents another step in its mission to be among the top threepharma companies of India in the coming few years, a goal its leader says itwill achieve "through organic growth, a sizable portion of which should accruefrom international associations and partnerships."
So far, three Phase II trials have indicated that eprotiromecan produce a "profound and clinically meaningful" lowering of severalimportant risk factors for the development of cardiovascular disease inpatients with high blood lipid levels, both when administered alone and whenused as an adjunct to ongoing statin and ezetimibe treatments.
Through the Phase III program focused on high-risk patientswith HeFH, Karo Bio expects that successful results could also "facilitate thefuture development of eprotirome for a broad primary care indication."
Looking even longer-term for the drug's potential for hiscompany, Lindgren notes that Karo Bio expects eprotirome to have "adequatepatent protection, at least until 2026."
Karo Bio describes eprotirome as a novel, liver-selectivethyroid hormone receptor agonist for the treatment of dyslipidemia, noting thatthe thyroid hormone is one of the body's ways of regulating lipids in theblood, with that effect exercised in the liver. Eprotirome's profile is unique,the company says, in that with a single compound, powerful reductions ofseveral independent risk factors for the development of atheroscleroticcardiovascular diseases are achieved.
The company describes trial results thus far as "veryencouraging, since many patients do not reach their treatment goals withcurrent drugs."
At a seminar held in August, John J.P. Kastelein, aprofessor of medicine and chairman of the Department of Vascular Medicine atAcademic Medical Center in Amsterdam, the Netherlands, provided support forKaro Bio's decision to use HeFH in its strategic approach to developing andultimately marketing eprotirome, noting that HeFH is the most common hereditarymetabolic disorder and should not be regarded as a small indication. In fact,Kastelein said he believes current assumptions about its prevalence to beunderestimated.
Patients with HeFH suffer from dyslipidemia at an early ageand in his studies of HeFH patients, Kastelein has observed an average age ofdeath at 38 years in male patients who have not started treatment in earlyadulthood. Kastelein says he sees ample room for drugs that lower LDLcholesterol in HeFH patients—because nearly 80 percent of patients do not reachtreatment goals with currently available treatments—and sees eprotirome as anopportunity that can bring new and efficient treatment a step further.
At the same seminar, Steven E. Nissen, a professor ofmedicine and chairman of the Department of Cardiovascular Medicine at theCleveland Clinic in Ohio, discussed the regulatory landscape for dyslipidemiadrugs and highlighted the clinical need for a new drug for HeFH patients,echoing Kastelein on the point that there are great benefits in bringing downthe levels of LDL cholesterol in HeFH patients as early as possible.