New TB drug making its way to India and Russia

Otsuka Pharmaceutical ties up with other major drugmakers in key markets

Along the way it has been forming partnerships with other drugmakers, such as Mylan of the U.S., granting it licenses to sell the drug in India and South Africa, and R-Pharm of Russia, licensing it to sell the drug in Russia and the Commonwealth of Independent States. It is also applying to market the drug in Indonesia and China.

According to the World Health Organization, 10.4 million people came down with the infectious disease in 2016. India had the highest number of patients, 2.79 million. Globally, TB is among the 10 leading causes of death, right up there with traffic accidents.

Many of the patients who are dying have multidrug-resistant strains of the disease. The new treatment, Delamanid, is the first anti-TB medicine in almost 40 years. Otsuka Pharmaceutical introduced it in 2014.

Delamanid is an upgrade of Rifampicin, which debuted in the 1960s. It works against drug-resistant TB by blocking the synthesis of mycolic acids, which make up the cell wall of mycobacterium tuberculosis.

While the drug made its way into Japan, South Korea and Europe in 2014 and 2015, there is a greater need for it in developing countries.

One problem in getting Delamanid where it is most needed is that it is expensive. In Japan, one 50mg pill costs 6,125 yen ($54), and patients must take four pills every day for about six months. It must also be prescribed with other medicines.

There are other hurdles, and to get over them Otsuka Pharmaceutical is forming partnerships with other drugmakers and applying for marketing permission on its own.

It granted Mylan the licenses to sell the drug in India and South Africa in August. So far, Mylan has won permission to bring Delamanid into India. Keizo Yamazaki, who heads Otsuka Pharmaceutical's global anti-TB project, said the partnership "will serve as a stepping stone to large nations that have many patients."

The partnership came about after the Indian government requested supplies of the drug, and Otsuka Pharmaceutical concluded that it could more quickly penetrate the market by taking advantage of Mylan's sales channels.

A month ealier, in July, Otsuka Pharmaceutical announced its tie-up with Russia's R-Pharm.

Although the number of TB patients is falling, the number of cases that cannot be treated with conventional therapies is on the rise.

The markets covered by the two partnerships account for 33% of the world's new TB cases every year.

Otsuka Pharmaceutical is also in the process of applying for permission to market the drug in Indonesia and China. In addition, Delamanid has been OK'd in the Philippines. These three countries account for 24% of the world's new TB cases every year.

Half of the 500,000 people who contract drug-resistant TB live in India, Russia and China.

The near-term goal is to nearly quintuple the total number of TB cases treated with Delamanid to 20,000 by 2020.

In Africa, Otsuka Pharmaceutical is taking the public-private route with Delamanid. In 2016, the company started providing the product to Africans via the Global Drug Facility, which allows preapproved drugs to be sold to countries in need.  

"There is enormous demand [in Africa]," Yamasaki said, "but the drug delivery system is limited by the region's conflicts and financial crises."

Like it did in India, the company determined it could move more Delamanid in Africa by cooperating with governments and other companies rather than by selling it on its own.

Otsuka Pharmaceutical began researching new medicines for TB and other diseases in 1971. At the time, the success of Rifampicin was causing pharmaceuticals to end their research into other TB remedies. Otsuka Pharmaceutical, however, continued on the path out of the belief that only one TB drug would be insufficient in preventing the disease from spreading.

Parent Otsuka Holdings' medical-related businesses booked 753 billion yen ($6.59 billion) in consolidated sales in 2016.

Because the company has no blockbuster drug -- defined as a medicine that brings in annual sales of $1 billion, Otsuka Pharmaceutical is pinning its hopes on sales of the group's Rexulti antipsychotic and Lonsurf anti-cancer treatments. Its patents on Abilify, an antipsychotic drug, expired in 2015.

Delamanid is not considered a blockbuster candidate because of the difficult logistical and political situations in many countries where Otsuka would like to market it.

Yet requests for Delamanid shipments continue to come from emerging countries via Japan's Ministry of Foreign Affairs and Ministry of Health, Labor and Welfare, making it important to further expand sales channels and get information to doctors.

Source: Nikkei Asian Review