Sunday, March 8, 2015

Upstart Incepta Pharma Beats Eleven Others To Market With A Generic Of Sofosbuvir -- Gilead's Brand: Sovaldi®


Well we all knew it was coming. . . .

And we all know that Merck continues its late stage work on similar Hep C next gen treatments, so this bit of market cannibalism is relevant here. Even wealthy Gilead had long anticipated this day, with W.H.O. and Doctors Without Borders pressuring it to treat sofosbuvir as an "essential medicine" in countries of limited means, and compelling licenses that greatly reduce Sovaldi®'s asking price.

To avoid that end, Gilead had signed deals with eleven generic makers, to sell reduced price copies of the drug, by the end of last year -- so called "authorized" generics.

But when a drug generates over $10 billion in worldwide sales (in only its first full year!), you may bet all the world sits up, and takes notice. And so, because Gilead either hasn't yet signed deals in countries like Brazil, Egypt, Thailand, Malaysia and Morocco, and Bangladesh -- or, if these are geographies where the essential compounds of sofosbuvir are not (yet) patented -- a nimble global marketeer could vastly benefit from the new geographies/market opportunities offered from cheap copies of sofosbuvir.

And, as Bloomberg points out today, Incepta Pharma just pulled off exactly that masterstroke. Here's a bit, but do go read it all:

. . . .Nearly a dozen Indian manufacturers are part of Gilead’s licensing pact for low-income countries, including Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd. and Natco. . . . [Editor's (Condor's) Note: However, Incepta is not. It is purely an "at risk" generic company, here.]

“I think everybody is very excited about this product because it offers such a wonderful treatment option,” [Incepta's] Muktadir said. “But the price is going to come down, and the treatment regimen is only for three months. So, I don’t think it’s going to be a big money-earner.”

Sovaldi was Gilead’s top-selling product last year, bringing in $10.3 billion in sales for the Foster City, California-based company.

Incepta’s copy of Sovaldi, called Hopetavir, is aimed more for international markets than Bangladesh, where hepatitis C prevalence is low, though there is no reliable nationwide data, Muktadir said.

Founded in 1999, Incepta has more than 600 products approved for sale in Bangladesh, ranging from oral solid pills to injectable human insulin, according to the company’s website. The company exports products to more than 40 countries, mostly less regulated markets like Mongolia, Kenya, Somalia, Ethiopia, Mauritania, Democratic Republic of Congo and Afghanistan. It also sells to more regulated markets such as Finland, Ukraine and Turkey, according to the site.

Brazil, home to 2.6 million people with hepatitis C, Thailand, with 1.5 million patients, and Morocco, with 625,000 patients, are all nations not included in Gilead’s agreement with the Indian generics companies. . . .


It is hard to overestimate how important this trend -- of making essential medicines affordable to rest of world -- is going to be, to the global pharmaceutical markets. Now, here's to a quiet Sunday evening. . . travel safely, one and all.

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