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Hepitatis quest moves from c to b.

http://www.bloomberg.com/news/articles/2015-02-04/hepatitis-quest-moves-from-c-to-b-under-former-gilead-executives
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Avatar universal
That's huge news. Thanks for sharing! For those that can't read the link:

(Bloomberg) -- Gilead Sciences Inc. raked in $10 billion last year with its Sovaldi pill for hepatitis C. Many of the people responsible for the drug are now competing to repeat that success for a more common liver disease: hepatitis B.

At OnCore Biopharma, the team seeking a cure is an honor roll of Sovaldi graduates. The drug’s principal inventor, Michael Sofia, founded OnCore with a sales executive from Pharmasset Inc., where Sovaldi originated. At ContraVir Pharmaceuticals Inc. and Chimerix Inc., the leadership ranks are similarly peppered with Gilead and Pharmasset alumni.

“We’re gunning for a cure,” Sofia said in an interview. “With Sovaldi, we clearly brought innovation with the drug’s discovery and getting it to market. We feel we can translate that experience to hep B.”



Biotechnology companies are captivated by liver disease because of the size of the market. About 240 million people suffer from a chronic hepatitis B liver infection, more than the hepatitis C population. At least 780,000 people die from the malady every year, according to the World Health Organization.

ContraVir, based in New York, is led by James Sapirstein, who helped build Gilead’s antiviral portfolio. At hepatitis partner Chimerix in Durham, North Carolina, Chief Executive Officer Michelle Berrey was chief medical officer of Pharmasset, bought by Gilead for $10.6 billion in 2012.

‘Next Frontier’

“This is absolutely the next frontier,” Sapirstein said, explaining the flight of talent to the startups. “I have access to some of the best Pharmasset scientists who put Sovaldi on the map. The sky’s the limit for us.”

Both forms of the disease are transmitted by bodily fluids, though hepatitis B is more complicated in terms of its ability to hide from the immune system. There are therapies, but no cure.

OnCore and ContraVir aren’t alone in the chase. Alnylam Pharmaceuticals Inc. and Arrowhead Research Corp. are working on hepatitis B, and their biggest rival -- Gilead -- is in pursuit.

“These players think the market is gigantic,” worth billions of dollars, Michael Yee, an analyst at RBC Capital Markets, said in a note after Alnylam won a patent last year.

Both forms of hepatitis are prevalent in developed and emerging markets, so the winner of the race faces a lucrative payoff. Gilead originally priced Sovaldi at $84,000 in the U.S. for a 12-week course. China presents a huge untapped opportunity for hep B, Sofia said.

Investors are eager. When Tekmira Pharmaceuticals Corp. of Canada agreed last month to buy OnCore, its shares surged 57 percent. ContraVir intends to list on the Nasdaq Stock Market this month, where Chimerix shares more than doubled last year.

Track Record

Leerink Partners raised its recommendation on Tekmira’s stock after the OnCore purchase, citing the track record of Bill Symonds, the OnCore senior adviser who was responsible for running tests that sealed Sovaldi’s success.

OnCore has begun testing a medicine dubbed TKM-HBV, while ContraVir is banking on a more potent yet less toxic variant of Viread, a Gilead drug used for hepatitis B and HIV. Viread can cause kidney damage and bone loss.

An early study of ContraVir’s medicine demonstrated safety and tolerability, which sets it apart from competitors, Sapirstein said. The company announced today that the U.S. has extended intellectual property protection on the drug, licensed from Chimerix, to at least 2031, from 2020.

Gilead may be first to market with a new hepatitis B drug, but the ContraVir/Chimerix medicine will be competitive on safety and pricing, Sapirstein said. OnCore’s candidate is aimed at curing the disease, something that may not be achieved by some rivals, according to Sofia.

Testing Race

Gilead is farthest along in testing, with Arrowhead and ContraVir/Chimerix close behind. OnCore’s drug is in the earliest phase of study, and Alnylam is preparing for the first stage.

Arrowhead’s drug, which aims to reduce viral proteins that suppress the immune system, had a setback last month when the U.S. Food and Drug Administration asked that a trial be conducted at a lower dosage. The shares plunged 24 percent.

The medicine “has the potential to enable a functional cure,” the Pasadena, California-based company said in an e-mail. “We have a sizable lead over competitors in terms of time.”

‘Best’ Quest

Alnylam expects that its RNA-based drug may become “best in class,” CEO John Maraganore said. It will seek approval for clinical trials “around year-end 2015.”

ContraVir may seek fast-track FDA approval to start late-stage trials this year, as its candidate is a variant of an approved drug.

The company recently enlisted another former Gilead scientist. Carol Brosgart, appointed to the ContraVir advisory board on Jan. 20, was on the team that developed Viread for Gilead.

If the upstarts are to win, they have to beat their former employer. Gilead has finished enrolling patients for a late-stage trial of a hepatitis B candidate, a spokeswoman said, declining to comment about competition from former employees.

“Gilead has a great track record” in recruiting talent and getting a drug to market, with the purchase of Pharmasset and Sovaldi’s development prime examples, Sapirstein said.

But with hep B, the challengers have a good shot, he said. “Half the team at Pharmasset went to OnCore, the other half went to Chimerix. And now we’ve got that team on our side.”
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Avatar universal
Yes it is, you are very welcome Lucky!
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Avatar universal
I can't believe! I can't wait! Go go go go America, we are waiting for CURE
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best news in the year?!
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I've only got a few concerns on this:

1.) What will it cost us? Let's hope it's not overpriced
2.) Where is their target? Just China? America? Worldwide? I hope worldwide for all sufferers!
3.) How long will it take? They were very quick on the C drug, will they be as quick on this?
4.) Will it be limited to certain type of Genotypes, etc.?
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Avatar universal
Be sure to be covered from insurances, Sure they will be very quick, first hand on business counts, they are talking for billions, money talks
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Avatar universal
Harvoni cure for Hep C. $1350 per a pill. 12 weeks or ppl with cirrhosis 24 weeks. 1350 X 12 weeks =113.400.00. i think when my insurance cover 80% that is still killing us. i believe it is goin to the same price as Harvoni.
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but i dont what is my insurance will be cover.
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Yes in did, my concern is how long 'll it takes to come to the market.
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Probably it will take 7 years
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7 years? This is a long time.
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Avatar universal
Yeah unfortunately this is how FDA works. From clinical trial to approval
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if 7 years later we really got a cure , that is not too bad?
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Yeah but you have to also think how many ppl will die in these 7 years from hbv arround the world
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If they find the cure eventually, they can request a fast track to approve their drugs.
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I think the cure will hapen when the antiviral patent expire which i think in 2018 then in 2020 they might introduce something
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Avatar universal
Mike, I think the anti-viral patent expires at the end of 2017 (into 2018). However, keep in mind that they are testing a new formula (I'm on the trial for it) so once it expires, it may be renewed immediately with the new formula...
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Mike911 hope not, while there is a cure it is  so weird to wait till the current antivirals expire. I am very optimistic with PS though!
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I really think cure on its way but not before 2020 just to make enough room for the approved antivirals to make their money. I could be wrong as it is my personal opinion
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2020-2030, very optimistic.Even though there is not a vaccine for hep c, how it come they already have cure for Hep C. They are not waiting long for hep b, because all the 2 last generations are already vaccinated, so no more new patients. This is logical. America is eager to be in first line of discovering new drugs, before Germany or Russia or France will show up. The third reason will be an orphan drug, so FDA will have access to approve it faster than other many drugs as are cardiovascular or diabetic drugs. We already have sequential cure that is a slow cure, what we are looking is a fast cure.
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Avatar universal
Mer971 it is very hard to say we have a sequential therapy cure since it really achieves rare. Let's hope for the fast cure only.
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