GSK seeks to expand low-platelet drug Promacta to hepatitis C patients...

Posted on 5/30/12 via MedCityNews.com. GSK seeking to expand drug level to include thrombocytopenia, both pre initiation of therapy for patients with low baseline platelets and  thrombocytopenia as a result of HCV therapy. 

GlaxoSmithKline (NYSE:GSK) wants now wants approval to use its low platelet drug Promacta to treat hepatitis C patients.

GSK has filed regulatory applications in Europe and the United States to add the new indication to the drug. The drug eltrombopag, which is marketed under the brand name Promacta in the United States and Revolade globally, is approved in 88 countires to treat immune thrombocytopenia, a condition in which a patients has low blood counts because the platelets are destroyed by the patient’s own immune system. The condition puts patients at the risk of bleeding. Promacta was co-discovered by GSK predecessor SmithKline Beecham and partner Ligand Pharmaceuticals.

The British pharmaceutical giant, which has its U.S. headquarters in Research Triangle Park, North Carolina, is now seeking to expand approval of the drug to increase platelet counts in patients who have chronic hepatitis C virus infection. The drug would allow them to start interferon-based therapy and could also be used to optimize interferon-based therapy, according to to GSK’s supplemental new drug application.

GSK last year completed a phase 3 study of Promacta in hepatitis C patients whose low platelet levels make them unable to start interferon therapy to treat the virus. The trial met the primary endpoint of improving the sustained virological response.

Promacta does come with some safety risks. Until late last year, the U.S. Food and Drug Administration required doctors and patients to follow a strict regimen in order to watch for adverse effects including liver damage, blood clots and bleeding risks after discontinuing the drug. But the FDA eased those requirements concluding that it was unlikely the safety data collected could determine whether adverse effects were caused by the drug or by the immune thrombocytopenia. While mandatory collection of safety data is no longer required, the agency continues to ask that any adverse events be reported.

Seeking Alpha - Achillion Will Soar Higher On New Hepatitis C Drug In 2013

Posted on 4/16/2012 on Seeking Alpha.com. I'm trying to figure this guy out. He makes some valid points on Achillion's PI ACH-1625, but says nothing about their NS5A inhibitors. Then he mentions GSK's Promacta (Eltrombobag) as a 'competitor' and a 'Hepatitis C drug', which doesn't do much for this particular person's street cred. Anyway, I like to root for Achillion and I like it when people say nice things about the company, so I'm including it here for your reading pleasure. 

Achillion Will Soar Higher On New Hepatitis C Drug In 2013

By Vatalyst - Seeking Alpha.com

April 12, 2012

Achillion Pharmaceuticals (ACHN) has risen 51% since last year, which is a surprising number for a development stage pharmaceutical industry with no FDA approved drugs on the market. The news has been hyping up Achillion's hepatitis C drug ACH-1625, which is only just now ending Phase 2 clinical trials. Along with ACH-1625, are four other hepatitis C drugs and one bacterial infection antibiotic, ACH-702. The hepatitis C drug pipeline is composed of some very unique drugs and mechanisms for treating hepatitis C.

Should these drugs gain FDA approval, there would be a major upside for the company to sell ACH-1625 state side and worldwide to nearly corner the market. However, ACH-1625 is only just finishing Phase 2 and releasing results. I always highly advise against investing in any company with promising drugs that have not been FDA approved.

The first reason is that Achillion is getting great news hype about ACH-1625, which is causing the stock price to increase very well. But, Achillion is now starting Phase 3 clinical trials and will not have any more news reports that would cause a stock rise in the next year. The second reason is that more often than not, drugs fail to gain FDA approval for hundreds of different reasons, including toxicity, efficacy, and potency. It is never safe to bet on a drug before it is FDA approved so do not invest until there are conclusive and positive phase 3 trial results released.

Finally, due to the fact that ACH-1625 is starting phase 3 trials in the beginning of 2012, we cannot expect to see the drug on the market until at least late 2013 or early 2014.

Phase 3 trials can take a year or longer, plus new drug application for the FDA takes a substantial amount of time. Therefore, I do not expect stock price to do much of anything until late 2013 at the earliest. If you are a long-term investor and already own stock with Achillion, sit tight until late 2013 when share price will see a major upside if the clinical results are positive. If you are short term, keep a close eye on the company until late 2013 and if the phase 3 results are positive then it is time to invest.

Achillion has a market cap of $773 million and a 52 week range of $4-$13. Achillion has a competitor in the hepatitis C drug Promacta by GlaxoSmithKline (GSK), which has a market capitalization of $223 billion, a 52-week range of $39-$47 and a price to earnings ratio of 27.45. Achillion's next competitor is a hepatitis C drug, TMC435, by Johnson & Johnson (JNJ) with a 52 week range of $59-$68, a price to earnings ratio of 18.74 and a market cap of $179 billion. The last competitor of Achillion are three hepatitis C drugs by Roche Holding AG (RHHBY.PK) with a price to earnings ratio of 14.3, a market cap of $145 billion and a 52-week range of $42-$43. For a company that has no FDA approved products on the market, Achillion seems to be in pretty good standing with its competitors.

Johnson & Johnson is set to be Achillion's biggest competitor. It currently has a hepatitis C drug, TMC435, entering Phase 3 trials. The results of the Phase 2 trials showed that the drug was effective, safe, and 83% of patients were able to discontinue treatment with TMC435 after 24 weeks. With the release of this positive clinical trial news, Johnson & Johnson is receiving equal amounts of positive hype over this hepatitis C drug as Achillion. It is possibly receiving even more hype when considering the other drugs currently in Phase 3 of the Johnson & Johnson pipeline. Share has stayed relatively the same over the past year with a nearly 10% increase. I feel that right now Achillion and Johnson & Johnson are going to mirror one another until the Phase 3 data is released. I recommend keeping an eye on both companies until then; once the data is released we will know which company has the better drug and which is worth investing in.

Roche Holding AG is currently developing three hepatitis C drugs in its pipeline. These drugs are all in Phase 2 testing and will not be ready for the market until late 2014 at the very earliest, most likely by 2016. This is assuming that the drugs even pass FDA regulation in the coming years. I see no real competition from Roche Holding AG in the next few years to hurt share price of Achillion, but Roche Holding AG would be a good company to keep an eye on and possibly invest in if ACH-1625 ends up failing FDA approval.

GlaxoSmithKline has developed an FDA approved drug, Promacta, used for the treatment of hepatitis C in compound with other treatments. I feel that this drug wont provide much competition for ACH-1625 should it become FDA approved. Promacta's main function is to increase blood platelet count in patients with hepatitis C while other drugs attack the hepatitis virus, whereas ACH-1625 directly treats hepatitis C with no need for compounding with other drugs. I feel that ACH-1625 would out-compete Promacta relatively easily and no reason to be wary of GlaxoSmithKline.

To sum up Achillion's stance on the market, it is too soon to be investing in ACH-1625. There is no current upside to raise share price substantially for at least the next year while the trials carry on. Considering Johnson & Johnson's position currently mirrors that of Achillion, it would be smart to let the research data of both company's respective drugs decide which is going to be the best bet in 2013. Lastly, I believe ACH-1625 will beat out GlaxoSmithKline's Promacta if it becomes FDA approved, so expect little competition on the market from GlaxoSmithKline.

UBS analysts see bright future in GSK's Promacta for HCV treatment-associated thrombocytopenia...

Article from Bloomberg.com. UBS analysts see potential 'blockbuster' status from GSK's Eltrombopag in the treatment of HCV treatment-associated thrombocytopenia.

Glaxo’s Promacta May Turn Into Blockbuster Medicine, UBS Says

By Makiko Kitamura

Nov. 7 (Bloomberg) -- GlaxoSmithKline Plc’s Promacta blood disorder medicine may generate as much as $2 billion in annual sales if the U.K.’s largest drugmaker can expand its use to the treatment of a condition associated with hepatitis C, according to UBS AG.

The medicine, already approved for sale in the U.S. to raise platelet counts in patients with a rare blood disorder, is being studied to extend use to patients with thrombocytopenia, a blood complication stemming from hepatitis C treatments. Glaxo will present results from the last of three stages of clinical testing required for regulatory approval on the new use at a medical meeting in San Francisco today.

As many as 170 million people worldwide are chronically infected with the hepatitis C virus, which can lead to cirrhosis of the liver and liver cancer, according to the World Health Organization. Glaxo’s Promacta would enable hepatitis C patients to be treated with antiviral medicines for longer periods of time, turning the drug into a “potential blockbuster,” said Gbola Amusa, a health-care analyst at UBS in London.

“Depending on how positive the data are, this could generate an additional $2 billion in annual sales,” Amusa said. Promacta had sales of 51 million pounds ($82 million) through the end of September, compared with 31 million pounds in 2010.

The study results are slated to be presented at the American Association for the Study of Liver Diseases’ annual Liver Meeting at 3:15 p.m. San Francisco time.

Sales Estimate

If the data are positive, an approval by regulators may come as early as the end of next year, Amusa said. The sales estimate assumes that antiviral medicines including interferon will continue to dominate hepatitis C treatments, Amusa said. Abbott Laboratories last month presented interim study results for a new alternative therapy that does not use interferon.

“Undoubtedly, this would be a big potential opportunity for the drug if it demonstrates strong results,” said Gustav Ando, a health-care analyst at consulting company IHS Global Insight in London. “We remain somewhat cautious until we see some of the side-effects data.”

Any potential damage to the liver in terms of toxicity along with blood clotting are of concern, Amusa and Ando said.

Glaxo said on Oct. 26 it plans to file as many as 10 drugs for approval next year. The compounds in late-stage development include Relovair, which Glaxo is developing as a successor to the Advair asthma inhaler. Advair, Glaxo’s best-selling product, generated 19 percent of total revenue in the first half of the year.

Three Glaxo products have been cleared for sale this year, including Benlysta, a therapy for the auto-immune disease lupus that was approved by U.S. regulators in March. The company’s global sales in the quarter ended Sept. 30 rose 4.3 percent to 7.1 billion pounds from a year earlier.

--Editors: Bruce Rule, Kristen Hallam

To contact the reporter responsible for this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net