Xifaxan Legal Development

Valeant Pharmaceuticals (VRX) PT Raised to $22 at Deutsche Bank on Xifaxan Legal Development

Deutsche Bank raised its price target on Valeant Pharmaceuticals (NYSE: VRX) to $22.00 (from $20.00) while maintaining a Buy rating.

Analyst Gregg Gilbert commented, “Xifaxan is VRX’s largest product (~13% of revenue) and an important growth driver. In the Xifaxan patent case vs. TEVA, the stay in litigation was recently extended from 4/30/18 to 7/30/18 (and may be further extended). Recall that the companies agreed to stay the patent case last year after FDA revised its draft bioequivalence guidance for Xifaxan generics in order for TEVA to evaluate the implications of the revised guidance. According to the court docket, the companies agreed to extend the stay “because the facts and circumstances that warranted a stay as of May 15, 2017 have not materially changed.” We previously modeled Xifaxan exclusivity through 2024, which represented a middle case scenario with generic competition ahead of patent expiry (the patents extend to 2030). Given that TEVA does not yet appear to have clarity on the path forward for its generic filing, we are now factoring in an additional year of exclusivity, which takes our PT to $22 (from $20). In our view, this could represent a decent “settlement” scenario if TEVA is able to resolve the issues with its filing. We look forward to an update from TEVA when the company reports 1Q18 results on 5/3. We continue to like the risk/reward for the stock, and are maintaining our Buy rating.”

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Copying Valeant’s Xifaxan

Copying Valeant’s Xifaxan just got ‘a lot easier,’ thanks to new FDA guidance: analyst

Valeant already has enough Xifaxan problems without more competition for its leading med. But thanks to the FDA, that competition may be on its way sooner than the embattled drugmaker would like.

On Friday, U.S. regulators posted new guidance on what’s needed for generics makers to show bioequivalence to the IBS-D fighter, and that guidance will make it “much easier” for them to do so, Wells Fargo analyst David Maris wrote in a note to clients. The agency will no longer look for a bioequivalence study with clinical endpoints in order to establish bioequivalence, making the copycat process much less risky and expensive.

“We believe this will open the door to a greater number of generic applicants, as the cost and risk of doing these BE studies is much lower than placebo controlled clinical trials,” Maris wrote, noting that he thinks the likelihood of generics entering in 2023 or earlier “has just increased dramatically.”

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The guidance follows a citizen petition from Valeant’s Salix, which last year asked the FDA not to approve generic applications that didn’t include, among other things, evidence that wannabe copycats’ active ingredients had the same polymorph profile as Xifaxan’s.

Valeant, though, “believes the new guidance is actually a positive,” Maris wrote in a separate note. As the Canadian company told him, the new guidance had “raised the bar” for knockoffs, and the way Valeant sees it, it “may delay generics which may not have conducted their studies to be compliant with the new guidance.”

Meanwhile, early generics competition is the last thing Valeant needs as it struggles to lift its lagging GI portfolio. Sales of Xifaxan and its fellow GI products aren’t where analysts expected them to be, a trend that prompted the company to roll out beefed-up marketing plans after a sale of the unit to Japan’s Takeda fell through. But according to Maris, more than 50 reps recently jumped ship, adding to Valeant’s well-documented turnover problems.

It hasn’t been all smooth sailing for Xifaxan’s lead competitor in the IBS-D space though, either. Last week, the FDA warned that the med’s nemesis, Allergan’s Viberzi, could cause pancreatitis deaths in patients without gallbladders.

FDA Accepts Generic Xifaxan

FDA Accepts Allergan’s ANDA for Generic Xifaxan

Allergan plc has received an acceptable for filing letter from the US Food and Drug Administration (FDA) for its abbreviated new Drug application (ANDA) seeking approval to market Rifaximin tablets, 550 mg, a generc version of Valeant Pharmaceuticals’ Xifaxan (rifaximin) 550 mg, which is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults and the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.

Based on available information, Allergan believes it is the first applicant”to file an ANDA for the generic version of Xifaxan 550 mg and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the 12 months ending December 31, 2015, Xifaxan 550 mg had total US sales of approximately $975 million, according to IMS Health data, and as reported by Allergan.

In company statement, Valeant says it has 22 Orange Book-listed patents covering Xifaxan 550 mg tablets that are scheduled to expire between August 2019 and October 2029. “Valeant is highly confident in its intellectual property rights relating to Xifaxan 550 mg tablets and intends to vigorously enforce such rights in all applicable venues,” said the company in the statement.

Source: Allergan

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What is Rifaximin

What is Rifaximin?

Rifaximin is a semisynthetic antibiotic based on rifamycin. It has poor oral bioavailability, meaning that very little of the drug will be absorbed into the blood stream when it is taken orally. Rifaximin is used in the treatment of traveler’s diarrhea and hepatic encephalopathy, for which it received orphan drug status from the U.S. Food and Drug Administration in 1998.
Mechanism of action?
Rifaximin interferes with transcription by binding to the β-subunit of bacterial RNA polymerase. This results in the blockage of the translocation step that normally follows the formation of the first phosphodiester bond, which occurs in the transcription process.

Why is this medication prescribed?

Generic Rifaximin 200mg / 400mg tablets are used to treat traveler’s diarrhea caused by certain bacteria in adults and children at least 12 years of age. Rifaximin 550mg tablets are used to prevent episodes of hepatic encephalopathy (changes in thinking, behavior, and personality caused by a build-up of toxins in the brain in people who have liver disease) in people at least 18 years of age who have liver disease. Rifaximin is in a class of medications called antibiotics. Rifaximin treats traveler’s diarrhea by stopping the growth of the bacteria that cause diarrhea. Rifaximin treats hepatic encephalopathy by stopping the growth of bacteria that produce toxins and that may worsen liver disease. Rifaximin will not work to treat diarrhea that is bloody or occurs with fever.

How should this medicine be used?

Rifaximin comes as a tablet to take by mouth with or without food. When rifaximin is used to treat traveler’s diarrhea, it is usually taken three times a day for 3 days. When rifaximin is used to prevent episodes of hepatic encephalopathy, it is usually taken twice a day. To help you remember to take rifaximin, take it around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rifaximin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking rifaximin to treat traveler’s diarrhea, your symptoms should improve within 24 to 48 hours after you start taking the medication. If your symptoms do not go away or they get worse, or if you develop a fever or bloody diarrhea, call your doctor.

Take rifaximin until you finish the prescription, even if you feel better. If you stop taking rifaximin to treat traveler’s diarrhea too soon, your infection may not be completely cured and the bacteria may become resistant to antibiotics. If you stop taking rifaximin to prevent hepatic encephalopathy, you may experience symptoms of encephalopathy.

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