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News Breaks
March 18, 2014
17:16 EDTHPTX, PRXHyperion says Par filed ANDA with FDA for generic version of RAVICTI
In a filing, the company said, "On March 10, Hyperion Therapeutics (HPTX) disclosed that it had become aware that the FDA on March 6, posted on its website that FDA’s Office of Generic Drugs had received an Abbreviated New Drug Application, ANDA, containing a Paragraph IV patent certification with respect to RAVICTI, glycerol phenylbutyrate, oral liquid on November 19, but that the company had not received notification of the Paragraph IV certification with respect to this filing. On March 17, the company received notification of the Paragraph IV certification from Par Pharmaceutical (PRX) advising the company that it had filed an ANDA with the FDA for a generic version of 1.1 gm/ml RAVICTI oral liquid. The Paragraph IV certification alleges that the company’s U.S. Patent No. 8,404,215, titled “Methods of therapeutic monitoring of nitrogen scavenging drugs,” which expires in March 2032, and U.S. Patent No. 8,642,012, titled “Methods of treatment using ammonia scavenging drugs,” which expires in September 2030, are invalid and/or will not be infringed by Par’s manufacture, use or sale of the product for which the ANDA was submitted. Par did not challenge the validity, enforceablility, or infringement of the company’s U.S. Patent No. 5,968,979, titled “Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders,” which expires in February 2015. The company intends to vigorously enforce its intellectual property rights relating to RAVICTI. As noted in the Initial Form 8-K, the Paragraph IV certification does not challenge or affect RAVICTI’s orphan drug exclusivity, which extends to February 2020."
News For HPTX;PRX From The Last 14 Days
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March 31, 2015
12:42 EDTHPTXAnalysts bullish on Horizon after Hyperion acquisition
A number of analysts were upbeat on the outlook for drugmaker Horizon Pharma (HZNP) after the company yesterday announced that it had agreed to acquire fellow drugmaker Hyperion Therapeutics (HPTX). WHAT'S NEW: Piper Jaffray analyst David Amsellem upgraded Horizon to Overweight from Neutral, saying that the acquisition of Hyperion is positive because it diversifies Horizon's products. The deal should increase Hyperion's price to earnings ratio because it expands the company's offerings beyond assets focused on primary care, while providing the company with a very well-positioned product, Ravicti, Amsellem explained. An ultra-orphan drug used to treat urea cycle disorders, Ravicti is a game changer, as only half of the patients with the disease have been diagnosed, the analyst stated. Moreover, it is far more "patent-friendly" than its competitor, Buphenyl, Amsellem reported. Over half of Buphenyl's patients have converted to Horizon's Ravicti and the latter drug has significant room for growth, according to the analyst, who set a $31 price target on Horizon. Also upbeat on Horizon after the deal was JMP Securities analyst Oren Livnat. The deal is positive because it strengthens Hyperion's orphan drug business, wrote Livnat, who increased his price target on the name to $31 from $25. Additionally, the transaction is likely to increase Horizon's earnings per share by 40c, in-line with the company's guidance, the analyst predicted. Although Horizon may ultimately have to pay a higher price for Hyperion, Horizon could pay slightly more and still obtain value from the deal, the analyst stated. He kept an Outperform rating on the stock. PRICE ACTION: In early afternoon trading, Horizon was little changed at $25.75 and Hyperion lost 0.5% to $45.80.
10:01 EDTHPTXOn The Fly: Analyst Downgrade Summary
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07:47 EDTHPTXHorizon Pharma cost savings view seems conservative, says Brean Capital
Brean Capital believes Horizon Pharma's (HPZN) guidance on annualized cost savings from its deal with Hyperion Therapeutics (HPTX) is conservative. The firm noted Horizon executes well on M&A, as it paid a reasonable price for Hyperion. Brean Capital reiterated its Buy rating and raised its price target to $33 from $27 on Horizon Pharma shares.
07:44 EDTHPTXHorizon Pharma price target raised to $31 from $25 at JMP Securities
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07:32 EDTHPTXHorizon Pharma estimates need to come up, says UBS
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07:27 EDTHPTXHyperion Therapeutics downgraded to Hold from Buy at Needham
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06:34 EDTHPTXHyperion Therapeutics downgraded to Hold from Buy at Cantor
Cantor Fitzgerald downgraded Hyperion Therapeutics (HPTZ) to Hold citing the takeover by Horizon Pharma (HZNP) as it does not expect a competing bidder to emerge. Cantor raised its price target for shares to $46 from $35.
05:52 EDTHPTXHorizon Pharma upgraded to Overweight from Neutral at Piper Jaffray
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March 30, 2015
16:22 EDTHPTXOn The Fly: Closing Wrap
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13:48 EDTHPTXHyperion Therapeutics downgraded to Neutral from Buy at Roth Capital
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12:47 EDTHPTXHyperion Therapeutics downgraded to Neutral from Outperform at Wedbush
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12:22 EDTHPTXOn The Fly: Midday Wrap
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11:49 EDTHPTXStreet Check: Hyperion bought after Brean noted takeout potential last month
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11:02 EDTHPTXHyperion Therapeutics downgraded to Hold from Buy at Brean Capital
Brean Capital downgraded Hyperion Therapeutics (HPTX) citing the takeover by Horizon Pharma (HZNP). Brean views the buyout price as "reasonable and fair."
07:02 EDTHPTXHorizon Pharma to host conference call
Conference call to discuss the acquisition of Hyperion Therapeutics (HPTX) will be held on March 30 at 8 am. Webcast Link
06:04 EDTHPTXHorizon Pharma to acquire Hyperion Therapeutics for $46.00 per share
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06:01 EDTHPTXHorizon Pharma to acquire Hyperion Therapeutics for $46.00 per share
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March 26, 2015
08:43 EDTHPTXHyperion Therapeutics management to meet with Needham
Meetings to be held in Detroit/Chicago on March 31 and in Chicago on April 1 hosted by Needham.
March 25, 2015
11:01 EDTHPTXHyperion Therapeutics price target raised to $51 from $40 at Brean Capital
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March 23, 2015
11:16 EDTHPTXHyperion Therapeutics price target raised to $52 from $36 at Wedbush
Wedbush raised Hyperion's price target to $52 ahead of the hepatic encephalopathy Phase III trial of Ravicti and the likelihood of success. Shares are Outperform rated.

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