Hard to believe it's just this. Not sure why the FDA gave the NDA priority, given there's already drugs for this out there and the SHPG drug did not have great results in the latest trial.
@@@@Shire (NASDAQ:SHPG) stock popped nearly 3% Thursday after the specialty drugmaker said the FDA had granted priority review to its dry-eye treatment lifitegrast. Shire said the FDA had set a deadline of Oct. 25 to make a decision on the product, which apparently was sooner than many investors had expected. The phase-three trials for the drug produced mixed results, which some analysts doubted would be sufficient for approval. In December, Leerink analyst Jason Gerberry modeled a 2017 launch for lifitegrast, saying that "first-pass approval looks challenging." Dry-eye disease is a fairly common disorder typically treated with Restasis, a product sold by Allergan before it was acquired last month by Actavis (NYSE:ACT). Restasis is a topical form of the old immunosuppressant drug cyclosporin, while lifitegrast is a new product developed by SARcode, which Shire acquired in 2013.
What makes you think he even has one? My understanding is this is a strategy he has adopted after the USPTO recently provided patent fighters the option of using an IPR (Inter Partes Review) procedure.
FDA approved an NDA and priority review on an SHPG dry eye disease drug.
@@@@@LEXINGTON, Massachusetts, April 9, 2015 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, 2015, based on the Prescription Drug User Fee Act V action date. The FDA grants Priority Review designation to drugs that have the potential to provide significant improvements in the safety or effectiveness for the treatment, diagnosis or prevention of a serious disease. Drugs with Priority Review designation have an accelerated review target of eight months, instead of the standard of 12 months
Will this turn out to be another fishing tale about a nice one that got away or will the fisherman come home with a nice catch?
@@@@April 08--The stock of San Rafael-based BioMarin Pharmaceutical Inc. spiked at the end of March following a report that Shire PLC, a biopharmaceutical company based in Ireland, is seeking to acquire it. Ben Harrington, a former mergers and acquisition editor at the Daily Telegraph who now writes for the blog Betaville, broke the news on March 26. Harrington wrote, "top sources (and I mean top)" had told him that "Shire has set its sights on combining with BioMarin." Harrington wrote that Shire had recently approached BioMarin about a deal "although it's not clear whether things have progressed further." In his post, Harrington also said that BioMarin had also engaged financial advisers "to defend the company from a larger predator." Harrington added that 18 months ago Swiss pharmaceutical giant Roche "took a good look at BioMarin." Founded in Novato in 1997, BioMarin specializes in the development and production of "orphan drugs," or medications that treat rare diseases. In January 2012, BioMarin moved its headquarters to downtown San Rafael and in 2013 it purchased the San Rafael Corporate Center for $116.5 million. It is currently building a three-story, 85,000-square-foot research and development facility at 791 Lincoln Ave. and a parking garage with 649 spaces at 788 Lincoln Ave.The company has five treatments currently on the market and many more in the pipeline. And in November, BioMarin purchased the Dutch biotech company Prosensa Holding N.V., which may give it the first approved treatment for Duchenne muscular dystrophy, a form of muscular dystrophy that worsens quickly.
Looks like he is going all out. He is attacking JAZZ now too. I despise the dirty games these hedge funds play. I hope this backfires on him real bad.
@@@@Hedge-Fund Manager Challenges Jazz Pharmaceuticals Patent 04/07/2015 | 11:16am US/Eastern Hedge-fund manager Kyle Bass filed a patent challenge late Monday against Jazz Pharmaceuticals PLC and its narcolepsy drug Xyrem. The challenge was the latest salvo in Mr. Bass's new battle against pharmaceutical companies that he believes host spurious patents to keep drug prices artificially high. The challenge was filed in the name of the Coalition for Affordable Drugs, an organization partly controlled by Mr. Bass. Xyrem had sales of $778.58 million last year, which represented 66.4% of the company's total revenues. Last week, Mr. Bass filed challenges against patents for two Shire drugs--the Lialda medicine for ulcerative colitis and the Gattex treatment for short bowel syndrome. Earlier, he challenged a patent that Acorda Therapeutics holds on its multiple sclerosis drug Ampyra. Acorda shares dropped dramatically after the challenges were filed. Mr. Bass's more than $2 billion Hayman Capital Management L.P. stands to profit if the patents are invalidated, as the firm has placed trades to bet on and against shares of companies involved in the disputes, people familiar with the firm said.
I disagree. He is yours and my new best friend. We are going to ride this pop up to the high 240s. Sell. Wait for the next round of Hayman #$%$. Buy on they corresponding drop. Then hold on for a long ride up. We did great on this. It was just like the Abbvie dip. What could be better than an artificial price drop on a great company especially when you know it's BS.
Yeah me too. I was waiting to see if SHPG would drop down into the 205 range on this scare tactic but it appears no such luck. I wonder if Hayman's plan all along was not to short the stock but rather crash it and buy it up then pull the petition. In any case, scru him
This is the third time I didn't pull the full trigger on the price I picked. I only got 50 shares this go around. I split the order in case it continued to fall. I'm so far up on these trades I may just double up on my bets next time. I wish all my trades were like this. It's not like you even have to worry about pipeline. They can buy pipeline.
SHPG tells Hayman to #$%$ Off, and reminds investors that SHPG's patent on Lialda has been challenged previously and without success to date.
@@@@@LEXINGTON, Massachusetts, April 6, 2015 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) acknowledges the two petitions filed with the U.S. Patent and Trademark Office (USPTO) on April 2nd by Hayman Capital Management regarding LIALDA® (mesalamine) and GATTEX® (teduglutide [rDNA origin]). The patents listed in the FDA Orange Book for LIALDA and GATTEX protect the innovation and value Shire brings to patients who benefit from these important medicines. Shire will continue to defend vigorously its patents and pursue all legal options available to protect its products. LIALDA remains the only once-daily mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. LIALDA is protected by the following FDA Orange Book listed patent: U.S. Patent No. 6,773,720, Mesalazine Controlled Release Pharmaceutical Compositions (the "'720 patent"), which expires in 2020. This patent has already withstood a challenge on its validity in the Federal District Court for the Southern District of Florida. There have not been any approvals of generic versions of LIALDA.
Saw this in a SA article on the patent challenge. Also, per that article, the patent office will decide whether or not the challenge is justified six months after the petition filing date, and a final decision would follow six months after that if the review proceeds.
I absolutely agree that, as you stated, even in the event the patent is ruled invalid, generics will not immediately and fully displace the current SHPG drugs, so the impact to revenue would be far less than 12%.
@@@@@The first IPR petition that was filed targets the patent that covers Lialda, listed in the FDA Orange Book. The petition challenges claims 1-4 of the '720 patent. On May 9, 2013, Shire won a court ruling that would prevent Actavis from selling generic versions of Lialda until the patent expires in 2020. The Federal Circuit later reversed the decision, which was then appealed to SCOTUS who vacated the CAFC decision and the case is now remanded back to the Federal Circuit for further review. Lialda is a significant drug for Shire as it generated $633m in revenue during 2014 and $528.9m in revenue during 2013 (Page 53). The IPR petition presents a significant risk to the company if the petition is granted and results in a final decision invalidating the patent claims. It would open the door for generic drug makers to start manufacturing generic versions of Lialda.