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January 23, 2013
17:23 EDTDEPO, SNTSSantarus announces receipt of paragraph IV certification for generic glumetza
Santarus (SNTS) disclosed that on January 21, Santarus received a paragraph IV certification from Watson Laboratories advising Santarus of the filing of an Abbreviated New Drug Application ANDA with the U.S. FDA for a generic version of Glumetza. Santarus promotes Glumetza in the U.S. under the terms of a commercialization agreement with Depomed (DEPO). Watson’s certification notice alleges that the four U.S. patents listed in the FDA’s Orange Book for Glumetza 500 mg, with expiration dates in 2016, 2020 and 2021, will not be infringed by Watson’s proposed product, are invalid and/or are unenforceable. Santarus and Depomed are evaluating the paragraph IV certification. The parties have 45 days from the receipt of the paragraph IV certification to commence a patent infringement lawsuit against Watson that would automatically stay, or bar, the FDA from approving Watson’s ANDA for 30 months or until a district court decision that is adverse to the asserted patents, whichever is earlier. In April 2012, Depomed filed a lawsuit against Watson in the U.S. District Court for the District of Delaware, in response to an ANDA and paragraph IV certification filed by Watson regarding Watson’s intent to market a generic version of Glumetza 1000 mg, which litigation is ongoing.
News For SNTS;DEPO From The Last 14 Days
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October 2, 2015
10:10 EDTDEPOOptions with increasing implied volatility
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September 30, 2015
10:36 EDTDEPOOptions with increasing implied volatility
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08:30 EDTDEPODepomed should be bought at current levels, says Roth Capital
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September 29, 2015
10:48 EDTDEPOOptions with increasing implied volatility
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September 28, 2015
16:19 EDTDEPOOn The Fly: Top stock stories for Monday
Stocks on Wall Street were sharply lower as investors continue to worry about the health of China's economy and continue to flee the biotech sector. The iShares NASDAQ Biotechnology Index (IBB) was down 6.33% today and is down about 18.5% since September 21, when Democratic presidential candidate Hillary Clinton pledged to take action against the high prices of specialty drugs. Adding to the tentative mood among investors was noted investor Carl Icahn's preview for a presentation that will be made available on his site tomorrow, entitled "Danger Ahead." The preview includes several cautious comments that the billionaire has publicly made recently regarding his concerns about the high-yield bond market and the stock market. ECONOMIC EVENTS: In the U.S., personal income grew 0.3% in August, versus expectations for it to rise 0.4%. Personal spending rose 0.4% last month, versus expectations for growth of 0.3%. The pending home sales index fell 1.4% in August, missing expectations for it to have risen 0.4%. The Dallas Fed manufacturing outlook survey for September had a reading of -9.5, versus expectations for a reading of -10.0. In China, industrial profits plunged 8.8% in August, adding to the recent string of weak data from the Asian giant. COMPANY NEWS: Apple (AAPL) reported that it set a record by selling more than 13M new iPhone 6s and iPhone 6s Plus models in the first three days after launch of the devices. However, shares of the tech giant slid about 2% to $112.44 following the announcement... Alcoa (AA) shares advanced 52c, or 5.73%, to $9.59 after the company announced that its board has approved a plan to separate into two independent, publicly-traded companies - an Upstream company that will operate under the Alcoa name and a new "Value-Add company" that will provide high-performance, multi-material products whose name will be announced at a later date... Biotech stocks continued recent declines, with Valeant (VRX) dropping 16.6% after a group of Democratic congressmen urged additional scrutiny of the company's "price hike" business model, while Epizyme (EPZM) and NewLink (NLNK) fell a respective 27% and 21% after presenting data at the 2015 European Cancer Congress... Shares of both Energy Transfer Equity (ETE) and Williams (WMB) fell after they announced a combination deal valued at approximately $37.7B, including the assumption of debt and other liabilities. Under the terms of their deal, an affiliate of ETE will acquire Williams at an implied current price of $43.50 per Williams share, the companies said. In late June, Energy Transfer Equity made a proposal to merge with Williams in an all-equity transaction valued at that time at $53.1B, including the assumption of debt and other liabilities. Under that prior merger proposal, ETE would have acquired all of the outstanding common stock of Williams at an implied price of $64 per Williams share, which represented a 32.4% premium to Williams' common share closing price as of June 19. Energy Transfer Equity shares closed down $2.95, or 12.69%, to $20.29 after announcing today's revised deal, while Williams dropped $5.03, or 12.09%, to close at $36.57. MAJOR MOVERS: Among the notable gainers was Republic Airways (RJET), which surged $2.38, or 81.8%, to $5.29 after announcing that the company and Teamsters Local 357 have reached a consensual tentative agreement on the terms of a new three-year contract for the 2,100 Republic pilots represented by the International Brotherhood of Teamsters. Also higher was Media General (MEG), which gained $2.49, or 22.3%, to $13.64 after Nexstar (NXST) proposed a cash-and-stock deal to acquire the company for $14.50 per share, which Media General said it would "carefully review." Additionally, Sanchez Energy (SN) rose 4.5% to $5.57 after agreeing to sell certain Eagle Ford Shale midstream assets to Sanchez Production Partners (SPP) for $345M. Among the noteworthy losers was Huntsman (HUN), which plunged $3.99, or 28.7%, to $9.92 after warning that headwinds would impact its third quarter earnings. Also lower were shares of Depomed (DEPO) and Horizon Pharma (HZNP), falling a respective 22% and 21%, after Depomed continued its criticism of Horizon's hostile takeover bid for the company. INDEXES: The Dow fell 312.78, or 1.92%, to 16,001.89, the Nasdaq lost 142.53, or 3.04%, to 4,543.97, and the S&P 500 dropped 49.57, or 2.57%, to 1,881.77.
06:44 EDTDEPODepomed issues statement on ISS report
Depomed (DEPO) issued the following statement regarding a report by Institutional Shareholder Services' on Horizon Pharma's (HZNP) solicitation to call two special meetings of Depomed's shareholders. Depomed commented, "The ISS recommendation does not change the fact that we believe Horizon's offer does not reflect the value inherent in Depomed's business nor Depomed's compelling prospects for long-term growth and value creation, and therefore is not in the best interests of shareholders... We strongly believe Depomed shareholders are being misled by Horizon and are entitled to know the facts. First, based on Friday's closing price of Horizon stock, Horizon's all-stock exchange offer has a current value of only $21.64 per Depomed share, nowhere near the $33.00 a share that Horizon continues to disingenuously tout in its communications to Depomed shareholders. Second, Horizon has misleadingly announced false deadlines to submit proxies. To be clear, Depomed's Board of Directors has set record dates for October 29 and November 13, 2015 and there is no deadline approaching for Depomed shareholders to submit proxy cards to call a special meeting. Moreover, there is absolutely no requirement for Depomed shareholders to take any action until after the October 29 and November 13, 2015 record dates."
September 23, 2015
08:02 EDTDEPODepomed announces two favorable decisions in review proceedings vs. Endo
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September 22, 2015
20:02 EDTDEPOClinton vows $250 cap on monthly drug costs in blast against biotechs, insurers
Democratic presidential candidate Hillary Clinton railed against biotech companies as well as health insurers at a community health care forum in Iowa on Tuesday. Clinton began her speech by praising the Affordable Care Act, but quickly noted that she wants to strengthen it due to what she called the rising cost of prescription drugs. She explained, "Our pharmaceutical and biotechnology industries deserve credit... [But] too often, these drugs cost a fortune. Now, sometimes there is a good reason for that. Scientific breakthroughs are often the result of major investment... so it may makes sense, for a short period of time, to have to charge a lot of money for a drug. But when a drug has no competition, when there aren't any other treatments that can do what it does, pharmaceutical companies can charge astronomical fees far beyond anything that it would take to recoup their investment, and far beyond what they charge consumers anywhere else in the world outside of America." Referencing the recent criticism against Turing Pharmaceuticals, Clinton went on to say that "pharmaceutical companies that acquire an existing affordable drug that people rely on, and then turn around and charge a fortune for it, [are just betting] on the fact that desperate people will find some way to pay for it." Preemptively responding to questions of whether greater regulation will dampen investment, Clinton commented that "some people worry that my proposals will threaten innovation, but I have designed a plan that will do exactly the opposite... Under my plan, drug companies that want to keep getting federal support will have to redirect more of their profits into meaningful investments in research and development." Clinton also criticized incremental drug improvements, saying that "too often, so-called new drugs are really old drugs that have just been tweaked a little bit, but then they're marketed as breakthrough drugs and they're sold for high prices." The Democratic candidate went on to condemn advertising in the drug industry, remarking that "I also want to tackle direct to consumer advertising... Other countries ban these ads because they are so often misleading. But at the very least, we shouldn't be encouraging them with corporate write-offs... Under my plan, we will instead use that taxpayer money to fund innovation... I would also like to make sure any ads the drug industry does run are approved by the FDA." Moving more broadly onto Medicaid and health insurers, Clinton stated, "I believe Medicare should be able to negotiate for lower prices for its members... I will require drug companies to provide higher rebates for prescription drugs to low income Medicare patients, just like they have to do for Medicaid patients... I think the insurance companies need to be put on notice." Providing more concrete details of her plan, Clinton concluded, "I will cap out of pocket drug costs for working families. You won't have to pay more than $250 a month for covered medications... Particularly for people who have a chronic illness. Also under my plan, you will be able to import cheaper drugs from other countries legally. If the medicine you need costs less in Canada, you should be able to buy it from Canada or any other country that meets our safety standards... I will also make sure we have more generics on the market [by boosting funding for] the FDA's office of generic drugs."
17:35 EDTDEPOHillary Clinton vows to cap out-of-pocket drug costs at $250 per month
Presidential candidate Hillary Clinton said in a tweet that, "Under my plan, I'll cap out-of-pocket drug costs for families. You won't have to pay more than $250/month for covered medications." Reference Link
14:45 EDTDEPODiplomat Pharmacy addresses unusual market activity
Diplomat Pharmacy (DPLO) is aware of unusual market activity in its stock, potentially in respect to a deal in which Diplomat was incorrectly referenced. Diplomat is aware of a recent development regarding Depomed (DEPO) and Horizon Pharma (HZNP), in which it is not involved. Diplomat heard from an investor that the Diplomat name was incorrectly referenced instead of Depomed, in a discussion between that investor and a bank earlier. We reference such statement only to explain the potential market confusion and we are not commenting on the validity of the statement in any respect. Diplomat has noted that in terms of both shares traded and stock price decline thus far Tuesday, its stock is unusually correlated to Depomed and Horizon Pharma.
08:23 EDTDEPOAnalysts say buy select biotech stocks ahead of Clinton drug plan
Ahead of Presidential candidate Hillary Clinton laying out her plan to tackle "price gouging" in the specialty drug market at an event in Iowa later today, analysts at research firms Jefferies and Piper Jaffray are recommending select biotech stocks that they view as buys amid the weakness in the space. DEBATE: Biotech stocks broadly declined yesterday, with the NASDAQ Biotechnology index (IBB) sliding roughly 4.4%, after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on a 62-year-old drug that fights complication of AIDS and cancer. Furor around the sudden price hike for Turing's Daraprim reignited a debate around drug prices that previously embroiled costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni. The news also follows Presidential candidate Bernie Sanders issuing a letter in August to Valeant (VRX) and Pfizer's (PFE) Hospira, in which he requested information on the "enormous" price increases of two drugs Valeant acquired earlier in the year. Presidential candidate Hillary Clinton sent the debate to center stage yesterday by criticizing the "outrageous" prices of specialty drugs and promising to lay out a plan today to tackle "price gouging" in the specialty drug market. Clinton's proposal, which she'll outline in a speech in Iowa later today, would force pharmaceutical companies to reinvest their profits into research, allow for more generic and imported drugs and allow Medicare to negotiate lower drug costs and cap out-of-pocket expenses, according to details of the plan shared with USA Today. Zeke Emanuel, chair of medical ethics and health policy at the University of Pennsylvania, appeared on Nightly Business Report to discuss the problem of high drug prices and his suggested solutions. During his interview, Emanuel contended that giving Medicare the ability to negotiate drug prices may drive up prices for everyone else. DEFENSES: The Jefferies Biotechnology research team, led by Brian Abrahams, Eun Yang and Biren Amin, say their Washington D.C. consultants indicate the recent political rhetoric around drug pricing is unlikely to result in any substantive future policy changes that would impact biotech sector fundamentals. As such, they recommend using yesterday's selloff to buy select companies including Celgene (CELG), BioMarin (BMRN) and Alkermes (ALKS). Pricing concerns are nothing new, and will likely continue to be a headwind for the sector, the analysts tell investors in a research note. Hillary Clinton's proposal to combat drug pricing is likely to include "some combination of old and tried policies that have been out there for a few years," they write. The analysts also like shares of AMAG Pharmaceuticals (AMAG), Alder Biopharmaceuticals (ALDR) and Cempra (CEMP). Meanwhile, Piper Jaffray analyst Edward Tenthoff recommends buying shares of Vertex Pharmaceuticals (VRTX) following yesterday's selloff. Tenthoff believes that drugs like Vertex's Orkambi will maintain premium pricing because of the disease modifying value to patients and payors. Orkambi is approved to treat cystic fibrosis in patients 12 years and older. The analyst reiterates an Overweight rating on Vertex with a $163 price target. DOWNGRADE: Brean Capital analyst Difei Yang downgraded Horizon Pharma (HZNP) to Hold saying "unsettling recent developments" make the stock's premium valuation no longer justified. The public discussion on high drug prices is a negative for the company while its attempt to acquire Depomed (DEPO) is unlikely to result in a completed deal, Yang tells investors in a research note. Further, Horizon's prescription trends are showing weakness, said Yang, who views the stock as more risky than in the past. PRICE ACTION: Horizon closed yesterday down $2.93, or 9.2%, at $28.99, while Vertex dropped $5.97, or 4.8%, to $118.19. A number of the biggest stocks in biotechnology were also weak yesterday, with Gilead sliding about 2.5%, Amgen (AMGN) dropping 2.3%, Celgene declining 2.8% and Biogen (BIIB) falling more than 5.5%.
06:43 EDTDEPOHorizon Pharma downgraded to Hold from Buy at Brean Capital
Brean Capital analyst Difei Yang downgraded Horizon Pharma (HZNP) to Hold saying "unsettling recent developments" make the stock's premium valuation no longer justified. The public discussion on high drug prices is a negative for the company while its attempt to acquire Depomed (DEPO) is unlikely to result in a completed deal, Yang tells investors in a research note. Further, Horizon's prescription trends are showing weakness, the analyst points out. Yang views the stock as more risky than in the past. Horizon closed yesterday down $2.93 to $28.99.

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