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Dec. 31, 2015, 1:32 PM
- Putting a positive spin on Endo International unit Auxilium Pharmaceuticals' (ENDP -1.6%) exit from its exclusive license for erectile dysfunction med STENDRA (avanafil) in the U.S. and Canada, VIVUS (VVUS +1%) CEO Seth Fischer says, "We are excited to reacquire the U.S. and Canadian commercial rights for STENDRA. We appreciate Endo's efforts to build the STENDRA brand and understand their decision to focus their resources on BELBUCA. We are in the process of evaluating ways for maximizing the value of STENDRA and expect to make an announcement by the end of [Q1 2016]."
- The FDA cleared STENDRA in April 2012. VIVUS inked its agreement with Auxilium in October 2013.
- BELBUCA (buprenorphine HCl buccal film) was cleared by the FDA in October 2015 for the management of pain severe enough to require around-the-clock opioid treatment. Endo secured global commercialization rights from BioDelivery Sciences (BDSI -0.2%) in January 2012.
- Previously: Endo backs out of STENDRA license deal with VIVUS (Dec. 30)
- Previously: Vivus, Auxilium sign Canadian marketing deal (Oct. 11, 2013)
Dec. 30, 2015, 5:08 PM
- Endo International (NASDAQ:ENDP), through its subsidiaries Auxilium Pharmaceuticals and Endo Ventures Limited, has notified VIVUS (NASDAQ:VVUS) that it will terminate the commercial supply and license agreements related to its exclusive right to commercialize STENDRA (avanafil) for any urological disease, including male erectile dysfunction in the U.S., Canada and related territories. The effective date of the termination is June 30, 2016.
- Separately, Endo subsidiary Endo Ventures Bermuda Limited submitted written notice to Acerus Pharmaceuticals (OTCPK:TRLPF) that it will terminate its exclusive license agreement for commercialization rights to Natesto (testosterone nasal gel) for the U.S. and Mexico on June 30, 2016. Natesto is a testosterone replacement therapy for men with hypogonadism.
- VVUS is down 1% after hours on modest volume.
- Previously: Leerink upbeat on Vivus after Stendra deal (Oct. 11, 2013)
- Previously: Vivus, Auxilium sign Canadian marketing deal (Oct. 11, 2013)
Dec. 22, 2015, 7:54 AM
- Noting significant short interest and recent selloffs, analyst Randall Stanicky makes INSY and SGNT his top "out of consensus" picks for 2016. INSY's short interest is 46% of the float and SGNT's is 4.4%.
- Though M&A will continue next year, there will be greater deal scrutiny and fewer targets, and Stanicky favors the targets vs. the accretive acquirers.
- Mylan (NASDAQ:MYL) and Impax Labs (NASDAQ:IPXL) are seen as most likely to pursue "transformative" deals, while Teva (NYSE:TEVA), Perrigo (NYSE:PRGO), Sagent, Eagle (NASDAQ:EGRX), Depomed (NASDAQ:DEPO), and Endo (NASDAQ:ENDP) are likely to pursue bolt-on purchases.
- Most likely targets: Akorn (NASDAQ:AKRX) and Flexion (NASDAQ:FLXN).
- Top large-cap picks: Endo and Teva.
- Related: 45% Upside For 2016's Top Takeover Target (Dec. 1)
Dec. 14, 2015, 7:40 AM
- Added to the Nasdaq 100 (NASDAQ:QQQ), effective Dec. 21 will be: Ctrip (NASDAQ:CTRP), Endo International (NASDAQ:ENDP), Expedia (NASDAQ:EXPE), Maxim Integrated (NASDAQ:MXIM), Norwegian Cruise Lines (NASDAQ:NCLH), T-Mobile (NASDAQ:TMUS), and Ulta Salon (NASDAQ:ULTA).
- To be removed: C.H. Robinson (NASDAQ:CHRW), Expeditors International (NASDAQ:EXPD), Keurig Green Mountain (NASDAQ:GMCR), Garmin (NASDAQ:GRMN), Staples (NASDAQ:SPLS), VimpelCom (NASDAQ:VIP), and Wynn Resorts (NASDAQ:WYNN). Also to be removed: LiLAC Class A Shares (NASDAQ:LILA), and LiLAC Class C Shares (NASDAQ:LILAK).
- Source: Press Release
Nov. 23, 2015, 2:47 PM
- Goldman Sachs' Hedge Fund VIP list of the 50 most-heavily-owned stocks have trailed the S&P 500 by about 500 basis points (down 2% vs. the S&P's 3% gain) year-to-date, including 720 basis points of underperformance since the start of October (down about 8% vs. down about 1%).
- Call it the Valeant effect: Health-care stocks have accounted for about 70% of the year-to-date 2% decline.
- Based on the most recent filing, hedge funds are bailing on some of their poorer performers, including Valeant (NYSE:VRX), HCA Holdings (NYSE:HCA), Endo (NASDAQ:ENDP), Ally Financial (NYSE:ALLY), and NorthStar Realty (NYSE:NRF), and have instead placed bets on Baidu (NASDAQ:BIDU), Mylan (NASDAQ:MYL), MGM Resorts (NYSE:MGM), and GE.
- After the shakeup, the top five hedge fund hotels: Allergan (NYSE:AGN), Facebook (NASDAQ:FB), Alphabet (GOOG, GOOGL), Time Warner Cable (NYSE:TWC), and Amazon (NASDAQ:AMZN).
Nov. 20, 2015, 1:22 PM
- Sucampo Pharmaceuticals (SCMP -0.3%) initiated with Hold rating and $19 (10% upside) price target by Jefferies.
- BioMarin Pharmaceutical (BMRN -4.8%) initiated with Buy rating and $158 (61% upside) price target; bluebird bio (BLUE +1.2%) with a Buy rating and $165 (104% upside) price target; Incyte (INCY -3.2%) with a Buy rating and $135 (20% upside) price target; Kite Pharma (KITE -0.2%) with a Buy rating and $111 (32% upside) price target and Seattle Genetics (SGEN +0.1%) with a Sell rating and $33 (25% downside risk) price target by Goldman Sachs.
- Mylan (MYL +0.4%) initiated with Overweight rating and $62 (21% upside) price target by Morgan Stanley.
- Athenahealth (ATHN +0.4%) initiated with Overweight rating and $170 (7% upside) price target and Allscripts Healthcare Solutions (MDRX +0.5%) with an Overweight rating and $17 (14% upside) price target by J.P. Morgan.
- Genomic Health (GHDX -0.7%) upgraded to Outperform from Market Perform by Cowen & Co. Price target raised to $35 (21% upside) from $27.
- Shire plc (SHPG -0.9%) upgraded to Outperform from Market Perform by Leerink. Price target raised to $239 (12% upside) from $220.
- Cempra (CEMP -0.5%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $38 (30% upside) from $25.
- Athenahealth (ATHN +0.4%) downgraded to Underweight from Equal Weight by Barclays. Price target lowered to $110 (31% downside risk) from $140.
- Osiris Therapeutics (OSIR +1.9%) downgraded to Sell from Hold by Brean Capital. Price target is $8 (25% downside risk).
- Endo International (ENDP -0.3%) downgraded to Neutral from Buy by Mizuho. Price target lowered to $55 from $82 (7% downside risk).
- Kite Pharma (KITE -0.2%) downgraded to Hold from Buy by Standpoint Research. Price target maintained at $100 (19% upside).
Nov. 18, 2015, 6:59 AM
- The resolution of patent litigation with Endo Pharmaceuticals (NASDAQ:ENDP) enables Depomed (NASDAQ:DEPO) to acquire the U.S. and Canadian rights to cebranopadol and its related follow-on compound from Grunenthal GmbH.
- Under the terms of its settlement agreement with Endo Pharma, the companies resolve their ongoing patent litigation over Endo's alleged infringement of three of Depomed's patents by Endo's OPANA ER product, formulated by Grunenthal, who indemnified Endo for certain IP matters, including the litigation with Depomed. Endo receives a non-exclusive patent license in the U.S. and a covenant not to sue outside of the U.S. for the current formulation of OPANA ER. Depomed extends a limited covenant to Grunenthal not to sue under certain Depomed Acuform drug delivery patents with specific drug substances, $25M cash payment, sales-based milestones and royalties on net sales. The deal is expected to close this quarter.
- Depomed CMO Srinivas Rao, M.D., Ph.D., says, "Cebranopadol is a truly differentiated molecule with a novel dual mechanism of action, functioning as a high-potency agonist of both the mu-opioid and the nociceptin receptors. Cebranopadol's pharmacology is likely to confer analgesic efficacy equivalent to that of traditional opioids in peripherally-mediated, nociceptive pain conditions, while potentially conferring great efficacy in neuropathic pain and other pain states characterized by more centralized pain. Moreover, the product does not appear to impact respiratory function to the degree that traditional mu-opioid receptor agonists do and the nociceptin receptor pharmacology also appears to substantially mitigate the abuse potential of cebranopadol."
- Depomed intends to commence a Phase 3 study in lower back pain and other pain conditions in 2017.
Nov. 6, 2015, 5:04 PM
- Specialty healthcare firm Endo International (NASDAQ:ENDP) says it's entering into a program to buy back up to $250M in its common stock.
- The moves will start Monday and it will repurchase shares as soon as practicable thereafter, it says, though it expects to wrap up the purchases by the end of 2015. The plans come as part of a previously authorized $2.5B plan.
- Endo, which finished today up 7% after exercising an option for new indications on XIAFLEX with its partner BioSpecifics Technologies, is up another 0.6% after hours.
Nov. 6, 2015, 10:20 AM
- BioSpecifics Technologies (BSTC -3.4%) earns a total of $1M in opt-in fees from XIAFLEX (collagenase clostridium histolyticum) development and commercialization partner Endo International (ENDP -0.6%) for the latter's exercise of its option for two new potential indications: lateral thigh fat and plantar fibromatosis. BioSpecifics will receive a $500K opt-in fee from Endo for each indication. Endo will responsible for all clinical development costs associated with the two conditions.
- Lateral thigh fat accumulation is common among women as they age. It can be difficult to improve its appearance through diet and exercise alone. Cryolipolysis and liposuction are two procedures commonly used to remove the fat deposits. There are no drugs approved for the indication.
- Plantar fibromatosis or Ledderhose disease, is a painful and potentially disabling condition caused by the thickening of the feet's deep connective tissue. This leads to the formation of nodules or cords along the tendons of the foot. Ledderhose sufferers also frequently have Dupuytren's contracture, Peyronie's disease and adhesive capsulitis.
- Endo currently owns the rights for XIAFLEX for above three indications and canine lipoma.
Nov. 5, 2015, 11:19 AM
- Endo (ENDP -10.8%) Q3 results: Revenues: $745.7M (+14.0%); R&D Expense: $21.3M (+29.1%); SG&A: $163.2M (+39.0%); Operating Loss: ($777.2M) (-666.1%); Net Loss: ($803.7M) (-999%); Loss Per Share: ($3.84) (-999%); Non-GAAP EPS: $1.02 (-1.0%); Quick Assets: $836.1M (+104.5%).
- 2015 Guidance: Total revenue: $3.22B - 3.27B; GAAP EPS: ($3.70) - (3.60); non-GAAP EPS: $4.50 - 4.60.
Nov. 5, 2015, 6:36 AM
- Endo (NASDAQ:ENDP): Q3 EPS of $1.02 beats by $0.03.
- Revenue of $745.73M (+14.0% Y/Y) beats by $9.57M.
Nov. 4, 2015, 5:30 PM
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Oct. 26, 2015, 7:11 AM
- The FDA approves BioDelivery Sciences' (NASDAQ:BDSI) BELBUCA (buprenorphine) buccal film for the treatment of chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The commercial launch will commence in Q1.
- BELBUCA, offered in seven dosage strengths (75 ug - 900 ug), utilizes the company's BEMA (BioErodible MucoAdhesive) technology, a drug delivery technology consisting of a small bioerodible polymer film that is applied inside the mouth to the lining of the cheek. The analgesic on the film is absorbed into the body through the oral mucosa. The film completely dissolves in 15 - 30 minutes.
- It is classified a Schedule III controlled substance which has a lower abuse potential than Schedule II drugs, which is where most opioids are classified.
- The FDA's clearance triggers a milestone payment from licensee Endo Pharmaceuticals (NASDAQ:ENDP) of up to $50M.
- Previously: BioDelivery Sciences earns $10M milestone from Endo (Feb. 23)
Oct. 21, 2015, 3:19 PM
- Like Allergan, Endo International (ENDP -9.7%) tries to preempt potential criticism by proactively issuing a statement about its use of specialty pharmacies to distribute its drugs. It admits that it uses them for certain products, such as XIAFLEX, AVEED, TESTOPEL, Supprelin LA, Vantas and Valstar, but the volume represents less than 10% of its U.S. Branded revenues and ~3% of its overall revenues for 2015.
- The company adds that the specialty pharmacies it uses are fully independent with no ownership interests or other affiliations.
- Previously: Allergan says only 3% of its business is through specialty pharmacies; trading resumes with shares down 4% (Oct. 21)
Oct. 21, 2015, 12:49 PM
Oct. 2, 2015, 8:09 AM
- Concordia Healthcare (NASDAQ:CXRX) initiated with Outperform rating and $86 (90% upside) price target by RBC.
- Mednax (NYSE:MD) initiated with Buy rating and $88 (15% upside) price target by Mizuho Securities.
- Valeant Pharmaceuticals (NYSE:VRX) initiated with Buy rating and $290 (61% upside) price target by B of A Merrill Lynch. Downgraded to Equal Weight from Overweight by Morgan Stanley with price target of $200 (11% upside) down from $284.
- Endo International (NASDAQ:ENDP) initiated with Buy rating and price target of $88 (26% upside) by Deutsche Bank.
- Celgene (NASDAQ:CELG) upgraded to Overweight from Neutral with $152 (35% upside) price target by JP Morgan.
- Cerner (NASDAQ:CERN) upgraded to Outperform from Sector Perform by RBC. Price target raised to $70 (17% upside) from $68.
- Bristol-Myers Squibb (NYSE:BMY) upgraded to Buy from Neutral by UBS. Price target raised to $75 (25% upside) from $65.
- Johnson & Johnson (NYSE:JNJ) upgraded to Buy from Hold by Deutsche Bank. Price target maintained at $110 (18% upside).
- Vertex Pharmaceuticals (NASDAQ:VRTX) upgraded to Buy from Hold by Argus Research. Price target maintained at $126 (18% upside).
- Ilumina (NASDAQ:ILMN) downgraded to Market Perform from Outperform by Leerink. Price target lowered to $185 (18% upside) from $225.
- Fibrocell Science (NASDAQ:FCSC) downgraded to Neutral from Outperform by Wedbush. Price target lowered to $6 (61% upside) from $7.
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