Mon, Jul. 13, 7:56 AM
Tue, Jul. 7, 7:52 AM
- Allergan (NYSE:AGN) acquires the worldwide rights to Merck's (NYSE:MRK) investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor agonists which are under development for the treatment and prevention of migraine.
- Under the terms of the agreement, Allergan will pay Merck an upfront fee of $250M, half when the deal clears antitrust review and half in April 2016. Merck will be eligible for development and commercial milestones and tiered double-digit royalties. Allergan will be responsible for the full development costs of the CGRP programs as well as manufacturing and commercialization.
- Specifically, Allergan obtains the rights to two CGRP receptor agonists:
- MK-1602, for the acute treatment of migraine. A Phase 2 study was just completed. After discussing the results with the FDA, a Phase 3 trial should begin in 2016.
- MK-8031, for the prevention of migraine. A Phase 2 trial is expected to commence in 2016.
- In July 2011, Merck discontinued development of an earlier oral CGRP antagonist, Telcagepant (MK-0974), due to potential liver toxicity. MK-1602 and MK-8031 belong to a different chemical series than Telcagepant and have shown no evidence of liver toxicity.
- Migraines affect ~36M Americans.
Mon, Jul. 6, 8:38 AM
- Allergan (NYSE:AGN) acquires South San Francisco-based Oculeve, a development stage device firm focused on treatments for dry eye disease, a condition that affects ~25M Americans. Its lead program is OD-01, a non-invasive neurostimulation device that increases tear production. Allergan intends to conduct two additional pivotal studies prior to FDA submission in 2016. Commercial launch is expected to commence in 2017.
- Under the terms of the deal, Allergan will make an upfront payment of $125M plus commercial milestones specific to OD-01.
- Allergan's 2015 EPS forecast remains unchanged.
Thu, Jun. 25, 8:14 AM
- The Court of Appeal in the UK rules that Eli Lilly's (NYSE:LLY) patent for its Alimta (pemetrexed) vitamin regimen would be indirectly infringed by certain alternate salt forms of pemetrexed proposed by potential competitor Actavis (NYSE:AGN). Lilly's UK patent is in effect until June 2021.
- The Court also held that there is no difference between the law in the UK and that in France, Italy and Spain as it relates to indirect infringement. This reverses the High Court's decision granting declarations of noninfringement over the Alimta vitamin regimen patents in those countries.
- Actavis may seek an appeal to the UK Supreme Court. It may also ask the High Court if a different proposed product would infringe the patent, as it has stated it may do.
- The compounded patents for Alimta will provide exclusivity through December 2015 in Europe. If the Court of Appeal's ruling holds, there is a strong likelihood that the vitamin regimen patents will provide exclusivity in France, Italy and Spain through June 2021.
- Alimta is Lilly's number two seller after Humalog, generating $2.7B in sales the past four quarters.
Fri, Jun. 19, 9:47 AM
- Kythera Biopharmaceuticals (KYTH) announces the commercial availability of Kybella (deoxycholic acid) injection in the U.S. Kybella is the first and only FDA-approved non-surgical treatment for reducing submental fullness, commonly known as double chin.
- The cost to physicians will be $300 per vial or $1,200 for a four-vial pack. The average dose will be 2-3 vials per treatment session (4-6 mL) so patients will need a purse as ample as their extra chin. If the doctor's cost is $600 - 900, then the patient's cost will be a multiple of this.
- The company was just acquired by Allergan (NYSE:AGN) for $75 per share or ~$2.1B.
Wed, Jun. 17, 8:29 AM
- Allergan (NYSE:AGN) acquires Kythera Biopharmaceuticals (NASDAQ:KYTH) for $75 per KYTH share in a cash-and-stock transaction valued at ~$2.1B, specifically 80% in cash and 20% in AGN shares. The deal is expected to be breakeven in 2016 and accretive thereafter.
- Kythera's sole marketed product is Kybella (deoxycholic acid) for the non-surgical contouring of moderate-to-severe submental fullness (double chin). It was cleared by the FDA in April. A key product candidate in development is KYTH-105 (setipiprant) for the prevention of male pattern baldness.
- Allergan will host a conference call this morning at 8:30 am ET to discuss the deal.
- KYTH is up 22% premarket on robust volume.
Tue, Jun. 9, 10:55 AM
- CVS Health (CVS -0.1%) initiated with Outperform rating and $115 (16% upside) price target by Macquarie.
- Galapagos (GLPG -3%) initiated with Overweight rating and $73 (36% upside) price target by Morgan Stanley.
- LifePoint Health (LPNT) initiated with Conviction Buy rating and $92 (25% upside) price target by Goldman Sachs.
- BioMarin Pharmaceutical (BMRN -2.2%) initiated with Overweight rating and $150 (24% upside) price target by Barclays.
- Universal Health Services (UHS +0.2%) initiated with Neutral rating and $140 (10% upside) price target by Goldman Sachs.
- Amsurg (AMSG -0.5%) initiated with Buy rating and $81 (17% upside) price target by Goldman Sachs.
- Momenta Pharmaceuticals (MNTA -2.6%) initiated with Buy rating and $26 (18% upside) price target by Stifel Nicolaus.
- Actavis (ACT -0.6%) initiated with Outperform rating and $344 (16% upside) price target by Raymond James.
Fri, May 29, 1:22 PM
- An appeals court rules that Actavis' (ACT -1%) plan to "hard switch" Namenda (memantine HCl) to the more expensive Namenda XR violates U.S. antitrust law. The company attempted to halt the distribution of original Namenda, which faced looming generic competition, in 2014 and convert the market to the newer, patent-protected and more expensive XR product.
- New York Attorney General Eric Scheiderman sued the company to prevent it from pulling the lower priced Namenda from the market. A federal court agreed so Actavis appealed. The appeals court ruling requires Actavis to continue supplying the cheaper medicine until 30 days after its patent expires on July 11, a modest victory for NY.
- The company says the market prefers the convenience of once daily Namenda XR versus twice daily for the original version. Over 40% of users have already transitioned to the new product.
- Namenda is indicated for the treatment of moderate-to-severe dementia of the Alzheimer's type.
- Previously: Judge orders Actavis to keep selling Alzheimer's drug (Dec. 12, 2014)
Wed, May 27, 5:26 PM
- The FDA approves two new drugs to treat adult patients with irritable bowel syndrome (IBS) with diarrhea. IBS affects as many as 15% of adult Americans. Those sufferers with loose or watery stools at least 25% of the time are a subgroup.
- Viberzi (main ingredient unspecified), manufactured by privately-held Patheon and distributed by Forest Pharmaceuticals (NYSE:ACT), activates receptors in the nervous system that can lessen bowel contractions. It is an oral medication taken twice per day.
- Xifaxan (rifaximin), developed by Salix Pharmaceuticals (NASDAQ:SLXP) (NYSE:VRX), is an antibiotic previously approved for the treatment of travelers' diarrhea caused by E. coli and for reducing the risk of overt hepatic encephalopathy. It is an oral medication taken three times per day for 14 days.
Thu, May 21, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
Thu, May 21, 9:17 AM
- New additions to Goldman's hedge fund hotels - 50 stocks which most frequently appear among the largest ten holdings of hedge funds: AerCap (NYSE:AER), Assured Guaranty (NYSE:AGO), Baker Hughes (NYSE:BHI), Citizens Financial (NYSE:CFG), Colony Capital (NYSE:CLNY), Dresser-Rand (NYSE:DRC), Family Dollar (NYSE:FDO), Hospira (NYSE:HSP), Netflix (NASDAQ:NFLX), NXP Semi (NASDAQ:NXPI), Pharmacyclics (NASDAQ:PCYC), Visa (NYSE:V), and Walgreens (NASDAQ:WBA).
- Since 2001, the basket has outperformed the S&P 500 in 66% of quarters by an average of 73 basis points. YTD, however, it has underperformed by nine bps. Goldman notes the current basket overweights Consumer Discretionary (22%) and underweights Consumer Staples (2%).
- Looking at the full list, Actavis (NYSE:ACT) leads the way, with 77 funds naming the stock as a top 10 holding. Next up is Apple (NASDAQ:AAPL) with 69, then Facebook (NASDAQ:FB) at 42. For the entire list of 50, the average is 26 funds making a stock a top 10 holding.
- The rest in order: Valeant (NYSE:VRX), Microsoft (NASDAQ:MSFT), DirecTV (NASDAQ:DTV), Citigroup (NYSE:C), Time Warner (NYSE:TWC), Delta (NYSE:DAL), Cheneire (NYSEMKT:LNG), Yahoo (NASDAQ:YHOO), Liberty Global (NASDAQ:LBTYK), AIG, SunEdison (NYSE:SUNE), Air Products (NYSE:APD), Amazon (NASDAQ:AMZN), GM, BofA (NYSE:BAC), JPMorgan (NYSE:JPM), Macquarie Infrastructure (NYSE:MIC), American Airlines (NASDAQ:AAL), Charter Communications (NASDAQ:CHTR), Google (GOOG, GOOGL), Ally Financial (NYSE:ALLY), NorthStar Realty (NYSE:NRF), Priceline (NASDAQ:PCLN), eBay (NASDAQ:EBAY), MasterCard (NYSE:MA), Alibaba (NYSE:BABA), Micron (NASDAQ:MU), Williams (NYSE:WMB), Gilead (NASDAQ:GILD), Berkshire Hathaway (BRK.A, BRK.B), Dolar General (NYSE:DG), NorthStar Asset (NYSE:NSAM), Brookdale Senior (NYSE:BKD), DISH Network (NASDAQ:DISH).
- See also: Goldman updates list of hedge funds most-shorted stocks (May 21)
Fri, May 15, 12:05 PM
- Cytori Therapeutics (CYTX -3.6%) initiated with Buy rating and $1.25 (95% upside) price target by Ascendiant Capital.
- Intuitive Surgical (ISRG -0.2%) initiated with Neutral rating and $505 (1% upside) price target by Piper Jaffray.
- Aduro Biotech (ADRO -2.4%) initiated with Buy rating and $40 (25% upside) price target by BofA Merrill Lynch and an Outperform rating and $48 (50% upside) price target by Leerink Swann.
- Cidara Therapeutics (CDTX -0.3%) initiated with Outperform rating and $24 (50% upside) price target by Leerink Swann.
- Paratek Pharmaceuticals (PRTK +0.6%) initiated with Buy rating and $37 (32% upside) price target by Guggenheim Securities.
- KemPharm (KMPH +0.4%) initiated with Outperform rating and $18 (44% upside) price target by RBC Capital.
- XTL Biopharmaceuticals (XTLB -1.4%) initiated with Buy rating and $6 (200% upside) price target by H.C. Wainwright.
- Actavis (ACT +0.3%) initiated with Buy rating and $358 (20% upside) price target by Mizuho Securities.
Mon, May 11, 7:28 AM
- Actavis (NYSE:ACT) Q1 results ($M): Total Revenues: 4,234.2 (+59.5%); North American Brands: 1,736.0 (+192.3%); NA Generics: 1,778.2 (+6.4%); Anda Distribution: 461.6 (+18.3%); Allergan: 258.4; Net Income: -535.2 (-654.6); EPS: -1.85 (-436.4); Quick Assets: 2,130.9 (+526.4%); CF Ops: 525.0 (+19.4%).
- Key Product Sales: Namenda: 396.0; Dermatology/Est. Brands: 228.3; Bystolic: 164.1; Delzicol/Asacol HD: 136.2; Linzess/Costella: 96.2.
- 2015 Guidance: Revenues: $20.5B - 21.0B; Non-GAAP EPS: $17.00 - 18.50.
Mon, May 11, 6:34 AM
Sun, May 10, 5:30 PM
Mon, May 4, 1:09 PM
- New York, NY-based Anterios (Pending:ANTE) is set for its IPO of 3.9M shares of common stock at $12 - 14.
- The clinical stage biopharmaceutical firm develops botulinum products for therapeutic and aesthetic applications. Botulinum toxin type A (botulinum) is currently almost a $3B global market, led by Allergan's (AGN) Botox.
- The firm's lead product candidate is the Phase 2-stage ANT-1207, a topical formulation of botulinum for the treatment of primary axillary hyperhidrosis (excessive underarm sweating), facial acne and lateral canthal lines (crow's feet wrinkles). Its second candidate is AI-09, an injectable botulinum that will be packaged as a ready-to-use liquid. Currently available injectable botulinum products are lyophilized which require reconstitution prior to use.
- 2014 Financials ($M): Operating Expenses: 5.7 (+50.3%); Net Loss: (5.7) (-34.1%); Cash Burn: (4.8) (-48.8%).
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