Fri, Feb. 27, 10:28 AM
- The FDA approves Allergan's (AGN +0.1%) Natrelle Inspira round gel-filled smooth breast implant. The product has a higher fill ratio which provides an additional shaping option for women undergoing reconstruction, augmentation or revision surgery.
- Allergan acquired the breast implant business via its buyout of Inamed in 2005.
Wed, Feb. 25, 5:34 PM
- The FDA approves Forest Laboratories subsidiary Forest Pharmaceuticals' (NYSE:ACT) Avycaz (ceftazidime-avibactam) for the treatment of adult patients with complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections, including kidney infections, who have limited or no alternative treatment options.
- Avycaz contains ceftazidime, a previously approved cephalosporin antibacterial drug and avibactam, a non-beta lactam beta-lactamase inhibitor antibiotic to extend bacterial resistance. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.
- Avycaz is a Qualified Infectious Disease Product (QIDP) which adds a five-year period of market exclusivity to the five-year exclusivity period provided under the Food, Drug and Cosmetic Act. It is the fifth QIDP-tagged drug cleared by the FDA.
- The product was developed under a collaboration between Forest Labs and AstraZeneca (NYSE:AZN).
Wed, Feb. 25, 1:02 PM
- The FDA's General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meets on Friday, February 27 to discuss the premarket approval application (PMA) from Merz Aesthetics seeking approval for the use of its Radiesse dermal filler to include subdermal implantation for hand augmentation to correct volume deficit in the hands.
- Radiesse is currently cleared for subdermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, and subdermal implantation for restorative and/or correction of the signs of facial fat loss (lipoatrophy) in people infected with HIV.
- Executive Summary, Panel Questions, Voting Questions Agenda
- Related tickers: (NYSE:AGN) (NYSE:ACT)
Wed, Feb. 25, 9:42 AM
- The FDA accepts for review the New Drug Application (NDA) from Teva Pharmaceutical Industries (TEVA -0.6%) for CEP-33237, its hydrocodone bitartrate extended release tablets for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- The product is formulated with its proprietary abuse-deterrent technology, although it does not specify the nature of the technology or how it works. In an oral human abuse liability study (HAL) in nondependent recreational opioid users, the abuse potential of finely crushed CEP-33237 powder was significantly lower based on peak at-the-moment drug liking. An intranasal HAL study produced the same result.
- Related tickers: (ZGNX -0.6%)(EGLT)(OTCQB:ELTP)(PFE -0.7%)(ACUR)(MNK -0.6%)(ACT +0.7%)(ABBV -0.6%)(LCI +1%)(ALKS -1.7%)
Tue, Feb. 24, 12:44 PM
- Allergan (AGN +0.3%) head honcho David Pyott could pocket as much as $100M if he is terminated following the close of the Actavis (ACT -1.2%) transaction. The golden parachute would include ~$89M in cash and stock that he would receive in exchange for not-yet-vested equity awards, ~$9.9M in cash and $2M for accrued pension and health benefits. Mr. Pyott would be eligible for the payouts if Actavis decides not to retain him. This appears likely since Actavis CEO Brent Saunders will lead the combined company.
- In a relative sense, the package is fairly standard, even modest, for executives in this situation. When ex-GE division head Bob Nardelli exited Home Depot after only a short time at the helm, he pocketed $223M.
Mon, Feb. 23, 12:07 PM
- Among the additions to the index (which fuels the IBLN ETF) are EMC, Google (GOOG, GOOGL), Goodyear (NASDAQ:GT), Mohawk Industries (NYSE:MHK), PVH, Time Warner (NYSE:TWX), and Yahoo (NASDAQ:YHOO). There are three health care additions as well: Allergan (NYSE:AGN), Amgen (NASDAQ:AMGN), and HCA. The lone energy name added is Consol Energy (NYSE:CNX).
- Exiting the index are energy names Halliburton (NYSE:HAL) and National-Oilwell Varco (NYSE:NOV), along with healthcare companies AbbVie (NYSE:ABBV), Aetna (NYSE:AET), Humana (NYSE:HUM), and Tenet Healthcare (NYSE:THC). Citigroup (NYSE:C), CBS, Crown Castle (NYSE:CCI), and Michael Kors (NYSE:KORS) round out those subtracted.
- IBLN tracks the highest-conviction S&P 500 picks by hot-handed billionaires who built their fortunes through hedge funds and investing. The list of billionaires tracked is updated each October, and the equity components are rebalanced each quarter after sifting through regulatory filings.
- IBillionaire Index Rebalance
Thu, Feb. 19, 12:55 PM
- Actavis (ACT +1.6%) commences concurrent public offerings of $4.2B of common stock and $4.2B of Mandatory Series A Convertible Preferred Shares. Net proceeds will assist in funding its acquisition of Allergan (AGN +0.5%). Underwriters over-allotments are 10% of the number of shares in each offering. Terms and pricing have yet to be announced.
Wed, Feb. 18, 8:53 AM
Wed, Feb. 18, 7:27 AM
- Actavis (NYSE:ACT) Q4 results ($M): Total Revenues: 4,056.9 (+46.0%); North America Brands: 1,830.9 (+163.2%); North America Generics & Intl: 1,782.7 (+4.8%); Anda Distribution: 443.3 (+15.7%).
- COGS: 1,831.3 (+24.4%); R&D Expense: 364.6 (+91.5%); SG&A Expense: 1,198.2 (+66.9%); Net Income: (732.9) (-393.9%); EPS: (2.76) (-220.9%); CF Ops: 811.6 (+24.5%); Quick Assets: 251.0 (-24.3%).
- Gross Profit: 2,226 (+70.2%); COGS: 45.1% (-14.7%); Gross Margin: 54.9% (+16.6%); Operating Earnings: 662.8 (+65.9%); Operating Earnings Yield: 16.3% (+13.6%); Net Earnings Yield: -18.1% (-238.3%).
- Key Product Sales: Namenda: 471.7; Delzicol/Asacol HD: 145.6; Bystolic: 154.0; Urology: 75.9; Dermatology/Established Brands: 242.9.
- 2015 Guidance: Revenues: ~$15B (unch); Non-GAAP EPS: $16.30 - 17.30 from $15.60 - 16.80.
Wed, Feb. 18, 6:43 AM
Tue, Feb. 17, 10:06 PM
- Elite Pharmaceuticals (OTCQB:ELTP) plans to commence a Phase 3 study in late March evaluating its abuse-deterrent opioid product candidate, ELI-200. The company has submitted a study protocol to the FDA and expects to receive its comments by mid-March. Patient dosing should start shortly thereafter.
- The multi-center, randomized, double-blind, placebo-controlled, parallel group clinical trial will assess the safety and efficacy of abuse-deterrent ELI-200 for the treatment of adult patients with moderate-to-severe pain following surgery. The study will enroll ~150 patients and will take ~eight weeks to complete.
- Elite projects submitting a New Drug Application (NDA) in Q3 and achieving regulatory clearance by early 2016.
- The company's abuse-deterrent technology is a multi-particulate capsule that contains an opioid agonist in addition to the opioid antagonist, naltrexone. If the multi-particulate beads are crushed or dissolved, the naltrexone is released which blocks the effects of the opioid. The technology is the firm's top priority, expected to add considerably to its modest revenues to date. Fiscal Q3's top line was only $1.4M.
- Related tickers: (NYSE:PFE) (NASDAQ:ACUR) (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
Tue, Feb. 17, 5:35 PM
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Tue, Feb. 17, 8:40 AM
- The FDA accepts for review the New Drug Application (NDA) from privately-held Canton, MA-based Collegium Pharmaceuticals for Xtampza ER, its abuse-deterrent extended-release oxycodone formulation for the treatment of chronic pain.
- Its abuse-deterrent technology is called DETERx, which preserves the extended-release properties following common methods of tampering. It also avoids the use of antagonists (Pfizer's (NYSE:PFE) ALO-02 and Embeda) and aversive agents (Acura's (NASDAQ:ACUR) AVERSION), thereby minimizing the risks to legitimate patients.
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
Tue, Feb. 17, 7:38 AM
- The U.S. District Court for the District of New Jersey rules that AstraZeneca's (NYSE:AZN) patent No. 7,524,834 (the '834 patent) protecting Pulmicort Respules is invalid. The patent, set to expire in 2018 and with pediatric exclusivity extending into 2019, will allow Actavis (NYSE:ACT) to release its generic version of the product. Teva Pharmaceutical Industries (NYSE:TEVA) has marketed a generic formulation for some time per a previous agreement with AstraZeneca.
- The court originally invalidated the '834 patent in April 2013 but the ruling was reversed and remanded in October 2013 by the U.S. Court of Appeals for the Federal Circuit.
- The company says the decision will not impact its 2015 guidance. Pulmicort generated $269M in sales in Q4 and $946M over the past 12 months. EVP, North America Paul Hudson says, "AstraZeneca strongly disagrees with the Court's decision. [The Company] has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules. We are reviewing the decision and considering our legal options, including an appeal."
- Shares are down 1.5% premarket on light volume.
Fri, Feb. 13, 7:22 PM
- Dan Loeb added new stakes in Citigroup (NYSE:C), Alibaba (NYSE:BABA), AIG, EMC and Allergan (NYSE:AGN) in the fourth quarter as the latest 13F from his Third Point fund indicates.
- The Alibaba addition of 2.8M shares to an existing 7.2M-share position brings Third Point to 10M shares. A new Citigroup position is 25M shares.
- Meanwhile, a 400K-share stake in Allergan is a new position, as is 7M shares in EMC and 3.5M shares of AIG.
- Loeb also unloaded a 750K-share position in FedEx (NYSE:FDX).
- Overall Third Point increased the value of equity holdings 27%, to $11.09B.
- After hours: BABA -0.5%; AGN +0.5%.
Fri, Feb. 13, 11:22 AM
- The FDA accepts for review Pfizer's (PFE -0.1%) New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- ALO-02 incorporates abuse-deterrent technology. The capsules contain pellets consisting of the opioid, oxycodone, surrounding sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, patients receive oxycodone in an extended release manner with no effect from the naltrexone. If the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released, counteracting the effects of oxycodone.
- Related tickers: (ZGNX +1.8%)(MNK +1.8%)(ACT +1.1%)(TEVA -0.6%)(ABBV +1%)(LCI -1%)(ALKS -3.7%)
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