Tue, Mar. 17, 10:10 AM
Wed, Mar. 11, 10:01 AM
- Based on feedback from the FDA, Egalet (EGLT) now plans to submit a New Drug Application (NDA) for its abuse-deterrent, extended-release oral morphine product, Egalet-001, by the end of the year.
- The company will initiate a pivotal bioequivalence study comparing the 60 mg dose to Purdue's MS Contin later this month. Bioequivalence to MS Contin has already been demonstrated at the 15 mg and 30 mg doses.
- Egalet-001 incorporates the company's Guardian Technology to deter abuse. It utilizes injection molding to create a hard matrix and shell that is designed to be difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.
- Related tickers: (ZGNX -23.4%)(ACUR)(ALKS +0.5%)(PFE +0.6%)(ABBV +0.7%)(LCI +1.6%)(ACT +1.7%)(MNK +1.6%)(TEVA +2.6%)
Tue, Mar. 10, 3:29 PM
Tue, Mar. 10, 10:24 AM
- Akorn (AKRX -14.4%) slumps on double normal volume in response to Actavis' (ACT -1.2%) after hours announcement of its U.S. launch of a generic version of Fougera's Temovate (clobetasol cream 0.05%) for the relief of inflammatory and pruritic dermatoses. Akorn's generic version was one of its top sellers last quarter.
- To assuage investors, Akorn reaffirms its 2015 revenue guidance of $960M - 980M and Non-GAAP EPS of $1.88 - 1.98.
Tue, Mar. 10, 8:01 AM
- Privately-held Collegium Pharmaceutical raises $50M from institutional investors to fund the advancement of its abuse-deterrent product candidate, Xtampa ER (oxycodone extended-release capsules) through FDA clearance and commercial launch as well as fund operational growth and other pipeline programs.
- The FDA accepted the company's New Drug Application (NDA) for Xtampa ER in February. Its abuse-deterrent technology is called DETERx, which combines oxycodone with fatty acid and waxes to form small spherical beads which resist particle size reduction and dose dumping when subjected to breaking, crushing, chewing and dissolving.
- Previously: FDA accepts Collegium's NDA for abuse-deterrent opioid (Feb. 17)
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT) (NYSE:PFE) (NASDAQ:ACUR)
Tue, Mar. 10, 7:29 AM
- Vivus (NASDAQ:VVUS) receives notice from Teva Pharmaceutical Industries (NYSE:TEVA) that it has filed an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of Qsymia (phentermine and topiramate extended release). The company is currently reviewed the notice but a patent infringement lawsuit will surely be initiated considering its suit against Actavis (NYSE:ACT) for its ANDA submission. Once filed, there is an automatic 30-month stay of regulatory clearance to allow for the legal process to play out.
- Previously: Vivus sues Actavis over generic version of Qsymia (March 9)
Mon, Mar. 9, 10:58 AM
- Vivus (VVUS -3.8%) files suit in the U.S. District Court for the District of New Jersey against Actavis (ACT -0.3%) in response to a second Paragraph IV certification notice from Actavis challenging the validity of two additional patents covering Qsymia (phentermine and topiramate extended release). The lawsuit is a customary response from a branded drug maker to the filing of an Abbreviated New Drug Application (ANDA) from a potential generic competitor. Once filed, there is an automatic 30-month stay of the FDA clearance of the generic version.
- Vivus filed an earlier suit against Actavis relative to its infringement of additional Qsymia patents.
Wed, Mar. 4, 2:25 AM
- Actavis (NYSE:ACT) sold the second-biggest corporate-bond offering in history yesterday, with a $21B deal fueled by investors' desire for income-generating investments when yields on government debt remain low.
- The giant sale comes as companies this year sell debt at the fastest pace on record, extending a multi-year boom that has financed a flurry of deal making and stock buybacks.
- Actavis plans to use the money for its $66B acquisition of Botox maker Allergan (NYSE:AGN).
Mon, Mar. 2, 9:47 AM
- The European Commission approves Actavis (ACT +1.1%) subsidiary Durata Therapeutics International's Xydalba (dalbavancin) for the treatment of adult patients acute bacterial skin and skin structure infections (ABSSSI), the first once-weekly intravenous (IV) antibiotic approved for this indication.
- Xydalba will be commercialized by Rome, Italy-based Angelini.
- The product is marketed in the U.S. under the brand name Dalvance.
- Actavis acquired Durata in October.
- Previously: Actavis to buy Durata (Oct. 6, 2014)
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.
Thu, Feb. 19, 12:55 PM
- Actavis (ACT +1.6%) commences concurrent public offerings of $4.2B of common stock and $4.2B of Mandatory Series A Convertible Preferred Shares. Net proceeds will assist in funding its acquisition of Allergan (AGN +0.5%). Underwriters over-allotments are 10% of the number of shares in each offering. Terms and pricing have yet to be announced.
Wed, Feb. 18, 8:53 AM| 3 Comments
Wed, Feb. 18, 7:27 AM
- Actavis (NYSE:ACT) Q4 results ($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.
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