Yesterday, 5:41 PM
- Orexigen Therapeutics (NASDAQ:OREX) enters into a supply agreement with Mallinckrodt (NYSE:MNK) for naltrexone, one of the active ingredients in its obesity pill Contrave. Orexigen will buy naltrexone at fixed prices, subject to certain limitations. The agreement will be effective through December 2018.
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%)
Tue, May 5, 9:10 AM
- Mallinckrodt (MNK +0.7%) FQ2 results: Revenues: $909.9M (+63.1%); COGS: $421.4M (+42.8%); R&D Expense: $47M (+13.5%); SG&A: $343.5M (+77.0%); Operating Income: $95.2M (+999%); Net Income: $76.5M (+553.8%); EPS: $0.66 (+230.0%); Quick Assets: $1,053.5M (+48.8%); CF Ops: $365.5M (+158.9%).
- 2015 Guidance: Sales: $3.75B - 3.85B; Adjusted EPS: $7.10 - 7.50; Non-GAAP effective tax rate: 18 - 20%.
Tue, May 5, 6:57 AM
Mon, May 4, 5:30 PM
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Mon, May 4, 5:30 PM
Mon, Apr. 27, 11:19 AM
- Drug manufacturers have long defended their pricing by citing the need to recoup ultra-high development costs. Now another price-raising scheme is drawing attention. In a report by the Wall Street Journal, there are a growing number of examples where companies acquire drugs they perceive as undervalued and then significantly raise the prices.
- In February, Valeant Pharmaceuticals (VRX -1.5%) purchased the rights to two heart drugs, Isuprel and Nitropress, from privately-held Marathon Pharmaceuticals for an undisclosed sum. It then immediately raised the prices 525% and 212%, respectively, based on the recommendations of a consultant who researched the price/benefit of each. According to Truven Health Analytics, the cost of a 1mL vial of Isuprel went from $215.46 to $1,346.62 while a 2mL vial of Nitropress went from $257.80 to $805.61.
- Last year, Mallinckrodt (MNK -0.7%) bought Cadence Pharmaceuticals to gain access to its Ofirmev pain meds. A short time later, the list price for a package of 24 vials jumped 2.5-fold to over $1,019.52.
- In 2013, Horizon Pharma increased the price of Vimovo pain tablets, after acquiring the rights from AstraZeneca, almost 600% to $959.04.
- Valeant is apparently leading the price-raising pack. It has boosted list prices by at least 20% about 122 times since early 2011.
- ETFs: IBB, BIB, BIS, DRGS
Fri, Apr. 17, 5:36 PM
Fri, Apr. 17, 8:11 AM
Wed, Apr. 8, 11:47 AM
- Mylan (MYL +10.4%) submits a non-binding proposal to Perrigo (PRGO +27.6%) to acquire it for $205 per share in a cash-and-stock deal. If consummated, the combined company would generate over $15B in annual sales.
- Generic drug-related tickers: (LCI +3%)(AKRX +4.4%)(MNK +2.8%)(IPXL +2.3%)(TARO +2.3%)(TEVA +3.2%)
Mon, Apr. 6, 12:23 PM
- Mallinckrodt (MNK -0.6%), through two subsidiaries, initiates a $1.2B offering of senior unsecured notes due 2020 and 2025 to fund its previously announced acquisition of all of the outstanding capital stock of Compound Holdings II and certain costs related to its buy of privately-held Ikaria.
- Previously: Mallinckrodt buys critical care firm for $2.3B (March 5)
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, 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)
Thu, Mar. 5, 1:23 PM
- Analysts at Deutsche Bank and Oppenheimer both like the strategic fit of Ikaria with Manllinckrodt's (MNK +4.8%) blended business.
- Deutsche maintains its "Buy" recommendations and raises its 2015 EPS estimate to $7.74 from $7.46 and price target to $130 (+7.4% upside) based on a P/E of 15.7.
- Oppenheimer maintains its "Outperform" rating and raises its price target to $140 based on a P/E of 16.1.
- Previously: Mallinckrodt buys critical care firm for $2.3B (March 5)
Thu, Mar. 5, 7:32 AM
- Mallinckrodt (NYSE:MNK) enters into a definitive agreement to acquire privately-held Ikaria for ~$2.3B. The takeover, expected to close by mid-year, will add $150M to Mallinckrodt's top line and at least $0.25 to EPS.
- The Hampton, NJ-based firm develops and commercializes therapies and delivery systems for the treatment of critically ill infants in the hospital neonatal intensive care unit setting. Its lead product is INOmax (inhaled nitric oxide), a vasodilator indicated, in conjunction with ventilatory support and other agents, for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.
- The transaction will strengthen Mallinckrodt's footprint in hospitals by extending its presence into surgical specialties. It also builds potential diversity in its nephrology rare disease pipeline with terlipressin (injection), currently being investigated for the treatment of Hepato-Renal Syndrome Type 1 (HRS1) , a rare life-threatening condition with no currently available therapies. Terlipressin is approved and recognized as the standard-of-care treatment of HRS1 internationally, including several countries in Europe.
- Mallinckrodt will host a conference call this morning at 8:30 am ET to discuss the deal.
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%)
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Mallinckrodt PLC develops, manufactures, markets & distributes generic specialty pharmaceutical products, active pharmaceutical ingredients and diagnostic imaging agents. It operates in two segments; Specialty Pharmaceuticals & Global Medical Imaging.
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