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Tue, Jul. 28, 7:16 AM
- As part of its plan to streamline its portfolio and focus on higher-growth, higher-margin opportunities in specialty pharmaceuticals, Mallinckrodt (NYSE:MNK) sells its contrast media and delivery systems (CMDS) business to French firm Guerbet for $270M. In H1, the CMDS unit generated $210M in sales.
- Beginning in Q4, MNK will report the business as a discontinued operation. This will reduce fiscal year revenues between $415M - 425M and reduce non-GAAP EPS between $0.35 and 0.45.
- The transaction should close in the next few months.
Tue, Jun. 30, 10:08 AM| Tue, Jun. 30, 10:08 AM | 3 Comments
Fri, May 29, 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
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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%)
Mallinckrodt PLC along with its subsidiaries operates in a specialty biopharmaceutical and nuclear imaging business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and nuclear imaging agents.
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