Aug. 22, 2014, 5:00 AM
- The DEA has reclassified hydrocodone combination drugs to stem a rise in their abuse, and will now label them in a category reserved for medical substances with the highest potential for harm.
- The move has been resisted by many drug makers and wholesalers, but others like Mallinckrodt (NYSE:MNK) support it and say it will have no significant impact on their business.
- Major makers of hydrocodone combination drugs include Actavis (NYSE:ACT), Teva (NYSE:TEVA), AbbVie (NYSE:ABBV), Zogenix (NASDAQ:ZGNX), Lannett (NYSE:LCI), and Alkermes (NASDAQ:ALKS).
Aug. 20, 2014, 5:35 PM
Aug. 14, 2014, 7:10 PM
Aug. 7, 2014, 9:21 AM
Aug. 7, 2014, 7:30 AM
- Mallinckrodt (MNK -1.7%) fiscal Q3 results: Net Sales: $653.1M (+14.6%); Gross Profit: $284.3M (+7.0%); Operating Loss: ($4.4M) (-633.3%); Net Loss: ($24.1M) (+13.6%); Loss Per Share: ($0.41) (+14.6%); Quick Assets: $327.9M (+19.0%): CF Ops (9 mo.): $168.1M (+999%).
- Fiscal 2014 Guidance: Net sales: $2.35B from $2.45B from $2.28 - 2.38B; Specialty Pharma sales: $1.425B - 1.500B from $1.38B - 1.43B; Global Medical Imaging sales: $850M - 900M (unch); Methylphenidate sales: at least $190M from at least $160M; non-GAAP EPS: $4.00 - 4.30 from $3.30 - 3.60.
Aug. 7, 2014, 7:14 AM
Aug. 6, 2014, 5:30 PM
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Aug. 4, 2014, 10:26 AM
Jul. 24, 2014, 10:23 AM
- Questcor (QCOR +0.8%) Q2 results: Net Sales: $278.8M (+51.0%), Pharmaceuticals: $261.4M (+47.7%); COGS: $23.2M (+34.9%); Gross Profit: $255.7M (+52.7%); R&D Expense: $22.0M (+80.3%); SG&A Expense: $83.6M (+63.9%); Operating Income: $147.8M (+43.4%); Net Income: $96.4M (+39.5%); EPS: $1.54 (+37.5%); Quick Assets: $392.8M (+60.3%).
- Acthar vials shipped: 8,850 (+25.5%); new paid Acthar prescriptions: 2,775 - 2,800 (+~23%), new paid Nephrotic Syndrome prescriptions: 480 - 490 (+~20%).
- No guidance given.
Jul. 24, 2014, 9:14 AM| 3 Comments
Jul. 23, 2014, 5:33 PM
- The FDA approves Purdue Pharmaceuticals' Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) for the treatment of severe pain requiring around-the-clock long-term opioids where alternative treatment options are inadequate.
- Targiniq incorporates abuse deterrent technology. When a pill is crushed and/or dissolved (for snorting or injecting) the naloxone blocks the euphoric effects of oxycodone making it less desirable for abusers than oxycodone alone.
- The agency requires a postmarket study to assess the risks of long-term use beyond 12 weeks and the effects of the abuse deterrent features.
- Related tickers: (NASDAQ:ZGNX) (NYSE:ABBV) (NYSE:TEVA) (NASDAQ:ALKS) (NYSE:MNK) (NYSE:PFE)
Jul. 14, 2014, 8:07 AM
- The SEC declares the Form S-4 (joint proxy statement/prospectus) effective on July 11 regarding Mallinckrodt's (NYSE:MNK) acquisition of Questcor Pharmaceuticals (NASDAQ:QCOR). Both firms have scheduled shareholder meetings on August 14, 2014 for shareholders of record on July 9, 2014 to vote on the transaction.
Jul. 11, 2014, 7:44 AM| 3 Comments
Jul. 11, 2014, 7:23 AM
- Sun Pharmaceutical Industries voluntarily recalls 41,127 bottles of antidepressant venlafaxine hydrochoride in the U.S. because the pills do not meet dissolution specifications. The recall is classified as Class II which means that the use of the drug may cause temporary or medically reversible adverse health consequences.
- Pfizer (PFE) recalled 104,000 bottles of the same drug several months ago after a pharmacist noticed that one of the bottles contained a heart medication. It sells in the U.S. under the brand name Effexor XR.
- Sun is also recalling 200 vials of the chemo drug gemcitabine in the U.S. due to a lack of assurance of sterility.
- Related tickers: (TEVA) (RDY) (MYL) (MNK) (PRGO)
Jul. 8, 2014, 3:59 PM
- Shares of Zogenix (ZGNX -12.9%) tumble today on more than a 2x surge in volume in response to the competitive threat from Purdue. The FDA granted its tamper-resistant hydrocodone product Priority Review which means that it could debut in the U.S. by the end of 2014.
- Zogenix is working on its own abuse deterrent version of Zohydro. It plans to submit an sNDA in October. The time frame for regulatory review may delay its U.S. launch until the mid-2015, however.
- Related tickers: (ABBV -3%) (TEVA -1.7%) (ALKS -2.4%) (MNK -2.2%) (PFE -1.1%)
Jul. 8, 2014, 7:16 AM
- The FDA grants Priority Review to Purdue for its tamper-resistant pain medication that competes with Zogenix's (ZGNX) Zohydro. The agency's review of the company's hydrocodone tablet should take ~six months.
- Purdue's chronic pain offering is hard for abusers to crush so it makes it more difficult to snort or inject. The FDA has stated that Zohydro could be pulled from the market if another manufacturer gets an abuse-deterrent version approved. Zogenix plans to submit an sNDA for an abuse-deterrent formulation of Zohydro in October. Two other competitors are in Phase 3 trials with their product candidates.
- Related tickers: (TEVA) (ABBV) (ALKS) (MNK) (PFE)
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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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