Mallinckrodt PLC (MNK) - NYSE
  • 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.
    | Jul. 23, 2014, 5:33 PM | 10 Comments
  • 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. 14, 2014, 8:07 AM | 3 Comments
  • Jul. 11, 2014, 7:44 AM
    • For the first time, Questcor (QCOR) is reporting adverse events of patients treated with Acthar Gel (repository corticotropin injection) are ~5%, notes The New York Times. The information is disclosed in a regulatory filing submitted yesterday.
    • 8-K (see paragraph 3 under "Product Safety")
    | 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. 11, 2014, 7:23 AM
  • Jul. 8, 2014, 3:59 PM
    | Jul. 8, 2014, 3:59 PM | 7 Comments
  • 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)
    | Jul. 8, 2014, 7:16 AM | 24 Comments
  • Jul. 3, 2014, 8:28 AM
    • In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
    • Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
    • One possible outcome of Teva's aggressive efforts to maintain a moat around Copaxone is that it may give it more empathy for branded drug makers when it goes after incumbent products with its own generic versions.
    • Related tickers: (MNK) (ACT) (JNJ) (MYL) (MNTA) (NVS)
    | Jul. 3, 2014, 8:28 AM | 1 Comment
  • Jul. 2, 2014, 7:54 AM
    • Zogenix (ZGNX) plans to submit an sNDA by October 2014 for a next-generation version of Zohydro (hydrocodone bitartrate) Extended-Release Capsules that incorporates unspecified abuse deterrent technology designed to make it more difficult to abuse via injection or snorting. If approved, the new formulation will be available in early 2015.
    • The company has also selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. The product will incorporate abuse deterrent technology that maintains the extended-release properties of Zohydro when the tablet is crushed or chewed. This minimizes one on the ways that opioids are abused. It will have additional features that addresses abuse by injection or nasal administration.  Zogenix plans to submit an NDA in H1 2016.
    • Related tickers: (TEVA) (ABBV) (ALKS) (MNK)
    | Jul. 2, 2014, 7:54 AM | 2 Comments
  • Jun. 23, 2014, 9:46 AM
    • Questcor Pharmaceuticals (QCOR +0.1%) acquires the commercial rights to Novartis' (NVS -0.7%) Synachthen (tetracosactrin) and Synacthen Depot in all countries worldwide except 13 European countries where NVS previously granted the rights to a third party.
    • The products are approved ex-U.S. for multiple indications including certain autoimmune and inflammatory conditions. Questcor has begun pre-clinical development work in the U.S.
    • Under the terms of the agreement, QCOR will have the right to develop, market, manufacture, distribute, sell and commercialize Synacthen in the assigned countries.
    | Jun. 23, 2014, 9:46 AM | 6 Comments
  • Jun. 5, 2014, 10:36 AM
    • The European Medicines Agency (EMA) reinstates the GMP certificate for India's generic drug maker Ranbaxy Laboratories' Toansa manufacturing site after the company implements corrective measures. The EMA suspended the GMP certificate in January after an on-site FDA inspection discovered significant deficiencies. An EMA inspection team concluded that there was no evidence that any drugs in the EU market containing Toansa-made ingredients were of unacceptable quality or presented a risk to patients.
    • Related generic drug tickers: (TEVA) (RDY) (MYL) (MNK) (PRGO)
    | Jun. 5, 2014, 10:36 AM
  • May 28, 2014, 8:34 AM
    • The FDA accepts Mallinckrodt's (MNK) NDA for MNK-155, an investigational extended-release oral formulation of hydrocodone and acetaminophen for the management of moderate to moderately severe pain where the use of opioids is appropriate.
    • The product incorporates Depomed's (DEPO) Acuform drug delivery technology. The USPTO has issued a notice of allowance to MNK relating to composition claims pertaining to the design, formulation, pharmacokinetic  and release characteristics of MNK-155.
    • The FDA's acceptance of the filing triggers a $5M milestone payment to DEPO. Regulatory clearance will trigger another $10M milestone plus a 7.5% royalty on sales.
    • Related tickers: (ZGNX) (TEVA) (ABBV) (ALKS)
    | May 28, 2014, 8:34 AM | 1 Comment
  • May 14, 2014, 9:43 AM
    • Questcor Pharmaceuticals (QCOR -0.8%) enters a collaboration with an undisclosed privately held European firm to develop novel melanocortin peptides. The deal includes an option to acquire the technology during clinical development.
    • The firm will focus on novel receptor-selective peptide compounds designed to target specific melanocortin cellular receptors in order to address specific autoimmune and inflammatory diseases with high unmet medical need. The agreement includes a technology platform that provides a library of these peptides.
    • Under the terms of the agreement, QCOR will fund the development work while securing an exclusive global license to the peptides and technology including the aforementioned option to acquire the technology at a later date.
    | May 14, 2014, 9:43 AM | 4 Comments
  • May 12, 2014, 10:58 AM
    • The FTC terminates the waiting period effective May 9 regarding Mallinckrodt's (MNK) acquisition of Questcor Pharmaceuticals (QCOR -0.1%) thereby satisfying one of the conditions of the merger. Both companies' shareholders must still vote on the deal. The transaction is expected to close in Q3.
    | May 12, 2014, 10:58 AM | 3 Comments
  • May 8, 2014, 6:38 AM
    • Mallinckrodt (MNK): FQ2 EPS of $0.95 beats by $0.20.
    • Revenue of $558M (-4.7% Y/Y) misses by $8.5M.
    • Shares +7.8% PM.
    | May 8, 2014, 6:38 AM
  • May 7, 2014, 5:30 PM
  • Apr. 28, 2014, 4:14 PM
    • Net sales: $227.1M (+68%). EPS: $1.20 (+85%).
    • Acthar shipments: 7,080 vials (+47%).
    • New paid Acthar prescriptions: 2,325 - 2,350 (+35%). Rheumatology indications: 570 - 580 (+297%).
    • R&D: $19.9M (+84%).
    • CF Ops: $106M (+159%).
    • Dividend: $0.30 payable by July 8 to shareholders of record July 1.
    • (QCOR -2.5%)
    | Apr. 28, 2014, 4:14 PM | 3 Comments
Company Description
Mallinckrodt Plc is a global specialty pharmaceuticals company. It develops, manufactures, markets and distributes both branded and generic specialty pharmaceutical products and medical imaging agents. The company operates its business through two segments: Specialty Pharmaceuticals and Global... More
Sector: Healthcare
Industry: Medical Instruments & Supplies
Country: Ireland