Nov. 20, 2014, 1:36 PM
- The FDA approves Purdue Pharma's Hysingla ER (hydrocodone bitartrate) for pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
- Hysingla ER incorporates abuse-deterrent properties that make the tablet difficult to crush, break or dissolve and it forms a viscous hydrogel that makes it difficult to prepare for injection.
- The agency is requiring postmarketing studies of Hysingla ER to assess the effects of its abuse-deterrent properties on the risk of abuse and the consequences of that abuse in the community. Purdue is also required to make educational programs available to healthcare professionals on now to safely prescribe ER/LA opioid analgesics in addition to medication guides and patient counseling documents.
- Opioid-related tickers: (ZGNX -0.8%)(PFE +0.2%)(EGLT +4.5%)(ACUR)(MNK +0.9%)(ABBV)(TEVA -0.1%)(ALKS +1.5%)
Nov. 19, 2014, 9:09 AM
- Mallinckrodt (MNK +0.4%) FQ4 results: Revenues: $789.3M (+44.8%); Specialty Pharmaceuticals revenue: $564.8M (+85.5%); Global Medical Imaging revenue: $213.4M (-6.8%); COGS: $388.7M (+32.6%); R&D Expense: $43.8M (+1.2%); SG&A: $280.5M (+107.0%); Operating Loss: ($356.5M) (-747.0%); Net Loss: ($352.4M) (-999%); Loss Per Share: ($4.14) (-813.8%).
- FY2014 results: Revenues: $2,540.4M (+15.2%); Specialty Pharmaceuticals revenue: $1,612.9M (+32.5%); Global Medical Imaging revenue: $881.5M (-5.8%); COGS: $1,337.3M (+13.4%); R&D Expense: $166.9M (+0.7%); SG&A: $842.1M (+38.1%); Operating Loss: ($284.1M) (-296.2%); Net Loss: ($319.3M) (-643.0%); Loss Per Share: ($4.92) (-582.4%); Quick Assets: $707.8M (+156.9%); CF Ops: $373.5M (+174.8%).
- No guidance given.
Nov. 19, 2014, 7:04 AM
Nov. 18, 2014, 5:30 PM
Nov. 13, 2014, 9:14 AM
- Mallinckrodt (NYSE:MNK) is down 8% premarket on average volume in response to the FDA's reclassification of its generic ADHD med.
- Previously: FDA downgrades classification of Mallinckrodt's ADHD med
Nov. 13, 2014, 9:10 AM
Nov. 13, 2014, 7:33 AM
- Citing its new draft guidance for determining bioequivalence of methylphenidate hydrochloride products, the FDA reclassifies Mallinckrodt's (NYSE:MNK) generic version of Janssen's (NYSE:JNJ) Concerta (methylphenidate HCL) from AB (freely substitutable at the pharmacy level) to BX (presumed to be therapeutically inequivalent).
- The draft guidance, published on November 6, has an open comment period through January 5, 2015. Nevertheless, the agency states that the change in classification would be reflected in the November 13 update of the Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- Unsurprisingly, the company strongly believes its product is safe and effective when used as indicated. President & CEO Mark Trudeau says, "We believe that the FDA's actions are not supported by sound scientific evidence and not consistent with the best interests of patients. Mallinckrodt methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA and in the 21 months since launch more than 88M doses of these products have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug (Concerta) to the company's methylphenidate ER products. We believe that this very low reporting rate is in line with response rates recorded for patients switching between different formulations of existing products."
- Since the agency's action was not contemplated in the company's October 14 guidance announcement, it will update it once the potential impact is fully assessed. Mallinckrodt will report fiscal Q4 and full-year results on November 19 before the open.
- Methylphenidate ER was the company's top seller in Q3 in the Specialty Generics and API segment generating $54.7M in sales. This represented 16.6% of the segment's total revenue of $329.4M and 8.4% of the firm's total Q3 revenue of $653.1M.
Oct. 20, 2014, 11:51 AM
Oct. 17, 2014, 5:20 PM
- The FDA approves new labeling for Pfizer's (PFE +0.4%) Embeda (morphine sulfate and naltrexone hydrochloride) extended release capsules. The opioid analgesic is indicated for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- The new labeling describes Embeda's abuse deterrent properties, which are designed to reduce, but not totally prevent, abuse of the drug when crushed and taken orally or snorted. When crushed, the naltrexone blocks some of the euphoric effects of the morphine and can precipitate withdrawal in opioid-dependent persons.
- When swallowed intact, though, Embeda can still be abused/misused because the naltrexone will not substantially block the effects of the morphine. It is also unknown whether Embeda's abuse deterrent properties will reduce IV abuse.
- The FDA is requiring postmarketing studies to further assess the impact of the abuse-deterrent properties.
- Opioid-related tickers: (ZGNX +1.9%)(EGLT +0.2%)(ACUR +2.3%)(MNK +4.1%)(ABBV +0.9%)(TEVA -0.8%)(ALKS +2.7%)
Oct. 14, 2014, 7:19 AM
- Mallinckrodt (NYSE:MNK) provides guidance for its fiscal year ended September 25, 2015.
- Net Revenues: $3.65B - 3.75B; Specialty Pharmaceuticals revenue: $2.87B - 2.92B; Global Medical Imaging revenue: $760M - 800M; non-GAAP EPS: $6.70 - 7.20; non-GAAP effective tax rate: 20 - 23%; capex: $130M - 150M.
- A conference call is scheduled for this morning at 9:00 am ET.
Oct. 7, 2014, 8:33 AM
- Danish biopharmaceutical firm Forward Pharma A/S (NASDAQ:FWP) is set for an IPO of 9.5M American Depository Shares at $20 - 22.
- Its lead product is FP187, a proprietary formulation of dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS), about to enter Phase 3 development.
- Meaningful revenues appear far in the distance, however. Patient recruitment for FP187's Phase 3 trial will take at least 18 months and the completion of the last patient's 48-week treatment will take a total of 30 months.
- The firm's operating losses for 2013 and 1H 2014 were $9M and $7.4M, respectively.
- MS-related tickers: (NASDAQ:BIIB) (NYSE:ABBV) (NYSEMKT:SYN) (NASDAQ:CNCE) (NYSE:SNY) (NASDAQ:XNPT) (NASDAQ:INO) (NASDAQ:OPXA) (NYSE:TEVA) (NASDAQ:ALKS) (NASDAQ:RCPT) (NASDAQ:AVNR) (NASDAQ:GCVRZ) (NYSE:NVS) (NASDAQ:QCOR)
Oct. 1, 2014, 10:37 AM
- Zogenix (ZGNX +4.3%) submits a supplemental New Drug Application to the FDA for an abuse deterrent version of Zohydro ER (hydrocodone bitartrate). The new capsule formulation contains additional inactive ingredients that make the product more difficult to abuse by injection and nasal insufflation (snorting).
- The company anticipates a target action date sometime in Q1 2015. If approved, the transition to the new formulation will occur in Q2.
- Related tickers: (MNK -1%)(ACT -2%)(TEVA -0.5%)(ABBV -0.9%)(LCI -4%)(ALKS -2.4%)(PFE -1.4%)
Sep. 25, 2014, 5:35 PM
Sep. 4, 2014, 10:26 AM
- In a slam dunk Phase 3 clinical trial, Mallinckrodt's (MNK +1.7%) opioid analgesic product candidate MNK-155 (7.5 mg hydrocodone and 325 mg acetaminophen) achieves its primary endpoint of improved pain scores versus placebo over the first 48 hours following bunionectomy (bunion removal).
- If a hydrocodone formulation can't beat placebo in relieving pain then something is bad wrong.
Sep. 3, 2014, 10:01 AM
- Mallinckrodt (MNK +1.9%) reports data from a Human Abuse Liability (HAL) study comparing the abuse-related effects of intact and crushed MNK-155, the company's generic version of Vicodin (hydrocodone bitartrate/acetaminophen) to branded Vicodin (ABBV +0.3%).
- In the HAL study, MNK-155 demonstrated statistically significant lower measures (p < 0.001) of drug liking, drug high and good drug effects compared to equivalent doses of Vicodin when measured at the peak drug effect. Mallinckrodt plans to present the data at this week's PAINWeek 2014 conference in Las Vegas, NV.
- The immediate- and extended-release components formulated into MNK-155 are patent protected.
- The company's NDA for MNK-155 is currently under FDA review.
Aug. 22, 2014, 9:17 AM
- Mallinckrodt (NYSE:MNK) announces the following executive changes pursuant to the Questcor (NASDAQ:QCOR) acquisition:
- SVP and Chief Strategy Officer Gary Phillips, M.D. appointed as SVP and President of Autoimmune and Rare Disease business (includes the commercial organization supporting H.P. Acthar Gel).
- Questcor SVP and Chief Compliance Officer Ray Furey appointed as SVP and Chief Compliance Officer at Mallinckrodt.
- Both executives will report to CEO Mark Trudeau. A search is underway for a Chief Strategy Officer.
MNK vs. ETF Alternatives
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.
Other News & PR