Mon, Feb. 2, 4:27 PM
- The first patient has been dosed in a 450-patient Phase 3 clinical trial assessing Flexion Therapeutics' (NASDAQ:FLXN) lead product candidate, FX006, for the treatment of moderate-to-severe pain associated with osteoarthritis of the knee.
- FX006 is a novel, non-opioid, sustained release, intra-articular formulation of triamcinolone acetonide. The company expects top line data in 2016.
- The FDA lifted its clinical hold on the company's Phase 2b trial in early December after it concluded its investigation of a case of septic shock in one patient.
- Previously: Clinical hold lifted for Flexion's lead product (Dec. 1, 2014)
- OA-related tickers: (NASDAQ:HZNP) (OTCPK:NRIFF) (NASDAQ:XENE) (NYSEMKT:AMPE) (NASDAQ:ANIK) (NYSE:MNK) (NASDAQ:CBYL)
Sat, Jan. 31, 12:35 PM
- The FDA approves Zogenix's (NASDAQ:ZGNX) Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek, a formulation technology that provides abuse-deterrent features without changing the release properties of hydrocodone.
- BeadTek incorporates pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents.
- The company intends to transition all Zohydro strengths to the BeadTek version in Q2. In H2, it expects to submit the results from its ongoing Human Abuse Liability Studies, which will further characterized the abuse-deterrent properties of the BeadTek formulation, to the FDA.
- Related tickers: (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NYSE:PFE)
Tue, Jan. 27, 1:13 PM
- Palo Alto, CA-based Carbylan Therapeutics (Pending:CBYL) is set for its IPO of 5.8M shares of common stock at $12 - 14. Underwriters over-allotment is an additional 870K shares.
- The clinical stage specialty pharmaceutical firm develops novel and combination therapies that address significant unmet medical needs. The technological basis for its products is a methodology that cross-links hyaluronic acid to form hydrogels. Alterations in the formula enable the formation of hydrogels in a wide range of textures, from soft to hard. Biologically-active agents can be directly incorporated into the gels, which can be applied topically or parenterally.
- Its lead product candidate is Hydros-TA, currently in Phase 3 development, an injectable therapy to treat the pain associated with osteoarthritis of the knee. The company expects to submit a New Drug Application (NDA) to the FDA for this indication in early 2017.
- Net losses for 2014 (9 mo.) and 2013 were $8.6M and $5.7M, respectively.
- OA-related tickers: (NASDAQ:HZNP) (OTCPK:NRIFF) (NASDAQ:XENE) (NYSEMKT:AMPE) (NASDAQ:FLXN) (NASDAQ:ANIK) (NYSE:MNK)
Fri, Jan. 23, 1:42 PM
- The Board of Directors of Mallinckrodt (MNK +1.5%) approves an open-ended $300M share repurchase program.
- CEO Mark Trudeau says, "Funding additional initiatives and seeking attractive business development opportunities remain top priorities as we continue to pursue a range of focused growth strategies. This authorization reflects our strong financial position and commitment to a disciplined capital allocation strategy while reaffirming our confidence in the company's outlook and long-term potential. It also gives us the flexibility to execute share repurchases in a measured and opportunistic manner over time."
Dec. 25, 2014, 12:41 PM
- Endo International plc (NASDAQ:ENDP) subsidiary Endo Pharmaceuticals and BioDelivery Sciences (NASDAQ:BDSI) submit a New Drug Application (NDA) to the FDA for Buprenorphine HCl Buccal Film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- The product uses BioDelivery's BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine across the buccal mucosa (inside lining of the cheek) via a thin film that adheres to the cheek lining in less than five seconds and then completely dissolves.
- Buprenorphine is a partial mu-opioid receptor agonist and a kappa antagonist which is different than full mu-opioid agonists like morphine. It is a Schedule III controlled substance which has a lower abuse potential than Schedule II drugs.
- Opioid-related tickers: (NASDAQ:ZGNX) (NYSE:PFE) (NASDAQ:EGLT) (NASDAQ:ACUR) (NYSE:MNK) (NYSE:ABBV) (NYSE:TEVA) (NASDAQ:ALKS)
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)
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