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Nov. 9, 2015, 7:26 AM
- A pilot study run by Mallinckrodt (NYSE:MNK) assessing H.P. Acthar Gel in patients with persistently active Systemic Lupus Erythematosus (SLE) on corticosteroid therapy failed to meet its primary endpoint of a clinical response defined by complete resolution of skin or joint activity as measured by the hybrid SLE Disease Activity Index (hSLEDAI) with no new organ system disease as measured by the British Isles Lupus Assessment Group-2004 (BILAG). The data were presented at poster session during the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in San Francisco.
- The company-sponsored study, "Repository Corticotropin Injection (H.P. Acthar Gel) Attenuates Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus (SLE) Requiring Corticosteroids" was an eight-week, double-blind, randomized placebo-controlled trial that assessed the clinical efficacy of repository corticotropin injection (RCI) in 38 patients with persistently active SLE involving skin and/or joints despite moderate dose corticosteroids. Subjects were randomized 2:1 to receive RCI 40 units subcutaneously every day, RCI 80 units subcutaneously every other day or volume-matched placebo gel.
- Although the study failed to achieve its primary efficacy endpoint, treatment with RCI did show improvement in secondary endpoints versus placebo, including reduction in total hSLEDAI, BILAG and CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) Activity scores, decreased tender and swollen joint count and increased proportion of subjects achieving response as defined by a composite index called SRI (SLE responder index).
- Most patients in the study were on multiple therapies so the clinical outcomes may not be solely attributable to Acthar, which has not been formally studied in combination with other commonly used SLE treatments.
- SLE, affecting more than 1.5M Americans, is an autoimmune disease in which the immune system produces antibodies to cells within the body that leads to widespread inflammation and tissue damage.
- H.P. Acthar Gel is currently FDA-approved for 19 indications but generates almost all of its sales in five areas: proteinuria in nephrotic syndrome, multiple sclerosis, infantile spasms, exacerbation or maintenance treatment of SLE and systemic dermatomyositis.
- Mallinckrodt obtained the rights to Acthar Gel via its $5.6B acquisition of Questcor Pharmaceuticals in August 2014.
Oct. 30, 2015, 8:25 AM
- Regulatory authorities in Australia and Japan approve an expanded label for Mallinckrodt's (NYSE:MNK) INOmax (nitric oxide), originally approved in 2007 and 2008, respectively, for the treatment of newborns with hypoxic respiratory failure.
- The Australian Therapeutic Goods Administration (TGA) clears INOmax for peri- and post-operative pulmonary hypertension in conjunction with cardiovascular surgery in neonates through adolescents up to age 17.
- The Japanese Ministry of Health, Labour and Welfare (MHLW) clears INOmax (marketed as INOflo/INOvent in country) for peri-operative pulmonary hypertension in conjunction with cardiovascular surgery for use in neonates through adults.
- INOmax, a vasodilator (opens blood vessels) that improves oxygen uptake and blood flow, is used in conjunction with ventilator support and other agents.
Oct. 16, 2015, 12:32 PM
- Opko Health (OPK +2.5%) initiated with Overweight rating and $14 (47% upside) price target by JP Morgan.
- Jazz Pharmaceuticals (JAZZ +1.7%) initiated with Outperform rating and $200 (44% upside) price target by Northland Capital Markets.
- Mallinckrodt (MNK) initiated with Outperform rating and $92 (37% upside) price target by Northland Capital Markets.
- Shire (SHPG +1.1%) initiated with Outperform rating and $288 (38% upside) price target by Northland Capital Markets.
- Nabriva Therapeutics (NBRV +2.2%) initiated with Outperform rating and $19 (90% upside) price target by Leerink.
- Penumbra (PEN -0.2%) initiated with Buy rating and $48 (20% upside) price target by Canaccord Genuity.
- REGENXBIO (RGNX -3.6%) initiated with Overweight rating and $36 (100% upside) price target by Piper Jaffray.
- Dyax (DYAX -0.9%) upgraded to Outperform from Market Perform by Leerink. Price target raised to $36 (29% upside) from $25.
- Eli Lilly (LLY +1.5%) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $105 (30% upside) from $89.
- Athenahealth (ATHN -4.6%) downgraded to Underperform from Buy by Jefferies. Price target lowered to $105 (22% downside risk) from $125.
- Halyard Health (HYH -1.5%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $27 (6% downside risk) from 38.
Oct. 5, 2015, 5:15 PM
- Biopharma Mallinckrodt (NYSE:MNK), down 1.8% after hours, is planning a business and financial guidance update for tomorrow morning.
- The company will give recast historical info showing its reclassification of its contrast media and delivery systems (CMDS) business as discontinued operations after agreeing to sell it to Guerbet for $270M in July. That deal is set to close in fiscal Q1 2016.
- A conference call to discuss the guidance, featuring a Q&A session, is set for 7:30 a.m. ET tomorrow.
- Shares fell 6.8% during market hours today.
Sep. 22, 2015, 1:51 PM
- The market's down day notwithstanding, thinly traded small cap ANI Pharmaceuticals (ANIP -16.2%) gets no help from Leerink analyst Jason Gerberry. Based on discussions with ANI and Mallinckrodt (MNK -1.3%), he says ANI's Acthar-similar won't pose much of a competitive threat to the latter's brand. He says ANI told him that it plans to market its version with a small sales force and offer only a modest discount to Acthar.
- Mr. Gerberry also cites the uncertainty about whether ANI's offering will be cleared for the same indications as Acthar since the package insert for the NDAs it acquired from Merck is not publicly available and the company is not making the documents available to investors. He says more clarity of ANI's development pathway won't be coming until mid-2016, after its meeting with the FDA.
- Previously: ANI Pharma picks up two NDAs from Merck for $75M (Sept. 21)
Sep. 10, 2015, 6:54 AM
- Mallinckrodt (NYSE:MNK) enters into an agreement to privately place $750M aggregate principal amount of 5.625% senior unsecured notes due October 2023 on September 24. The debt will help finance the company's previously announced acquisition of TGG Medical Solutions for $1.325B, which includes subsidiary Therakos.
- Previously: Mallinckrodt takes out Therakos for $1.3B (Aug. 10)
Aug. 10, 2015, 8:00 AM
- Mallinckrodt (NYSE:MNK) acquires privately-held West Chester, PA-based Therakos for $1.325B. The transaction is expected to close in Q3.
- Therakos develops autologous immune cell therapies delivered through extracorporeal photopheresis via its CELLEX and UVAR XTS systems. It employs extracorporeal (outside the body) photopheresis (certain components of the blood are separated and treated with a photosensitizing agent) to treat leukocyte-enriched blood for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma in patients that have not responded to other treatments. Specifically, the systems irradiate extracorporeally circulating blood with ultraviolet-A in the presence of the photoactive drug 8-methoxypsoralen.
- The deal is expected to add at least $0.10 per share to MNK's non-GAAP EPS in fiscal 2016 and increasingly accretive thereafter. Therakos' top line contribution will be $185M - 195M in fiscal 2015 with high single-digit growth going forward.
- MNK will fund the transaction with cash on hand plus debt.
Aug. 4, 2015, 9:35 AM
- Mallinckrodt (MNK -6.3%) FQ3 results: Revenues: $965.1M (+47.8%); COGS: $431.6M (+17.0%); R&D Expense: $45M (+5.4%); SG&A: $332.7M (+50.3%); Operating Income: $133.6M (+999%); Net Income: $58M (+340.7%); EPS: $0.48 (+214.3%); Quick Assets: $225.3M (-68.2%).
- No guidance given.
Aug. 4, 2015, 6:56 AM
- Mallinckrodt (NYSE:MNK): FQ3 EPS of $2.05 beats by $0.23.
- Revenue of $965.1M (+47.8% Y/Y) misses by $20.2M.
Aug. 3, 2015, 5:30 PM
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Jul. 28, 2015, 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.
Jun. 30, 2015, 10:08 AM| Jun. 30, 2015, 10:08 AM | 3 Comments
May 29, 2015, 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.
May 21, 2015, 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.
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May 5, 2015, 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%.
May 5, 2015, 6:57 AM
- Mallinckrodt (NYSE:MNK): FQ2 EPS of $1.72 beats by $0.20.
- Revenue of $909.9M (+63.1% Y/Y) beats by $49.01M.
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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