Mallinckrodt Initiates Amyotrophic Lateral Sclerosis Study
Zacks Investment Research | Jun 16, 2017 04:22AM ET
Mallinckrodt plc (NYSE:MNK) announced that it has enrolled the first patient in its phase IIB study, PENNANT. The study is designed to assess the efficacy and safety of H.P. Acthar Gel for the treatment of amyotrophic lateral sclerosis (ALS).
The study will enroll patients between ages 18 to 75 with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ two years prior to the screening visit.
The patients (n=195) will be randomized on a 2:1 basis to receive subcutaneous (SC) Acthar Gel 0.2 mL (16 units) daily or SC matching placebo 0.2 mL daily for 36 weeks.
The efficacy of Acthar gel will be evaluated using standard measures of functional decline, including change from baseline in the ALS Functional Rating Scale-Revised, assessed after 36 weeks of therapy.
The company’s shares fell 16.6% year to date compared with the Zacks classified Medical – Generics Drugs industry’s decline of 5.0%.
The FDA granted the company's request for a Fast Track designation and orphan status for its H.P. Acthar Gel Investigational New Drug application in patients with ALS.
Acthar has been approved by the FDA to be used for 19 indications. The drug currently generates the company’s net sales from 10 of the on-label indications. The indications include the treatment of proteinuria in nephrotic syndrome of the idiopathic type, the treatment of acute exacerbations of multiple sclerosis in adults, the treatment of infantile spasms in infants and children under two years, and the treatment of the pulmonology indication of sarcoidosis. It also includes the treatment of ophthalmic conditions related to severe acute and chronic allergic and inflammatory processes and the treatment of certain rheumatology-related conditions, including the treatment of rare and closely related neuromuscular disorders dermatomyositis and polymyositis.
Mallinckrodt is working on boosting Acthar sales for the approved indications including rheumatology and pulmonology as well as underserved patient populations.
Performance of the drug has been impressive so far, propelled by solid demand for rheumatology, pulmonology, ophthalmology, and nephrology and expanded access in more recently promoted indications such as lupus and sarcoidosis, as well as mature indications such as infantile spasms and nephrotic syndrome.
The product is projected to grow in the mid-single to low double-digit range. The label expansion of the product is expected to boost sales further.
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Zacks Rank and Stocks to Consider
Mallinckrodt currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the health care sector include VIVUS, Inc. (NASDAQ:VVUS) , MEI Pharma, Inc. (NASDAQ:MEIP) and Geron Corp. (NASDAQ:GERN) . VIVUS and Mei Pharma sport a Zacks Rank #1 (Strong Buy) while Geron carries a Zacks Rank #2 (Buy). You can see .
VIVUS’ loss per share estimates have narrowed from 50 cents to 39 cents for 2017 in the last 60 days. The company delivered positive earnings surprises in the four trailing quarters, with an average beat of 233.69%.
MEI Pharma’s estimates have moved up from loss per share of 1 cent to earnings per share of 1 cent for 2017 in the last 60 days. The company delivered positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%.
Geron’s loss per share estimates have narrowed from 10 cents to 9 cents for 2017 over the last 60 days. The company delivered positive earnings surprises in each of the four trailing quarters, with an average beat of 27.98%.
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