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DERM Delights With A Hat-trick, Shot In The Arm For APRI, FDA Nod For TEVA


Apricus Biosciences Inc.'s (APRI) Vitaros, an on-demand topical cream indicated for the treatment of patients with erectile dysfunction, has been approved in Mexico.
Vitaros will be marketed by Apricus' commercialization partner, Ferring Pharmaceuticals.

Apricus has an exclusive Vitaros distribution agreement with Ferring in Latin America, Germany, Austria, Belgium, Denmark, Finland, Iceland, Luxembourg, Norway, the Netherlands, Sweden, Switzerland and certain countries in Asia, the United Kingdom and Korea.

Under the terms of the agreement, Apricus has received a total of $4.5 million in upfront payments from Ferring, in addition to a regulatory milestone payment of $1.6 million. Apricus is eligible to receive up to an additional $28 million in regulatory, launch and sales milestones, plus royalties on future net sales.

APRI closed Wednesday's trading at $2.86, up 89.40%.

ARCA biopharma Inc.'s (ABIO) seamless phase 2B/3 clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation has enrolled the 150th patient.

The trial, dubbed GENETIC-AF, is currently enrolling patients in the United States, Canada and Europe.

The Data Safety Monitoring Board (DSMB) will conduct an interim efficacy, safety and futility analysis of the trial, and the outcome of this interim analysis is expected in the third quarter of 2017.

ABIO closed Wednesday's trading at $2.70, up 3.85%.

CoLucid Pharmaceuticals Inc. (CLCD) is all set to be acquired by Eli Lilly and Co. (LLY) for $46.50 per share in cash, which equates to a total value of approximately $960 million. The offer price represents a premium of 33% to Jan.17 closing price of $34.90.

Lilly expects this acquisition to enhance its existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.

CoLucid's lead product candidate is Lasmiditan, which is under phase III testing, for the acute treatment of migraine. CoLucid has completed the first of two pivotal Phase 3 trials. A data read-out for the second Phase 3 trial, SPARTAN, is expected in the second half of 2017. If this trial is positive, submission of Lasmiditan for U.S. regulatory approval could occur in 2018.

The transaction is expected to close by the end of the first quarter of 2017, subject to customary conditions.

CLCD closed Wednesday's trading at $46.25, up 32.52%.

Dermira Inc.'s (DERM) third and final phase III trial of Cimzia in adult patients with moderate-to-severe chronic plaque psoriasis has also met the key goals.

The trial, dubbed CIMPACT, assessed the percentage of patients on Cimzia who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75), compared with placebo, at week 12.

The previous phase III trials of Cimzia in adult patients with moderate-to-severe chronic plaque psoriasis, dubbed CIMPASI-2 and CIMPASI-1, had also produced positive results.

Cimzia is currently approved and marketed by Belgium-based biopharmaceutical firm UCB Pharma S.A. for the treatment of numerous inflammatory diseases like Crohn's disease, rheumatoid arthritis and psoriatic arthritis in adults in multiple countries, including the United States.

In July 2014, UCB granted Dermira an exclusive license to develop Cimzia in psoriasis in the U.S., Canada and the European Union.

UCB intends to submit marketing applications to regulatory authorities, seeking approval of Cimzia in moderate-to-severe chronic plaque psoriasis, in the third quarter of 2017.

DERM closed Wednesday's trading at $29.20, up 2.67%.

Immunomedics Inc. (IMMU) expects to submit a Biological License Application to the FDA for accelerated approval of IMMU-132 in metastatic triple-negative breast cancer patients in mid-2017.

IMMU-132, which is under phase II testing, has produced rapid and durable responses in metastatic TNBC patients, with only limited and manageable Grade 3 or 4 toxicity. Last month, the company achieved the goal of enrolling 100 TNBC patients, as requested by FDA for BLA filing.

IMMU closed Wednesday's trading at $4.17, up 7.20%.

Paratek Pharmaceuticals Inc. (PRTK) has completed enrollment, reaching the target of 750 subjects, in the pivotal phase III clinical study evaluating Omadacycline for the treatment of Community Acquired Bacterial Pneumonia.

The top-line data from this study are anticipated in the second quarter of 2017.

A phase III trial of Sarecycline for the potential treatment of acne and rosacea in the community setting is ongoing. Allergan owns the U.S. rights for the development and commercialization of Sarecycline. Paratek retains all ex-U.S. rights.

Allergan initiated two identical phase III registration studies in December 2014 for Sarecycline for the treatment of moderate to severe acne vulgaris. Top line Phase 3 data are expected in early 2017.

PRTK closed Wednesday's trading at $14.35, down 1.03%.

Synthetic Biologics Inc. (SYN) plans to initiate a phase IIb/III adaptive pivotal trial for SYN-010 to treat the underlying cause of irritable bowel syndrome with constipation by the end of the first quarter of 2017.

The 12-week, multi-center, double-blind, placebo-controlled study will enroll approximately 840 adult subjects diagnosed with IBS-C.

SYN closed Wednesday's trading at $0.82, down 1.07%. In after-hours, the stock was up 6.10% to $0.82.

Teva Pharmaceutical Industries Ltd.'s (TEVA) VANTRELA ER has received FDA approval 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 drug's label describes the product's abuse-deterrent properties against abuse in the three most common routes—oral, intranasal and intravenous.

Last June, an FDA panel recommended the approval of VANTRELA ER.

TEVA closed Wednesday's trading at $34.10, up 1.04%.

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