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Botox Effect Lasts Longer At Higher Doses, TEVA Gets FDA Nod, KNSA On Watch

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Today's Daily Dose brings you news about results from Allergan's clinical study evaluating higher doses of BOTOX Cosmetic; CEL-SCI's better capitalization, following exercise of warrants; Kiniksa's phase 1a/1b clinical trial of KPL-716 in moderate-to-severe atopic dermatitis, and FDA approval of Teva's preventive treatment of migraine.

Read on...

Allergan plc's (AGN) clinical study evaluating higher doses of BOTOX Cosmetic, say, 40, 60, and 80 unit doses compared to BOTOX Cosmetic 20 unit dose at week 24 in patients with moderate to severe glabellar lines has met primary endpoint demonstrating that higher doses of BOTOX Cosmetic produce greater duration of treatment effect.

According to the trial results, the primary efficacy endpoint was met and was statistically significant for BOTOX Cosmetic 40 and 80 units versus 20 unit in 226 subjects at 24 weeks.

In the trial, 32% of patients were responders at week 24 in the BOTOX Cosmetic 40 unit group, 30.6% in the BOTOX Cosmetic 60 unit group, and 38.5% in the BOTOX Cosmetic 80 unit group compared to 16% in the 20 unit group. The dose effect was observed across additional outcome variables, added the Company.

Currently, the approved dose of BOTOX Cosmetic for glabellar lines is 20 Units in 0.5 mL.

In other news, Allergan is all set to acquire Bonti, Inc., a privately held clinical-stage biotechnology company focused on the development and commercialization of novel, fast-acting neurotoxin programs for aesthetic and therapeutic applications, for an upfront payment of $195 million and additional potential commercial milestone payments, subject to certain adjustments and other customary closing conditions.

AGN closed Friday's trading at $188.22, down 0.98%.

CEL-SCI Corp. (CVM) has received $5.44 million through the exercise of warrants to purchase shares of the Company's common stock during August through September 13, 2018.

As of September 13, 2018, the Company had 27,351,324 outstanding shares of common stock.

Commenting on the recent fund, CEL-SCI's CEO Geert Kersten said, "CEL-SCI, now better capitalized with $12 million raised in the first half of the year and the recent $5.4 million from the warrant exercises, moves forward towards the anticipated data readout on our pivotal, global Phase 3 study in head and neck cancer."

Near-term Catalyst:

-- The top line results from a phase III trial of its investigational immunotherapy Multikine in the treatment of head and neck cancer may be available as soon as early 2019.

CVM closed Friday's trading at $3.59, up 13.61%.

Kiniksa Pharmaceuticals Ltd.'s (KNSA) single intravenous and subcutaneous doses of KPL-716 were found to be well-tolerated and showed reduction in pruritus in a phase 1a/1b clinical trial in both adult healthy volunteers and adult subjects with moderate-to-severe atopic dermatitis experiencing moderate-to-severe pruritus.

The results support Kiniksa's plans for expanding clinical development into multiple chronic pruritic diseases, including prurigo nodularis.

KNSA closed Friday's trading at $26.48, up 6.00%.

The FDA, on Friday, approved Teva Pharmaceutical Industries Ltd.'s (TEVA) AJOVY (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults with quarterly (675 mg) and monthly (225 mg) dosing options.

The first approved therapy designed specifically for migraine prevention is Novartis' Aimovig. It was approved in the U.S. in May of this year, and in the EU in July.
Aimovig works by blocking calcitonin gene-related peptide receptor (CGRP-R), which plays an important role in migraine. Teva's AJOVY also belongs to the same class as that of Aimovig.

The U.S. Wholesale Acquisition Cost of AJOVY is $575 per monthly dose and $1,725 per quarterly dose. AJOVY will be available through retail and specialty pharmacies in approximately two weeks. There is a savings offer for AJOVY. Commercially insured patients may pay as little as $0 on prescriptions for AJOVY until the offer expires, noted Teva.

AJOVY is expected to generate peak sales of about $960 million by 2022, according to Clarivate Analytics.

TEVA closed Friday's trading at $21.50, down 1.15%.

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