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LLY Gets Headache Relief, XENE Abuzz, 3rd Time's A Charm For PFE's Epogen Biosim

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Today's Daily Dose brings you news about FDA approval of the first and only biosimilar erythropoiesis-stimulating agent in the U.S., Titan Pharma's better-than-expected Q1 results; Sol-Gel's clinical trial catalysts; Xenon Pharma's positive phase I interim data of epilepsy drug candidate XEN1101, and Lilly's phase III data of migraine drug candidate Galcanezumab.

Read on…

AmpliPhi Biosciences Corp. (APHB) is planning to meet with the FDA in mid-2018 to define a path forward to regulatory approval for AB-SA01 and AB-PA01.

If all goes well as planned, the Company expects to initiate a phase II or registrational clinical study of AB-SA01 and AB-PA01, targeting multidrug-resistant Staphylococcus aureus and Pseudomonas aeruginosa, as early as the fourth quarter of 2018.

APHB closed Tuesday's trading at $1.19, up 6.25%.

Apollo Medical Holdings Inc. (AMEH) has reported a 50% drop in net income, and a 46% growth in revenue for the first quarter ended March 31, 2018.

Net income attributable to the Company declined to $2.2 million or $0.06 per share in the first quarter of 2018 from $4.3 million or $0.15 per share in the comparable period of 2017, a decrease of 50%. The decrease in net income was due to post-merger integration-related costs and investments to support two new management services agreements.

Net revenue in the recent first quarter was $124.2 million, up from $85.3 million in the comparable period of 2017, an increase of 46%.

AMEH closed Tuesday's trading at $16.90, up 0.78%.

Eli Lilly and Co. (LLY) has announced results from its two phase III trials of its migraine drug candidate Galcanezumab.

The phase III trial of Galcanezumab in patients with episodic cluster headache met its primary endpoint while the phase III study of Galcanezumab for patients with chronic cluster headache did not meet its primary endpoint.

Cluster headache is a rare type of headache characterized by unilateral (one sided) pain, usually centered over one eye, one temple or the forehead. There are two types of cluster headache - episodic cluster headache and chronic cluster headache.

In about 80% of people with cluster headache the bouts (or "clusters") of head pain last for 4 to 12 weeks once a year often at the same time and often in the Spring or Autumn. It may then disappear for several months or even years. This is known as episodic cluster headache. The remaining 20% of people do not have these pain free intervals and are said to have "chronic cluster headache" (Source: the migraine test).

In the episodic cluster headache trial, Galcanezumab demonstrated statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period.

A statistically significantly greater percentage of patients treated with Galcanezumab also achieved at least a 50 percent reduction in weekly cluster headache attacks compared to placebo at Week 3, the gated secondary endpoint.

However, another phase III study, which evaluated Galcanezumab for patients with chronic cluster headache, which represents 10 to 15 percent of cluster headache cases, did not meet its primary endpoint.

The two studies, which evaluated a combined 343 patients, are the largest controlled preventive trials conducted in cluster headache to date.

LLY closed Tuesday's trading at $82.21, down 1.04%.

Looks like third time's a charm for Pfizer Inc.'s (PFE) RETACRIT, a biosimilar to Amgen's anemia drugs Epogen and Procrit.

The FDA had turned down RETACRIT in October 2015 and June 2017.

Now that it has been approved, RETACRIT becomes the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S. The drug is also Pfizer's third approved biosimilar in the U.S.

Retacrit received EU approval in December 2007.

PFE closed Tuesday's trading at $35.69, down 0.47%.

Sol-Gel Technologies Ltd. (SLGL) expects to commence pivotal phase III trials of its topical product candidate TWIN in acne vulgaris in the second half of 2018 as planned.

The Company has also submitted a Special Protocol Assessment request with the FDA regarding Epsolay and expects to commence the pivotal Phase III trials in subtype II rosacea in the first half of 2018 as planned.

A bioequivalence study for a generic drug candidate is expected to commence this year.

SLGL closed Tuesday's trading at $8.43, up 12.40%.

Sophiris Bio Inc. (SPHS) has an important catalyst to watch out for in the second quarter.

The Company's phase 2b study of Topsalysin in treating men with clinically significant localized prostate cancer completed enrollment last December, and a total of 38 patients have been treated with the drug candidate.

The Company expects biopsy data from all patients in the phase II study receiving the first dose of Topsalysin to be available by the end of the second quarter of 2018, and final biopsy data in the fourth quarter of 2018 from all patients who receive a second administration of Topsalysin.

SPHS closed Tuesday's trading at $3.52, up 13.92%.

Shares of Titan Pharmaceuticals Inc. (TTNP) soared more than 25% in extended trading on Tuesday, following better-than-expected financial results for the first quarter ended March 31, 2018.

Net loss applicable to common shareholders in the first quarter of 2018 was approximately $2.6 million or $0.12 per share on revenue of $1.1 million. Analysts polled by Thomson Reuters were expecting a loss of $0.13 per share and revenue of $70 thousand.

Revenues for the 2018 period reflect approximately $1.0 million related to the sale to Molteni of the European intellectual property rights to Probuphine and $25,000 related to the recognition of royalties earned on net sales of Probuphine by Braeburn.

In the year-ago first quarter, the net loss applicable to common shareholders was $3.0 million or $0.14 per share, on revenue of approximately $40,000. Revenue for the 2017 period reflects the recognition of royalties earned on net sales of our Probuphine product by Braeburn.

The Company ended Q1, 2018 with cash of $3.5 million, which is believed to be sufficient to fund its planned operations into the third quarter of 2018.

Titan is exploring several financing alternatives to fund its operations.

TTNP closed Tuesday's trading at $0.80, down 4.63%. In after-hours, the stock was up 25% to $1.00.

Xenon Pharmaceuticals Inc. (XENE) has announced positive interim data from its ongoing phase I clinical trial of XEN1101 in healthy subjects, along with transcranial magnetic stimulation (TMS) study.

XEN1101 is a next-generation Kv7 potassium channel opener for the potential treatment of epilepsy.

The XEN1101 pharmacokinetic profile from the current Phase 1 clinical trial supports the potential for once daily dosing with XEN1101 compared to Ezogabine's three-times daily dosing. From a safety perspective, the majority of adverse events were mild and resolved spontaneously, with an overall profile showing XEN1101 as safe and well tolerated, according to the Company.

XENE closed Tuesday's trading at $6.65, up 10.83%.

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