Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) Files An 8-K Regulation FD Disclosure

ME Staff 8-k

6 years ago

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) Files An 8-K Regulation FD DisclosureItem 7.01 Regulation FD Disclosure.

On December3, 2018, Biohaven Pharmaceutical Holding Company Ltd. (the “Company”) issued a press release announcing data from the Company’s randomized, controlled Phase 3 clinical trial (BHV3000-303 or Study 303) evaluating the efficacy and safety of its Zydis® orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine. A copy of the press release is furnished herewith as Exhibit99.1 to this Current Report on Form8-K.

In addition, on December3, 2018, members of management of the Company held a conference call to discuss the results of the trial. A copy of the presentation that accompanied the conference call is available on the Company’s website at www.biohavenpharma.com, and is furnished herewith as Exhibit99.2 to this Current Report on Form8-K.

The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, are being “furnished” and shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liability of that section or Sections 11 and 12(a)(2)of the Securities Act of 1933, as amended (the “Securities Act”). The information in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be incorporated by reference into any registration statement or other document to the Securities Act or into any filing or other document to the Exchange Act, except as otherwise expressly stated in any such filing.

Item 8.01 Other Events.

On December3, 2018, the Company announced positive topline data from a randomized, controlled Phase 3 clinical trial (BHV3000-303 or Study 303) evaluating the efficacy and safety of its Zydis® orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine.

In Study 303, rimegepant Zydis ODT statistically differentiated from placebo on the two co-primary endpoints as well as the first 21 consecutive primary and secondary outcome measures that were pre-specified in hierarchical testing. Consistent with the two previous Phase 3 clinical trials, Study 303 met its co-primary registrational endpoints of pain freedom and freedom from most bothersome symptom (MBS) at 2 hours using a single dose (Table 1). Importantly, patients treated with the rimegepant Zydis ODT formulation began to numerically separate from placebo on pain relief as early as 15 minutes, and this difference was statistically significant at 60 minutes (p < 0.0001) (Figure 1). Additionally, a significantly greater percentage of patients treated with rimegepant Zydis ODT returned to normal functioning by 60 minutes as compared to placebo (p < 0.002). Lasting clinical benefit was observed through 48 hours after a single dose of rimegepant on freedom from pain (p < 0.001), pain relief (p < 0.001), freedom from the most bothersome symptom (p < 0.001), and freedom from functional disability (p < 0.003). Superiority over placebo was also demonstrated in multiple other secondary endpoints. The vast majority of rimegepant Zydis ODT treated patients (85%) did not use any rescue medications.

Table 1: Met Co-Primary Endpoints of Pain Freedom& Freedom from Most Bothersome Symptom

2HourEndpoint	Rimegepant (N=669)	Placebo (N=682)	Difference	p-value
Pain Freedom	21.2	%	10.9	%	10.3	%	< 0.0001
Freedom from MBS(1)	35.1	%	26.8	%	8.3	%	0.0009

(1) Most Bothersome Symptom of Photophobia, Phonophobia or Nausea

Figure 1: Kaplan-Meier Pain Relief Curve Through 2 Hours after Single Dose of Rimegepant 75 Mg Zydis ODT

Figure 1 shows the percentage of patients reporting pain relief between 0 and 2 hours after dosing for patients who took a single dose of rimegepant Zydis ODT 75 mg or placebo. Data are Kaplan-Meier estimates of the time to first report of pain relief (report of no pain, or mild pain). Subjects were censored who took rescue medication or were lost to follow-up.

The safety and tolerability observations of rimegepant in Study 303 were consistent with the profile previously observed in Studies 301 and 302. Table 2 shows the pooled safety data across all three trials. In study 303, no single adverse event (AE) occurred in the rimegepant group with an incidence higher than 1.6% and overall rates of AEs were similar to placebo. With regard to liver function tests, one patient treated with placebo and one patient treated with rimegepant showed LFTs > 3x ULN in Study 303. Pooled liver function test results across the three pivotal trials (n=3,556) performed to date showed that rimegepant was similar to placebo with regard to aminotransferase (ALT or AST) levels above the upper limit of normal (ULN) and no patients experienced elevations in bilirubin > 2x ULN (Table 3).

Table 2: Pooled Adverse Event (AE) Safety Data: Rimegepant was Similar to Placebo Across Studies

AEs from Studies 301, 302 and 303 with an incidence > 1%

AdverseEvent	Rimegepant N=1,771	Placebo N=1,785
> 1 On-Study AE(1)	252 (14.2%)	209 (13.2%)
Nausea	26 (1.5%)	15 (0.8%)
UTI	21 (1.2%)	12 (0.7%)
SAEs(2)	3 (0.2%)	3 (0.2%)

(1) No other individual AEs > 1% in rimegepant treated subjects than those listed in table. Includes all AEs without attribution to drug relatedness.

(2) No drug-related Serious Adverse Events (SAEs). Two of the subjects with SAE in rimegepant group and one in placebo group had not been dosed before onset of SAE.

Biohaven Pharmaceutical Holding Co Ltd. ExhibitEX-99.1 2 a18-41019_1ex99d1.htm EX-99.1 Exhibit 99.1 Biohaven Delivers Positive Phase 3 Results with Rimegepant Zydisâ Orally Dissolving Tablet (ODT): Rapid and Lasting Benefit for the Acute Treatment of Migraine · Single dose,…To view the full exhibit click here