Announces Encouraging Pharmacodynamic Data
from Previous XP23829 Phase 1 Trial
XenoPort, Inc. (Nasdaq: XNPT) announced today financial results
for the third quarter and nine months ended September 30, 2013.
Revenues for the third quarter were $2.5 million, compared to $0.4
million for the same period in 2012. Net loss for the third quarter
was $18.8 million, compared to a net loss of $16.8 million for the
same period in 2012. At September 30, 2013, XenoPort had cash, cash
equivalents and short-term investments of $74.3 million.
XenoPort Third Quarter Events
Since the start of the third quarter:
- XenoPort reported favorable preliminary
results from two Phase 1 clinical trials and three 13-week
toxicology studies of XP23829, a novel fumaric acid ester compound
that is a prodrug of monomethyl fumarate (MMF). The first
healthy-subject Phase 1 study assessed the pharmacokinetics, safety
and tolerability of multiple doses of two different oral
formulations of XP23829, as well as the approved dose of TECFIDERA®
(dimethyl fumarate; DMF). The second Phase 1 study examined the
metabolism and distribution of radiolabeled XP23829 in healthy
subjects. The toxicology studies, each of which included a DMF
control arm, were conducted in three different animal species.
XP23829 is being developed for the potential treatment of relapsing
forms of multiple sclerosis and/or psoriasis.
- XenoPort announced the inclusion of
gabapentin enacarbil in treatment guidelines published by the
International Restless Legs Syndrome Study Group and the
Willis-Ekbom Disease (WED) Foundation.
Additional Results from Previous Phase 1 Trial of
XP23829
XenoPort also announced today encouraging pharmacodynamic data
from its previous Phase 1, randomized, double-blind,
placebo-controlled, multiple ascending dose study of two
formulations of XP23829 in healthy adult subjects dosed for up to
12 days. Compared to pre-dosing baseline, XP23829 dosed once or
twice a day selectively reduced blood lymphocytes and increased
blood eosinophils when assessed after 12 days of dosing. Individual
subject end-of-treatment lymphocyte and eosinophil counts were
within normal limits with few exceptions. There were no subjects
with post-treatment lymphocyte counts below 500 per microliter.
Lymphocyte counts returned to near baseline levels when assessed
eight to ten days after the last dose. These effects were not
observed in placebo-dosed subjects, and there was no effect of
XP23829 on other monitored blood cell populations.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort,
stated, “The mechanism of action of fumaric acid esters is complex,
but generally believed to involve modulation of the immune system.
Studies in psoriasis and multiple sclerosis patients indicate that
FUMADERM (dimethyl fumarate and monoethyl fumarate salts) and
TECFIDERA reduce blood lymphocytes, with the maximal effect
occurring after many months of dosing. Both products are also known
to cause transient minor increases in blood eosinophils. Though our
previous study of XP23829 was small, necessitating caution in
interpreting results, we are intrigued by certain aspects of the
data – the rapid onset and reversibility of the XP23829 effect on
lymphocytes observed in the study and the observation that
once-a-day dosing had similar effects as twice-a-day dosing on
modulation of these two biomarkers. These results suggest that
future studies of XP23829 should include examination of once-a-day
dosing as well as lower doses that may be well-tolerated and
effective as a consequence of the potential rapid onset of immune
modulation.”
Dr. Barrett continued, “In the last quarter, we believe that we
made considerable progress in our core value-driving activities –
advancing the development of XP23829 and executing on our focused
plan to commercialize HORIZANT and demonstrate its value to
patients and our stockholders. Though we have only completed the
first full quarter of our launch of HORIZANT after the drug supply
stock-out of our previous partner, we believe we have already seen
several encouraging signs that our efforts are impacting sales in
the regions where we are promoting HORIZANT.”
XenoPort Third Quarter and Nine-Month Financial
Results
Revenues for the third quarter and nine months ended September
30, 2013 were $2.5 million and $5.1 million, respectively, compared
to $0.4 million and $21.1 million for the same periods in 2012.
Revenues in the third quarter and nine months ended September 30,
2013 were principally due to XenoPort’s acquisition of the HORIZANT
business on May 1, 2013, which resulted in the company’s first
commercial sales of HORIZANT during the second quarter of 2013.
HORIZANT net product sales for the third quarter and nine months
ended September 30, 2013 were $2.0 million and $3.7 million,
respectively. The decline in revenues for the nine months ended
September 30, 2013 compared to the same period in 2012 was
primarily due to the recognition of a $10.0 million milestone
payment from Astellas Pharma Inc. in connection with the approval
of REGNITE® (gabapentin enacarbil) Extended-Release Tablets in
Japan in 2012 and the recognition of a $10.0 million contingent
payment from GlaxoSmithKline (GSK) in connection with the first
commercial sale of HORIZANT by GSK for the management of
postherpetic neuralgia in adults in 2012.
Research and development expenses for the third quarter of 2013
were $6.0 million, compared to $9.4 million for the same period in
2012. The decrease in research and development expenses in the
three months ended September 30, 2013 compared to the same period
in 2012 was principally due to decreased net costs for arbaclofen
placarbil (AP) development and manufacturing and decreased
personnel costs primarily related to decreased headcount and
decreased non-cash stock-based compensation. Research and
development expenses for the nine months ended September 30, 2013
were $29.6 million, compared to $32.3 million for the same period
in 2012. The decrease in research and development expenses in the
nine months ended September 30, 2013 compared to the same period in
2012 was principally due to decreased net costs for AP development
and decreased personnel costs primarily related to decreased
headcount and decreased non-cash stock-based compensation,
partially offset by increased net costs for XP23829, primarily
related to clinical, manufacturing and consulting costs.
Selling, general and administrative expenses for the third
quarter and nine months ended September 30, 2013 were $14.9 million
and $41.5 million, respectively, compared to $7.8 million and $22.8
million for the same periods in 2012. The increase in selling,
general and administrative expenses in the third quarter and nine
months ended September 30, 2013 compared to the same periods in
2012 was principally due to costs related to the commercialization
and promotion of HORIZANT, specifically increased professional
fees, which included contract sales force costs and marketing
costs, as well as increased personnel costs.
Net loss for the third quarter of 2013 was $18.8 million,
compared to a net loss of $16.8 million for the same period in
2012. Net loss for the nine months ended September 30, 2013 was
$66.7 million, compared to a net loss of $33.9 million for the same
period in 2012. Basic and diluted net loss per share were both
$0.39 in the third quarter of 2013 versus basic and diluted net
loss per share of $0.41 for the same period in the prior year. For
the nine-month period ended September 30, 2013, basic and diluted
net loss per share were both $1.41 versus basic and diluted net
loss per share of $0.90 for the same period in 2012.
Conference Call
XenoPort will host a conference call at 5:00 p.m. Eastern Time
today to discuss its financial results and provide general business
updates, and to review additional clinical data and program
developments for XP23829. To access the conference call via the
Internet, go to www.XenoPort.com. To access the live conference
call via phone, dial 1-888-275-3514. International callers may
access the live call by dialing 706-679-1417. The reference number
to enter the call is 77314561.
The replay of the conference call may be accessed after 8:00
p.m. Eastern Time today via the Internet, at www.XenoPort.com, or
via phone at 1-855-859-2056 for domestic callers, or 404-537-3406
for international callers. The reference number to enter the replay
of the call is 77314561. Dial-in access to the replay of the call
will be available for approximately one week, and the Internet
replay of the call will be available for approximately one month
following the live call.
HORIZANT IMPORTANT SAFETY INFORMATION
INDICATION: HORIZANT® (gabapentin enacarbil)
Extended-Release Tablets are indicated for the treatment of
moderate-to-severe primary Restless Legs Syndrome (RLS) in
adults.
Effects on Driving
HORIZANT may cause significant driving impairment. Patients
should not drive until they have enough experience on HORIZANT to
know if it impairs their driving. Patients’ ability to assess their
driving competence and degree of somnolence caused by HORIZANT can
be imperfect.
Somnolence/Sedation and Dizziness
HORIZANT causes somnolence/sedation and dizziness. Patients
should not drive or operate other complex machinery until they have
enough experience on HORIZANT to know if it impairs their ability
to perform these tasks.
Lack of Interchangeability with Gabapentin
HORIZANT is not interchangeable with other gabapentin products
because of differing pharmacokinetic profiles. The same dose of
HORIZANT results in different plasma concentrations of gabapentin
relative to other gabapentin products. The safety and effectiveness
of HORIZANT in patients with epilepsy have not been studied.
Suicidal Behavior and Ideation
HORIZANT is a prodrug of gabapentin, an antiepileptic drug
(AED). AEDs increase the risk of suicidal thoughts or behavior in
patients taking these drugs for any indication. As a prodrug of
gabapentin, HORIZANT also increases this risk. Patients treated
with any AED for any indication should be monitored for new or
worsening depression, suicidal thoughts or behavior, and/or any
unusual changes in mood or behavior. Anyone considering prescribing
HORIZANT must balance the risk of suicidal thoughts or behavior
with the risk of untreated illness.
Patients, caregivers, and families should be informed that
HORIZANT increases the risk of suicidal thoughts and behavior and
should be advised of the need to be alert for new or worsening
signs of and symptoms of depression, any unusual changes in mood or
behavior, or the emergence of suicidal thoughts, behavior, or
thoughts of self-harm. Behaviors of concern should be reported
immediately to healthcare providers.
Drug Reaction With Eosinophilia and Systemic Symptoms
(DRESS)/Multiorgan Hypersensitivity
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS),
also known as multiorgan hypersensitivity, has been reported in
patients taking antiepileptic drugs, including gabapentin. HORIZANT
is a prodrug of gabapentin. Some of these events have been fatal or
life-threatening. DRESS typically, although not exclusively,
presents with fever, rash, and/or lymphadenopathy, in association
with other organ system involvement, such as hepatitis, nephritis,
hematological abnormalities, myocarditis, or myositis sometimes
resembling an acute viral infection. Eosinophilia is often present.
Because this disorder is variable in its expression, other organ
systems not noted here may be involved.
It is important to note that early manifestations of
hypersensitivity, such as fever or lymphadenopathy, may be present
even though rash is not evident. If such signs or symptoms are
present, the patient should be evaluated immediately. HORIZANT
should be discontinued if an alternative etiology for the signs or
symptoms cannot be established.
Discontinuation of HORIZANT
When discontinuing HORIZANT, patients with RLS receiving 600 mg
or less once daily can discontinue the drug without tapering. If
the recommended dose is exceeded, the dose should be reduced to 600
mg daily for 1 week prior to discontinuation to minimize the
potential of withdrawal seizure.
Tumorigenic Potential
In an oral carcinogenicity study, gabapentin enacarbil increased
the incidence of pancreatic acinar cell adenoma and carcinoma in
male and female rats. The clinical significance of this finding is
unknown.
ADVERSE REACTIONS
The most common adverse reactions for patients with RLS
receiving HORIZANT 600 mg, 1,200 mg, and placebo, respectively,
were somnolence/sedation (20%, 27%, and 6%), dizziness (13%, 22%,
and 4%), headache (12%, 15%, and 11%), nausea (6%, 7%, and 5%), and
fatigue (6%, 7%, and 4%). A daily dose of 1,200 mg provided no
additional benefit compared with the 600-mg dose, but caused an
increase in adverse reactions.
DRUG INTERACTIONS
Gabapentin enacarbil is released faster from HORIZANT
Extended-Release tablets in the presence of alcohol. Consumption of
alcohol is not recommended when taking HORIZANT. HORIZANT taken in
conjunction with morphine causes increased somnolence/sedation,
dizziness, and nausea.
USE IN SPECIAL POPULATIONS
Pregnancy and Lactation
Based on animal data, HORIZANT may cause fetal harm. There are
no adequate and well-controlled studies of HORIZANT in pregnant
women. HORIZANT should be used during pregnancy only if potential
benefit justifies potential risk to fetus. HORIZANT is converted to
gabapentin, which is secreted into human milk. Discontinue nursing
or discontinue HORIZANT, taking into account the importance of
HORIZANT to the mother, due to potential for adverse reactions in
nursing infants.
Renal Impairment
In patients with RLS who have compromised renal function,
HORIZANT should be dosed based upon creatinine clearance (CrCl): 30
to 59 mL/min, start with 300 mg per day and increase to 600 mg as
needed; 15 to 29 mL/min, use 300 mg per day; <15 mL/min, use 300
mg every other day. HORIZANT is not recommended for use in patients
receiving hemodialysis.
For HORIZANT Prescribing Information/Medical Guide, please see
the following
Websites:http://www.HORIZANT.com/docs/HORIZANT_PrescribingInformation.pdfhttp://www.HORIZANT.com/docs/HORIZANT_MedGuide.pdf
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on
developing and commercializing a portfolio of internally discovered
product candidates for the potential treatment of neurological
disorders. XenoPort is currently commercializing HORIZANT in the
United States and developing its novel fumaric acid ester product
candidate, XP23829, as a potential treatment for relapsing forms of
multiple sclerosis and/or psoriasis. REGNITE is being marketed in
Japan by Astellas Pharma Inc. XenoPort's pipeline of product
candidates also includes potential treatments for patients with
spasticity related to spinal cord injury and Parkinson's
disease.
To learn more about XenoPort, please visit the Web site at
www.XenoPort.com.
Forward-Looking Statements
This press release contains “forward-looking” statements,
including, without limitation, all statements related to the
XP23829 clinical development program, including conducting future
clinical trials; XP23829’s mechanism of action and potential
modulation of the immune system; the commercial opportunity and
value proposition for HORZIANT; the potential suitability of
XP23829 as a treatment for relapsing forms multiple sclerosis
and/or psoriasis; and the therapeutic and commercial potential of
XenoPort's product candidates. Any statements contained in this
press release that are not statements of historical fact may be
deemed to be forward-looking statements. Words such as “believe,”
“may,” “plan,” “potential,” “suggest” and similar expressions are
intended to identify forward-looking statements. These
forward-looking statements are based upon XenoPort's current
expectations. Forward-looking statements involve risks and
uncertainties. XenoPort's actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to
XenoPort’s lack of commercialization experience and its ability to
successfully market and sell HORIZANT; the difficulty and
uncertainty of pharmaceutical product development and the uncertain
results and timing of clinical trials and other studies, including
the risk that success in preclinical testing and early clinical
trials does not ensure that later clinical trials will be
successful, and that the results of clinical trials by other
parties may not be indicative of the results in trials that
XenoPort may conduct; XenoPort’s ability to successfully advance
XP23829 development and to conduct clinical trials in the
anticipated timeframes, or at all; the uncertainty of the U.S. Food
and Drug Administration’s review process and other regulatory
requirements; XenoPort’s dependence on future collaborative
partners; XenoPort’s need for and the availability of resources to
develop XenoPort’s product candidates and support XenoPort’s
operations; and the uncertain therapeutic and commercial value of
XenoPort’s product candidates. These and other risk factors are
discussed under the heading "Risk Factors" in XenoPort’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2013, filed with
the Securities and Exchange Commission on August 7, 2013. XenoPort
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in the company's
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
HORIZANT, REGNITE and XENOPORT are registered trademarks of
XenoPort, Inc.
XNPT2F
XENOPORT, INC.
BALANCE SHEETS
(In thousands)
September 30,
December 31,
2013 2012 (Unaudited) Current
assets: Cash and cash equivalents $ 13,517 $ 36,134 Short-term
investments 60,785 102,868 Accounts receivable, net 867 — Right to
the HORIZANT business — 13,557 Inventories 1,944 — Prepaids and
other current assets
4,172
2,529 Total current assets 81,285 155,088
Property and equipment, net 2,896 1,528 Long-term inventories
10,341 — Restricted investments and other assets
1,960 2,432 Total
assets
$ 96,482 $
159,048 Liabilities: Current liabilities $
11,865 $ 13,771 Noncurrent liabilities
14,288
15,067 Total liabilities
26,153 28,838
Stockholders’ equity : Common stock 48 47 Additional paid-in
capital and other 588,626 581,763 Accumulated deficit
(518,345 ) (451,600
) Total stockholders’ equity
70,329 130,210 Total
liabilities and stockholders’ equity
$
96,482 $ 159,048
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months
Ended September
30,
Nine MonthsEnded September
30,
2013
2012 2013
2012 (In
thousands, except per share amounts) Revenues: Product sales,
net $ 2,037 $ — $ 3,677 $ — Collaboration revenue 379 379 1,137
11,137 Royalty revenue 111 — 258 — Net revenue from unconsolidated
joint operating activities
—
— —
10,000 Total revenues
2,527
379 5,072
21,137 Operating expenses: Cost
of product sales 305 — 554 — Research and development* 6,047 9,365
29,636 32,347 Selling, general and administrative*
14,928 7,833
41,451 22,822 Total
operating expenses
21,280
17,198 71,641
55,169 Loss from operations (18,753 ) (16,819 )
(66,569 ) (34,032 ) Interest income 43 66 182 176 Interest expense
(106 ) —
(358 )
— Net loss
$ (18,816
) $ (16,753 )
$ (66,745 ) $
(33,856 ) Basic and diluted net loss per
share
$ (0.39 )
$ (0.41 ) $
(1.41 ) $ (0.90
) Shares used to compute basic and diluted net loss
per share
47,691
41,016
47,471
37,480
* Includes employee non-cash
stock-based compensation as follows:
Research and development
$
618
$
935
$
2,523
$
3,043
Selling, general and administrative
1,851
1,881
5,785
6,096
Total non-cash stock-based compensation
expense
$
2,469
$
2,816
$
8,308
$
9,139
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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