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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 7, 2010
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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000-51863
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03-0491827 |
(Commission File No.)
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(IRS Employer Identification No.) |
9605 Medical Center Drive
Suite 300
Rockville, Maryland 20850
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (240) 599-4500
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
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Item 5.02. |
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Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory
Arrangements of Certain Officers. |
(b) On January 7, 2010, David R. Ramsay resigned as a member of the Board of Directors of Vanda
Pharmaceuticals Inc. (the Company) and as a member of the Audit Committee of the Board of
Directors. In accordance with the Companys Certificate of Incorporation and Bylaws, the Companys
Board of Directors has reduced the number of directors of the Company from seven to six. Howard
Pien, one of the Companys current directors, has been appointed to serve on the Audit Committee in
replacement of Mr. Ramsay.
On January 11, 2010, the Company issued a press release announcing the commercial launch of
Fanapt by Novartis Pharmaceuticals Corporation. The full text of this press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K.
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Item 9.01. |
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Financial Statements and Exhibits. |
(d) Exhibits
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Exhibit No. |
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Description |
99.1
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Press release of Vanda Pharmaceuticals Inc. dated January 11, 2010. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: January 11, 2010 |
VANDA PHARMACEUTICALS INC.
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By: |
/s/ Stephanie R. Irish
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Name: |
Stephanie R. Irish |
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Title: |
Acting Chief Financial Officer and
Treasurer |
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exv99w1
Exhibit 99.1
News Release
Fanapt Launches in the U.S.
ROCKVILLE, MD, January 11, 2010 Vanda Pharmaceuticals (NASDAQ: VNDA) today announced that
Novartis Pharmaceuticals Corporation has launched Fanapt (iloperidone) in the U.S. Fanapt was
approved by the U.S. Food and Drug Administration on May 6, 2009 for the acute treatment of
schizophrenia in adults.
In October 2009, Vanda and Novartis Pharma AG entered into an agreement, pursuant to which Novartis
has exclusive U.S. and Canadian commercialization rights to Fanapt. Under this agreement, Vanda
received an upfront payment of $200 million and is eligible for future payments totaling up to $265
million upon the achievement of certain commercial and development milestones for Fanapt, as well
as royalties based upon net sales. Novartis assumed the commercialization and further clinical
development activities in the U.S. and Canada, including the development and commercialization of a
long-acting injectable (or depot) formulation of Fanapt.
Vanda retains the right to commercialize Fanapt oral and depot formulations outside the U.S. and
Canada. At Novartis option, the parties will enter into good faith discussions relating to an
agreement for the co-commercialization of Fanapt outside of the U.S. and Canada or, alternatively,
Novartis will receive a royalty based upon net sales.
About Schizophrenia
Schizophrenia is a chronic, severe and disabling mental disorder, characterized by profound
disruptions in thinking, affecting language, perception, and the sense of self. It often includes
psychotic experiences, such as hearing voices or delusions. Schizophrenia typically begins in late
adolescence or early adulthood and affects 2.4 million Americans or 1.1% of the adult population.
About Fanapt
Fanapt belongs to a class of medications for schizophrenia known as atypical antipsychotics. The
term atypical refers to the different mechanisms of action of second-generation antipsychotics.
The FDA approval of Fanapt was supported by two placebo- and active-controlled short-term (4- and
6-week) trials and safety data derived from more than 2,000 patients. Both trials enrolled patients
who met the DSM-III/IV criteria for schizophrenia. Fanapt was shown to be superior to placebo in
controlling symptoms of schizophrenia across doses of 12 mg to 24 mg per day which is the
recommended daily target dose range. Titration to the target dose of 12 mg per day can be achieved
in 4 days.
IMPORTANT SAFETY INFORMATION FOR FANAPT (iloperidone) TABLETS
Fanapt tablets are indicated for the acute treatment of schizophrenia in adults.
Elderly patients are at an increased risk of death when compared with patients who are treated with
a placebo. Fanapt is not approved for the treatment of elderly patients (aged 65 and older) with
psychosis related to dementia.
Serious Side Effects
Fanapt may change your heart rhythm (meaning there is more time between heart beats). Heart
rhythm changes have occurred in patients taking Fanapt and are a risk factor for serious, even
life-threatening medical issues. You should tell your doctor if you have or had heart problems.
Call your doctor right away if you feel faint or have unpleasant feelings of irregular or forceful heart beats as any of these
feelings could be a sign of a rare, but serious side effect that could be fatal.
Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood
pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but
serious side effect which could be fatal.
Abnormal or uncontrollable movements of the face, tongue, or other parts of body may be signs of a
serious condition called tardive dyskinesia (TD), which could become permanent.
If you have diabetes or risk factors for diabetes (for example, obesity, family history of
diabetes), or you have unexpected increases in thirst, urination, or hunger, your blood sugar
should be monitored. Increases in blood sugar levels (hyperglycemia), in some cases serious and
associated with coma or death, have been reported in patients taking Fanapt and medicines like it.
Tell your doctor if you have a history of or are at risk for seizures, have liver disease, or if
you are pregnant or intend to become pregnant. Tell your doctor about all prescription and
nonprescription medicines you are taking, since there are some risks for drug interactions.
Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising
quickly from a sitting or lying position (orthostatic hypotension) has been reported with Fanapt.
Decreases in white blood cells (infection-fighting cells) have been reported in some patients
taking antipsychotic agents, including Fanapt. Patients with a history of a significant decrease in
white blood cell (WBC) count or who have experienced a low WBC count due to drug therapy should
have their blood tested and monitored during the first few months of therapy.
Fanapt can increase the level of the hormone prolactin. Tell your doctor if you have signs of high
prolactin levels, such as breast enlargement, breast pain, or breast discharge.
Medicines like Fanapt can impact your bodys ability to reduce your temperature. You should avoid
overheating. You should drink fluids so that you do not become thirsty (dehydrated).
Fanapt and medicines like it have been associated with swallowing problems (dysphagia). If you had
or have swallowing problems, you should tell your doctor.
As with many conditions that affect the way you think and feel, thoughts of suicide may occur. If
you get these feelings, seek help immediately from your doctor, or local emergency room.
For males, in the rare event you have a painful or prolonged erection (priapism), lasting 4 or more
hours, stop using Fanapt and seek immediate medical attention.
Fanapt and medicines like it can affect your judgment, thinking, or motor skills. You should not
drive or operate hazardous machinery including automobiles until you know how Fanapt affects you.
Common Side Effects
The most common side effects include dizziness, dry mouth, feeling unusually tired or sleepy,
stuffy nose, orthostatic hypotension, racing heart beat, and weight gain. The average weight gain
in clinical studies was 5 lbs. If you experience any of these symptoms, talk with your doctor.
When taking Fanapt, you should avoid drinking alcohol, and you should not breastfeed.
If you would like more information, talk with your doctor. You can also visit the Fanapt Web site
at www.Fanapt.com or call Novartis Pharmaceuticals Corporation at: 1-888-NOW-NOVA (1-888-669-6682)
Monday-Friday, 8:30 am 5:00 pm ET.
About Vanda
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and
commercialization of clinical-stage products for central nervous system disorders. For more on
Vanda, please visit http://www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this release are forward-looking statements under the securities laws.
Words such as, but not limited to, believe, expect, anticipate, estimate, intend, plan,
targets, likely, will, would, and could, and similar expressions or words, identify
forward-looking statements. Forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions and uncertainties. Important factors that
could cause actual results to differ materially from those reflected in the companys
forward-looking statements include, among others: the extent and effectiveness of the development,
sales and marketing and distribution support Fanapt receives; Vandas ability to successfully
commercialize Fanapt outside of the U.S. and Canada; delays in the completion of Vandas clinical
trials; a failure of Vandas products to be demonstrably safe and effective; Vandas failure to
obtain regulatory approval for its products or to comply with ongoing regulatory requirements for
its products; a lack of acceptance of Vandas products in the marketplace, or a failure to become
or remain profitable; Vandas expectations regarding trends with respect to its costs and expenses;
Vandas inability to obtain the capital necessary to fund its commercial and research and
development activities; Vandas failure to identify or obtain rights to new products; Vandas
failure to develop or obtain sales, marketing and distribution resources and expertise or to
otherwise manage its growth; a loss of any of Vandas key scientists or management personnel;
losses incurred from product liability claims made against Vanda; a loss of rights to develop and
commercialize Vandas products under its license and sublicense agreements and other factors that
are described in the Risk Factors section (Part II, Item 1A) of Vandas quarterly report on Form
10-Q for the fiscal quarter ended September 30, 2009 (File No. 001-34186). In addition to the risks
described above and in Part II, Item 1A of Vandas quarterly report on Form 10-Q, other unknown or
unpredictable factors also could affect Vandas results. There can be no assurance that the actual
results or developments anticipated by Vanda will be realized or, even if substantially realized,
that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can
be given that the outcomes stated in such forward-looking statements and estimates will be
achieved.
All written and verbal forward-looking statements attributable to Vanda or any person acting on its
behalf are expressly qualified in their entirety by the cautionary statements contained or referred
to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda
makes or that are made on its behalf. The information in this release is provided only as of the
date of this release, and Vanda undertakes no obligation, and specifically declines any obligation,
to update or revise publicly any forward-looking statements, whether as a result of new
information, future events or otherwise.
CONTACT: Investors, Stephanie R. Irish, stephanie.irish@vandapharma.com, or Media, Cristina
Murphy, cristina.murphy@vandapharma.com, both of Vanda Pharmaceuticals Inc.,
+1-240-599-4500