Forest Laboratories, Inc. (NYSE: FRX) (“Forest”) today announced
that its indirect wholly-owned subsidiary, Magnolia Acquisition
Corp. (“Magnolia”), has accepted for purchase all of the securities
validly tendered and not validly withdrawn pursuant to its tender
offer for all outstanding shares of common stock of, and certain
outstanding notes and warrants convertible into or exercisable for
the common stock of, Clinical Data, Inc. (NASDAQ: CLDA) (“Clinical
Data”). The offering period and withdrawal rights expired at 12:00
midnight, New York City time on Monday April 11, 2011. American
Stock Transfer & Trust Company, LLC, the depositary for the
tender offer, has advised Forest that as of the expiration of the
offering period, approximately 27,868,256 shares of Clinical Data
common stock; 93,556 2005 Warrants; 113,817 2006 Warrants; 757,461
2008 Warrants; 1,527,650 Series A 2009 Warrants; 1,527,650 Series B
2009 Warrants; and $50,000,000 aggregate principal amount of
convertible notes, convertible into 6,110,599 shares of Clinical
Data common stock, were validly tendered and not validly withdrawn
prior to the expiration of the offering period. The securities
validly tendered and not validly withdrawn represent approximately
82.8% of the outstanding shares of Clinical Data common stock on a
fully-diluted basis.
Magnolia intends to convert the entire principal amount of
convertible notes it acquires in the tender offer into 6,110,599
shares of Clinical Data common stock and, if necessary to become
the owner of more than 90% of the outstanding shares of common
stock, to exercise its top-up option pursuant to the terms of the
previously announced merger agreement among Forest, FL Holding CV,
an indirect wholly-owned subsidiary of Forest, Magnolia and
Clinical Data (the “Merger Agreement”) to acquire additional shares
of Clinical Data common stock from Clinical Data. Following
conversion of the Clinical Data notes and, if applicable, exercise
of the top-up option, Forest intends to complete the acquisition of
Clinical Data through what is known as a short-form merger under
Delaware law without a vote of the remaining stockholders of
Clinical Data. Forest expects the merger to be completed within the
next several days. Upon completion of the merger, all outstanding
shares of Clinical Data common stock (other than shares held by
Magnolia or Clinical Data, or shares held by Clinical Data
stockholders who have and validly exercise appraisal rights under
Delaware law) will be canceled and converted into the right to
receive the same $30.00 per share in cash plus contingent
consideration of up to $6.00 per share that was offered in the
tender offer and holders of any outstanding warrants to purchase
shares of Clinical Data common stock will receive the amounts set
forth in the Merger Agreement. Payment of any contingent
consideration will be governed by the terms of a Contingent Value
Rights Agreement to be entered into by Forest, FL Holding CV, an
indirect wholly-owned subsidiary of Forest, and American Stock
Transfer & Trust Company, LLC, as rights agent, for the benefit
of tendering security holders based upon achievement of certain
milestones related to Viibryd™. Information regarding the merger is
being mailed to Clinical Data stockholders who did not tender their
shares, warrants or notes in the tender offer and, following
completion of the merger, instructions will be mailed to those
stockholders outlining the steps to be taken to obtain the merger
consideration.
Upon completion of the merger, Clinical Data will become a
wholly-owned subsidiary of Forest and Clinical Data’s common stock
will cease to be traded on the NASDAQ.
About Viibryd™
Viibryd (vilazodone) is a novel antidepressant for the treatment
of major depressive disorder (MDD). The efficacy of Viibryd was
established in two 8-week, multi-center, randomized, double -blind,
placebo-controlled studies in adult (18-80 years of age)
outpatients who met the Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV-TR) criteria for MDD. The mechanism of action of
Viibryd is not fully understood but is thought to be related to
enhancement of serotonergic activity in the central nervous system
through selective inhibition of serotonin reuptake. Viibryd is also
a partial agonist of serotonergic 5-HT1a receptors; however, the
net result of this action on serotonergic transmission and its role
in Viibryd antidepressant effect are unknown.
Important Safety Information
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of
suicidal thinking and behavior (suicidality) in children,
adolescents, and young adults in short-term studies of Major
Depressive Disorder (MDD) and other psychiatric disorders. Anyone
considering the use of Viibryd or any other antidepressant in a
child, adolescent, or young adult must balance this risk with the
clinical need. Short-term studies did not show an increase in the
risk of suicidality with antidepressants compared to placebo in
adults beyond age 24; there was a reduction in risk with
antidepressants compared to placebo in adults aged 65 and older.
Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Patients of all
ages who are started on antidepressant therapy should be monitored
appropriately and observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and
caregivers should be advised of the need for close observation and
communication with the prescriber. Viibryd is not approved for use
in pediatric patients.
Contraindications
VIIBRYD must not be used concomitantly in patients taking MAOIs
or in patients who have taken MAOIs within the preceding 14 days
due to the risk of serious, sometimes fatal, drug interactions with
serotonergic drugs. Allow at least 14 days after stopping VIIBRYD
before starting an MAOI.
Warnings and Precautions
- All patients treated with
antidepressants should be monitored appropriately and observed
closely for clinical worsening, suicidality, and unusual changes in
behavior, especially during the first few months of treatment and
when changing the dose. Consider changing the therapeutic
regimen, including possibly discontinuing the medication, in
patients whose depression is persistently worse or includes
symptoms of anxiety, agitation, panic attacks, insomnia,
irritability, hostility, aggressiveness, impulsivity, akathisia,
hypomania, mania, or suicidality that are severe, abrupt in onset,
or were not part of the patient's presenting symptoms. Families
and caregivers of patients being treated with antidepressants
should be alerted about the need to monitor patients.
- The development of potentially
life-threatening serotonin syndrome or Neuroleptic Malignant
Syndrome (NMS)-like reactions has been reported with
antidepressants alone, but particularly with concomitant use of
serotonergic drugs (including triptans) with drugs which impair
metabolism of serotonin (including MAOIs), or with antipsychotics
or other dopamine antagonists. Symptoms of serotonin syndrome were
noted in 0.1% of patients treated with VIIBRYD. Serotonin syndrome
symptoms may include mental status changes (e.g., agitation,
hallucinations, coma), autonomic instability (e.g., tachycardia,
labile blood pressure, hyperthermia), neuromuscular aberrations
(e.g., hyperreflexia, incoordination) and/or gastrointestinal
symptoms (e.g., nausea, vomiting, diarrhea). Patients should be
monitored for the emergence of serotonin syndrome or NMS-like signs
and symptoms while treated with VIIBRYD.
- Symptoms of mania/hypomania were noted
in 0.1% of patients treated with VIIBRYD in clinical studies. As
with all antidepressants, VIIBRYD should be used cautiously in
patients with a history or family history of mania or
hypomania.
- Prior to initiating treatment with an
antidepressant, patients with depressive symptoms should be
adequately screened to determine if they are at risk for bipolar
disorder. VIIBRYD is not approved for use in treating bipolar
depression.
- Discontinuation symptoms have been
reported with discontinuation of serotonergic drugs such as
VIIBRYD. Gradual dose reduction is recommended, instead of abrupt
discontinuation, whenever possible. Monitor patients for these
symptoms when discontinuing VIIBRYD. If intolerable symptoms occur
following a dose decrease or upon discontinuation of treatment,
consider resuming the previously prescribed dose and decreasing the
dose at a more gradual rate.
- Like other antidepressants, VIIBRYD
should be prescribed with caution in patients with a seizure
disorder.
- The use of drugs that interfere with
serotonin reuptake, including VIIBRYD, may increase the risk of
bleeding events. Patients should be cautioned about the risk of
bleeding associated with the concomitant use of VIIBRYD and NSAIDs,
aspirin, or other drugs that affect coagulation or bleeding.
- Advise patients that if they are
treated with diuretics, or are otherwise volume depleted, or are
elderly they may be at greater risk of developing hyponatremia
while taking VIIBRYD. Although no cases of hyponatremia resulting
from VIIBRYD treatment were reported in the clinical studies,
hyponatremia has occurred as a result of treatment with SSRIs and
SNRIs. Discontinuation of VIIBRYD in patients with symptomatic
hyponatremia and appropriate medical intervention should be
instituted.
Adverse Reactions
- The most commonly observed adverse
reactions in MDD patients treated with VIIBRYD in
placebo-controlled studies (incidence ≥ 5% and at least twice the
rate of placebo) were: diarrhea (28% vs. 9%), nausea (23% vs. 5%),
insomnia (6% vs. 2%), and vomiting (5% vs. 1%).
About Forest Laboratories
Forest Laboratories’ (NYSE: FRX) longstanding global
partnerships and track record developing and marketing
pharmaceutical products in the United States have yielded its
well-established central nervous system and cardiovascular
franchises and innovations in anti-infective and respiratory
medicine. The Company’s pipeline, the most robust in its history,
includes product candidates in all stages of development across a
wide range of therapeutic areas. The Company is headquartered in
New York, NY. To learn more, visit www.FRX.com.
A Caution Concerning Forward Looking Statements
Certain statements in this press release may be forward-looking
statements. Forest cautions that these forward-looking statements
are subject to a number of risks and uncertainties that could cause
actual results to differ from those set forth in the forward
looking statements, including that the merger may not be timely
completed, if at all; the timing and the benefits of the business
combination transaction involving Forest and Clinical Data, the
risk that the businesses will not be integrated successfully;
uncertainties regarding the timing of launch of Viibryd and future
sales of Viibryd; the risk that the cost savings and any other
synergies from the transaction may not be fully realized or may
take longer to realize than expected; the difficulty of predicting
FDA approvals, the acceptance and demand for new pharmaceutical
products, the impact of competitive products and pricing, the
timely development and launch of new products, and the risk factors
listed from time to time in Forest Laboratories' Annual Report on
Form 10-K, Quarterly Report on Form 10-Q, and any subsequent
filings with the United States Securities and Exchange Commission
(the “SEC”) and Clinical Data’s Annual Report on Form 10-K,
Quarterly Report on Form 10-Q, and any subsequent filings with the
SEC.
Notice to Investors
This press release is neither an offer to purchase nor a
solicitation of an offer to sell any securities. On March 8, 2011,
Forest and Magnolia filed a tender offer statement on Schedule TO
with the SEC, and have mailed an offer to purchase, forms of letter
of transmittal and related documents to Clinical Data
securityholders. Clinical Data has filed with the SEC and mailed to
Clinical Data securityholders, a solicitation/recommendation
statement on Schedule 14D-9 with respect to the offer. The
materials, in each case as amended, contain important information
that should be read carefully. These materials (and all other
materials filed by Clinical Data with the SEC) will be available at
no charge from the SEC through its website at www.sec.gov. Free
copies of the offer to purchase, the related letters of transmittal
and certain other offering documents may be obtained by directing a
request to Forest at www.frx.com.
The Depositary for the tender offer is American Stock
Transfer & Trust Company, LLC, Operations Center, Attn:
Reorganization Department, P.O. Box 2042, New York, NY 10272-2042.
The Dealer Manager for the tender offer is Morgan Stanley & Co.
Incorporated, 1585 Broadway, New York, NY 10036. The Information
Agent for the tender offer is MacKenzie Partners, Inc., 105 Madison
Avenue, New York, NY 10016. The tender offer materials may be
obtained at no charge by directing a request by mail to MacKenzie
Partners, Inc. or by calling toll-free at (800) 322-2885 or collect
at (212) 929-5500. Additionally, any questions related to the
tender offer may be directed to MacKenzie Partners, Inc. at the
mailing address or telephone numbers provided above.
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