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 1934
Date of Report: May 5, 1997
INTERNEURON PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in charter)
DELAWARE
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(State of other jurisdiction of incorporation)
0-18728 043047911
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(Commission File Number) (IRS Employer Identification No.)
One Ledgemont Center, 99 Hayden Avenue, Lexington, Massachusetts 02173
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(Address of principal executive offfices) (Zip Code)
Registrant's telephone no. including area code: (617) 861-8444
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Item 5. Other Events
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On May 5, 1997, Interneuron Pharmaceuticals, Inc. ("Interneuron")
announced that the Drug Enforcement Agency ("DEA") has published a
recommendation for the removal of fenfluramine and its isomers, including
dexfenfluramine, from Schedule IV and all other controls of the Controlled
Substances Act. Reference is made to Interneuron's Press Release dated May 5,
1997, which is attached hereto as Exhibit 99.1 and incorporated by reference
herein.
On May 5, 1997, Interneuron announced that it had made arrangements
with a financial institution under which Interneuron intends to purchase in
private transactions capped call options representing Interneuron's right to
purchase from the financial institution up to a total of 1,200,000 shares of
Interneuron's Common Stock at specified strike prices to be determined. In
exchange for such purchase, Interneuron intends to sell to the same financial
institution call options entitling the institution to purchase from Interneuron
up to approximately 2,000,000 shares of Interneuron Common Stock at a strike
price expected to be $40 per share in May 1999. Reference is made to
Interneuron's Press Release dated May 5, 1997, which is attached hereto as
Exhibit 99.2 and incorporated by reference herein.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
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(c) Exhibits
99.1 Press Release dated May 5, 1997
99.2 Press Release dated May 5, 1997
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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.
INTERNEURON PHARMACEUTICALS INC.
By: /s/ Thomas F. Farb
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Thomas F. Farb,
Executive Vice President - Finance
Chief Financial Officer
Dated: May 6, 1997
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EXHIBIT 99.1
FOR IMMEDIATE RELEASE
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CONTACT, AT INTERNEURON, (617)-861-8444:
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GLENN L. COOPER, M.D. WILLIAM B. BONI
PRESIDENT AND CEO VP, CORP. COMMUNICATIONS
FEDERAL AGENCY RECOMMENDS DESCHEDULING OF REDUX
NEW STATUS WOULD SIMPLIFY PRESCRIPTION WRITING, ELIMINATE REFILL LIMITS
LEXINGTON, MA, May 5, 1997 -- Interneuron Pharmaceuticals, Inc. (NASDAQ: IPIC)
today announced that the Drug Enforcement Agency (DEA) has published a
recommendation for the removal of fenfluramine and its isomers, including
dexfenfluramine, from Schedule IV and all other controls of the Controlled
Substances Act. Dexfenfluramine is the active ingredient in Redux, a
prescription anii-obesity drug currently marketed by the Wyeth-Ayerst division
of American Home Products (NYSE: AHP).
As a Schedule IV substance, Redux is currently subject to controls related to
recordkeeping procedures for dispensing pharmacists and procedural mandates for
prescribing physicians. If after a comment period the DEA were to issue a final
rule consistent with its proposal, then Redux would no longer carry the C-IV
designation and be subject to DEA controls. Certain states will deschedule the
drug automatically upon federal descheduling while other states have varying
procedures for descheduling.
"This decision follows the review by three federal agencies, the DEA, the Food
and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA),
of an extensive body of scientific, animal and human data which indicates the
absence of abuse potential related to dexfenfluramine," said Glenn L. Cooper,
M.D., president and chief executive officer of Interneuron.
In March 1991, Interneuron submitted a petition to the DEA to remove
fenfluramine and its isomers from the agency's list of controlled substances.
Such substances are deemed to have potential for abuse. In September 1995, a
joint committee of the Endocrinologic and Metabolic Advisory Committee and the
FDA Drug Abuse Advisory Committee voted to recommend removal of fenfluramine and
its isomers from Schedule IV and all other DEA controls. The National Institute
on Drug Abuse also has supported the de-scheduling of these compounds.
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Interneuron Pharmaceuticals is a diversified biopharmaceutical company engaged
in the development and commercialization of a portfolio of products and product
candidates primarily for neurological and behavioral disorders. Interneuron is
also developing products and technologies, generally outside the central nervous
system field, through four subsidiaries: Intercardia, Inc. focused on
cardiovascular disease, Progenitor, Inc. focused on developmental genomics,
Trnascell Technologies, Inc. focused on carbohydrate-based drug discovery, and
InterNutria, Inc. focused on dietary supplement products.
Except for the descriptions of historical facts contained herein, this news
release contains forward- looking statements that involve risks and
uncertainties as detailed from time to time in Interneuron's SEC filings under
the Securities Act of 1933 and the Securities Exchange Act of 1934, including,
in particular, risks relating to the commercialization of Redux, such as
marketing, safety and regulatory, patent, product liability, supply, contractual
obligations and other risks, uncertainties relating to clinical trials, risks
relating to product launches and managing growth, government regulation, patent
risks, dependence upon third parties and competition.
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EXHIBIT 99.2
FOR IMMEDIATE RELEASE
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Contact at (617) 861-8444
Thomas F. Farb (ext.607) William B. Boni (ext. 606)
Executive VP and CFO VP, Corp. Communications
INTERNEURON PHARMACEUTICALS ANNOUNCES CALL
OPTION ARRANGEMENTS
COMPANY TO PURCHASE UP TO 1,200,000 CALL OPTIONS AND TO ISSUE CALL
OPTIONS ON UP TO 2,000,000 SHARES OF OWN STOCK
LEXINGTON, MA, May 5, 1997 -- Interneuron Pharmaceuticals, Inc. (NASDAQ:IPIC)
today announced that it has made arrangements with a financial institution under
which Interneuron intends to purchase in private transactions capped call
options on its own common stock. These call options will give Interneuron the
right to purchase from the financial institution up to a total of 1,200,000
shares of Interneuron common stock at specified strike prices to be determined.
Alternately, Interneuron may elect cash settlement of these options. The call
options are expected to be exercisable only at their maturities, which will be
specified dates from approximately four to 16 months following the dates the
call options are purchased by Interneuron.
In exchange for the purchase of these call options, Interneuron intends to sell
to the same financial institution call options entitling the institution to
purchase from Interneuron at a strike price expected to be $40.00 per share, up
to approximately 2,000,000 shares of Interneuron common stock in May 1999.
"The call options purchased by Interneuron will provide Interneuron the right to
acquire its common stock at fixed prices and will thus allow the Company to
benefit from potential appreciation in its stock price above the strike prices.
The call options sold by the Company would be exercised by the financial
institution in the event the stock price at the maturity date exceeds the
expected $40.00 strike price, a price we believe is attractive to issue
additional shares," said Glenn L. Cooper, M.D., president and chief executive
officer of Interneuron.
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The purchases and sales of call options by the Company are expected to occur in
several transactions, with the final number of options, strike price, cap price,
maturity, purchase price and certain other terms to be agreed to at the time of
each purchase, based on a number of factors, including the market price of
Interneuron's common stock at the time each option is issued. Completion and
pricing of the transactions is subject to market conditions. The Company will
have the right to settle the call options with cash or stock, subject to certain
conditions. The call options which the Company purchases are expected to be
settled, if exercised, with cash in an amount equal to the difference between
the strike price and the market price, subject to certain caps which will limit
the total amount of cash the Company could receive. The caps will increase the
strike prices in the case of stock settlement. If exercised, the Company expects
to settle the call options that it sells with stock, subject to the
effectiveness of a registration statement covering the resale of the shares
delivered to the financial institution in settlement.
The purchases and sales of call options are in addition to Interneuron's
previously announced program to repurchase up to 1,500,000 shares of its common
stock. As of March 31, 1997, the Company has purchased approximately 142,500
shares of its stock in the open market. As of March 31, 1997, the Company had
approximately 41.1 million shares outstanding.
The financial institution has advised Interneuron that it may engage in
transactions, including market purchases and sales of Interneuron's securities,
to offset its risk relating to the options.
The securities to be sold by Interneuron to the financial institution have not
been registered under the Securities Act and may not be offered or sold in the
U.S. absent registration or an applicable exemption from registration
requirements.
Interneuron Pharmaceuticals is a diversified biopharmaceutical company engaged
in the development and commercialization of a portfolio of products and product
candidates primarily for neurological and behavioral disorders. Interneuron is
also developing products and technologies, generally outside the central nervous
system field, through four subsidiaries: Intercardia, Inc. focused on
cadiovascular disease, Progenitor, Inc. focused on developmental genomics,
Transcell Technologies, Inc. focused on carbohydrate-based drug discovery, and
InterNutria, Inc. focused on dietary supplement pruducts.
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Except for the descriptions of historical facts contained herein, this news
release contains forward-looking statements that involve risks and
uncertainties, as detailed from time to time in Interneuron's SEC filings under
the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk
Factors" and elsewhere. Actual results could differ materially from those
currently anticipated due to a number of factors including factors that may
affect the Company's business, financial condition, and results of operations
and the market price of the Company's common stock.
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