EXHIBIT 99.1
FOR IMMEDIATE RELEASE
INVESTOR RELATIONS CONTACT
Don Weinberger Leah Berkovits
Wolfe Axelrod Weinberger Associates Bio-Technology General Corp.
212-370-4500 732-632-8800
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BIO-TECHNOLOGY GENERAL TO ACQUIRE MYELOS CORPORATION
-- PROMISING NEW DRUG FOR DIABETIC NEUROPATHIC PAIN IN CLINICAL DEVELOPMENT --
Iselin, New Jersey, February 22, 2001 -- Bio-Technology General Corp.
(NASDAQ:BTGC) today announced it has entered into a definitive agreement to
acquire Myelos Corporation, a privately-held biopharmaceutical company focused
on the development of novel therapeutics to treat diseases of the nervous
system.
Myelos' technology platform enables the isolation of stimulatory peptides (short
chains of amino acids) derived from growth factors. This has led to the
development of Prosaptide-TM-, a promising new compound for the treatment of
neuropathic pain associated with diabetic peripheral neuropathy. A Phase II
human clinical trial in Type I and Type II diabetes mellitus already completed
by Myelos demonstrated that Prosaptide effectively decreases pain associated
with diabetic peripheral neuropathy without deleterious side effects.
Diabetic peripheral neuropathy is a serious and debilitating complication of
Type I and Type II diabetes mellitus that usually affects the feet and legs.
Symptoms include pain, numbness, and tingling. An estimated 8.8 million
diabetics have peripheral neuropathy, while approximately 2.6 million of them
have been diagnosed and are symptomatic. Due to the fact that available
treatment options for pain associated with diabetic peripheral neuropathy are
often unsatisfactory and frequently accompanied by unacceptable side effects,
only approximately one-third of
patients who are diagnosed and symptomatic are currently treated. BTG believes
that the annual worldwide market potential for Prosaptide in the treatment of
diabetic neuropathic pain may be in excess of $800 million.
Moreover, in a series of animal studies, Prosaptide was shown to not only
alleviate peripheral neuropathic pain but also to reverse the underlying
neuropathy, thereby inducing neuronal regeneration and preventing neuronal
death. The data from these studies strongly suggest that if these findings are
replicated in human clinical trials, there may well be additional potential for
Prosaptide in the treatment of diabetic peripheral neuropathy, over and above
its demonstrated ability to decrease neuropathic pain. No approved drugs are
available to prevent or reverse the neuropathy itself.
Under the terms of the agreement, BTG will pay Myelos stockholders $35 million
in a combination of cash and stock ($14 million in cash and $21 million in
equity (approximately 2.3 million shares of common stock)). As a result of the
transaction, shares outstanding will increase by approximately 4%. Despite this
increase in shares, BTG should be able to achieve EPS growth in 2001 over 2000.
The shares being issued to Myelos are unregistered. Although BTG has agreed to
register the shares under the Securities Act, each principal stockholder of
Myelos has agreed to limit their sale of BTG shares in any three-month period.
This lockup agreement expires after two years.
An additional future payment of $30 million in a combination of cash and stock
is contingent upon BTG being in position to file a New Drug Application for FDA
approval of Prosaptide in the treatment of neuropathic pain. A final payment of
15% of worldwide net sales in the third year of commercialization will be made
in a combination of cash and stock. The consummation of the acquisition is
subject to customary closing conditions including approval by the stockholders
of Myelos. The Company expects to close the acquisition during March 2001.
Sim Fass, Chairman and CEO of Bio-Technology General Corp., stated: "The
acquisition of Myelos enhances our prospects for future growth by the addition
of an exciting proprietary product with large market potential to our pipeline
of drugs in development. Based on the data
from Myelos' pre-clinical and clinical program, we believe that Prosaptide is a
drug that can make a much-needed contribution to the treatment of diabetic
peripheral neuropathy, and that it may one day prove to be effective in the
treatment of peripheral neuropathy associated with other medical conditions. In
addition, beyond Prosaptide's potential, the Myelos technology platform could
lead to the development of new peptides to treat other diseases of the nervous
system."
Bio-Technology General Corp., a leading biopharmaceutical company, develops,
manufactures and markets genetically engineered and other products for human
health care. BTG's products are marketed worldwide. Products sold in the
United States are Oxandrin-Registered Trademark- (oxandrolone, USP), marketed
by BTG and by the Ross Products Division of Abbott Laboratories under a
co-marketing agreement, Delatestryl-Registered Trademark- (testosterone
enanthate), marketed by BTG, Mircette-TM- (oral contraceptive), marketed by
Organon, Inc., and BioLon-TM- (sodium hyaluronate), marketed by Akorn, Inc.
Products sold internationally are Bio-Tropin-TM-(recombinant human growth
hormone), BioLon-TM- (sodium hyaluronate), Bio-Hep-B-TM- (hepatitis B
vaccine), and Silkis-Registered Trademark- (vitamin D derivative).
BTG's news releases and other information are available on the Company's website
at www.btgc.com.
BTG will be offering a live webcast of a discussion by BTG management of the
earnings and the Company's business on Thursday, February 22, 2001, at 10:30
a.m. (EST). The webcast can be accessed by going to BTG's website at
www.btgc.com. It will be archived and available after the discussion via our
website through March 1, 2001. A replay will also be available for one week by
calling 888-203-1112 (US) or 719-457-0820 (from overseas), passcode 771458.
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