SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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) May 3, 1996
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BioCryst Pharmaceuticals, Inc.
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(Exact name of registrant as specified in charter)
Delaware 000-23186 62-1413174
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
2190 Parkway Lake Drive, Birmingham, Alabama 35244
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (205) 444-4600
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N.A.
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(Former name or former address, if changed since last report.)
Item 5. Other Events
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See attached press releases.
These press releases contain projections or other forward-looking
statements regarding future events or the future financial performance
of the Company. These statements are only predictions and the actual
events or results may differ materially. Please refer to the
documents the Company files from time to time with the Securities and
Exchange Commission, specifically the Company's most recent Form 10-K
and Form 10-Q. These documents contain and identify important factors
that could cause the actual results to differ materially from those
contained in the projections or forward-looking statements.
Item 7. Exhibits
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10.1+ Form of License Agreement, dated May 31, 1996, between
Registrant and Torii Pharmaceuticals Co., Ltd. ("Torii").
10.2+ Form of Stock Purchase Agreement, dated May 31, 1996,
between Registrant and Torii.
_________________
+ Confidential Treatment Requested
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.
BioCryst Pharmaceuticals, Inc.
(Registrant)
By: /s/ Ronald E. Gray
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Name: Ronald E. Gray
Title: Chief Financial Officer
Dated: June 24, 1996
BIOCRYST PHARMACEUTICALS, INC.
2190 PARKWAY LAKE DRIVE
BIRMINGHAM, AL 35244
205-444-4600
205-444-4640 (FAX)
Contact:
BioCryst Pharmaceuticals, Inc.
John L. Higgins Burns McClellan, Inc.
Vice President, Corporate James W. Heins (Media)
Development Jonathan M. Nugent (Investors)
(205) 444-4600 (212) 505-1919
FOR IMMEDIATE RELEASE
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BioCryst Reports Encouraging Preliminary Results from a
Phase II Trial of its Lead Compound, BCX-34,
for Topical Treatments of Psoriasis
Birmingham, AL -- May 3, 1996 -- BioCryst Pharmaceuticals, Inc. (Nasdaq NM:
BCRX) today announced encouraging preliminary results from a Phase II trial of
its lead compound, BCX-34, for the topical treatment of psoriasis. The Phase II
double-blind, placebo-controlled trial treated 90 patients with plaque psoriasis
for three months with a topical cream containing one-percent drug concentration
of BCX-34. The endpoints for the trial were reductions in erythema, scaling and
thickness of plaques, which were combined for a total score, and a global
physician assessment. The trial had two parallel patient groups, one receiving
drug and the other receiving placebo. The preliminary data from this trial will
be summarized in conjunction with previous Phase II clinical trial data at the
57th Annual Meeting of the Society for Investigative Dermatology being held May
1-4 in Washington, D.C.
The trial was conducted at four geographically diverse sites: two in northern
climates and two in the Sunbelt. Analysis of the combined data from all sites
did not reveal a clear drug effect different from placebo; however, there was a
statistically significant difference in the data from the northern and Sunbelt
patient groups which did not allow for a meaningful comparative analysis of the
combined data from all sites. Consequently, the two regions were analyzed
separately. Data from the northern sites showed a statistically significant
outcome for the total clinical score and the global physician assessment after
12 weeks of treatment. In the Sunbelt sites, there was a large response in
placebo-treated patients, which masked any apparent drug effect. The difference
in placebo responses between the sites in the north and the sites in the Sunbelt
is believed by the Company to have been caused by the phototherapeutic effect of
the sun in southern climates. There were no significant adverse events reported
at any of the four sites.
BioCryst Pharmaceuticals, Inc.
Page 2
"Data from the northern sites support the clinical efficacy of BCX-34 for the
topical treatment of psoriasis," said George A. Omura, M.D., Vice President,
Clinical Development of BioCryst. "The elevated placebo response in the Sunbelt
sites, in our opinion, is attributable to increased exposure to the warmer
climate and sunlight, which has a well-known therapeutic effect on skin
conditions such as psoriasis."
"We have gained valuable clinical data from these trials and are satisfied that
the results warrant advancing BCX-34 to the next stage of development," said
Charles E. Bugg, Ph.D., President and Chief Executive Officer of BioCryst. "We
will request a meeting with the FDA to discuss the design and initiation of
Phase III trials. These next trials will be designed to compensate for
phototherapeutic and other non-drug related effects, and give a definitive
assessment of the drug's efficacy and safety."
Psoriasis is a chronic and recurrent disease characterized by red, thick scaling
or welt-covered portions of the skin. An estimated five million people in the
United States are affected by psoriasis. Current therapies for psoriasis are
not optimal or are associated with side effects.
The Company is currently conducting a multi-center Phase III clinical trial with
topical BCX-34 for the treatment of cutaneous T-cell lymphoma (CTCL) and a Phase
I/II clinical trial with an oral formulation of BCX-34 to treat T-cell cancers.
These diseases and others, including rheumatoid arthritis, multiple sclerosis
and psoriasis, are associated with the proliferation of T-cells. Based upon the
results of the ongoing Phase I/II oral trial, BioCryst plans to initiate oral
trials for additional indications including the treatment of psoriasis. BCX-34
is a potent, small-molecule inhibitor of purine nucleoside phosphorylase (PNP),
a human enzyme that plays a central role in the proliferation of T-cells. BCX-
34 was granted Orphan Drug Status in October 1993 for CTCL and qualifies for
accelerated review as a new drug to treat serious and life-threatening
illnesses.
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 BioCryst's SEC filings under the Securities Act
of 1933 and the Securities Exchange Act of 1934, including, among other things,
uncertainties as to the clinical and commercial success of BCX-34, and
competitive, patent, regulatory and product liability issues. The trial
outcomes discussed in this press release are not necessarily predictive of the
results of future trials.
Founded in 1986, BioCryst Pharmaceuticals, Inc. designs and develops novel,
small molecule pharmaceuticals using structure-based drug design, an approach to
drug discovery that integrates advanced biology, biophysics and medicinal
chemistry. BioCryst's lead drug, BCX-34, is in clinical trials with both
topical and oral formulations. The Company is developing drug treatments for
immunological and infectious diseases.
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BIOCRYST PHARMACEUTICALS, INC.
2190 PARKWAY LAKE DRIVE
BIRMINGHAM, AL 35244
205-444-4600
205-444-4640 (FAX)
Contact:
BioCryst Pharmaceuticals, Inc.
John L. Higgins Burns McClellan, Inc.
Vice President, Corporate James W. Heins (Media)
Development Jonathan M. Nugent (Investors)
(205) 444-4600 (212) 505-1919
FOR IMMEDIATE RELEASE
- ---------------------
BioCryst Enters License Agreement with Japanese Pharmaceutical
Company for Lead Drug Program
Birmingham, AL -- June 3, 1996 -- BioCryst Pharmaceuticals, Inc. (Nasdaq NM:
BCRX) announced today that it has entered into an exclusive license agreement
with Torii Pharmaceutical Co., Ltd. of Japan for the development, manufacture
and commercialization of certain of its purine nucleoside phosphorylase (PNP)
inhibitors in Japan. Under the license agreement, Torii will focus on the
development and commercialization of BioCryst's lead drug, BCX-34, for three
indications, including rheumatoid arthritis, T-cell cancers and atopic
dermatitis.
Under the terms of the agreement, Torii will pay a total of $22 million in
license fees, an equity investment and milestone payments. Torii will also be
responsible for all development and commercialization expenses in Japan and will
pay royalties on sales of licensed products. Pursuant to the agreement, Torii
has paid BioCryst $3.0 million upfront, consisting of a $1.5 million license fee
and a $1.5 million equity investment for the purchase of 76,608 shares of common
stock at a price of $19.58 per share. In addition to the upfront payments,
Torii will pay the remaining $19 million in development milestone payments over
a number of years. Torii will focus its development efforts on three
indications and can negotiate additional payments with BioCryst to develop PNP
inhibitors for other indications.
"Considering Torii's experience in developing and commercializing major
pharmaceutical products for multiple indications, we believe they are an ideal
partner to assist with the commercialization of BCX-34 in Japan. Torii shares
our excitement and vision for the potential of our PNP program," said Charles E.
Bugg, Ph.D., President and CEO of BioCryst. "Given our recent clinical
progress, we are eager to work with our new partner to initiate clinical
development in a major foreign market."
BioCryst Pharmaceuticals, Inc.
Page 2
"One of BioCryst's strategic goals for 1996 was to enter a license agreement in
Japan to initiate clinical development. As our first major collaboration, our
deal with Torii provides an endorsement of our PNP program and significant
revenue potential with future milestone and royalty payments," said John L.
Higgins, Vice President, Corporate Development. "Throughout the negotiating
process, we built a strong working relationship with Torii. We are very
impressed with the company and their experience developing novel therapeutics."
Torii, founded in 1872, focuses its operations primarily on ethical drugs and
has been marketing highly novel drugs in several specialized areas. The company
was responsible for launching the first cephalosporin antibiotic in Japan in
1965 when it introduced the Glaxo-developed drug Ceporan. Its leading product,
Futhan, a protease inhibitor developed in-house for the treatment of acute
pancreatitis, is the market leader in its category with 41 percent of the market
in 1995. The company recently invested US$100 million in a new R&D center.
Torii, which until 1988 was majority-owned by Merck and Co. Ltd., is now
controlled by Asahi Breweries Ltd., Japan's second largest brewing company. In
October 1993, Torii gained a separate listing on the Tokyo Stock Exchange. In
the year ended March 31, 1995, Torii had net sales of US$407 million, placing it
in the top 100 pharmaceutical companies worldwide based on sales.
BioCryst is currently conducting a multi-center Phase III clinical trial with
topical BCX-34 for the treatment of cutaneous T-cell lymphoma (CTCL) and a Phase
I/II clinical trial with an oral formulation of BCX-34 to treat T-cell cancers.
These diseases and others, including rheumatoid arthritis, multiple sclerosis,
psoriasis and atopic dermatitis, are associated with the proliferation of T-
cells. Depending upon the results of the ongoing Phase I/II oral trial,
BioCryst plans to initiate oral trials for additional indications including the
treatment of psoriasis and rheumatoid arthritis. BCX-34 is a potent, small-
molecule inhibitor of purine nucleoside phosphorylase (PNP), a human enzyme that
plays a central role in the proliferation of T-cells. BCX-34 was granted Orphan
Drug Status in October 1993 for CTCL and may qualify for accelerated review as a
new drug to treat serious and life-threatening illnesses.
Founded in 1986, BioCryst Pharmaceuticals, Inc. designs and develops novel,
small-molecule pharmaceuticals using structure-based drug design, an approach to
drug discovery that integrates advanced biology, biophysics and medicinal
chemistry. BioCryst's lead drug, BCX-34, is in clinical trials with both
topical and oral formulations. The Company is developing drug treatments for
immunological and infectious diseases.
This press release contains projections or other forward-looking statements
regarding future events or the future financial performance of the Company.
These statements are only predictions and the actual events or results may
differ materially. Please refer to the documents the company files from time to
time with the Securities and Exchange
BioCryst Pharmaceuticals, Inc.
Page 3
Commission, specifically the Company's most recent Form 10-K and Form 10-Q.
These documents contain and identify important factors that could cause the
actual results to differ materially from those contained in the projections or
forward-looking statements.
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