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As filed with the Securities and Exchange Commission on April 9, 1999
Registration No.333-
================================================================================
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
---------------------
FORM S-3
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
--------------------------
MAGAININ PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)
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Delaware 2834 13-3445668
<S> <C> <C>
(State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Identification No.)
incorporation or organization) Classification No.)
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5110 CAMPUS DRIVE
PLYMOUTH MEETING, PA 19462
(610) 941-4020
(Address, including zip code, and telephone number, including area code,
of registrant's principal executive offices)
---------------------------------
MICHAEL R. DOUGHERTY
PRESIDENT AND CHIEF EXECUTIVE OFFICER
MAGAININ PHARMACEUTICALS INC.
5110 CAMPUS DRIVE
PLYMOUTH MEETING, PA 19462
(610) 941-4020
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
---------------------------------
Copies of all communications to:
DAVID R. KING
MORGAN, LEWIS & BOCKIUS LLP
1701 MARKET STREET
PHILADELPHIA, PA 19103
(215) 963-5000
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: As soon as
practicable after the effective date of this Registration Statement.
If the only securities being registered on this Form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. [_]
If any of the securities being registered on this Form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. [X]
If this Form is filed to register additional securities for an offering pursuant
to Rule 462(b) under the Securities Act, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same offering. [_]
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [_]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [_]
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CALCULATION OF REGISTRATION FEE
============================================================================================================================
Title of each class of Amount to be Proposed maximum offering price Proposed maximum Amount of
securities to be registered registered per share aggregate offering registration fee
price
- ----------------------------------------------------------------------------------------------------------------------------
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Common Stock, 620,540 $1.73(1) $1,076,264(1) $317.50(1)
$.002 par value
============================================================================================================================
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(1) Based on the average of the reported high and low sales of the Common Stock
reported on the Nasdaq National Market on April 7, 1999 estimated solely
for the purpose of calculating the registration fee pursuant to Rule
457(c).
The Registrant hereby amends this Registration Statement on such date or dates
as may be necessary to delay its effective date until the Registrant shall file
a further amendment which specifically states that this Registration Statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
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The information in this prospectus is not complete and may change. These
securities may not be sold until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer
to sell these securities and it is not soliciting an offer to buy these
securities in any state where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED APRIL 9, 1999
PROSPECTUS
- ----------
620,540 SHARES
MAGAININ PHARMACEUTICALS INC.
COMMON STOCK
__________
This Prospectus relates to 620,540 shares of common stock of Magainin
Pharmaceuticals Inc. which are being offered by Genentech, Inc. We are
registering these shares as required under the terms of an agreement with
Genentech to provide Genentech with freely tradable securities. The registration
of the shares does not necessarily mean that any of the shares will be offered
or sold by Genentech. We will receive no proceeds of any sales of the shares,
but will incur expenses in connection with the offering. See "Selling
Stockholder" and "Plan of Distribution."
Genentech may from time to time offer and sell the shares held by them
directly or through agents or broker-dealers on terms to be determined at the
time of sale. To the extent required, the names of any agent or broker-dealer
and applicable commissions or discounts and any other required information with
respect to any particular offer will be set forth in the section of this
prospectus entitled "Plan of Distribution" or in an accompanying prospectus
supplement. Genentech reserves the sole right to accept or reject, in whole or
in part, any proposed purchase of the shares to be made directly or through
agents. Genentech has not advised us of any specific plans for the distribution
of the shares covered by this Prospectus, but we anticipate that the shares will
be sold from time to time primarily in transactions (which may include block
transactions) on the Nasdaq National Market at the market price then prevailing,
although sales may also be made in negotiated transactions or otherwise. See
"Plan of Distribution."
Our common stock is quoted on the Nasdaq National Market under the symbol
"MAGN." On April 7, 1999 the last reported closing price of our common stock was
$1.75 per share.
INVESTING IN THE SHARES INVOLVES RISKS. RISK FACTORS BEGIN ON PAGE 6.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS
PROSPECTUS IS ACCURATE OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
THE DATE OF THIS PROSPECTUS IS APRIL 9, 1999
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TABLE OF CONTENTS
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Page
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Where You Can Find More Information......................................... 2
About this Prospectus....................................................... 3
Forward-Looking Statements.................................................. 3
Our Company................................................................. 4
Risk Factors................................................................ 6
Use of Proceeds............................................................. 15
Selling Stockholder......................................................... 16
Plan of Distribution........................................................ 16
Legal Opinion............................................................... 18
Experts..................................................................... 18
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WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other
information with the Securities and Exchange Commission (the "SEC"). You may
read and copy any reports, statements or other information we file at the SEC's
public reference rooms located at Judiciary Plaza, 450 Fifth Street, N.W.,
Washington, D.C. 20549, Citicorp Center, 500 West Madison Street, Suite 1400,
Chicago, IL 60661 and 7 World Trade Center, Suite 1300, New York, NY 10048.
Please call the SEC at 1-800-SEC-0330 for further information on the public
reference rooms. Our SEC filings are also available to the public from
commercial document retrieval services and at the web site maintained by the SEC
at "http://www.sec.gov."
We have filed a Registration Statement on Form S-3, of which this
Prospectus forms a part, to register the securities with the SEC. As allowed by
SEC rules, this Prospectus does not contain all the information you can find in
the Registration Statement or the exhibits to the Registration Statement.
The SEC allows us to "incorporate by reference" information into this
Prospectus, which means that we can disclose important information to you by
referring you to another document filed separately with the SEC. The information
incorporated by reference is deemed to be part of this Prospectus, except for
any information superseded by information in this Prospectus. This Prospectus
incorporates by reference the documents set forth below that we have previously
filed with the SEC. These documents contain important information about us, our
business and our finances.
The documents that we are incorporating by reference are:
. Our Annual Report on Form 10-K for the year ended December 31, 1998;
. Our Current Report on Form 8-K filed with the SEC on January 7, 1999;
. Our Current Report on Form 8-K filed with the SEC on March 15, 1999;
and
. The description of our common stock which is contained in our Form 8-A
Registration Statement filed with the SEC on November 7, 1991 and
amended on January 15, 1993.
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Any documents which we file pursuant to Sections 13(a), 13(c), 14 or 15(d)
of the Exchange Act after the date of this Prospectus but before the end of any
offering of securities made under this Prospectus will also be considered to be
incorporated by reference.
If you request, either orally or in writing, we will provide you with a
copy of any or all documents which are incorporated by reference. We will
provide such documents to you free of charge, but will not include any exhibits,
unless those exhibits are incorporated by reference into the document. You
should address written requests to Michael R. Dougherty, President and Chief
Executive Officer, Magainin Pharmaceuticals Inc., 5110 Campus Drive, Plymouth
Meeting, PA 19462, (610) 941-5228.
ABOUT THIS PROSPECTUS
You should only rely on the information contained in this Prospectus. We
have not authorized anyone to provide you with information different from that
contained in this Prospectus. Genentech is offering to sell, and seeking offers
to buy, shares of common stock only in jurisdictions where offers and sales are
permitted. The information contained in this Prospectus is accurate only as of
the date of this Prospectus, regardless of the time of delivery of this
Prospectus or of any sale of common stock.
FORWARD-LOOKING STATEMENTS
Our disclosure and analysis in this Prospectus contains some forward-
looking statements. Forward-looking statements give our current expectations or
forecasts of future events. You can identify these statements by the fact that
they do not relate strictly to historical or current facts. Such statements may
include words such as "anticipate", "estimate", "expect", "project", "intend",
"plan", "believe" and other words and terms of similar meaning in connection
with any discussion of future operating or financial performance. In particular,
these include statements relating to present or anticipated scientific progress,
development of potential pharmaceutical products, future revenues, capital
expenditures, research and development expenditures, future financing and
collaborations, personnel, manufacturing requirements and capabilities, and
other statements regarding matters that are not historical facts or statements
of current condition.
Any or all of our forward-looking statements in this Prospectus may turn
out to be wrong. They can be affected by inaccurate assumptions we might make or
by known or unknown risks and uncertainties. Many factors mentioned in the
discussion below will be important in determining future results. Consequently,
no forward-looking statement can be guaranteed. Actual future results may vary
materially.
We undertake no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events or otherwise.
You are advised, however, to consult any further disclosures we make on related
subjects in our 10-Q, 8-K and 10-K reports to the SEC. Also note that we provide
the following cautionary discussion of risks and uncertainties relevant to our
business. These are factors that we think could cause our actual results to
differ materially from expected results. Other factors besides those listed here
could also adversely affect us. This discussion is provided as permitted by the
Private Securities Litigation Reform Act of 1995.
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OUR COMPANY
Magainin is a biopharmaceutical company engaged in the development of
medicines for serious diseases. Our development efforts are focused on anti-
infectives, oncology, and pulmonary and allergic disorders.
Our research and drug development efforts are focused on two technology
platforms:
. Host-Defense Drug Discovery--we isolate and develop therapeutically active
compounds from the host defense systems of animals. Magainin peptides
represent a new class of antibiotics being developed for the treatment of
infection and cancer. Our second host defense class, aminosterols, is a new
class of pharmaceuticals which we believe may have multiple applications,
including the control of cell proliferation.
. Asthma Genomics--we employ a range of genomics techniques to identify genes
associated with the pathogenesis of asthma, with the objective of utilizing
the optimal biologic gene targets in the development of novel therapeutics
for asthma and allergy.
MAGAININ PEPTIDES--PEXIGANAN ACETATE
Our most advanced class of compounds under development are magainin
peptides. Discovered in the skin of the African clawed frog, magainins have
demonstrated broad activity against a variety of pathogens in preclinical
studies. These molecules act by puncturing the membrane of the pathogen cell,
resulting in the death of the pathogen.
Pexiganan acetate (formerly called Cytolex), a topical cream antibiotic is
our lead product development candidate. We have completed two pivotal Phase III
clinical trials of pexiganan acetate for the treatment of infection in diabetic
foot ulcers. These studies were designed as equivalence trials, with the goal of
demonstrating that topically applied pexiganan acetate is comparable to orally
administered ofloxacin, a quinolone antibiotic indicated for the treatment of
infection, including skin and soft tissue infections. In July 1998, we submitted
a New Drug Application to the U.S. Food and Drug Administration based on the
results of these trials.
In March 1999, the Anti-Infectives Drug Advisory Committee of the FDA, by a
vote of 7 to 4 declined to recommend approval for pexiganan acetate. We are
working with the FDA to resolve issues discussed by the Advisory Committee, and
we expect in the future to be able to speak more specifically about our plans
for pexiganan acetate.
In February 1997, we entered into a development, supply and distribution
agreement with SmithKline Beecham ("SmithKline") pursuant to which SmithKline
will market and sell pexiganan acetate in North America. Under this agreement,
SmithKline has paid $10.0 million to us, and may make additional payments of up
to $22.5 million, upon the occurrence of certain product milestones. SmithKline
will also fund a majority of development expenses for any additional indications
for pexiganan acetate.
AMINOSTEROLS--SQUALAMINE
Squalamine is the lead product development candidate in our aminosterol
program. Squalamine was discovered in the body tissues of the dogfish shark. The
shark was initially examined because of its known resistance to infection and
cancer. Since the discovery of squalamine, we have discovered several other
aminosterol compounds in the shark. In preclinical testing conducted to date,
certain of these compounds have demonstrated an ability to control cell growth,
along with other pharmacological properties. These
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properties may have application in the treatment of disease indications
characterized by cell proliferation, such as cancer.
Our initial disease focus for squalamine is solid tumors. The formation of
new blood vessels, or angiogenesis, is believed to be a critical factor in tumor
growth. Squalamine may be of benefit in the treatment of a number of solid
tumors by inhibiting new blood vessel growth required for tumor nourishment.
We are conducting Phase I clinical testing of squalamine in patients with
advanced malignancy.
ASTHMA GENOMICS
In 1996, we initiated a research program in the genomics of asthma. These
efforts led to the identification of IL9, a gene which varies in DNA structure
and function in asthmatic and allergic humans and animals. We maintain a
research and development program to identify additional genes in the IL9
biologic pathway. The IL9 receptor has been discovered in humans as a key second
gene candidate in the IL9 pathway, and other genes have also been identified by
us. We continue to investigate the role of these genes in the allergic
inflammatory response, with the objective of utilizing the optimal biologic gene
targets in the development of novel therapeutics for asthma and allergy.
In December 1998, we entered into a collaborative research and option
agreement with Genentech, Inc. ("Genentech") relating to the development of a
protein therapeutic in asthma.
Magainin was incorporated in the State of Delaware in June 1987. Our
primary offices and research facility are located at 5110 Campus Drive, Plymouth
Meeting, PA 19462, and our telephone number is (610) 941-4020.
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RISK FACTORS
You should carefully consider the following risk factors and the other
information presented in this Prospectus before deciding to invest in the shares
of common stock.
WE DEPEND HEAVILY ON PEXIGANAN ACETATE, WHICH IS STILL IN THE DEVELOPMENT STAGE
AND MAY NEVER BE APPROVED FOR COMMERCIAL USE.
We have submitted a New Drug Application with the FDA for our lead drug
product development candidate, pexiganan acetate. The NDA submission includes
the results of two multi-center, randomized, Phase III clinical equivalence
trials comparing 1% pexiganan acetate cream to ofloxacin, an oral antibiotic
indicated for skin and soft tissue infections. The NDA, as submitted, includes
data analyses for a number of primary endpoints. These include clinical response
of infection, overall microbiological response of infection and therapeutic cure
(a combination of clinical and overall microbiological cures), which were
analyzed over a number of patient cohorts and timepoints. The Company's data
package also includes extensive additional data, including microbiology data for
specific pathogens and wound healing data. Certain of the data favor ofloxacin.
The guidelines pursuant to which clinical trials of this nature are to be
conducted have evolved since the commencement of these studies
In March 1999, the Anti-Infectives Drug Advisory Committee of the FDA, by a
vote of 7 to 4 declined to recommend approval for pexiganan acetate. We are
working with the FDA to resolve issues discussed by the Advisory Committee, and
we expect in the future to be able to speak more specifically about our plans
for p exiganan acetate.
The FDA generally follows the recommendations of its Advisory Committee in
granting or withholding approval of NDA applications. As a result, we may not
receive approval of pexiganan acetate. The FDA may require us to conduct further
clinical studies to secure approval. This would be expensive and time consuming,
and we may not be able to conduct these studies. Even if the FDA does approve
our product, they may place certain restrictive conditions on the approval which
affect the commercial viability of the product.
WE HAVE NEVER BEEN PROFITABLE AND ANTICIPATE THAT WE WILL INCUR CONTINUED LOSSES
FOR THE FORESEEABLE FUTURE.
To date, we have engaged primarily in the research and development of drug
candidates. We have not generated any revenues from product sales and have
incurred losses in each year since our inception. As of December 31, 1998, we
had an accumulated deficit of approximately $132.9 million. Our operations are
subject to various competitive and regulatory risks. As a result, we are unable
to predict when or if we will achieve product revenues. Moreover, we expect to
experience substantial losses in the foreseeable future as we continue our
significant research, development and testing efforts.
WE NEED ADDITIONAL FUNDING AND WE MAY NOT HAVE ACCESS TO CAPITAL.
We will need to raise substantial additional funds to continue our research
and development programs and to commercialize our potential products. If we are
unable to raise such funds, we may be unable to complete our development
activities for any of our proposed products, including pexiganan acetate.
We regularly explore alternative means of financing our operations and
intend to seek additional funding through various sources, including:
. public and private securities offerings;
. collaborative, licensing and other arrangements with third parties; and
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. debt financing, such as bank loans.
We currently do not have any commitments to obtain additional funds, and
may be unable to obtain sufficient funding in the future on acceptable terms. If
we cannot obtain funding when needed, we may need to delay, scale back or
eliminate research and development programs or enter into collaborations with
third parties to commercialize potential products or technologies that we might
otherwise seek to develop or commercialize ourselves, or seek other
arrangements. This will result in lower consideration to the Company upon
commercialization of such products than if no arrangements were entered into, or
if such arrangements were entered into at later stages in the product
development process.
MANUFACTURING UNCERTAINTIES AND DEPENDANCIES MAY RESTRICT OUR ABILITY TO
COMMERCIALIZE PRODUCTS
We currently have neither the resources, the facilities nor the
capabilities to manufacture any of our proposed products in the quantities and
quality required for commercial sale. We have no current plans to establish a
manufacturing facility. We depend upon contract manufacturers for commercial
scale manufacturing of our proposed products in accordance with regulatory
standards. This dependence may restrict our ability to develop and deliver
products on a timely, profitable and competitive basis. Additionally, the number
of companies that are capable of producing bulk peptides on the scale that we
expect to require to commercialize pexiganan acetate is limited. We may be
unable to maintain arrangements with qualified outside contractors to
manufacture materials at costs which are affordable to us, if at all.
Contract manufacturers may utilize their own technology, our technology, or
technology acquired or licensed from third parties in developing a manufacturing
process In order to engage another manufacturer, we may need to obtain a license
or other technology transfer from the original contract manufacturer. Even if a
license is available from the original contract manufacturer on acceptable
terms, we may be unable to successfully effect the transfer of the technology to
the new contract manufacturer. Any such technology transfer may also require the
transfer of requisite data for regulatory purposes, including information
contained in a proprietary Drug Master File held by a contract manufacturer. We
will rely more heavily on a contract manufacturer that owns the Drug Master File
because our ability to change contract manufacturers may be more limited.
We have been working for many years with Abbott Laboratories in the
development of a process to manufacture bulk drug substance for pexiganan
acetate. We currently depend upon Abbott for the production of bulk drug
substance for pexiganan acetate. If Abbott cannot manufacture bulk drug
substance for pexiganan acetate we will need to secure other manufacturing
arrangements. The process developed by Abbott is proprietary. If we desire to
utilize, or have another party utilize, such process, we would be required to
pay Abbott a license fee.
The production of peptides (such as pexiganan acetate and other magainins)
is expensive relative to the production of the traditional antibiotics. We are
pursuing alternative manufacturing sources, including recombinant manufacturing,
in order to improve the gross margins available to us on sales of pexiganan.
These programs, however, are at an early stage and will require significant
expenditures over an extended period of time. Ultimately, we may be unable to
develop a more cost-effective manufacturing process and even if we develop a
more cost-effective process, the FDA may not approve such a process.
We are also currently working with outside contractors for the chemical
production of squalamine. Production of squalamine and other proposed products
will also require significant expenditure.
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WE DEPEND UPON THIRD PARTIES FOR MARKETING AND SALES, WHICH MAY RESTRICT OUR
ABILITY TO COMMERCIALIZE PRODUCTS.
We currently do not have our own sales and marketing staff. We believe that
in order to successfully develop and market our products, we must enter into
marketing, distribution, development or other arrangements with third parties.
We have entered into an arrangement with SmithKline with respect to pexiganan
acetate in North America. We may also be required to delegate the responsibility
for all or a significant portion of the development and regulatory approval
process to our partners. If our collaborators do not develop an approvable or
marketable product or do not market a product successfully, our business will be
adversely affected. We may be unable to enter into successful sales and
marketing arrangements in the future.
We do not have control over the amount and timing of resources to be
devoted to our products by our collaborative partners. In the future, the
interests of our collaborators may not be consistent with our interests.
Collaborators may develop products independently or through third parties which
could compete with our proposed products. With respect to pexiganan acetate,
SmithKline maintains a significant presence in the antibiotic area and currently
sells a topical antibiotic product indicated for the treatment of certain skin
infections. Furthermore, SmithKline may terminate our agreement with them at any
time.
As an alternative, we may decide to establish our own sales force to market
and sell our products. Although certain members of our management have
experience in the marketing of pharmaceutical products, we have no experience
with respect to marketing our products. If we choose to pursue this alternative,
we will need to spend significant additional funds and devote significant
management resources and time to establish a successful sales force.
OUR PRODUCT CANDIDATES ARE IN THE EARLY STAGE OF DEVELOPMENT AND MAY NEVER BE
COMMERCIALIZED.
Most of our proposed products are in a relatively early developmental stage
and will require significant research, development and testing. We must also
obtain regulatory approvals for all of our proposed products prior to
commercialization of the product. In addition, there has been only limited
research in the area of the use of naturally occurring host-defense compounds
for the treatment of infectious and other diseases.
The success of each of our drug development programs depends upon many
factors and is subject to numerous risks, including the risks that:
. the product candidate is found to be ineffective or unsafe;
. the product candidate later exhibits adverse effects that prevent
widespread use or require withdrawal from the market;
. the product candidate cannot be developed into a commercially viable
product;
. the product candidate is difficult or costly to manufacture;
. third party competitors hold proprietary rights that preclude us from
marketing the product; and
. third party competitors market a more effective, or more cost-effective,
product.
PEXIGANAN ACETATE MAY NOT ACHIEVE MARKET ACCEPTANCE, WHICH COULD ADVERSELY
AFFECT OUR BUSINESS.
Even if we receive regulatory approval for pexiganan acetate, we may be
unable to achieve market acceptance of the drug. A number of factors may affect
market acceptance of pexiganan acetate, including:
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. the perception by physicians and other members of the health care community
of the safety and efficacy of pexiganan acetate on an absolute basis or in
comparison to other drugs;
. the price of pexiganan acetate relative to other drugs or competing
treatment modalities;
. the availability of third-party reimbursement; and
. the effectiveness of our sales and marketing efforts relative to the sales
and marketing efforts of competitors.
In addition, side effects or unfavorable publicity concerning pexiganan
acetate or comparable drugs on the market may affect our ability to obtain
physician, patient or third-party payor acceptance.
WE MAY NOT BE ABLE TO OBTAIN THE REGULATORY APPROVALS REQUIRED TO COMMERCIALIZE
ANY OF OUR PRODUCT CANDIDATES.
Numerous governmental authorities, including the FDA in the United States,
regulate our business and activities. Federal, state and foreign governmental
agencies impose rigorous preclinical and clinical testing and approval
requirements on our product candidates. In general, the process of obtaining
government approval is time consuming and costly.
Governmental authorities may delay or deny the approval of any of our drug
candidates. In addition, governmental authorities may enact new legislation or
regulations that could limit or restrict our efforts. A delay or denial of
regulatory approval for any of our drug candidates, particularly pexiganan
acetate, could materially affect our business. Even if we receive approval of a
product candidate, it may be conditioned upon certain limitations and
restrictions as to the drugs used and may be subject to continuous review. If
we fail to comply with any applicable regulatory requirements, we could be
subject to penalties, including:
. warning letters;
. fines;
. withdrawal of regulatory approval;
. product recalls;
. operating restrictions;
. injunctions; and
. criminal prosecution.
The primary regulatory agency overseeing all phases of our drug development
and marketing programs is the FDA. In order to obtain FDA approval, we must
submit proof of safety, efficacy and quality for each of our proposed products
for each treatment, which requires extensive and time consuming preclinical and
clinical testing. The results of preclinical studies are submitted to the FDA
as part of an Investigational New Drug ("IND") Application. Once the IND
Application is effective, human clinical trials may be conducted. The results
of the clinical trials are submitted to the FDA as part of a New Drug
Application. Following review of the New Drug Application, the FDA may:
. grant marketing approval;
. require additional testing or information; or
. deny the application.
Detailed manufacturing information is also required to be included in the
New Drug Application for review and approval by the FDA. All manufacturing
facility and processes must comply with the good manufacturing practice
regulations prescribed by the FDA. All manufacturers must, among other things,
pass an inspection of their plants and provide detailed manufacturing records
and
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processes. Among other things, it must be demonstrated that:
. the drug product can be consistently manufactured at the same quality
standard;
. the drug product is stable over time; and
. the level of chemical impurities in the drug product are under a
designated level.
Peptides are an especially difficult group of compounds to manufacture at
these standards, particularly in the quantities at which we anticipate pexiganan
acetate will be required to be manufactured. Additionally, there have been a
number of changes over time in the manufacture of pexiganan acetate bulk drug
substance and final drug, including changes in process, scale and vendors. It
is necessary to demonstrate the product has been consistently manufactured over
time despite such changes.
The FDA's review of manufacturing for pexiganan acetate is on-going. The
FDA did initiate an inspection at the facility operated by one of our drug
product manufacturer; however, this inspection was curtailed due to the fact
that we would not be ready for this inspection until a later date. This
inspection, as well as additional inspections at our facility and at Abbott,
must be successfully conducted and completed prior to any FDA approval of
pexiganan acetate. Failure to pass these inspections would prevent or delay the
commercialization of pexiganan acetate.
We will continue to be subject to regulation by the FDA even after our drug
products have been approved and commercialized. Among other things, the FDA
may:
. require additional submissions if there are any modifications to the
drug product including, for example, any changes inmanufacturing
process, labeling, or manufacturing facility;
. require post-marketing testing and surveillance to monitor the effects
of approved drug products; and
. enforce conditional approvals that restrict the commercial
applications of a drug product.
Further, the FDA has numerous requirements governing labeling, promotional
material, storage, record keeping and reporting that may adversely affect our
business.
The Prescription Drug User Fee Act of 1992 imposes substantial fees on a
one-time basis for applications for approval, and on an annual basis for
manufacturing and marketing, of prescription drugs.
We are also subject to regulation by other regulatory authorities,
including the Occupational Safety and Health Administration, the Environmental
Protection Agency, the Nuclear Regulatory Commission, the Drug Enforcement
Agency and the United States Department of Agriculture, and to regulation under
the Toxic Substances Control Act, the Resource Conservation and Recovery Act and
other regulatory statutes. In the future we may be subject to additional
federal, state or local regulations.
Drug product marketing outside the United States is subject to foreign
regulatory requirements which may or may not be influenced by FDA approval.
While the requirements vary widely from country to country, generally, the drug
product must be approved by a foreign regulatory authority comparable to the FDA
prior to marketing the product in those countries. The time required to obtain
foreign approvals may be longer than that in the United States.
In the future, we may be subject to additional federal, state or local
regulations or additional fees. Efforts are continually underway to reform
federal regulation of
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drug products. Although some of these changes could streamline and otherwise
benefit development, marketing and related requirements for drugs, others could
increase regulatory requirements.
WE FACE INTENSE COMPETITION IN THE BIOPHARMACEUTICAL INDUSTRY.
The pharmaceutical industry is characterized by intense competition. Many
companies, research institutions and universities are conducting research and
development activities in a number of areas similar to our fields of interest.
We are aware that research on compounds derived from animal host-defense systems
is being conducted by others. Many companies are also currently involved in
research and development activities focused on the pathogenesis of disease, and
the competition among companies attempting to find genes responsible for disease
is intense. Furthermore, many companies are engaged in the development and sale
of products, such as traditional antibiotics, which may be, or are, competitive
with our proposed products. Most of these entities have substantially greater
financial, technical, manufacturing, marketing, distribution and other resources
than we have. We will also face competition from companies using different or
advanced techniques that may render our products obsolete.
We expect technological developments in the biopharmaceutical field to
occur at a rapid rate and expect competition to intensify as advances in this
field are made. Accordingly, we must continue to devote substantial resources
and efforts to research and development activities in order to maintain a
competitive position in this field. Our compounds, products or processes may
become obsolete before we are able to recover a significant portion of our
research and development expenses. We will be competing with companies that have
significantly more experience in undertaking preclinical testing and human
clinical trials of new or improved therapeutic products and obtaining regulatory
approvals of suchproducts. Some of these companies may be in advanced phases of
clinical testing of various drugs that may be competitive with our proposed
products.
Colleges, universities, governmental agencies and other public and private
research organizations are becoming more active in seeking patent protection and
licensing arrangements to collect royalties for use of technology that they have
developed, some of which may be directly competitive with our technology. In
addition, these institutions, along with pharmaceutical and specialized
biotechnology companies, can be expected to compete with us in recruiting highly
qualified scientific personnel.
Pexiganan acetate may not be successfully marketed against oral antibiotics
for the treatment of infection in diabetic foot ulcers. These infections have
historically been treated with systemically administered antibiotics, which may
be perceived by some medical professionals as having certain advantages over
pexiganan acetate. In addition, we may be unable to manufacture pexiganan
acetate at a cost which will allow it to be sold at a competitive price relative
to oral antibiotics or other topical antibiotics that may be used for this
indication.
Many companies are working to develop and market products intended for the
additional disease areas being targeted, including cancer and asthma. A number
of major pharmaceutical companies have significant franchises in these disease
areas, and can be expected to invest heavily to protect their interests. In the
cancer field, anti-angiogenic agents are under development at a number of
companies. In the asthma field, other biopharmaceutical companies have also
reported the discovery of genes relating to asthma.
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WE DEPEND ON PATENTS AND PROPRIETARY RIGHTS, WHICH OFFER ONLY LIMITED PROTECTION
AGAINST POTENTIAL INFRINGEMENT.
Our success depends, in part, on our ability to develop and maintain a
strong patent position for our products and technologies both in the United
States and other countries. As with most biotechnology and pharmaceutical
companies, our patent position is highly uncertain and involves complex legal
and factual questions. We cannot be certain that:
. patents will issue from any of these patent applications;
. our patent rights will be sufficient to protect our technology;
. our patents will not be successfully challenged or circumvented by our
competitors; or
. our patent rights will provide us with any commercial advantages.
The process of obtaining patent rights can be time consuming and expensive.
Even after significant expenditure, a patent may not issue. We can never be
certain that we were the first to develop the technology or that we were the
first to file a patent application for the particular technology because U.S.
patent applications are maintained in secrecy until a patent issues and
publications in the scientific or patent literature lag behind actual
discoveries.
Even after we are issued patent rights, we cannot be certain that:
. others will not develop similar technologies or duplicate the
technology;
. others will not design around the patented aspects of the technology;
. we will not be obliged to defend ourselves in court againstallegations
of infringement of third-party patents;
. our issued patents will be held valid in court; and
. an adverse outcome in a suit would not subject us to significant
liabilities to third parties, require rights to be licensed from third
parties, or require the Company to cease using such technology.
The cost of litigation can be substantial, regardless of the outcome.
There may be disputes arising as to the ownership of our technology. Most
of our research and development team previously worked at other biotechnology
companies, pharmaceutical companies, universities, or research institutions.
These entities may raise questions as to when the technology was developed, and
assert rights to the technology. These kind of disputes have occurred in the
past. We may not prevail in any such disputes.
Similar technology ownership disputes may arise in the context of
consultants, vendors or third parties, such as contract manufacturers. For
example, our consultants are employed by or have consulting agreements with
third parties. There may be dispute as to the capacity in which consultants are
operating when they make certain discoveries. We may not prevail in any such
disputes.
In order to protect our proprietary technology and processes, we also rely
on trade secrets and confidentiality agreements with our corporate partners,
employees, consultants, outside scientific collaborators and sponsored
researchers and other advisors. We may find that these agreements will be
breached, or that our trade secrets have otherwise become known or independently
developed or discovered by our competitors.
Certain of our exclusive rights to patents and patent applications are
governed by contract. Generally, such
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contracts require that we pay royalties on sales of any products which are
covered by patent claims. If we are unable to pay the royalties we may lose our
patent rights. Additionally, some of these agreements also require that we
develop the licensed technology under certain timelines. If we do not adhere to
an acceptable schedule of commercialization, we may lose our patent rights.
WE DEPEND ON KEY PERSONNEL WHOM WE MAY NOT BE ABLE TO RECRUIT OR RETAIN.
We depend to a considerable degree on a limited number of key personnel.
Many key responsibilities have been assigned to a relatively small number of
individuals. We do not maintain "key man" insurance on any of our employees.
The loss of certain senior management could adversely affect our business. Our
success will depend upon the successful recruitment and retention of qualified
personnel.
WE ARE SUBJECT TO PRODUCT LIABILITY CLAIMS, WHICH COULD ADVERSELY AFFECT OUR
BUSINESS.
We are subject to significant potential product liability risks inherent in
the testing, manufacturing and marketing of human therapeutic products,
including the risk that:
. our proposed products cause some undesirable side effects or injury
during clinical trials;
. our commercialized products cause undesirable side effects or injury;
or
. third parties that we have agreed to indemnify incur liability.
While we carry insurance, we may be unable to maintain adequate coverage at
acceptable terms.
WE MAY NOT RECEIVE THIRD-PARTY REIMBURSEMENT FOR ANY OF OUR DRUG CANDIDATES.
Our ability to commercialize our proposed products depends on the extent to
which our customers are eligible for reimbursement from health care
organizations and the government.
In both the United States and elsewhere, prescription pharmaceutical sales
depend in part on the availability of reimbursement from third-party payers,
such as government health administration authorities, private health insurers
and other organizations. These organizations are increasingly challenging the
prices charged for medical products and services, particularly where they
believe that there is only an incremental therapeutic benefit which does not
justify the additional cost. Coverage and reimbursement may not be available for
our proposed products or, if available, may not be adequate.
There has been a trend to propose and enact government reforms intended to
contain or reduce the cost of health care. In certain foreign markets, pricing
or profitability of prescription pharmaceuticals is subject to government
control. In the United States, there have been a number of federal and state
proposals to implement similar government control.
We expect this reform trend to continue, but we cannot predict the nature
or extent of any reform that results. It is possible that reform could impact
pharmaceutical marketing and pricing. Not only would this affect our profit
margin, it could adversely affect our ability to obtain financing for the
continued development of our proposed products. Furthermore, reforms could have
a broader impact by limiting overall growth of health care spending, such as
Medicare and Medicaid spending, which could also adversely effect our business.
OUR STOCK PRICE IS EXTREMELY VOLATILE DUE TO A NUMBER OF FACTORS, CERTAIN OF
WHICH ARE BEYOND OUR CONTROL.
The market prices for securities of biopharmaceutical and biotechnology
companies, including ours, have
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historically been highly volatile. Future events affecting our business or that
of our competitors may significantly impact our stock price, including:
. product testing results,
. technological innovations,
. new commercial products,
. government regulations,
. proprietary rights,
. regulatory actions, and
. litigation.
WE MAY BE SUBJECT TO YEAR 2000 COMPLIANCE RISKS WHICH COULD ADVERSELY AFFECT OUR
BUSINESS.
We use computers in various aspects of our business, and are therefore
exposed to Year 2000 ("Y2K") problems. In mid-1998, we initiated a compliance
program with the following objectives:
. identifying potentially non-compliant internal systems;
. updating and/or replacing aging hardware;
. upgrading or updating software/network systems;
. assuring company-wide Y2K compliance;
. assessing third-party risks; and
. establishing contingency plans for any third-party risks identified.
We have identified, through internal testing and discussions with
significant vendors, that some administrative computers and software, as well as
some laboratory systems used for research, are not Y2K compliant. In order to
make these systems compliant, we have elected to replace hardware or upgrade
softwaresystems. We expect to have critical internal systems and computers Y2K
compliant by November 1, 1999 at a cost of less than $100,000. Replacements and
upgrades of certain computers and systems would likely have been considered
independent of Y2K concerns.
We are in the process of contacting significant vendors to determine the
extent of third-party Y2K risks. Most third-parties have advised us that they
will make every effort to be compliant prior to December 31, 1999; however, no
assurances could be given. We have important third-party relationships with
sales and marketing partners, manufacturers and clinical study administrators.
None of our contracts with these vendors address Y2K problems or their
remediation or prevention, and no assurances of compliance can be given by these
parties. We will assess contingency plans if any significant risks are
identified. Necessary contingency plans or remedies could be expensive.
In a worst case scenario, we could experience delays in receiving R&D
supplies, commercial supplies and accessing data on patients enrolled in
clinical studies. These delays could slow commercialization efforts and research
and development programs, or impact our ability to effectively manage and
monitor these programs. Our Y2K compliance program is expected to reduce our
level of uncertainty about internal Y2K problems and, in addition, about the Y2K
compliance and readiness of significant third-parties with which we conduct
business.
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THE EXERCISE OF OPTIONS AND WARRANTS AND OTHER ISSUANCES OF SHARES COULD HAVE AN
ADVERSE EFFECT ON OUR STOCK PRICE.
As of December 31, 1998, we had outstanding options to purchase an
aggregate of 3,558,000 shares of common stock at prices ranging from $0.002 per
share to $16.75 per share, of which approximately 2,022,000 were exercisable as
of such date. Also outstanding at December 31, 1998 were warrants to purchase
229,739 shares of our common stock exercisable at $8.00 per share, a warrant to
purchase 300,000 shares of our common stock, exercisable at $7.50 per share, and
warrants to purchase an aggregate of 1,030,905 shares of our common stock,
exercisable from $5.99-$8.31 per share, subject to adjustment. Exercise of
options and warrants at prices below the market price of the our common stock
could adversely affect the price of our common stock. Additional dilution may
result from the issuance of shares in connection with collaborations or
manufacturing arrangements, or in connection with other financing efforts.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares by Genentech.
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SELLING STOCKHOLDER
Prior to this offering, Genentech owned 620,540 shares of our Common Stock,
all of which are being offered hereby. Accordingly, Genentech will not own any
of our shares following completion of this offering. The shares are being
registered to permit public secondary trading of the shares, and Genentech may
offer the shares for resale from time to time. See "Plan of Distribution."
In recognition of the fact that Genentech may wish to be legally permitted
to sell its Shares when it deems appropriate, we have filed a registration
statement with the SEC with respect to the resale of the shares by Genentech
from time to time on the Nasdaq National Market or in privately-negotiated
transactions and have agreed to prepare and file such amendments and supplements
to the registration statement as may be necessary to keep the registration
statement effective until the shares are no longer required to be registered for
the sale thereof by Genentech.
We entered into an agreement with Genentech, under which we granted
Genentech certain rights to IL9. In connection with this arrangement, Genentech
purchased the shares from us in a private placement transaction.
PLAN OF DISTRIBUTION
Genentech may from time to time, in one or more transactions, sell all or a
portion of the shares on the Nasdaq National Market, in negotiated transactions,
in underwritten transactions or otherwise, at prices then prevailing or related
to the then current market price or at negotiated prices. The offering price of
the shares from time to time will be determined by Genentech and, at the time of
such determination, may be higher or lower than the market price of the shares
on the Nasdaq National Market. In connection with an underwritten offering,
underwriters or agents may receive compensation in the form of discounts,
concessions or commissions from a Selling Shareholder or from purchasers of
shares for whom they may act as agents, and underwriters may sell shares to or
through dealers, and such dealers may receive compensation in theform of
discounts, concessions or commissions from the underwriters and/or commissions
from the purchasers for whom they may act as agents. Under agreements that may
be entered into by us, underwriters, dealers and agents who participate in the
distribution of shares may be entitled to indemnification by the Company against
certain liabilities, including liabilities under the Securities Act, or to
contribution with respect to payments which such underwriters, dealers or agents
may be required to make in respect thereof. The shares may be sold directly or
through broker-dealers acting as principal or agent, or pursuant to a
distribution by one or more underwriters on a firm commitment or best-efforts
basis. The methods by which the shares may be sold include: (a) a block trade in
which the broker-dealer so engaged will attempt to
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sell the shares as agent but may position and resell a portion of the block as
principal to facilitate the transaction; (b) purchases by a broker-dealer as
principal and resale by such broker-dealer for its account pursuant to this
Prospectus; (c) ordinary brokerage transactions and transactions in which the
broker solicits purchasers; (d) privately negotiated transactions; and (f)
underwritten transactions. Genentech and any underwriters, dealers or agents
participating in the distribution of the Offered Shares may be deemed to be
"underwriters" within the meaning of the Securities Act, and any profit on the
sale of the shares by Genentech and any commissions received by any such broker-
dealers may be deemed to be underwriting commissions under the Securities Act.
When Genentech elects to make a particular offer of shares, a prospectus
supplement, if required, will be distributed which will identify any
underwriters, dealers or agents and any discounts, commissions and other terms
constituting compensation from Genentech and any other required information.
In order to comply with the securities laws of certain states, if
applicable, the Shares may be sold only through registered or licensed brokers
or dealers. In addition, in certain states, the shares may not be sold unless
they have been registered or qualified for sale in such state or an exemption
from such registration or qualification requirement is available and is complied
with.
We have agreed to pay all costs and expenses incurred in connection with
the registration under the Securities Act of the shares, including, without
limitation, all registration and filing fees, printing expenses and fees and
disbursements of counsel and our accountants. We will pay any brokerage fees and
commissions, fees and disbursements of legal counsel for Genentech and stock
transfer and other taxes attributable to the sale of the shares. We also have
agreed to indemnify Genentech and their respective officers, directors and
trustees and each person who controls (within the meaning of the Securities Act)
Genentech against certain losses, claims, damages, liabilities and expenses
arising under the securities laws in connection with this offering. Genentech
has agreed to indemnify us, our officers and directors and each person who
controls (within the meaning of the Securities Act) Magainin against any losses,
claims, damages, liabilities and expenses arising under the securities laws in
connection with this offering with respect to written information furnished to
us by such Selling Shareholder.
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LEGAL OPINION
Morgan, Lewis & Bockius LLP, Philadelphia, Pennsylvania, will pass on the
validity of the shares.
EXPERTS
The financial statements of Magainin Pharmaceuticals Inc. as of December
31, 1998 and 1997, and for each of the years in the three-year period ended
December 31, 1998 have been incorporated by reference herein in reliance upon
the report of KPMG LLP, independent certified public accountants, incorporated
by reference herein, and upon the authority of said firm as experts in
accounting and auditing.
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PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table shows the estimated expenses of the issuance and
distribution of the securities offered hereby.
Commission fee $ 317.50
Nasdaq listing fee $12,410.80
Legal fees, accounting fees and expenses $12,000.00
Total $24,728.30
==========
All of the amounts shown are estimates except for the fees payable to the
Securities and Exchange Commission and the National Association of Securities
Dealers.
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 145 of the Delaware General Corporation Law ("Section 145") permits
indemnification of directors, officers, agents and controlling persons of a
corporation under certain conditions and subject to certain limitations. Article
9 of the Company's By-Laws provides for the indemnification of directors,
officers, employees and agents of the Company to the maximum extent permitted by
the Delaware General Corporation Law. Section 145 empowers a corporation to
indemnify any person who was or is a party or is threatened to be made a party
to any threatened, pending or completed action, suit or proceeding, whether
civil, criminal, administrative or investigative, by reason of the fact that he
is or was a director, officer or agent of the corporation or another enterprise
if serving at the request of the corporation. Depending on the character of the
proceeding, a corporation may indemnify against expenses (including attorneys'
fees), judgments, fines and amounts paid in settlement actually and reasonably
incurred in connection with such action, suit or proceeding if the person
indemnified acted in good faith and in respect to any criminal action or
proceeding, had no reasonable cause to believe his conduct was unlawful. In the
case of an action by or in the right of the corporation, no indemnification may
be made with respect to any claim, issue or matter as to which such person shall
have been adjudged to be liable to the corporation unless and only to the extent
that the Court of Chancery or the court in which such action or suit was brought
shall determine that despite the adjudication of liability such person is fairly
and reasonably entitled to indemnity for such expenses which the court shall
deem proper. Section 145 further provides that to the extent a director,
officer, employee or agent of a corporation has been successful in the defense
of any action, suit or proceeding referred to above or in the defense of any
claim, issue or matter therein, he shall be indemnified against expenses
(including attorneys' fees) actually and reasonably incurred by him in
connection therewith.
The Company's By-laws permit it to purchase insurance on behalf of such
person against any liability asserted against him and incurred by him in any
such capacity, or arising out of his status a such, whether or not the Company
would have the power to indemnify him against such liability under the foregoing
provision of the By-laws.
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ITEM 16. LIST OF EXHIBITS
The exhibits filed as part of this registration statement are as follows:
EXHIBIT
NUMBER DESCRIPTION
- ------ -----------
5.1* Opinion of Morgan, Lewis & Bockius LLP regarding legality of
securities being registered.
23.1 Consent of Morgan, Lewis & Bockius LLP (included in its
opinion filed as Exhibit 5.1 hereto).
23.2* Consent of KPMG LLP
24.1 Powers of Attorney (included on signature page).
__________
* Filed herewith.
ITEM 17. UNDERTAKINGS
The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling persons of the
Registrant pursuant to its Restated Certificates of Incorporation, its By-laws,
or otherwise, the Registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy
as expressed in the Securities Act of 1933 and is, therefore, unenforceable. In
the event that a claim for indemnification against such liabilities (other than
the payment by the Registrant of expenses incurred or paid by a director,
officer or controlling person of the Registrant in successful defense of any
action, suit or proceeding) is asserted by such director, officer or controlling
person in connection with the securities being registered, the Registrant will,
unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against a public policy as expressed in the
Securities Act of 1933 and will be governed by the final adjudication of such
issue.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To include any prospectus required by section 10(a)(3) of the
Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set forth
in the registration statement;
(iii) To include any material information with respect to the plan of
distribution not previously disclosed in the registration statement or
any material change to such information in the registration statement;
Provided, however, that paragraph (I)(i) and 1(ii) do not apply if the
registration statement is on Form S-3 or Form S-8, and the information required
to be included in a post-effective amendment by those paragraphs is contained in
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<PAGE>
periodic reports filed by the registrant pursuant to section 13 or section 15(d)
of the Securities Exchange Act of 1934 that are incorporated by reference in the
registration statement.
(2) That, for the purpose of determining any liability under the Securities
Act of 1933, each such post-effective amendment shall be deemed to be a
registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the termination of the
offering.
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EXHIBIT
NUMBER DOCUMENT PAGE NUMBER
- ------- ------------------------- -----------
5.1* Opinion of Morgan, Lewis & Bockius LLP regarding
legality of Securities being registered.
23.1 Consent of Morgan, Lewis & Bockius LLP (included in its
opinion filed as Exhibit 5.1 hereto).
23.2* Consent of KPMG LLP
24.1 Powers of Attorney (included on the signature page).
______________________
* Filed herewith
<PAGE>
EXHIBIT 5.1
[Morgan, Lewis & Bockius LLP letterhead]
April 9, 1999
Magainin Pharmaceuticals Inc.
5110 Campus Drive
Plymouth Meeting, PA 19462
Re: Magainin Pharmaceuticals Inc. -- Form S-3 Registration Statement
----------------------------------------------------------------
Ladies and Gentlemen:
We have acted as counsel to Magainin Pharmaceuticals Inc., a Delaware
corporation (the "Company") in connection with the preparation of the above-
referenced Registration Statement on Form S-3 (the "Registration Statement") for
filing with the Securities and Exchange Commission pursuant to the Securities
Act of 1933, as amended (the "Act"), and the rules and regulations promulgated
thereunder.
The Registration Statement relates to 620,540 shares of the Company's Common
Stock, par value $.002 per share (the "Common Stock"). We have examined copies
of the Company's Restated Certificate of Incorporation, as amended, By-Laws,
resolutions adopted by the board of directors and such other documents, and have
made such inquiries of the Company's officers, as we have deemed relevant in
rendering this opinion. As to matters of fact, we have relied on representations
of officers of the Company. In our examination, we have assumed the genuineness
of documents submitted to us as originals and the conformity with the original
of all documents submitted to us as copies thereof.
Based upon the foregoing, we are of the opinion that the Company's Common Stock
has been validly issued, fully paid and non-assessable.
We hereby consent to the use of this opinion as Exhibit 5.1 to the Registration
Statement. In giving such consent, we do not thereby admit that we are acting
within the category of persons whose consent is required under Section 7 of the
Act or the rules or regulations of the Securities and Exchange Commission
thereunder.
Very truly yours,
/s/ Morgan, Lewis & Bockius LLP
<PAGE>
EXHIBIT 23.2
The Board of Directors
Magainin Pharmaceuticals Inc.:
We consent to the use of our report incorporated herein by reference and to the
reference to our firm under the heading "Experts" in the prospectus.
KPMG LLP
Princeton, New Jersey
April 7, 1999
