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As filed with the Securities and Exchange Commission on June 28, 1999
Registration No.333-75991
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SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
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Amendment No. 2 to
Form S-3
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
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MAGAININ PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)
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Delaware 2834 13-3445668
(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)
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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)
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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.[X]
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. [_]
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. [_]
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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SUBJECT TO COMPLETION, DATED JUNE 28, 1999
PROSPECTUS
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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.
Our common stock is quoted on the Nasdaq National Market under the
symbol "MAGN." On June 24, 1999 the last reported closing price of our
common stock was $1.8125 per share.
Investing in the shares involves risks. Please refer to the Risk
Factors section beginning 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 June 28, 1999
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TABLE OF CONTENTS
Page
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About this Prospectus................ 3
Our Company.......................... 4
Risk Factors......................... 6
Forward-Looking Statements........... 16
Where You Can Find More Information.. 16
Use of Proceeds...................... 18
Selling Stockholder.................. 18
Plan of Distribution................. 18
Legal Opinion........................ 20
Experts.............................. 20
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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.
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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:
o Host-Defense Drug Discovery-we isolate and develop therapeutically active
compounds from the host defense systems of animals. Our first class of
compounds, the 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.
o Asthma Genomics-we employ a range of techniques to identify genes associated
with the disease process 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 peptide
antibiotics. Discovered in the skin of the African clawed frog, these magainin
peptides 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, which we formerly referred to as Cytolex, is a topical
cream antibiotic and 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 provide more specific details about our
plans for pexiganan acetate.
In February 1997, we entered into a development, supply and distribution
agreement with SmithKline Beecham 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. Aminosterols are a novel class of small molecules that were 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 of these 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 properties may have application in the
treatment of disease indications characterized by cell
4
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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 II clinical testing of squalamine in patients with
non-small cell lung cancer.
Asthma Genomics
In 1996, we initiated a research program in the genomics of asthma.
Genomics is the study of the effects that genes have on biological processes,
and by studying the genome we are hoping to better understand and treat asthma.
These efforts led to the identification of IL9, a gene that varies in DNA
structure and function in asthmatic and allergic humans and animals. We
maintain a research and development program to identify additional genes that
may play a role in asthma. The IL9 receptor has been discovered in humans as
another candidate gene responsible for asthma, and we have also identified other
genes that may impact asthma. 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. 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.
The Negative Advisory Committee Recommendation May Result in the FDA Denying
Approval for Pexiganan Acetate, Which Would Harm Our Business.
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 provide more specific details about our
plans for pexiganan acetate.
The FDA generally follows the recommendations of its advisory committee in
granting or withholding approval of new drug applications, or NDA's. As a
result, we may not receive marketing approval of pexiganan acetate. This would
negatively impact our ability to generate revenues in the near future. 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.
Our 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. Our
equivalence trial is meant to demonstrate that pexiganan acetate is as effective
as ofloxacin treatment in the treatment of infection in diabetic foot ulcers.
Our 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, which is a combination of clinical and
overall microbiological cures. These endpoints were analyzed over a number of
patient cohorts and timepoints. Our 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 for conducting
clinical trials of this nature have evolved since the commencement of these
studies.
The principal concerns of the advisory committee included:
o the design of our clinical studies, in that we compared our topical
antibiotic to an active control, ofloxacin, as opposed to evaluating our drug
against a placebo, or no treatment. Several committee members felt that a
placebo study should be conducted in order to best assess the efficacy of our
drug;
o difficulties prescribing physicians might have in identifying the appropriate
patient group who might benefit from pexiganan acetate; and
o less favorable results at certain data points for patients in the pexiganan
acetate group as compared to the ofloxacin group, particularly in the first
of our two clinical studies.
Several discussions have occurred with the FDA since the March 1999 advisory
committee meeting. The issues raised at the advisory committee meeting have been
discussed, and we have provided responses to additional questions and requests
put forth by the FDA.
The FDA has not yet rendered a decision as to the approvability of pexiganan
acetate, or in the absence of approval, those additional development activities
that will be necessary to gain approval. We expect such a decision no later than
July 24, 1999, the one year anniversary of the filing of our NDA application.
In the event pexiganan acetate is not approved, we will need to consider
the feasibility of continuing the program,
6
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including the time and expense involved in conducting additional development
activities, and our ability to finance these activities. We are awaiting
specific feedback from the FDA before making these decisions. Additional
development activities may be required by the FDA in both the clinical and
manufacturing areas and may be expensive and time consuming. These activities
will be largely incremental to our already existing needs to invest in
alternative manufacturing processes for pexiganan acetate.
Even if the FDA does approve our product, they may place certain
restrictive conditions on the approval concerning the breadth of approved use,
manufacturing requirements or the necessity of post-marketing clinical studies.
These conditions could reduce the sales potential, delay market launch, require
substantial additional investment or reduce the profitability of pexiganan
acetate and may affect its commercial viability.
If We Do Not Gain Marketing Approval for Pexiganan Acetate and Our Other
Products, We Will Continue to Incur Substantial Losses and Continue to Have
Negative Results of Operations.
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 March 31, 1999, we had
an accumulated deficit of approximately $136.1 million.
Most of our proposed products are in a relatively early developmental stage
and will require significant research, development and testing. We must obtain
regulatory approvals for all of our proposed products prior to commercialization
of the product. Our operations are also subject to various competitive and
regulatory risks. As a result, we are unable to predict when or if we will
achieve any product revenues. We expect to experience substantial losses in the
foreseeable future as we continue our significant research, development and
testing efforts, which will cause us to have continued negative results of
operations.
If We Do Not Raise Additional Capital, We May Not be Able to Continue Our
Research and Development Programs and May Never Commercialize Any Products.
We will need to raise substantial additional funds in the near future 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 maintained cash and investments of $18.9 million at March 31, 1999. At
March 31, 1999, we had current liabilities of $10.2 million. In the absence of
raising additional funds or significantly reducing expenses, we do not have
sufficient resources to sustain operations beyond 1999.
We regularly explore alternative means of financing our operations and
intend to seek additional funding through various sources, including:
o public and private securities offerings;
o collaborative, licensing and other arrangements with third parties; and
o 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. If we engage in collaborations, we will receive lower
consideration upon commercialization of such products than if we had not entered
into such arrangements, or if we entered into such arrangements at later stages
in the product development process.
7
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If We Do Not Develop and Maintain Relationships With Contract Manufacturers, We
May Not Successfully Commercialize Our Products.
1) Contract Manufacturing:
We currently have neither the resources, facilities nor 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
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 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.
2) Abbott Laboratories:
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.
We have an arrangement with Abbott Laboratories that initially provides for
the purchase of approximately $10 million of bulk drug substance for pexiganan
acetate. Since FDA approval of pexiganan acetate has not occurred, we have
recorded charges to research and development expense relating to this contract.
Through March 1999, we paid Abbott $656,000 under this arrangement, and we
expect to make additional payments in the remainder of 1999 and 2000.
Our prior development arrangement with Abbott provided for our issuance to
Abbott of up to 500,000 shares of our Common Stock and the obligation to pay a
royalty on any future sales of pexiganan acetate. When we issued stock to Abbott
we were required to record a charge to earnings representing the fair value of
the shares when issued. As of March 31, 1999, we have issued 250,000 shares of
common stock to Abbott. Possible future stock issuances are related to the
achievement by Abbott of contractual performance milestones.
3) Alternative Production Processes:
The production of peptides, such as pexiganan acetate and other magainin
peptides, 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-
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effective manufacturing process and, even if we develop a more cost-effective
process, the FDA may not approve such a process.
4) Alternative Future Uses of Pexiganan Acetate:
There are no currently identified alternative uses of bulk drug substance
for pexiganan acetate.
We Rely on Our Marketing and Development Partners and if They Do Not Perform as
Expected, We May Not Successfully Commercialize Our 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 and distribution arrangements with third parties. We also expect
to delegate the responsibility for all or a significant portion of the
development and regulatory approval for certain products to partners. If our
partners do not develop an approvable or marketable product or do not market a
product successfully, we may not achieve necessary product revenues.
Additionally, we may be unable to enter into successful arrangements like these,
as is required in our business.
We maintain two collaborative relationships at the current time. We have
entered into a development, supply and distribution agreement with SmithKline
Beecham in North America for pexiganan acetate, and a collaborative research
and option agreement with Genentech in the asthma area.
SmithKline may terminate our agreement with them at any time. If they
terminate our agreement, we would have difficulty finding an alternate partner
that could market our product as effectively as SmithKline. Our sales and
profits could suffer if SmithKline terminated our agreement. Future milestone
payments and sales proceeds from SmithKline occur only in the event that
pexiganan acetate is approved.
Genentech may choose not to exercise its option to negotiate a fuller asthma
development and commercialization agreement with us. We will need partners in
this area to assist us, and we may be unable to enter into a similar agreement
or find as effective a partner. Without support from partners in this area, our
development and commercialization efforts would suffer.
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. SmithKline maintains a significant
presence in the antibiotic area and currently sells a topical antibiotic product
indicated for the treatment of certain skin infections.
We may also decide to establish our own sales force to market and sell
certain 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. Given our
inexperience in establishing and managing a salesforce, this effort may not be
successful. With our modest financial resources, efforts in this area would be
modest compared to our competitors.
If Pexiganan Acetate Does Not Achieve Market Acceptance, We May Not Achieve Any
Significant Revenues.
Even if we receive regulatory approval for pexiganan acetate, we may be
unable to achieve market acceptance of the drug. Without market acceptance, we
may be unable to generate revenue levels necessary for profitability.
A number of factors may affect market acceptance of pexiganan acetate,
including:
o the perception by physicians and other members of the health care
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community of the safety and efficacy of pexiganan acetate on an absolute basis
or in comparison to other drugs;
o the price of pexiganan acetate relative to other competing treatment
alternatives;
o the availability of third-party reimbursement; and
o 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 payer acceptance.
If We Do Not Obtain Required Regulatory Approvals, We Will Not Be Able 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:
o warning letters;
o fines;
o withdrawal of regulatory approval;
o product recalls;
o operating restrictions;
o injunctions; and
o criminal prosecution.
1) FDA Marketing Approval:
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 Application, IND. 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 NDA, the FDA may:
o grant marketing approval;
o require additional testing or information; or
o deny the application.
2) FDA Manufacturing Approval:
Detailed manufacturing information is also required to be included in the
NDA for review and approval by the FDA. All manufacturing facilities 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
processes. Among other things, it must be demonstrated that:
o the drug product can be consistently manufactured at the same quality
standard;
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o the drug product is stable over time; and
o 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.
Manufacturing inspections must be successfully conducted and completed
prior to any FDA approval of pexiganan acetate. The FDA's review of
manufacturing for pexiganan acetate is on-going. Inspections have been carried
out at our facility and at our contract manufacturers. The FDA has issued
observations of failures to comply with good manufacturing practices. We have
submitted responses to these observations, which are considered by the FDA in
their continuing review of the approvability of pexiganan acetate. The FDA may
require corrective actions to be taken, or additional studies to be undertaken,
which may prevent or delay the commercialization of pexiganan acetate.
3) Ongoing FDA Oversight:
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:
o require additional submissions if there are any modifications to the drug
product including, for example, any changes in manufacturing process, labeling,
or manufacturing facility;
o require post-marketing testing and surveillance to monitor the effects of
approved drug products; and
o 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.
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.
4) Other Regulatory Bodies:
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 drug products. Although some of these changes could
streamline and otherwise benefit development, marketing and related requirements
for drugs, others could increase regulatory requirements.
If We Are Not Able to Innovate and Develop Products as Rapidly as Our
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Competitors, Our Products may Not Achieve Market Acceptance.
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 such products. 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.
We Depend on Our Intellectual Property and If We Are Unable to Protect Our
Intellectual Property, We May Not Realize Optimal Value from Our Technology.
1) Patents:
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. Without patent and other protections, other companies
could offer substantially identical products for sale without incurring the
sizeable development and testing costs that
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we have incurred. Our ability to recoup these expenditures and profit could be
diminished.
We cannot be certain that:
o patents will issue from any of these patent applications;
o our patent rights will be sufficient to protect our technology;
o our patents will not be successfully challenged or circumvented by our
competitors; or
o 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:
o others will not develop similar technologies or duplicate the technology;
o others will not design around the patented aspects of the technology;
o we will not be obliged to defend ourselves in court against allegations of
infringement of third-party patents;
o our issued patents will be held valid in court; and
o 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
us to cease using such technology.
The cost of litigation can be substantial, regardless of the outcome.
2) Potential Ownership Disputes:
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 disputes as to the capacity in which consultants
-
are operating when they make certain discoveries. We may not prevail in any
such disputes.
3) Other Intellectual Property:
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 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.
If We Cannot Recruit and Retain Qualified Management, We May Not Be Able to
Successfully Develop and Commercialize Our Products.
<PAGE>
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 management and technical personnel could adversely affect
our ability to develop and commercialize products.
We are Subject to Product Liability Claims, Which Could result in Significant
Expense if a Claim Arose.
We are subject to significant potential product liability risks inherent in
the testing, manufacturing and marketing of human therapeutic products,
including the risk that:
o our proposed products cause some undesirable side effects or injury during
clinical trials;
o our commercialized products cause undesirable side effects or injury; or
o third parties that we have agreed to indemnify incur liability.
While we carry insurance, this coverage is expensive and we may be unable
to maintain adequate coverage at acceptable terms.
If We Do Not Receive Adequate Third-Party Reimbursement for Any of Our Drug
Candidates, Some Patients May Be Unable to Afford Our Products, and Sales Could
Suffer.
In both the United States and elsewhere, the availability of reimbursement
from third-party payers, such as government health administration authorities,
private health insurers and other organizations impacts prescription
pharmaceutical sales. 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. Without
insurance coverage, many patients may be unable to afford our products, and we
may not reach optimal sales levels.
There has also been a trend toward 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
margins, 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.
The market prices and trading volumes for securities of biopharmaceutical and
biotechnology companies, including ours, have historically been, and may
continue to be, highly volatile. Future events affecting our business or that
of our competitors may significantly impact our stock price, including:
o product testing results,
o technological innovations,
o new commercial products,
o government regulations,
o proprietary rights,
o regulatory actions, and
o litigation.
<PAGE>
Some of they factors are beyond our control.
We May be Subject to Year 2000 Compliance Risks, Which Could Disrupt Our
-
Operations and the Operations of Our Collaborators.
We use computers in various aspects of our business, and are therefore
exposed to Year 2000, Y2K, problems. If unresolved, these computer system
problems could result in operational delays, financial miscues, manufacturing
errors, lost clinical data or other unforeseen consequences. In mid-1998, we
initiated a compliance program with the following objectives:
o identifying potentially non-compliant internal systems;
o updating and/or replacing aging hardware;
o upgrading or updating software/network systems;
o assuring company-wide Y2K compliance;
o assessing third-party risks; and
o 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
software systems. We expect to have critical internal systems and computers Y2K
compliant by November 1, 1999 at a cost of less than $100,000. We would likely
have considered replacing or upgrading certain computers and systems 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,
these third-parties could not provide us with assurances that they will be
compliant on a timely basis. 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 continue to monitor the progress of these third-party vendors
and will adjust our 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.
The Exercise of Options and Warrants and Other Issuances of Shares Could have
Dilutive Effect on Our Stock Price.
As of December 31, 1998, there were outstanding options to purchase an
aggregate of 3,588,000 shares of our 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
<PAGE>
collaborations or manufacturing arrangements, or in connection with other
financing efforts.
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 unanticipated occurrences
besides those listed here could also adversely affect us. This discussion is
provided as permitted by the Private Securities Litigation Reform Act of 1995.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other
information with the Securities and Exchange Commission, 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
<PAGE>
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:
o Our Annual Report on Form 10-K for the year ended December 31, 1998, SEC file
000-19651;
o Our Current Report on Form 8-K filed with the SEC on January 7, 1999, SEC
file 000-19651;
o Our Current Report on Form 8-K filed with the SEC on March 15, 1999, SEC file
000-19651;
o Our Quarterly Report on Form 10-Q for the three months ended March 31, 1999,
SEC file 000-19651; and
o 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, SEC files 33-43579 and 000-19651 respectively.
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.
<PAGE>
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares by Genentech.
SELLING STOCKHOLDER
Prior to this offering, Genentech owned 620,540 shares of our
Common Stock, all of which are being offered for registration at this
time. 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
We will receive no proceeds of any sales of the shares, but will
incur expenses in connection with the offering. 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 here or in the 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 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 the form 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 us 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:
<PAGE>
o a block trade in which the broker-dealer so engaged will attempt to
sell the shares as agent but may position and resell a portion of the
block as principal to facilitate the transaction;
o purchases by a broker-dealer as principal and resale by such
broker-dealer for its account pursuant to this prospectus;
o ordinary brokerage transactions and transactions in which the
broker solicits purchasers;
o privately negotiated transactions; and
o 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 these 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"
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 Genentech.
<PAGE>
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 in this prospectus and in
the registration statement in reliance upon the report of KPMG LLP, independent
certified public accountants, incorporated by reference in this prospectus and
in the registration statement, and upon the authority of KPMG LLP as experts in
accounting and auditing.
<PAGE>
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.
<TABLE>
<S> <C>
Commission fee...................................................... $317.50
Nasdaq listing fee.................................................. $12,410.80
Legal fees, accounting fees and expenses............................ $22,000.00
Total..................................................... $34,728.30
==========
</TABLE>
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.
<PAGE>
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.
** Previously filed.
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
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.
<PAGE>
(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.
<PAGE>
SIGNATURES AND POWER OF ATTORNEY
Pursuant to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned thereunto duly
authorized, in Plymouth Meeting, Pennsylvania, on this 28th day of June, 1999.
MAGAININ PHARMACEUTICALS INC.
BY: /s/ Michael R. Dougherty
----------------------------------
Michael R. Dougherty
President, Chief Executive Officer, and
Chief Financial Officer and Director
<TABLE>
<CAPTION>
Signature Title Date
_________ _____ ____
<S> <C> <C>
/s/Zola P. Horovitz, Ph.D.* Chairman of the Board June 28, 1999
- ----------------------------------
Zola P. Horovitz, Ph.D.
/s/Bernard Canavan, M.D.* Director June 28, 1999
- ----------------------------------
Bernard Canavan, M.D.
/s/Michael R. Dougherty* President, Chief Executive Officer, Chief June 28, 1999
- ---------------------------------- Financial Officer and Director
Michael R. Dougherty (Principal Executive, Financial and Accounting
Officer)
/s/Roy C. Levitt, M.D.* Chief Operating Officer and Director June 28, 1999
- ----------------------------------
Roy C. Levitt, M.D.
/s/Charles A. Sanders, M.D.*
- ---------------------------------- Director June 28, 1999
Charles A. Sanders, M.D.
/s/Robert F. Shapiro* Director June 28, 1999
- ----------------------------------
Robert F. Shapiro
/s/James B. Wyngaarden, M.D.* Director June 28, 1999
- ----------------------------------
James B. Wyngaarden M.D.
/s/Michael A. Zasloff, M.D., Vice Chairman, Executive Vice President and June 28, 1999
Ph.D.* Director
- ----------------------------------
Michael A. Zasloff, M.D., Ph.D.
</TABLE>
* Signed by Michael R. Dougherty as true and lawful power of attorney.
<PAGE>
<TABLE>
<CAPTION>
Exhibit
Number Document
- --------- --------------------
<S> <C>
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).
__________
</TABLE>
* Filed herewith.
** Previously filed.
<PAGE>
Exhibit 23.2
Consent of Independent Certified Public Accountants
---------------------------------------------------
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
June 28, 1999
